CLM 104 C 30

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Medicare Claims Processing Manual

Chapter 30 - Financial Liability Protections


Table of Contents
(Rev. 11210, 01-21-22)

Transmittals for Chapter 30


10 - Financial Liability Protections (FLP) Provisions
20 - Limitation On Liability (LOL) Under §1879 Where Medicare Claims Are Denied
20.1 - LOL Coverage Denials to Which the Limitation on Liability Applies
20.2 - Denials When the LOL Provision Does Not Apply
20.2.1 - Categorical Denials
30 - Determining Liability for Disallowed Claims Under §1879
30.1 - Beneficiary’s Knowledge and Liability
30.1.1 - Other Evidence of Knowledge
30.2 - Healthcare Provider or Supplier Knowledge and Liability
30.2.1 - Evidence of Healthcare Provider or Supplier Knowledge
30.2.2 - Medical Record Evidence of Healthcare Provider or Supplier
Knowledge
30.2.3 - Acceptable Standards of Practice
30.3 – The Right to Appeal
30.4 - Fraud, Abuse, Patently Unnecessary Items and Services
40 - Written Notice as Evidence of Knowledge
40.1 - Sources of Written Notice
40.2 - Written Notice Standards
40.2.1 - Other Written Notice Standards
40.2.2 - Written Notice Special Considerations
40.3 - Medical Emergency or Otherwise Under Great Duress Situations
40.4- Emergency Medical Treatment and Active Labor Act (EMTALA)
Situations
50 - Advance Beneficiary Notice of Non-coverage (ABN)
50.1 - ABN Scope
50.2 - ABN Uses
50.2.1 - Optional ABN Uses
50.3 - Issuance of the ABN
50.4 - ABN Triggering Events
50.5 - ABN Standards
50.6 - Completing the ABN
50.7 - Retention Requirements
50.8 - ABN Delivery Requirements
50.8.1 – Options for Delivery Other than In-Person
50.9 - Effects of Lack of Notification, Medicare Review and Claim Adjudication
50.10 - Using ABNs for Medical Equipment and Supplies Claims When Denials
Under §1834(a)(17)(B) of the Act (Prohibition Against Unsolicited Telephone
Contacts) Are Expected
50.11 - ABNs for Medical Equipment and Supplies Claims Denied Under
§1834(j)(1) of the Act (Because the Supplier Did Not Meet Supplier Number
Requirements)
50.12 - ABNs for Claims Denied in Advance Under §1834(a)(15) of the Act
50.13 - ABN Standards for Upgraded Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS)
50.14 - ABNs for items listed in a DMEPOS Competitive Bidding Program
(CBP)
50.15 - Collection of Funds and Refunds
50.15.1 - Physicians’ Services RR
50.15.2 - DMEPOS RR Provision for Claims for Medical Equipment and
Supplies
50.15.3 - Time Limits and Penalties for Healthcare Providers and
Suppliers in Making Refunds
50.15.4 - Supplier’s Right to Recover Resalable Items for Which Refund
Has Been Made
50.16 - CMS Regional Office (RO) Referral Procedures
50.17 - ABN Special Considerations
60 - Home Health Change of Care Notice (HHCCN), Form CMS-10280
60.1 - Background on the HHCCN
60.2 - Scope of the HHCCN
60.3 - Triggering Events for HHCCN/ Written Notice
60.4 - Completing the HHCCN
60.5 - HHCCN Delivery
70 - Skilled Nursing Facility Advance Beneficiary Notice of Non-coverage (SNF ABN)
70.1 - SNF ABN Standards
70.2 - Situations in Which a SNF ABN Should Be Given
70.3 - Situations in Which a SNF ABN Is Not Needed to Transfer Financial Liability to
the Beneficiary
70.4 - SNF ABN Specific Delivery Issues
70.5 - Special Rules for SNF ABNs
70.6 - Establishing When Beneficiary Is On Notice of Non-coverage
70.6.1 - Source of Beneficiary Notification
80 - Hospital ABNs (Hospital-Issued Notices of Noncoverage - HINN)
100 - Indemnification Procedures for Claims Falling Within the Limitation on Liability
Provision
100.1 - Contractor and Social Security Office (SSO) Responsibility in
Indemnification Claims
100.2 - Conditions for Indemnification
100.3 - Development and Documentation of Indemnification Requests
100.3.1 - Proof of Payment
100.4 - Beneficiary Requests Indemnification, but Had No Financial Interest in
the Claim
100.5 - Questionable Indemnification Requests Procedure
100.6 - Determining the Amount of Indemnification
100.7 - Notifying the Provider, Practitioner, or Supplier
100.8 - Making Payment Under Indemnification
100.9 - Limitation on Liability Determination Does Not Affect Medicare
Exclusion
100.10 - Exhibits
Exhibit 1 - Letter to Provider
Exhibit 2 - Letter to Beneficiary Who Requests Indemnification
Exhibit 3 - Letter to Someone Other Than Beneficiary Who Requests
Indemnification
Exhibit 4 - Letter to Practitioner or Supplier (Noninstitutional Services)
Exhibit 5 - Letter to Beneficiary Who Requests Indemnification
(Noninstitutional Services)
Exhibit 6 - Letter to Someone Other Than Beneficiary Who Requests
Indemnification (Noninstitutional Services)
Exhibit 7 - Statement of Claimant or Other Person
110 - Contractor Instructions for Application of Limitation On Liability
110.1 - Payment Under Limitation on Liability
110.2 - When to Make Limitation on Liability Decisions
110.3 - Preparation of Denial Notices
110.4 - Bill Processing
110.5 - Contractor Review of ABNs
110.5.1 - General Rules
110.5.2 - Situations in Which Contractor Review of ABNs is Indicated
110.5.3 - Other Reasons for Contractor Request for Copies of ABNs
120 - Contractor Specific Instructions for Application of Limitation on Liability
120.1 - Documentation of Notices Regarding Coverage
120.2 - Availability of Coverage Notices to Operating Personnel
120.3 - Applicability of Limitation on Liability Provision to Claims for Outpatient
Physical Therapy Services Furnished by Clinics
120.4 - Limitation on Liability Notices to Beneficiaries From Contractors
120.5 - Contractor Redeterminaions or Reconsiderations in Assignment Cases
Conducted at the Request of Either the Beneficiary or the Assignee
120.5.1 - Guide Paragraphs for Contractors to Use Where §1879 Is
Applicable at Redetermination Level
130 - A/B MAC (A) and (HHH) Specific Instructions for Application of Limitation on
Liability
130.1 - Applicability of the Limitation on Liability Provision to Claims for
Ancillary, Outpatient Provider and Rural Health Clinic Services Payable Under
Part B
130.1.1 - Determining Beneficiary Liability in Claims for Ancillary and
Outpatient Services
130.1.2 - Determining Provider Liability in Claims for Ancillary and
Outpatient Services
130.2 - Prior Hospitalization and Transfer Requirements for SNF Coverage as
Related to Limitation on Liability
130.3 - Application of Limitation on Liability to SNF and Hospital Claims for
Services Furnished in Noncertified or Inappropriately Certified Beds
130.4 - Determining Liability for Services Furnished in a Noncertified SNF or
Hospital Bed
140 - Physician Refund Requirements (RR) Provision for Nonassigned Claims for
Physicians Services Under §1842(l) - Instructions for Contractors and Physicians
140.1 - Services Furnished Before October 1, 1987
140.2 - Services Furnished Beginning October 1, 1987
140.3 - Time Limits for Making Refunds
140.4 - Situations Where a Refund Is Not Required
140.5 - Appeal Rights
140.6 - Processing Initial Denials
140.6.1 - Initial Beneficiary Notices
140.6.2 - Initial Physician Notices
140.7 - Processing Beneficiary Requests for Appeal
140.8 - Processing Physician Requests for Appeal
140.8.1 - Appeal of the Denial or Reduction in Payment
140.8.2 - Beneficiary Given ABN and Agreed to Pay
140.8.3 - Physician Knowledge
140.9 - Guide Paragraphs for Inclusion in Appeal Determination
140.10 - Physician Fails to Make Refund
140.11 - OIG Referral Procedures
140.12 - Imposition of Sanctions
150 - DMEPOS Refund Requirements (RR) Provision for Claims for Medical Equipment
and Supplies under §§1834(a)(18), 1834(j)(4), and 1879(h) - Instructions for Contractors
and Suppliers
150.1 - Definition of Medical Equipment and Supplies
150.1.1 - Unassigned Claims Denied on the Basis of the Prohibition on
Unsolicited Telephone Contacts
150.1.2 - Unassigned Claims Denied on the Basis of Not Being
Reasonable and Necessary
150.1.3 - Unassigned Claims Denied on the Basis of Failure of the
Supplier to Meet Supplier Number Requirements
150.1.4 - Assigned Claims Denied on the Basis of the Prohibition on
Unsolicited Telephone Contacts
150.1.5 - Assigned Claims Denied on the Basis of Failure of the Supplier
to Meet Supplier Number Requirements
150.1.6 - Assigned Claims Denied on the Basis of Not Being Reasonable
and Necessary
150.2 - Items and Services Furnished on an Unassigned Basis on or After January
1, 1995
150.3 - Items and Services Furnished On an Assigned Basis On or After January
1, 1995
150.4 - Time Limits for Making Refunds
150.5 - Supplier Knowledge Standards for Waiver of Refund Requirement
150.5.1 - Knowledge Standards for §1862(a)(1) Denials
150.5.2 - Knowledge Standards for §1834(a)(15) Denials
150.5.2.1 - Denial of Payment in Advance
150.5.2.2 - When a Request for an Advance Determination of
Coverage Is Mandatory
150.5.2.3 - When a Request for an Advance Determination of
Coverage Is Optional
150.5.2.4 - Presumption for Constructive Notice
150.5.2.5 - Presumption When Advance Determination was
Requested
150.5.2.6 - Presumption for Listed Overutilized Items
150.5.2.7 - Presumption for Listed Suppliers
150.5.2.8 - Presumption for Medical Necessity
150.5.2.9 - Presumption About Beneficiary Knowledge
150.5.3 - Knowledge Standards for §1834(a)(17)(B) Denials
150.5.4 - Knowledge Standards for §1834(j)(1) Denials
150.5.5 - Additional Knowledge Standards for All Medical Equipment and
Supplies Denials
150.6 - Advance Beneficiary Notice Standards for Waiver of Refund Requirement
150.7 - Appeal Rights
150.8 - Processing Initial Denials
150.9 - Processing Beneficiary Requests for Appeal
150.10 - Processing Supplier Requests for Appeal
150.10.1 - Appeal of the Denial of Payment
150.10.2 - Beneficiary Given Advance Beneficiary Notice and Agreed to
Pay
150.10.3 - Supplier Knowledge
150.11 - Guide Paragraphs for Inclusion in Appeal Determination
150.12 - Supplier Fails to Make Refund
150.13 - CMS Regional Office (RO) Referral Procedures
150.14 - Imposition of Sanctions
150.15 - Supplier’s Right to Recover Resaleable Items for Which Refund Has
Been Made
200 - Expedited Determinations of Inpatient Hospital Discharges
200.1- Statutory Authority
200.2 - Scope
200.2.1 - Exceptions
200.3 - Important Message from Medicare (IM)
200.3.1 - Alterations to the IM
200.3.2 - Completing the IM
200.3.3 - Hospital Delivery of the IM
200.3.4 - Required Delivery Timeframes
200.3.4.1 First IM
200.3.4.2 Follow-up copy of the IM
200.3.5 - Refusal to Sign the IM
200.3.6 - Amending the Date of the IM
200.3.7 - IM Delivery to Representatives
200.3.8 - Notice Retention for the IM
200.4 - Expedited Determination Process
200.4.1 - Beneficiary Responsibilities
200.4.1.1 - Timeframe for Requesting an Expedited Determination
200.4.1.2 - Provide Information to BFCC-QIO
200.4.2 - Beneficiary Liability During BFCC-QIO Review
200.4.3 - Untimely Requests for Review
200.4.4 - Hospital Responsibilities
200.4.5 - The Detailed Notice of Discharge (DND)
200.5 - BFCC-QIO Responsibilities
200.5.1 - Receive Beneficiary Requests for Expedited Review
200.5.2 - Notify Hospitals and Allow Explanation of Why Covered
Services Should End
200.5.3 - Validate Delivery of IM
200.5.4 - Solicit the Views of the Beneficiary
200.5.5 - Solicit the Views of the Hospital
200.5.6 - Make Determination and Notify Required Parties
200.6 - Effect of a BFCC-QIO Expedited Determination
200.6.1 - Right to Pursue an Expedited Reconsideration
200.6.2 - Effect of BFCC-QIO Determination on Continuation of Care
200.6.3 - Right to Pursue the Standard Claims Appeal Process
220 - Hospital Requested Expedited Review
220.1 - Responsibilities of the Hospital
220.2 - Responsibilities of the QIO
220.3 - Effect of the Hospital Requested Expedited Determination
220.4 - General Notice Requirements
220.5 - Exhibit 3 - Model Language Notice of Hospital Requested Review (HRR)
240 - Preadmission/Admission Hospital Issued Notice of Noncoverage (HINN)
240.1 - Delivery of the Preadmission/Admission HINN
240.2 - Notice Delivery Timeframes and Liability
240.3 - Timeframes for Submitting a Request for a QIO Review
240.4 - Results of the QIO Review
240.5 - Effect of the QIO Review
240.6 - Exhibit 4 - Model Language Preadmission/Admission Hospital Issued
Notice of Noncoverage
260 - Expedited Determinations of Provider Service Terminations
260.1 - Statutory Authority
260.2 - Scope
260.2.1 - Exceptions
260.3 - Notice of Medicare Non-Coverage
260.3.1 - Alterations to the NOMNC
260.3.2 - Completing the NOMNC
260.3.3 - Provider Delivery of the NOMNC
260.3.4 - Required Delivery Timeframes
260.3.5 - Refusal to Sign the NOMNC
260.3.6 - Financial Liability for Failure to Deliver a Valid NOMNC
260.3.7 - Amending the Date of the NOMNC
260.3.8 - NOMNC Delivery to Representatives
260.3.9 - Notice Retention for the NOMNC
260.3.10- Hours of NOMNC Delivery
260.4 - Expedited Determination Process
260.4.1 - Beneficiary Responsibilities
260.4.1.1 - Timeframe for Requesting an Expedited Determination
260.4.1.2 - Provide Information to QIO
260.4.1.3 - Obtain Physician Certification of Risk (Home Health
and CORF services only)
260.4.2 - Beneficiary Liability During QIO Review
260.4.3 - Untimely Requests for Review
260.4.4 - Provider Responsibilities
260.4.5 - The Detailed Explanation of Non-Coverage
260.5 - QIO Responsibilities
260.5.1 - Receive Beneficiary Requests for Expedited Review
260.5.2 - Notify Providers and Allow Explanation of Why Covered
Services Should End
260.5.3 -Validate Delivery of NOMNC
260.5.4 - Solicit the Views of the Beneficiary
260.5.5 - Solicit the Views of the Provider
260.5.6 - Make Determination and Notify Required Parties
260.6 - Effect of a QIO Expedited Determination
260.6.1 - Right to Pursue an Expedited Reconsideration
260.6.2 - Effect of QIO Determination on Continuation of Care
260.6.3 - Right to Pursue the Standard Claims Appeal Process
261 - Expedited Determination Notice Association with Advance Beneficiary Notices
300 - Expedited Reconsiderations
300.1 - The Role of the Beneficiary and Liability
300.2 - The Responsibilities of the IRE
300.3 - The Responsibilities of the QIO
300.4 - The Responsibilities of the Provider
300.5 - Coverage During an Expedited Reconsideration
400 - Part A Medicare Outpatient Observation Notice
400.1 - Statutory Authority
400.2 - Scope
400.3 - Medicare Outpatient Observation Notice
400.3.1 - Alterations to the MOON
400.3.2 - Completing the MOON
400.3.3 - Hospital Delivery of the MOON
400.3.4 - Required Delivery Timeframes
400.3.5 - Refusal to Sign the MOON
400.3.6 - MOON Delivery to Representatives
400.3.7 - Ensuring Beneficiary Comprehension
400.3.8 - Completing the Additional Information Field of the MOON
400.3.9 - Notice Retention for the MOON
400.4 - Intersection with State Observation Notices
500- Glossary
10 - Financial Liability Protections (FLP) Provisions of Title XVIII
(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

The FLP provisions of the Social Security Act (hereinafter referred to as the Act) protect
beneficiaries, healthcare providers, and suppliers under certain circumstances from
unexpected liability for charges associated with claims that Medicare does not pay. The
FLP provisions apply after an item or service’s coverage determination is made. This
chapter discusses the following FLP provisions:

• Limitation On Liability (LOL) under §1879(a)-(g) of the Act.

• Refund Requirements (RR) for Non-assigned Claims for Physicians Services


under §1842(l) of the Act.

• Refund Requirements (RR) for Assigned and Non-assigned Claims for Medical
Equipment and Supplies under §§1834(a)(18), 1834(j)(4), and 1879(h) of the Act.

In most cases, the FLP provisions apply only to beneficiaries enrolled in the Original
Medicare FFS program Parts A and B.

The FLP provisions apply only when both of the following are met:

• Items and/or services are denied on the basis of specific statutory or regulatory
provisions.; and

• Involve determinations about beneficiary and/or healthcare provider/supplier


knowledge of whether Medicare was likely to deny payment for the items and/or
services.

The LOL provisions apply to all Part A services and all assigned claims for Part B
services. The RR apply to both assigned and unassigned claims for medical equipment
and supplies and to unassigned claims for physicians’ services. However, RR do not
apply to claims for Part A services.

20 - Limitation On Liability (LOL) Under §1879 Where Medicare


Claims Are Denied
(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)
In general, application of the LOL provisions depends upon two primary factors:
1. Whether the claim for the item and/or service provided was denied for certain
specific reasons. See §21 of this chapter for more examples.
Type of Denial Description Example
Statutory Basis The LOL provisions apply only Items and services found to be
to claims for items and/or not reasonable and necessary for
services submitted by healthcare the diagnosis or treatment of
providers or suppliers that have illness or injury or to improve the
Type of Denial Description Example
taken assignment, and only to functioning of a malformed body
claims for items and/or services member. (§1862(a)(1)(A) of the
not otherwise statutorily Act)
excluded, that are denied on the
basis of §1862(a)(1),
§1862(a)(9), §1879(e), or
§1879(g) of the Act.
Dependent When Medicare payment is Under §§1814(a)(2)(C) and
Services made under the LOL provisions, 1835(a)(2)(A) of the Act, home
the payment determination health aide services can be
includes claims for any covered only if a beneficiary
dependent services that are needs intermittent skilled nursing
denied as an indirect result of care. When coverage is denied
the original denial. Thus, where for intermittent skilled nursing
a particular qualifying service is services (the qualifying primary
denied as not reasonable and services) under §1862(a)(1) or
necessary under §1862(a)(1)(A) (9) of the Act, home health aide
of the Act, any dependent services (the dependent services)
services are also denied as not likewise are not covered. In such
reasonable and necessary under cases, if Medicare payment is
§1862(a)(1)(A) of the Act. If made under the LOL provision
the LOL provisions apply to the for the primary services, it would
denial of the qualifying service, be made for the dependent
it will also apply to the services as well, provided the
dependent service, and services meet all conditions for
Medicare will make payment coverage and payment (i.e. a
for both services, provided all physician’s certification of the
other conditions for coverage need for the dependent services
and payment are met. and proof that the services are
reasonable and necessary).
Higher Levels Normally, Medicare payment is A deluxe or aesthetic feature of
of Care and denied for items and/or services an upgraded item of medical
“Excess that are not reasonable and equipment is an “excess
Components” necessary on the basis of component.” Charge increases
§1862(a)(1)(A) of the Act. on the basis of purported
However, the LOL provisions premium quality services are not
may apply if a reduction in considered to be “excess
payment occurs because the components” since that would
furnished items or services are constitute circumvention of
at a higher level of care and payment limits and applicable
provide more extensive items or charging limits (e.g., limiting
services than was reasonable charges in the case of unassigned
and necessary to meet the needs claims for physicians’ services
of the beneficiary. and fee schedule amounts in the
case of assigned claims).
2. Whether the beneficiary and/or the healthcare provider or supplier knew or
could reasonably have been expected to know that the item or service was not
covered.
Knowledge of the Non- Liability Payment Responsibility
covered Item/Service
If the beneficiary knew, or Rests with the The beneficiary is responsible for
should have known (e.g. a beneficiary making payment for the usual and
valid liability notice such as customary charges to the
an ABN, Form CMS-R-131 healthcare provider or supplier
was issued and the for the denied item and/or
beneficiary consented to service.
receiving the item or service).
If the beneficiary did not Rests with the The beneficiary may not be
know (and should not have healthcare charged for any costs related to
known), and the healthcare provider or the denied item and/or service,
provider or supplier knew, or supplier including copayments and
should have known. deductibles.
If neither the beneficiary nor Neither the The Medicare program makes
the healthcare provider or beneficiary or the payment for the assigned claim.
supplier knew, and could not healthcare
reasonably be expected to provider or
have known. supplier

20.1 - LOL Coverage Denials (Rev. 1, 10-01-03)


(Rev.:4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

A. Statutory Basis

The following table provides examples of denials based on §1862(a)(1), §1862(a)(9),


§1879(e), or §1879(g) of the Act:

Statutory Provision Description


(section of the Act)
§1862(a)(1)(A) Items and services found to be not reasonable and necessary
for the diagnosis or treatment of illness or injury or to improve
the functioning of a malformed body member.
§1862(a)(1)(B) & Pneumococcal vaccine and its administration, influenza
§1861(s)(10) vaccine and its administration, and hepatitis B vaccine and its
administration furnished to an individual at high or
intermediate risk of contracting hepatitis B, that are not
reasonable and necessary for the prevention of illness.
§1862(a)(1)(C) In the case of hospice care, items and services that are not
reasonable and necessary for the palliation or management of
terminal illness.
Statutory Provision Description
(section of the Act)
§1862(a)(1)(E) Items and services that, in the case of research conducted
pursuant to §1142 of the Act, are not reasonable and necessary
to carry out the purposes of that section (which concerns
research on outcomes of health care services and procedures).
§1862(a)(1)(F) Screening mammography that is performed more frequently
than is covered under §1834(c)(2) of the Act or that is not
conducted by a facility described in §1834(c)(1)(B) of the Act
and screening pap smears and screening pelvic exams
performed more frequently than is provided for under
§1861(nn) of the Act.
§1862(a)(1)(F) Screening for glaucoma, which is performed more frequently
than is provided under §1861(uu) of the Act.
§1862(a)(1)(G) Prostate cancer screening tests (as defined in §1861(oo) of the
Act), which are performed more frequently than is covered
under such section.
§1862(a)(1)(H) Colorectal cancer screening tests, which are performed more
frequently than is covered under §1834(d) of the Act.
§1862(a)(1)(I) The frequency and duration of home health services which are
in excess of normative guidelines that the Secretary shall
establish by regulation.
§1862(a)(1)(J) Drugs or biologicals specified in §1847A(c)(6)(C) of the Act,
for which payment is made under part B, furnished in a
competitive area under §1847B of the Act, but not furnished
by an entity under a contract under §1847(B) of the Act.
§1862(a)(1)(K) An initial preventive physical examination, which is performed
more than 1 year after the date the individual’s first coverage
period begins under Medicare Part B.
§1862(a)(1)(L) Cardiovascular screening blood tests (as defined in
§1861(xx)(1) of the Act), which are performed more
frequently than is covered under §1861(xx)(2).
§1862(a)(1)(M) A diabetes screening test (as defined in §1861(yy)(1) of the
Act), which is performed more frequently than is covered
under §1861(yy)(3) of the Act.
§1862(a)(1)(N) An ultrasound screening for abdominal aortic aneurysm which
is performed more frequently than is provided for under
§1861(s)(2)(AA) of the Act.
§1862(a)(1)(O) Kidney disease education services (as defined in
§1861(ggg)(1) of the Act) which are furnished in excess of the
number of sessions covered under §1861(ggg)(4) of the Act.
§1861(dd)(3)(A) Hospice care determined to be non-covered because the
beneficiary was not “terminally ill,” as referenced by
§1879(g)(2) of the Act since the Balanced Budget Act of 1997.
§1862(a)(1)(O) Personalized prevention plan services (as defined in § 1861
(hhh)(1) of the Act), which are performed more frequently
than is covered under such section.
Statutory Provision Description
(section of the Act)
§1814(a)(2)(C) & Home health services determined to be non-covered because
§1835(a)(2)(A) on or the beneficiary was not “homebound” or did not require
after July 1, 1987 “intermittent” skilled nursing care.

§1879(g)(1) before
December 31, 1995
§1879(e) Inpatient hospital services or extended care services if payment
is denied solely because of an unintentional, inadvertent, or
erroneous action that resulted in the beneficiary’s transfer from
a certified bed (one that does not meet the requirements of
§1861(e) or (j) of the Act) in a skilled nursing facility (SNF) or
hospital.
§1862(a)(9) Custodial care, unless otherwise permitted under paragraph
§1862(a)(1)(C) of the Act.

20.2 - Denials When the LOL Provision Does Not Apply


(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

Type of Description Example(s)


Denial
Categorical Categorical Denials are • Personal comfort items
circumstances in which the (§1862(a)(6) of the Act).
LOL provision does not apply • Routine physicals and most
because the Medicare payment screening tests (§1862(a)(7) of the
denial is based on a statutory Act).
provision not referenced in
• Most immunizations
§1879 of the Act. Refer to
(vaccinations) (§1862(a)(7) of the
§1862(a) of the Act for a
complete listing. Act).
• Routine eye care, most eyeglasses
and examinations (§1862(a)(7) of
the Act).
• Hearing aids and hearing aid
examinations (§1862(a)(7) of the
Act).
• Cosmetic surgery (§1862(a)(10) of
the Act).
• Orthopedic shoes and foot
supports (orthotics) (§1862(a)(8)
of the Act).
Type of Description Example(s)
Denial
NOTE: §22.1 of this chapter provides
a more expansive list of examples.
Technical When coverage requirements • Payment for the additional cost of
are not met for a particular a private room in a hospital or SNF
item or service, it is not a is denied when the private
Medicare benefit; therefore, accommodations are not required
Medicare denies payment or for medical reasons (§1861(v)(2)
when payment for a medically of the Act).
unreasonable or unnecessary
• Payment for a dressing is denied
item or service that is also
because it does not meet the
barred because of failure to
meet a condition of payment definition for “surgical dressings”
required by regulations. (§1861(s)(5) of the Act).
• Payment for SNF stays not
preceded by the required 3-day
hospital stay or Payment for SNF
stay because the beneficiary did
not meet the requirement for
transfer to a SNF and for receiving
covered services within 30 days
after discharge from the hospital
and because the special
requirements for extension of the
30 days were not met (§1861(i) of
the Act).
• Drugs and biologicals which are
usually self-administered by the
patient.
• Ambulance services denied
because transportation by other
means is not contraindicated or
because regulatory criteria
specified in 42 CFR 410.40, such as
those relating to destination or
nearest appropriate facility, are
not met. (See the Medicare
Benefit Policy Manual, Chapter 10)
• Other items or services that must
be denied under 42 CFR 410.12
through 410.105 of the Medicare
regulations.
20.2.1 - Categorical Denials
(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

Below is a more expansive list of examples of categorical denials:

Statutory Description
Provision
(section of the
Act)
§1862(a)(12) Dental care and dentures (in most cases).
§1862(a)(13) Routine foot care and flat foot care.
§1862(a)(19) Services under a physician’s private contract.
§1862(a)(3) Services paid for by a governmental entity that is not Medicare.
§1862(a)(4) Health care received outside of the U. S. not covered by
Medicare.
§1862(a)(11) Services by immediate relatives.
§1862(a)(5) Services required as a result of war.
§1862(a)(2) Services for which there is no legal obligation to pay.
§1862(a)(21) Home health services furnished under a plan of care, if the
agency does not submit the claim.
§1862(a)(16) Items and services excluded under the Assisted Suicide Funding
Restriction Act of 1997.
§1862(a)(17) Items or services furnished in a competitive acquisition area by
any entity that does not have a contract with the Department of
Health and Human Services (except in a case of urgent need).
§1862(a)(14) Physicians’ services performed by a physician assistant,
midwife, psychologist, or nurse anesthetist, when furnished to
an inpatient, unless they are furnished under arrangement with
the hospital.
§1862(a)(18) Items and services furnished to an individual who is a resident
of a skilled nursing facility or of a part of a facility that includes
a skilled nursing facility, unless they are furnished under
arrangements by the skilled nursing facility.
§1862(a)(15) Services of an assistant at surgery without prior approval from
the peer review organization.
§1862(a)(20) Outpatient occupational and physical therapy services furnished
incident to a physician’s services.
§1862(a)(22) Claims submitted other than in an electronic form specified by
the Secretary, subject to the exceptions set forth in §1862(h) of
the Act.
Statutory Description
Provision
(section of the
Act)
§1862(a)(23) Claims for the technical component of advanced diagnostic
imaging services described in §1834(e)(1)(B) of the Act for
which payment is made under the fee schedule established under
§1848(b) of the Act and that are furnished by a supplier (as
defined in §1861(d) of the Act), if such supplier is not
accredited by an accreditation organization designated by the
Secretary under §1834(e)(2)(B) of the Act.
§1862(a)(24) Claims for renal dialysis services (as defined in §1881(b)(14)(B)
of the Act) for which payment is made under such section unless
such payment is made under such section to a provider of
services or a renal dialysis facility for such services.

30 - Determining Liability for Disallowed Claims Under §1879


(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

When a Medicare contractor determines that a review under the LOL provisions is
appropriate under §20 of this chapter, the Medicare contractor must next determine who
is liable, based on who knew, or should have known that Medicare was going to deny
payment on the item or service. In order to make this determination, the contractor must
take the following steps:
Determine Evidence Knowledge: * The Medicare
whether the must show program shall not
beneficiary that the * Is established when make a payment to the
is liable. beneficiary the healthcare beneficiary.
knew or provider or supplier
should have gives a valid ABN, * The beneficiary can
known the Form CMS-R-131 or appeal both the
item and/or other written notice. coverage issue, and
service the contractor’s
would not be * May be established determination of
covered. when the beneficiary beneficiary liability
receives notice of a for the cost of the
recent claim denial for non-covered item or
the same item or service.
service.

If the Evidence * Had actual knowledge * The Medicare


beneficiary must show of the non-coverage of program shall not make
is not found that the item and/or service in a a payment to the
liable, then healthcare particular case; healthcare provider or
the provider/ supplier.
Medicare supplier * Could reasonably
contractor knew or have been expected to * The healthcare
should should have have such knowledge; provider or supplier can
determine if known the or appeal both the
the item and/or coverage issue, and the
healthcare service * The beneficiary was contractor’s
provider or would not be shown not to have determination of
supplier is covered. knowledge (found not healthcare provider or
liable liable). supplier liability for the
cost of the non-covered
item or service.

If the healthcare provider or supplier


is not found liable, the Medicare
program will accept liability.

NOTE: If both the beneficiary and the healthcare provider or supplier are found to have
knowledge, the beneficiary will be held liable.
30.1 - Beneficiary’s Knowledge and Liability
(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

Beneficiary knowledge standards vary between the §1879 LOL provision and the two
Refund Requirement (RR) provisions as shown in the table below.

Provision Description Beneficiary Knowledge


Limitation On §1879(a)(2) of the Act requires • Knowledge based on
Liability that the beneficiary “did not written notice having
know, and could not reasonably been provided to the
have been expected to know, beneficiary.
that payment would not be • Knowledge based on
made* * *,” for items or any other means from
services that are excluded from
which it is determined
coverage.
that the beneficiary
knew, or should have
known, that payment
would not be made.
Medical Equipment §1834(a)(18)(A)(ii) of the Act • Knowledge must be
and Supplies RR [which is incorporated by evidenced by a signed
reference into §1834(j)(4) and written notice and
§1879(h) of the Act] requires agreement to pay
that “before the item was personally in case of a
furnished, the patient was denial.
informed that payment under
this part may not be made for
that item and the patient has
agreed to pay for that item,” that
is, for medical equipment and
supplies denied on the basis of
§1834(a)(17)(B), §1834(j)(1),
§1834(a)(15), or §1862(a)(1) of
the Act.
Physician RR §1842(l)(1)(C)(ii) of the Act • Knowledge must be
requires that “before the service evidenced by a signed
was provided, the individual written notice and
was informed that payment agreement to pay
under this part may not be made personally in case of a
for the specific service and the denial.
individual has agreed to pay for
that service,” that is, for
physician services that are
denied because they were not
reasonable and necessary under
§1862(a)(1) of the Act.
Knowledge is determined on a case by case basis. In certain circumstances, being in
receipt of a valid ABN or other written notice does not guarantee that the beneficiary had
knowledge that an item or service would not be covered. For instance, in a case where a
beneficiary received a valid ABN and then, upon initial determination, the claim was paid
as covered, that original ABN cannot be used as evidence of knowledge for future claims
relating to a similar or reasonably comparable item or service, since the original ABN
was belied by the favorable payment decision.

In reviewing a determination of liability on appeal, a beneficiary’s allegation that s/he did


not know, in the absence of evidence to the contrary, is acceptable evidence for LOL
purposes.

30.1.1 - Other Evidence of Knowledge


(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

While 42 CFR 411.404 provides criteria for beneficiary knowledge based on written
notice, §1879(a)(2) of the Act specifies only that knowledge must not exist in order to
apply the LOL provision. If it is clear and obvious that a beneficiary in fact did know,
prior to receiving an item or service, that Medicare payment for that item or service
would be denied, the administrative presumption favorable to the beneficiary is rebutted.
For example, if the beneficiary admits that s/he had prior knowledge that payment for an
item or service would be denied, no further evidence is required.

In the case in which the Medicare contractor has such evidence of prior knowledge on the
beneficiary’s part, the beneficiary must be held liable under the LOL provision, even if
no written notice was given by the appropriate source.

30.2 - Healthcare Provider or Supplier Knowledge and Liability


(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

In order to determine whether the healthcare provider or supplier had prior knowledge
that the item and/or service furnished to the beneficiary would likely be denied or
whether knowledge of the denial could have been expected, the Medicare contractors
review the information they maintain and/or disseminate to a particular healthcare
provider or supplier and the denial’s relevant facts.

If the healthcare provider or supplier cannot show that the beneficiary received proper
written notice, the healthcare provider or supplier will be presumed to have knowledge
(and, thereby, liability) unless s/he can prove that s/he did not know, and could not
reasonably have been expected to know, that Medicare would not pay for the item and/or
service. If the healthcare provider or supplier can make such a convincing showing, the
Medicare contractor will find that the healthcare provider or supplier did not have the
requisite knowledge and Medicare will be liable for the payment.
30.2.1 - Evidence of Healthcare Provider or Supplier Knowledge
(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

In accordance with regulations at 42 CFR 411.406, evidence that the healthcare provider
or supplier did, in fact, know or should have known that Medicare would not pay for an
item or service includes:

• A Medicare contractor’s prior written notice to the healthcare provider or supplier


of Medicare denial of payment for similar or reasonably comparable item or
service. This also includes notification of Quality Improvement Organization
(QIO) screening criteria specific to the condition of the beneficiary for whom the
furnished item and/or service are at issue and of medical procedures subject to
preadmission review by the QIO. Instructions for application of the LOL
provision to QIO determinations are in the QIO Manual;

• Medicare’s general notices to the medical community of Medicare payment denial


of item or service under all or certain circumstances (such notices include, but are not
limited to, manual instructions, bulletins, and Medicare contractors’ written guidance);

• Provision of the item and service being inconsistent with acceptable standards of
practice in the local medical community.

• Written notification from the healthcare provider or supplier’s utilization review


committee informing the healthcare provider or supplier that the item and/or
service was not covered;

• The healthcare provider or supplier issuing a written notice of the likelihood of


Medicare payment denial for an item and/or service to the beneficiary; or

• The healthcare provider or supplier being previously notified by telephone and/or


in writing that an item or service is not covered or that coverage has ended.

If any of the circumstances described above exists, a healthcare provider or supplier is


held to have knowledge.

30.2.2 - Medical Record Evidence of Healthcare Provider or Supplier


Knowledge
(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

The healthcare provider or supplier is also accountable for information contained in the
beneficiary’s medical records, such as the beneficiary’s medical chart, attending
physicians’ notes, or similar records. When the medical records clearly show that the
beneficiary received only non-covered services as described in the Medicare Benefit
Policy Manual, the healthcare provider or supplier will be presumed to have knowledge
of non-coverage.

Examples:

• A physician clearly indicated in the beneficiary’s medical record that the patient
no longer needed the services or the level of care provided;

• The physician indicated the patient could be discharged;

• The attending physician refused to certify or recertify the beneficiary’s need for a
particular level of care covered by Medicare because he/she determined that the
patient does not require a covered level of care; or

• The contractor requested additional medical evidence after a certain number of


days to determine whether continued coverage is warranted. However, the
healthcare provider or supplier did not submit the evidence within the stipulated
time.

30.2.3 - Acceptable Standards of Practice


(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

When an item and/or service furnished do not meet locally acceptable standards of
practice, the healthcare provider or supplier is considered to have known that Medicare
payment would be denied. Because healthcare provider and supplier licensure is
premised on the assumption that they are knowledgeable about locally acceptable
standards of practice, healthcare providers and suppliers are presumed to have knowledge
about locally acceptable standards of practice for liability determinations. No other
evidence of knowledge of local medical standards of practice is necessary.

In order to determine what “acceptable standards of practice” exist within the local
medical community, Medicare contractors will rely on the following:

• published medical literature; 1

• a consensus of expert medical opinion; 2 and

1
“Published medical literature” refers generally to scientific data or research studies that have been
published in peer-reviewed medical journals or other specialty journals that are well recognized by the
medical profession, such as the “New England Journal of Medicine” and the “Journal of the American
Medical Association.”
2
Consensus of expert medical opinion might include recommendations that are derived from technology
assessment processes conducted by organizations such as the Blue Cross and Blue Shield Association or
the American College of Physicians, or findings published by the Institute of Medicine.
• consultations with their medical staff, medical associations, including local
medical societies, and other health experts.

NOTE: A healthcare provider or supplier may indicate on the claim (via Occurrence
Code 32 or the applicable Healthcare Common Procedure Coding System code modifier
(i.e. GA, GX, ext.) on contractor claims) that they gave the beneficiary a valid written
notice before furnishing the item and/or service. In that instance, the Medicare contractor
will hold the beneficiary, not the healthcare provider or supplier liable for the denied
charges. If it is determined that the written notice was invalid, the contractor will
override the GA code, and the healthcare provider or supplier will be found liable.

30.3 – The Right to Appeal


(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

The beneficiary, healthcare provider, or supplier has the right to appeal both the issue of
coverage for the claim and determination of liability. For purposes of determining the
amount in controversy for an appeal of the coverage determination, payment made under
§1879 of the Act should be disregarded. For more information see Chapter 29 of this
manual, Appeals of Claims Decisions.

30.4 - Fraud, Abuse, Patently Unnecessary Items and Services


(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

Generally, the protection under the FLP provisions cannot be afforded to a healthcare
provider or supplier if a formal finding of fraud or abuse has been made with regard to a
healthcare provider’s or supplier’s billing practices. In cases where a formal finding of
fraud or abuse is made, an immediate finding of liability for the healthcare provider or
supplier results. Abuse exists when a healthcare provider or supplier furnishes item
and/or service that are inconsistent with accepted sound medical practices, are clearly not
within the concept of reasonable and necessary as defined by law or regulations, and, if
paid for, would result in an unnecessary financial loss to the program. The Medicare
contractor will also make an immediate finding of liability in situations where a
healthcare provider or supplier furnishes items and/or services that are so patently
unnecessary that all healthcare providers or suppliers could reasonably be expected to
know that they are not covered.
40 - Written Notice as Evidence of Knowledge
(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

One regulatory basis for determining beneficiary knowledge can be found at 42 CFR
411.404. Under these regulations, there is a presumption that the beneficiary knew, or
could reasonably have been expected to know, that Medicare payment for an item or
service would be denied if written notice was given to the beneficiary that the items or
services were not covered. A written notice that a beneficiary received may be
considered as evidence of prior knowledge with respect to such same or similar item(s)
and/or service(s) that is denied Medicare payment for the same reason in both cases.

In accordance with 42 CFR 411.404, a written notice of Medicare denial of payment must
contain sufficient information to enable the beneficiary to understand the basis for the
denial of the item and/or service that otherwise might be paid for, that Medicare certainly
or probably will not pay for in that particular occasion.

The written notice allows the beneficiary to:

• make an informed decision whether or not to receive the item and/or service, and

• better participate in his/her own health care treatment decisions.

If the healthcare provider or supplier expects payment for the item and/or service to be
denied by Medicare, the healthcare provider or supplier must advise the beneficiary in
advance that, in its opinion, the beneficiary will be personally and fully responsible for
payment. To be “personally and fully responsible for payment” means that the
beneficiary will be liable to make payment “out-of-pocket,” through other insurance
coverage (e.g., employer group health plan coverage), or through Medicaid or other
Federal or non-Federal payment source.

40.1 - Sources of Written Notice


(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

Generally, the written notice of the likelihood of Medicare payment denial (e.g. an ABN,
Form CMS-R-131) should be furnished to the beneficiary:

• By a healthcare provider or supplier before the item and/or service is furnished;

• After the Medicare contractor, during the course of the beneficiary’s stay, advised
the healthcare provider or supplier that covered care had ceased;

• By a healthcare provider or supplier utilization review committee that, on


admission or during the patient’s stay, advised that the beneficiary no longer
required covered care;

• By the Medicare contractor; or


• By a qualified notifier so that the beneficiary may have confidence in and rely
upon the accuracy and credibility of the notice.
40.2 - Written Notice Standards
(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

The healthcare provider or supplier should issue a written notice each time, and as soon
as, it makes the assessment that Medicare payment certainly or probably will not be made
in order to transfer potential financial liability to the beneficiary. A healthcare provider
or supplier, should notify a beneficiary by means of timely and effective delivery of a
written notice document to a qualified recipient. Any written notice should meet the
following written notice standards as evidence of the beneficiary’s knowledge for the
purposes of the FLP provisions, except as otherwise explicitly specified. A notification
which does not meet the following written notice standards may be ruled invalid and may
not serve to protect the interests of the notifier.

A written notice will not be considered as acceptable evidence of knowledge if the


written notice is:

• Unreadable, illegible, or otherwise incomprehensible, or the individual


beneficiary is incapable of understanding the written notice due to the particular
circumstances (even if others may understand);

• Given during any emergency, or the beneficiary is under great duress, or the
beneficiary is, in any way, coerced or misled by the notifier, by the contents of the
written notice, and/or by the manner of delivery of the written notice;

• Routinely given to all beneficiaries for whom the notifier furnishes items and/or
services;

• No more than a statement to the effect that there is a possibility that Medicare
may not pay for the items or services; or

• Delivered to the beneficiary more than one year before the items and/or services
are furnished.

NOTE: A previously furnished written notice is acceptable evidence of written notice for
current items and/or services if the previous written notice cites similar or reasonably
comparable items and/or services for which denial is expected on the same basis in both
cases. A written denial (on the same basis in both cases) of payment from a Medicare
contractor for a claim for the same or similar item and/or service received by the
beneficiary is acceptable evidence of written notice for current item and/or service.
Written Notice Standard Description
Proper Written Notice Documents • An approved standard form (e.g.,
Form CMS-R-131); or
• A CMS approved model notice
language (e.g., Form CMS-10055)
Qualified Notifiers “Notifiers” are generally the healthcare
provider or supplier that furnished or
ordered the item(s) and/or service(s).
Capable Recipient The beneficiary must:
• Be able to read, understand, act on
his/her rights, and comprehend the
notice;
• Be issued the written notice in a
manner that allows her/him to
comprehend the contents of the
written notice. (e.g., when the
beneficiary (or authorized
representative) is unable to read the
notice due to a disability such as
blindness, visual impairment or
deafness) This can be done by a
verbal or electronic reading of the
notice, by providing the written
notice in Braille or large print, or by
the use of other assistive technology.
The notifier should document any
actions taken to assist with the
delivery of the written notice on the
notice; and
• Be afforded the verbal or written
assistance in other languages to assist
in understanding the notice. If a
translator who can speak the
beneficiary’s language is not
available, the notifier should assist by
calling 1-800-MEDICARE so a
customer service representative can
connect the beneficiary with the
Language Line for translation services.
Identification of Notifier The header of the written notice must
identify the notifier or notifier(s). In
situations where the notifier is not the
billing entity, it is permissible to enter the
names of more than one entity in the
header of the notice.
Written Notice Standard Description

If the header identifies the entity or person


that obtained the written notice, rather
than the entity or person that is billing for
the item and/or service, the Medicare
contractor will consider the written notice
form to be valid so long as it was
otherwise properly executed.

40.2.1 - Other Written Notice Standards


(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

A. Timeliness

Written notice delivery:

• Must be issued far enough in advance of an event (e.g., receiving a medical


service) so that the beneficiary can make a rational, informed decision without
undue pressure; or
• Should take place before a procedure is initiated and before physical preparation
of the patient (e.g., disrobing, placement in or attachment of diagnostic or
treatment equipment) begins.
Written notice is permissible:

• If a situation arises when a notifier sees a need for a previously unforeseen item or
service and expects that Medicare will not pay for it only in certain specific denial
reasons, provided that the beneficiary is capable of receiving notice and has a
meaningful opportunity to act on it (e.g., the beneficiary is not under general
anesthesia); or

• Where it is foreseeable that the need for service for which Medicare likely would
not pay may arise during the course of an encounter, and the beneficiary is either
certain or likely not to be capable of receiving notice during the initial service
(e.g., the beneficiary will be under anesthesia).

NOTE: Last minute notification can be coercive, and a coercive notice is an invalid
notice.

B. Written Notice Delivery

A written notice:

• Should be delivered in person to the beneficiary or authorized representative


whenever possible. Delivery is the notifier’s responsibility;
• Must be prepared with an original and at least two copies. The notifier should
retain the original and give the copy to the beneficiary or authorized
representative. Legible duplicates (carbons, etc.), fax copies, electronically
scanned copies, or photocopies will suffice;

• Copy should be given to the beneficiary (or authorized representative)


immediately after the beneficiary (or authorized representative) signs it.

If a beneficiary is not given a copy of the written notice and if the beneficiary later
alleges that the written notice presented to the Medicare contractor by the notifier is
different in any material respect from the written notice s/he signed, the Medicare
contractor will give credence to the beneficiary’s allegations. If the notifier is unable to
deliver the notice to the beneficiary, the Medicare contractor will hold that the
beneficiary did not receive proper written notice and will hold the notifier liable.

In a case where the notifier that gives a written notice is not the entity which ultimately
bills Medicare for the item(s) and/or service(s), (e.g., when a physician draws a test
specimen and sends it to a laboratory for testing) the notifier should give a copy of the
signed written notice to the billing entity as well as the beneficiary.

C. Reason for Predicting Denial

The written notice must give the beneficiary a reasonable idea of why the notifier is
predicting the likelihood of Medicare denial so that the beneficiary can make an informed
decision whether or not to receive the item or service and pay for it. Statements of
reasons for predicting Medicare denial of payment at a level of detail similar to the
approved “Medical Necessity” messages for Medicare Summary Notices are acceptable
for written notice purposes. If more than one reason for denial could apply (e.g.,
exceeding a frequency limit and “same day” duplication; cases where the reason for
denial could depend upon the result of a test; etc.), the Medicare contractor will not
invalidate a written notice on the basis of citing more than one reason for denial.

The following could result in an invalid written notice:


• Simply stating “medically unnecessary” or the equivalent is not an acceptable
reason, as it does not explain why the healthcare provider or supplier believes the
item and/or service will be denied as not reasonable and necessary.

• Listing several reasons which apply in different situations without indicating


which reason is applicable in the beneficiary’s particular situation generally is not
an acceptable practice.

40.2.2 - Written Notice Special Considerations


(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)
A. Responsiveness to Inquiries

A notifier must answer any questions from a beneficiary regarding the written notice.
This includes requests for further information and/or assistance in understanding and
responding to a notice. The Medicare contractor will hold that a beneficiary did not
receive proper written notice in any case where it finds that the notifier refused to answer
inquiries.

B. Dealing With Beneficiary Refusals

A beneficiary who has been given a written notice may decide to receive the item(s)
and/or service(s). In this case, the beneficiary should indicate that s/he is willing to be
personally and fully responsible for payment. When a beneficiary decides to decline an
item or service, s/he should so indicate. If a beneficiary refuses to sign a valid written
notice, the notifier should consider not furnishing the item or service, unless the
consequences (health and safety of the patient, or civil liability in case of harm) are such
that this is not an option. Additionally, the notifier may annotate the written notice
indicating the circumstances and persons involved. The notifier should have the
annotation witnessed.

• Claims to Which LOL Provisions Apply - If the beneficiary demands the item
or service and refuses to pay, the notifier should have a second person witness the
provision of the written notice and the beneficiary’s refusal to sign. Where there
is only one person on site (e.g., in a “draw station”), the second witness may be
contacted by telephone to witness the beneficiary’s refusal to sign the written
notice by telephone and may sign the written notice annotation at a later time. An
unused patient signature line on the written notice form may be used for such an
annotation; writing in the margins of the form is also permissible. The notifier
should file its claim as having given the written notice. The beneficiary will be
held liable in case of a denial.

• Claims to Which RR Provisions Apply - if the physician or supplier does


furnish the item or service, the beneficiary’s signature is meant to attest both to
receipt of the written notice and to the beneficiary’s agreement to pay. The
beneficiary must receive a valid written notice so that s/he is “on notice” (that is,
the beneficiary “knew, or could reasonably have been expected to know, that
payment could not be made”) and must agree to pay. The beneficiary has the
same two legitimate choices as the cases of claims to which LOL provisions
apply. If the beneficiary demands the item or service and refuses to pay (will not
sign or else marks out the agreement to pay language), the physician or supplier
must take into account the fact that it will not be able to collect from the
beneficiary in deciding whether or not to furnish the items or services. Although
there would be little point in having a second person witness the provision of the
written notice and the beneficiary’s refusal to agree to pay (because the
requirement that the beneficiary agree to pay still would not be fulfilled), the
physician or supplier may annotate the written notice. If the items or services are
furnished despite the beneficiary’s refusal to pay, the physician or supplier should
file the claim as not having obtained a signed written notice. The Medicare
contractor will not hold the beneficiary liable and will hold the physician or
supplier liable.

NOTE: In either case, the beneficiary who does receive an item or service, of course,
always
has the right to a Medicare determination and the claim must be filed with Medicare.

C. Routine Notice Prohibition

In general, the “routine” use of written notices is not effective and therefore is not an
acceptable practice. By “routine” use, CMS means giving written notice to beneficiaries
where there is no specific, identifiable reason to believe Medicare will not pay. Notifiers
should only give written notices to beneficiaries when there is some genuine doubt that
Medicare will make payment. If the Medicare contractor identifies a pattern of routine
notices in situations where such notices clearly are not valid, it will write to the notifier
and remind it of these standards. While in general, routine written notices are invalid and
will not protect the notifier from liability, there are some exceptions.

• Generic Written Notices – “Generic written notices” are routine written notices
to beneficiaries which do no more than state that Medicare denial of payment is
possible, or that the notifier never knows whether Medicare will deny payment.
Such “generic written notices” are not considered to be acceptable evidence of
written notice and will not protect the notifier from liability. The written notice
must specify the item and/or service and a genuine reason that denial by Medicare
is expected. Written notice standards likewise are not satisfied by a generic
document that is little more than a signed statement by the beneficiary to the
effect that, should Medicare deny payment for anything, the beneficiary agrees to
pay for the item and/or service.

• Blanket Written Notices - Giving written notices for all claims or items or
services (i.e., “blanket written notices”) is not an acceptable practice. Notice must
be given to a beneficiary on the basis of a genuine judgment about the likelihood
of Medicare payment for that individual’s claim.

• Signed Blank Written Notices - A notifier is prohibited from obtaining


beneficiary signatures on blank written notices and then completing the written
notices later. In order for a written notice to be effective, it must be completed
before delivery to the beneficiary. The Medicare contractor will hold any written
notice that was blank when it was signed to be an invalid notice that will not
protect the notifier from liability.
• Routine Written Notice Prohibition Exceptions - In general, routine written
notices will not be considered valid. There are, however, a few limited
circumstances when a routine notice can be given to a beneficiary and considered
effective.

Exception Description
Items or Services Which Are Always In any case where a national coverage
Denied for Medical Necessity decision provides that a particular item or
service is never covered, under any
circumstances, as not reasonable and
necessary under §1862(a)(1) of the Act
(e.g., at present, all acupuncture services
by physicians are denied as not reasonable
and necessary), a written notice that gives
as the reason for expecting denial that:
“Medicare never pays for this
item/service” may be routinely given to
beneficiaries, and no claim need be
submitted to Medicare. If the beneficiary
demands that a claim be submitted to
Medicare, the notifier should submit the
claim as a demand bill.
Experimental Items and Services When any item or service which Medicare
considers to be experimental (e.g.,
“Research Use Only” and “Investigational
Use Only” laboratory tests) is to be
furnished, since all such items or services
are denied as not reasonable and
necessary under §1862(a)(1) of the Act
because they are not proven safe and
effective, the beneficiary may be given a
written notice that gives as the reason for
expecting denial that: “Medicare does not
pay for items or services which it
considers to be experimental or for
research use.” Language with respect to
“Medicare coverage for clinical trials”
may be substituted as the reason for
expecting denial.
Frequency Limited Items and Services When Medicare has established a
frequency limit for any item or service, a
routine written notice can be given. This
is applicable anytime a frequency
limitation is made through statute or
regulation, through medical national
coverage determinations, or on the basis
of the Medicare contractor’s local
Exception Description
coverage determinations. In any such
routine written notice, the notifier must
state the frequency limitation as the
reason for expecting denial (e.g.,
“Medicare does not pay for this item or
service more often than frequency limit”).
Medical Equipment and Supplies Given that Medicare denials of payment
Denied Because the Supplier Had No under §1834(j)(1) of the Act, and under
Supplier Number or the Supplier Made §1834(a)(17)(B) of the Act, apply to all
an Unsolicited Telephone Contact varieties of medical equipment and
supplies and to all Medicare beneficiaries
equally, the usual prohibition on routine
notices to all beneficiaries does not apply
in these cases.

NOTE: A routine written notice, like any other written notice, is valid only for the
denial reason specified on the notice. A written notice will not be considered a valid
notice in the case of any Medicare denial of the claim for any reason other than that
specified on the notice.

40.3 - Medical Emergency or Otherwise Under Great Duress Situations


(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

A written notice should not be obtained from a beneficiary in a medical emergency or


otherwise under great duress (i.e., when circumstances are compelling and coercive)
since that individual cannot be expected to make a reasoned informed decision. A
beneficiary (or authorized representative) cannot be expected to make an informed,
rational decision when in an emergency situation and therefore cannot be considered a
capable recipient. If the beneficiary is not capable of receiving the notice, then the
beneficiary has not received proper written notice and cannot be held liable where the
LOL or RR provisions apply, and the notifier may be held liable.

Examples:

• Ambulance companies may not give written notices to beneficiaries (or


authorized representatives) in any emergency transport because such beneficiaries
are under great duress.

• Skilled nursing facilities may not give written notices in the case of “middle-of-
the-night” emergencies or in any other emergency circumstances, since the
beneficiary clearly cannot make an informed decision.

NOTE: The Medicare contractor will consider any written notice given in any kind of
coercive circumstances, including medical emergencies, to be invalid. The Medicare
contractor will determine the healthcare provider’s or supplier’s liability by the
appropriate knowledge standards which are used in cases where written notices are not
given and beneficiary agreements to pay are not obtained.

40.4 - Emergency Medical Treatment and Active Labor Act (EMTALA)


Situations
(Rev.: 4197; Issued: 01-11-19; Effective: 04-15-19; Implementation: 04-15-19)

A written notice should not be given to a beneficiary in any case in which EMTALA
(§1867 of the Act) applies, until the hospital has met its obligations under EMTALA.
These include completion of a medical screening examination (MSE) to determine the
presence or absence of an emergency medical condition, or until an emergency medical
condition has been stabilized. The CMS published this policy in the November 10, 1999
OIG/HCFA Special Advisory Bulletin on the Patient Anti-Dumping Statute: “A hospital
would violate the patient anti-dumping statute if it delayed a medical screening
examination or necessary stabilizing treatment in order to prepare an ABN and obtain a
beneficiary signature. The best practice would be for a hospital not to give financial
responsibility forms or notices to an individual, or otherwise attempt to obtain the
individual’s agreement to pay for services before the individual is stabilized. This is
because the circumstances surrounding the need for such services, and the individual’s
limited information about his or her medical condition, may not permit an individual to
make a rational, informed consumer decision.” This policy applies in any case in which
EMTALA applies, not only to EMTALA cases seen in emergency rooms (ERs). This
policy also includes times when a beneficiary does not appear to have a life threatening
condition, rather, h/she is seeking primary care services at an ER, if EMTALA applies.

A written notice that is otherwise appropriate may be given to a Medicare beneficiary


who is seen in the ER after completion of an MSE, but a written notice should not be
given unless there is a genuine reason to expect that Medicare will deny payment for the
item and/or service. EMTALA does not prohibit asking payment questions entirely,
rather, only doing so before screening/stabilization. After screening/stabilization,
EMTALA no longer applies and written notices may be given, as applicable, to
beneficiaries who come to emergency care settings after they have received a medical
screening examination and are stabilized.

50 - Advance Beneficiary Notice of Non-coverage (ABN)


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)
A. General Statutory Authority - Applicability to Limitation on Liability (LOL)

Section 1879 of the Act (where the LOL provisions are located) requires a healthcare
provider or supplier (i.e. notifier) to notify a beneficiary in advance of furnishing an item
or service when s/he believes that items or services will likely be denied by Medicare for
any of the reasons specified in the statutory provision in order to shift financial liability to
the beneficiary for the denial. For example, advance notice is required if the item or
service may be denied as not reasonable and necessary under §1862(a)(1) of the Act or
because the item or service constitutes custodial care under §1862(a)(9) of the Act.
Notice (e.g., the ABN) is a way for healthcare providers or suppliers to establish
beneficiary knowledge of non-coverage and therefore, shift financial liability for these
items or services if Medicare denies the claim.

B. Compliance with Limitation on Liability Provisions


A notifier who fails to comply with the ABN instructions risks financial liability and/or
sanctions. LOL provisions shall apply as required by law, regulations, rulings and
program instructions. Additionally, when authorized by law and regulations, sanctions
under the Conditions of Participation (COPs) may be imposed.

The Medicare contractor may hold any healthcare provider or supplier who either failed
to give notice when required, or gave defective notice, financially liable. A notifier who
can demonstrate that s/he did not know and could not reasonably have been expected to
know that Medicare would not make payment will not be held financially liable for
failing to give notice. However, a notifier who gave defective notice may not claim that
s/he did not know or could not reasonably have been expected to know that Medicare
would not make payment, as the issuance of the notice is clear evidence of knowledge. A
notifier who cannot demonstrate that adequate advance notice was furnished to the
beneficiary will not be able to use the provisions in section 1879 of the Act to transfer
financial liability to the beneficiary.

ABN - Quick Glance Guide3

Notice Name: Advance Beneficiary Notice of Non-coverage (ABN)


Notice Number: Form CMS-R-131
Issued by: Healthcare providers and suppliers of Medicare Part B items and services;
Hospice and Religious Non-medical HealthCare Institute (RNHCI) providing Medicare Part A
items and services;
and home health agencies(HHAs) for Part A and Part B items and services
Recipient: Original Medicare FFS (fee for service) beneficiary;
Type of Must be issued: Timing of notice: Optional use:
notice:

Financial Prior to providing an item or service that Prior to delivery of the item Yes. Prior to
liability is usually paid for by Medicare under Part or service in question. providing an item or
notice B (or under Part A for hospice, HHA, and Provide enough time for the service that is never
RNHCI providers only) but may not be beneficiary to make an covered by Medicare
paid for in this particular case because it informed decision on (i.e. not a Medicare
is not considered medically reasonable whether or not to receive the benefit).
and necessary service or item in question
Prior to providing custodial care and accept potential
For hospice providers, prior to caring for financial liability.
a patient who is not terminally ill
For Durable Medicare Equipment (DME)
suppliers
For HHA providers, prior to providing
care when the individual is not confined
to the home or does not need intermittent
skilled nursing care.
3
This is an abbreviated reference tool and is not meant to replace or supersede any of the directives contained in Section
50.

50.1 - ABN Scope


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

The ABN is an Office of Management and Budget (OMB)-approved written notice issued
by healthcare providers and suppliers for items and services provided under Medicare
Part B. With the exception of DME suppliers, only healthcare providers and suppliers
who are enrolled in Medicare can issue the ABN to beneficiaries.

The ABN is given to beneficiaries enrolled in the Medicare FFS program. It is not used
for items or services provided under the Medicare Advantage (MA) Program or for
prescription drugs provided under the Medicare Prescription Drug Program (Part D).

Skilled Nursing Facilities (SNFs) issue the ABN for Part B services only. The Skilled
Nursing Facility Advance Beneficiary Notice of Non-coverage (SNF ABN), CMS Form
10055, is issued for Part A SNF items and services. Section 70 of this chapter contains
information on SNFABN issuance.

50.2 - ABN Uses


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

The following provisions necessitate delivery of the ABN:

• §1862(a)(1) of the Act (not reasonable and necessary);

• §1834(a)(17)(B) of the Act (violation of the prohibition on unsolicited telephone


contacts);

• §1834(j)(1) of the Act (medical equipment and supplies supplier number


requirements not met);

• §1834(a)(15) of the Act (medical equipment and/or supplies denied in advance);

• §1862(a)(9) of the Act (custodial care);

• §1879(g)(2) of the Act (hospice patient who is not terminally ill);

• §1879(g)(1) of the Act (home health services requirements are not met – not
confined to the home or no need for intermittent skilled nursing care);

• §1862(a)(1)(P) of the Act, Medicare covered personalized prevention plan services


(as defined in §1861(hhh)(1)) that are performed more frequently than indicated per
coverage guidelines are not reasonable and necessary for the diagnosis or treatment of
illness or injury or to improve the functioning of a malformed body member);

• Under 42 CFR §414.408(e)(3)(ii) when a noncontract supplier furnishes an item


included in the Durable Medical Equipment, Prosthetic, Orthotics, and Supplies
(DMEPOS) Competitive Bidding Program (CBP) for a Competitive Bidding Area
(CBA). Although all other denial reasons triggering mandatory use of the ABN are
found in §1879 of the Act, in this situation, §1847(b)(5)(D) of the Act permits use of
the ABN with respect to these items and services; or

• When Medicare considers an item or service experimental (e.g., a “Research Use


Only” or “Investigational Use Only” laboratory test), payment for the experimental
item or service is denied under §1862(a)(1) of the Act as not reasonable and
necessary. In circumstances such as this, the beneficiary must be given an ABN.

50.2.1 - Optional ABN Uses


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

ABNs are not required for care that is either statutorily excluded from coverage under
Medicare (i.e. care that is never covered) or most care that fails to meet a technical
benefit requirement (i.e. lacks required certification). However, CMS strongly encourage
healthcare providers and suppliers to issue the ABN for care that is never covered such
as:

• Care that fails to meet the definition of a Medicare benefit as defined in §1861 of the
Social Security Act;

• Care that is explicitly excluded from coverage under §1862 of the Social
Security Act. Examples include:

° Services for which there is no legal obligation to pay;


° Services paid for by a government entity other than Medicare (this
exclusion does not include services paid for by Medicaid on behalf of dual-
eligibles);
° Services required as a result of war;
° Personal comfort items;
° Routine eye care;
° Dental care; and
° Routine foot care.

When the ABN is used in this way it serves as a courtesy to the beneficiary in
forewarning him/her of impending financial obligation. The beneficiary should not be
asked to choose an option box or sign the notice. The healthcare provider or supplier is
not required to adhere to the issuance guidelines for the ABN.
NOTE: Certain DME items/services that fail to meet a technical requirement may require
an ABN as outlined in the mandatory use section above.

50.3 - Issuance of the ABN


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)
Notifiers May direct an employee or a
subcontractor to deliver an ABN. The
billing entity will always be held
responsible for effective delivery
regardless of who gives the notice.

When multiple entities are involved in


rendering care, it is not necessary to
give separate ABNs. Either party
involved in the delivery of care can be
the notifier when:

• There are separate “ordering” and


“rendering” healthcare providers or
supplier (e.g. a physician orders a
lab test and an independent
laboratory delivers the ordered
tests);
• One healthcare provider or supplier
delivers the “technical” and the other
the “professional” component of the
same service ( e.g. a radiological test
that an independent diagnostic
testing facility renders and a
physician interprets); or
• The entity that obtains the signature
on the ABN is different from the
entity that bills for services (e.g.
when one laboratory refers a
specimen to another laboratory
which then bills Medicare for the
test).

When the notifier is not the billing


entity, the notifier must know how to
direct the beneficiary who received the
ABN to the billing entity for questions
and should annotate the Additional
Information section of the ABN with
this information. It is permissible to
enter the names of more than one entity
in the header of the notice.

Representatives of Beneficiaries If the beneficiary has a known, legally


authorized representative, the ABN must
be issued to the existing representative. If
a beneficiary does not have a
representative and one is necessary, a
representative may be appointed for
purposes of receiving notice following
CMS guidelines and as permitted by State
and Local law. When a representative is
signing the ABN on behalf of a
beneficiary, the ABN should be annotated
to identify that the signature was penned
by the “rep” or “representative”. If the
representative’s signature is not clearly
legible, the representative’s name should
be printed on the ABN. See section 500
of this manual under “Authorized
representative” for more information.

50.4 - ABN Triggering Events


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

Reductions
Initiations Terminations

A reduction occurs
The beginning of a A termination is the
when there is a
new patient discontinuation of
decrease in a
encounter, start of a certain items or
component of care (i.e.
plan of care, or services. The ABN is
frequency, duration,
beginning of only issued at
etc.). The ABN is not
treatment. termination if the
issued every time an beneficiary wants to
item or service is continue receiving care
reduced. But, if a that is no longer
reduction occurs and medically reasonable
the beneficiary wants and necessary.
to receive care that is
no longer considered
medically reasonable
and necessary, the
ABN must be issued
prior to delivery of this
non-covered care.

50.5 - ABN Standards


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

The ABN, Form CMS-R-131, is the OMB approved standard written notice. Failure to
use this notice as mandated could result in the notice being invalidated and/or the notifier
being held liable for the items or services in question.

The online replicable copies of the OMB approved ABN (CMS-R-131) and instructions
for notice completion are available on the CMS website at:
http://www.cms.gov/Medicare/Medicare-General- Information/BNI/ABN.html

A. Language Choice

The ABN is available in English and Spanish under a dedicated link on the web page
given above. Notifiers should choose the appropriate version of the ABN based on the
language the beneficiary best understands. Insertions must be in English when the
English language ABN is used. Similarly, when a Spanish language ABN is used, the
notifier should make insertions on the notice in Spanish, if applicable. In addition, verbal
assistance in other languages may be provided to assist beneficiaries in understanding the
document. However, the printed document is limited to the OMB-approved English and
Spanish versions. Notifiers should document any types of translation assistance that are
used in the “Additional Information” section of the notice.

B. Effective Versions

ABNs are effective as of the OMB approval or expiration date given at the bottom of
each notice. The routine approval is for 3-year use. Notifiers are expected to exclusively
use the current version of the ABN. CMS will allow a transition period for healthcare
providers and suppliers to switch from using expiring notices to newly approved notices.

C. General Notice Preparation Requirements

Number of Copies A minimum of two copies, including the


original, should be made so the
beneficiary and notifier each have one.
The notifier should retain the original
whenever possible.
Reproduction Notifiers may reproduce the ABN by
using self-carbonizing paper,
photocopying, digitized technology, or
another appropriate method. All
reproductions should conform to
applicable requirements.
Length and Size of Page The ABN form must not exceed one
page in length; however, attachments
are permitted for listing additional items
and services. If attachments are used,
they should allow for clear matching of
the items or services in question with
the reason and cost estimate
information. The ABN is designed as a
letter- sized form. If necessary, it may
be expanded to a legal-sized page.
Contrast of Paper and Print A visually high-contrast combination of
dark ink on a pale background should be
used. Do not use reversed print (i.e.
white print on black paper), or block-
shaded (highlighted) text.
Font Fonts as they appear in the ABN
downloaded from the CMS web site
should be used. In cases where changes
need to occur, notifiers should use
alternative fonts that are easily
readable, such as Arial, Arial Narrow,
Times New Roman, and Courier.
Any other changes to the font, such as
italics, embossing, bold, etc., should not
be used since they can make the ABN
more difficult to read. The font size
generally should be 12 point. Titles
should be 14-16 point, but insertions in
blanks of the ABN can be as small as 10
point if needed.
Information inserted by notifiers in the
blank spaces on the ABN may be typed
or legibly hand-written.
Customization Notifiers are permitted to do some
customization of ABNs, such as pre-
printing information in certain blanks to
promote efficiency and to ensure clarity
for beneficiaries. Notifiers may develop
multiple versions of the ABN specialized
to common treatment scenarios, using
the required language and general
formatting of the ABN.
Blanks (G)-(I) must be completed by the
beneficiary when the ABN is issued and
should not be pre-filled. Lettering of the
blanks (A-J) should be removed prior to
issuance of an ABN. If pre-printed
information is used to describe
items/services and/or common reasons
for non-coverage, the notifier must
clearly indicate on the ABN which
portions of the pre- printed information
are applicable to the beneficiary
Healthcare providers or suppliers who
pre-print a menu of items or services
may wish to list a cost estimate
alongside each item or service.
Modification The ABN may not be modified except as
specifically allowed by these
instructions.
Notifiers must exercise caution before
adding any customizations beyond these
guidelines, since changing ABNs too
much could result in invalid notice and
healthcare provider or supplier liability
for non-covered charges. Validity
judgments are generally made by
Medicare contractors, usually when
reviewing ABN-related claims; however,
any complaints received may be
investigated by contractors and/or CMS
central or regional offices.

50.6 - Completing the ABN


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)
Step-by-step instructions for notice completion are posted along with the notice on the
CMS website and can be downloaded via this link:
http://www.cms.gov/Medicare/Medicare-General-Information/BNI/ABN.html

A. Other Considerations During ABN Completion

1. Beneficiary Changes His/her Mind

If after completing and signing the ABN, a beneficiary changes his/her mind, the notifier
should present the previously completed ABN to the beneficiary and request that the
beneficiary annotate the original ABN. The annotation must include a clear indication of
his/her new option selection along with the beneficiary's signature and date of annotation.
In situations where the notifier is unable to present the ABN to the beneficiary in person,
the notifier may annotate the form to reflect the beneficiary's new choice and
immediately forward a copy of the annotated notice to the beneficiary to sign, date, and
return.

In both situations, a copy of the annotated ABN should be provided to the beneficiary as
soon as possible. If a related claim has been filed, it should be revised or cancelled if
necessary to reflect the beneficiary’s new choice.

2. Beneficiary Refuses to Complete or Sign the Notice

If the beneficiary refuses to choose an option and/or refuses to sign the ABN when
required, the notifier should annotate the original copy of the ABN indicating the refusal
to sign or choose an option and may list witness(es) to the refusal on the notice although
this is not required. If a beneficiary refuses to sign a properly delivered ABN, the notifier
should consider not furnishing the item/service, unless the consequences (health and
safety of the patient, or civil liability in case of harm) are such that this is not an option.

In any case, the notifier should provide a copy of the annotated ABN to the beneficiary,
and keep the original version of the annotated notice in the patient’s file.

50.7 - ABN Retention


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)
The notifier should retain the ABN delivered to the beneficiary on file should there be
any question regarding whether the beneficiary had knowledge of the potential financial
liability. In certain situations, such as delivery by fax, the notifier may not have access
to the original document upon signing. Retention of a copy of the signed document
would be acceptable in specific cases such as this.

In a case where the notifier that gives an ABN is not the entity that ultimately bills
Medicare for the item or service (e.g. when a physician issues an ABN, draws a test
specimen, and sends it to a laboratory for testing), the notifier should give a copy of the
signed ABN to the billing entity.

In general, it is 5 years from discharge/completion of delivery of care when there are no


other applicable requirements under State law. Electronic retention of the signed paper
document is acceptable. Notifiers may scan the signed paper or “wet” version of the
ABN for electronic medical record retention and if desired, give the paper copy to the
beneficiary.
50.8 - Effective ABN Delivery
(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

ABN delivery is considered to be effective when the ABN is:

1. Delivered by a suitable notifier to a capable recipient and comprehended by


that recipient.

2. Provided using the correct OMB approved notice with all required
blanks completed. Failure to use the correct notice may lead to the
notifier being found liable since the burden of proof is on the notifier to
show that knowledge was conveyed to the beneficiary according to CMS
instructions.

3. Delivered to the beneficiary in person if possible.

4. Provided far enough in advance of delivering potentially non-covered items


or services to allow sufficient time for the beneficiary to consider all
available options.

5. Explained in its entirety, and all of the beneficiary’s related questions are
answered timely, accurately, and completely to the best of the notifier’s ability.

The notifier should direct the beneficiary to call 1-800-MEDICARE if the


beneficiary has questions s/he cannot answer. If a Medicare contractor finds that
the notifier refused to answer a beneficiary’s inquiries or direct them to 1-800-
MEDICARE, the notice delivery will be considered defective, and the notifier will
be held financially liable for non-covered care.

6. Signed by the beneficiary.

A. Period of Effectiveness/Repetitive or Continuous Non-covered Care

An ABN remains effective after valid delivery so long as there has been no change in:

• Care from what is described on the original ABN;


• The beneficiary’s health status which would require a change in the subsequent
treatment for the non-covered condition; and/or
• The Medicare coverage guidelines for the items or services in question (i.e., updates
or changes to the policy of an item or service).

NOTE: If any of the above changes during the course of treatment, a new ABN must
be issued.

For items or services that are repetitive or continuous in nature, notifiers may issue
another ABN to a beneficiary after one year for subsequent treatment for the non-
covered condition. However, this is not required unless any of the conditions described
above apply to the given situation.

Notifiers may give a beneficiary a single ABN describing an extended or repetitive


course of non-covered treatment provided that the ABN lists all items and services that
the notifier believes Medicare will not cover. If applicable, the ABN must also specify
the duration of the period of treatment. If during the course of treatment additional non-
covered items or services are needed, the notifier must give the beneficiary another
ABN.

If a beneficiary is receiving repetitive non-covered care, but the healthcare provider or


supplier failed to issue an ABN before the first or the first few episodes of care were
provided, the ABN may be issued at any time during the course of treatment. However,
if the ABN is issued after repetitive treatment has been initiated, the ABN cannot be
retroactively dated or used to shift liability to the beneficiary for care that had been
provided before ABN issuance. In cases such as this, care that was provided before
ABN delivery would be the financial responsibility of the healthcare provider or
supplier.

B. Incomplete ABNs

Allegations of improper or incomplete notices will be investigated by Medicare


contractors. If the notifier is found to have given improper or incomplete notice, the
applicable Medicare contractor will not hold the beneficiary liable in the individual case.

C. Electronic Issuance of the ABN

Electronic issuance of ABNs is not prohibited. If a healthcare provider or supplier elects


to issue an ABN that is viewed on an electronic screen before signing, the beneficiary has
the option of requesting paper issuance over electronic if that is what s/he prefers. Also,
regardless of whether a paper or electronic version is issued and regardless of whether the
signature is digitally captured or manually penned, the beneficiary should be given a
paper copy of the signed ABN to keep for his/her own records.

50.8.1- Options for Delivery Other than In-Person


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

ABNs should be delivered in-person and prior to the delivery of medical care which is
presumed to be non-covered. In circumstances when in-person delivery is not possible,
notifiers may deliver an ABN using another method. Examples include:

• Direct telephone contact;


• Mail;
• Secure fax machine; or
• Internet e-mail.

All methods of delivery require adherence to all statutory privacy requirements under
HIPAA. The notifier must receive a response from the beneficiary or his/her
representative in order to validate delivery.

When delivery is not in-person, the notifier must verify that contact was made in his/her
records. In order to be considered effective, the beneficiary should not dispute such
contact. Telephone contacts should be followed immediately by either a hand-delivered,
mailed, emailed, or a faxed notice. The beneficiary should sign and retain the notice and
send a copy of this signed notice to the notifier for retention in the patient’s record.

The notifier must keep a copy of the unsigned notice on file while awaiting receipt of the
signed notice. If the beneficiary does not return a signed copy, the notifier should
document the initial contact and subsequent attempts to obtain a signature in appropriate
records or on the notice itself.

50.9 - Effects of Lack of Notification, Medicare Review and Claim


Adjudication
(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

A. Beneficiary Liability

A beneficiary who has been given a properly delivered ABN and agrees to pay may be
held liable. The charge may be the healthcare provider or supplier’s usual and customary
fee for that item or service and is not limited to the Medicare fee schedule. If the
beneficiary does not receive proper notice when required, s/he is relieved from liability.

Notifiers may not issue ABNs to shift financial liability to a beneficiary when full
payment is made through bundled payments. In general, ABNs cannot be used where the
beneficiary would otherwise not be financially liable for payment for the service because
Medicare made full payment.

B. Healthcare Provider or Supplier Liability

A notifier will likely have financial liability for items or services if s/he knew or should
have known that Medicare would not pay and fails to issue an ABN when required, or
issues a defective ABN. In these cases, the notifier is precluded from collecting funds
from the beneficiary and is required to make prompt refunds if funds were previously
collected. Failure to issue a timely refund to the beneficiary may result in sanctions.

A notifier may be protected from financial liability when an ABN is required if s/he is
able to demonstrate that s/he did not know or could not reasonably have been expected to
know that Medicare would not make payment.
50.10 - Using ABNs for Medical Equipment and Supplies Claims When
Denials Under §1834(a)(17)(B) of the Act (Prohibition Against
Unsolicited Telephone Contacts) Are Expected
(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

To qualify for waiver of the Refund Requirements (RR) provision under §1834(a)(18) or
§1879(h)(3) of the Act (unassigned and assigned claims, respectively), an ABN must
clearly identify the particular item or service and state that the supplier expects that
Medicare will deny payment for that particular medical equipment or supplies because
the supplier violated the prohibition on unsolicited telephone contacts. Since it is the
unsolicited telephone contact which is prohibited by law, giving notice by telephone does
not qualify as notice and is not permissible. Telephone notice may not be used in this
case.

Since giving or mailing an ABN and obtaining the beneficiary’s agreement to pay before
telephoning is equivalent to obtaining the beneficiary’s written permission for the
supplier to telephone under §1834(a)(17)(A)(i) of the Act, a supplier has little to gain
from using the ABN process instead of simply seeking the beneficiary’s written
permission to contact him or her. If a supplier does use an ABN prior to calling, the
beneficiary’s agreement to pay is essential under the Refund Requirements in order for
the supplier to collect from the beneficiary. Medicare denial of payment because of the
prohibition on unsolicited telephone contacts applies to all varieties of medical equipment
and supplies and to all Medicare beneficiaries equally. Therefore, the usual restriction on
routine notices to all beneficiaries does not apply in this case.

Since unsolicited telephone contacts are expressly prohibited by statute, there is


presumption of supplier knowledge of this provision. To rebut this presumption, the
supplier must submit convincing evidence showing ignorance of the prohibition. A
previous denial of a claim for any item furnished by a particular supplier on the basis of
this prohibition is considered actual notice to that supplier. Such a denial shall be
construed as actual knowledge on all future claims.

50.11 - ABNs for Medical Equipment and Supplies Claims Denied


Under §1834(j)(1) of the Act (Because the Supplier Did Not Meet
Supplier Number Requirements)
(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)
To qualify for waiver of the RR under §1834(j)(4)(A) and §1879(h)(1) of the Act
(unassigned and assigned claims, respectively) for medical equipment and supplies for
which payment will be denied due to failure to meet supplier number requirements under
§1834(j)(1) of the Act, the ABN must state that Medicare will deny payment for any
medical equipment or supplies because the supplier does not have a supplier number.
The supplier should keep the ABN on file for documentation that the beneficiary has
knowledge of this particular denial and that the beneficiary accepts financial liability. This
relieves the supplier, which has duly notified a beneficiary of its lack of a supplier
number and the fact that Medicare will not pay, from the necessity of obtaining a signed
agreement from the beneficiary every time the beneficiary does business with the
supplier.

Exception to ABN Requirement

A supplier which can show that it did not know and could not reasonably have been
expected to know that a customer was a Medicare beneficiary, or that a customer was
making a purchase for a Medicare beneficiary, can seek protection under the LOL
provision or, in the case of unassigned claims, under the applicable RR provision,
§1834(j)(4) of the Act. Below are situations where the supplier may seek protection
under the LOL provision or the RR provision:

• If the supplier can show that a person who is not a Medicare beneficiary made a
purchase on behalf of a person who is a Medicare beneficiary and did not apprise the
supplier of the fact that the purchase was being made on behalf of a Medicare
beneficiary, the supplier may be protected.

• If the supplier can show that a Medicare beneficiary who made a purchase did not
identify himself or herself as a Medicare beneficiary and that the person’s age or
appearance was such that the supplier could not reasonably have been expected to
know or surmise that the person was a Medicare beneficiary, the supplier may be
protected. These protections are meant for an honest supplier in the rare case where a
Medicare beneficiary who is relatively youthful, healthy and able in appearance does
not identify himself or herself as a beneficiary and the supplier understandably does
not surmise that he or she might be a Medicare beneficiary.

If the involved Medicare beneficiary is found to be obviously aged and/or disabled, such
that any adult person working for a supplier would reasonably surmise that he or she
could be a Medicare beneficiary, the supplier’s allegation may not be accepted. If the
beneficiary purchased an item which would strongly suggest to any reasonable adult
person working for a supplier that the beneficiary is aged and/or disabled, the supplier’s
allegation may not be accepted.

• If a supplier can show that a customer, who is a Medicare beneficiary or was making
a purchase for a Medicare beneficiary and did not identify him/herself accordingly to
the supplier, was on notice of the necessity to so self-identify, the beneficiary may be
held liable, in which case the supplier could collect from the beneficiary.

Given the possible difficulty of showing conclusively that it did not know and could not
reasonably have been expected to know that a customer was a Medicare beneficiary, or
that a customer was making a purchase for a Medicare beneficiary, a supplier would be
well advised to consider using signage, giving public notice alerting customers that they
need to inform the supplier if they are a Medicare beneficiary or are making a purchase
for a Medicare beneficiary. If a supplier which does not have a supplier number provides
adequate public notice to a Medicare beneficiary before medical equipment or supplies
are furnished (e.g., by means of clearly visible signs, and if the adequacy of such public
notice is not disputed by the beneficiary) the supplier can qualify for waiver of the
Refund Requirements. Such public notices must be such that Medicare beneficiaries:

1. Are virtually certain to see them before purchasing or renting Medicare-covered


medical equipment or supplies from the supplier (that is, they are posted in places
where they are most likely to be seen by the target audience), and

2. May reasonably be expected to be able to read them and understand them.

Therefore, such public notices must be readily visible, in easily readable plain language,
in large print, and would have to be provided in the language(s) commonly used in the
locality.

Do not hold any beneficiary who cannot read any such public notice of a supplier to be
properly notified in advance by the supplier that Medicare will not pay. If a supplier
alleges that it provided adequate public notice to Medicare beneficiaries but a beneficiary
disputes the allegation, in the absence of conclusive evidence in favor of the supplier, do
not hold the beneficiary to be properly notified in advance by the supplier that Medicare
will not pay; hold the supplier liable. The RR provision that the beneficiary must agree
to pay for the item or service makes the use of signage without an ABN a risk for the
supplier. It would be in a supplier’s best interest to issue ABNs advising beneficiaries
that they will have to pay for supplies and to post public notices in its store(s) which
inform beneficiaries of the fact that it is not a Medicare enrolled supplier, and that claims
for supplies purchased from that supplier will be denied payment by Medicare. The use
of notices in conjunction with public notices will provide maximum protection to
suppliers as well as more surely providing proper notice to beneficiaries so that they can
make informed consumer decisions.

Medicare denial of payment on the basis of a supplier’s lack of a supplier number applies
to all varieties of medical equipment and supplies and to all Medicare beneficiaries
equally. Therefore, the usual restriction on routine notices to all beneficiaries does not
apply in this case.

50.12 - ABNs for Claims Denied in Advance Under §1834(a)(15) of the


Act
(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

A. Mandatory

A request for an advance determination of coverage of medical equipment and supplies is


mandatory under §1834(a)(15)(C)(i) & (ii) of the Act when:

• The item is listed by the Secretary as being subject to unnecessary utilization in your
contractor’s service area under §1834(a)(15)(A); or
• The supplier is listed by the Secretary under §1834(a)(15)(B) of the Act as a supplier
who has submitted a substantial number of claims, which have been denied as not
medically reasonable and necessary under §1862(a)(1) of the Act or the Secretary has
identified a pattern of over utilization.

In cases in which an advance coverage determination is mandatory, an ABN must be


issued to the beneficiary prior to furnishing the item. If the advance coverage
determination has not been received, or if the determination is that Medicare will not pay
for the care, an ABN is required prior to furnishing the requested item.

B. Optional

A request for an advance determination of coverage of medical equipment and supplies is


optional under §1834(a)(15)(C)(iii) of the Act when the item is customized and either the
beneficiary or the supplier requests an advance determination. In cases where an advance
coverage determination is optional and the beneficiary requests such a determination, an
ABN must be furnished prior to furnishing the requested item.

Every supplier is expected to know whether or not an advance coverage determination is


required for Medicare payment. The presumption of that supplier’s knowledge becomes
non-rebuttable after a single denial under §1834(a)(15) of a claim by a particular supplier.

50.13 - ABN Standards for Upgraded Durable Medical Equipment,


Prosthetics, Orthotics, and Supplies (DMEPOS)
(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

Notifiers must give an ABN before a beneficiary receives a Medicare covered item
containing upgrade components that are not medically reasonable and necessary and not
paid for by the supplier. DME upgrades involve situations in which the upgraded item or
component has a different Heath Insurance Common Procedure Coding System (HCPCS)
code than the item that will be covered by Medicare. Please refer to Chapter 20, Section
120 in this manual for information on billing procedures for ABN upgrades.

ABNs cannot be used to charge beneficiaries for premium quality services described as
“excess components.” Similarly, ABNs cannot be used to shift liability for an item or
service that is described on the ABN as being “better” or “higher quality” on an ABN but
do not exceed the HCPCS code description.

50.14 - ABNs for items listed in a DMEPOS Competitive Bidding


Program (CBP)
(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

Section 1862 (a)(17) of the Act excludes Medicare payment for CBP items/ services that
are provided by a non-contract supplier in a Competitive Bidding Area (CBA) except in
special circumstances. A non-contracted supplier is permitted to provide a beneficiary
with an item or service listed in the CBP when the supplier properly issues an ABN prior
to delivery of the item or service per 42 CFR §414.408(e)(3)(ii). In order for the ABN to
be considered valid when issued under these circumstances, the reason that Medicare
may not pay must be clearly and fully explained on the ABN that is signed by the
beneficiary.

To be a valid ABN, the beneficiary must understand the meaning of the notice. Suppliers
must explain to the beneficiary that Medicare will pay for the item if it is obtained from a
different supplier in the area. While some suppliers may be reluctant to direct
beneficiaries to a specific contracted supplier, the non-contracted supplier should at least
direct the beneficiary to 1-800 –MEDICARE to find a local contracted supplier at the
beneficiary’s request.

50.15 - Collection of Funds and Refunds


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)
Collection of Funds

A beneficiary’s agreement to be responsible for payment on an ABN means that the


beneficiary agrees to pay for expenses out-of-pocket or through any insurance other than
Medicare that the beneficiary may have. The notifier may bill and collect funds from the
beneficiary for non-covered items or services immediately after an ABN is signed, unless
prohibited from collecting in advance of the Medicare payment determination by other
applicable Medicare policy, State or local law. Regardless of whether they accept
assignment or not, healthcare providers and suppliers are permitted to charge and collect
the usual and customary fees; therefore, funds collected are not limited to the Medicare
allowed amounts.

If Medicare ultimately denies payment of the related claim, the notifier retains the funds
collected from the beneficiary unless the claim decision finds the healthcare provider or
supplier liable. When Medicare finds the healthcare provider or supplier liable or if
Medicare or a secondary insurer subsequently pays all or part of the claim for items or
services previously paid by the beneficiary to the notifier, the notifier must refund the
beneficiary the proper amount in a timely manner.

50.15.1 - Physicians’ Services RR


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

The physicians’ services RR provision, found in §1842(l) of the Act as amended by the
Omnibus Budget Reconciliation Act (OBRA) of 1986, requires timely refunds for certain
services. When a reduction in payment, not a full denial, occurs, the physician must
refund to the beneficiary amounts collected which exceed the Medicare payment for the
less extensive item or service. These RR apply to both participating and non-
participating physicians.
When the beneficiary signs an ABN agreeing to accept responsibility for payment before
services are delivered, the collected funds can be retained. A refund is not required if the
physician did not know and could not reasonably have been expected to know that
Medicare would not pay for the services because they were not reasonable and necessary.

The Medicare contractor must notify the beneficiary in any case in which the physician
requests review of the denial or reduction in payment or asserts that a refund is not
required.

50.15.2 - DMEPOS RR Provision for Claims for Medical Equipment


and Supplies
(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

All suppliers who sell or rent medical equipment and supplies to Medicare beneficiaries
are subject to the refund provisions of §§1834(a)(18), 1834(j)(4) and 1879(h) of the Act,
whether accepting assignment or not. Medical equipment and supplies are defined in the
following statutes applicable to this section:

• Durable medical equipment, as defined in §1861(n) of the Act;

• Prosthetic devices, as described in §1861(s)(8) of the Act;

• Orthotics and prosthetics, as described in §1861(s)(9) of the Act;

• Surgical dressings, as described in §1861(s)(5) of the Act;

• Home dialysis supplies and equipment, as described in §1861(s)(2)(F) of the Act;

• Immunosuppressive drugs, as described in §1861(s)(2)(J) of the Act;

• Therapeutic shoes for diabetics, as described in §1861(s)(12) of the Act;

• Oral drugs prescribed for use as an anticancer therapeutic agent, as described in


§1861(s)(2)(Q) of the Act;

• Self-administered erythropoietin, as described in §1861(s)(2)(P) of the Act; and

• Other items as determined by the Secretary.

If a proper ABN is not issued prior to the receipt of one of the preceding items and the
above provisions apply, the beneficiary has no financial responsibility. The refund
provisions of the Act apply to both assigned and unassigned claims.
50.15.3 - Time Limits and Penalties for Healthcare providers and
Suppliers in Making Refunds
(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)
A required refund must be made within specified time limits:

• The refund must be made to the beneficiary within 30 days after the date the
healthcare provider or supplier receives the remittance advice (RA) if the healthcare
provider or/supplier does not request review of an initial full or partial denial; or

• The refund must be made to the beneficiary within 15 days after the date the
healthcare provider or supplier receives the notice of the review determination if the
healthcare provider or supplier requests review within 30 days of receipt of the notice
of the initial determination.

Healthcare provider or suppliers who knowingly and willfully fail to make a refund
where required within these time limits may be subject to civil money penalties and/or
exclusion from the Medicare program.

The beneficiary should contact the contractor or CMS when a healthcare provider or
supplier fails to make a timely refund. If the contractor determines that a healthcare
provider or supplier failed to make a refund, it will contact the healthcare provider or
supplier in person or by telephone to discuss the facts of the case. The contractor will
attempt to determine why the required refund has not been made and will explain the
legal requirements. The contractor will determine whether referral to the Office of
Inspector General (OIG) or CMS is appropriate and will make appropriate referrals OIG
if necessary. The OIG or CMS may impose civil money penalties, assessments, and
sanctions if he or she fails to make the required refund. The contractor will retain a
detailed written report of contact.

50.15.4 - Supplier’s Right to Recover Resalable Items for Which Refund


Has Been Made
(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

If the Medicare contractor denies Part B payment for an item of medical equipment or
supplies on the basis of §1862(a)(1), §1834(a)(17)(B), §1834(j)(1), or §1834(a)(15) of the
Act, and the beneficiary is relieved of liability for payment for that item under
§1834(a)(18) of the Act, the effect of the denial, subject to State law, cancels the contract
for the sale or rental of the item. If the item is resalable or re-rentable, the supplier is
permitted to repossess the item. Suppliers are strongly discouraged from recovering
items which are consumable or not fit for resale or re-rental.

If a supplier makes proper refund under §1834(a)(18) of the Act, Medicare rules do not
prohibit the supplier from recovering from the beneficiary items which are resalable or
re-rentable. When the contract of sale or rental is cancelled on the basis described above,
the supplier may enter into a new sale or rental transaction with the beneficiary as long as
the beneficiary has been informed of their liability. If the circumstances which preclude
payment for the item have been removed (e.g. the supplier has now obtained a supplier
number when that supplier did not have one before), the supplier may submit to the
Medicare contractor a new claim based on the resale or re-rental of the item to the
beneficiary. If payment is still precluded, the supplier can issue an ABN.

Under the capped-rental method, if the Medicare contractor determines that the supplier
is obligated to make a refund, the supplier must repay Medicare those rental payments
that the supplier has received for the item. However, the Medicare beneficiary must
return the item to the supplier.

50.16 - CMS Regional Office (RO) Referral Procedure


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

Prior to submitting any materials to the RO, the Medicare contractor will contact the
RO to determine how to proceed in referring a potential sanction case for violation of
refund requirements. When referring these types of cases to the region, the contractor
should include the following:

Background of the Subject The subject’s business name, address,


Medicare Identification Number, owner’s
full name and Social Security Number,
Tax Identification Number (if different),
and a brief description of the subject’s
special field of medical equipment,
supplies, or services.

Origin of the Case A brief description of how the violations


were discovered.

Statement of Facts A statement of facts in chronological


order describing each failure to comply
with the refund requirements.

Written Correspondence and Written Copies of any meetings or telephone


Summaries contacts with the beneficiary and the
supplier regarding the supplier’s failure
to make a refund.
List of the following for each item or •Beneficiary Name and Medicare
service not refunded to the beneficiary beneficiary identifier;
by the supplier (grouped by beneficiary): •Claim Control Number;
•Procedure Code (CPT-4 or HCPCS) of
non-refunded item or service;
•Procedure Code modifier;
•Date of Service;
•Place of Service Code;
•Submitted Charge;
•Units (quantity) of Item or Service; and
•Amount Requested to be refunded.
Additional Information Any information that may be of value to
the RO.

50.17 – ABN Special Considerations


(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

A. Obligation to Bill Medicare

Upon receipt of an ABN, beneficiaries always have the right to ask the notifer to submit a
claim to Medicare for an official payment decision. A beneficiary must receive the
item/service described in the ABN and choose Option 1 in order to request Medicare
claim submission.

Healthcare providers or suppliers should refer to Publication 100-4, Chapter 1, Section 60


for instructions on submitting claims for statutorily non-covered items or services.

Note: Healthcare providers or suppliers will not violate mandatory claims submission
rules under Section 1848 of the Social Security Act when a claim is not submitted to
Medicare at the beneficiary’s request by their choice of Option 2 on the ABN.

B. Dually Eligible Individuals (Has a Qualified Medicare Beneficiary (QMB)


Program and/or Medicaid coverage)

Dually Eligible beneficiaries must be instructed to check Option Box 1 on the ABN in
order for a claim to be submitted for Medicare adjudication.

The provider must strike through Option Box 1 as provided below:

□ OPTION 1. I want the (D) listed above. You may ask to be paid now,
but I also want Medicare billed for an official decision on payment, which is sent to me
on a Medicare Summary Notice (MSN). I understand that if Medicare doesn’t pay, I am
responsible for payment, but I can appeal to Medicare by following the directions on
the MSN.

These edits are required because the provider cannot bill the dual eligible beneficiary
when the ABN is furnished. Providers must refrain from billing the beneficiary pending
adjudication by both Medicare and Medicaid in light of federal law affecting coverage
and billing of dual eligible beneficiaries. If Medicare denies a claim where an ABN was
needed in order to transfer financial liability to the beneficiary, the claim may be crossed
over to Medicaid or submitted by the provider for adjudication based on State Medicaid
coverage and payment policy. Medicaid will issue a Remittance Advice based on this
determination.

Once the claim is adjudicated by both Medicare and Medicaid, providers may only
charge the patient in the following circumstances:

• If the beneficiary has QMB coverage without full Medicaid coverage, the ABN could
allow the provider to shift financial liability to the beneficiary per Medicare policy.

• If the beneficiary has full Medicaid coverage and Medicaid denies the claim (or will
not pay because the provider does not participate in Medicaid), the ABN could allow
the provider to shift financial liability to the beneficiary per Medicare policy, subject
to any state laws that limit beneficiary liability.
Note: These instructions should only be used when the ABN is used to transfer potential
financial liability to the beneficiary and not in voluntary instances. More information on
dual eligible beneficiaries may be found at: https://www.cms.gov/Outreach-and-
Education/Medicare-Learning-Network-
MLN/MLNProducts/downloads/Medicare_Beneficiaries_Dual_Eligibles_At_a_Glan
ce.pdf

C. Ambulance Transports

Emergency or urgent situations In general, a notifier may not issue


an ABN to a beneficiary who has a
medical emergency or is under
similar duress. Forcing delivery of
an ABN during an emergency may
be considered coercive. ABN
usage in the ER may be
appropriate in some cases where
the beneficiary is medically stable
with no emergent health issues.
Non-emergent/urgent ambulance If the provider or supplier wants to
transport transfer liability to the beneficiary,
issuance of the ABN is mandatory for
ambulance transport services if all of
the following 3 criteria are met::

1. The service being provided is a


Medicare covered ambulance
benefit under §1861(s)(7) of the SSA
and regulations under this section as
stipulated in 42 CFR
§410.40 -.41;

2. The healthcare provider or


supplier believes that the service
may be denied, in part or in full, as
“not reasonable and necessary”
under § 1862(a)(1)(A) for the
beneficiary on that particular
occasion; and

3. The ambulance service is


being provided in a non-
emergency situation. (The
patient is not under duress.)

ABN issuance is mandatory only when a beneficiary’s covered ambulance transport is


modified to a level that is not medically reasonable and necessary and will incur
additional costs. If an ambulance transport is statutorily excluded from coverage because
it fails to meet Medicare’s definition of the ambulance benefit, a voluntary ABN may be
issued to notify the beneficiary of his/her financial liability as a courtesy.

D. Hospice

Mandatory use of the ABN is very limited for hospices. Hospice providers are
responsible for providing the ABN when required as listed below for items and services
billable to hospice. Hospices are not responsible for issuing an ABN when a hospice
patient seeks care outside of the hospice’s jurisdiction.

The three situations that would require issuance of the ABN by a hospice are:

• Ineligibility because the beneficiary is not determined to be “terminally ill” as defined


in §1879(g)(2) of the Act; or
• Specific items or services that are billed separately from the hospice payment, such as
physician services, are not reasonable and necessary as defined in either
§1862(a)(1)(A) or §1862(a)(1)(C); or

• The level of hospice care is determined to be not reasonable or medically necessary as


defined in §1862(a)(1)(A) or §1862(a)(1)(C), specifically for the management of the
terminal illness and/or related conditions.

Note: It is the hospice’s responsibility to issue an ABN when a beneficiary who has
elected the hospice benefit chooses to receive inpatient hospice care in a hospital that is
not under contract with the hospice. The hospice may delegate delivery of the ABN to
the hospital in these cases.
End of all Medicare covered hospice care –

When it is determined that a beneficiary who has been receiving hospice care is no longer
terminally ill and the beneficiary is going to be discharged from hospice, the hospice may
be required to issue the Notice of Medicare Non-coverage (NOMNC), CMS 10123. If
upon discharge the patient wants to continue receiving hospice care that will not be
covered by Medicare, the hospice would issue an ABN to the beneficiary in order to
transfer liability for the non-covered care to the beneficiary. If no further hospice
services are provided after discharge, ABN issuance would not be required.

ABNs are not required for Hospice Services in these situations:

• Revocations - Hospice beneficiaries or their representatives can revoke the hospice


benefit. Revocations are not considered terminations under liability notice policy
since the beneficiary is exercising his/her own freedom of choice. Therefore, no
ABN is required.

• Respite Care Beyond Five Consecutive Days - Respite care is limited to five
consecutive days under the Act. When respite care exceeds five consecutive days, an
ABN is not required since additional days of respite care are not part of the hospice
benefit. CMS encourages hospice providers to give the ABN as an optional notice to
inform patients of financial liability when more than five days of respite care will be
provided.

• Transfers - Beneficiaries are allowed one transfer to another hospice during a benefit
period. However, subsequent transfers within the same benefit period are not
permitted. In either case, an ABN is not required.

• Failure to Meet the Face to Face Requirement - The ABN must not be issued when
the face to face requirement for hospice recertification is not met within the required
timeframe. Failure to meet the face to face requirement for recertification should not
be misrepresented as a determination that the beneficiary is no longer terminally ill.

• Room and Board Costs for Nursing Facility Residents - Since room and board are
not part of the hospice benefit, an ABN would not be required when the patient elects
hospice and continues to pay out of pocket for long term care room and board.

E. Comprehensive Outpatient Rehabilitation Facility (CORF)

Since Comprehensive Outpatient Rehabilitation Facility (CORF) services are billed under
Part B, CORF providers must issue the ABN according to the instructions given in this
section. The ABN is issued by CORFs before providing a service that is usually covered
by Medicare but may not be paid for in a specific case because it is not medically
reasonable and necessary.

When all Medicare covered CORF services are going to end, CORF’s are required to
issue a notice regarding the beneficiary’s right to an expedited determination called a
NOMNC, CMS 10123. Upon termination of all CORF care, the ABN would be issued
only if the beneficiary wants to continue receiving some or all services that will not be
covered by Medicare because they are no longer considered medically reasonable and
necessary. An ABN would not be issued if no further CORF services are provided.

F. Home Health Agency (HHA)

The following chart summarizes the statutory provisions related to ABN issuance for
LOL purposes:

Application of LOL for the Home Health Benefit


Citation Brief Recommen
from the Descripti ded
Act on of Explanation
§1862(a)(1)( Care is not Medicare does not
A) reasonable and pay for care that is
necessary not medically
reasonable and
§1862(a)(9) Custodial care is Medicare does not
the only care usually pay for
delivered custodial care,
§1879(g)(1) Beneficiary is Medicare requires
(A) not homebound that a beneficiary
cannot leave home
(with certain
exceptions) in order
to cover services
§1879(g)(1) Beneficiary does Medicare requires
(B) not need skilled part-time or
nursing care on intermittent need for
an intermittent skilled nursing care
basis in order to cover

Triggering Events for ABN issuance by HHAs*

HHAs may be required to provide an ABN to an Original Medicare beneficiary when a


triggering event occurs.

EVENT DESCRIPTION EXAMPLE


Initiation An ABN must be issued to the A beneficiary
beneficiary prior to receiving requires
care that is usually covered by skilled nursing
Medicare, but in this particular wound care 3
instance, it is not covered or times weekly;
may not be covered by however, she
Medicare because the care is is not confined
not medically reasonable and to the home.
necessary, the beneficiary is She wants the
not confined to his/her home care done at
(considered homebound), or her home by
the beneficiary does not need the HHA.
skilled nursing care on an
intermittent basis, or the
beneficiary is receiving
custodial care only.
Reduction Reductions involve any decrease in The beneficiary
services or supplies, such as frequency, requires physical
amount, or level of care, provided by therapy (PT) for gait
the HHA and/or care that is part of the retraining 5 times per
POC. week for 2 weeks,
If a reduction occurs for an item or then reduce to 3
service that will no longer be covered times weekly for 2
by Medicare but the beneficiary wants weeks. After 2 weeks
to continue to receive the care and of PT, the beneficiary
assume the financial charges, the HHA wants to continue
must issue the ABN prior to providing therapy 5 times a
the non-covered items or services. week even though
this amount of
therapy is no longer
medically reasonable
and necessary. The
HHA would issue an
ABN to the
beneficiary so that he
understands the
situation and can
consent to financial
responsibility for the
PT not covered by
Medicare.
Termination When an HHA expects that Medicare
coverage will end for all items and
services in total.
*If the beneficiary does not want the item or service that is being initiated, reduced, or
terminated, no ABN is required.
When an HHA performs an initial assessment of a beneficiary prior to admission but does
not admit the beneficiary, an ABN is not required if there is no charge for the assessment.
However, if an HHA charges for an assessment, the HHA must provide notice to the
beneficiary before performing and charging for this service.

Since Medicare has specific requirements for payment of home health services, there may
be occasions where a payment requirement is not met, and therefore, the HHA expects
that Medicare will not pay for the services. The HHA cannot use the ABN to transfer
liability to the beneficiary when there is concern that a billing requirement may not be
met. For example, a home health agency can’t issue an ABN at initiation of home care
services in order to charge the beneficiary if the healthcare provider face to face
encounter requirement is not met.

When all Medicare covered home health care is terminated, HHAs may sometimes be
required to deliver the NOMNC, CMS- 10123. The NOMNC informs beneficiaries of
the right to an expedited determination by a Quality Improvement Organization (QIO) if
they feel that termination of home health services is not appropriate. If a beneficiary
requests a QIO review upon receiving a NOMNC, the QIO will make a fast decision on
whether covered services should end. If the QIO decides that Medicare covered care
should end and the patient wishes to continue receiving care from the HHA even though
Medicare will not pay, an ABN must be issued to the beneficiary since this would be an
initiation of non-covered care.

HHA Exceptions to ABN Notification Requirements

ABN issuance is NOT required in the following HHA situations:

• initial assessments (in cases where beneficiaries are not admitted) for which HHAs do
not charge;

• care that is never covered by Medicare under any circumstances (i.e., an HHA offers
complimentary hearing aid cleaning and maintenance);

• telehealth monitoring used as an adjunct to regular covered HH care; or

• non-covered items/services that are part of care covered in total under a Medicare
bundled payment (e.g., HH prospective payment system (PPS) episode payment).

60 - Home Health Change of Care Notice (HHCCN), Form CMS-10280


(Rev. 2781, Issued: 09-06-13, Effective: 12-09-13, Implementation: 12-09-13)

This section provides the standards for use by home health agencies (HHAs) in
implementing the Home Health Change of Care Notice (HHCCN), Form CMS-10280,
requirements. The HHCCN is issued to Original Medicare beneficiaries before reducing
or terminating most ongoing care provided by the HHA.
HHCCN Quick Glance Guide
This is an abbreviated reference tool and is not meant to replace or supersede any of the directives contained in
Section 60.
Notice Name Home Health Change of Care Notice (HHCCN)
Notice Number Form CMS-10280
Issued by Home Health Agency (HHA) provider
Recipient Original Medicare (fee for service) beneficiary receiving home health care
Pertinent Information The HHCN replaces HHABN Option Box 2 and Option Box 3.
The Advance Beneficiary Notice of Noncoverage (ABN), CMS-R-131, replaces
HHABN Option Box 1.
See section 50 for ABN information and instructions.
Change of care notice Prior to the HHA reducing or Immediately on determination, or if No.
discontinuing care listed in the possible, provide enough time for
beneficiary’s plan of care (POC) for the beneficiary to arrange to obtain
administrative reasons specific to the the reduced or discontinued home
HHA on that occasion health care service(s) from a
different HHA.
Prior to the HHA reducing or Notify the beneficiary before the No.
discontinuing Medicare covered care actual reduction or discontinuation,
listed in the POC because of a if possible.
physician ordered change in the plan
of care or a lack of orders to
continue the care

The HHCCN replaces the Home Health Advance Beneficiary Notice (HHABN), CMS-R-
296, Option Box 2 and Option Box 3. Option Box 1 of the HHABN is replaced by the
existing Advance Beneficiary Notice of Noncoverage (ABN),CMS-R-131, which is
detailed in Section 50 of this chapter. HHAs should begin using the ABN and HHCCN
in place of the HHABN as soon as possible since the HHABN will be discontinued. The
date for mandatory use of the HHCCN and ABN in place of the HHABN will be posted
on the web link for home health notices at http://www.cms.gov/Medicare/Medicare-
General-Information/BNI/index.html.

Table 1 HHA Notice Changes


Instead of: Use:
HHABN Option Box 1 ABN (CMS-R-131)
HHABN Option Box 2 HHCCN
HHABN Option Box 3 HHCCN

60.1 - Background on the HHCCN


(Rev. 2781, Issued: 09-06-13, Effective: 12-09-13, Implementation: 12-09-13)

HHAs have issued HHABNs related to the absence or cessation of Medicare coverage
when a beneficiary had liability protection under §1879 of the Social Security Act (the
Act) since 2002. The HHABN gained additional notification capabilities in 2006
following the U.S. Court of Appeals (2nd Circuit) decision in Lutwin v. Thompson, 361
F.3d 146; 2004 U.S. App. LEXIS 3774. Following Lutwin, the HHABN was modified so
that it could also be used by HHAs to notify beneficiaries receiving home health services
of any care changes in accordance with the HHA conditions of participation (COPs) in
§1891 of the Act.

To account for this expanded use, the HHABN was revised to contain three
interchangeable Option Boxes within the body of the notice designated as Option Box 1,
Option Box 2, and Option Box 3. Option Box 1 language was applicable to situations
involving potential beneficiary liability for HHA services as directed by §1879 of the
Act. Option Box 2 or Option Box 3 was inserted into the HHABN form to notify
beneficiaries of changes in a home health plan of care that are subject to the requirements
of § 1891 of the Act.

In order to streamline, reduce, and simplify notices issued to Medicare beneficiaries, the
HHABN is being discontinued. HHABN, Option Box 1, which is the liability portion of
the notice, is replaced by the existing Advance Beneficiary Notice of Noncoverage
(ABN), CMS-R-131. The change of care notification portions of the HHABN, Option
Box 2 and Option Box 3, is replaced by the newly approved HHCCN.

60.2 - Scope of the HHCCN


(Rev. 2781, Issued: 09-06-13, Effective: 12-09-13, Implementation: 12-09-13)

A. Statutory Authorization for HHCCN

The requirement to give an HHCCN is based on the HHA COPs in §1891 of the Act. The
COPs are further implemented through Title 42 of the Code of Federal Regulations
(CFR), Part 484.

§1891(a)(1)(E) stipulates that beneficiaries have:

“The right to be fully informed orally and in writing (in advance of coming under the care
of the [home health] agency) of –

all items and services furnished by (or under arrangement with) the agency for which
payment may be made under this title,

the coverage available for such items and services under this title, title XIX or any
other Federal program of which the agency is reasonably aware,

any charges for items and services not covered under this title and any charges the
individual may have to pay with respect to items and services furnished by (or under
arrangement with) the agency, and

any changes in the charges or items and services described in clause (i), (ii) or (iii).”

HHAs are required to use the HHCCN to notify the beneficiary of reductions and
terminations in health care in accordance with Medicare COPs.
B. HHAs and Other CMS Notices

HHAs will now use the Advanced Beneficiary Notice (ABN), Form CMS-R-131 for
liability notification instead of the HHABN Option Box 1. The ABN and form
instructions can be downloaded from the CMS website at:
http://www.cms.gov/Medicare/Medicare-General-Information/BNI/ABN.html

HHAs must continue to issue an expedited determination notice called the Notice of
Medicare Provider Non-Coverage, (NOMNC), CMS-10123, if applicable, when all
covered services are being terminated. Please see the “FFS ED Notices” link at:
http://www.cms.gov/Medicare/Medicare-General-Information/BNI/FFSEDNotices.html
for information on the delivery of expedited determination notices.

C. HHCCN Issuers and Recipients

HHAs are the only type of Medicare provider that issues the HHCCN to notify the
beneficiary of care changes involving reductions or terminations of items and/or services.
The recipients of the HHCCN are beneficiaries enrolled in Original Medicare only.
HHCCNs are not used in Medicare managed care. When a beneficiary transitions to
Medicare managed care from Original Medicare during a home health episode, HHCCN
issuance is required only if there is a specific need to provide notification of changes in
care as the transfer occurs.

Subcontractors may deliver HHCCNs under the direction of a primary HHA; however,
notification responsibility, including effective delivery, always rests with the primary
HHA. HHAs are always responsible for providing HHCCNs associated with the care that
they provide. In the form instructions and instructions in this section, the term
“beneficiary” is used to mean the beneficiary or the beneficiary's representative, as
applicable. For more information on representatives, see §40.3.5 and §40.3.4.3 of this
chapter.

HHAs should contact their CMS Regional Office if they have questions on the HHCCN
or related instructions. Beneficiaries who need assistance may be directed to call 1-800-
MEDICARE.

60.3 - Triggering Events for HHCCN/Written Notice


(Rev. 2781, Issued: 09-06-13, Effective: 12-09-13, Implementation: 12-09-13)

HHAs may be required to provide an HHCCN to an Original Medicare beneficiary at two


points in time, for reasons not related to Medicare coverage called “triggering events”:

Table 2
Triggering Events for HHCCN Issuance
EVENT DESCRIPTION
Reduction When an HHA reduces or stops an item and/or
of a service service during a spell of illness while continuing
others, including when one home health
discipline ends but others continue.
Termination When an HHA ends delivery of all services.
of all services

A. Reductions

Reductions involve any decrease in items and/or services, such as frequency, amount, or
level of care, provided by the HHA. When care that is listed on the POC or provided by
the HHA is reduced, the beneficiary must receive the HHCCN listing the items/services
being reduced and the reason for the reduction, regardless of who is responsible for
paying for that service.

When a reduction occurs because the HHA decides to stop providing the service for
administrative reasons or because of a physician’s order, the HHCCN must be issued.

Example 1 – Reduction for HHA reasons:

Because of a temporary staffing shortage, an HHA reduces daily physical therapy


(PT) to PT 3 times weekly for 2 weeks.

The HHCCN must be issued to the beneficiary prior to this care reduction that is
due to an agency administration issue.

Example 2 –Reduction based on physician’s orders:

The beneficiary met PT goals sooner than expected, and the attending physician
writes an order to discontinue home PT. Physical therapy services are
discontinued with no change in existing skilled nursing orders.

The HHCCN must be issued to the beneficiary prior to this care reduction that is a
change to the existing POC because of a physician’s order. Reductions include
cases, such as this, where one type of care ends, but the beneficiary continues to
receive another type of home health service.

An ABN is issued (and not the HHCCN) if a reduction occurs for an item or service that
will no longer be covered by Medicare but the beneficiary wants to continue to receive
the care and assume the financial charges. See Section 50.15.4.

B. Terminations

A termination is the cessation of all services provided by the HHA and can include
Medicare covered and noncovered care. When all home health care is ending for reasons
not related to Medicare coverage, the HHA issues the HHCCN with information
appropriate to the specific situation.
Example 1 – care termination due to agency reasons (such as staffing, closure of the
HHA, concerns for staff safety), not related to Medicare coverage.

An HHA decides to stop providing care because guard dogs at the home where
the care is being furnished have posed safety issues for staff.

Because termination is due to an HHA administrative decision, the HHCCN must be


given to the beneficiary prior to discontinuation of services.

Example 2 – care termination due to agency reasons (failure to meet face to face
encounter requirement)

An HHA has initiated care for a beneficiary, and the beneficiary has not yet had
the required face to face encounter with the certifying physician or an allowed
non-physician practitioner (NPP). The HHA believes that the face to face
encounter requirement will not be met in the allowed time frame and decides to
stop providing care.

This termination is due to an HHA administrative decision; thus, the HHCCN must be
given to the beneficiary prior to discontinuation of services. Issuing the HHCCN does not
affect financial liability but serves as a written change of care notice as required by the
HHA COPs.

Example 3 – care termination due to a physician’s orders to discontinue care or a


lack of orders to continue care

A physician orders discontinuation of all home health services or fails to order


continued home health services.

The Notice of Medicare Provider Non-Coverage (NOMNC), CMS-10123 must be issued


to the beneficiary when all Medicare covered services are ending based on the
physician’s orders. Since the NOMNC provides written notification of the forthcoming
termination of all home health care, it satisfies the regulatory requirement for change of
care advisement (HHCCN issuance). Thus, when the NOMNC is issued as required, the
HHA doesn’t have to issue a separate HHCCN. When home health services end because
of physician’s orders, HHAs have the option of issuing the NOMNC alone or both the
NOMNC and the HHCCN.

Detailed information and instructions for issuing the NOMNC can be found on the CMS
website at: http://www.cms.gov/Medicare/Medicare-General-
Information/BNI/FFSEDNotices.html

C. Effect of Other Insurers/Payers

HHCCN requirements apply only when home health services are expected to be partially
or fully covered by Medicare. When a beneficiary is not receiving any services that are
expected to be covered under the Medicare home health benefit, the HHCCN is not
required. For example, if a dual eligible beneficiary (having both Medicare and
Medicaid) is not receiving any Medicare covered home health services, HHCCN issuance
wouldn’t be required when changes of care occur. (NOTE: HHAs are required to issue
the ABN to dual eligible beneficiaries when applicable. See Section 50.15.4 C)

D. Exceptions to HHCCN Notification Requirements

The HHCCN is NOT required when changes in care involve:

• increase in care;

• changes in HHA caregivers or personnel as decided by the HHA;

• changes in expected arrival or departure time for HHA staff as determined by the
HHA;

• changes in brand of product, ( i.e., the same item produced by a different


manufacturer) as determined by the HHA;

• change in the duration of services that has been included in the POC and
communicated to the beneficiary by the HHA, ( i.e., shorter therapy sessions as
health status improves, such as a reduction from an hour to 45 minutes);

• lessening the number of items or services in cases where a range of services is


included in the POC;

Example: The POC order states: PT 3-5x per week as needed for gait
training. The therapist begins therapy at 5 times per week, and as the patient
progresses, therapy is reduced to 3 times per week. No HHCCN would be
needed in this case.

• changes in the mix of services delivered in a specific discipline (e.g., skilled


nursing) with no decrease in frequency with which that discipline is delivered;

Example: A beneficiary is receiving several skilled nursing services during


visits that are scheduled 3 times a week. One service within that discipline, a
blood draw 1 time a week, is discontinued. Other skilled nursing services
(wound care and education) continue, such that skilled nursing visits continue
to occur 3 times per week. No HHCCN is required when the blood draws are
discontinued, only when skilled nursing is reduced in frequency.

• changes in the modality affecting supplies employed as part of specific treatment


(e.g., wound care) with no decrease in the frequency with which those supplies
are provided; or
Example: A specific wound care product like Alldress is stopped, and a
Hydrogel pad is started. Since this represents a change in the modality (or
intervention) and not a reduction, no HHCCN is necessary.

• changes in care that are the beneficiary’s decision and are documented in the
medical record.

60.4 - Completing the HHCCN


(Rev. 2781, Issued: 09-06-13, Effective: 12-09-13, Implementation: 12-09-13)

A. Notices and General Notice Requirements

The HHCCN and the general instructions for preparing the HHCCN are available for
download at the home health notice link found at
http://www.cms.gov/Medicare/Medicare-General-Information/BNI/index.html.

The notice is available in English and Spanish, and in PDF and Word formats. The
HHCCN is the Office of Management and Budget (OMB) approved standard notice for
use by Medicare HHAs to inform beneficiaries of changes in the POC when required by
the COPs for HHAs. HHAs must use the OMB approved standard notice. HHAs must
not add any customizations to the notice beyond what is permitted by the accompanying
HHCCN form instructions and the guidelines published in this section.

B. Choosing the Correct Language Version

HHAs should choose the appropriate version of the HHCCN based on the language the
beneficiary best understands. When a Spanish-language HHCCN is used, the HHA
should make insertions on the notice in Spanish. If this is impossible, the HHA must take
additional steps needed to assure beneficiary comprehension and document this on the
HHCCN.

If needed, HHAs must provide verbal assistance in other languages to assist beneficiaries
in understanding the document. HHAs should document any types of translation
assistance used in the “Additional Information” section of the notice.

C. Compliance with Paperwork Reduction Act of 1995

Consistent with the Paperwork Reduction Act of 1995, the valid OMB control number for
this information collection appearing on the HHCCN is 0938-1196. The estimated time
required to complete this information collection is 4 minutes for a single notice. This
includes the time to prepare the notice, review it with the beneficiary, and obtain the
beneficiary’s signature.

D. Effective Dates

HHCCNs are effective for HHA use per the OMB assigned date given at the bottom of
each notice unless CMS instructs HHAs otherwise. The routine approval is for 3-year
use. HHAs are expected to exclusively use the effective version of the HHCCN per CMS
directives.

60.5 - HHCCN Delivery


(Rev. 2781, Issued: 09-06-13, Effective: 12-09-13, Implementation: 12-09-13)

HHAs must make every effort to ensure beneficiaries understand the entire HHCCN prior
to signing it. When delivering HHCCNs, HHAs are required to explain the notice and its
content, and answer beneficiary questions to the best of their ability. If abbreviations are
used, the HHA should explain their meaning to the beneficiary. If the beneficiary
requests additional information while completing the HHCCN, the HHA must respond
timely, accurately, and completely to the information request.

While in-person delivery of the HHCCN is preferable, it is not required consistent with
general ABN requirements, see Medicare Claims Processing Manual, Chapter 30,
§40.3.4.1.

If a mode other than in person delivery is used, the HHA must adhere to the requirements
under the Health Insurance Portability and Accountability Act (HIPAA). Instructions on
ABN telephone notice found in §40.3.4.2 of this chapter are also applicable to HHCCNs.

Delivery when change of care is due to agency administrative reasons

The HHA should review the text associated with the box that was checked on the
HHCCN by the HHA and verbally explain to the beneficiary that he/she may be able to
obtain the same or similar care from another HHA, since coverage through Medicare is
not affected. HHAs are encouraged to do as much as possible to offer ideas to
beneficiaries for contacting other HHAs and must inform ordering physicians of
reductions/terminations consistent with the COPs for HHAs.

Delivery when change of care is due to physician orders

The HHA should review the text associated with the box that was checked on the
HHCCN by the HHA, and inform the beneficiary that the HHA will no longer provide
certain care because the physician’s order has changed. When requested, the HHA may
facilitate contact and understanding between the physician and beneficiary. The
beneficiary may also seek to contact the physician directly.

Retention of the HHCCN

The HHA keeps a copy of the completed, signed or annotated HHCCN in the
beneficiary’s record, and the beneficiary receives a copy. HHA’s may retain a scanned
copy of the paper copy document in an electronic medical record if desired. The primary
HHA must retain the HHCCN if a subcontractor is used.
Applicable retention periods are discussed in Chapter 1 of this manual, §110. In general,
this is 5 years from discharge when there are no other applicable requirements under
State law.

Other Considerations During Completion

1. Beneficiary Unable to Sign

If the beneficiary is physically unable to sign the HHCCN and is fully capable of
understanding the notice a representative is not required for signature. The beneficiary
may allow the HHA to annotate the HHCCN on his/her behalf regarding this
circumstance. For example, a fully cognizant beneficiary with two broken hands may
allow an HHA staff person to sign and date the notice in the presence of and under the
direction of the beneficiary, inserting the beneficiary’s name along with his/her own
name, i.e., “John Smith, Shiny HHA, signing for Jane Doe.” Such signatures should be
witnessed by a second person whenever possible. Further, the medical record should
support the beneficiary’s inability to write in the applicable time period.

2. Timely Notice

There are no exact time frames for HHCCN delivery. Delivery timing of the notice may
sometimes occur immediately upon the HHA finding that a change in care is warranted.
However, in general, HHCCN should be delivered far enough in advance of the care
change so that the beneficiary may pursue alternatives to continue receiving the care
noted on the HHCCN. When plans for issuance of the notice are known in advance, the
HHCCN should not be issued so far in advance as to cause confusion regarding the
information it conveys.

Some allowance is made for “immediate” delivery prior to furnishing the care at issue
when unforeseen circumstances arise such as an impending, unforeseen agency staffing
shortage or a dangerous home situation. This should be avoided whenever possible, but
is permissible when a situation occurs prompting an immediate determination to reduce
or end services that could not have been made in advance.

70 - Skilled Nursing Facility Advance Beneficiary Notice of Non-(Rev.: 4198; Issued:


01-11-19; Effective: 04-30-18; Implementation: 04-30-18)

The following are the standards for use by Skilled Nursing Facilities (SNFs) in
implementing the SNF ABN (CMS-Approved Model Form CMS-10055) requirements.
This section provides instructions, consistent with the SNF prospective payment system
(SNF PPS), regarding the SNF ABN.

SNF ABN - Quick Glance Guide 3

3
This is an abbreviated reference tool and is not meant to replace or supersede any of the directives contained in Section 70.
Notice Name: SNF ABN
Notice Number: CMS-Approved Model, Form CMS-10055
Issued by: SNFs for non-covered SNF PPS extended care items or services.
Recipient: Original Medicare fee-for-service (FFS) beneficiary

Additional Information:

The ABN, Form CMS-R-131 should be used for Part B non-covered items or services. SNFs should no
longer use the 5 SNF Notices of Non-coverage (Denial Letters) or the NEMB-SNF (CMS-20014) as these
have been discontinued with the 2018 SNF ABN revision.

Type of Must be issued in order to transfer Timing of notice: Optional/Voluntary


Notice: liability to the beneficiary: use:
Financial Before SNF PPS extended care items or Prior to delivery of the Yes. It is
liability services are furnished, reduced, or care item or service in recommended, but
notice terminated when the SNF, the UR question. Provide enough not necessary to
entity, the QIO, or the Medicare time for the beneficiary to transfer liability, for
contractor believes that Medicare may make an informed SNFs to issue prior
not pay for, or will not continue to pay decision on whether or to furnishing a care
for, those extended care services on the not to receive the service item or service that
basis of one of the following statutory or item in question and is never covered by
exclusions: accept potential financial Medicare (i.e. not a
liability. Medicare benefit).
• Not reasonable and necessary
(“medical necessity”) for the
diagnosis or treatment of illness,
injury, or to improve the
functioning of a malformed body
member (§1862(a)(1) of the Act);
or

• Custodial care (“not a covered


level of care”) (§1862(a)(9) of the
Act).

70.1 - SNF ABN Standards


(Rev.: 4198; Issued: 01-11-19; Effective: 04-30-18; Implementation: 04-30-18)

Step by step instructions for notice completion are posted along with the online replicable
copies of the CMS-Approved Model, Form CMS-10055 on the CMS website. SNFs must
not add any customizations to the notice beyond what is permitted by the accompanying
SNF ABN form instructions and the guidelines published in this section. SNFs should
follow the same standards when completing the SNF ABN as the ABN, Form CMS-R-
131 in §50.6 of this chapter, as applicable.
70.2 - Situations in Which a SNF ABN Should Be Given
(Rev.: 4198; Issued: 01-11-19; Effective: 04-30-18; Implementation: 04-30-18)

A. Triggering Events

A SNF ABN is evidence of beneficiary knowledge about the likelihood of a Medicare


denial, for the purpose of determining financial liability for expenses incurred for
extended care items or services furnished to a beneficiary and for which Medicare does
not pay. If Medicare is expected to deny payment (entirely or in part) on the basis of one
of the exclusions listed in §70 of this chapter for extended care items or services that the
SNF furnishes to a beneficiary, a SNF ABN must be given to the beneficiary in order to
transfer financial liability for the item or service to the beneficiary. The initiation,
reduction and termination of such extended care items or services, that Medicare may not
pay, are considered triggering events. The following describe the three triggering events
for a SNF ABN:

EVENT DESCRIPTION
Initiation In the situation in which a SNF believes Medicare
will not pay for extended care items or services
that a physician has ordered, the SNF must
provide a SNF ABN to the beneficiary before it
furnishes those non-covered extended care items
or services to the beneficiary.
Reduction In the situation in which a SNF proposes to
reduce a beneficiary’s extended care items or
services because it expects that Medicare will
not pay for a subset of extended care items or
services, or for any items or services at the
current level and/or frequency of care that a
physician has ordered, the SNF must provide a
SNF ABN to the beneficiary before it reduces
items or services to the beneficiary.
Termination In the situation in which a SNF proposes to stop
furnishing all extended care items or services to
a beneficiary because it expects that Medicare
will not continue to pay for the items or services
that a physician has ordered and the beneficiary
would like to continue receiving the care, the
SNF must provide a SNF ABN to the
beneficiary before it terminates such extended
care items or services.

B. Effect of Other Insurers/Payers


Some States have specific rules established regarding completion of liability notices in
situations where dual-eligibles need to accept liability for Medicare non-covered care that
will be covered by Medicaid. Medicaid has the authority to make this assertion under
Title XIX of the Act, where Medicaid is recognized as the “payer of last resort”, meaning
other Federal programs like Medicare (Title XVIII) must pay in accordance with their
own policies before Medicaid picks up any remaining charges. If the patient is a
Medicare-Medicaid dual-eligible and a triggering event occurs, the SNF needs to give the
beneficiary a SNF ABN.

On a practical basis, physician-prescribed items or services continue without interruption


or reduction when a patient changes “payer eligibility” from Medicare to Medicaid.
From the Medicare coverage vantage-point, however, there is a reduction or termination
when Medicare, which has been paying, stops paying. In other words, there is a
triggering event, which underlies the change in “payer eligibility.” In these instances, a
SNF ABN must be issued to transfer financial liability to the beneficiary.

70.3 - Situations in Which a SNF ABN Is Not Needed to Transfer


Financial Liability to the Beneficiary
(Rev.: 4198; Issued: 01-11-19; Effective: 04-30-18; Implementation: 04-30-18)

SNFs need not issue a SNF ABN to transfer financial liability to the beneficiary:

• If the extended care item or service is not a Medicare benefit (e.g., personal
comfort items excluded under §1862(a)(6)).

• If a beneficiary is being furnished post-hospital extended care services while a


resident in a SNF and payment is expected to be denied for an otherwise
Medicare covered benefit because it does not meet a technical benefit
requirement (e.g., SNF stay not preceded by the required prior three-day
hospital stay or the beneficiary is exhausting his/her 100 benefit days).

• If Medicare is expected to deny payment for Part B covered medical and other
health services which the SNF furnishes, either directly or under arrangements
with others, to an inpatient of the SNF, where payment for these services
cannot be made under Part A (e.g., the beneficiary has exhausted his/her
allowed days of inpatient SNF coverage under Part A in his/her current spell
of illness or was determined to be receiving a non-covered level of care).
• If the SNF will not furnish the extended care items or services. A SNF must
not give a beneficiary a SNF ABN and then refuse to furnish extended care
items or services even though the beneficiary elects to receive these items or
services by selecting Option 1, as this is equivalent to the prohibited practice
of the SNF pre-selecting Option 2 (not to receive items or services) on a SNF
ABN. This rule also applies when the beneficiary agrees with the triggering
event (i.e., terminating therapy) and the beneficiary will not be receiving the
extended care items or services.

NOTE: This rule is not applicable in the situation where the beneficiary
elects to receive extended care items or services but refuses to sign the SNF
ABN attesting to being personally and fully responsible for payment, in which
case, the SNF may then consider not furnishing the specified items or
services.
• For Medicare Advantage (Part C) enrollees nor for non-Medicare patients
because it is to be used solely for individuals enrolled in the Medicare FFS
program (Parts A and B).

• When extended care items or services are reduced or terminated in accordance


with a physician’s order, where a physician does not order the items or
services at issue, or where the physician agrees in writing with the SNF’s, the
UR entity’s, the QIO’s, or the Medicare contractor’s assessment that the
extended care items or services are not necessary.

• For swing-bed determinations. The Preadmission/Admission HINN (HINN 1)


should be given.

NOTE: An ABN, Form CMS-R-131 may be required if a SNF has been acting as a
supplier of Part B services or supplies outside a physician’s plan of care. See Section 50
of this manual, as applicable.

70.4 - SNF ABN Specific Delivery Issues


(Rev.: 4198; Issued: 01-11-19; Effective: 04-30-18; Implementation: 04-30-18)

When completing and delivering the SNF ABN, SNFs must meet the written notice
standards in §50.6 and 50.7 of this chapter, unless otherwise specified. Failure to provide
a proper SNF ABN in situations where a physician has ordered the extended care item or
service may result in the SNF being held financially liable under the LOL provisions,
where such provisions apply. SNFs may also be sanctioned for violating the conditions
of participation (42 CFR 483.10) regarding resident (beneficiary) rights.
NOTE: The SNF ABN is not a replacement for, but is in addition to, the required UR
entity notices. The SNF ABN protects the SNF from liability in the event the
beneficiary, for some reason, does not receive the UR entity notice.

70.5 - Special Rules for SNF ABNs


(Rev.: 4198; Issued: 01-11-19; Effective: 04-30-18; Implementation: 04-30-18)

A. Collection from Beneficiary

When a SNF ABN is properly executed and given timely to a beneficiary and Medicare
denies payment on the related claim, the SNF must wait for the beneficiary to receive a
Medicare Summary Notice (MSN) before it can collect payment on the related claim.
Medicare does not limit the amount that the SNF may collect from the beneficiary in such
a situation. A beneficiary’s agreement to “be personally and fully responsible for
payment” means that the beneficiary agrees to pay out of pocket or through any other
insurance that the beneficiary may have, e.g., through employer group health plan
coverage, through Medicaid, or through some other Federal or non-Federal payment
source.

NOTE: The beneficiary may request a demand bill at any point in her or his care.

B. Unbundling Prohibition

The SNF ABNs may not be used to shift financial liability to a beneficiary in the case of
services for which full payment is bundled into other payments; that is, where the
beneficiary would otherwise not be financially liable for payment for an extended care
item or service because Medicare made a bundled payment. Using a SNF ABN to collect
from a beneficiary where full payment is made on a bundled basis would constitute
double billing. A SNF ABN may be used to shift financial liability to a beneficiary in the
case of extended care items or services for which partial payment is bundled into other
payments; that is, where part of the cost is not included in the bundled payment made by
Medicare.

C. Acceptance or Rejection of SNF ABN

These instructions are to assist the Medicare contractor in advising SNFs with respect to
their responsibilities in advising beneficiaries with respect to their rights and protections
and in dealing with complaints from beneficiaries, or authorized representatives, about
the lack of notice or defective notice. The SNF should:

• Answer inquiries from a beneficiary regarding the basis for the SNF’s, the UR
entity’s, the QIO’s, or the Medicare contractor’s assessment that extended care
items or services may not be covered and, if requested by the beneficiary, the SNF
must give the beneficiary access to medical record information or other
documents upon which these entities based their assessment, to the extent
permissible or required under applicable state law.

NOTE: Where state law prohibits such direct disclosure, the SNF should advise
a beneficiary who has requested access to such information how to obtain that
information from the SNF once a demand bill has been submitted.

• Respond timely, accurately, and completely to a beneficiary who requests


information about the extent of the beneficiary’s personal financial liability.

• Timely submit additional information to the Medicare contractor, if a beneficiary


or a physician provides that additional information with respect to Medicare
coverage of the subject extended care items or services.

70.6 - Establishing When Beneficiary Is On Notice of Non-coverage


(Rev.: 4198; Issued: 01-11-19; Effective: 04-30-18; Implementation: 04-30-18)

If the beneficiary has previously been informed in writing that similar or reasonably
comparable extended care items or services were non-covered and it was clear that the
beneficiary knew that the circumstances were the same, the beneficiary is liable. With
this exception, the beneficiary is presumed not to have known, nor to have been expected
to know, that the extended care items or services are not covered unless, or until, s/he
receives notification from an appropriate source.

70.6.1 - Source of Beneficiary Notification


(Rev.: 4198; Issued: 01-11-19; Effective: 04-30-18; Implementation: 04-30-18)

Written Notification must be given by one of the following sources:


A. The SNF that is furnishing non-covered extended care items or services.

Examples:

• On or before the day of admission, the SNF furnishes to the beneficiary a SNF
ABN notifying the beneficiary that the extended care item(s) or service(s) is non-
covered; or

• During the inpatient stay, the SNF timely furnishes to the beneficiary a SNF ABN
notifying the beneficiary that the covered extended care item(s) or service(s) will
no longer be covered.

B. The UR entity of the SNF that is furnishing non-covered extended care items or
services.

Example:

• The UR entity timely furnishes to the beneficiary a SNF ABN notifying the
beneficiary that the extended care item(s) or service(s) is no longer covered.

C. The QIO or Medicare contractor.

Example:

• The QIO, where a beneficiary is in a swing bed, timely furnishes to the


beneficiary, a SNF ABN notifying the beneficiary that the extended care item(s)
or service(s) is not covered or the item(s) or service(s) is no longer covered.

NOTE: This occurs after the beneficiary receives a HINN 1


(Preadmission/Admission HINN) and after the QIO’s decision of the non-
coverage.

• The Medicare contractor sends the beneficiary her or his first notification of non-
coverage (e.g., the MSN).

70.7 – 70.13 New sections to be added

80 - Hospital ABNs (Hospital-Issued Notices of Noncoverage - HINN)


(Rev. 594, Issued: 06-24-05, Effective: 07-01-05, Implementation: 07-01-05)

Instructions for the Hospital ABN have been retracted. Instructions related to HINNs
have been relocated as follows:
• Instructions regarding HINNs are found in this instruction, CR 3903, which
precedes the placement of full instructions in Chapter 30.

• Instructions regarding hospital billing for cases involving QIO review will be
relocated to a new section in Chapter 1 of this manual in the near future. Current
procedures should not change in the interim.

Related instructions for QIOs can be found in the Medicare Quality Improvement
Organization Manual, Publication 100-10, Chapter 7.

100 - Indemnification Procedures for Claims Falling Within the


Limitation on Liability Provision
(Rev. 1, 10-01-03)

Section 1879(b) of the Act provides that when a provider, practitioner, or supplier is held
liable for the payment of expenses incurred by a beneficiary for noncovered items or
services and such provider, practitioner, or supplier requests and receives payment from
the beneficiary or any person(s) who assumed financial responsibility for payment of
expenses, the Medicare program indemnifies the beneficiary or other person(s).

Further, any such indemnification payments are considered overpayments to the provider,
practitioner, or supplier.

A provider, practitioner, or supplier who is determined liable may not seek payment from
a third party payer. (See §30.2.B.)

100.1 - Contractor and Social Security Office (SSO) Responsibility in


Indemnification Claims
(Rev. 1, 10-01-03)

The contractor, SSO, RO, or central office may receive requests or inquiries concerning
indemnification. However, a beneficiary or person(s) who made payment on behalf of the
beneficiary to a liable provider usually visits his/her nearest SSO or deals directly with
the contractor to file a request for indemnification.

Those offices are responsible for assisting beneficiaries or any person(s) in filing claims
for indemnification.

100.2 - Conditions for Indemnification


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

A beneficiary or any person(s) who assumed financial responsibility for payment is


indemnified for claims filed if all of the following conditions are met:
• The contractor has determined that the beneficiary is without liability under
authority of §1879 of the Act for items and services furnished by a provider,
practitioner, or supplier;

• The contractor or the QIO has determined that the provider, practitioner, or
supplier is liable under §1879 for the items and services furnished to the
beneficiary. A provider, practitioner, or supplier is considered to have knowledge
that payment will not be made under Medicare for items or services in a particular
claim where the following evidence is established regarding the provider,
practitioner, or supplier;

(1) Evidence that a provider, practitioner, or supplier knew, or could reasonably


be expected to have known, of exclusion of items or services

o General notice to the medical community regarding exclusion of certain


items or services: e.g., colonic irrigation, acupuncture.

o General notice to the medical community that services exceeding certain


frequencies would be denied or subject to additional review, e.g., vitamin B12
injections, or nursing home visits more frequent than once a month.

o Written notice to the particular provider, practitioner, or supplier that a


type of service or item would be noncovered in all or certain circumstances.

A distinction must be maintained between coverage rules that specify that a type
of service or item would be not reasonable or necessary in all or certain
circumstances, and utilization guidelines the contractor established to identify
excessive services. Any written policies or other internal edits that are disclosed
to a provider, practitioner, or supplier would not be considered as a “notice” of
exclusion, since they are used for referring claims for further development rather
than as rules to make a contractor coverage decision.

In addition to instances when the Medicare program has given notice, the
allegation of a provider, practitioner, or supplier is not accepted without further
verification in situations of potential program abuse involving a pattern of
unnecessary services by a provider, practitioner, or supplier to a number of
beneficiaries. When a provider, practitioner, or supplier frequently renders
unnecessary services, i.e., services that significantly exceed the frequency with
which the general medical community renders them, it is reasonable to expect the
provider, practitioner, or supplier to know that such a pattern deviates from the
standard practice.

(2) Evidence that provider, practitioner, or supplier did not have knowledge of
exclusion of services.

In contrast to subsection 1, there may be situations where an assumption can be


made that neither the beneficiary nor the provider, practitioner, or supplier had
knowledge of exclusion, and liability can be limited by the reviewer without a
statement by either party. In the following situations, further development would
not be necessary:

a. The service is for a type of treatment that can be rendered only by a


physician, but the contractor has not previously denied payment for the
treatment, and it is not unreasonable that a particular physician might
consider the treatment appropriate. In order to determine whether the
services are reasonable and necessary, the contractor requests its physician
consultant or CMS to advise whether the services are covered. This is a
case for which there are no general coverage guidelines for the services;
the contractor has not advised either the physician or the medical
community regarding the coverage of the services; and the contractor is
uncertain without expert consultation. In such a case, it may be presumed
that neither the beneficiary nor the physician could have known that the
services would be noncovered.

b. The item or service is ordinarily covered, but a question is raised as to


whether it is reasonable and necessary in treatment of a particular
diagnosis. Neither the provider, practitioner, or supplier nor the medical
community has been advised that the item or service is not covered for
that diagnosis. The case requires a determination by the contractor’s
medical consultant or is referred to CMS for guidance. As in example (a),
the liability of both parties should be limited.

c. The provider, practitioner, or supplier is newly arrived in the contractor


service area, and the contractor has not yet communicated to the provider,
practitioner, or supplier information in an existing general notice that the
item or service is not covered, always or under certain circumstances.

NOTE: If any provider, practitioner, or supplier could reasonably be


expected, by virtue of normal medical knowledge, to know that the service
was unneeded, the presumption suggested in the above examples would
not apply.

• The requester for indemnification has paid the provider, /practitioner or supplier
all or some of the charges for items and services for which the beneficiary’s
liability has been waived under §1879 of the Act; and

• The requester seeks indemnification by filing a written statement prior to the end
of the sixth month following:

o The month in which payment was made to the provider, practitioner or


supplier; or

o The month in which the contractor advised the beneficiary that the beneficiary
was not liable for the noncovered items or services, whichever is later.
The contractor extends the six month time limit if good cause is shown. The contractor
uses the principles for determining good cause outlined in Chapter 29, “Appeals of Claim
Decisions.”

100.3 - Development and Documentation of Indemnification Requests


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

When the contractor receives a request or inquiry concerning indemnification directly


from the beneficiary or the beneficiary’s authorized representative, it must obtain the
following information and documentation:

• Identifying information sufficient for the contractor to locate the claim(s) for
noncovered items or services for which payment has been made to the provider,
practitioner, or supplier by the beneficiary or other person and for which the
liability of the beneficiary was limited. Ordinarily, the initial MSN or appeal
determination suffices.

• A statement on Form SSA-795, “Statement of Claimant or Other Person,” (see


§100.10, Exhibit 4 ) to the effect that the requester paid the provider, practitioner,
or supplier all or some of the charges for the noncovered items or services for
which the beneficiary’s liability was limited. The statement must specify the
amount the requester has paid the provider, practitioner, or supplier. If the
requester submits this information in a letter, the letter serves as the signed
statement.

100.3.1 - Proof of Payment


(Rev. 1, 10-01-03)

The following types of documentation are sufficient to establish that payment was made
in the amount alleged:

• An itemized bill from the provider, practitioner, or supplier reflecting the items
and services for which the provider, practitioner, or supplier has been found liable
and has received payment along with the payer’s cancelled check, money order
receipt, or statement of receipt from the provider, physician, or supplier;

• A summary bill from the provider, practitioner, or supplier which pertains to the
items and services for which the provider, practitioner, or supplier has been found
liable and has collected from the beneficiary or other person along with the
payer’s cancelled check, money order receipt, or a statement of receipt from the
provider, practitioner, or supplier showing the same total amount;

• The payer’s cancelled check, money order receipt, or the statement of receipt
from the provider, practitioner, or supplier if the contractor’s records reflect the
provider, practitioner, or supplier’s charges for the items and services for which
the provider, practitioner, or supplier has been found liable and these equal the
total of the amount paid; or

• If the requester alleges that the provider, practitioner, or supplier did not furnish
an itemized bill or a receipted statement and no other proof of payment is
available, the contractor obtains a statement on Form SSA-795 to this effect from
all parties involved, including the provider, physician, or supplier if possible. The
statement should describe the circumstances, such as the manner of payment, and
the reasons for not obtaining a receipt or any proof of payment. If there were any
witnesses to the payment, the contractor obtains their statements on Form
SSA-795. The contractor refers any questions as to the acceptability of proof of
payment to the RO.

When the beneficiary or other person on behalf of the beneficiary initially contacts the
SSO, that office sends the statements and evidence relevant to the indemnification claim
to the appropriate contractor. If future contact with the beneficiary or other person is
necessary, the contractor proceeds with a direct contact unless the assistance of the SSO
is needed.

100.4 - Beneficiary Requests Indemnification, but Had No Financial


Interest in the Claim
(Rev. 1, 10-01-03)

If a request for indemnification is received from the beneficiary but the beneficiary did
not have full financial interest in the claim, then any other person(s) who made full or
partial payment to the provider, practitioner, or supplier must be contacted to ascertain if
that person wishes to file for indemnification.

If the individual declines to file for the indemnification payment, the SSO or contractor
staff should assist in preparing a statement to that effect for the individual’s signature. No
payment is made in this instance; however, the contractor notifies all involved parties.

If more than one person helped pay the bill; e.g., sons and daughters of the beneficiary
got together and each paid a portion of the bill; the contractor must determine the
indemnification amount for each payer unless they all agree in writing that payment is to
be made to one person. Explain this to the requester for indemnification in such
instances.

100.5 - Questionable Indemnification Requests Procedure


(Rev. 1, 10-01-03)

If the contractor receives a request for indemnification that does not appear to meet the
conditions outlined in §100.2, and there is some uncertainty concerning the
indemnification claim, it undertakes development to resolve the issues. If the issues
cannot be adequately resolved, it obtains the assistance of the RO.

100.6 - Determining the Amount of Indemnification


(Rev. 1, 10-01-03)

In accordance with §1879(b) of the Act, the contractor indemnifies the beneficiary or
other person(s) for actual charges paid to a provider, practitioner, or supplier, rather than
the usual allowable charges as determined by the Medicare program, PPS amounts, or
established per diem rates that apply to certain provider, practitioner, or suppliers.

Additionally, §4096 of P.L. 100-203 (OBRA of 1987) revises certain limitation on


liability requirements for indemnification under §1879(b) of the Act. A beneficiary
qualifying for indemnification for denied items and services furnished on or after
January 1, 1988 is no longer responsible for paying deductible and coinsurance charges
related to the denied claim. Where such indemnification is made, the contractor may not
charge the beneficiary’s Medicare utilization record for the denied items and services
furnished.

100.7 - Notifying the Provider, Practitioner, or Supplier


(Rev. 1, 10-01-03)

After the contractor has reviewed the claim for indemnification and the indemnification
amount has been determined, it notifies the provider or physician/supplier of the
proposed indemnification action. (A sample letter for these situations is contained in
§100.10, Exhibit l.) The essential elements of this written notice are:

• An explanation of the items and services for which the provider or


physician/supplier is liable with reference to the original notice to the provider or
physician/supplier;

• A statement of the provision of §1879 which allows the program to indemnify the
beneficiary and recover an overpayment from the provider, practitioner, or
supplier;

• An explanation of the amount determined payable to the requester for


indemnification;

• A statement that the amount the contractor has determined to be payable is paid to
the requester and that it constitutes an overpayment to the provider, practitioner,
or supplier which is to be recovered from future Medicare payments made to it;

• A statement encouraging the provider, practitioner, or supplier to refund any


amount(s) already collected; and

• A reminder to the provider, practitioner, or supplier of his/her/its Medicare appeal


rights.

If the provider, practitioner, or supplier does not respond to this notice within 15 days, the
contractor makes payment to the requester in accordance with §100.8. If the provider,
practitioner, or supplier disputes the indemnification or the amount to be paid, the
contractor resolves any discrepancies before making payment. The payment process takes
place even if the provider, practitioner, or supplier might appeal the contractor’s initial
determination which held the provider, practitioner, or physician liable and that appeal is
still pending at the time payment of the indemnification amount is to take place. If the
appeal decision reverses the initial determination, then adjustments are to be made at that
time in the contractor and provider, practitioner, or supplier records. In all cases, the
contractor encourages the provider, practitioner, or supplier to refund any and all amounts
collected to this point. If the provider, practitioner, or supplier chooses to refund any
money collected, the contractor verifies that such a refund has actually been made to the
requester.

100.8 - Making Payment Under Indemnification


(Rev. 1, 10-01-03)

The contractor pays the indemnification amount if the provider, practitioner, or supplier
does not make refund. It takes action to recover this amount as an overpayment from the
provider, practitioner, or supplier. Also, it issues a letter of explanation to the requester
for indemnification. (See §100.10, Exhibit 2 and Exhibit 3.) It sends a copy of this notice
to the provider, /practitioner or supplier. The fundamental points of the notice include:

• Name of the provider, practitioner, or supplier and dates the services in question
were rendered; and

• the amount of the indemnification check that the requester is to receive.

100.9 - Limitation on Liability Determination Does Not Affect Medicare


Exclusion
(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

A determination to limit the liability of the beneficiary, as well as a finding that the
physician’s or supplier’s liability may be limited and program payment made, does not
change noncovered items or services into covered items or services. This means that the
coverage question can still be raised as an issue at a level subsequent to an appeal
determination that authorized program payment under §1879. It also means that, for
purposes of determining an amount in controversy for an appeal, payment made under
§1879 should be disregarded because coverage is still at issue and the amount charged is
still in controversy.

100.10 - Exhibits
(Rev. 1, 10-01-03)

1. Letter to Provider (Institutional Services).


2. Letter to Beneficiary Who Requests Indemnification (Institutional Services).
3. Letter to Someone Other Than Beneficiary Who Requests Indemnification.
4. Letter to Practitioner or Supplier (Noninstitutional Services)
5. Letter to Beneficiary Who Requests Indemnification (Noninstitutional Services)
6. Letter to Someone Other Than Beneficiary Who Requests Indemnification
(Noninstitutional Services)
7. Form SSA-795, Statement of Claimant or Other Person.

Exhibit 1 - Letter to Provider


(Rev. 1, 10-01-03)

To: Provider

Dear Administrator:

Under §1879 of the Social Security Act, a Medicare beneficiary is relieved of the liability
for certain noncovered services if the beneficiary did not know and could not reasonably
have been expected to know that the items or services were not covered. Further, the law
provides that the provider is liable if it is found that the provider knew or could
reasonably have been expected to know that the items or services were not covered by
Medicare.

On (date of limitation on liability notice), your facility was notified that the services
provided to (beneficiary’s name) during the period (_________) to (_________) were not
covered under Medicare and that you were liable for these items and services.

(Requester’s name) has submitted evidence that establishes that he paid your facility
(amount paid) for the services received by (beneficiary’s name). Because your facility
has collected payment from (requester’s name) after being determined liable for these
services, §1879(b) of the Act requires that the Medicare program make direct payment
(indemnification) to him for this amount, for which (beneficiary’s name) is responsible.

A check in the amount of (amount of check) is being sent to (requester’s name). This
indemnification payment represents an overpayment to your facility and it will be
withheld from future Medicare payments due you unless you advise this office that
refund of the incorrect amount(s) has been made to (requester’s name).

If you do not agree with the amount determined to have been paid you, please contact this
office in writing within 15 days of the date of this letter.

Sincerely yours,

Exhibit 2 - Letter to Beneficiary Who Requests Indemnification


(Rev. 1, 10-01-03)

Dear (Beneficiary’s Name):

Your request for refund of improper payment under §1879 of the Social Security Act (the
limitation on liability provision) for the noncovered services provided you at (name of
provider) from (date) to (date) has been received.
The evidence submitted establishes that, even though you were not responsible for the
services you received, you paid (provider’s name) (amount paid) for the services. Your
refund for these payments to (name of provider) has been calculated to be
(indemnification amount). This figure represents full repayment for the charges you paid.

Your Medicare utilization record will not be charged where noncovered services were
provided to you and you were determined not liable.

If you have any questions concerning the matters discussed in this letter or the amount of
the check enclosed, please call this office. If you prefer to visit your local social security
office, please take this letter with you.

Sincerely yours,

Exhibit 3 - Letter to Someone Other Than Beneficiary Who Requests


Indemnification
(Rev. 1, 10-01-03)

Dear (Person’s Name):

Your request for refund of improper payment under Section 1879 of the Social Security
Act (limitation of liability provision) for the noncovered services provided (beneficiary’s
name) at (name of provider) from (date) to (date) has been received.

It was determined that (beneficiary’s name) was not liable for the services. The evidence
you submitted establishes that you paid (provider) (amount paid) for the services
provided (beneficiary’s name). Your refund has been calculated to be (indemnification
amount). This figure represents full repayment based on the expenses incurred by
(beneficiary’s name) in the amount of $(amount).

If you have any questions concerning the matters discussed in this letter or the amount of
the check enclosed, please call this office. If you prefer, you may visit the local social
security office. If you do, take this letter with you.

Sincerely yours,

Exhibit 4 - Letter to Practitioner or Supplier (Noninstitutional Services)


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

Dear ____________________:

Under §1879 of the Social Security Act, a Medicare beneficiary is relieved of the liability
for certain categories of noncovered items or services submitted as assigned claims if the
beneficiary did not know and could not reasonably be expected to know that the items or
services would not be covered. Further, the law provides that the practitioner or supplier
will be liable for the charges if it is found that he/she knew or could reasonably be
expected to know that Medicare would not cover the items or services.
On (date of limitation on liability notification), you were notified that the following items
or services provided to (name of beneficiary) were not covered and that you were liable
for the charges for these items or services:

Description of Services Date Provided

(Beneficiary or other person on behalf of beneficiary) has submitted evidence which


establishes that he/she paid you $______ for the items or services described above. Since
it has been determined that you are liable for the items or services, §1879(b) of the Act
requires that the Medicare program make payment (indemnification) to him/her for this
amount. The amount of this payment will be treated as an overpayment to you and
appropriate collection action will be taken unless you advise this office that refund has
been made to (name of requester).

If you do not agree with the amount that (name of requester(s)) has established he/she
paid you, please notify this office.

If we do not hear from you regarding the amount of the payment or that you will make
refund directly by_____________ (15 days after date of this notice) payment will be
made to (name of requester(s)) and action will be taken to collect the overpayment from
you.

If you disagree with this determination, you may request a redetermination. The bases for
such a request are: (1) that the services you provided were reasonable and necessary; (2)
that you did not know, and could not reasonably have been expected to know, that
Medicare would not pay for the services; or (3) that you notified the beneficiary in
writing, before the services were furnished, that Medicare likely would not pay for the
services. The request for redetermination must be in writing, and it must be filed within
120 days of the date you received the initial determination. If you have already received
an adverse redetermination, you may request a reconsideration within 180 days of the
date you received the redetermination. Our office will assist you if you need help in
requesting a redetermination or a reconsideration. You need not file another request for a
redetermination or a reconsideration if you already have taken such action.

Exhibit 5 - Letter to Beneficiary Who Requests Indemnification


(Noninstitutional Services)
(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

Dear (Beneficiary’s name):

Your request for indemnification (i.e., refund of improper payment) under §1879 of the
Social Security Act (the limitation on liability provision) for the noncovered services
provided you by (physician’s/supplier’s name) on (date) has been received.

The evidence submitted establishes that you paid (physician/supplier) (amount paid) for
the noncovered services. It was determined upon redetermination that you were not liable
for these charges. Your refund for these payments to (physician/supplier) has been
calculated to be (indemnification amount). This figure represents full repayment for the
charges you paid.

If your (physician/supplier) requests an appeal of this claim, it is possible that Medicare


might find that your (physician/supplier) also did not know that Medicare would not pay
for this service, or that this service should not have been denied. In that case, Medicare
would pay your (physician/supplier) for this service. Also, you would be responsible for
any deductible and coinsurance amounts. If this happens, you will receive a copy of the
notice to your (physician/supplier).

Any future items or services of this type provided to you will be your responsibility
because this is your notice that Medicare does not cover these services.

If you have further questions concerning this matter, please call this office. If you prefer
to visit your social security office, please take this letter with you.

Exhibit 6 - Letter to Someone Other Than Beneficiary Who Requests


Indemnification (Noninstitutional Services)
(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

Dear (Person’s name):

Your request for indemnification (i.e., refund of improper payment) under §1879 of the
Social Security Act (limitation on liability provision) for the noncovered services
provided (beneficiary’s name) by (name of physician/supplier) on (date) has been
received.

It was determined upon redetermination that (beneficiary’s name) was not liable for the
charges.

The evidence establishes that you paid (physician/supplier) (amount paid) for the services
provided (beneficiary’s name). Your refund has been calculated to be (indemnification
amount). This figure represents full repayment for the expenses incurred by
(beneficiary’s name).

If his/her (physician/supplier) requests an appeal of this claim, it is possible that Medicare


might find that the (physician/supplier) also did not know that Medicare would not pay
for this service, or that this service should not have been denied. In that case, Medicare
would pay the (physician/supplier) for this service. Also, (beneficiary’s name) would be
responsible for any deductible and coinsurance amounts. If this happens, (beneficiary’s
name) will receive a copy of the notice to his/her (physician/supplier).

Any future items or services of this type provided to (beneficiary’s name) will be his/her
responsibility because this is your notice that Medicare does not cover these services.
If you have further questions concerning the matters discussed in this letter or the amount
of the check enclosed, please call this office. If you prefer to visit the social security
office, please take this letter with you.

Exhibit 7 - Statement of Claimant or Other Person


(Rev. 1, 10-01-03)

Link to an exhibit of the Form SSA-795, “Statement of Claimant or Other Person,” at:

http://www.ssa.gov/online/ssa-795.pdf.

110 - Contractor Instructions for Application of Limitation On Liability


(Rev. 1, 10-01-03)

110.1 - Payment Under Limitation on Liability


(Rev. 1, 10-01-03)

When it is determined during the course of a beneficiary’s inpatient stay or during the
patient’s course of home health visits, or during a patient’s course of treatment from a
practitioner, physician or other supplier that the care is not covered but both the
beneficiary and the provider of services are entitled to limitation on liability, the
Medicare program may make payment for the noncovered services up to the date of
notice and, if, for inpatient or home health services, the A/B MAC (A) or (HHH)
determines that additional time is needed to arrange for post-discharge care, also for a
“grace period” of l day after the date of notice to the provider or to the beneficiary,
whichever is earlier. If it is determined that even more time is required in order to arrange
post-discharge care, 1 additional “grace period” day may be paid for. (See §§30 and 40
for definition of notice.)

When the provider is given notice as described in §40.1, it is required to advise the
beneficiary in writing of the determination on the same date it received the A/B MAC (A)
or (HHH) notice. Where the provider fails to give the beneficiary such timely notice, the
beneficiary is protected from liability until the beneficiary receives the notice.

For example, if a SNF received the A/B MAC (A)’s notice of noncoverage on February
15 but failed to advise the beneficiary until February 19, the beneficiary is protected from
liability through February 19 - the date on which the beneficiary first received notice.
However, the SNF is entitled to program payment only through the date - February 15 -
on which it received notice, and for whatever “grace period” is allowed thereafter. In a
case in which a SNF received the A/B MAC (A)'s notice on February 15 but failed to
give the beneficiary notice until the next day - February 16 - the beneficiary and provider,
if the A/B MAC (A) determines that additional time is needed to arrange post-discharge
care, would be protected from liability under the “grace period” only for the additional
day - February 16 - unless it is determined that even more time is required to arrange
post-discharge care, in which case 1 additional “grace period” day may be paid for.
NOTE: The “grace period” is applicable only where circumstances have permitted
program payment under §1879 of the Act, i.e., limitation on liability was applicable both
to the beneficiary and the provider of services. Where the A/B MAC (A) or (HHH)
concurs with a URC’s decision that covered care has ended, any payments made during
the “grace period” after the URC’s notice are made under the authority of that statutory
provision (§1814 of the Act) rather than under §1879.

110.2 - When to Make Limitation on Liability Decisions


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

A - Initial Claims

In implementing the limitation on liability provision, the contractor makes a coverage


decision before making a limitation on liability decision. Section 1879 of the Act
provides that limitation on liability can be allowed only in cases:

Where - (1) a determination is made that, by reason of §1862(a)(l) or (9)


or by reason of a coverage denial described in subsection (g) of the Act,
payment may not be made under Part A or Part B of this title for any
expenses incurred for items or services furnished an individual by a
provider of services... (Section 1879(a)(1) of the Social Security Act.)

NOTE: Subsection (g) refers to home health service denials under §§1814(a)(2)(C) and
1835(a)(2)(A), i.e., the patient is or was not confined to home; or the patient does or did
not need skilled nursing care on an intermittent basis; and to hospice denials under
§1861(dd)(3)(A) for services determined to be noncovered because the beneficiary was
not “terminally ill”.

Only after the contractor makes a decision that care is not reasonable or necessary, is
custodial, is not reasonable and necessary for the palliation or management of terminal
illness in hospice denials, or does not meet the homebound or intermittent nursing care
requirements in home health service denials, or does not meet the “terminally ill”
condition for hospice care, should a determination be made regarding limitation on
liability. In every such case there will be two parts to the limitation on liability
determination:

1. Whether and when the beneficiary knew or should have known that the services
were noncovered, and

2. Whether and when the provider knew or should have known that the services
were noncovered.

In any case where the provider gave the beneficiary notice that the services would be
noncovered, the contractor will find that the provider knew that the services were
noncovered.
B – Redetermination

At the redetermination level, again the contractor first makes a determination on the
coverage issue. It considers the question of limitation on liability, if applicable, only if
the initial adverse coverage decision is wholly or partially affirmed. (See Chapter 29,
“Appeals of Claim Decisions,” for discussion of the appeals process.)

110.3 - Preparation of Denial Notices


(Rev. 3560, Issued: 07-15-16, Effective: 10-17-16, Implementation: 10-17-16)

The provider and beneficiary notification procedures discussed in §§30 and 40 for
determining liability do not change the instructions for the preparation and issuance of
denial notices in Medicare Claims Processing Manual, Chapter 21, “Medicare Summary
Notices.”

Accordingly, in cases where the services are found to be custodial care or not reasonable
and necessary, or in the case of HHA services, are denied for technical reasons under
§1814(a)(2)(C) or §1835(a)(2)(A) of the Act, or in the case of hospice services, are
denied for technical reasons under §1861(dd)(3)(A) of the Act:

An MSN denying the service(s) is sent to the beneficiary in cases where only the
beneficiary is entitled to limitation on liability for any part of the noncovered stay. The
notice advises the beneficiary of the beneficiary’s entitlement to indemnification (see
§100.) in the event the provider seeks payment from the beneficiary for the noncovered
services. It uses MSN messages 50.36.2:

It appears that you did not know that we would not pay for this service, so
you are not liable. Do not pay your provider for this service. If you have
paid your provider for this service, you should submit to this office three
things: (1) a copy of this notice, (2) your provider’s bill, and (3) a receipt
or proof that you have paid the bill. You must file your written request for
payment within 6 months of the date of this notice. Future services of this
type provided to you will be your responsibility.

All denial notices explain any decision regarding limitation on liability for either the
provider, practitioner, or supplier or the beneficiary. (See Chapter 21, “Medicare
Summary Notices.”)

All denial notices, where either the beneficiary or provider, practitioner, or supplier has
been found liable, must state that the provider has a right to a redetermination.

Providers, practitioners, and suppliers do not receive a separate written notification or


copy of the MSN. Providers, practitioners, and suppliers must utilize the coding
information (e.g., Remittance Advice Remark Codes) conveyed via the Remittance
Advice (RA) to ascertain reasons associated with Medicare claims determinations
affecting payment and applicable appeal rights and/or appeals information.
110.4 - Bill Processing
(Rev. 3187, Issued: 02-06-15, Effective: 03-06-15, Implementation: 03-06-15)

Where payment is made under the limitation on liability provision, because it was
determined that both the provider, practitioner, or supplier and the beneficiary did not
know and could not have been expected to know that services were not reasonable and
necessary, the usual deductible and coinsurance amounts apply.

When payment under limitation on liability is made for noncovered services, the
contractor processes the bill in the same manner as any payment bill for covered services.
For institutional services, if both the beneficiary and the provider have liability waived,
the A/B MAC (A) charges the number of days or visits paid for under the limitation on
liability provision to the beneficiary’s utilization record. For noninstitutional services, it
applies deductible and coinsurance, and, where applicable, statutory limits on services.

For situations where the contractor determines that the provider, practitioner, or supplier
knew or should have known that the services were not reasonable and necessary, and the
beneficiary did not know and could not have been expected to know that the services
were not reasonable and necessary, the beneficiary qualifies for indemnification and is
not responsible for paying deductible and coinsurance charges related to the denied
claim. Additionally, where such indemnification is made, the contractor does not charge
the beneficiary’s Medicare utilization record days, visits, deductibles, or coinsurance (nor
does it apply statutory limits, e.g., the psychiatric services Limit) for the denied items and
services furnished.

The contractor follows the no-payment procedures in the relevant bill processing
instructions in the following cases:

• Either the beneficiary or the provider/practitioner/supplier, or both knew or


should have known that services were not covered.

• The provider, practitioner, or supplier knew or should have known that the
services were not covered even though the beneficiary did not know. In these
cases, the notice to the beneficiary will have informed the beneficiary that, even
though no Medicare payment is being made, the beneficiary is not liable for the
cost of the services and that the beneficiary may be indemnified for any improper
payments the beneficiary made to the provider, practitioner, or supplier.

Where no Medicare payment is made because limitation on liability does not apply, or
where payment ceases because of notice in a noncovered case, the normal provisions for
no-payment situations apply.

For ancillary and outpatient services billed by institutional providers, the provider follows
the instructions in Chapter 4 for hospitals, Chapter 7 for SNFs, and Chapter 10 for HHAs
to process bills for these types of claims. Further, where ancillary services may not be
paid under Part A because they were rendered in connection with a noncovered inpatient
stay, the provider may still bill under Part B for ancillary services that may be covered
under §1861(s)(3)-(9) of the Act.
110.5 - Contractor Review of ABNs
(Rev. 1, 10-01-03)

110.5.1 - General Rules


(Rev. 1, 10-01-03)

A. Generally, notifiers (physicians, practitioners, suppliers, providers) are not required to


routinely submit copies of ABNs (CMS-R-131) to their Medicare contractor along with
their claims (see §50.6.3). This is based on a rebuttable administrative presumption that a
certain modifier (GA) or occurrence code (32) on the claims signify that notifiers are
using the proper standard form CMS-R-131 and are preparing and delivering ABNs in
compliance with the instructions in this Chapter.

B. Contractors may and should request CMS-R-131 ABNs (or any other ABN if the
circumstances demand) be submitted to them for review in any circumstance in which the
contractor is not confident that the administrative presumption is correct or in which the
contractor has good reason to examine the ABNs of either particular notifiers or any class
of notifiers. In the case where a contractor requests submission of copies of ABNs, the
notifiers must submit such copies (see §50.6.3).

C. All Hospital ABNs (HINNs) will be reviewed by QIOs (see §80.5) and all HHABNs
and SNFABNs will be reviewed when the contractor performs complex medical review
of the demand bills.

110.5.2 - Situations in Which Contractor Review of ABNs is Indicated


(Rev. 1, 10-01-03)

Circumstances involving ABNs (viz., with respect to claims on which there is any
payment denial, that include either or both the GA modifier and occurrence code 32, and
that do not include a copy of the ABN) in which the contractor should not be confident
that the administrative presumption, viz., that notifiers are using the proper form and are
properly preparing and delivering ABNs, is correct and should request submission of
ABNs include, but are not limited to, the following:

A. Any claim where the contractor has any indication that the notifier may not have
given proper notice, either no notice at all or defective notice, whether based on the
contractor’s experience (with the notifier or class of notifiers, or with the class of items or
services), on beneficiary complaint, on any other plausible allegation, or on any other
reasonable basis. (Contractors, of course, may not make baseless or capricious requests
for routine submission of ABNs.)

B. Any claim for payment for more than one item or service. (In such cases, the
contractor must ascertain which item(s) and/or service(s) the ABN specified and,
therefore, to which claimed item(s) and/or service(s) the ABN applies with respect to
assigning liability to the beneficiary. Liability is shifted to the beneficiary only if the
ABN accurately specifies the items or services and if the specified expected reason for
denial turns out to be the actual reason for denial.)

C. Any claim for an item or service for which there is a coverage frequency limit, and
which includes one or more other items or services which are not frequency-limited.
(Since ABNs may be given routinely for frequency-limited items and services, it is
predictable that virtually all claims which include any frequency-limited item or service
will include the GA modifier and/or occurrence code 32. When other, non-frequency-
limited items or services are included on such a claim, any ABN specifying a frequency-
limit as the expected reason for denial would not be applicable to the liability
determination with respect to any item or service on such a claim that is not frequency-
limited, nor with respect to any different frequency-limited item or service.)

D. Any claim for an item or service for which there is a coverage frequency limit and on
which there is a payment denial on any basis other than exceeding the frequency limit.
(Since the notifier can be reasonably expected to have given routine notice on the basis of
the frequency limit, and since an ABN specifying a frequency-limit as the expected
reason for denial would not be applicable to the liability determination with respect to
any item or service on such a claim that is denied on any basis other than that particular
frequency limit, such ABNs need to be reviewed for their correct application to any
denial.)

E. Any claim about which there is any suspicion of fraud or abuse, whether with respect
to the notifier, the category of notifiers, or the class of items or services involved.

110.5.3 - Other Reasons for Contractor Request for Copies of ABNs


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

Other good reasons for contractors to request submission of copies of ABNs include, but
are not limited to, the following:

A - Any need that arises from the appeals processes for documentation.

B - Any practical need to identify the particular items and/or services, dates of
service, reasons for predicting Medicare denial of payment, or other pertinent
facts about the beneficiary notification.

C - Any plausible allegation or dispute as to the form, content, or delivery of a


particular ABN or a particular group of ABNs, e.g., all ABNs furnished by a
particular notifier, all ABNs for a particular item, etc.

D - For the purposes of a data analysis, utilization study, or other investigation or


study.

120 - Contractor Specific Instructions for Application of Limitation on


Liability
(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)
120.1 - Documentation of Notices Regarding Coverage
(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

A critical step in the implementation of the limitation on liability provision is the


distribution by contractors of notices regarding coverage issues to the medical
community, or to specific segments of it, such as laboratories or certain physician
specialty groups. An ongoing program of communication by contractors is essential.
Timely communication of existing general notices to physicians and suppliers new to a
contractor’s service area is essential. The existence of written general notices will often
determine the extent of program liability. As a minimum, the contractor should have a
program for dissemination of the coverage guidelines published in the National Coverage
Determinations Manual and the Medicare Benefit Policy Manual, as well as other
guidelines contained in this manual for determining medical necessity and others issued
from time to time in other CMS issuances.

120.2 - Availability of Coverage Notices to Operating Personnel


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

All review personnel should have ready access to a file of general notices regarding
coverage for processing review cases involving the issue of limitation on liability.

In addition to general notices, the contractor must have a mechanism for identifying and
locating correspondence with individual physician/suppliers regarding coverage of
particular services or items. This mechanism should meet at least the following minimum
requirements:

• The contractor must be able to determine if a practitioner or supplier has been sent
an explanation, in lieu of, or in addition, to, a routine MSN denial notice, that a
type of service or item is not reasonable and necessary. Such explanation may
consist of a general notice or may be individual correspondence with the
physician/supplier such as is usually found in contractor correspondence units or
comparable units. Claims history files can also be checked, but these are generally
useful only when the identical item or service in question has been previously
denied as not meeting the requirements of §1862(a)(1);

• A copy of such an explanation must be readily available to appeal personnel; and

• Procedures must be established requiring that a check of all files be made to


determine if such an explanation was ever sent before the physician/supplier’s
liability is limited.

Once a physician/supplier receives an explanation of denial for an item or service after an


appeal determination, that determination would be considered a notice that should be
readily accessible for future use for a similar claim(s).
120.3 - Applicability of Limitation on Liability Provision to Claims for
Outpatient Physical Therapy Services Furnished by Clinics
(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

A – General

The limitation on liability provision is applicable to claims for items or services furnished
by a physician-directed outpatient physical therapy (OPT) clinic that are denied on the
basis of §1862(a)(1).

The limitation on liability determination for OPT clinic claims will be made by
contractors at the initial determination level, in accordance with §120.4. The procedures
discussed in §120.2, second bullet , for determining a physician’s/supplier’s liability will
be followed when processing this category of claims.

120.4 - Limitation on Liability Notices to Beneficiaries From


Contractors
(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

The contractor adds MSN Limitation of Liability Message 50.36.2 to the MSN sent to the
beneficiary (who is presumed not to have knowledge of nonpayment by Medicare) at the
time of the initial determination.

To message 50.36.2, it also adds the following language:

Do not apply if your (doctor/supplier) told you in writing, before


furnishing the service, that Medicare would not pay.

The contractor adds MSN Limitation of Liability Message 50.36.1 to the MSN
sent to the beneficiary (who is held to have had knowledge of nonpayment by
Medicare) at the time of the initial determination.

The contractor adds, from the Remittance Advice Remarks Codes, the Justification for
Services Remark M25 to the RA sent to the physician/supplier (who is presumed to have
knowledge of nonpayment by Medicare) at the time of the initial determination.

The contractor adds, from the Remittance Advice Remarks Codes, the Justification for
Services Remark M38 to the RA sent to the physician/supplier who is held to be not
liable because the beneficiary is held liable at the time of the initial determination.

In addition to the above, as appropriate, the contractor notifies both the beneficiary and
the physician/supplier at the time of the initial determination of their appeal rights (this is
contained on the back of the MSN and the RA).
120.5 - Contractor Redeterminations or Reconsiderations in Assignment
Cases Conducted at the Request of Either the Beneficiary or the
Assignee
(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

In every appeal where the limitation on liability provision is applicable, the


redetermination consists of two stages. The first stage is a new, independent and critical
reexamination of the facts regarding the coverage issue. If the original decision regarding
coverage was appropriate, the second stage is the decision whether to limit the liability of
the beneficiary and, if so, whether to also limit the liability of the provider, practitioner,
or supplier.

Redeterminations in assignment cases are conducted at the request of either the


beneficiary or the assignee. Frequently, the redetermination request is received from only
one of the parties, either the provider/physician/supplier or the beneficiary, and the only
notice to the other party that a redetermination has been requested is a copy of the
determination, i.e., after the fact. In a limitation on liability case, the parties may have
adverse interests in the limitation on liability decision, since a provider, practitioner, or
supplier may seek to show reason why the beneficiary’s liability should not be limited in
order to be able to collect his/her fee from the beneficiary. Therefore, when the contractor
receives a request for a redetermination, it sends a notice that a request has been filed to
the other party to the redetermination indicating that that party may submit additional
evidence. This is necessary to satisfy the statutory requirement that both parties be
informed of their rights and privileges in the appeal process.

120.5.1 - Guide Paragraphs for Contractors to Use Where §1879 Is


Applicable at the Redetermination Level
(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

The contractor uses the following paragraphs (in addition to other required appeal
decision paragraphs) where the limitation on liability provision applies at the appeal level
in the various situations shown below:

Situation I - To the provider, practitioner, or supplier when neither the provider,


practitioner, or supplier nor the beneficiary is determined liable (program payment made
under §1879 of the Act)

Paragraph(s):

Section 1879 of the Social Security Act permits Medicare payment to be made on behalf
of a beneficiary to a physician/supplier who has accepted assignment for certain services
for which payment would otherwise not be made under Medicare, if neither the
beneficiary nor the physician/supplier knew, or could reasonably have been expected to
know, that the services were excluded. The services affected by this provision are those
that are not reasonable and necessary for the diagnosis or treatment of illness or injury or
to improve the functioning of a malformed body member. After reviewing (beneficiary’s
name’s) claim for (description of services), we have concluded that these services are
excluded under Medicare. However, since we find that neither (beneficiary’s name) nor
you knew, or could reasonably have been expected to know, that the services were
excluded from coverage, the Medicare program will reimburse you under this provision
of the law for the reasonable charge for the services, less any deductible and coinsurance.
(Beneficiary’s name) is responsible for any deductible and coinsurance amounts. Upon
receipt of this notice, it will be considered that you now have knowledge of the exclusion
of (description of service) for similar conditions, and this limitation of liability will not
apply to future claims for the same or substantially similar services.

cc: Beneficiary

Situation II - To provider, practitioner, or supplier when the provider or practitioner or


supplier is held liable

Paragraph(s);

Section 1879 of the Social Security Act permits Medicare payment to be made on behalf
of a beneficiary to a provider or practitioner or supplier who has accepted assignment for
certain services for which payment would otherwise not be made under Medicare.
Medicare may make payment under this situation if neither the beneficiary nor the
provider, practitioner, or supplier knew, or could reasonably have been expected to know,
that the services were excluded. The services affected by this provision are those that are
not reasonable and necessary for the diagnosis or treatment of illness or injury or to
improve the functioning of a malformed body member. After reviewing (beneficiary’s
name’s) claim for (description of services), we have determined that (beneficiary’s name)
did not know and could not have been expected to know, that these services were
excluded from coverage. However, we find that (select applicable phraseology from the
following): (l) based upon the claim of (date) which was a similar claim in which
payment was denied; (2) (our notification to you of (date) that such services are
excluded); (3) (or any other basis used to determine the provider, practitioner, or supplier
to be liable)), you knew, or could have been expected to know, that these services were
excluded. We also find that you did not notify the beneficiary in writing, before the
services were furnished, that Medicare likely would not pay for the services. Because of
this, you are held liable for the full charges for the services.

We have also reviewed the claim with regard to the issue of whether the services were
not reasonable and necessary. We found that the services were not reasonable and
necessary.

If you disagree with this determination regarding your liability, on the basis that the
services were necessary, or on the basis that you did not know, and could not reasonably
have been expected to know, that Medicare would not pay for the services, or on the basis
that you notified the beneficiary in writing, before the services were furnished, that
Medicare likely would not pay for the services, you may request a reconsideration within
180 days of receipt of this notice, at which time you may present any new evidence that
would have a material effect on this determination. Our office, or your social security
office, will assist you if you need help in requesting a reconsideration.

cc: Beneficiary

Situation III - To the beneficiary when the beneficiary is held liable

Paragraph(s):

We have reviewed your claim for (description of the services). When we reviewed your
claim, we considered two things. First, we considered whether the service you received
was reasonable and necessary. Medicare will only pay for reasonable and necessary
services. We found that the service was not reasonable and necessary.

Second, we considered whether you knew, or were told, that Medicare would not pay.
Medicare would not hold you liable if you did not know and your (doctor/supplier) did
not tell you in advance, in writing, that Medicare would not pay. In that case, we would
pay you any amount you pay or paid your (doctor/supplier) for the service. Our review
shows that (choose one of the following to complete the sentence: (the (doctor/ supplier)
told you in writing, before giving the service, that Medicare would not pay); (this service
had been denied on other claims for you); OR (we told you in a letter dated (DATE) that
Medicare would not pay for this service)). Since we believe you knew Medicare would
not pay for this service, Medicare cannot pay. You are liable for the charges.

If you do not agree with our decision, ask for a reconsideration from a Qualified
Independent Contractor (QIC). The QIC will decide whether the service was reasonable
and necessary. The QIC will also decide whether you knew, or were told, Medicare
would not pay. You must ask for a reconsideration within 180 days of the date you
receive this notice. At the reconsideration, you may present any new evidence which
would affect our decision. If you need help, your social security office will help you
request a reconsideration.

cc: Physician/Supplier

Situation IV - Rider paragraph to be included in the copy of the notice to the beneficiary
when the physician/supplier is held liable

If you paid any amounts to (physician’s/supplier’s name) for this service, Medicare will
pay you back the amount you paid. To get this payment, bring or send to this office three
things. (1) A copy of this notice. (2) Your (doctor’s/supplier’s) bill. (3) A receipt or other
proof you have paid the bill.

(See §§120.4 for handling requests for indemnification where payment has been made to
a liable practitioner or supplier.)

130 - A/B MAC (A) and (HHH) Specific Instructions for Application of
Limitation on Liability
(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

See §120.5.1 for guide language.

130.1 - Applicability of the Limitation on Liability Provision to Claims


for Ancillary, Outpatient Provider and Rural Health Clinic Services
Payable Under Part B
(Rev. 3187, Issued: 02-06-15, Effective: 03-06-15, Implementation: 03-06-15)

The following sections discuss how the limitation on liability provision is applied to
claims involving ancillary, outpatient and rural health clinic services billed to the A/B
MAC (A), where reimbursement is sought under Part B. The A/B MAC (A) determines
whether limitation on liability applies to these categories of claims when the basis for the
denial is that the services were not reasonable and necessary (under §1862(a)(l) of the
Act).

130.1.1 - Determining Beneficiary Liability in Claims for Ancillary and


Outpatient Services
(Rev. 594, Issued: 06-24-05, Effective: 07-01-05, Implementation: 07-01-05)

A presumption will be made that the beneficiary did not know that items or services are
not covered unless there is evidence to the contrary. Indication on the claim that the
beneficiary received proper advance beneficiary notice before receiving the noncovered
ancillary, outpatient, or rural health clinic services is evidence to the contrary which
rebuts the presumption in the beneficiary’s favor. The definitions of proper “advance
beneficiary notice” to the beneficiary are set forth in §40.3. Note that if the reason
liability is at issue coincides with the end of coverage for a period of care in specific
settings-- inpatient hospital, skilled nursing, home health, hospice or comprehensive
outpatient rehabilitation facilities-- notification under the expedited determination process
will be required as of July 1, 2005. See CR#3903 for preliminary information on the
expedited process, including its interaction with liability notice policy (i.e., ABNs).

130.1.2 - Determining Provider Liability in Claims for Ancillary and


Outpatient Services
(Rev. 1, 10-01-03)

The procedures in §30.2 apply for determining liability for providers. A provider may
have its liability waived in an individual claim if it can establish that it did not know and
could not have been expected to know that Medicare would not make payment for the
items or services.

130.2 - Prior Hospitalization and Transfer Requirements for SNF


Coverage as Related to Limitation on Liability
(Rev. 1, 10-01-03)
In order to qualify for post-hospital extended care services, the individual must meet the
prior hospitalization and transfer requirements discussed in “Coverage of Extended Care
Services Under Hospital Insurance,” Chapter 8 of the Medicare Benefit Policy Manual.
The following sections discuss the relationship of these requirements to the limitation on
liability provision.

A. Three-Day Prior Hospitalization

Before Medicare can pay for post-hospital extended care services, it must determine
whether the beneficiary had a prior qualifying hospital stay of at least three consecutive
calendar days. When a beneficiary’s liability for a hospital stay is waived, the hospital
days to which the limitation on liability applies cannot be used to satisfy the 3-day prior
hospitalization requirement, since the services rendered during the days in question were
found noncovered because they were not considered reasonable and necessary or because
they constituted custodial care. (See “Coverage of Extended Care (SNF) Services Under
Hospital Insurance,” Chapter 8, of the Medicare Benefit Policy Manual for determining
whether the 3-day prior hospitalization requirement is met.) If a beneficiary’s hospital
stay was partially covered, the A/B MAC (A) considers the covered portion of the stay in
determining whether the SNF prior hospitalization requirement is met.

B. Transfer Requirements

1. Transfer Period

The A/B MAC (A) applies the limitation on liability provision where it determines
that all the SNF care received during the period serving to satisfy the transfer
requirements described in “Coverage of Extended Care Services Under Hospital
Insurance,” Chapter 8 of the Medicare Benefit Policy Manual, either constituted
custodial care or was not reasonable and necessary.

Where the A/B MAC (A) determines that only the beneficiary’s liability can be
waived, the limitation on liability applies through the date of the notice to the
beneficiary including any inpatient days beyond the transfer period. If the provider is
also entitled to limitation on liability and program payment is possible under the
limitation on liability provision, such payment is appropriate through the date of the
notice and, if the A/B MAC (A) determines that additional time is needed to arrange
for post-discharge care, for up to 24 hours after the date of notice to the provider or
the beneficiary, whichever is earlier. If the A/B MAC (A) determines that even more
time is needed to arrange post-discharge care, up to 24 additional hours may be paid
for. (See §50.)

Where a beneficiary who is entitled to limitation on liability starts to require and


receives reasonable and necessary or noncustodial services only after the expiration
of the SNF transfer period, the beneficiary nevertheless may have his/her liability
waived for days where such services were rendered, in addition to those days waived
during the noncovered transfer period but only through the date of notice to the
beneficiary. If the provider is also entitled to limitation on liability, program payment
may be made under the limitation on liability provision through the date of notice of
noncoverage and, if the A/B MAC (A) determines that additional time is needed to
arrange for post-discharge care, for a “grace period” of l day thereafter. If the A/B
MAC (A) determines that even more time is needed to arrange post-discharge care, 1
additional “grace period” day may be paid for. (See §50.) This payment is made
because it is inequitable to waive liability for noncovered services rendered during the
transfer period but not for a period thereafter (prior to notice) during which the
beneficiary needed and received an otherwise covered level of care.

2. Delayed Transfer Due to Medical Appropriateness

The law also provides for an extension of the usual 30-day time limit for transfer
where the patient’s condition makes it medically appropriate. (“Coverage of Extended
Care Services Under Hospital Insurance,” in the Medicare Benefit Policy Manual,
Chapter 8.) However, if the A/B MAC (A) determines that such an extension is not
allowable because an interval of more than 30 days for transfer to a SNF was not
medically appropriate, it denies the SNF services because the transfer requirement
was not met. The limitation on liability provision is not applicable in such a case.

130.3 - Application of Limitation on Liability to SNF and Hospital


Claims for Services Furnished in Noncertified or Inappropriately
Certified Beds
(Rev. 4001, Issued: 03-16-18, Effective: 06-19-18, Implementation: 06-19-18)

A. General

Payment for SNF and hospital claims may not be denied solely on the basis of a
beneficiary’s placement in a non-certified portion of the same institution that also
includes a participating SNF or hospital. When requested by the beneficiary or his/her
authorized representative, a provider must submit a claim to the A/B MAC (A) for
services rendered in a non-certified bed. When the A/B MAC (A) reviews a claim for
services rendered in a non-certified bed, it first determines whether the beneficiary
consented to the placement. (See subsection C.) If the A/B MAC (A) finds that the
beneficiary consented, it denies the claim. If it finds that the beneficiary did not consent,
it determines whether there are any other reasons for denying the claim. (See subsection
D.) If there is another reason for denying the claim, the A/B MAC (A) denies it.
However, if none of the reasons for denial exist, beneficiary liability must be waived as
provided under §1879(e) of the Act and a further determination must be made as to
whether the provider, rather than the Medicare program, must accept liability for the
services in question. (See “Coverage of Extended Care Services Under Hospital
Insurance” in the Medicare Benefit Policy Manual, Chapter 8.)

B. Provider Notice Requirements

When a SNF or hospital places a patient in a noncertified or inappropriately certified


portion of the institution because it believes the patient does not require a covered level
of care, or for any other reason, it must notify the patient (or authorized representative) in
writing that services in a noncertified or inappropriately certified bed are not covered.
The provider uses the appropriate notice specified in §70 for SNFs or swing beds, §80 for
inpatient hospitals, to advise the beneficiary of its decision to place him/her in a
noncertified bed, using language such as:

We are placing you in a part of the institution that is not appropriately certified by
Medicare because (you do not require a level of care that will qualify as skilled
nursing care/or covered hospital services under Medicare)/(or state any other
reasons for the noncertified bed placement). Nonqualifying services furnished a
patient in a noncertified or inappropriately certified bed are not payable by
Medicare. However, you may request us to file a claim for Medicare benefits.
Based on this claim, Medicare will make a formal determination and advise
whether any benefits are payable to you.

(For related general billing requirements, see Chapter 1, §60 of this manual, or other
chapters specific to the benefit being billed: Chapter 3 for inpatient hospitals and swing
beds, Chapter 6 for swing bed PPS and inpatient SNFs, and Chapter 7 for outpatient
SNFs.)

C. Determining Beneficiary Consent

The CMS presumes that the beneficiary did not consent to being placed in a noncertified
bed. In order to rebut the presumption of lack of consent, the provider must indicate on
the bill the date it provided the beneficiary with an ABN notifying the beneficiary that the
accommodations would no longer be covered; and requested the beneficiary’s signed
acknowledgement (on the ABN) of having received such a statement. Moreover, in any
case in which a Medicare beneficiary gives his/her consent to placement in a noncertified
bed, the provider must, if requested by the A/B MAC (A) (contemplated only at an
appeal level of claim processing), submit a copy of the ABN signed by the beneficiary to
the A/B MAC (A), for a determination of the ABN’s validity. The ABN must be signed
by the beneficiary (provided he/she is competent to give such consent) or by the
beneficiary’s authorized representative. If the beneficiary or his/her authorized
representative refuses to sign the form, the provider may annotate the file to indicate it
presented the ABN to the beneficiary (or his/her authorized representative), but the
beneficiary refused to sign. As long as the provider’s ABN notifies the beneficiary of the
likely Medicare noncoverage, the beneficiary’s refusal to sign the ABN does not render it
invalid. (See §40.3.4.6.) If any of the above requirements is not met, the A/B MAC (A)
automatically determines the ABN is defective.

When the A/B MAC (A) receives a claim with an indication that the provider has
provided the beneficiary or his/her authorized representative, with an ABN, the A/B
MAC (A) denies the claim and notifies the beneficiary that §1879 limitation on liability
cannot be applied because of the beneficiary’s valid consent to be cared for in a
noncertified or inappropriately certified bed. If the A/B MAC (A) determines that the
ABN is not valid, the A/B MAC (A) processes the claim in accordance with §130.4.

If the beneficiary appeals the initial denial, the A/B MAC (A) obtains the ABN from the
provider and determines whether it is valid. If the A/B MAC (A) determines that the
ABN is invalid, it notifies the provider and the beneficiary that payment may be made to
the extent that all other requirements are met.

D. Determining Whether Other Requirements for Payment are Met

Denials still are appropriate for any of the following reasons. The A/B MAC (A) must
undertake the development needed to permit a determination as to whether:

• The patient did not receive or require otherwise covered hospital services or a
covered level of SNF care;

• The benefits are exhausted;

• The physician’s certification requirement is not met;

• There was no qualifying 3-day hospital stay (applicable to SNFs only); or

• Transfer from the hospital to the SNF was not made on a timely basis. (However,
if transfer to an institution which contains a participating SNF is made on a timely
basis, a claim cannot be denied solely on the grounds that the transfer requirement
is not met because the bed in which the beneficiary is placed is not a certified
SNF bed.)

The A/B MAC (A) denies cases falling within these categories under existing procedures.
Also, if the beneficiary receives care in a totally nonparticipating institution, denial on the
grounds that the beneficiary was not in a participating SNF or hospital is still appropriate.

130.4 - Determining Liability for Services Furnished in a Noncertified


SNF or Hospital Bed
(Rev .4001, Issued: 03-16-18, Effective: 06-19-18, Implementation: 06-19-18)

The A/B MAC (A) presumes that the provider properly notified the beneficiary of
noncoverage, and that the beneficiary assented, if the claim includes the proper indicators
of liability notification.

The following development occurs only if the beneficiary appeals the A/B MAC (A)’s
decision that the beneficiary may not have liability waived because the provider gave
him/her timely notice that Medicare would not cover the accommodation; and that he/she
consented to being placed in a noncertified bed.

A. Beneficiary Liability

If the A/B MAC (A) determines that the beneficiary did not consent to placement in a
noncertified portion of the same institution that also includes the participating facility
(see §130.3.C), and that no other basis for denial of the claim exists (see §130.3.D), it
finds the beneficiary not liable under §1879 of the Act.
B. Provider Liability

If the beneficiary is found not liable under §1879, liability may rest with the provider, or
with the program. Liability rests with the Medicare program, unless any of the following
conditions exist, in which case the provider is liable for the services.

The provider did not give timely written notice to the beneficiary of the implications
of receiving care in a noncertified or inappropriately certified bed as discussed in
§130.3.B;

The provider failed to provide the beneficiary with an appropriate ABN and/or did
not attempt to obtain a valid consent statement from the beneficiary. (See §130.3.C.);
or

The A/B MAC (A) determined from medical records in its claims files that it is clear
that the beneficiary required and received services equivalent to a covered level of
SNF care, or that constituted covered hospital services, and the provider had no
reasonable basis for placing the beneficiary in a noncertified bed. Following are
examples of situations in which it would be found that the provider did in fact have a
reasonable basis to place a beneficiary in a noncertified bed:

EXAMPLES:

• The A/B MAC (A), a QIO, or Utilization Review Committee had advised the
provider that the beneficiary did not require a covered level of SNF care or
covered hospital services preadmission/admission;

• The beneficiary’s attending physician specifically advised the provider (verified


by documentation in the medical record) that the beneficiary no longer required a
covered level of care or services; note that if covered care had previously existed,
effective July 1, 2005, notification under the expedited determination process
would be required (see §20);

• A beneficiary not requiring covered services had a change in his/her condition


that later required a covered level of care or services and the provider had no
certified bed available (of course, the SNF transfer requirement must be met, see
the Medicare Benefit Policy Manual, Chapter 8.); or

• The A/B MAC (A) has other sufficient evidence to determine that the provider
acted in good faith but inadvertently placed the beneficiary in a noncertified bed.
140 - Physician Refund Requirements (RR) Provision for Nonassigned
Claims for Physicians Services Under §1842(l) - Instructions for
Contractors and Physicians
(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

Following are the procedures for implementing §1842(l) of the Act. Under §9332(c) of
OBRA 1986 (P.L. 99-509), which added §1842(l) to the Act, new liability protections for
Medicare beneficiaries affect nonparticipating physicians.

140.1 - Services Furnished Before October 1, 1987


(Rev. 1, 10-01-03)

Before October 1, 1987, a physician who did not accept Medicare assignment was
permitted to collect from a Medicare beneficiary his/her full charge for services which
were subsequently denied because they were not reasonable and necessary under
§1862(a)(1) of the Act, even though the beneficiary may not have known that Medicare
would not pay for the services. This was in contrast to the rules applicable to assigned
claims. Where a physician agrees to accept assignment (either on an individual claims
basis or by entering into a Medicare participation agreement), the physician is effectively
precluded by the indemnification procedures under the limitation of liability provision
from receiving payment for services that are not reasonable and necessary if it is
established that the physician knew or should have known that Medicare would not pay
for the services and the beneficiary did not. However, under the limitation of liability
provision, program payment may be made to the physician if neither the physician nor
the patient knew, nor could reasonably have been expected to know, that Medicare would
not pay for the items and services.

140.2 - Services Furnished Beginning October 1, 1987


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

Under §1842(l) of the Act, effective for services furnished on or after October 1, 1987,
nonparticipating physicians who

1. Do not accept assignment,

2. Do not claim payment after the death of the beneficiary, and

3. Do not bill under the indirect payment procedure must refund to beneficiaries any
amounts collected for physicians’ services which are denied because they are not
reasonable and necessary under §1862(a)(1).

This provision is applicable in any case in which the contractor denies payment or
reduces the level of payment on the basis of §1862(a)(1). In the latter situation, there is,
in effect, a denial of the more extensive service or procedure on the basis that it is not
reasonable and necessary under §1862(a)(1), even though Medicare payment is made for
the less extensive service or procedure (e.g., an intermediate office visit is allowed as a
brief office visit). Where a reduction in the level of payment occurs, the physician must
refund to the beneficiary any amounts he/she collects which exceed his/her maximum
allowable actual charge (MAAC) for the less extensive procedure. Of course, in the
unusual case where the physician’s MAAC for the less extensive service equals or
exceeds his/her actual charge for the more extensive service, no refund is required.

Section 1842(l) of the Act applies only to physicians’ services subject to the Medicare
Economic Index (MEI). Certain services, such as those involving injections that can be
given by a paramedical person other than a physician (e.g., pneumococcal and hepatitis
vaccine injections) which may be denied under §1862(a)(1) are not physicians’ services
for purposes of the MEI. Therefore, denials of payment on the basis of §1862(a)(1)(B) of
the Act for those services are not subject to §1842(l) refund requirements. Additionally,
services of physician extenders (e.g., physician’s assistants, nurse practitioners,
MEDEXes, etc.) are not physicians’ services and are not subject to §1842(l) refund
requirements. The application of §1842(1) refund requirements on the correct statutory
basis, i.e., only on the basis of §1862(a)(1), and only to physicians’ services subject to the
MEI, is essential. Incorrect application improperly takes away physicians’ rights to bill
beneficiaries for denied services and incurs unnecessary expenses for review,
development, and appeals.

140.3 - Time Limits for Making Refunds


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

A required refund must be made within specified time limits. Physicians who knowingly
and willfully fail to make refund within these time limits may be subject to civil money
penalties and/or exclusion from the Medicare program. Under §1842(1) , a refund of any
amounts collected must be made to the beneficiary within the following time limits:

• If the physician does not request an appeal of the initial denial or reduction in
payment within that time, the refund must be made to the beneficiary within 30
days after the date the physician receives notice of the initial determination. (See
§140.6 for notice requirements.); or

• If the physician requests an appeal within 30 days of receipt of the notice of the
initial determination, the refund must be made to the beneficiary within 15 days after
the date the physician receives the notice of the appeal determination.

140.4 - Situations Where a Refund Is Not Required


(Rev. 1, 10-01-03)

Under §1842(1), a refund is not required of the physician if either of the following
conditions is met:

1. The physician did not know and could not reasonably have been expected to
know that Medicare would not pay for the services because they were not
reasonable and necessary. To determine whether the physician knew, or could
reasonably have been expected to know, use the rules for determining physician
liability under §1879. (See §30.2.); or

2. Before the service was furnished, the physician notified the beneficiary in writing
of the likelihood that Medicare would not pay for the specific service and, after
being so informed, the beneficiary signed a statement agreeing to pay the
physician for the service.

To qualify for waiver of the refund requirements of §1842(1), the advance notice to the
beneficiary must be in writing, must clearly identify the particular service, must state that
the physician believes Medicare is likely to deny payment for the particular service, and
must give the physician’s reason(s) for his/her belief that Medicare is likely to deny
payment for the service. The Advance Beneficiary Notice (ABN, Form CMS-R-131),
given in compliance with §40.3 and §50, satisfies the statutory requirements for the
physician’s advance notice and the beneficiary’s agreement to pay.

140.5 - Appeal Rights


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

Nonparticipating physicians have the same rights to appeal the contractor’s


redetermination in an unassigned claim for physicians’ services if the contractor denies or
reduces payment on the basis of §1862 (a)(1) as they or participating physicians have in
assigned claims. These rights of appeal also extend to determinations that a refund is
required either because the physician knew or should have known that Medicare would
not pay for the service, or because the beneficiary was not properly informed in writing in
advance that Medicare would not pay or was unlikely to pay for the service or, if so
informed, did not sign a statement agreeing to pay. In addition to the beneficiary’s right
to appeal the contractor’s decision to deny or reduce payment on the basis of §1862
(a)(1), the beneficiary becomes a party to any request for appeal filed by the physician.
Since the beneficiary and the physician may have adverse interests in a decision
regarding refund, it is essential to notify the beneficiary in any case in which the
physician requests an appeal of the denial or reduction in payment or asserts that a refund
is not required because one of the conditions in §140.4 is met. (See Chapter 29, “Appeals
for detailed appeals instructions.”)

140.6 - Processing Initial Denials


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

In any unassigned claim for physician’s services furnished on or after October 1, 1987, in
which the contractor denies or reduces payment on the basis of §1862(a)(1), the
contractor will send separate notices to both the beneficiary and the physician. In some
cases, the beneficiary (or physician) may submit a copy of an ABN which satisfies the
requirements in §140.4. The contractor should not make an automatic finding that the
service is not reasonable and necessary merely because the beneficiary has submitted an
ABN. The fact that there is an acceptable ABN must in no way prejudice the contractor’s
determination as to whether there is or is not sufficient evidence to justify a denial under
§1862(a)(1). In the case where there is an acceptable ABN, the contractor will mail a
standard denial MSN notice to the beneficiary. In the absence of an acceptable ABN, and
depending on whether there is a full denial or a partial reduction in payment, the
contractor will include, in addition to one of the “medical necessity” denial notices, one
of the following notices in the MSN sent to the beneficiary.

140.6.1 - Initial Beneficiary Notices


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

Notice 1 - Full Denial

If the doctor should have known that Medicare would not pay for the
denied services and did not tell you in writing before providing the
services, you may be entitled to a refund of any amounts you paid.
However, if the doctor requests an appeal of this claim within 30 days, a
refund is not required until we complete our appeal. If you paid for this
service and do not hear anything about a refund within the next 30 days,
contact your doctor’s office.

Notice 2 - Reduction in Payment

If the doctor should have known that Medicare would not pay for the more
extensive service and did not tell you this in writing before providing the
service, you may be entitled to a refund of any amount you paid which is
more than the doctor is allowed by law to charge under Medicare for the
less extensive service. However, if the doctor requests an appeal of this
claim within 30 days, a refund is not required until we complete our
appeal. If you paid for the more extensive service and do not hear anything
about a refund within the next 30 days, contact your doctor’s office.

In addition, add the following paragraph:

You could have avoided paying $_______, the difference between the maximum
amount the doctor or supplier is allowed to charge and the amount Medicare
approved for the lesser service, if the claim had been assigned.

140.6.2 - Initial Physician Notices


(Rev. 4250; Issued: 03-08-10; Effective: 04-08-19; Implementation: 04-08-19)

The term Medicare beneficiary identifier (Mbi) is a general term describing a


beneficiary's Medicare identification number. For purposes of this manual, Medicare
beneficiary identifier references both the Health Insurance Claim Number (HICN) and
the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition
period and after for certain business areas that will continue to use the HICN as part of
their processes.

Include in the notice to the physician the following:


• The patient’s name and Medicare beneficiary identifier;

• A description of the service by procedure code, date and place of service, and
amount of the charge;

• The same denial notice included on the beneficiary’s MSN; and

• Depending on whether the beneficiary submitted a copy of an acceptable ABN


with his/her claim, include in the notice to the physician one of the following:

Notice 1 - Advance Beneficiary Notice Received Prior to Initial Determination

(The service identified above has been denied because/although payment


has been made to the patient for a less extensive service,) the information
furnished did not substantiate the need for the (more extensive) service.
Since you informed the beneficiary in writing prior to furnishing the
service that Medicare was likely to deny payment for the (more extensive)
service and the beneficiary signed a statement agreeing to pay, the
beneficiary is liable for (this/the more extensive) service.

Or

Notice 2 - Advance Beneficiary Notice Not Submitted

(The service identified above has been denied because/Although payment


has been made to the patient for a less extensive service,) the information
furnished did not substantiate the need for the (more extensive) service).

If you have collected (any amount from the patient/any amount that
exceeds your maximum allowable actual charge (MAAC) for the less
extensive service), the law requires you to refund that amount to the
patient within 30 days of receiving this notice. The law permits exceptions
to this refund requirement in two cases:

• If you did not know, and could not have reasonably been
expected to know, that Medicare would not pay for this
service; or

• If you notified the beneficiary in writing before providing


the service that you believed that Medicare was likely to
deny the service, and the beneficiary signed a statement
agreeing to pay for the service.

If you come within either exception, or if you believe the contractor was
wrong in its determination that Medicare does not pay for this service, you
should request an appeal of this determination by the contractor within 30
days of receiving this notice. Your request for appeal should include any
additional information necessary to support your position.

If you request an appeal within this 30 day period, you may delay
refunding the amount to the beneficiary until you receive the results of the
appeal. If the appeal determination is favorable to you, you do not have to
make any refund. If, however, the appeal is unfavorable, the law specifies
that you must make the refund within 15 days of receiving the unfavorable
appeal decision.

The law also permits you to request an appeal of the determination at any
time within six months of receiving this notice. An appeal requested after
the 30 day period does not permit you to delay making the refund.
Regardless of when an appeal is requested, the patient will be notified that
you have requested one, and will receive a copy of the determination.

The patient has received a separate notice of this denial decision. The
notice advises that he or she may be entitled to a refund of any amounts
paid, if you should have known that Medicare would not pay and did not
tell him or her. It also instructs the patient to contact your office if he or
she does not hear anything about a refund within 30 days.

The requirements for refund are in §1842(1) of the Social Security Act.
Section 1842(1) specifies that physicians who knowingly and willfully fail
to make appropriate refunds may be subject to civil money penalties
and/or exclusion from the Medicare program.

If you have any questions about this notice, please contact (Contractor
contact, telephone number).

The contractor will ensure that the telephone number puts the physician in touch with a
knowledgeable professional who can discuss the basis for the denial or reduction in
payment.

NOTE: These procedures do not apply to claims the contractor automatically denies
under the A/B link procedures. In those cases, the QIO is responsible for notifying the
beneficiary and physician of the refund requirements of §1842(1) and making the refund
determination where appropriate.

140.7 - Processing Beneficiary Requests for Appeal


(Rev. 4250; Issued: 03-08-10; Effective: 04-08-19; Implementation: 04-08-19)

The term Medicare beneficiary identifier (Mbi) is a general term describing a


beneficiary's Medicare identification number. For purposes of this manual, Medicare
beneficiary identifier references both the Health Insurance Claim Number (HICN) and
the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition
period and after for certain business areas that will continue to use the HICN as part of
their processes.

Where a beneficiary requests an appeal of the initial denial or reduction in payment, the
contractor will process the appeal in the normal fashion except that, where the appeal
results in a reversal to full or partial payment, the contractor will include the following
special paragraph in the appeal notice sent to the beneficiary:

The doctor who furnished this service has been informed of this decision
and advised that he/she may collect (his/her full charge for the service/up
to the maximum amount he/she is allowed by law to charge under
Medicare for the less extensive service for which payment has been
made).

If the reversal is for the less extensive service, the contractor will incorporate in the
notice the following:

You could have avoided paying $_______, the difference between the
maximum amount the doctor is allowed to charge and the amount
Medicare approved for the lesser service, if the claim had been assigned.

The contractor will send the physician who furnished the service a separate notice which
clearly identifies the service for which full or partial payment is being made (i.e.,
includes the patient’s name, Medicare beneficiary identifier, a description of the service
billed by procedure code, date and place of service, and amount of the charge. Where
only partial payment is being made, the contractor will clearly indicate the less extensive
service for which payment has been made). The contractor will include the following
language:

You were previously advised that Medicare payment could not be made for this
service. However, after reviewing this claim, we have determined that payment
may be made (for a less extensive service). Therefore, if you have already
refunded the amounts you collected from the beneficiary for this service, you may
recollect (these amounts/any amounts which do not exceed your maximum
allowable actual charge (MAAC) for the less extensive service for which payment
has been made).

140.8 - Processing Physician Requests for Appeal


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

Where a physician requests an appeal, the contractor will notify the beneficiary as
discussed in §140.5. The appeal process consists of three stages, even though the
physician may be contesting only one issue (e.g., the physician may assert that he/she did
not know, and could not have reasonably have been expected to know, that Medicare
would not pay for the services).

140.8.1 - Appeal of the Denial or Reduction in Payment


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

The first part of the appeal is a new, independent, and critical reexamination of the facts
regarding the denial or reduction in payment. If the contractor finds that the initial denial
or reduction in payment was appropriate, the contractor will go on to §140.8.2.

140.8.2 - Beneficiary Given ABN and Agreed to Pay


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

A physician who has given the beneficiary an ABN and has obtained the beneficiary’s
signed statement agreeing to pay, is not required to make a refund. If the physician claims
to have given an ABN to the beneficiary, the contractor will ask the physician to furnish a
copy of the signed ABN. The contractor will examine the ABN to determine whether it
meets the guidelines in §140.4. In the absence of acceptable evidence of advance notice,
the contractor will go on to §140.8.3.

140.8.3 - Physician Knowledge


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

In determining whether the physician knew, or could reasonably have been expected to
know, that Medicare would not pay for the services, the contractor will apply the same
rules that are applicable in determining physician liability under §1879 of the Act. (See
§30.2.)

140.9 - Guide Paragraphs for Inclusion in Appeal Determination


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

The contractor, upon completion of its appeal, will send the physician an appeal notice
and send a copy to the beneficiary. If the initial payment determination is reversed to full
or partial payment, the contractor will include in the appeal notice the physician notice
language required in §140.7. Otherwise, the contractor will include one of the following
paragraphs concerning refund.

Paragraph 1. Refund Not Required - Beneficiary Was Given Advance Beneficiary Notice
and Agreed to Pay

Under §1842(l) of the Social Security Act, a physician who does not accept assignment
and collects any amounts from a Medicare beneficiary for services for which Medicare
does not pay on the basis of §1862(a)(1) of the Social Security Act, must refund these
amounts to the beneficiary. However, a refund is not required if, prior to furnishing the
services, the physician notified the beneficiary in writing that Medicare would not pay for
the services and the beneficiary signed a statement agreeing to pay for them. After
reviewing this claim, we have determined that you informed the beneficiary in advance
that Medicare does not pay for the above services and the beneficiary agreed to pay for
them. Therefore, you are not required to make a refund in this case. The beneficiary has
been sent a copy of this notice.
Paragraph 2. Refund Not Required - Physician Did Not Know That Medicare Would Not
Pay For the Services

Under §1842(1) of the Social Security Act, a physician who does not accept assignment
and collects any amounts from a Medicare beneficiary for services for which Medicare
does not pay on the basis of §1862(a)(1) of the Social Security Act, must refund these
amounts to the beneficiary. However, a refund is not necessary if the physician did not
know, and could not reasonably have been expected to know, that Medicare does not pay
for the services. After reviewing this claim, we find that you did not know, and could not
reasonably have been expected to know, that Medicare would not pay for the above
services. Therefore, you are not required to make a refund in this case. Upon your receipt
of this notice, it is considered that you now have knowledge of the fact that Medicare
does not pay for (description of services) for similar conditions. The beneficiary has been
sent a copy of this notice.

Paragraph 3. Adverse Action on Denial - Refund Required

Under §1842(1) of the Social Security Act, a physician who does not accept assignment
and collects any amounts from a Medicare beneficiary for services for which Medicare
does not pay on the basis of §1862(a)(1) of the Social Security Act, must refund these
amounts to the beneficiary. A refund is not required if (1) the physician did not know,
and could not reasonably have been expected to know, that Medicare would not pay for
the services; or (2) the physician notified the beneficiary in writing before furnishing the
services that Medicare would not pay for the services and the beneficiary signed a
statement agreeing to pay for them. After reviewing this claim, we have determined that
neither of these conditions is met in this case. You must therefore refund any amount you
collected for these services within 15 days from the date you receive this notice. A refund
must be made within 15 days from receipt of this notice for you to be in compliance with
the law. If we paid for a less extensive procedure, you need refund only the amount
which exceeds your maximum allowable actual charge (MAAC) for the less extensive
procedure. The beneficiary has been sent a copy of this notice. Physicians who
knowingly and willfully fail to make appropriate refunds may be subject to assessments
of double the violative charges, civil money penalties (up to $2000 per violation), and/or
exclusion from the Medicare program for a period of up to 5 years.

140.10 - Physician Fails to Make Refund


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

Under §1842(1) of the Act, a physician who knowingly and willfully fails to make refund
within the time limits in §140.3 may be subject to sanctions (i.e., civil money penalties
and/or exclusion from the Medicare program). Generally, the failure of a physician to
make a refund comes to the contractor’s attention as a result of a beneficiary complaint to
the contractor, Social Security Administration (SSA), or CMS. If necessary, the
contractor will contact the beneficiary to clarify the information in the complaint and to
determine the amount the beneficiary paid the physician for the denied services. If the
contractor determines that a physician failed to make a refund, it will contact the
physician in person or by telephone to discuss the facts of the case. The contractor will
attempt to determine why the amounts collected have not been refunded and will explain
that the law requires that the physician make refund to the beneficiary and that if he/she
fails to do so, the OIG may impose civil money penalties and assessments, and sanctions.
The contractor will make a dated report of contact and include the information relayed to
the physician and the physician’s response. The contractor will recontact the beneficiary
in 15 days to determine whether the refund has been made. When the amount in question
is $300 or more or where there are at least three outstanding violations by the physician,
the contractor will contact the Sanctions Coordinator in the appropriate field office of the
OIG by telephone to discuss whether referral to OIG is appropriate. If the case should be
referred, the contractor will make the referral to the regional OIG Sanctions Coordinator
in accordance with the procedures following. The contractor should not make a referral
until the physician’s appeal rights have been exhausted, or until the time limit for an
appeal has passed.

140.11 - OIG Referral Procedures


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

The contractor will include in the sanction recommendation to the OIG/FO (to the extent
appropriate) the following:

• Identification of the Subject - The subject’s name, address and a brief description
of the subject’s special field of medicine.

• Origin of the Case - A brief description of how the violations were discovered.

• Statement of Facts - A statement of facts in chronological order describing each


failure to comply with the refund requirements in §1842(1).

• Documentation - Copies of written correspondence and written summaries of any


meetings or telephone contacts with the beneficiary and the physician regarding
the physician’s failure to make refund.

• Other Significant Issues - Any information that may be of value in the event of a
hearing to bar a physician from receiving Medicare payment.

140.12 - Imposition of Sanctions


(Rev. 1, 10-01-03)

Section 1842(1)(3) of the Act provides that if a physician knowingly and willfully fails to
make a required refund, the Secretary may impose the sanctions provided in §§1842(j)(2)
of the Act. These include assessments of double the violative charges, civil money
penalties (up to $2000 per violation), and/or exclusion from the Medicare program for a
period of up to five years. However, sole community physicians and physicians who are
the sole source of an essential specialty are not excluded from the program. The OIG
makes determinations to levy a monetary penalty or program exclusion based upon a
failure to make a refund.
150 - DMEPOS Refund Requirements (RR) Provision for Claims for
Medical Equipment and Supplies under §§1834(a)(18), 1834(j)(4), and
1879(h) - Instructions for Contractors and Suppliers
(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

Following are the procedures for implementing §§1834(a)(18), 1834(j)(4) and 1879(h) of
the Act. Under §132 of SSAA-1994 (Social Security Act Amendments of 1994, P.L. 103-
432) which adds §1834(a)(18) to the Act, and under §133 of SSAA-1994 which adds
§1834(j)(4) and §1879(h) to the Act, new liability protections for Medicare beneficiaries
affect suppliers of medical equipment and supplies. All suppliers who sell or rent medical
equipment and supplies to Medicare beneficiaries are subject to the refund provisions of
§§1834(a)(18), 1834(j)(4) and 1879(h) of the Act. Beneficiaries’ liability for payment for
certain items and services, that is, for otherwise covered medical equipment and supplies
as defined in §150.10 , which are furnished on or after January 1, 1995, and for which
Medicare payment is denied for one of several reasons specified below, may be limited as
follows. For both assigned and unassigned claims, for which the supplier knew or should
have known of the likelihood that payment would be denied (that is, the supplier is held
to be liable) and for which the beneficiary did not know, the beneficiary has no financial
responsibility and the refund provisions of the Act apply in virtually all cases. The single
exception to this rule of applicability is that, with respect to medical equipment and
supplies for which the supplier accepted assignment and for which payment is denied
because the item or service is not medically reasonable and necessary under §1862(a)(1)
of the Act, the §1879 Limitation on Liability provisions which applied to such denials
prior to January 1, 1995, still apply. The refund provisions do not apply to these denials.

In claims for medical equipment and supplies, payment reductions may be based on
partial denials of coverage for additional expenses not attributable to medical necessity.
A medical necessity “partial denial” is the denial of coverage for the unnecessary
component of a covered item or service, when that component is in excess of the
beneficiary’s medical needs. Any such excess component is not medically reasonable and
necessary and therefore, under §1862(a)(1) of the Act, it is not covered. A partial denial
may be used to base payment on the least costly, medically appropriate, alternative. The
beneficiary liability protections of §1879 and of §1834(j)(4) of the Act apply to any
payment reductions due to partial denials of coverage for medical equipment or supplies
on the basis of medical necessity under §1862(a)(1) of the Act. (See §140 for its similar
provision for the applicability of the refund requirements under §1842(l) of the Act to
partial denials of coverage for physicians’ services.)

When the refund provisions of §§1834(a)(18), 1834(j)(4) and 1879(h) of the Act apply
and the supplier is held to be liable, a required refund must be made on a timely basis.
Suppliers which knowingly and willfully fail to make refund within specified time limits
may be subject to civil money penalties and/or exclusion from the Medicare program.

Refund is not required if the supplier is held not to be liable, that is, if it is held that the
supplier did not know and could not reasonably have been expected to know that
Medicare would not pay on the basis of §1834(a)(17)(B), §1834(j)(1), §1834(a)(15), or
§1862(a)(1) of the Act, or if it is held that, before the item or service was furnished, the
beneficiary was informed by the supplier that Medicare would not pay and the
beneficiary agreed to pay for the item or service. In any case where the supplier is held
not to be liable, the beneficiary is liable for payment.

150.1 - Definition of Medical Equipment and Supplies


(Rev. 1, 10-01-03)

The following definitions of medical equipment and supplies control the application of
the provisions of this section.

150.1.1 - Unassigned Claims Denied on the Basis of the Prohibition on


Unsolicited Telephone Contacts
(Rev. 1, 10-01-03)

For unassigned claims denied on the basis of the prohibition on unsolicited telephone
contacts under §1834(a)(17)(B) of the Act, the term “medical equipment and supplies”
means:

• Durable medical equipment, as defined in §1861(n) of the Act; and


• Medical supplies, as described in §1861(m)(5) of the Act, including catheters,
catheter supplies, ostomy bags, and supplies related to ostomy care.

150.1.2 - Unassigned Claims Denied on the Basis of Not Being


Reasonable and Necessary
(Rev. 1, 10-01-03)

For unassigned claims denied on the basis of not being reasonable and necessary under
§1862(a)(1) of the Act; or Medicare payment being denied in advance under
§1834(a)(15) of the Act; the term “medical equipment and supplies” means:

• Durable medical equipment, as defined in §1861(n) of the Act;

• Prosthetic devices, as described in §1861(s)(8) of the Act;

• Orthotics and prosthetics, as described in §1861(s)(9) of the Act;

• Surgical dressings, as described in §1861(s)(5) of the Act; and

• Such other items as the Secretary may determine.

150.1.3 - Unassigned Claims Denied on the Basis of Failure of the


Supplier to Meet Supplier Number Requirements
(Rev. 1, 10-01-03)
For unassigned claims denied on the basis of failure of the supplier to meet supplier
number requirements under §1834(j)(1) of the Act, the term “medical equipment and
supplies” means:

• Durable medical equipment, as defined in §1861(n) of the Act;

• Prosthetic devices, as described in §1861(s)(8) of the Act;

• Orthotics and prosthetics, as described in §1861(s)(9) of the Act;

• Surgical dressings, as described in §1861(s)(5) of the Act;

• Home dialysis supplies and equipment, as described in 1861(s)(2)(F) of the


Act;

• Immunosuppressive drugs, as described in 1861(s)(2)(J) of the Act;

• Therapeutic shoes for diabetics, as described in 1861(s)(12) of the Act;

• Oral drugs prescribed for use as an anticancer therapeutic agent, as described


in 1861(s)(2)(Q) of the Act;

• Self-administered erythropoietin, as described in 1861(s)(2)(P) of the Act; and

• Such other items as the Secretary may determine.

150.1.4 - Assigned Claims Denied on the Basis of the Prohibition on


Unsolicited Telephone Contacts
(Rev. 1, 10-01-03)

For assigned claims denied on the basis of the prohibition on unsolicited telephone
contacts under §1834(a)(17)(B) of the Act; or Medicare payment being denied in advance
under §1834(a)(15) of the Act; the term “medical equipment and supplies” means:

• Durable medical equipment, as defined in §1861(n) of the Act;

• Prosthetic devices, as described in §1861(s)(8) of the Act;

• Orthotics and prosthetics, as described in §1861(s)(9) of the Act;

• Surgical dressings, as described in §1861(s)(5) of the Act; and

• Such other items as the Secretary may determine.


150.1.5 - Assigned Claims Denied on the Basis of Failure of the Supplier
to Meet Supplier Number Requirements
(Rev. 1, 10-01-03)

For assigned claims denied on the basis of failure of the supplier to meet supplier number
requirements under §1834(j)(1) of the Act, the term “medical equipment and supplies”
means:

• Durable medical equipment, as defined in §1861(n) of the Act;

• Prosthetic devices, as described in §1861(s)(8) of the Act;

• Orthotics and prosthetics, as described in §1861(s)(9) of the Act;

• Surgical dressings, as described in §1861(s)(5) of the Act;

• Home dialysis supplies and equipment, as described in 1861(s)(2)(F) of the Act;

• Immunosuppressive drugs, as described in 1861(s)(2)(J) of the Act;

• Therapeutic shoes for diabetics, as described in 1861(s)(12) of the Act;

• Oral drugs prescribed for use as an anticancer therapeutic agent, as described in


1861(s)(2)(Q) of the Act;

• Self-administered erythropoietin, as described in 1861(s)(2)(P) of the Act; and

• Such other items as the Secretary may determine.

150.1.6 - Assigned Claims Denied on the Basis of Not Being Reasonable


and Necessary
(Rev. 1, 10-01-03)

For assigned claims denied on the basis of not being reasonable and necessary under
§1862(a)(1) of the Act, the term “medical equipment and supplies” means:

• Durable medical equipment, as defined in §1861(n) of the Act;

• Medical supplies, as described in §1861(m)(5) of the Act;

• Prosthetic devices, as described in §1861(s)(8) of the Act;

• Orthotics and prosthetics, as described in §1861(s)(9) of the Act;

• Surgical dressings, as described in §1861(s)(5) of the Act; or


• Such other items as the Secretary may determine.

150.2 - Items and Services Furnished on an Unassigned Basis on or


After January 1, 1995
(Rev. 1, 10-01-03)

Nonparticipating suppliers which (1) Do not accept assignment, (2) Do not claim
payment after the death of the beneficiary, and (3) Do not bill under the indirect payment
procedure, if held to be liable, must refund to beneficiaries any amounts collected for
medical equipment and supplies for which Medicare payment is denied for one of the
following reasons:

• Under §1834(a)(18)(A) of the Act, the supplier violated the prohibition on


unsolicited telephone contacts under §1834(a)(17)(B) of the Act; or

• Under §1834(j)(4) of the Act, the supplier did not meet supplier number
requirements under §1834(j)(1); or the item is denied in advance under
§1834(a)(15) of the Act; or payment is denied as not reasonable and necessary
under §1862(a)(1) of the Act.

In any such payment denial under §1834(a)(17)(B), §1834(j)(1), §1834(a)(15), or


§1862(a)(1) of the Act, the beneficiary has no financial responsibility and the refund
provisions of §§1834(a)(18), 1834(j)(4) or 1879(h) of the Act, as appropriate, apply, if it
is held that the supplier knew or should have known of the likelihood that payment would
be denied and that the beneficiary did not know.

For medical equipment and supplies furnished prior to January 1, 1995, Federal law does
not limit beneficiaries’ liability with respect to unassigned claims for which payment was
denied.

150.3 - Items and Services Furnished On an Assigned Basis On or After


January 1, 1995
(Rev. 1, 10-01-03)

Under §1879(h) of the Act, suppliers, whether nonparticipating or participating, which


accept assignment, if held to be liable, must refund to beneficiaries any amounts collected
for medical equipment and supplies for which Medicare payment is denied for one of the
following reasons:

• Under §1879(h)(1) of the Act, payment is denied because the supplier did not
meet the supplier number requirements under §1834(j)(1) of the Act;

• Under §1879(h)(2) of the Act, payment is denied in advance under §1834(a)(15)


of the Act; and
• Under §1879(h)(3) of the Act, payment is denied based on §1834(a)(17)(B) of the
Act, the prohibition on unsolicited telephone contacts.

In any such payment denial under §1834(j)(1), §1834(a)(15), or §1834(a)(17)(B) of the


Act, the beneficiary has no financial responsibility and the refund provisions apply, if it is
held that the supplier knew or should have known of the likelihood that payment would
be denied and that the beneficiary did not know. However, in a denial of an assigned
claim under §1862(a)(1) of the Act (i.e., payment is denied because the item or service is
not reasonable and necessary), the §1879 Limitation on Liability provisions which
applied to such denials prior to January 1, 1995, still apply.

150.4 - Time Limits for Making Refunds


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

A refund of any amounts collected must be made to the beneficiary on a timely basis.
Refund is considered to be on a timely basis only if made within the following time
limits:

• If the supplier does not request an appeal of the initial denial or reduction in
payment within that time, the refund must be made to the beneficiary within 30
days after the date the supplier receives the remittance advice (RA).

• If the supplier requests an appeal within 30 days of receipt of the notice of the
initial determination, the refund must be made to the beneficiary within 15 days
after the date the supplier receives the notice of the contractor’s determination of
the supplier’s appeal.

150.5 - Supplier Knowledge Standards for Waiver of Refund


Requirement
(Rev. 1, 10-01-03)

A refund is not required of the supplier if the supplier did not know and could not
reasonably have been expected to know that Medicare would not pay for the medical
equipment or supplies. Following are the knowledge standards applicable to the different
types of denials.

150.5.1 - Knowledge Standards for §1862(a)(1) Denials


(Rev. 1, 10-01-03)

In determining whether the supplier knew, or could reasonably have been expected to
know, that Medicare would not pay on the basis of medical necessity, apply the same
rules that are applicable in determining supplier liability under §1879 of the Act.

150.5.2 - Knowledge Standards for §1834(a)(15) Denials


(Rev. 1, 10-01-03)
150.5.2.1 - Denial of Payment in Advance
(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

Denial of payment in advance under §1834(a)(15) of the Act refers both to cases in which
the supplier requested an advance determination and the contractor determined that the
item would not be covered, and to cases in which the supplier failed to request an
advance determination when such a request is mandatory.

150.5.2.2 - When a Request for an Advance Determination of Coverage


Is Mandatory
(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

A request for an advance determination of coverage of medical equipment and supplies is


mandatory under §1834(a)(15)(C)(i) & (ii) of the Act, respectively, when:

• The item is on the list developed by the Secretary under §1834(a)(15)(A) of items
which are frequently subject to unnecessary utilization in your contractor service
area; or

• The supplier is on the list developed by the Secretary under §1834(a)(15)(B) of


the Act of suppliers for which a substantial number of claims have been denied as
not medically reasonable and necessary under §1862(a)(1) of the Act or the
Secretary has identified a pattern of overutilization resulting from the business
practice of the supplier.

150.5.2.3 - When a Request for an Advance Determination of Coverage


Is Optional
(Rev. 1, 10-01-03)

A request for an advance determination of coverage of medical equipment and supplies is


optional under §1834(a)(15)(C)(iii) of the Act when the item is a customized item (other
than inexpensive items specified by the Secretary) and the patient to whom the item is to
be furnished or the supplier requests an advance determination.

150.5.2.4 - Presumption for Constructive Notice


(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

In determining whether the supplier knew, or could reasonably have been expected to
know, that Medicare would deny payment in advance under §1834(a)(15) of the Act,
presume that the supplier knew that Medicare would not pay in all cases in which the
supplier failed to request a mandatory advance determination, on the basis of constructive
notice of the lists of items and of suppliers to the supplier through the contractor’s regular
newsletter/bulletin publication. The supplier would have to submit convincing evidence
to the contrary to rebut this presumption.
150.5.2.5 - Presumption When Advance Determination was Requested
(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

In determining whether the supplier knew, or could reasonably have been expected to
know, before furnishing the item, that Medicare would deny payment in advance under
§1834(a)(15) of the Act, presume that the supplier knew that Medicare would not pay in
all those cases in which a request for advance determination was made, and the contractor
denied payment in advance on the basis that the item is not reasonable and necessary
under §1862(a)(1) of the Act or that the item is not covered. This is a nonrebuttable
presumption.

150.5.2.6 - Presumption for Listed Overutilized Items


(Rev. 1, 10-01-03)

Any denial of a claim for a particular item furnished by a particular supplier because the
item is on the §1834(a)(15)(A) list of potentially overutilized items is actual notice to that
supplier that an advance determination must be requested for all future claims for that
item, and for any other items which are identified in the same notification of denial as
being on the list of potentially overutilized items. Presume, on that basis, that that
supplier has knowledge that an advance determination must be requested for all future
claims for any and all items which are identified in the notification of denial as being on
the list of potentially overutilized items. This is a nonrebuttable presumption.

150.5.2.7 - Presumption for Listed Suppliers


(Rev. 1, 10-01-03)

Any denial of a claim for an item furnished by a particular supplier because the supplier
is on the §1834(a)(15)(B) list of suppliers, is actual notice to that supplier that an advance
determination must be requested for all future claims for any item of medical equipment
and supplies which that supplier furnishes. Presume, on that basis, that that supplier has
knowledge that an advance determination must be requested for all future claims for any
and all items of medical equipment and supplies which it furnishes. This is a
nonrebuttable presumption.

150.5.2.8 - Presumption for Medical Necessity


(Rev. 1, 10-01-03)

In the case of an optional request for an advance determination of coverage of a


customized item of medical equipment and supplies under §1834(a)(15)(C)(iii) of the Act
by the patient to whom the item is to be furnished or the supplier, in determining whether
the supplier knew, or could reasonably have been expected to know, that Medicare would
deny payment in advance under §1834(a)(15) of the Act, presume that the supplier knew
that Medicare would not pay in all cases in which you denied payment in advance on the
basis that the item is not reasonable and necessary under §1862(a)(1) of the Act or that
the item is not covered. This is a nonrebuttable presumption.
150.5.2.9 - Presumption About Beneficiary Knowledge
(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

Presume that a Medicare beneficiary does not know, and cannot reasonably be expected
to know, that Medicare will deny, or has denied, payment in advance under §1834(a)(15)
of the Act unless and until the beneficiary has received a proper advance beneficiary
notice (ABN) to that effect from the supplier before the item is furnished to them.

150.5.3 - Knowledge Standards for §1834(a)(17)(B) Denials


(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

In determining whether the supplier knew, or could reasonably have been expected to
know, that Medicare would not pay because of the prohibition on unsolicited telephone
contacts under §1834(a)(17)(B) of the Act, presume that the supplier knew that Medicare
would not pay on the basis of constructive notice to the supplier through publication of
the prohibition on such contacts through the contractor’s professional relations function,
as well as publicity through trade organizations’ own publications, professional training,
conventions, etc. The supplier would have to submit convincing evidence to the contrary,
showing ignorance of the prohibition on the supplier’s part, to rebut this presumption. A
single denial of a claim for any item furnished by a particular supplier on the basis of the
prohibition on unsolicited telephone contacts shall be held to be actual notice of the
prohibition to that supplier; and that supplier shall be considered, on that basis, to have
had knowledge that payment would be denied for all such future claims, even those for
different items of medical equipment and supplies. That is, after a single denial under
§1834(a)(17)(B) of a claim by a particular supplier, the presumption of that supplier’s
knowledge becomes nonrebuttable.

150.5.4 - Knowledge Standards for §1834(j)(1) Denials


(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

In determining whether the supplier knew, or could reasonably have been expected to
know, that Medicare would not pay due to failure to meet supplier number requirements
under §1834(j)(1) of the Act, presume that the supplier knew that Medicare would not
pay. Every supplier is expected to know whether or not it has a supplier number, and to
know that Medicare will not make payment for medical equipment and supplies furnished
a Medicare beneficiary by a supplier which does not have a supplier number. All
suppliers should have this knowledge on the basis of the contractor’s professional
relations function, as well as publicity through trade organizations’ own publications,
professional training, conventions, etc. The supplier would have to submit extraordinary
evidence to the contrary to rebut this presumption. If a supplier submits evidence the
contractor finds credible, consult your regional office before rebutting the presumption of
supplier knowledge. After a single denial under §1834(j)(1) of a claim by a particular
supplier, the presumption of that supplier’s knowledge becomes nonrebuttable.

150.5.5 - Additional Knowledge Standards for All Medical Equipment


and Supplies Denials
(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

The contractor may make a determination, as provided for in Section I.2.D.2.b. imputing
a lack of knowledge to a supplier, on the basis that the supplier did not know and could
not reasonably have been expected to know that Medicare would not pay, if the supplier
did not know and could not reasonably have been expected to know that a purchase (or
rental) of medical equipment or supplies involved a Medicare beneficiary.

150.6 - Advance Beneficiary Notice Standards for Waiver of Refund


Requirement
(Rev. 1, 10-01-03)

A refund is not required of the supplier if, before the medical equipment or supplies were
furnished, the beneficiary was informed by the supplier that Medicare would not pay for
the specific item or service and, after receiving such an advance beneficiary notice, the
beneficiary agreed to pay for the item or service. This requirement for advance notice
may be satisfied by a properly executed Advance Beneficiary Notice (ABN) Form
CMS-R-131 used in accordance with the instructions at §50.

150.7 - Appeal Rights


(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

Nonparticipating suppliers have the same rights to appeal the contractor’s determination
in an unassigned claim for medical equipment and supplies if the contractor denies
payment on the basis of §1862(a)(1) , §1834(a)(17)(B) , §1834(j)(1), or §1834(a)(15) of
the Act as they or participating suppliers have in assigned claims. These rights of appeal
also extend to determinations that a refund is required either because the supplier knew or
should have known that Medicare would not pay for the item or service, or because the
beneficiary was not properly informed in writing in advance that Medicare would not pay
or was unlikely to pay for the item or service. In addition to the beneficiary’s right to
appeal the contractor’s decision to deny payment on the basis of §1862(a)(1),
§1834(a)(17)(B), §1834(j)(1), or §1834(a)(15) of the Act, the beneficiary becomes a
party to any appeal request filed by the supplier. Since the beneficiary and the supplier
may have adverse interests in a decision regarding refund, it is essential to notify the
beneficiary in any case in which the supplier requests an appeal of the denial or asserts
that a refund is not required because one of the conditions in §150.5 is met. (See Chapter
29, “Appeals of this Claims Decision,” for detailed appeals instructions.)

150.8 - Processing Initial Denials


(Rev. 4250; Issued: 03-08-10; Effective: 04-08-19; Implementation: 04-08-19)

The term Medicare beneficiary identifier (Mbi) is a general term describing a


beneficiary's Medicare identification number. For purposes of this manual, Medicare
beneficiary identifier references both the Health Insurance Claim Number (HICN) and
the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition
period and after for certain business areas that will continue to use the HICN as part of
their processes.

In any unassigned claim for medical equipment and supplies furnished on or after
January 1, 1995, in which the contractor denies payment on the basis of §1862(a)(1),
§1834(a)(17)(B), §1834(j)(1), or §1834(a)(15) of the Act, send separate notices to both
the beneficiary (a Medicare Summary Notice (MSN)) and the supplier (a remittance
advice (RA)).

NOTE: This instruction to send a remittance advice to the supplier in the case of denial
of an unassigned claim is a specific requirement of §1834(a)(18)(C) of the Act,
incorporated by reference into §1834(j)(4) and §1879(h) of the Act, applicable to denials
of claims for medical equipment and supplies furnished on or after January 1, 1995.

If the beneficiary signed an ABN which satisfies the requirements in subsection II.6 and
the supplier included a GA modifier on the claim to that effect, do not make an automatic
finding that the claim should be denied on the basis of §1862(a)(1), §1834(a)(17)(B),
§1834(j)(1), or §1834(a)(15) of the Act, merely because the supplier submitted a GA
modifier. The fact that an ABN was given to the beneficiary will in no way prejudice the
contractor’s determination as to whether there is or is not sufficient evidence to justify a
denial. In the case where there is an ABN, mail a standard denial MSN notice to the
beneficiary. If the beneficiary did not sign an ABN and the supplier included a GZ
modifier on the claim to that effect, include, in addition to one of the denial notices in
Chapter 21, “Medicare Summary Notices,” the following initial beneficiary notice in the
MSN sent to the beneficiary.

A. Initial Beneficiary Notice

(MSN 8.54)

If the supplier knew that Medicare wouldn’t pay and you paid, you might
get a refund unless you signed a notice in advance. Refunds may be
delayed if the provider appeals. Call your supplier if you don’t hear
anything within 30 days.

(MSN 8.54) - In Spanish

Si pagó por un servicio que su proveedor sabía Medicare no iba a pagar,


usted tiene derecho a un reembolso, a menos de que haya firmado un aviso
por adelantado. Los reembolsos se pueden demorar si el proveedor apela
la decisión. Llame a su proveedor si no escucha nada en 30 días.

B. Initial Supplier Notice

Include in the notice to the supplier the following;

• The patient’s name Medicare beneficiary identifier;


• A description of the item or service by procedure code, date and place
of service, and amount of the charge;

• The same denial notice included on the beneficiary’s MSN, (see


Chapter 21, “Medicare Summary Notices”); and

• If the supplier submitted a GA modifier (signed ABN obtained),


include in the notice to the supplier the following Notice 1. However,
if the supplier submitted a “-GZ” modifier (a signed ABN was not
obtained), include in the notice to the supplier the following Notice 2.

Notice 1. – Signed Advance Beneficiary Notice Obtained

(Remittance Advice Remark Code N124)

Payment has been (denied for the/made only for a less extensive)
service/item because the information furnished does not substantiate the
need for the (more extensive) service/item. The patient is liable for the
charges for this service/item as you informed the patient in writing before
the service/item was furnished that we would not pay for it, and the patient
agreed to pay.

Remittance Advice Remark Codes cannot be reported without a Claim


Adjustment Reason Code and a Group Code. For Notice 1 where ABN
has been obtained, use CARC 96 - Non-covered charge(s), and Group
Code – PR (Patient Responsibility).
Or

Notice 2. – Signed Advance Beneficiary Notice Not Obtained

(Remittance Advice Remark Code N125)

Payment has been (denied for the/made only for a less extensive)
service/item because the information furnished does not substantiate the
need for the (more extensive) service/item. If you have collected any
amount from the patient, you must refund that amount to the patient within
30 days of receiving this notice. The law permits exceptions to this refund
requirement in two cases: if you did not know, and could not have
reasonably been expected to know, that Medicare would not pay for this
service/item; or if you notified the beneficiary in writing before providing
it that Medicare likely would deny the service/item, and the beneficiary
signed a statement agreeing to pay.

Remittance Advice Remark Codes cannot be reported without a Claim


Adjustment Reason Code and a Group Code. For Notice 2 where ABN
has NOT been obtained, use CARC 96 - Non-covered charge(s), and
Group Code – CO (Contractual obligation).

If an exception applies to you, or you believe the contractor was wrong in


denying payment, you should request an appeal of this determination by
the contractor within 30 days of receiving this notice. Your request for
appeal should include any additional information necessary to support
your position. If you request an appeal within 30-days, you may delay
refunding to the beneficiary until you receive the results of the appeal. If
the appeal determination is favorable to you, you do not have to make any
refund. If the appeal is unfavorable, you must make the refund within 15
days of receiving the unfavorable appeal decision.

You may request an appeal of the determination at any time within 120
days of receiving this notice. An appeal requested after the 30-day period
does not permit you to delay making the refund. Regardless of when an
appeal is requested, the patient will be notified that you have requested
one, and will receive a copy of the determination.

The patient has received a separate notice of this denial decision. The
notice advises that he or she may be entitled to a refund of any amounts
paid, if you should have known that Medicare would not pay and did not
tell him or her. It also instructs the patient to contact your office if he or
she does not hear anything about a refund within 30 days.

The requirements for refund are in §1834(a)(18) of the Act (and in


§§1834(j)(4) and 1879(h) by cross-reference to §1834(a)(18)). Section
1834(a)(18)(B) specifies that suppliers which knowingly and willfully fail
to make appropriate refunds may be subject to civil money penalties
and/or exclusion from the Medicare program. If you have any questions
about this notice, please contact (contractor contact, telephone number).

Ensure that the telephone number puts the supplier in touch with a knowledgeable
professional who can discuss the basis for the denial or reduction in payment.

NOTE: These procedures do not apply where the contractor automatically denies Part B
services related to hospital inpatient services denied by the Quality Improvement
Organization (QIO). In those cases, the QIO is responsible for notifying the beneficiary
and supplier of the refund requirements of §§1834(a)(18), 1834(j)(4), and 1879(h) of the
Act and making the refund determination where appropriate.

150.9 - Processing Beneficiary Requests for Appeal


(Rev. 4250; Issued: 03-08-10; Effective: 04-08-19; Implementation: 04-08-19)

The term Medicare beneficiary identifier (Mbi) is a general term describing a


beneficiary's Medicare identification number. For purposes of this manual, Medicare
beneficiary identifier references both the Health Insurance Claim Number (HICN) and
the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition
period and after for certain business areas that will continue to use the HICN as part of
their processes.

Where a beneficiary requests an appeal of the initial denial, process the appeal in the
normal fashion except that, where the appeal results in a reversal, include the following
special paragraph in the appeal notice sent to the beneficiary:

The supplier which furnished this item or service has been informed of
this decision and advised that it may collect its full charge for the item or
service.

Send the supplier which furnished the item or service a separate notice which clearly
identifies the item or service for which payment is being made (i.e., include the patient’s
name, Medicare beneficiary identifier, a description of the item or service billed by
procedure code, date and place of service, and amount of the charge. Include the
following language:

You were previously advised that Medicare payment could not be made for this
item or service. However, after reviewing this claim, we have determined that
payment may be made. Therefore, if you have already refunded the amounts you
collected from the beneficiary for this item or service, you may recollect these
amounts.

150.10 - Processing Supplier Requests for Appeal


(Rev. 1186, Issued: 02-23-07; Effective: 01-01-06; Implementation: 05-23-07)

Where a supplier requests an appeal, notify the beneficiary as discussed in §150.7 . The
appeal process consists of three stages, even though the supplier may be contesting only
one issue (e.g., the supplier may assert that it did not know, and could not have
reasonably have been expected to know, that Medicare would not pay for the items or
services).

150.10.1 - Appeal of the Denial of Payment


(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

The first stage of the appeal is a new, independent, and critical reexamination of the facts
regarding the denial of payment. If the contractor finds that the initial denial of payment
was appropriate, go on to §150.10.2.

150.10.2 - Beneficiary Given Advance Beneficiary Notice and Agreed to


Pay
(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

A supplier which has given the beneficiary an ABN and has obtained the beneficiary’s
signed statement agreeing to pay, is not required to make a refund. If the supplier claims
to have given an ABN to the beneficiary, the contractor will ask the supplier to furnish a
copy of the ABN. Examine the ABN to determine whether it meets the standards in §40.3
and §50. In the absence of acceptable evidence of advance beneficiary notice, go on to
§150.10.3.

150.10.3 - Supplier Knowledge


(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

A supplier which did not know and could not reasonably have been expected to know
that Medicare would not pay for the medical equipment or supplies is not required to
make a refund. If the supplier claims not to have had any such knowledge, the contractor
will determine whether the supplier knew, or could reasonably have been expected to
know, that Medicare would not pay by applying the knowledge standards provided in
§150.5.

150.11 - Guide Paragraphs for Inclusion in Appeal Determination


(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

Upon completion of the appeal, the contractor will send the supplier an appeal notice.
Send a copy to the beneficiary. If the initial payment determination is reversed to
payment, include in the appeal notice the supplier notice language required in §150.9.
Otherwise, include one of the following paragraphs concerning refund.

Paragraph 1. Refund Not Required - Beneficiary Was Given Advance Beneficiary Notice
and Agreed to Pay

Under §1834(a)(18) and under §1834(j)(4) of the Social Security Act, a


supplier which does not accept assignment and collects any amounts from
a Medicare beneficiary for medical equipment and supplies for which
Medicare does not pay on the basis of §1834(a)(17)(B), §1862(a)(1),
§1834(j)(1), or §1834(a)(15) of the Social Security Act, must refund these
amounts to the beneficiary. However, a refund is not required if, prior to
furnishing the items or services, the supplier notified the beneficiary in
writing that Medicare would not pay for the items or services and the
beneficiary signed a statement agreeing to pay for them. After reviewing
this claim, we have determined that you informed the beneficiary in
advance that Medicare does not pay for the above items or services and
the beneficiary agreed to pay for them. Therefore, you are not required to
make a refund in this case. The beneficiary has been sent a copy of this
notice.

Paragraph 2. Refund Not Required - Supplier Did Not Know That Medicare Would Not
Pay For the Services

Under §1834(a)(18) and §1834(j)(4) of the Social Security Act, a supplier


which does not accept assignment and collects any amounts from a
Medicare beneficiary for medical equipment and supplies for which
Medicare does not pay on the basis of §1834(a)(17)(B), §1862(a)(1),
§1834(j)(1), or §1834(a)(15) of the Social Security Act, must refund these
amounts to the beneficiary. However, a refund is not necessary if the
supplier did not know, and could not reasonably have been expected to
know, that Medicare does not pay for the items or services. After
reviewing this claim, we find that you did not know, and could not
reasonably have been expected to know, that Medicare would not pay for
the above items or services. Therefore, you are not required to make a
refund in this case. Upon your receipt of this notice, it is considered that
you now have knowledge of the fact that Medicare does not pay for
(description of item or service) similar conditions. The beneficiary has
been sent a copy of this notice.

Paragraph 3. Adverse Action on Denial - Refund Required

Under §1834(a)(18) and §1834(j)(4) of the Social Security Act, a supplier


which does not accept assignment and collects any amounts from a
Medicare beneficiary for medical equipment and supplies for which
Medicare does not pay on the basis of §1834(a)(17)(B), §1862(a)(1),
§1834(j)(1), or §1834(a)(15) of the Social Security Act, must refund these
amounts to the beneficiary. A refund is not required if (1) The supplier did
not know, and could not reasonably have been expected to know, that
Medicare would not pay for the items or services; or (2) The supplier
notified the beneficiary in writing before furnishing the items or services
that Medicare would not pay for the items or services and the beneficiary
signed a statement agreeing to pay for them. After reviewing this claim,
we have determined that neither of these conditions is met in this case.
You must therefore refund any amount you collected for these items or
services within 15 days from the date you receive this notice. A refund
must be made within 15 days from receipt of this notice for you to be in
compliance with the law. The beneficiary has been sent a copy of this
notice.

Suppliers which knowingly and willfully fail to make appropriate refunds may be subject
to civil money penalties (up to $10,000 per item or service), assessments (three times the
amount of the claim), and exclusion from the Medicare program.

NOTE: For claims presented to the contractor prior to January 1, 1997, the amount of
the civil money penalty is up to $2,000 per item or service and the assessment is not more
than twice the amount claimed.

150.12 - Supplier Fails to Make Refund


(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

Under §1834(a)(18)(B) of the Act, a supplier which knowingly and willfully fails to
make refund within the time limits in §150.4 may be subject to sanctions under §1128A
the Act (i.e., civil money penalties (up to $10,000 per item or service), assessments (three
times the amount of the claim), and exclusion from the Medicare program).

NOTE: For claims presented to the contractor prior to January 1, 1997, the amount of
the civil money penalty is up to $2,000 per item or service and the assessment is not more
than twice the amount claimed.

Generally, the failure of a supplier to make a refund to a beneficiary comes to the


contractor’s attention as a result of a beneficiary complaint or a referral from the Social
Security Administration (SSA) or the CMS. Document beneficiary complaints and, if
necessary, contact the beneficiary to clarify the information in the complaint and
determine the amount the beneficiary paid the supplier for the denied items or services. If
the contractor determines that a supplier failed to make a refund, the contractor will
contact the supplier in person or by telephone (if that is not feasible, contact the supplier
by letter) to discuss the facts of the case. The contractor will attempt to determine why
the amounts collected have not been refunded. Explain that the law requires that the
supplier make a refund to the beneficiary and that if it fails to do so, the Secretary may
impose civil money penalties, assessments, and exclusion from the Medicare program.
Make a dated report of contact. Include the information relayed to the supplier and the
supplier’s response. Re-contact the beneficiary in 15 days to determine whether the
refund has been made. Do not make any referral to the CMS regional office until the
supplier has been formally notified to refund the money and the supplier’s appeal rights
have been exhausted, or until the time limit for an appeal has passed.

150.13 - CMS Regional Office (RO) Referral Procedures


(Rev. 4250; Issued: 03-08-10; Effective: 04-08-19; Implementation: 04-08-19)

The term Medicare beneficiary identifier (Mbi) is a general term describing a


beneficiary's Medicare identification number. For purposes of this manual, Medicare
beneficiary identifier references both the Health Insurance Claim Number (HICN) and
the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition
period and after for certain business areas that will continue to use the HICN as part of
their processes.

Prior to submitting any materials to the RO, the contractor will contact the RO to
determine how to proceed in referring a potential sanction case. When referring a
sanction case to the region, include in the sanction recommendation (to the extent
appropriate) the following:

Background of the Subject

The subject’s business name, address, Medicare beneficiary identifier, owner’s full name
and Social Security Number, Tax Identification Number (if different), and a brief
description of the subject’s special field of medical equipment and supplies business.

Origin of the Case


A brief description of how the violations were discovered.

Statement of Facts

A statement of facts in chronological order describing each failure to comply with the
refund requirements.

Documentation

Include copies of written correspondence and written summaries of any meetings or


telephone contacts with the beneficiaries and the supplier regarding the supplier’s failure
to make refunds. Include a listing of the following for each item or service not refunded
to the beneficiary by the supplier (grouped by beneficiary):

• Beneficiary Name and Medicare beneficiary identifier;

• Claim Control Number;

• Procedure Code (CPT-4 or HCPCS) of nonrefunded item or service;

• Procedure Code modifier;

• Date of Service;

• Place of Service Code;

• Submitted Charge;

• Units (quantity) of Item or Service; and

• Amount Requested to be Refunded.

Other Significant Issues

Include any information that may be of value to the RO while they review and possibly
develop a case to impose sanctions.

150.14 - Imposition of Sanctions


(Rev. 1, 10-01-03)

Section 1834(a)(18)(B) of the Act provides that if a supplier knowingly and willfully fails
to make required refunds, the Secretary may impose the sanctions provided in
§1842(j)(2) of the Act in the same manner as such sanctions are authorized under §1128A
of the Act. These include civil money penalties, assessments, and exclusion from the
Medicare program for a period of up to five years. The CMS RO will make the
determination on whether to proceed in developing a monetary penalty or program
exclusion case based upon a failure to make refunds.
150.15 - Supplier’s Right to Recover Resaleable Items for Which
Refund Has Been Made
(Rev. 1587, Issued: 09-05-08, Effective: 03-03-08, Implementation: 03-01-09)

If the contractor denies Part B payment for an item of medical equipment or supplies on
the basis of §1862(a)(1), §1834(a)(17)(B), §1834(j)(1), or §1834(a)(15) of the Act, and
the beneficiary is relieved of liability for payment for that item under §1834(a)(18) of the
Act, the effect of the denial, subject to State law, cancels the contract for the sale or rental
of the item and, if the item is resaleable or re-rentable, permits the supplier to repossess
that item for resale or re-rental. In the case of consumable items or any other items which
are not fit for resale or re-rental and which cannot be made fit for resale or re-rental,
suppliers are strongly discouraged from recovering these items since such actions
reasonably could be viewed as purely punitive in nature. If a supplier makes proper
refund under §1834(a)(18) of the Act, Medicare rules do not prohibit the supplier from
recovering from the beneficiary items which are resalable or re-rentable.

Alternatively, when the contract of sale or rental is cancelled on the basis described
above, whether or not the supplier physically repossesses the resaleable or re-rentable
item, the supplier may enter into a new sale or rental transaction with the beneficiary with
respect to that item as long as the beneficiary has been informed of their liability. If the
circumstances which preclude payment for the item have been removed, e.g., the supplier
has now obtained a supplier number, the supplier may submit to the contractor a new Part
B claim based on the resale or re-rental of the item to the beneficiary. If Part B payment
is still precluded, the supplier can establish the beneficiary’s liability for payment for the
denied resold or re-rented item by giving the beneficiary an ABN notifying the
beneficiary of the likelihood that Medicare will not pay for the item and obtaining the
beneficiary’s signed agreement to pay for the item. The resale or re-rental of the item to
the beneficiary does not change the fact that the beneficiary is relieved of liability in
connection with the original transaction.

Under the capped-rental method, if the contractor determines that the supplier is
obligated to make a refund, the supplier must repay Medicare those rental payments that
the supplier has received for the item. However, the Medicare beneficiary must return
the item to the supplier.

200 - Expedited Determinations of Inpatient Hospital Discharges


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

Medicare beneficiaries who are hospital inpatients have a statutory right to appeal to a
BFCC-QIO for an expedited review when a hospital, with physician concurrence,
determines that inpatient care is no longer necessary.
200.1 - Statutory Authority
(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

• Sections 1866(a)(1)(M),

• 1869(c)(3)(C)(iii)(III), and

• 1154(e) of the Act.

This process was implemented through a final rule with comment period, CMS-1655-F
(81 FR 56761, 57037 through 57052, August 22, 2016), effective October 1, 2016. The
resulting regulations are located at 42 CFR Part 405.1205 and 405.1206).

There is a parallel process for beneficiaries enrolled in Medicare health plans. (See 42
CFR 422.620 - 422.622 and §100.1 in the Parts C & D Enrollee Grievances,
Organization/Coverage Determinations, and Appeals Guidance.) Please see the Parts C
& D Enrollee Grievances, Organization/Coverage Determinations, and Appeals
Guidance for Medicare Advantage instructions.

200.2 - Scope
(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

The expedited determination process is available to beneficiaries in Original Medicare


who are being discharged from a Medicare covered inpatient hospital stay. All
beneficiaries receiving covered inpatient hospital care must receive an Important
Message from Medicare (IM). This includes, but is not limited to, beneficiaries in the
following circumstances:

• Beneficiaries for whom Medicare is either the primary or secondary payer.


• Beneficiaries with brief inpatient hospital stays.
• Beneficiaries physically discharged from the hospital or discharged to a lower
level of care (such as a Swing Bed) in the same hospital.

NOTE:
For purposes of these instructions, the term “beneficiary” means either beneficiary or
representative, when a representative is acting for a beneficiary.

Hospitals Affected by these Instructions. These instructions apply to hospitals as well


as Critical Access Hospitals (CAHs) per section 1861(e) and section 1861(mm) of the
Social Security Act. CAHs, as well as psychiatric hospitals, are included in the scope of
these instructions.
200.2.1 - Exceptions
(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

The following situations are not eligible for an expedited determination. Hospitals
should not deliver an IM in these instances.

• When a beneficiary transfers to another hospital at the same level of care (e.g., a
beneficiary transfers from one hospital to another while remaining a hospital
inpatient).

• When beneficiaries exhaust their benefits (e.g., a beneficiary reaches the number
of lifetime reserve days of the Medicare inpatient hospital benefit.)

• When beneficiaries end care on their own initiative (e.g., a beneficiary elects the
hospice benefit).

• Condition Code 44 (CC44) (See Section 50.3 of Chapter 1 of the Medicare Claims
Processing Manual)

• Physician does not concur with discharge. (See Section 220 of this chapter.)

NOTE:
The IM should only be given when an inpatient admission is pending or has occurred. It
should not be given ‘just in case’, such as a hospital delivering to all Medicare patients
being treated in a hospital emergency room.

200.3 - Important Message from Medicare (IM)


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

The IM is subject to the Paperwork Reduction Act (PRA) process and approval by the
Office of Management and Budget (OMB). The IM may only be modified as per the
accompanying instructions, as well as per guidance in this section. Unapproved
modifications cannot be made to the OMB-approved, standardized IM. The notice and
accompanying instructions may be found online at Hospital Discharge Appeal Notices.

200.3.1 - Alterations to the IM


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

• The IM must remain two pages. The notice can be two sides of one page or one
side of two separate pages, but must not be condensed to one page.
• Hospitals may include their business logo and contact information on the top of
the IM. Text may not be shifted from page 1 to page 2 to accommodate large
logos, address headers, etc.

• Hospitals may include information in the optional “Additional Information”


section relevant to the beneficiary’s situation.

NOTE:
Including information normally included in the Detailed Notice of Discharge (DND) in
the “Additional Information” section does not satisfy a hospital’s responsibility to
deliver the DND, if otherwise required. See §200.4.5 ‘The Detailed Notice of Discharge
(DND)’.

200.3.2 - Completing the IM


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

Hospitals must use the OMB-approved IM (CMS-10065). Hospitals must add the
following information in the corresponding blanks of the IM:

1. Patient name
2. Patient number
3. BFCC-QIO contact information

NOTE:
The Patient number may be a unique medical record or other provider-issued
identification number. It may not be the Social Security Number, HICN or any other
Medicare number issued to the beneficiary such as the MBI (Medicare Beneficiary
Identifier).

200.3.3 - Hospital Delivery of the IM


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

Hospitals must deliver the IM to all beneficiaries eligible for the expedited determination
process per §200.2. An IM must be delivered even if the beneficiary agrees with the
discharge.

• The hospital must ensure that the beneficiary or representative signs and dates
the IM to demonstrate that the beneficiary or representative received the notice
and understands its contents. See 200.3.7 ‘Ensuring Beneficiary
Comprehension’.

• Use of assistive devices may be used to obtain a signature.


• Electronic issuance of the IM is permitted.

If a hospital elects to issue an IM viewed on an electronic screen before signing, the


beneficiary must be given the option of requesting paper issuance over electronic
issuance if that is what the beneficiary prefers. Regardless of whether a paper or
electronic version is issued and regardless of whether the signature is digitally captured
or manually penned, the beneficiary must be given a paper copy of the IM, as specified in
200.3.9, and the required beneficiary specific information must be inserted, at the time of
notice delivery.

200.3.4- Required Delivery Timeframes


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

200.3.4.1- First IM
(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

Hospitals must deliver the first copy of the IM at or near admission, but no later than 2
calendar days following the date of the beneficiary’s admission to the hospital.

Hospitals may deliver the first copy of the notice if the beneficiary is seen during a
preadmission visit, but not more than 7 calendar days in advance of admission.

A hospital must deliver the IM to all inpatients, including those in the hospital for a short
stay.
• Once the discharge date is planned, a hospital does not need discharge orders in
advance of delivering the IM.

Timing of First IM Delivery

Pre-Admission Up to 7 days before admission

At Admission At admission

After Admission Up to 2 days following admission

200.3.4.2 - Follow-Up Copy of the IM


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

Hospitals must deliver the follow up copy of the IM within 2 days of discharge. It may be
given as late as four hours prior to discharge.

However, if delivery of the first IM is within 2 calendar days of the date of discharge, no
follow-up notice is required. For example, if a beneficiary is admitted on Monday, the
IM is delivered on Wednesday and the beneficiary is discharged on Friday, no follow-up
notice is required.
• A hospital may deliver a new copy of the IM (not a copy of the signed IM) during
the required timeframes; however, the hospital must obtain the beneficiary’s or
representative’s signature and date on the notice again at that time, or

• A hospital may deliver a copy of the signed, first IM with the date of delivery of
the follow up copy indicated on the IM.

Timing of Follow-Up IM Delivery

No sooner than: Two days before discharge

No later than: Four hours prior to discharge

Notes:
• If two or fewer days have passed since delivery of the first IM, no follow-up IM is
required.

• The follow-up IM may be copy of signed first IM and does not need to be re-
signed.

200.3.5 - Refusal to Sign the IM


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

If the beneficiary refuses to sign the IM the provider should annotate the notice to that
effect, and indicate the date of refusal on the notice. The date of refusal is considered to
be the date of notice receipt. Beneficiaries who refuse to sign the IM remain entitled to an
expedited determination.

200.3.6 - Ensuring Beneficiary Comprehension


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

The OMB-approved standardized IM is available in English and Spanish. If the


individual receiving the notice is unable to read its written contents and/or comprehend
the required oral explanation, hospitals and CAHs must employ their usual procedures to
ensure notice comprehension. Usual procedures may include, but are not limited to, the
use of translators, interpreters, and assistive technologies. Hospitals and CAHs are
reminded that recipients of Federal financial assistance have an independent obligation
to provide language assistance services to individuals with limited English proficiency
(LEP) consistent with section 1557 of the Affordable Care Act and Title VI of the Civil
Rights Act of 1964. In addition, recipients of Federal financial assistance have an
independent obligation to provide auxiliary aids and services to individuals with
disabilities free of charge, consistent with section 1557 of the Affordable Care Act and
section 504 of the Rehabilitation Act of 1973.
200.3.7 - IM Delivery to Representatives
(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation:04-21-2022)

The IM may be delivered to a beneficiary’s appointed or authorized representative.

Types of Representative

Appointed Representative Authorized Representative

Appointed representatives are individuals An authorized representative is an


designated by beneficiaries to act on their individual who, under State or other
behalf. A beneficiary may designate an applicable law, may make health care
appointed representative via the decisions on a beneficiary’s behalf
“Appointment of Representative” form, the (e.g., the beneficiary’s legal guardian,
CMS-1696. See Chapter 29 of the Medicare or someone appointed in accordance
Claims Processing Manual, section 270.1, with a properly executed durable
for more information on appointed medical power of attorney).
representatives.

Notes:
• However, if a beneficiary is temporarily incapacitated and there is no
representative, a person (typically, a family member or close friend) whom the
hospital has determined could reasonably represent the beneficiary, but who has
not been named in any legally binding document, may be a representative for the
purpose of receiving the IM. Such a representative should act in the beneficiary’s
best interests and in a manner that is protective of the beneficiary and the
beneficiary’s rights. Therefore, a representative should have no relevant conflict
of interest with the beneficiary.

• In instances where the notice is delivered to a representative who has not been
named in a legally binding document, the hospital must annotate the IM with the
name of the staff person initiating the contact, the name of the person contacted,
and the date, time, and method (in person or telephone) of the contact.

Delivery to off-site representatives


If the IM must be delivered to a representative who is not physically present, the hospital
is not required to personally deliver the IM or have the IM delivered via courier to the
representative. The hospital must complete the IM as required and may instead
telephone the representativeand then mail the IM. The date and time of the telephone call
is considered the receipt date of the IM.

The hospital must complete all of the following actions.

1. Verbally convey all contents of the IM;


2. Note the date and time this information is communicated verbally;

3. Annotate the “Additional Information” section to reflect that IM was


communicated verbally to the representative; and

4. Annotate the “Additional Information” section with the name of the staff person
initiating the contact, the name of the representative contacted by phone, the date
and time of the telephone contact, and the telephone number called.

5. Mail a copy of the annotated IM to the representative the day telephone contact is
made.

A hard copy of the IM must be sent to the representative by certified mail, return receipt
requested, or any other delivery method that can provide signed verification of delivery
(e.g., FedEx, UPS). The burden is on the hospital to demonstrate that timely contact was
attempted with the representative and that the notice was delivered.

If the hospital and the representative both agree, the hospital may send the notice by fax
or e-mail; however, the hospital or CAH’s fax and e-mail systems must meet the Health
Insurance Portability and Accountability Act of 1996 (HIPAA) privacy and security
requirements.

200.3.8- Notice Retention for the IM


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

The hospital or CAH must retain the signed IM in the beneficiary’s medical record. The
beneficiary receives a paper copy of the IM that includes all of the required information
described in this section. Electronic notice retention is permitted.

Hospitals must also document delivery of the follow-up copy of the IM in the patient
records, when applicable. For example, hospitals may use the “Additional Information”
section of the IM to document delivery of the follow-up copy by adding a line for the
beneficiary’s or representative’s initials and date.

200.4 - Expedited Determination Process


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

200.4.1 - Expedited Determination Process


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022 )
200.4.1.1 - Timeframe for Requesting an Expedited Determination
(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

A beneficiary who receives an IM and disagrees with the discharge may request an
expedited determination by the appropriate BFCC-QIO for the state where the services
were provided. The beneficiary must contact the BFCC-QIO by midnight of the day of
discharge, before leaving the hospital. The beneficiary may contact the BFCC-QIO by
telephone or in writing.

200.4.1.2 - Provide Information to BFCC-QIO


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

The beneficiary must be available to answer questions or supply information requested


by the BFCC-QIO. The beneficiary may, but is not required to, supply additional
information to the BFCC-QIO that he or she believes is pertinent to the case.

200.4.2 - Beneficiary Liability During BFCC-QIO Review


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

When the beneficiary makes a timely request for a BFCC-QIO expedited determination
per §200.4.1.1, the beneficiary is not financially responsible for inpatient hospital
services (except applicable coinsurance and deductibles) furnished before noon of the
calendar day after the date the beneficiary receives notification of the expedited
determination from the BFCC-QIO. Please see §200.5.6 for QIO notification
requirements.

When Liability Begins

BFCC-QIO determination Liability begins

Noon of the day after the BFCC-QIO


Unfavorable to the beneficiary notifies the beneficiary of the decision.

Once the hospital again determines that


the beneficiary no longer requires
Favorable to the beneficiary inpatient care, determines a new last date
of coverage and notifies the beneficiary
with a follow-up copy of the IM.
200.4.3 - Untimely Requests for Review
(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

Untimely request timeframes

Beneficiary location BFCC-QIO determination


Beneficiary in hospital BFCC-QIO will make its determination
and notify the beneficiary, the hospital,
[may request expedited review anytime while and the physician of its determination
in hospital] within 2 calendar days after it receives all
requested information.

Beneficiary left hospital BFCC-QIO will make its determination


and notify the beneficiary, the hospital,
[may request expedited review within 30 days and the physician of its determination
of discharge] within 30 calendar days after it receives
all requested information.

The coverage protections discussed in §200.4.2 do not apply to a beneficiary who makes
an untimely request to the BFCC-QIO.

200.4.4 - Hospital Responsibilities


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

When a hospital is notified by a BFCC-QIO of a beneficiary request for an expedited


determination, the provider must perform all of the following actions.

1. Deliver the beneficiary a DNC (see §200.4.5) as soon as possible, but no later than
noon of the day after BFCC-QIO notification;

2. Supply the BFCC-QIO with copies of the IM and DNC as soon as possible, but no
later than noon of the day after BFCC-QIO notification;

3. Supply all information, including medical records, requested by the BFCC-QIO. The
BFCC-QIO may allow this required information to be supplied via phone, writing, or
electronically. If supplied via phone, the provider must keep a written record of the
information it provides within the patient record; and

4. Furnish the beneficiary, at their request, with access to or copies of any


documentation it provides to the BFCC-QIO. The hospital may charge the
beneficiary a reasonable amount to cover the costs of duplicating and delivering the
documentation. This documentation must be provided to the beneficiary by close of
business of the first day after the material is requested.
200.4.5 - The Detailed Notice of Discharge (DND)
(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

The Detailed Notice of Discharge (DND) is subject to the Paperwork Reduction Act
(PRA) process and approval by the Office of Management and Budget (OMB). The DND
may only be modified as per the accompanying instructions, as well as per guidance in
this section. Unapproved modifications cannot be made to the OMB-approved,
standardized DND. The notice and accompanying instructions may be found online at
https://www.cms.gov/Medicare/Medicare-General-
Information/BNI/HospitalDischargeAppealNotices

Hospitals are responsible for the delivery of the DND to beneficiaries who request an
expedited determination by the BFCC-QIO.

The DND must contain all the following information:


1. The facts specific to the beneficiary’s discharge and provider’s determination that
coverage should end.

2. A specific and detailed explanation of why services are either no longer reasonable
or necessary or no longer covered.
3. A description of, and citations to, the Medicare coverage rule, instruction, or other
policies applicable to the review.
The delivery must occur in person by noon of the day after the BFCC-QIO notifies the
provider that the beneficiary has requested an expedited determination.

The DND does not require a signature but should be annotated in the event of a
beneficiary’s refusal to accept the notice upon delivery.

200.5 – BFCC-QIO Responsibilities


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

200.5.1 - Receive Beneficiary Requests for Expedited Review


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

BFCC-QIOs must be available to receive beneficiary requests for review 24 hours a day,
7 days a week.

200.5.2 - Notify Hospitals and Allow Explanation of Why Covered Services


Should End
(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

When the BFCC-QIO receives a request from a beneficiary, the BFCC-QIO must
immediately notify the provider of services that a request for an expedited determination
was made. If the request is received after normal working hours, the BFCC-QIO should
notify the provider as soon as possible on the morning after the request was made.

200.5.3 - Validate Delivery of the IM


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

The BFCC-QIO should determine that IM delivery was valid if all of the following
criteria are met:

• The notice used is the OMB approved IM published by CMS.


• The notice was delivered timely per 200.3.4.
• The notice was signed and dated by the beneficiary.

If the BFCC-QIO determines that the hospital did not deliver a valid notice, the BFCC-
QIO will provide education to the hospital on valid notice requirements.

200.5.4 - Solicit the Views of the Beneficiary


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

The BFCC-QIO must solicit views of the beneficiary who requested the expedited
determination.

200.5.5 - Solicit the Views of the Hospital


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

The BFCC-QIO must afford the provider an opportunity to explain why the discharge is
appropriate.

200.5.6 - Make Determination and Notify Required Parties


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

No later than one calendar day after it receives all requested information, the BFCC-
QIO must make its determination on whether the discharge is appropriate based on
medical necessity or other Medicare coverage policies.
The BFCC-QIO must perform the following actions.

1. Notify the beneficiary, the beneficiary’s physician, and the provider of services of
its determination. This notification must include the rationale for the
determination and an explanation of Medicare payment consequences and
beneficiary liability.

2. Inform the beneficiary of the right to an expedited reconsideration by the BFCC-


QIO and how to request a timely expedited reconsideration.
3. Make its initial notification via telephone and follow up with a written
determination letter.

NOTE:
If the BFCC-QIO does not receive supporting information from the hospital, it may make
its determination based on the evidence at hand, or defer a decision until it receives the
necessary information. If this delay results in continued services for the beneficiary, the
provider may be held financially liable for these services as determined by the BFCC-
QIO.

200.6 - Effect of a BFCC-QIO Expedited Determination


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation:0 4-21-2022)

The BFCC-QIO determination is binding unless the beneficiary pursues an expedited


reconsideration per section 300 of this chapter.

200.6.1 - Right to Pursue an Expedited Reconsideration


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)
If dissatisfied with the expedited determination, the beneficiary may request an expedited
reconsideration according to the procedures described in section 300 of this chapter.

200.6.2 - Effect of a BFCC-QIO Determination on Continuation of Care


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022)

A beneficiary may choose to remain in the hospital beyond the last day of coverage, but
may be liable for services after that day. The hospital should issue a Hospital-Issued
Notice of Non-coverage (HINN 12) to inform the beneficiary of potential liability. Please
see (https://www.cms.gov/Medicare/Medicare-General-Information/BNI/HINNs) for
HINN delivery instructions.

200.6.3 - Right to Pursue the Standard Claims Appeal Process


(Rev. 11210; Issued: 01-21-2022; Effective: 04-21-2022; Implementation: 04-21-2022 )

If the beneficiary is no longer an inpatient in the hospital and is dissatisfied with this
determination, the determination is subject to the general claims appeal process (See
Chapter 29 of this manual.).

220 - Hospital Requested Expedited Review


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

When a hospital determines that a beneficiary no longer needs inpatient care, but is
unable to obtain the agreement of the physician, the hospital may request a QIO review.
Hospitals must notify the beneficiary that the review has been requested. These
instructions stem directly from Section 1154(e) of the Act and 42 CFR Part 405.1208.

220.1 - Responsibilities of the Hospital


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

The hospital must comply with the following procedures when requesting a QIO review:

Notify the Beneficiary. Hospitals must notify the beneficiary that the hospital has
requested a review using a model language notice called the Hospital Requested Review
(HRR) described in this section. See Section 220.4 for General Notice Requirements.

Supply information to the QIO. Hospitals must supply any pertinent information the
QIO needs to conduct its review and must make it available by phone or in writing, by
close of business on the first full day immediately following the day the hospital submits
the request for review.

220.2 - Responsibilities of the QIO


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

The QIO’s responsibilities are as follows:

Receive request and examine records. The QIO must notify the hospital that it has
received the request for review and must notify the hospital if it has not received
pertinent records, examine the pertinent records pertaining to the services, and solicit the
views of the beneficiary.

Issue a determination. QIOs make their determinations based on criteria in §1154(a) of


the Act, which specifies that QIOs will determine whether:

• the services are reasonable and medically necessary,

• the services meet professionally recognized standards of care, and

• the services could be safely be delivered in another setting.

The QIO will make a determination and notify the beneficiary, the hospital, and the
physician of its decision within 2 days of the hospital’s request and receipt of any
pertinent information submitted by the hospital.

Notification. When the QIO issues the determination, it must notify the beneficiary, the
hospital, and the physician of its decision by telephone and subsequently in writing. The
written notice of the expedited initial determination must contain the following:

• The basis for the determination;


• A detailed rationale for the determination;

• A statement explaining the Medicare payment consequences of the expedited


determination and the date of liability if any; and

• A statement informing the beneficiary of his or her appeal rights and the
timeframe for requesting an appeal.

220.3 - Effect of the Hospital Requested Expedited Determination


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

The expedited determination is binding on the beneficiary, physician, and hospital, except
in the following circumstances:

When the beneficiary remains in the hospital. When the beneficiary is still an
inpatient in the hospital and is dissatisfied with this determination, he or she may request
a reconsideration according to the procedures described in Section 300 of this Chapter.

When the beneficiary is no longer an inpatient in the hospital. If the beneficiary is no


longer an inpatient in the hospital and is dissatisfied with this determination, this
determination is subject to the general claims appeal process (See Chapter 29 of this
manual).

220.4 - General Notice Requirements


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

Providers should use the HRR to notify a beneficiary that it has requested a QIO review.
This notice can be found at http://www.cms.gov/Medicare/Medicare-General-
Information/BNI/ Since the HRR uses model language, providers have some flexibility
in the preparation of this notice. However, it is highly recommended that hospitals use
the model language provided in this instruction, or by their QIO, in order to avoid
questions of invalid notice. Providers should utilize the General Notice Requirements in
Section 200.5 and the Translation requirements in Section 200.6.1 when preparing the
notice.

220.5 - Exhibit 3 – Model Language for Notice of Hospital Requested


Review
(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

Hospital Identifier

Model Notice of Hospital Requested Review (HRR)

Name of Patient: ____________________Name of Physician:____________________


Patient ID Number: __________________Date Issued:_________________________
______________________________________________________________________
We believe that Medicare will not continue to cover your hospital care because these
services are no longer considered medically necessary in your case. Because your
doctor disagreed with our finding, the hospital is asking the quality improvement
organization (QIO) to review your case. The QIO is an outside reviewer hired by
Medicare to look at your case to decide if you are ready to leave the hospital. The name
of the QIO is ____ (insert the name of the QIO)_________________.

• The QIO will contact you to solicit your views about your case and the care you
need.

• You do not need to take any action until you hear from the QIO.

For more information about this notice, call 1-800-MEDICARE (1-800-633-4227), or


TTY: 1-877-486-2048.

Please sign your name, the date and time. Your signature does not mean that you
agree with this notice, just that you received the notice and understand it.
__________________________________ __________ ________
Signature of Patient or Representative Date Time
240 - Preadmission/Admission Hospital Issued Notice of Noncoverage
(HINN)
(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

Regulations found at 42 CFR Part 476.71 require QIOs to review the medical necessity of
hospital discharges and admissions, in addition to other requirements specified in that
section of the regulation. Therefore, a beneficiary has a right to request an expedited
review by the QIO when a hospital (acting directly or through its utilization review
committee) has determined at the time of preadmission or admission, that the beneficiary
is facing a non-covered hospital stay because the services are not considered to be
reasonable and necessary in this case, the services could be safely provided in another
setting, or the care is considered custodial in nature.

The utilization review committee or the hospital may issue a preadmission/admission


HINN. QIOs may also issue such notices after having been contacted by a hospital
regarding care believed to be medically unnecessary, inappropriate, or custodial. The
hospital need not obtain the attending physician's concurrence, or the QIO's, prior to
issuing the preadmission/admission HINN. This also applies to direct admissions to
swing beds (i.e., the beneficiary is admitted to the swing bed when the hospital
determines that the beneficiary does not need hospital-level care, but instead needs only
skilled nursing (SNF) or custodial nursing (NF) level services).

240.1 - Delivery of the Preadmission/Admission HINN


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

When delivering the Preadmission/Admission HINN, hospitals must follow the notice
delivery requirements in Section 200.3.1 regarding:

• In-Person Delivery,
• Notice Delivery to Representatives,
• Ensuring Beneficiary Comprehension.
• Beneficiary Signature and Date.
• Refusal to Sign.
• Notice Delivery and Retention.

240.2 - Notice Delivery Timeframes and Liability


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

Preadmission: In preadmission situations, the beneficiary is liable, if admitted, for


customary charges for all services furnished during the stay, except for those services for
which he or she is eligible to receive payment under Part B.

Admission: If the admission notice is issued at 3 p.m. or earlier on the day of admission,
the beneficiary is liable for customary charges for all services furnished after receipt of
the notice, except for those services for which the beneficiary is eligible to receive
payment under Part B.
If the admission notice is issued after 3 p.m. on the day of admission, the beneficiary is
liable for customary charges for all services furnished on the day following the day of
receipt of the notice, except for those services for which the beneficiary is eligible to
receive payment under Part B.

240.3 - Timeframes for Submitting a Request for a QIO Review


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

Preadmission: In preadmission situations, a beneficiary who chooses to exercise the


right to a QIO review should request immediately, but no later than 3 calendar days after
receipt of the notice, or if admitted, at any point during the stay, an immediate review of
the facts related to the admission.

Admission: In admission situations, a beneficiary who chooses to exercise the right to a


QIO review should request immediately, or at any point in the stay, an immediate review
of the facts related to the admission.

240.4 - Results of the QIO Review


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

If the QIO disagrees with the hospital’s determination and says the stay is reasonable
and necessary, the beneficiary will be refunded any amount collected except applicable
coinsurance and deductibles, and convenience items or services not covered by Medicare.

If the QIO agrees with the hospital determination and says the stay is not reasonable
and necessary, the beneficiary will be responsible for all services on the date specified by
the QIO.

240.5 - Effect of the QIO Review


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

The QIO will send the beneficiary a formal determination of the medical necessity and
appropriateness of the hospitalization determination is binding on the beneficiary, the
physician, and hospital except in the following circumstances:

Right to pursue a reconsideration. If the beneficiary is still an inpatient in the hospital


and is dissatisfied with the determination, he or she may request a reconsideration
according to the procedures described in §405.1204 (See Section 300 of this chapter.)

Right to pursue the general claims appeal process. If the beneficiary is no longer an
inpatient in the hospital, the determination is subject to the general claims appeal process
(See Chapter 29 of this manual.)
240.6 - Exhibit 4 – Model Language for Preadmission/Admission
Hospital Issued Notice of Noncoveage
(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

Hospital Identifier

Preadmission or Admission Hospital-Issued Notice of Noncoverage (HINN)


Model Language

Name of Patient: ____________________Name of Physician:____________________

Patient ID Number: __________________Date Issued: _________________________

We believe that Medicare is not likely to pay for your admission for
_____________________(specify service or condition)__________________ because:

____it is not considered to be medically necessary

____it could be furnished safely in another setting

____other________________________________________________.

However, this notice is not an official Medicare decision.

If you disagree with our finding:

• You should talk to your doctor about this notice and any further health care you may
need.

• You also have the right to an appeal, that is, an immediate review of your case by a
Quality Improvement Organization (QIO). The QIO is an outside reviewer hired by
Medicare to make a formal decision about whether your admission is covered by
Medicare. See page 2 for instructions on how to request a review and contact the
QIO.

• If you decide to go ahead with the hospitalization, you will have to pay for:
________________________________________________________________1

CONTINUED ON PAGE 2
1
For preadmission notices, insert: "customary charges for all services furnished during the stay,
except for those services for which you are eligible under Part B."

For admission notices issued not later than 3:00 P.M. on the date of admission, insert:
"customary charges for all services furnished after receipt of this hospital notice, except for those
services for which you are eligible under Part B." (If these requirements are not met, insert the
liability phrase below.)
For admission notices issued after 3:00 P.M. on the day of admission, insert: "customary
charges for all services furnished on the day following the day of receipt of this notice, except for
those services for which you are eligible to receive payment under Part B."

If you want an immediate review of your case:

________________(insert one of the following as appropriate)_____________

Preadmission:

• Call the QIO immediately at the number listed below, but no later than 3 calendar days
after you receive this notice. If you are admitted, you may call the QIO at any point in the
stay.

Admission:

• Call the QIO immediately at the number listed below or you may call the QIO at
any point during your stay.

• You may also call the QIO for quality of care issues.

QIO Contact Information: _______(insert name of QIO in bold)________________


_______(insert telephone number of QIO)_____________

If you do not want an immediate review:

• You may still request a review within 30 calendar days from the date of receipt of
this notice by calling the QIO at the number below.

Results of the QIO Review:

• The QIO will send you a formal decision about whether your hospitalization is
appropriate according to Medicare’s rules, and will tell you about your reconsideration
and appeal rights.

° IF THE QIO FINDS YOUR HOSPITAL CARE IS COVERED, you will be


refunded any money you may have paid the hospital except for any applicable
copays, deductibles, and convenience items or services normally not covered by
Medicare.
° IF THE QIO FINDS THAT YOUR HOSPITAL CARE IS NOT COVERED, you
are responsible for payment for all services beginning on ______(specify
date)____. (see footnote1 on page 1).

For more information, call 1-800-MEDICARE (1-800-633-4227), or TTY: 1-877-486-2048.


_____________________________________________________________________
Please sign your name, the date and time. Your signature does not mean that you agree with this
notice, just that you received the notice and understand it.

______________________________________ __________ ________


Signature of Patient or Representative Date
Time
260 - Expedited Determinations of Provider Service Terminations
(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

260.1 - Statutory Authority


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

Section 1869(b)(1)(F) of the Social Security Act (the Act), as amended by section 521 of
the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000
(BIPA) (Pub. L. 106-554) granted beneficiaries in Original Medicare the right to an
expedited determination process to dispute the end of their Medicare covered care in
certain provider settings.

This process was implemented though a final rule with comment period, CMS-4004-FC
(69 FR 69252, November 26, 2004), effective July 1, 2005. The resulting regulations are
located at 42 CFR Part 405, §§405.1200 - 405.1204. There is a parallel process for
beneficiaries enrolled in Medicare health plans. (See §§90.2-90.8 in Chapter 13 of the
Medicare Managed Care Manual (CMS Pub. 100-16.)

260.2 - Scope
(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

The expedited determination process is available to beneficiaries in Original Medicare


whose Medicare covered services are being terminated in the following settings. All
beneficiaries receiving services in these settings must receive a Notice of Medicare Non-
Coverage (NOMNC) before their services end: For purposes of this instruction, the term
“beneficiary” means either beneficiary or representative, when a representative is acting
for a beneficiary.

• Home Health Agencies (HHAs)

• Comprehensive Outpatient Rehabilitation Services (CORFs)

• Hospice

• Skilled Nursing Facilities (SNFs)-- Includes services covered under a Part A stay,
as well as Part B services provided under consolidated billing (i.e. physical
therapy, occupational therapy, and speech therapy). A NOMNC must be
delivered by the SNF at the end of a Part A stay or when all of Part B therapies
are ending. For example, a beneficiary exhausts the SNF Part A 100-day benefit,
but remains in the facility under a private pay stay and receives physical and
occupational therapy covered under Medicare Part B. A NOMNC must be
delivered by the SNF when both Part B therapies are ending.

Skilled Nursing Facilities includes beneficiaries receiving Part A and B services in Swing
Beds.
260.2.1 - Exceptions
(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

The following service terminations, reductions, or changes in care are not eligible for an
expedited review. Providers should not deliver a NOMNC in these instances.

When beneficiaries never received Medicare covered care in one of the covered settings
(e.g., an admission to a SNF will not be covered due to the lack of a qualifying hospital
stay or a face-to-face visit was not conducted for the initial episode of home health care).

When services are being reduced (e.g., an HHA providing physical therapy and
occupational therapy discontinues the occupational therapy).

When beneficiaries are moving to a higher level of care (e.g., home health care ends
because a beneficiary is admitted to a SNF).

When beneficiaries exhaust their benefits (e.g., a beneficiary reaches 100 days of
coverage in a SNF, thus exhausting their Medicare Part A SNF benefit).

When beneficiaries end care on their own initiative (e.g., a beneficiary decides to revoke
the hospice benefit and return to standard Medicare coverage).

When a beneficiary transfers to another provider at the same level of care (e.g., a
beneficiary transfers from one SNF to another while remaining in a Medicare-covered
SNF stay).

When a provider discontinues care for business reasons (e.g., an HHA refuses to continue
care at a home with a dangerous animal or because the beneficiary was receiving physical
therapy and the provider’s physical therapist leaves the HHA for another job).

260.3 - Notice of Medicare Non-Coverage


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

The notice is subject to the Paperwork Reduction Act Process and approval by the Office
of Management and Budget. OMB-approved notices may only be modified as per their
accompanying instructions. Unapproved modifications may invalidate the NOMNC. The
notice and accompanying instructions may be found online at
http://www.cms.gov/Medicare/Medicare-General-Information/BNI

260.3.1 - Alterations to the NOMNC


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

The NOMNC must remain two pages. The notice can be two sides of one page or one
side of two separate pages, but must not be condensed to one page.
Providers may include their business logo and contact information on the top of the
NOMNC. Text may not be shifted from page 1 to page 2 to accommodate large logos,
address headers, etc.

Providers may include information in the optional “Additional Information” section


relevant to the beneficiary’s situation.

Note: Including information normally included in the Detailed Explanation of Non-


Coverage (DENC) in the “Additional Information” section does not satisfy a provider’s
responsibility to deliver the DENC, if otherwise required.

260.3.2 - Completing the NOMNC


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

Providers must use the OMB-approved NOMNC (CMS-10123). Providers must type or
write the following information in the corresponding blanks of the NOMNC:

• Patient name
• Medicare patient number
• Type of coverage (SNF, Home Health, CORF, or Hospice)
• Effective date (last day of coverage)

Note: The effective date is always the last day beneficiaries will receive coverage for
their services. Beneficiaries have no liability for services received on this date, but may
face charges for services received the day following the effective date of the NOMNC for
home health, hospice, and CORF services. Because SNFs cannot bill the beneficiary for
services furnished on the day of (but before the actual moment of) discharge,
beneficiaries may leave a SNF the day after the effective date and not face liability for
such services.

260.3.3 – Provider Delivery of the NOMNC


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

Providers must deliver the NOMNC to all beneficiaries eligible for the expedited
determination process per §260.2. A NOMNC must be delivered even if the beneficiary
agrees with the termination of services.

Medicare providers are responsible for the delivery of the NOMNC. Providers may
formally delegate the delivery of the notices to a designated agent such as a courier
service; however, all of the requirements of valid notice delivery apply to designated
agents.

The provider must ensure that the beneficiary or representative signs and dates the
NOMNC to demonstrate that the beneficiary or representative received the notice and
understands that the termination decision can be disputed. Use of assistive devices may
be used to obtain a signature.
Electronic issuance of NOMNCs is not prohibited. If a provider elects to issue a NOMNC
that is viewed on an electronic screen before signing, the beneficiary must be given the
option of requesting paper issuance over electronic if that is what is preferred. Regardless
of whether a paper or electronic version is issued and regardless of whether the signature
is digitally captured or manually penned, the beneficiary must be given a paper copy of
the NOMNC, with the required beneficiary-specific information inserted, at the time of
notice delivery.

260.3.4 - Required Delivery Timeframes


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

The NOMNC should be delivered to the beneficiary at least two calendar days before
Medicare covered services end or the second to last day of service if care is not being
provided daily. For example, if the last day of covered SNF care is a Friday, the
NOMNC should be delivered no later than the preceding Wednesday.

Note: The two day advance requirement is NOT a 48 hour requirement. For example, if a
patient’s last covered home health service is at 10AM on Wednesday and the notice is
delivered at 4PM on the prior Monday, it is considered timely.

If home health services are being provided less frequently than daily, the notice must be
delivered no later than the next to last visit before Medicare covered services end. For
example, if home health care is provided on Tuesdays and Thursdays, and Tuesday is the
last day of Medicare covered services, the notice must be delivered no later than the
preceding Thursday.

The NOMNC may be delivered earlier than two days preceding the end of covered
services. However, delivery of the notice should be closely tied to the impending end of
coverage so a beneficiary will more likely understand and retain the information
regarding the right to an expedited determination.

The notice may not be routinely given at the time services begin. An exception is when
the services are expected to last fewer than two days. In these instances, the notice may
be given by the provider when services begin.

There is an accepted circumstance when the NOMNC may be delivered sooner than two
days or the next to last visit before coverage ends. This exception is limited to cases
where a beneficiary receiving home health services is found to no longer be homebound,
and thus ineligible for covered home health care. In this circumstance, the NOMNC
should be immediately delivered to the beneficiary upon discovery of the loss of
homebound status. We expect that in the vast majority of cases, in all settings, the
decision of a physician to end care will be based on medical necessity, and thus,
foreseeable by the provider within the required time frames for notice delivery.

260.3.5 - Refusal to Sign the NOMNC


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)
If the beneficiary refuses to sign the NOMNC the provider should annotate the notice to
that effect, and indicate the date of refusal on the notice. The date of refusal is
considered to be the date of notice receipt. Beneficiaries who refuse to sign the NOMNC
remain entitled to an expedited determination.

260.3.6 - Financial Liability for Failure to Deliver a Valid NOMNC


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

If a Qualified Independent Contractor (QIO) determines that a provider did not deliver a
valid NOMNC to a beneficiary, the provider is financially liable for continued services
until two days after the beneficiary receives valid notice, or until the effective date of the
valid notice, whichever is later.

260.3.7 - Amending the Date of the NOMNC


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

If the initial NOMNC was delivered to a beneficiary and the effective date was changed,
the provider may amend the notice to reflect the new date. The newer effective date may
not be earlier than the effective date of the original notice except in those cases involving
the abrupt end of services, as discussed in §260.3.4.

The beneficiary must be verbally notified as soon as possible after the provider is aware
of the change. The amended NOMNC must be delivered or mailed to the beneficiary and
a copy retained in the beneficiary’s file.

If an expedited determination is already in progress, the provider must immediately


notify the QIO of the change and provide an amended notice to the QIO.

260.3.8 – NOMNC Delivery to Representatives


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

The NOMNC may be delivered to a beneficiary’s appointed or authorized representative.


Appointed representatives are individuals designated by beneficiaries to act on their
behalf during the appeal process. A beneficiary may designate an appointed
representative via the “Appointment of Representative” form, the CMS-1696.
http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms1696.pdf See
Chapter 29 of the Medicare Claims Processing Manual, section 270.1, for more
information on appointed representatives.

CMS usually requires that notification to a beneficiary who has been deemed legally
incompetent be made to an authorized representative of the beneficiary. Generally, an
authorized representative is an individual who, under State or other applicable law, may
make health care decisions on a beneficiary’s behalf (e.g., the beneficiary’s legal
guardian, or someone appointed in accordance with a properly executed durable medical
power of attorney).
However, if a beneficiary is temporarily incapacitated a person (typically, a family
member or close friend) whom the provider has determined could reasonable represent
the beneficiary, but who has not been named in any legally binding document, may be a
representative for the purpose of receiving the notices described in this section. Such a
representative should have the beneficiary’s best interests at heart and must act in a
manner that is protective of the beneficiary and the beneficiary’s rights. Therefore, a
representative should have no relevant conflict of interest with the beneficiary.

In these instances of delivering a notice to an unnamed representative, the provider


should annotate the NOMNC with the name of the staff person initiating the contact, the
name of the person contacted, and the date, time, and method (in person or telephone) of
the contact. A copy of the NOMNC with this information should be retained in the
beneficiary’s record.

Note - Exceptions to in person notice delivery. If the NOMNC must be delivered to a


representative not living with the beneficiary, the provider is not required to make off-site
in- person notice delivery to the representative. The provider must complete the
NOMNC as required and telephone the representative at least two days prior to the end of
covered services. The provider should inform the representative of the beneficiary’s right
to appeal a coverage termination decision.

The information provided should include the following:

• The beneficiary’s last day of covered services, and the date when the
beneficiary’s liability is expected to begin.

• The beneficiary’s right to appeal a coverage termination decision.

• A description of how to request an appeal by a QIO.

• The deadline to request a review as well as what to do if the deadline is


missed.

• The telephone number of the QIO to request the appeal.

The date the provider communicates this information to the representative, whether by
telephone or in writing, is considered the receipt date of the NOMNC.

The NOMNC must be annotated with the following information on the day that the
provider makes telephone contact:

Reflect that all of the information indicated above was communicated to the
representative;

Note the name of the staff person initiating the contact, the name of the representative
contacted by phone, the date and time of the telephone contact, and the telephone number
called.
A copy of the annotated NOMNC should be mailed to the representative the day
telephone contact is made and a dated copy should be placed in the beneficiary’s medical
file.

If the provider chooses to communicate the information in writing, a hard copy of the
NOMNC must be sent to the representative by certified mail, return receipt requested, or
any other delivery method that can provide signed verification of delivery (e.g. FedEx,
UPS) The burden is on the provider to demonstrate that timely contact was attempted
with the representative and that the notice was delivered.

The date that someone at the representative’s address signs (or refuses to sign) the receipt
is considered the date received. Place a copy of the annotated NOMNC in the
beneficiary’s medical file.

If both the provider and the representative agree, providers may send the notice by fax or
e-mail, however, providers fax and e-mail systems must meet the The Health Insurance
Portability and Accountability Act of 1996 (HIPAA) privacy and security
requirements.

260.3.9 - Notice Retention for the NOMNC


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

The provider must retain the original signed NOMNC in the beneficiary’s file. The
beneficiary should receive a paper copy of the NOMNC that includes all of the required
information such as the effective date and covered service at issue. Electronic notice
retention is permitted if the NOMNC was delivered electronically.

260.3.10 - Hours of NOMNC Delivery


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

Notice delivery should occur within the normal operating hours of the provider.
Providers are not expected to extend their hours or days of business solely to meet the
requirements of the expedited determination process. However, it is expected that all
notices be provided as timely as possible within these constraints.

260.4 - Expedited Determination Process


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

260.4.1 - Beneficiary Responsibilities


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

260.4.1.1 - Timeframe for Requesting an Expedited Determination


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)
A beneficiary who receives a NOMNC and disagrees with the termination of services
may request an expedited determination by the appropriate QIO for the state where the
services were provided. The beneficiary must contact the QIO by noon of the day before
the effective date on the NOMNC. The beneficiary may contact the QIO by telephone or
in writing. If the QIO is unable to accept the request, the beneficiary must submit the
request by noon of the next day the QIO is available.

260.4.1.2 - Provide Information to QIO


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

The beneficiary must be available to answer questions or supply information requested by


the QIO. The beneficiary may, but is not required to, supply additional information to the
QIO that he or she believes is pertinent to the case.

260.4.1.3 - Obtain Physician Certification of Risk (Home Health and


CORF services only)
(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

A beneficiary must obtain a physician certification stating that failure to continue home
health or CORF services is likely to place the beneficiary’s health at significant risk.
Without such a certification statement a QIO may not make a determination for service
terminations in these settings.

The physician certification is a written statement from any licensed physician contacted
by a beneficiary. This is a special certification required only in this expedited
determination process for expedited determinations in home health and CORF settings.

A beneficiary may request an expedited determination from a QIO before obtaining this
certification of risk. Once the QIO is aware of a review request, it will instruct the
beneficiary on how to obtain the necessary certification from a physician.

260.4.2 - Beneficiary Liability During QIO Review


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

A provider may not bill a beneficiary who has timely filed an expedited determination for
disputed services until the review process, including a reconsideration by a Qualified
Independent Contractor (QIC), if applicable, is complete.

260.4.3 - Untimely Requests for Review


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

If the beneficiary makes an untimely request to the QIO, the QIO will accept the request
for review, but is not required to complete the review within its usual 72-hour deadline.
The QIO will make a determination as soon as possible upon receipt of the request.
Beneficiaries have up to 60 days from the effective date of the NOMNC to make an
untimely request to a QIO. When the beneficiary is still receiving services, the QIO must
make a determination and notify the parties within 7 days of receipt of the request. When
the beneficiary is no longer receiving services, the QIO will make a determination within
30 days of the request.

The coverage protections discussed in 260.4.2 do not apply to a beneficiary who makes
an untimely request to the QIO.

260.4.4 - Provider Responsibilities


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

When a provider is notified by a QIO of a beneficiary request for an expedited


determination, the provider must:

• Deliver the beneficiary a DENC (see §260.4.5) by close of business the day they
are notified;

• Supply the QIO with copies of the NOMNC and DENCs by close of business of
the day of the QIO notification;

• Supply all information, including medical records, requested by the QIO. The
QIO may allow this required information to be supplied via phone, writing, or
electronically. If supplied via phone, the provider must keep a written record of
the information it provides within the patient record; and

Furnish the beneficiary, at their request, with access to or copies of any documentation it
provides to the QIO. The provider may charge the beneficiary a reasonable amount to
cover the costs of duplicating and delivering the documentation. This documentation
must be provided to the beneficiary by close of business of the first day after the material
is requested.

260.4.5 - The Detailed Explanation of Non-Coverage


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

The DENC is subject to the Paperwork Reduction Act Process and approval by the Office
of Management and Budget. OMB-approved notices may only be modified as per their
accompanying instructions. Unapproved modifications may invalidate the DENC. The
notice and accompanying instructions may be found online at
http://www.cms.gov/Medicare/Medicare-General-Information/BNI. Medicare providers
are responsible for the delivery of the DENC to beneficiaries who request an expedited
determination by the QIO.

The DENC must contain the following information:

• The facts specific to the beneficiary’s discharge and provider’s determination that
coverage should end.
• A specific and detailed explanation of why services are either no longer
reasonable and necessary or no longer covered.

• A description of, and citations to, the Medicare coverage rule, instruction, or other
policies applicable to the review.

The provider should make insertions on the notice in Spanish, if necessary. If this is
impossible, additional steps should be taken to ensure that the beneficiary comprehends
the content of the notice. Providers may resource CMS multilingual services provided
through the 1-800-MEDICARE help line if needed.

The delivery must occur in person by close of business of the day the QIO notifies the
provider that the beneficiary has requested an expedited determination. A provider may
also choose to deliver the DENC with the NOMNC.

The DENC does not require a signature but should be annotated in the event of a
beneficiary’s refusal to accept the notice upon delivery.

Note: An HHA is not required to make a separate trip to the beneficiary’s residence
solely to deliver a DENC. Upon notification from the QIO of a beneficiary’s request for
an expedited determination, an HHA may telephone the beneficiary to provide the
information contained on the DENC, annotate the DENC with the date and time of
telephone contact and file with the beneficiary’s records. A hard copy of the DENC
should be sent to the beneficiary via tracked mail or other personal courier method by
close of business of the day the QIO notifies the provider that the beneficiary has
requested an expedited determination. The burden is on the provider to demonstrate that
timely contact was attempted with the beneficiary and that the notice was delivered.

DENC delivery to representatives, DENC hours of delivery, and DENC retention


requirements are the same as the NOMNC requirements outlined in §260.3.

Expedited Determination Scenario in a Skilled Nursing Facility - Example

On June 2nd, the SNF delivers a NOMNC to Bob Mills notifying him that his Medicare
covered stay will end on June 4th. Bob decides to request an expedited determination.
June 2nd June 3nd June 4rd June 5th June 6th

NOMNC Bob must request NOMNC If Bob made his If Bob made his
Delivered an expedited Effective Date request on June request on
Bob receives a determination by 2nd:
This is the last day June 3rd:
NOMNC noon today. of coverage, as The QIO makes its The QIO makes its
indicating that stated on the decision and notifies decision and
his coverage is NOMNC. Bob and the SNF by notifies Bob and
ending June 4th. COB. the SNF by COB.
The QIO must The beneficiary If QIO decision is
notify the SNF of has no liability unfavorable:
Bob’s request for this day as Beginning today
for an expedited this is the last day Bob is liable for his
determination. of coverage in the stay if he does not
SNF. leave the SNF.
The SNF must
deliver the
DENC to Bob by
COB today.

The SNF must


provide relevant
medical records
to the QIO by
COB today.
260.5 - QIO Responsibilities
(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

260.5.1 - Receive Beneficiary Requests for Expedited Review


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

QIOs must be available to receive beneficiary requests for review 24 hours a day, 7 days
a week.

260.5.2 - Notify Providers and Allow Explanation of Why Covered


Services Should End
(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

When the QIO receives a request from a beneficiary, the QIO must immediately notify
the provider of services that a request for an expedited determination was made. If the
request is received after normal working hours, the QIO should notify the provider as
soon as possible on the morning after the request was made.

260.5.3 - Validate Delivery of NOMNC


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

The QIO must validate that the NOMNC included the required elements outlined below:

• Date that coverage of services ends.

• Date that beneficiary’s financial liability begins.

• Description of right to an expedited determination (and how to request an


expedited determination) and the right to submit relevant information to the QIO.

• Right to detailed information on why the provider believes Medicare will no


longer cover services.

• Contact information for QIO in the state where services were delivered.

The QIO should determine that NOMNC delivery was valid if all of the following criteria
are met:

• All elements stated above are included.

• The beneficiary signed and dated the notice. If the NOMNC was annotated
because the beneficiary refused to sign the notice upon delivery, the QIO may still
conduct an expedited determination in these instances.
• Notice was delivered at least two days before services terminate. For a non-
residential provider, the notice may be delivered at the next to last visit before
services terminate.

Invalidating a NOMNC should be a rare occurrence. The only reasons to invalidate are
the lack of one of the criteria stated above or a pattern of minor errors as established by
the provider.

If a QIO invalidates a NOMNC, a new NOMNC must be issued to the beneficiary with
an effective date at least two days after the beneficiary receives valid notice. If the
beneficiary again disagrees with the termination of care, a new request to the QIO must
be made.

260.5.4 - Solicit the Views of the Beneficiary


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

The QIO must solicit the views of the beneficiary who requested the expedited
determination.

260.5.5 - Solicit the Views of the Provider


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

The QIO must afford the provider an opportunity to explain why the discharge is
appropriate.

260.5.6 - Make Determination and Notify Required Parties


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

No later than 72 hours after receipt of the request for an expedited determination, the QIO
must make its determination on whether the discharge is appropriate based on medical
necessity or other Medicare coverage policies.

Note: If the QIO does not receive supporting information from the provider, it may make
its determination based on the evidence at hand, or defer a decision until it receives the
necessary information. If this delay results in continued services for the beneficiary, the
provider may be held financially liable for these services as determined by the QIO.

The QIO must notify the beneficiary, the beneficiary’s physician, and the provider of
services of its determination. This notification must include the rationale for the
determination and an explanation of Medicare payment consequences and beneficiary
liability. QIOs must also inform the beneficiary of the right to an expedited
reconsideration by the Qualified Independent Contractor (QIC) and how to request a
timely expedited reconsideration. The QIO will make its initial notification via telephone
and will follow up with a written determination letter.
260.6 - Effect of a QIO Expedited Determination
(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

The QIO determination is binding unless the beneficiary pursues an expedited


reconsideration per section 270 of this chapter.

260.6.1 - Right to Pursue an Expedited Reconsideration


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

If dissatisfied with the expedited determination, the beneficiary may request an expedited
reconsideration according to the procedures described in section 270 of this chapter.

260.6.2 - Effect of QIO Determination on Continuation of Care


(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

If the QIO decision extends coverage to a period where a physician’s orders do not exist,
either because of the duration of the expedited determination process, or because the
physician has already concurred with the termination of care, providers cannot deliver
care. In the event of a QIO decision favorable to a beneficiary without physician orders,
the ordering physician should be made aware the QIO has ruled coverage should
continue, and be given the opportunity to reinstate orders. The beneficiary may also seek
other personal physicians to write orders for care as well as find another service provider.
The expedited determination process does not override regulatory or State requirements
that physician orders are required for a provider to deliver care.

If a QIO decision is favorable to the beneficiary and the beneficiary resumes covered
services, a new NOMNC should be delivered if that care is later terminated, per the
requirements of this section. If the beneficiary again disagrees with the termination of
care, a new request to the QIO must be made.

The QIO decision will affect the necessity of subsequent Advance Beneficiary Notice of
Noncoverage (ABN) deliveries.

Example: If covered home health care continues following a favorable QIO decision for
the beneficiary, the HHA would resume issuance of Home Health Advanced Beneficiary
Notices (HHABNs) as warranted for the remainder of this home health episode. If the
QIO decides that Medicare covered care should end and the patient wishes to continue
receiving care from the HHA, even though Medicare will not pay, an HHABN with
Option Box 1 must be issued to the beneficiary since this would be an initiation of non-
covered care.

Example: If covered Skilled Nursing Facility (SNF) care continues following a favorable
QIO decision for the beneficiary but later ends due to the end of Medicare coverage, and
the patient wishes to continue receiving uncovered care at the SNF, a SNFABN must be
issued to the beneficiary.
260.6.3 - Right to Pursue the Standard Claims Appeal Process
(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

If a beneficiary receives services of the type at issue in the expedited determination after
the coverage end date, and coverage is denied, the beneficiary may appeal the denial
within the standard claims appeal process (See Chapter 29 of this manual.)

261 - Expedited Determination Notice Association with Advance


Beneficiary Notices
(Rev. 2711, Issued: 05-24-13, Effective: 08-26-13, Implementation: 08-26-13)

Delivery of the NOMNC does not replace the required delivery of other mandatory
notices, including ABNs. Notice delivery must be determined by the individual NOMNC
requirements per this section and ABN delivery requirements per §1879 of the Act and
per guidance in this chapter. Both the NOMNC and an ABN may be required in certain
instances.

Only one notice may be required when Medicare covered care is ending.

Example: A beneficiary is receiving CORF services and all covered CORF care is
ending. A NOMNC must be delivered at least two days, or two visits, prior to the end of
coverage. If the beneficiary does not continue the CORF services, an ABN should not be
issued.

Some situations may require two notices at the end of Medicare covered care.

Example: A beneficiary’s Part A stay is ending because skilled level care is no longer
medically necessary and the beneficiary wishes to remain in the SNF receiving custodial
care. The beneficiary must receive the NOMNC two days prior to the end of coverage. A
SNFABN must also be delivered before custodial care begins.

It is also possible that no notice is required when Medicare coverage is ending.

Example: A beneficiary exhausts the 100 day benefit in a SNF. In this instance, the
NOMNC should not be delivered. The SNFABN is not required in this situation.
However, it can be issued voluntarily, as a courtesy to the beneficiary.

300 - Expedited Reconsiderations


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

A beneficiary who is dissatisfied with a QIO determination can request a reconsideration


by an independent review entity (IRE). Such reconsiderations are codified in regulations
effective July 1, 2005 (42 CFR 405.1204) but are familiar to inpatient hospital providers
as the process previously available under §1155 of the Act. This reconsideration process
is the same for hospital and non-hospital providers.
300.1 - The Role of the Beneficiary and Liability
(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

Submitting a Request: A beneficiary who chooses to exercise the right to an expedited


reconsideration must submit a request to the appropriate IRE in writing or by telephone
no later than noon of the calendar day following the initial notification (whether by
telephone or in writing) of the QIO’s determination. The beneficiary, upon request of the
QIO, should be available to discuss the case or supply information that the IRE may
request. The beneficiary may, but is not required to, submit written evidence to be
considered by the IRE.

Untimely Requests: When the beneficiary fails to make a timely request for an
expedited reconsideration subsequently may request a reconsideration under the standard
claims appeal process (See Chapter 29 of this Manual), but the coverage protection
described in Section 300.5 would not extend through this reconsideration, nor would the
notification timeframes or the escalation process described in Section 300.2 apply.

300.2 - The Responsibilities of the IRE


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

Receipt of the Request. On the day the IRE receives the request for an expedited
reconsideration, the IRE must immediately notify the QIO that made the expedited
determination and the provider of services of the request for the expedited
reconsideration.

Examine Records and Other Information. The IRE must offer the beneficiary and the
provider an opportunity to provide further information.

Notification. Unless the beneficiary requests an extension (see below), the IRE must
notify the QIO, the beneficiary, and the provider of services of its decision no later than
72 hours after receipt of the request for an expedited reconsideration, and any such
records needed for the reconsideration. The initial notification may be done by telephone
followed by a written notice that includes:

• The rationale for the reconsideration decision,


k
• An explanation of the Medicare payment consequences of the determination
and the beneficiary’s date of liability,

• Information about the beneficiary’s right to appeal the IRE’s reconsideration


decision to an ALJ, including how to request an appeal and the time period for
doing so.

Escalation. Unless the beneficiary requests an extension, if the IRE does not issue a
decision within 72 hours of receipt of the request, the IRE must notify the beneficiary of
his or her right to have the case escalated to the ALJ hearing level if the amount
remaining in controversy is $100 or more.
Extensions. A beneficiary who requests an expedited reconsideration may request
(either in writing or orally) that an IRE grant such additional time as the beneficiary
specifies (not to exceed 14 days) for the reconsideration. If an extension is granted, the
deadlines described above under notification, do not apply.

300.3 - The Responsibilities of the QIO


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

When an IRE notifies the QIO that a beneficiary has requested an expedited
reconsideration, the QIO must supply all information that the IRE needs to make its
expedited reconsideration as soon as possible, but no later than by close of business of the
day that the IRE notifies the QIO of the request for the reconsideration.

At the beneficiary’s request, the QIO must furnish the beneficiary with a copy of, or
access to, any documentation that it sends to the IRE. The QIO may charge the
beneficiary a reasonable amount to cover the costs of duplicating the documentation
and/or delivering it to the beneficiary. The QIO must accommodate the request by no
later than close of business of the first day after the material is requested.

300.4 - The Responsibilities of the Provider


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

The provider may, but is not required to, submit evidence to be considered by an IRE in
making its decision. If a provider fails to comply with an IRE’s request for additional
information beyond that furnished by the QIO for purposes of the expedited
determination, the IRE makes its reconsideration decision based on the information
available.

300.5 - Coverage During an Expedited Reconsideration


(Rev. 1257, Issued: 05-25-07; Effective: 07-01-07; Implementation: 07-02-07)

When a beneficiary makes a timely request for an expedited determination, the provider
may not bill the beneficiary for any disputed services until the IRE makes its
determination. Beneficiary liability for continued services is based on the QIO’s decision.

400 - Part A Medicare Outpatient Observation Notice


(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)

The MOON informs all Medicare beneficiaries when they are an outpatient receiving
observation services, and are not an inpatient of the hospital or critical access hospital
(CAH).

400.1 - Statutory Authority


(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)
On August 6, 2015, Congress enacted the Notice of Observation Treatment and
Implication for Care Eligibility Act (NOTICE Act) Public Law 114-42, amending
Section 1866(a)(1) of the Social Security Act (the Act) (42 U.S.C. 1395cc(a)(1)), by
adding a new subparagraph (Y). The NOTICE Act requires hospitals and CAHs to
provide written and oral explanation of such written notification to individuals who
receive observation services as outpatients for more than 24 hours.

The process for delivery of this notice, the Medicare Outpatient Observation Notice
(MOON), was addressed in rulemaking, including a final rule, CMS-1655-F (81 FR
56761, 57037 through 57052, August 22, 2016), effective October 1, 2016. The resulting
regulations are located at 42 CFR Part 489.20(y).

400.2 - Scope
(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)

The MOON must be delivered to beneficiaries in Original Medicare (fee-for-service) and


Medicare Advantage enrollees who receive observation services as outpatients for more
than 24 hours. The hospital or CAH must provide the MOON no later than 36 hours after
observation services as an outpatient begin. This also includes beneficiaries in the
following circumstances:

• Beneficiaries who do not have Part B coverage (as noted on the MOON,
observation stays are covered under Medicare Part B).

• Beneficiaries who are subsequently admitted as an inpatient prior to the required


delivery of the MOON.

• Beneficiaries for whom Medicare is either the primary or secondary payer.

NOTES:

• For purposes of these instructions, the term “beneficiary” means either


beneficiary or representative, when a representative is acting for a beneficiary.

• Please see Chapter 13 of the Medicare Managed Care Manual for Medicare
Advantage instructions.

The statute expressly provides that the MOON be delivered to beneficiaries who receive
observation services as an outpatient for more than 24 hours. In other words, the statute
does not require hospitals to deliver the MOON to all beneficiaries receiving outpatient
services. The MOON is intended to inform beneficiaries who receive observation
services for more than 24 hours that they are outpatients receiving observation services
and not inpatients, and the reasons for such status, and must be delivered no later than 36
hours after observation services begin. However, hospitals and CAHs may deliver the
MOON to an individual receiving observation services as an outpatient before such
individual has received more than 24 hours of observation services. Allowing delivery of
the MOON before an individual has received 24 hours of observation services affords
hospitals and CAHs the flexibility to deliver the MOON consistent with any applicable
State law that requires notice to outpatients receiving observation services within 24
hours after observation services begin. The flexibility to deliver the MOON any time up
to, but no later than, 36 hours after observation services begin also allows hospitals and
CAHs to spread out the delivery of the notice and other hospital paperwork in an effort to
avoid overwhelming and confusing beneficiaries.

Hospitals Affected by these Instructions. These instructions apply to hospitals as well as


CAHs per section 1861(e) and section 1861(mm) of the Social Security Act.

400.3 - Medicare Outpatient Observation Notice


(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)

The MOON is subject to the Paperwork Reduction Act (PRA) process and approval by
the Office of Management and Budget (OMB). The MOON may only be modified as per
their accompanying instructions, as well as per guidance in this section. Unapproved
modifications cannot be made to the OMB-approved, standardized MOON. The notice
and accompanying instructions may be found online at
http://www.cms.gov/Medicare/Medicare-General-Information/BNI

400.3.1 - Alterations to the MOON


(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)

In general, the MOON must remain two pages, unless inclusion of additional information
per section 400.3.8 or State-specific information per section 400.5 below results in
additional page(s). Hospitals and CAHs subject to State law observation notice
requirements may attach an additional page to the MOON to supplement the “Additional
Information” section in order to communicate additional content required under State
law, or may attach the notice required under State law to the MOON. The pages of the
notice can be two sides of one page or one side of separate pages, but must not be
condensed to one page.

Hospitals may include their business logo and contact information on the top of the
MOON. Text may not be shifted from page 1 to page 2 to accommodate large logos,
address headers, or any other information.

400.3.2 - Completing the MOON


(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)

Hospitals must use the OMB-approved MOON (CMS-10611). Hospitals must type or
write the following information in the corresponding blanks of the MOON:

• Patient name;
• Patient number; and
• Reason patient is an outpatient.
400.3.3 - Hospital Delivery of the MOON
(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)

Hospitals and CAHs must deliver the MOON to beneficiaries in accordance with section
400.2 above. Hospitals and CAHs must provide both the standardized written MOON, as
well as oral notification.

Oral notification must consist of an explanation of the standardized written MOON. The
format of such oral notification is at the discretion of the hospital or CAH, and may
include, but is not limited to, a video format. However, a staff person must always be
available to answer questions related to the MOON, both in its written and oral delivery
formats.

The hospital or CAH must ensure that the beneficiary or representative signs and dates
the MOON to demonstrate that the beneficiary or representative received the notice and
understands its contents. Use of assistive devices may be used to obtain a signature.

Electronic issuance of the MOON is permitted. If a hospital or CAH elects to issue a


MOON viewed on an electronic screen before signing, the beneficiary must be given the
option of requesting paper issuance over electronic issuance if that is what the beneficiary
prefers. Regardless of whether a paper or electronic version is issued and regardless of
whether the signature is digitally captured or manually penned, the beneficiary must be
given a paper copy of the MOON, as specified in 400.3.9, and the required beneficiary
specific information inserted, at the time of notice delivery.

400.3.4 - Required Delivery Timeframes


(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)

The MOON must be delivered to a beneficiary who receives observation services as an


outpatient for more than 24 hours, and must be delivered not later than 36 hours after
observation services begin. The MOON must be delivered before 36 hours following
initiation of observation services if the beneficiary is transferred, discharged, or admitted.
The MOON may be delivered before a beneficiary receives 24 hours of observation
services as an outpatient.

The start time of observation services, for purposes of determining when more than 24
hours of observation services have been received, is the clock time observation services
are initiated (furnished to the patient), as documented in the patient’s medical record, in
accordance with a physician’s order. This follows the elapsed clock time, rather than the
billed time, associated with the observation services.

400.3.5 - Refusal to Sign the MOON


(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)

If the beneficiary refuses to sign the MOON, and there is no representative to sign on
behalf of the beneficiary, the notice must be signed by the staff member of the hospital or
CAH who presented the written notification. The staff member’s signature must include
the name and title of the staff member, a certification that the notification was presented,
and the date and time the notification was presented. The staff member annotates the
“Additional Information” section of the MOON to include the staff member’s signature
and certification of delivery. The date and time of refusal is considered to be the date of
notice receipt.

400.3.6 - MOON Delivery to Representatives


(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)

The MOON may be delivered to a beneficiary’s appointed representative. Appointed


representatives are individuals designated by beneficiaries to act on their behalf. A
beneficiary may designate an appointed representative via the “Appointment of
Representative” form, the CMS-1696. http://www.cms.gov/Medicare/CMS-Forms/CMS-
Forms/downloads/cms1696.pdf. See Chapter 29 of the Medicare Claims Processing
Manual, section 270.1, for more information on appointed representatives.

The MOON may also be delivered to an authorized representative. Generally, an


authorized representative is an individual who, under State or other applicable law, may
make health care decisions on a beneficiary’s behalf (e.g., the beneficiary’s legal
guardian, or someone appointed in accordance with a properly executed durable medical
power of attorney).

Notification to a beneficiary who has been deemed legally incompetent is typically made
to an authorized representative of the beneficiary. However, if a beneficiary is
temporarily incapacitated, a person (typically, a family member or close friend) whom
the hospital or CAH has determined could reasonably represent the beneficiary, but who
has not been named in any legally binding document, may be a representative for the
purpose of receiving the MOON. Such a representative should act in the beneficiary’s
best interests and in a manner that is protective of the beneficiary and the beneficiary’s
rights. Therefore, a representative should have no relevant conflict of interest with the
beneficiary.

In instances where the notice is delivered to a representative who has not been named in a
legally binding document, the hospital or CAH annotates the MOON with the name of
the staff person initiating the contact, the name of the person contacted, and the date,
time, and method (in person or telephone) of the contact.

NOTE: There is an exception to the in-person notice delivery requirement. If the


MOON must be delivered to a representative who is not physically present to receive
delivery of the notice, the hospital or CAH is not required to make an off-site delivery to
the representative. The hospital or CAH must complete the MOON as required and
telephone the representative.

• The information provided telephonically includes all contents of the MOON;


• Note the date and time the hospital or CAH communicates (or makes a good faith
attempt to communicate) this information telephonically, per 400.2 above, to the
representative is considered the receipt date of the MOON;

• Annotate the “Additional Information” section to reflect that all of the


information indicated above was communicated to the representative; and

• Annotate the “Additional Information” section with the name of the staff person
initiating the contact, the name of the representative contacted by phone, the date
and time of the telephone contact, and the telephone number called.

Mail a copy of the annotated MOON to the representative the day telephone contact is
made.

A hard copy of the MOON must be sent to the representative by certified mail, return
receipt requested, or any other delivery method that can provide signed verification of
delivery (e.g., FedEx, UPS). The burden is on the hospital or CAH to demonstrate that
timely contact was attempted with the representative and that the notice was delivered.

If the hospital or CAH and the representative both agree, the hospital or CAH may send
the notice by fax or e-mail; however, the hospital or CAH’s fax and e-mail systems must
meet the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy
and security requirements.

400.3.7 - Ensuring Beneficiary Comprehension


(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)

The OMB-approved standardized MOON is available in English and Spanish. If the


individual receiving the notice is unable to read its written contents and/or comprehend
the required oral explanation, hospitals and CAHs must employ their usual procedures to
ensure notice comprehension. Usual procedures may include, but are not limited to, the
use of translators, interpreters, and assistive technologies. Hospitals and CAHs are
reminded that recipients of Federal financial assistance have an independent obligation to
provide language assistance services to individuals with limited English proficiency
(LEP) consistent with section 1557 of the Affordable Care Act and Title VI of the Civil
Rights Act of 1964. In addition, recipients of Federal financial assistance have an
independent obligation to provide auxiliary aids and services to individuals with
disabilities free of charge, consistent with section 1557 of the Affordable Care Act and
section 504 of the Rehabilitation Act of 1973.

400.3.8 - Completing the Additional Information Field of the MOON


(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)

This section may be populated with any additional information a hospital wishes to
convey to a beneficiary.

Such information may include, but is not limited to:


• Contact information for specific hospital departments or staff members.

• Additional content required under applicable State law related to notice of


observation services.
• Part A cost-sharing responsibilities if a beneficiary is admitted as an inpatient
before 36 hours following initiation of observation services.

• The date and time of the inpatient admission if a patient is admitted as an


inpatient prior to delivery of the MOON.

• Medicare Accountable Care Organization information.

• Hospital waivers of the beneficiary’s responsibility for the cost of self-


administered drugs.

• Any other information pertaining to the unique circumstances regarding the


particular beneficiary.

If a hospital or CAH wishes to add information that cannot be fully included in the
“Additional Information” section, an additional page may be attached to supplement the
MOON.

400.3.9 - Notice Retention for the MOON


(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)

The hospital or CAH must retain the original signed MOON in the beneficiary’s medical
record. The beneficiary receives a paper copy of the MOON that includes all of the
required information described in section 400.3.2 and, as applicable, sections 400.3.5,
400.3.6 and 400.3.8. Electronic notice retention is permitted.

400.4 - Intersection with State Observation Notices


(Rev. 3698, Issued: 01-27-17, Effective: 02-21-17; Implementation: 02-21-17)

As noted in sections 400.3.1 and 400.3.8 above, hospitals and CAHs in States that have
State-specific observation notice requirements may add State-required information to the
“Additional Information” field, attach an additional page, or attach the notice required
under State law to the MOON.

500 - Glossary
(Rev. 10862; Issued: 07-14-21; Effective: 10-14-21; Implementation: 10-14-21)

The following terms are defined only for purposes of this Chapter 30 of the Medicare
Claims Processing Manual.

Advance notice of non-coverage– 42 CFR 418.408(d)(2) states that if Medicare would


be likely to deny payment as not medically reasonable and necessary, before the service
was provided, the physician informed the beneficiary, or someone acting on the
beneficiary's behalf, in writing that the physician believed Medicare was likely to deny
payment for the specific service and that the beneficiary signed a statement agreeing to
pay for that service. This statement may appear as the notice of non-coverage (e.g.
Advance Beneficiary Notice of Non-coverage (ABN), Form CMS-R-131, Skilled
Nursing Facility Advance Beneficiary Notice of Non-Coverage (SNF ABN), Form CMS-
10055, Home Health Change of Care Notice (HHCCN), Form CMS-10280), as defined
in 42 CFR 411.404.)

Advance Beneficiary Notice of Non-coverage (ABN, Form CMS-R-131) - Issued by


healthcare providers and suppliers to Original Medicare (fee for service) beneficiaries in
situations where Medicare payment is expected to be denied.

Authorized representative – An individual authorized under State or other applicable


law, e.g., a legally appointed representative or guardian of the beneficiary (if, for
example, the beneficiary has been legally declared incompetent by a court) to act on
behalf of a beneficiary when the beneficiary is temporarily or permanently unable to act
for himself or herself. The authorized representative will have all of the rights and
responsibility of a beneficiary or party, as applicable. In states which have health care
consent statutes providing for health care decision making by surrogates on behalf of
patients who lack advance directives and guardians, reliance upon individuals appointed
or designated under such statutes to act as authorized representatives is permissible. The
Appointment of Representative, Form CMS-1696 is available for the convenience of
the beneficiary or any other individual to use when appointing a representative.

For purposes of this chapter, when the term beneficiary is used, for legal purposes, and
the beneficiary has an authorized representative, the use of either beneficiary or
authorized representative are exchangeable of each other, unless otherwise indicated.

Beneficiary – Individual who is enrolled to receive benefits under Medicare Part A


and/or Part B.

Detailed Explanation of Non-Coverage (DENC, Form CMS-10124) – Medicare Fee-


For-Service (FFS) Expedited Determination Notice given only if a beneficiary requests
an expedited determination. The DENC explains the specific reasons for the end of
services.

Detailed Notice of Discharge (DND, Form CMS-10066) – Hospital Discharge Appeal


Notice given to beneficiaries who choose to appeal a discharge decision from the hospital
or their Medicare Advantage plan, if applicable.

Financial Liability Protections (FLP) Provisions – The FLP provisions of the Social
Security Act protect beneficiaries, healthcare providers, and suppliers under certain
circumstances from unexpected liability for charges associated with claims that Medicare
does not pay. The FLP provisions apply after an item or service’s coverage
determination is made.
Healthcare provider – Healthcare provider means a “provider of services” (or provider)
(as defined under Section 1861(u) of the Social Security Act), a hospital, a critical access
hospital (CAH), a skilled nursing facility (SNF), a comprehensive outpatient
rehabilitation facility, a home health agency, or a hospice that has in effect an agreement
to participate in Medicare, or a clinic, a rehabilitation agency, or a public health agency
that has in effect a similar agreement but only to furnish outpatient physical therapy or
speech pathology services, or a community mental health center that has in effect a
similar agreement but only to furnish partial hospitalization services).

Home Health Change of Care Notice (HHCCN, Form CMS-10280) - Used by Home
Health Agencies (HHAs) to notify Original Medicare beneficiaries receiving home health
care benefits of plan of care changes. HHAs are required to provide notification to
beneficiaries before reducing or terminating an item and/or service.

Hospital-Issued Notices of Non-coverage (HINNs) - Hospitals provide to beneficiaries


prior to admission, at admission, or at any point during an inpatient stay if the hospital
determines that the care the beneficiary is receiving, or is about to receive, is not covered
by Medicare.

Important Message from Medicare (IM, Form CMS-R-193) – Hospital Discharge


Appeal Notice delivered to all Medicare beneficiaries (Original Medicare beneficiaries
and Medicare Advantage plan enrollees) who are hospital inpatients. The IM informs
hospitalized inpatient beneficiaries of their hospital discharge appeal rights.

Limitation on Liability (LOL) Provision– The LOL provisions, §1879(a)-(g) of the


Social Security Act, fall under the FLP provisions and provide financial relief and
protection to beneficiaries, healthcare providers, and suppliers by permitting Medicare
payment to be made, or requiring refunds to be made, for certain items and/or services for
which Medicare payment would otherwise be denied.

Limitation on Recoupment – The requirement that (in certain cases) Medicare must
cease or delay recovery of an overpayment when a valid first or second level appeal
request is received from a provider on an overpayment, in accordance with Section 1893
of the Social Security Act. For more information, see 100-06 Medicare Financial
Management Manual, Chapter 3, Overpayments.

Medicare Beneficiary Identifier (MBI) - is a general term describing a beneficiary's


Medicare identification number. Medicare beneficiary identifier references both the
Health Insurance Claim Number (HICN) and the Medicare Beneficiary Identifier (MBI)
during the new Medicare card transition period and after for certain business areas that
will continue to use the HICN as part of their processes.

Medicare Contractor - An entity that contracts with the Federal government to review
and/or adjudicate claims, determinations and/or decisions.

Medicare Outpatient Observation Notice (MOON, Form CMS-10611) - A


standardized notice to inform Medicare beneficiaries (including health plan enrollees)
that they are outpatients receiving observation services and are not inpatients of a hospital
or CAH.

Notice of Medicare Non-Coverage (NOMNC, Form CMS-10123) - FFS Expedited


Determination Notices that informs beneficiaries on how to request an expedited
determination from their Quality Improvement Organization (QIO) and gives
beneficiaries the opportunity to request an expedited determination from a QIO.

Overpayment Recovery Waiver – An allowance providing that beneficiaries, healthcare


providers, and suppliers can keep Medicare overpayments (in certain circumstances) if
they are determined to be “without fault” for causing the overpayment, in accordance
with Section 1870 of the Social Security Act. For more information, see 100-06
Medicare Financial Management Manual, Chapter 3, Overpayments.

Refund Requirements (RR) for Non-assigned Claims for Physicians Services - Under
§9332(c) of OBRA 1986 (P.L. 99-509), which added §1842(l) to the Social Security Act,
new liability protections for Medicare beneficiaries affect nonparticipating physicians.

Refund Requirements (RR) for Assigned and Non-assigned Claims for Medical
Equipment and Supplies – Under §132 of SSAA-1994 (Social Security Act
Amendments of 1994, P.L. 103-432) which adds §1834(a)(18) to the Social Security Act,
and under §133 of SSAA-1994 which adds §1834(j)(4) and §1879(h) to the Social
Security Act, new liability protections for Medicare beneficiaries affect suppliers of
medical equipment and supplies. All suppliers who sell or rent medical equipment and
supplies to Medicare beneficiaries are subject to the refund provisions of §§1834(a)(18),
1834(j)(4) and 1879(h) of the Social Security Act.

Skilled Nursing Facility Advance Notice of Non-coverage (SNF ABN, Form CMS-
10055) – Issued in order for a Skilled Nursing Facility (SNF) to transfer financial liability
to an Original Medicare beneficiary for items or services, paid under the SNF PPS, that
Medicare is expected to deny payment (entirely or in part).

Supplier – Unless the context otherwise requires, a physician or other practitioner, a


facility, or entity (other than a provider of services) that furnishes health services covered
by Medicare.
Transmittals Issued for this Chapter

Rev # Issue Date Subject Impl Date CR#

R11210CP 01/21/2022 Expedited Review Process for Hospital 04/21/2022 12546


Inpatients in Original Medicare

R10862CP 07/14/2021 Section 50 in Chapter 30 of Publication 10/14/2021 12242


(Pub.) 100-04 Manual Updates

R4197CP 01/11/2019 Chapter 30 Revisions in Publication (Pub.) 04/15/2019 10848


100-04, Medicare Claims Processing
Manual

R4250CP 03/08/2019 Update to Chapter 30 in Publication (Pub.) 04/08/2019 11165


100-04 to Provide Language-Only Changes
for the New Medicare Card Project

R4198CP 01/11/2019 Skilled Nursing Facility Advance 04/30/2018 10567


Beneficiary Notice of Non-Coverage (SNF
ABN)

R4001CP 03/16/2018 Internet Only Manual Updates to Pub. 100- 06/19/2018 10512
01, 100-02 and 100-04 to Correct Errors
and Omissions (SNF) (2018)

R4011CP 03/30/2018 Skilled Nursing Facility Advance 04/30/2018 10567


Beneficiary Notice of Non-Coverage (SNF
ABN)- Rescinded and replaced by
Transmittal 4198

R3698CP 01/27/2017 Medicare Outpatient Observation Notice 02/21/2017 9935


(MOON) Instructions

R3695CP 01/20/2017 Medicare Outpatient Observation Notice 02/10/2017 9935


(MOON) Instructions – Rescinded and
replaced by Transmittal 3698

R3560CP 07/15/2016 Correction of Remark Code Information 10/17/2016 9641

R3187CP 02/06/2015 Language Only Update to Pub 100-04, 03/06/2015 8992


Chapter 30 for ASC X12 and Claim
References
Rev # Issue Date Subject Impl Date CR#

R2911CP 03/14/2014 Manual Updates to Clarify Skilled Nursing 03/25/2014 8644


Facility Advanced Beneficiary Notice (SNF
ABN) Requirements Pursuant to Jimmo vs.
Sebelius

R2878CP 02/21/2014 Correction CR - Advance Beneficiary 05/15/2014 8597


Notice of Noncoverage (ABN), Form CMS-
R-131

R2782CP 09/06/2013 Advance Beneficiary Notice of 12/09/2013 8404


Noncoverage (ABN), Form CMS-R-131

R2781CP 09/06/2013 Home Health Change of Care Notice 12/09/2013 8403


(HHCCN), Form CMS-10280, Manual
Instructions. This CR rescinds and fully
replaces CR 7323.

R2711CP 05/24/2013 Expedited Determinations for Provider 08/26/2013 7903


Service Terminations

R2480CP 06/01/2012 Advanced Beneficiary Notice of 09/04/2012 7821


Noncoverage (ABN), Form CMS-R-131,
Updated Manual Instructions

R2362CP 12/01/2011 Home Health Advance Beneficiary Notice, 02/03/2012 7323


(HHABN), Form CMS-R-296

R1983CP 06/11/2010 Clarification on Use of the SNF ABN and 07/12/2010 6987
Denial Letters

R1587CP 09/05/2008 Revised Form CMS-R-131 Advance 03/01/2009 6136


Beneficiary Notice of Noncoverage

R1257CP 05/25/2007 Important Message From Medicare (IM) 07/02/2007 5622


and Expedited Determination Procedures
for Hospital Discharges

R1186CP 02/23/2007 Changes to Chapter 30 - Updates to 05/23/2007 5348


Amount in Controversy Requirement and
Correction of Appeals Terminology
Rev # Issue Date Subject Impl Date CR#

R1035CP 08/18/2006 Updating Publication 100-04, Chapter 30 09/18/2006 5214


Regarding the CD ROM Initiative for the
Annual "Dear Doctor" Mailing

R1025CP 08/11/2006 Revised Home Health Advance Beneficiary 09/01/2006 5009


Notice

R994CP 06/30/2006 Special Issues Associated with the Advance 09/29/2006 5117
Beneficiary Notice (ABN) for Hospice
Providers and Comprehensive Outpatient
Rehabilitation Facilities (CORFs)

R594CP 06/24/2005 Preliminary Instructions: Expedited 07/01/2005 3903


Determinations/ Reviews for Original
Medicare

R577CP 06/03/2005 Preliminary Instructions: Expedited 07/01/2005 3903


Determinations/Reviews for Original
Medicare

R001CP 11/01/2003 Initial Publication of Manual NA NA

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