Proposed Transgender and Abortion Rule

*This HHS‐approved document is being submitted to the Office of the Federal Register (OFR) for publication and has
not yet
been placed on public display or published in the Federal Register. This document may vary slightly from the published
document if minor editorial changes are made during the OFR review process. The document published in the Federal
Register is the official HHS‐approved document.
*Individuals using assistive technology may not be able to fully access information in this document. For assistance, please
contact the Office for Civil Rights at (800) 368‐1019 or (800) 537–7697 (TDD).
4153-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Docket No.: [INSERT DOCKET NUMBER]
42 CFR Parts 438, 440, and 460; 45 CFR Parts 86, 92, 147, 155, and 156
RIN 0945-AA11
Nondiscrimination in Health and Health Education Programs or Activities
AGENCY: Office for Civil Rights (OCR), Office of the Secretary, HHS
ACTION: Proposed rule.
SUMMARY: The Department of Health and Human Services (“the Department”) is
committed to ensuring the civil rights of all individuals who access or seek to access health
programs or activities of covered entities under Section 1557 of the Patient Protection and
Affordable Care Act. The Department proposes to revise its Section 1557 regulation in
order to better comply with the mandates of Congress, address legal concerns, relieve
billions of dollars in undue regulatory burdens, further substantive compliance, reduce
confusion, and clarify the scope of Section 1557 in keeping with pre-existing civil rights
statutes and regulations prohibiting discrimination on the basis of race, color, national
origin, sex, age, and disability.
1
*This HHS‐approved document is being submitted to the Office of the Federal Register (OFR) for publication and has not yet
DATES: Submit comments on or before [INSERT DATE 60 DAYS AFTER DATE OF
PUBLICATION IN THE FEDERAL REGISTER].
ADDRESSES: You may submit comments to this proposed rule, identified by RIN 0945-
AA11, by any of the following methods:
• Federal eRulemaking Portal. You may submit electronic comments at
http://www.regulations.gov by searching for the Docket ID number [INSERT DOCKET
NUMBER]. Follow the instructions at http://www.regulations.gov online for submitting
comments through this method.
• Regular, Express, or Overnight Mail: You may mail comments to U.S. Department of
Health and Human Services, Office for Civil Rights, Attention: Section 1557 NPRM, RIN
0945-AA11, Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue, SW,
Washington, DC 20201.
• Hand Delivery / Courier: You may hand deliver comments to the U.S. Department of
Health and Human Services, Office for Civil Rights, Attention: Section 1557 NPRM, RIN
0945-AA11, Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue, SW,
Washington, DC 20201.
All comments received by the methods and due date specified above will be posted without
change to http://www.regulations.gov, including any personal information provided, and
such posting may occur before or after the closing of the comment period.
2
We will consider all comments received by the date and time specified in the
“DATES” section above, but, because of the large number of public comments we normally
receive on Federal Register documents, we are not able to provide individual
acknowledgements of receipt.
Please allow sufficient time for mailed comments to be timely received in the event
of delivery or security delays. Because access to the interior of the Hubert H. Humphrey
Building is not readily available to persons without Federal government identification,
commenters are encouraged to leave their comments in the mail drop slots located in the
lobby of the building. Electronic comments with attachments should be in Microsoft Word
or Excel; however, we prefer Microsoft Word.
Please note that comments submitted by fax or email and those submitted after the
comment period will not be accepted.
Docket: For complete access to background documents or posted comments, go to
http://www.regulations.gov and search for Docket ID number [INSERT DOCKET NUMBER].
FOR FURTHER INFORMATION CONTACT: Luben Montoya, Supervisory Civil Rights
Analyst, HHS Office for Civil Rights at (202) 619-0403 or (800) 537–7697 (TDD).
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Background on Section 1557 and Its Rulemaking
3
B. Litigation Challenging the Section 1557 Regulation

C. Summary of the Proposed Rule
D. Cost-Effective Design of the Proposed Rule
II. Reasons for the Proposed Rulemaking
A. Section 1557 of the PPACA Does Not Prevent or Limit Reconsideration of the
Current Rule.
B. The Final Rule Adopted Novel and Inconsistent Legal Interpretations of Long-
Standing Civil Rights Law.
1. The Final Rule Interpreted the Scope of Section 1557 Too Broadly.
2. The Final Rule Improperly Blended Substantive Requirements and
Enforcement Mechanisms of the Underlying Statutes.
3. The Final Rule Inconsistently Applied Federal Nondiscrimination Law.
4. The Final Rule Created New Provisions Concerning Language Access
Requirements Not Adequately Justified By Law or Policy.
5. The Final Rule’s Definition of Discrimination “On the Basis of Sex” Has
Been Enjoined by Federal Courts.
a. Background on Title IX of the Education Amendments
b. HHS’s Title IX Regulations
c. Need for Consistency Among Components of HHS
d. Pending Federal Litigation over Section 1557 Regulation, Title IX,
and Title VII
e. HHS’s Inconsistency with Other Federal Departments
f. Need for Consistency with the Department of Justice on
Implementation and Enforcement of Nondiscrimination Laws
g. Clarity and Sensitive Balancing of Competing Interests at the Local
Level
C. The Costs of the Final Rule Were Unnecessary and Unjustified.
1. The Section 1557 Regulation Imposed Substantially Higher Regulatory
Costs Than Predicted.
2. The Section 1557 Regulation’s Burdens Are Not Justified by Need.
III. Nondiscrimination in Health Programs and Activities
Provisions of the Proposed Section 1557 Rule at 45 CFR Part 92
Proposed “Subpart A—General Provisions”
Proposed “45 CFR § 92.1 Purpose.”
Proposed “45 CFR § 92.2 Nondiscrimination requirements.”
Proposed “45 CFR § 92.3 Scope of application.”
Proposed “45 CFR § 92.4 Assurances.”
Proposed “45 CFR § 92.5 Enforcement mechanisms.”
Proposed “45 CFR § 92.6 Relationship to other laws.”
Proposed “Subpart B—Specific Application to Health Programs or Activities”
Proposed “45 CFR § 92.101 Meaningful access for individuals with limited
English proficiency.”
4
Proposed “45 CFR § 92.102 Effective communication for individuals with

disabilities.”
Proposed “45 CFR § 92.103 Accessibility standards for buildings and
facilities.”
Proposed “45 CFR § 92.104 Accessibility of information and communication
technology.”
Proposed “45 CFR § 92.105 Requirement to make reasonable modifications.”
Request for Comments on Proposed 45 CFR § 92.102 through 92.105
B. Current Section 1557 Regulation Provisions Proposed for Repeal or
Reconsideration
1. Taglines, Notices, Language Access Plans, and Video Interpretation
Standards
2. Redundant Provisions Duplicative of Pre-Existing Regulations
IV. Need for Conforming Amendments
A. Nondiscrimination in Education Programs or Activities
Proposed “45 CFR § 86.18 Amendments to conform to statutory exemptions.”
B. Proposed Conforming Amendments
C. Technical Amendments
V. Interim Treatment of Subregulatory Guidance
VI. Regulatory Impact Analysis
A. Executive Orders 12866 and Related Executive Orders on Regulatory Review
1. Summary of the Proposed Rule
2. Need for the Proposed Rule
3. Consideration of Regulatory Alternatives
4. Considerations for Cost-Effective Design
5. Methodology for Cost-Benefit Analysis
6. Cost-Benefit Analysis
a. Overview
b. Generally Applicable Tangible and Intangible Benefits and Burdens
c. Baseline Assumptions
d. Covered Entities
(1) Entities Covered By Section 1557
(a) Entities with a Health Program or Activity, Any Part
of Which Receives Federal Financial Assistance from the
Department
(b) Programs or Activities Administered by the
Department under Title I of the PPACA
(c) Entities Established under Title I of PPACA
(2) Entities Covered by Title IX
e. Cost Savings from Eliminating Notice and Taglines Requirement
f. Cost Arising from Removal of Notice and Taglines Requirement
g. Cost Savings from Changes to Language Access Plan Provisions
5
h. Cost Savings Attributed to Covered Entities’ Handling of Certain

Grievances
i. Additional Costs for Training and Familiarization under the
Proposed Rule
(1) Number of Covered Entities That May Train Workers
(2) Number of Individuals Who Will Receive Training
(3) Total Cost of Training
j. Additional Costs for Revising Policies and Procedures
k. Other Costs Due to Reversion to Previous Practices
l. Other Benefits or Costs
7. Impact on State, Local, and Tribal Entities under Executive Orders 12866,
13132, and 13175
a. State and Local Governments
b. Tribal Governments
8. Avoidance of Inconsistent, Incompatible, or Duplicative Regulations
B. Executive Order 13771 on Reducing and Controlling Regulatory Costs
C. Congressional Review Act
D. Unfunded Mandates Reform Act
E. Regulatory Flexibility Act and Executive Order 13272 on Proper Consideration of
Small Entities in Agency Rulemaking
F. Executive Order 12250 on Leadership and Coordination of Nondiscrimination
Laws
G. Paperwork Reduction Act
VII. Effective Date
VIII. Delegation of Authority
IX. Request for Comment
I. Executive Summary
A. Background on Section 1557 and Its Rulemaking
Section 1557 of the Patient Protection and Affordable Care Act (“PPACA”) 1 prohibits
discrimination on the basis of race, color, national origin, sex, age, or disability under any
health program or activity that receives Federal financial assistance, or under any program
1Patient Protection and Affordable Care Act, Pub. L. 111-148, sec. 1557, 124 Stat. 119, 260 (Mar. 23, 2010)
(codified at 42 U.S.C. 18116). In this Notice of Proposed Rulemaking, we refer interchangeably to Section
1557 and 42 U.S.C. 18116.
6
or activity that is administered by an executive agency under Title I of the PPACA or by an
entity established under such Title. Section 1557 cites Title VI of the Civil Rights Act of
1964 (42 U.S.C. 2000d et seq.) (“Title VI”), Title IX of the Education Amendments of 1972
(20 U.S.C. 1681 et seq.) (“Title IX”), the Age Discrimination Act of 1975 (42 U.S.C. 6101 et
seq.) (“Age Act”), and Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794) (“Section
504”).2 It further states that “[t]he enforcement mechanisms provided for and available”
under those laws “shall apply for purposes of violations” of Section 1557. 3
Section 1557 authorizes, but does not require, the Secretary of Health and Human
Services (“Secretary”) to promulgate regulations implementing Section 1557’s
nondiscrimination requirements.4
On August 1, 2013, the Department issued a Request for Information (RFI) soliciting
input on regulations under Section 1557. 78 FR 46558. Thereafter, on September 8, 2015,
the Department issued a Notice of Proposed Rulemaking (NPRM) to add a new part 92 to
Title 45 of the Code of Federal Regulations and thereby impose numerous new
requirements on covered entities.5 80 FR 54172.
2 While Section 1557 does not incorporate nondiscrimination provisions by reference to Title VII, it provides
that nothing in Title I of the PPACA is to be construed as invalidating or limiting the rights, remedies,
procedures, or legal standards available under certain civil rights laws, and mentions Title VII specifically. 42
U.S.C. 18116(b).
3 42 U.S.C. 18116(a).
4 42 U.S.C. 18116(c).
5 See 45 CFR § 92.4 (“Covered entity means: (1) An entity that operates a health program or activity, any part
of which receives Federal financial assistance; (2) An entity established under Title I of the PPACA that
administers a health program or activity; and (3) The Department.”).
7
On May 18, 2016, the Department finalized its proposed regulations for Section
1557 in 45 CFR Part 92 (the “Final Rule,” “current rule,” or the “Section 1557 Regulation”).
81 FR 31376.6 As noted above, Section 1557 bars discrimination on grounds prohibited
under several civil rights statutes, including on the ground of sex under Title IX of the
Education Amendments of 1972. In its Section 1557 Regulation, the Department defined
discrimination “on the basis of sex” to cover, among other things, discrimination on the
basis of sex stereotyping, gender identity, and termination of pregnancy, but explicitly
declined to include discrimination on the basis of sexual orientation. 81 FR at 31390 (“OCR
has decided not to resolve in this rule whether discrimination on the basis of an
individual’s sexual orientation status alone is a form of sex discrimination.”). As explained
more fully below, the Final Rule, among other things, imposed specific requirements
regarding language assistance services, multi-language “taglines,” and nondiscrimination
notices.
The Department estimated that, collectively, the Final Rule’s new requirements,
backed by the threat of enforcement action, would cost health care providers and other
covered entities over $942.5 million in the first five years of implementation. 81 FR at
31459.
The Final Rule became effective on July 18, 2016, except to the extent that the Rule
required changes to health insurance or group health plan benefits or benefit design, in
6The Final Rule was later revised on July 18, 2016, when the Department issued a technical correction
deleting an incorrect toll-free telephone number to call the Department to file a civil rights complaint. 81 FR
46613 (July 18, 2016).
8
which case the Final Rule applied on the first day of the first plan year that began on or
after January 1, 2017. 45 CFR § 92.1.
On January 20, 2017, the President issued E.O. 13765 “Minimizing the Economic
Burden of the Patient Protection and Affordable Care Act Pending Repeal,” that requires,
among other things, “[t]o the maximum extent permitted by law, the Secretary of Health
and Human Services . . . shall exercise all authority and discretion available to [] waive,
defer, grant exemptions from, or delay the implementation of any provision or requirement
of the [PPACA] that would impose a fiscal burden on any State or a cost, fee, tax, penalty, or
regulatory burden on individuals, families, healthcare providers, health insurers, patients,
recipients of healthcare services, purchasers of health insurance, or makers of medical
devices, products, or medications.” 82 FR 8351 (Jan. 24, 2017).
B. Litigation Challenging the Section 1557 Regulation
Lawsuits challenging the regulations followed promulgation of the Final Rule. On
August 23, 2016, the States of Texas, Wisconsin, Nebraska, Kentucky, and Kansas, along
with three private health care providers, filed a complaint in the U.S. District Court for the
Northern District of Texas challenging the Section 1557 Regulation. See Franciscan Alliance,
Inc., et al. v. Burwell, et al., 227 F. Supp. 3d 660 (N.D. Tex. 2016). The complaint stated that,
“by redefining a single word used in the Affordable Care Act … HHS has created a massive
new liability for thousands of healthcare professionals unless they cast aside their medical
judgment and perform controversial and even harmful medical transition procedures.”
Complaint, Franciscan Alliance, Inc., et al. v. Burwell, et al., No. 7:16-cv-00108-O (N.D. Tex.
9
Aug. 23, 2016). Two other cases with similar objections were filed in the U.S. District Court
for the District of North Dakota. Religious Sisters of Mercy, et al. v. Burwell, et al., No. 3:16-
cv-386 (D.N.D. filed Nov. 7, 2016); Catholic Benefits Association, et al. v. Burwell, et al., No.
3:16-cv-432 (D.N.D. filed Dec. 28, 2016). 7
On December 31, 2016, the U.S. District Court in Franciscan Alliance issued a
nationwide preliminary injunction against the Department, barring it from enforcing the
Section 1557 Regulation’s prohibition against discrimination on the basis of “gender
identity” and “termination of pregnancy.” 227 F. Supp. 3d at 696. The district court held
that the Department had adopted an erroneous interpretation of “sex” under Title IX, and
that the regulation was also arbitrary and capricious for failing to incorporate Title IX’s
religious and abortion exemptions. Id. The district court concluded that the Department’s
interpretation was not entitled to deference under Chevron U.S.A., Inc. v. Natural Resources
Defense Council, Inc., 467 U.S. 837 (1984), because “the meaning of sex in Title IX
unambiguously refers to the biological and anatomical differences between male and
female students as determined at their birth.” 227 F. Supp. 3d at 687 (citations omitted).
The Franciscan Alliance district court also held that plaintiffs had established a
likelihood of success on the merits of their claims that the Department had violated the
Administrative Procedure Act (APA) and the Religious Freedom Restoration Act (RFRA). Id.
at 693. Regarding the RFRA claim, the district court found that HHS had not demonstrated
7Religious Sisters of Mercy, et al. v. Burwell, et al., No. 3:16-cv-386; Catholic Benefits Association et al., v.
Burwell, et al., No. 3:16-cv-432 (D.N.D. order of Jan. 23, 2017, consolidating North Dakota cases).
10
a compelling interest in enforcing the regulation against the plaintiffs. Id. at 696. And even
if the Department had demonstrated that compelling interest, the court held that the
Department failed to show that its interest could not be pursued through less restrictive
means for providing access to, and coverage for, services related to gender dysphoria. Id. at
693. The U.S. District Court for the District of North Dakota found the Franciscan Alliance
order to be “thorough and well-reasoned,” and on that basis temporarily stayed
enforcement of Section 1557's prohibitions against discrimination on the bases of gender
identity and termination of pregnancy against the named plaintiffs in that court’s two
consolidated cases.8
On July 10, 2017, the Franciscan Alliance court stayed proceedings to allow time for
agency reconsideration, finding that the preliminary injunction order “provides sufficient
guidance for HHS’s review of the Rule.”9 The U.S. District Court for the District of North
Dakota also further stayed the proceedings in its two cases on July 10, 2017 and on August
24, 2017.10 Neither the previous Administration nor the current one appealed the
nationwide preliminary injunction, or the orders in Franciscan Alliance, Religious Sisters of
Mercy, or Catholic Benefits Association, staying proceedings. On May 2, 2017, the
Department of Justice (DOJ) moved the Northern District of Texas for a voluntary remand
and stay to allow HHS to “reassess the reasonableness, necessity, and efficacy of the two
8 Religious Sisters of Mercy, et al. v. Burwell, et al., Nos. 3:16-cv-386 & 3:16-cv-432 (D.N.D. Order of January 23,
2017).
9 Franciscan Alliance, No. 7:16-cv-00108-O (filed July 10, 2017).
10 Religious Sisters of Mercy, et al. v. North Dakota v. Burwell, et al., No. 3:16-cv-386 (D.N.D. Order filed on July
10, 2017; Catholic Benefits Association v. Burwell, No. 3:16-cv-432 (D.N.D. Order filed Aug. 24, 2017).
11
aspects of the [Section 1557] regulation that are challenged” in litigation. 11 DOJ filed a
similar motion with the District of North Dakota later that month. 12
On July 10, 2017, the Franciscan Alliance court stayed proceedings to allow time for
agency reconsideration, finding that the court’s preliminary injunction order “provides
sufficient guidance for HHS’s review of the Rule.”13 The district court in North Dakota
similarly stayed proceedings on August 24, 2017, in order to allow HHS “to reconsider the
controversial rules and regulations at issue.”14
On February 4, 2019, the plaintiffs in the Franciscan Alliance case filed briefs in
support of their renewed motions for summary judgment. On April 5, 2019, DOJ filed a brief
in response to plaintiffs’ motion summary judgment on behalf of HHS, 15 stating that “the
relevant provisions of Title IX and Section 1557 unambiguously exclude gender-identity
discrimination.” Id. at 14. In this brief, DOJ stated the position of the U.S. Government on the
meaning of “sex” under Title VII of the Civil Rights Act, Title IX of the Education
Amendments of 1972, and Section 1557 of PPACA. DOJ stated, “Since the [Section 1557
Final] Rule was issued, the United States has returned to its longstanding position that the
term ‘sex’ in Title VII does not refer to gender identity, and there is no reason why Section
1557, which incorporates Title IX’s analogous prohibition on ‘sex’ discrimination, should be
treated differently.” Id. at 6. Therefore, DOJ concluded, “the [Final] Rule’s prohibitions on
11 See Defendant’s Motion, Franciscan Alliance, No. 7:16-cv-00108-O (filed May 2, 2017).
12 Defendant’s Motion, Religious Sisters of Mercy, No. 3:16-cv-386 (filed May 26, 2017).
13 Franciscan Alliance, No. 7:16-cv-00108-O (filed July 10, 2017).
14 Religious Sisters of Mercy, No. 3:16-cv-432 (order of Aug. 24, 2017).
15 See Defendant’s Memorandum in Response to Plaintiffs’ Motions for Summary Judgment, Franciscan
Alliance, No. 7:16-cv-00108-O (filed April 5, 2019).
12
discrimination on the basis of gender identity and termination of pregnancy conflict with
Section 1557 and thus are substantively unlawful under the APA.” Id. DOJ continued, “[t]he
[Final] Rule also fails to incorporate Title IX’s exemptions despite Section 1557’s directive
to the contrary, thereby prohibiting conduct the statute permits.” Id.
While it reconsiders its Section 1557 Regulation through the rulemaking process,
the Department continues to abide by the preliminary injunction, which remains in place.
C. Summary of the Proposed Rule
In order to better comply with the mandates of Congress, address legal concerns,
relieve billions of dollars in undue regulatory burdens, further substantive compliance,
reduce confusion, and clarify the scope of Section 1557, the Department proposes to make
substantial revisions to the Section 1557 Regulation and to eliminate provisions that are
inconsistent or redundant with pre-existing civil rights statutes and regulations prohibiting
discrimination on the basis of race, color, national origin, sex, age, and disability. In
addition, to resolve confusion raised by the Section 1557 Regulation’s reliance on an
outdated version of the Department’s Title IX regulation, the Department proposes to
amend its Title IX regulation to implement statutory amendments made by Congress to
Title IX in 1988.16
16See Civil Rights Restoration Act of 1987, Pub. L. 100-259, 102 Stat. 28 (Mar. 22, 1988) (amending Title IX).
These proposed changes would better align HHS’s regulations to the Title IX regulations adopted by other
agencies and the position of the Department of Justice, the Federal civil rights coordinating authority under
Executive Order 12250. See Executive Order 12250 on Leadership and Coordination of Nondiscrimination
Laws, 45 FR 72995 (Nov. 2, 1980).
13
The proposed rule would retain the obligation imposed on covered entities to
submit assurances of compliance, certain provisions concerning language access for
individuals with limited English proficiency (LEP), and certain provisions ensuring access
for individuals with disabilities. The proposed rule would empower the Department to
continue its robust enforcement of civil rights laws prohibiting discrimination on the basis
of race, color, national origin, sex, age, or disability in Department-funded health programs
or activities, and would make it clear that such civil rights laws remain in full force and
effect.
The Department further proposes to make limited conforming amendments to ten
provisions in relevant Department regulations.
D. Cost‐Effective Design of the Proposed Rule
The proposed rule would be an economically significant deregulatory action. The
Department projects that the proposed rule would result in approximately $3.6 billion in
cost savings (undiscounted) over the first five years after finalization. The Department
anticipates that the largest proportion of these estimated savings would result from
repealing the Section 1557 Regulation’s provisions related to mandatory notices.
Specifically, the proposed rule would repeal requirements on covered entities to mail
beneficiaries, enrollees, and others, notices concerning non-discrimination and the
availability of language assistance services (in 15 languages) with every “significant”
publication and communication larger than a postcard or brochure. The Department
projects additional savings from eliminating the requirement for OCR to weigh the
14
presence or absence of language access plans, and from repealing provisions that duplicate
disability and sex discrimination regulatory requirements concerning covered entities
establishing grievance procedures. The Department estimates that there will be some
additional costs to covered entities regarding training and revision of policies and
procedures if the proposed regulation is finalized.
The Department believes that the anticipated benefits—which include compliance
with Federal law, appropriate respect for the roles of Federal courts and Congress, and
reduction or elimination of ineffective, unnecessary, or confusing provisions—far outweigh
any costs or burdens that may arise from the proposed changes.
II. Reasons for the Proposed Rulemaking
Section 1557 does not require any implementing regulations, but incorporates and
builds on the existing civil rights framework of Title VI, Title IX, Age Act, and Section 504 by
making the nondiscrimination requirements of such laws applicable to certain health
programs or activities and related entities to the extent they do not already apply to such
programs or activities. With this background in mind, the Department has decided to
substantially revise the Section 1557 Regulation for several reasons.
The Department believes that the Final Rule exceeded its authority under Section
1557, adopted erroneous and inconsistent interpretations of civil rights law, caused
confusion, and imposed unjustified and unnecessary costs. As stated in the Franciscan
Alliance litigation, “the Rule’s prohibitions of discrimination on the basis of gender identity
and, without the accompanying statutory protections, termination of pregnancy are
15
substantively unlawful under the APA.” 17 The existence of lawsuits and court orders
blocking enforcement of significant parts of the Final Rule for over two years indicates that
changes in the proposed rule may minimize litigation risk.
For all these reasons, the Department proposes to exercise its discretionary
regulatory authority to revise the Section 1557 Regulation to implement Federal civil rights
law consistent with the applicable statutes as passed by Congress. The Department believes
these amendments would reduce the significant confusion and unjustified burdens caused
by the Final Rule.
First, the Final Rule created inconsistencies with, and unnecessarily duplicated, the
Department’s long-standing existing civil rights regulations. See 45 CFR Parts 80 and 81
(Title VI), 84 and 85 (Section 504), 86 (Title IX), 90 and 91 (Age Act). Therefore, the
Department proposes to repeal the provisions of the Final Rule that are confusing and
redundant.
Second, the U.S. District Court for the Northern District of Texas preliminarily
enjoined enforcement of parts of the Section 1557 Regulation because it found that the
Department had exceeded its statutory authority. 18 The Department proposes this rule to
address the overbroad interpretations, adopted in the current rule, of Section 1557 that
were identified by the court and other Federal precedents. The Department also proposes
to address the court’s findings by incorporating, into the Department’s implementing
Alliance, No. 7:16-cv-00108-O at *5 (filed April 5, 2019).
18 See Franciscan Alliance, 227 F. Supp. 3d at 696.
16
regulations, certain amendments to the statutes expressly identified by Congress in Section
1557.
Third, the Department estimates that the prior rulemaking did not anticipate or
account for an annual burden of approximately $147 million (low-end) to $1.34 billion
dollars (high-end), as further described in the Regulatory Impact Analysis of this proposed
rule. The Department does not believe those burdens are justified by need, or by the
benefits obtained by the rulemaking. In total, the proposed rule would relieve the American
people of approximately $3.6 billion in unjustified costs over five years, while continuing to
provide for vigorous enforcement of civil rights protections in health care. See Executive
Order 13765, 82 FR 8351 (Jan. 20, 2017)(“Minimizing the Economic Burden of the Patient
Protection and Affordable Care Act Pending Repeal”).
As discussed below, the Department believes the repeal and replacement of
significant portions of the Section 1557 Regulation would provide much needed finality,
predictability, administrability, consistency, relief of burdens, and clarity, all of which
would benefit covered entities, beneficiaries of Exchanges, and Department-funded or
administered health programs or activities, the courts, and the general public.
In light of these determinations, through this proposed rule, the Department
proposes to codify the longstanding application of the civil rights laws cited in Section 1557
to health programs or activities receiving Federal financial assistance or programs or
activities administered by the Department under Title I of the PPACA or by entities
established under such Title, both in terms of the protections those civil rights laws provide
17
and the enforcement mechanisms they entail. This approach faithfully implements the
Congressional mandate and seeks to avoid further litigation and uncertainty regarding the
implementing regulations. The Department seeks comment on all of the provisions that are
retained under this proposed rule, or that this rule proposes to repeal, amend, or add,
including comment on whether provisions of the current Section 1557 Regulation that the
Department does not propose to retain in this proposed rule, if any, are in keeping with
Congress’s mandate such that the Department should consider retaining them – and
whether any of such provisions should be incorporated into the Department’s regulations
implementing the underlying civil rights laws.
A. Section 1557 of the PPACA Does Not Prevent or Limit Reconsideration of the Current
Rule.
Section 1557(c) states that the Secretary “may” promulgate implementing
regulations. This language contrasts with the multiple other areas of Title I of the PPACA
where Congress directed that the Secretary (or Secretaries) “shall” issue regulations. 42
U.S.C. 18116(c). Section 1557 accordingly authorizes, but does not require, the Secretary to
implement the statute through regulation. That approach makes sense because “Section
1557 builds on a landscape of existing civil rights laws.” 78 FR 46559 (RFI) (Aug. 1, 2013).
Section 1557 vests the Department with discretion to determine whether and to what
degree implementing regulations are needed, and to revisit that determination, as
appropriate, at a later date. Encino Motorcars v. Navarro, 146 S.Ct. 2117, 2125 (2016)
(“Agencies are free to change their existing policies as long as they provide a reasoned
18
explanation for the change”). (ConocoPhillips Co. v. U.S. E.P.A., 612 F.3d 822, 832 (5th Cir.
2010) (“[e]mbedded in an agency’s power to make a decision is its power to reconsider
that decision.”); New England Power Generators Assn. v. FERC, 879 F.3d 1192 (D.C. Cir.
2018) (“So long as any change is reasonably explained, it is not arbitrary and capricious for
an agency to change its mind in light of experience, or in the face of new or additional
evidence, or further analysis or other factors indicating that the agency’s earlier decision
should be altered or abandoned.”). Thus, an agency action to substantially repeal a prior
rule, or parts thereof, is not necessarily subject to a higher standard of justification in the
exercise of such discretion compared to the level of justification required under the prior
rulemaking on a blank slate. See FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009)
(“When an agency changes its existing position, it need not always provide a more detailed
justification than what would suffice for a new policy created on a blank slate. But the
agency must at least display awareness that it is changing position and show that there are
good reasons for the new policy.”). The agency’s use of its rulemaking discretion in
revisiting its original position is not, therefore, subject to a higher standard under the APA
(5 U.S.C. 706); otherwise, agencies would be limited in their ability to revisit past
regulations to cure defects or provide clarifications.
B. The Final Rule Adopted Novel and Inconsistent Legal Interpretations of Long‐
Standing Civil Rights Law.
1. The Final Rule Interpreted the Scope of Section 1557 Too Broadly.
19
The Department has now concluded that its existing Section 1557 Regulation
impermissibly extends to programs and entities not covered by the text of the statute. With
respect to the receipt of Federal financial assistance, the current rule defines “health
program or activity” to cover “all [] operations” of entities principally engaged in providing
or administering “health services or health insurance coverage or other health coverage.”
45 CFR § 92.4. The scope of the regulation then includes all the operations of entities that
provide “health insurance coverage or other health coverage,” whether or not they provide
any health care.
The Civil Rights Restoration Act of 1987 (CRRA), however, defined “program or
activity” for purposes of Title VI, Section 504 of the Rehabilitation Act, the Age Act, and
Title IX to cover all operations of regulated entities only when they are “principally engaged
in the business of providing education, health care, housing, social services, or parks and
recreation.” Pub. L. 100-259, 102 Stat. 28 (Mar. 22, 1988) (emphasis added). The “business
of providing . . . health care” differs substantially from the business of providing health
insurance coverage (or other health coverage) for such health care. Thus, the Final Rule
goes beyond the CRRA by covering all the operations of entities that provide “health
insurance coverage or other health coverage” and extends to those that are not principally
engaged in the business of providing health care, and to those who provide no health care
at all.19 Moreover, the Department had not previously interpreted the CRRA to cover all the
19The preamble to the Final Rule acknowledges the relevance of the CRRA, 81 FR at 31386, but does not
explain how the provision of “health care” covers the provision of “health insurance, even if only part of the
health program or activity receives such assistance.”
20
operations of health insurance providers under any of the antidiscrimination laws covered
by the CRRA (Title VI, Title IX, the Age Act, and Section 504) until it promulgated the
Section 1557 regulation – over a quarter century after the CRRA was passed – despite there
being nothing in Section 1557 indicating any abrogation – or expansion – of the CRRA.
Therefore, the Department is now proposing to clarify that health insurance programs
administered by entities not principally engaged in providing health care will only be
covered by the Rule to the extent those programs (as opposed those entities) receive
Federal financial assistance from the Department.
2. The Final Rule Improperly Blended Substantive Requirements and Enforcement
Mechanisms of the Underlying Statutes.
The PPACA states that the “enforcement mechanisms for and available under [] title
VI, title IX, section 504, or such Age Discrimination Act shall apply,” for purposes of
enforcing Section 1557. 42 U.S.C. 18116(a). Interpreting this provision in 2015, a Federal
court held “Congress’s express incorporation of the enforcement mechanisms from those
four Federal civil rights statutes, as well as its decision to define the protected classes by
reference thereto, manifests an intent to import the various different standards and
burdens of proof into a Section 1557 claim, depending upon the protected class at issue.”
Southeastern Pennsylvania v. Gilead, 102 F. Supp. 3d 688, 698-99 (E.D. Pa. 2015) (emphasis
added). See also Briscoe v. Health Care Serv. Corp., 281 F. Supp. 3d 725, 738 (N.D. Ill. 2017)
(“If Congress intended for a single standard to apply to all § 1557 discrimination claims,
21
repeating the references to the civil-rights statutes and expressly incorporating their
distinct enforcement mechanisms would have been a pointless (and confusing) exercise.”).
In interpreting and enforcing Section 1557 prior to the promulgation of the Final
Rule – i.e., from 2010 to 2016 – the Department applied Title VI, Title IX, Section 504, and
the Age Act regulations as independent authorities. However, contrary to the text of Section
1557, the Final Rule did not merely take existing protected classes and enforcement
mechanism and apply them to health care programs or activities. Rather, it made certain
individualized requirements, prohibitions, or enforcement mechanisms apply across all
protected classes without sufficient statutory or regulatory support. This hodgepodge
approach at times resulted in conflicts with precedents of the U.S. Supreme Court and
lower Federal courts. See 81 FR 31387 (stating in the preamble of the Final Rule that there
is “ a cognizable national origin discrimination claim under Title VI, Section 1557, and this
part when the claim alleges that a covered entity’s use of a facially neutral policy or
practice related to citizenship or immigration status has a disparate impact on individuals
of a particular national origin group”); see also 81 FR at 31440 (“OCR interprets Section
1557 as authorizing a private right of action for claims of disparate impact discrimination
on the basis of any of the criteria enumerated in the legislation”); 81 FR 31405 (“OCR
recognizes that discrimination based on health status, claims experience, medical history,
or genetic information can, depending on the facts, have a disparate impact that results in
discrimination on a basis prohibited by Section 1557 and will process complaints alleging
22
such discrimination accordingly”). But see Alexander v. Sandoval, 532 U.S. 275, 282 (2001)
(denying private rights of action for disparate impact theories under Title VI).
The Final Rule stated that an individual or entity may bring a civil action to
challenge a violation of Section 1557 or of the regulation in Federal court. 45 CFR §
92.302(d). The Department explained in the preamble to the Final Rule that private rights
of action were available for Section 1557 claims against recipients of Federal financial
assistance or State Exchanges for racial, national origin, sex, age, or disability
discrimination. See 81 FR at 31440 (stating that “both the proposed and the final rule
specify that a private right of action is available under Section 1557” and such actions are
available “on the basis of any of the criteria enumerated in the legislation”). Multiple
Federal courts have held that Section 1557, or the statutes underlying it, do not permit
private rights of action for disparate impact claims of discrimination on the basis of race 20
or sex,21 and there is a split on the question with respect to disability, with one Federal
appellate court holding that such private rights of action are not available and other
Federal appellate courts holding that such private rights of action are available for claims of
discrimination on the basis of disability.22
20 See Southeastern Pennsylvania Transp. Authority v. Gilead, 102 F. Supp. 3d 688, 698-701 (E.D. Pa. 2015)
(holding that Section 1557, incorporating Title VI, does not permit a private right of action for a disparate
impact claim on the basis of race); see also Alexander v. Sandoval, 532 U.S. 275, 282-83 (2001).
21 See Condry v. UnitedHealth Group, No. 17-cf-00183-VC (N.D. Calif. 2018) (“disparate impact
claims on the basis of sex are not cognizable under section 1557”); Weinreb v. Xerox Business Services, 323 F.
Supp. 3d 501, 521 (S.D.N.Y. 2018); Briscoe v. Health Care Serv. Corp., 281 F. Supp. 3d 725, 738 (N.D. Ill. 2017);
York v. Wellmark, Inc., No. 4:16-cv-00627-RGE-CFB, at *15-16 (S.D. Iowa Sep. 6, 2017); Southeastern
Pennsylvania v. Gilead, 102 F. Supp. 3d 688 (E.D. Pa. 2015).
22 Compare Crocker v. Runyon, 207 F.3d 314, 321 (6th Cir. 2000); Doe v. Bluecross Blueshield, No. 2:17-cv-
02793-TLP-cgc, 2018 WL 3625012 (W.D. Tenn. 2018); and Briscoe v. Health Care Serv. Corp., 281 F. Supp. 3d
23
These judicial interpretations of Section 1557 relied on Congress’s decision to
include a rule of construction in Title IX stating that it does not require educational
institutions to use preferential treatment based on a disparate impact basis, 23 and the U.S.
Supreme Court’s decisions precluding a right of action for disparate impact claims under
Title VI.24
The Final Rule also stated that compensatory damages are available in appropriate
administrative and judicial actions under the Section 1557 Regulation, 45 CFR § 92.301(b),
and the Department stated in its preamble that this was added “to make clear in the
regulation that compensatory damages are available. Our interpretation of Section 1557 as
authorizing compensatory damages is consistent with our interpretations of Title VI,
Section 504, and Title IX,” 81 FR at 31440. However, the Department of Justice’s Title VI
Manual states that, under applicable Federal case law, compensatory damages are
generally unavailable for claims based solely on an agency’s disparate impact regulations. 25
725, 738 (N.D. Ill. 2017), with Valencia v. City of Springfield, Ill., 883 F.3d 959, 967 (7th Cir. 2018); and
Hollenbeck v. U.S. Olympic Comm. 513 F.3d 1191, 1197 (10th Cir. 2008). To the Department’s knowledge, no
disparate impact claims on the basis of age have been filed under Section 1557 in a Federal court.
23 20 U.S.C. 1681(b) (Title IX “[s]hall not [be] construe[d] to require an educational institution to grant
preferential or disparate treatment to the members of one sex on account of an imbalance which may exist
with respect to the total number or percentage of persons of that sex participating in or receiving the benefits
of any Federally supported program or activity, in comparison with the total number or percentage of
persons of that sex in any community, State, section, or other area.”).
24 Alexander v. Sandoval, 532 U.S. 275, 282 (2001) (holding that private rights of action for disparate impact
are not authorized by Title VI).

25 DOJ Title VI manual, https://www.justice.gov/crt/fcs/T6Manual9 (citing Alexander v. Sandoval, 532 U.S.
275, 282-83 (2001), Barnes v. Gorman, 536 U.S. 181, 187 (2002), and Gebser v. Lago Vista Indep. Sch., 524 U.S.
274, 87 (1998)).
24
The Final Rule also newly extended provisions applicable only to some of the
underlying civil rights laws to apply to all of the prohibited bases of discrimination under
Section 1557. For example, although only the Section 504 (disability) and Title IX (sex)
regulations prohibit recipients from perpetuating discrimination by providing significant
assistance to any agency, organization, or person that discriminates, the Final Rule
extended this prohibition to Title VI and Age Act claims under Section 1557. 26 The Section
1557 Regulation similarly extended the prohibition, in the Title VI, Section 504, and Age
Discrimination Act regulations, on the utilization of criteria or methods of administration
that have the effect of subjecting individuals to discrimination, to claims of discrimination
on the basis of sex under Section 1557, although that prohibition is not included in the Title
IX regulations.27
3. HHS Interpreted Federal Nondiscrimination Law Differently From Other Federal
Agencies.
Because Section 1557, Title VI, Title IX, Section 504, and the Age Act are cross-
cutting civil rights laws enforced by multiple Federal agencies the Department’s
interpretation of these laws should be consistent with other interpretations within the
26 See 45 CFR § 84.4(b)(1)(v) (Section 504), 86.23(b)(7) (Title IX). But see 45 CFR § 92.101(a)(4)(ii)
(extended to age under Section 1557 Regulation), § 92.101(b)(1)(ii) (extended to race, color or national
origin under Section 1557 Regulation).
27 See 45 CFR § 80.3(b)(2) (Title VI), § 84.4(b)(4) (Section 504), § 91.11(b) (Age Act). But see 45 CFR §
92.101(b)(3)(ii) (extended to sex under Section 1557 Regulation).
25
Executive Branch.28 By applying different substantive requirements and enforcement
mechanisms, as discussed above, HHS’s Final Rule differed from other agencies’ regulations
on Title VI, Title IX, Section 504, and the Age Act. HHS’s Section 1557 Regulation is limited
in scope to HHS-funded or HHS-administered health programs, activities, and PPACA Title I
entities, but Section 1557 of the PPACA applies to health programs or activities which
receive Federal financial assistance from any Executive agency. 29 Although the then-OCR
Director encouraged other agencies to adopt the standards in the Final Rule in 2016, 30 each
agency has its own enforcement responsibility for the programs they fund that fall within
Section 1557 jurisdiction. One agency’s implementation and enforcement of a civil rights
law that is inconsistent with other agencies would result in confusion for entities regulated
by more than one agency and for the public as a whole, which is particularly imprudent
28 Pursuant to Executive Order 12250, the Attorney General has the responsibility to “coordinate the
implementation and enforcement by Executive agencies of (a) Title VI of the Civil Rights Act of 1964 (42 U.S.C.
2000d et seq.). (b) Title IX of the Education Amendments of 1972 (20 U.S.C. 1681 et seq.).
(c) Section 504 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794), (d) Any other provision of
Federal statutory law which provides, in whole or in part, that no person in the United States shall, on the
ground of race, color, national origin, handicap, religion, or sex, be excluded from participation in, be denied
the benefits of, or be subject to discrimination under any program or activity receiving Federal financial
assistance.” Executive Order 12250 at sec. 1-2(b), 45 FR 72995 (Nov. 2, 1980). See also 42 U.S.C. 6103
(requiring each Federal department or agency to submit Age Act enforcement reports to and obtain approval
of their Age Act regulations by HHS).
29 Compare 42 U.S.C. 18116(a) (stating that Section 1557 applies to “any health program or activity, any part
of which is receiving Federal financial assistance, including credits, subsidies, or contracts of insurance, or
under any program or activity that is administered by an Executive Agency or any entity established under
this title (or amendments)”) (emphasis added) with 45 CFR § 92.1 (stating that Part 92 applies to health
programs or activities administered by recipients of Federal financial assistance from the Department, Title I
entities that administer health programs or activities, and Department-administered health programs or
activities) (emphasis added).
30 Memorandum from OCR Director to Civil Rights Heads of Federal Agencies, Enforcement Responsibilities
under Section 1557 of the Affordable Care Act (July 12, 2016),
https://www.hhs.gov/sites/default/files/directors-memo-july2016.pdf.
26
given that Federal courts have implied the availability of monetary damages in private
rights of action under the underlying civil rights statutes. 31
4. The Final Rule Created New Provisions Concerning Language Access Not Adequately
Justified by Law or Policy.
Title VI prohibits discrimination against persons on the basis of national origin
under any program or activity receiving Federal financial assistance. Under governing U.S.
Supreme Court case law, Title VI obligates recipients of Federal financial assistance to
provide individuals with limited English proficiency (LEP) meaningful access to Federally
funded programs or activities.32 In 2016, the Section 1557 Final Rule added certain
language access provisions that were not required by Title VI case law or the underlying
Title VI regulation.33
Additionally, the Final Rule introduced confusing and costly notice and tagline
requirements that were not required by law, were inconsistent with tagline requirements
required by other components of the Department and, as discussed further below,
provided relatively minimal benefit to LEP individuals. Complicating matters further,
31 Blunt v. Lower Merion Sch. Dist., 767 F.3d 247, 272 (3d Cir. 2014) (Title VI); Franklin v. Gwinnett Cty. Pub.
Sch., 503 U.S. 60 (1992) (Title IX).
32 Lau v. Nichols, 414 U.S. 563 (1974) (interpreting Title VI in the Department of Health Education and
Welfare’s Title VI regulation). The Title VI statute does not expressly mention “limited English proficiency.”
42 U.S.C. 2000d et seq. Lau and its progeny relied on the word “national origin” in Title VI to encompass
limited English proficiency (LEP).
33 See 45 CFR Parts 80 and 81 (the Department’s Title VI regulations do not expressly reference LEP). Lau and
subsequent case law interpreted the Title VI regulations’ prohibition on recipients of Federal financial
assistance “utiliz[ing] criteria or methods of administration which have the effect of subjecting individuals to
discrimination” on the basis of national origin to require recipients to take reasonable steps to provide
persons with limited English proficiency (LEP) meaningful access to Federally funded programs or activities.
The Supreme Court has not specified what particular linguistic requirements may constitute “meaningful
access” outside of the education context.
27
because the Section 1557 Regulation applies only to health care programs or activities, a
recipient of Federal financial assistance from the Department for health care services is
subject to different notice and tagline requirements than a recipient receiving Federal
financial assistance from the Department for human services alone, such as a child welfare
agency.
Furthermore, the Final Rule newly required the OCR Director, in evaluating
compliance, to take into account whether a recipient of Federal financial assistance has
“developed and implemented an effective written language access plan that is appropriate
to its particular circumstances, to be prepared to meet its obligations”
under Section 1557. 45 CFR § 92.201(b)(a). Before the promulgation of the Final Rule, an
Executive Order directed Executive agencies to prepare language access plans applicable to
their Federally conducted programs and activities (for example, the Veterans
Administration’s hospitals), but the Section 1557 provision applied to recipients of Federal
financial assistance (for example, private hospitals accepting Medicaid). E.O. 13166, sec. 2,
65 FR 50121, 50121 (Aug. 16, 2000). The last section of the Executive Order also stated
that it “does not create any right or benefit, substantive or procedural, enforceable at law.”
65 FR at 50122.
5. The Final Rule’s Definition of Discrimination “On the Basis of Sex” Has Been Enjoined
by Federal Courts.
In its Section 1557 Regulation, the Department interpreted the “sex” discrimination
prohibited by Section 1557 to include discrimination on the basis of “gender identity.” 81
28
FR 31376, 31467 (definition of “on the basis of sex,” codified at 45 CFR § 92.4). In
particular, the Department took the view that one can identify as “male, female, neither, or
a combination of male and female” and that this identification may differ from one’s “sex
assigned at birth” because, according to the regulation, gender identity ultimately relies on
a subjective “internal sense.” 81 FR at 31467; 45 CFR § 92.4 (definition of “gender
identity”). It then reasoned that Title IX’s prohibition of discrimination on the basis of sex
(as incorporated by Section 1557) includes discrimination on the basis of pregnancy
termination,34 sex stereotyping,35 and gender identity.36
Interpreting Section 1557, through Title IX, to prohibit gender identity
discrimination was a relatively novel legal theory when the Department adopted the Final
Rule. The theory, was not, and has not been, endorsed by the Supreme Court. See, e.g., Baker
34 The preamble to the Final Rule cites the Department’s Title IX regulation, which contains provisions on
termination of pregnancy, but does not analyze this regulatory language in light of Title IX’s statutory
provisions about abortion. See 81 FR at 31387 (citing 45 CFR § 86.40(b)); but see 20 U.S.C. 1688 (“Nothing in
this title shall be construed to require or prohibit any person, or public or private entity, to provide or pay for
any benefit or service, including the use of facilities related to an abortion…”).
35 The Final Rule defines “sex stereotypes” as “stereotypical notions of masculinity or femininity, including
expectations of how individuals represent or communicate their gender to others, such as behavior, clothing,
hairstyles, activities, voice, mannerisms, or body characteristics. These stereotypes can include the
expectation that individuals will consistently identify with only one gender and that they will act in
conformity with the gender-related expressions stereotypically associated with that gender. Sex stereotypes
also include gender expectations related to the appropriate roles of a certain sex.” 81 FR at 31468 (codified at
45 CFR § 92.4).
36 The Final Rule defines “gender identity” as “an individual’s internal sense of gender, which may be male,
female, neither, or a combination of male and female, and which may be different from an individual’s sex
assigned at birth.” 81 FR at 31467 (codified at 45 CFR § 92.4). The Final Rule notes, in the definition, that “the
way an individual expresses gender identity is frequently called ‘gender expression,’ and may or may not
conform to social stereotypes associated with a particular gender.” Id. The definition also notes that “[a]
transgender individual is an individual whose gender identity is different from the sex assigned to that
person at birth.” Id. The regulation requires covered entities to treat individuals “consistent with their gender
identity” except that covered entities “may not deny or limit health services that are ordinarily or exclusively
available to individuals of one sex, to a transgender individual based on the fact that the individual’s sex
assigned at birth, gender identity, or gender otherwise recorded is different from the one to which such
health services are ordinarily or exclusively available.” 45 CFR § 92.206 and § 92.207(b)(3).
29
v. Aetna, 228 F. Supp. 3d 764, 768-69 (N.D. Texas 2017) (noting no controlling U.S. Supreme
Court legal precedent recognizing gender identity as prohibited discrimination under
Section 1557).
a. Background on Title IX of the Education Amendments
Title IX prohibits discrimination on the basis of sex in educational programs or
activities that receive Federal financial assistance. Specifically, the statute states that ‘‘[n]o
person in the United States shall, on the basis of sex, be excluded from participation in, be
denied the benefits of, or be subjected to discrimination under any education program or
activity receiving Federal financial assistance….” 20 U.S.C. 1681. The statute uses the word
“sex” but not “sexual orientation” or “gender identity.” Although it does not contain an
express definition of the term “sex,” additional provisions in Title IX use explicitly binary
terms such as “men” and “women,” “father-son,” “mother-daughter,” “boys” and “girls,”
“both sexes,” and “one sex” and “the other sex.”37
Congressional activity in this area suggests that “sex” under Title IX does not include
sexual orientation or gender identity. See Food & Drug Admin.v. Brown & Williamson
Tobacco Corp., 529 U.S. 120, 122 (2000) (when “Congress several times considered and
rejected bills” that would have granted the agency authority, Congress “evidenced a clear
intent to preclude a meaningful policymaking role for any administrative agency”). For
37Although Congress did not include a definition of the term “sex”, provisions in Title IX refer to “men” and
“women,” “father-son,” “mother-daughter,” “boys” and “girls,” “both sexes,” and “one sex” and “the other sex
42 U.S.C. 1681(a)(2)(“both sexes”), (a)(2)(“one sex” and “other sex”), (a)(6)(B)(“Men’s” and “Women’s”),
(a)(6)(B)(“Boy” and “Girl”); (a)(7)(A)(“Boys” and “Girls”), (a)(7)(B)(i)(“Boys” and “Girls”), (a)(8)(“father-
son”, “mother-daughter”), and (a)(8) (“one sex” and “other sex”). See also 42 U.S.C. 1681(a)(2)(6)(“fraternity”
and “sorority”).
30
example, in 2016, Senator Mazie Hirono introduced the Patsy T. Mink Gender Equity in
Education Act, S. 3147 (114th Cong. 2016), to “support educational entities so that such
entities have the support to fully implement [T]itle IX” and to define “sex discrimination” to
include “[a]ctual or perceived sex, sexual orientation, gender, or gender identity.” See also
H.R. 5682 (114th Cong. 2016) (companion measure introduced in the House of
Representatives). However, there was no action on the Senate bill after it was referred to
the Senate Committee on Health, Education, Labor and Pensions. Congress has repeatedly
considered bills that would add the bases of sexual orientation or gender identity to other
statutes that already prohibited discrimination on the basis of sex, but has done so in only
limited instances.38
Over the past three decades, Members of Congress have repeatedly proposed to
amend the Civil Rights Act to add the words “sexual orientation” and “gender identity” as
prohibited bases of discrimination, but as of the date of publication of this proposed rule,
such measures have never become Federal law. 39
38 18 U.S.C. 249(c)(4) (the Matthew Shepard and James Byrd, Jr. Hate Crimes Prevention Act prohibits hate
crimes which are based on “actual or perceived religion, national origin, gender, sexual orientation, gender
identity, or disability”); 34 U.S.C. 12291(b)(13)(A) (the Violence Against Women Reauthorization Act (VAWA)
prohibits discrimination on the basis of “actual or perceived…sex, gender identity… [or] sexual orientation”).
39 Over the past three decades, the Employment Non-Discrimination Act (ENDA) has been introduced ten
times in the U.S. House of Representatives, but ENDA, which would prohibit employment discrimination on
the basis of sexual orientation and gender identity, has never proceeded out of committee in the House. See
H.R. 4636 (103rd Cong. 1994); H.R. 1863 (104th Cong. 1995); H.R. 1858 (105th Cong. 1997); H.R. 2355
(106th Cong. 1999); H.R. 2692 (107th Cong. 2001); H.R. 3285 (108th Cong. 2003); H.R. 2015 (110th Cong.
2007); H.R. 2981 (111th Cong. 2009); H.R. 1397 (112th Cong. 2011); H.R. 1755 (113th Cong. 2013). The
Equality Act has similarly been introduced in three successive sessions of Congress. See H.R. 3185 (114th
Cong. 2015); S. 1828 (114th Cong. 2015); H.R. 2282 (115th Cong. 2017); S. 1006 (115th Cong. 2017); H.R. 5
(116th Cong.) (introduced Mar. 3, 2019). It did not proceed out of committee in the 114th and 115th
Congresses, and it passed the House of Representatives on May 17, 2019. The Equality Act would amend the
31
b. HHS’s Title IX Regulations
In 1975, the predecessor to HHS (the Department of Health, Education, and Welfare
(HEW)) became the first agency to adopt Title IX implementing regulations. 40 FR 24128
(June 4, 1975). The agency received and considered more than 9,700 comments before
issuing its final regulations, and Congress held six days of hearings to determine whether
the regulations were consistent with the statute.40 The regulations,41 like Title IX itself,
included no explicit definition of “sex.”42 Like Title IX, however, the Title IX regulations do
use explicitly binary terms such as “male and female” (§ 86.41(c)) and “one sex… [and] the
other sex” (passim).
When HHS interpreted “on the basis of sex” under Title IX through its Section 1557
regulation, HHS did not add the definition to its Title IX regulation. Neither did HHS amend
its Title IX Regulation to adjust the references to “male and female” or “one sex… [and] the
other sex” to conform to the novel definition in the Section 1557 regulation. Compare 81 FR
31467 (May 18, 2016) (Section 1557 Regulation) with 70 FR 24320 (May 9, 2005) (the last
time HHS’s Title IX regulations were amended).
Civil Rights Act to include “gender identity” and “sexual orientation” in addition to “sex” as prohibited
grounds of discrimination, and would also include a definition of the terms “sex” and “gender identity.”
40 Subcommittee on Postsecondary Education of the House Committee on Education and Labor, Review of
Regulations to Implement Title IX of Public Law 92-318 Conducted Pursuant to Sec. 431 of the General
Education Provisions Act (94th Cong. June 17, 20, 23, 24, 25, 26, 1975); see also Title IX Common Rule, 65 FR
52857 (Sept. 29, 2000) (the HEW regulations were “the result of an extensive public comment process and
congressional review”).
41 See 45 CFR Part 86.
42 Consistent with the statutory language, the Title IX regulations used the same binary and biological
language about sexes as found in Title IX, including “both sexes,” “the other sex,” and “boys” and “girls.” See 45
CFR § 86.2(s), § 86.7, § 86.17(b)(2), § 86.21(c)(4), § 86.31(c), § 86.32(b)(2) and (c)(2), § 86.33, § 86.37(a)(3),
§ 86.41(b) and (c), § 86.55(a), § 86.58(a) and (b), § 86.60(b), and § 86.61.
32
c. Need for Consistency Among Components of HHS
Since 2012, other components of the Department adopted an interpretation of sex
different from the definition OCR adopted in the Section 1557 Regulation. The
Department’s failure to address these other definitions in the Final Rule has resulted in
substantial confusion and inconsistency.
In 2014, the National Institutes of Health (NIH) announced its policy that
researchers seeking NIH grant funds should explain how differences between males and
females on the basis of biology are factored into research designs, analyses, and reporting
in clinical research as a biological variable. 43 This approach, according to NIH,
acknowledged that research about male and female differences may be critical to the
interpretation, validation, and generalizability of research findings and may inform clinical
interventions. In 2017, NIH issued guidance to grant recipients about this policy 44 and
continues to fund research that uses “sex” as a biological variable. 45 Using sex as a
biological variable addresses binary male/female differences found to impact the practice
43 Janine A. Clayton and Francis S. Collins, Policy: NIH to balance sex in cell and animal studies, Nature (May 14,
2014) (discussing disease-causing effects of Y-chromosome genes as different from X-chromosome genes,
and intrinsic sex differences of female and male cells in vitro), https://www.nature.com/news/policy-nih-to-
balance-sex-in-cell-and-animal-studies-1.15195; NIH, Consideration of Sex as a Biological Variable in NIH‐
Funded Research, NOT-OD-15-102 (June 9, 2015), https://grants.nih.gov/grants/guide/notice-files/not-od-
15-102.html.
44NIH Guidance, Consideration of Sex as a Biological Variable in NIH‐funded Research (2017),
https://orwh.od.nih.gov/sites/orwh/files/docs/NOT-OD-15-102 Guidance.pdf.
45 Suk Kyeong Lee, Sex as an important biological variable in biomedical research, BMB Rep. 167 (Apr. 2018),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5933211; Terry Lynn Cornelison, Considering Sex as a

Biomedical Variable in Biomedical Research, Gender and the Genome (June 1, 2017),
https://journals.sagepub.com/doi/pdf/10.1089/gg.2017.0006; Inna Belfer, J. White, et al., Considering sex as
a biological variable (SABV) in research: a primer for pain investigators, The Journal of Pain (Mar. 2018),
https://www.jpain.org/article/S1526-5900(17)31024-6/pdf.
33
of medicine by influencing proper diagnosis, prognosis, and treatment of patients. 46
Medical research prior to and subsequent to the Section 1557 Regulation have addressed
differences between males and females as binary and biological. 47
NIH also funded conferences of mental health professionals who developed the
latest clinical manual on the diagnosis of “gender dysphoria” that defines “sex” (as distinct
from “gender identity”) in biological terms.48 Specifically, the Diagnostic and Statistical
Manual of Mental Disorders (DSM-5) provides, “[t]his chapter employs constructs and
46Janine A. Clayton, Applying the new SABV (sex as a biological variable) policy to research and clinical care,
Physiology and Behavior (Aug 17, 2017), https://doi.org/10.1016/j.physbeh.2017.08.012; see also Leah R.
Miller, Cheryl Marks, et al., Considering sex as a biological variable in preclinical research, 31 Federation of
American Societies for Experimental Biology Journal 29-34 (Sept. 2017) (defining “Sex” as “being XY or XX”),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6191005.
47 See. e.g., Douglas C. Dean III, E. M. Planalp, et al., Investigation of brain structure in the 1‐month infant, Brain
Structure and Function 1-18 (Jan. 5, 2018), https://www.ncbi.nlm.nih.gov/pubmed/29305647 (finding

differences between male and female infants at the age of 1 month, “[c]onsistent with findings from studies
of later childhood and adolescence, subcortical regions appear more rightward asymmetric”); Wei Yang,
Nicole M. Warrington, et al., Clinically Important Sex differences in GBM biology revealed by analysis of male
and female imaging, transcriptome and survival data, Science Translational Medicine (Jan. 21, 2019),
https://www.ncbi.nlm.nih.gov/pubmed/30602536S (identifying sex-specific molecular subtypes of
glioblastoma); Stefan Ballestri, Fabio Nascimbeni, et al., NAFLD as a Sexual Dimorphic Disease: Role of Gender
and Reproductive Status in the Development and Progression of Nonalcoholic Fatty Liver Disease and Inherent
Cardiovascular Risk, Advances in Therapy (May 19, 2017),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5487879; Ester Serrano-Saiz, Meital Oren-Suissa, et al.,
Sexually Dimorphic Differentiation of a C. elegans Hub Neuron Is Cell Autonomously Controlled by a Conserved
Transcription Factor, 27 Current Biology 199 (Jan. 5, 2017),
https://www.ncbi.nlm.nih.gov/pubmed/28065609; Anke Samulowitz, Ida Gremyr, et al., “Brave Men” and
“Emotional Women”: A Theory‐Guided Literature Review on Gender Bias in Health Care and Gendered Norms
towards Patients with Chronic Pain, Pain Research and Management (Feb. 25, 2018),
https://www.ncbi.nlm.nih.gov/pubmed/29682130 (stating that “the response to opioid receptor
antagonists may generate a difference between men’s and women’s experiences of pain”); Susan Sullivan,
Anna Campbell, et al., What’s good for the goose is not good for the gander: Age and gender differences in
scanning emotion faces, 72:3 Journals of Gerontology 441 (May 1, 2017),
https://www.ncbi.nlm.nih.gov/pubmed/25969472; Ramona Stone and W. Brent Webber, Male‐Female
Differences in the Prevalence of Non‐Hodgkin Lymphoma, 81 Journal of Environmental Health 16 (Oct. 2018).
48 NIH sponsored thirteen scientific conferences that assisted in research evaluation by hundreds of mental
health specialists for the American Psychiatric Association to produce the standard classifications of mental
disorders of the Diagnostic and Statistical Manual of Mental Disorders Handbook of Differential Diagnosis
(DSM-5).
34
terms as they are widely used by clinicians from various disciplines with specialization in
this area. In this chapter, sex and sexual refer to the biological indicators of male and
female (understood in the context of reproductive capacity), such as in sex chromosomes,
gonads, sex hormones, and nonambiguous internal and external genitalia.” 49
Additionally, NIH requires research grant applicants to consider sex as a biological
variable “defined by characteristics encoded in DNA, such as reproductive organs and other
physiological and functional characteristics.” 50 According to an NIH article, “[s]ex as a
biological variable (SABV) is a key part of the new National Institutes of Health (NIH)
initiative to enhance reproducibility through rigor and transparency. The SABV policy
requires researchers to factor sex into the design, analysis, and reporting of vertebrate
animal and human studies. The policy was implemented as it has become increasingly clear
that male/female differences extend well beyond reproductive and hormonal issues.
Implementation of the policy is also meant to address inattention to sex influences in
biomedical research. Sex affects: cell physiology, metabolism, and many other biological
functions; symptoms and manifestations of disease; and responses to treatment. For
example, sex has profound influences in neuroscience, from circuitry to physiology to pain
perception. Extending beyond the robust efforts of NIH to ensure that women are included
49 Although the Section 1557 Final Rule proposed to address insurance coverage for care related to gender
dysphoria on the basis of a sex discrimination theory, neither the Notice of Proposed Rulemaking in 2015 nor
the Final Rule in 2016 referenced the DSM-5’s definition of the term “sex.” 81 FR at 31429.
50 NIH Guidance, Consideration of Sex as a Biological Variable in NIH‐funded Research at 1 (2017),
https://orwh.od.nih.gov/sites/orwh/files/docs/NOT-OD-15-102_Guidance.pdf.
35
in clinical trials, the SABV policy also includes rigorous preclinical experimental designs
that inform clinical research.”
In 2014, the Department’s Office of Refugee Resettlement (ORR) published an
Interim Final Rule51 which adopted a biologically based definition of “sex” that was distinct
from gender identity, to implement section 1101(c) of the Violence Against Women
Reauthorization Act of 2013.52 In setting forth standards and procedures to prevent, detect,
and respond to sexual abuse and sexual harassment involving unaccompanied alien
children in ORR's care provider facilities, the rule defines “sex” as “a person’s biological
status and is typically categorized as male, female, or intersex.” 45 CFR § 411.5. The
definition notes that “[t]here are a number of indicators of biological sex, including sex
chromosomes, gonads, internal reproductive organs, and external genitalia.” Id. The
regulation gives a separate definition for “gender identity” as “one’s sense of oneself as a
male, female, or transgender.” Id. The rule then uses these terms differently, setting forth
protections and policies concerning “sex,” distinct from those protections and policies
concerning “gender” or “gender identity.”53 The definitions section of the ORR regulation
states “‘Gender’ refers to the attitudes, feelings, and behaviors that a given culture
51 ORR Final Rule, Standards to Prevent, Detect, and Respond to Sexual Abuse and Sexual Harassment
Involving Unaccompanied Children, 79 FR 77767 (Dec. 24, 2014).
52 See 127 Stat. 61 (Violence Against Women’s Act reauthorization).
53 Compare, e.g., 45 CFR § 411.14 (“Care provider facilities must not search or physically examine a UC for the
sole purpose of determining the UC's sex. If the UC's sex is unknown, it may be determined during
conversations with the UC, by reviewing medical records, or, if necessary, learning that information as part of
a broader medical examination conducted in private by a medical practitioner.”) with § 411.41(c) (“Only
trained staff are permitted to talk with UCs to gather information about their sexual orientation or gender
identity, prior sexual victimization, history of engaging in sexual abuse, mental health status, and mental
disabilities for the purposes of the assessment required under paragraph (a) of this section.”).
36
associates with a person’s biological sex.” 45 CFR § 411.5 In the preamble to the rule, ORR
added, “This term [‘gender’] is not to be confused with ‘sex,’ as defined [elsewhere in the
rule].” 79 FR at 77771.
In 2015, the Office of the National Coordinator for Health Information Technology
(ONC) promulgated regulations54 that included standards and requirements for coding
certain health data. The regulations contained data sets for “sex,” separate from those for
“gender identity” and “sexual orientation.” See 45 CFR § 170.207(n) (“sex”); § 170.207(o)
(“sexual orientation and gender identity”). In its preamble, ONC explained that it did not
adopt a separate category for “assigned birth sex” because “we already require the
capturing of birth sex as described under the ‘‘sex’’ section above.” 55 Furthermore, ONC
stated that questions about patients’ gender identity and sexual orientation “have not yet
been scientifically validated for use in health care settings” and, thus, it did not adopt
54 ONC Final Rule, 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015
Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program
Modifications, 80 FR 62601 (Oct. 16, 2015); see also 80 FR 76868 (Dec. 11, 2015) (making technical
corrections and clarifications).
55 80 FR at 62619. Requiring health care entities to code as male all persons who self-identify as male,
regardless of biology, may lead to adverse health consequences. See, e.g., Daphne Stroumsa, Elizabeth F.S.
Roberts, et al., “The Power and Limits of Classification – A 32 Year Old Man with Abdominal Pain,” New
England Journal of Medicine (May 16, 2019), https://www.ncbi.nlm.nih.gov/pubmed/31091369; Marilynn
Marchione, “Blurred Lines,” Associated Press (May 15, 2019),
https://apnews.com/b5e7bb73c6134d58a0df9e1cee2fb8ad (identification of pregnant transgender person
as male in medical records contributed to stillbirth of child).
37
them.56 However, ONC added that, although not required, providers can separately code
“gender identity”57 and “sexual orientation”58 if they opt to include such questions.59
OCR itself has adopted different interpretations of “on the basis of sex” under
Section 1557. In 2012, the then-OCR Director announced in a letter60 that OCR was
accepting and investigating complaints of discrimination on the basis of “actual or
perceived sexual orientation or gender identity” under Section 1557. Three years later,
OCR changed its position and declined to include sexual orientation (unlike gender
identity) as a per se protected class throughout the Section 1557 rulemaking process. See
Proposed Rule, 81 FR 54176 (Aug. 15, 2015) (“Current law is mixed on whether existing
Federal nondiscrimination laws prohibit discrimination on the basis of sexual orientation
as a part of their prohibitions of sex discrimination”); Final Rule, 81 FR 31390 (May 18,
2016) (“OCR has decided not to resolve in this rule whether discrimination on the basis of
an individual’s sexual orientation status alone is a form of sex discrimination.”). It appears
that OCR’s letter in 2012 was the first time any HHS component departed from a binary and
biological understanding of sex for purposes of sex discrimination and adopted a definition
that included gender identity or sexual orientation.
d. Pending Federal Litigation Over Section 1557 Regulation, Title IX, and Title VII
56 80 FR at 62620.
57 Options under the category “gender identity” were “Male”, “Female, transgender male/Trans man/Female-
to-male,” “Transgender female/Trans woman/Male-to-female,” “Genderqueer, Neither exclusively male nor
female,” “Additional gender category/(or other), please specify,” or “Decline to answer.”
58 Options under the category “sexual orientation” were “Straight or heterosexual,” “Lesbian, gay, or
homosexual,” “Bisexual,” “Something else, please describe,” or “Don’t know.”

59 80 FR at 62620.
60 See 81 FR 31387, n.57.
38
In addition to Franciscan Alliance in the U.S. District Court for the Northern District
of Texas and Sisters of Mercy in the U.S. District Court for the District of North Dakota, other
Federal courts have gender identity discrimination cases, filed under Section 1557, pending
on their dockets. See Tovar v. Essentia Health, 342 F. Supp. 3d 947 (D. Minn. Sept. 20, 2018)
(on remand from 8th Cir.); Boyden v. Conlin, 341 F. Supp.3d 979 (W.D. Wis. 2018) (appealed
to 7th Cir., No. 3:18-3408 and No. 18-3485, on Nov. 9, 2018); Flack v. Wisconsin Department
of Health Services, 328 F. Supp.3d 931(W.D. Wis. 2018) (pending motion for class
certification); Smith v. Highland Hospital of Rochester, No. 17-CV-6781-CJS (W.D.N.Y. filed
Oct 2, 2018) (appealed to 2d Circuit on Nov. 6, 2018); Prescott v. Rady Children’s Hospital‐
San Diego, 265 F.Supp.3d 1090 (S.D. Cal. Sept. 27, 2017) (protective order granted on Nov.
6, 2018); Edmo v. Idaho Dept. of Correction, No. 1:17-cv-00151, 2018 WL 2745898 (D. Id.
filed Oct. 9, 2018) (motion to stay pending February 13, 2019); Enstad v. Peacehealth, No.
2:17-cv-01496-RSM (W.D. Wash. filed Oct. 5, 2017) (granted stay of litigation on Sept. 24,
2018); Robinson v. Dignity Health, No. 16-CV-3035 YGR, 2016 WL 7102832 (N.D. Cal. filed
Dec. 6, 2016) (on remand from U.S. Supreme Court).
Some Federal courts have declined to recognize gender identity discrimination
claims under Title IX, and instead deferred to U.S. Supreme Court to settle the legal
question. See, e.g., Evancho v. Pine‐Richland School District, 237 F. Supp.3d 267, 299 (W.D.
Pa. February 27, 2017) (“what makes the current legal landscape even more unsettled is
that the Supreme Court is currently poised to grapple with these very issues”). While four
39
appellate courts have addressed the issue, 61 a large volume of district court opinions have
been inconsistent on the issue. See Texas v. United States, 201 F. Supp. 3d 810 (N.D. Tex.
2016) (holding that Title IX does not prohibit discrimination based on gender identity or
transgender status); Johnston v. Univ. of Pittsburgh, 97 F. Supp. 3d 657 (W.D. Pa. 2015); but
see Adams v. School Board of St. Johns County, 318 F. Supp. 3d 1293 (M.D. Fla. 2018)
(recognizing gender identity discrimination claim under Title IX); A.H. v. Minersville Area
School District, 290 F. Supp. 3d 321 (M.D. Pa. 2017). Appellate courts have also been split
over the legal question whether discrimination on the basis of gender identity is prohibited
by Title VII. Compare Etsitty v. Utah Transit Auth., 502 F.3d 1215, 1220-1221 (10th Cir.
2007) with Mitchell v. Kallas, No. 15-cv-108 (7th Cir. 2018). On April 22, 2019, the U.S.
Supreme Court granted three petitions for writs of certiorari, raising the question whether
Title VII’s prohibition on discrimination on the basis of sex also bars discrimination on the
basis of gender identity or sexual orientation. 62 Because Title IX adopts the substantive and
legal standards of Title VII, 63 a holding by the U.S. Supreme Court on the definition of “sex”
61 See, e.g., Doe ex rel. Doe v. Boyertown Area Sch. Dist., 893 F.3d 179 (3d Cir.), slip op. 23-31, vacated on reh’g,
897 F.3d 515 (3d Cir.), and superseded by 897 F.3d 518 (3d Cir. 2018); Whitaker ex rel. Whitaker v. Kenosha
Unified Sch. Dist. No. 1 Bd. of Educ., 858 F.3d 1034, 1046-54 (7th Cir. 2017), cert. dismissed, 138 S. Ct. 1260
(2018); G.G. ex rel. Grimm v. Gloucester Cnty. Sch. Bd., 822 F.3d 709, 720-723 (4th Cir. 2016), vacated and
remanded, 137 S. Ct. 1239 (2017); Dodds v. U.S. Dept. of Education, 845 F.3d 217 (6th Cir. 2016). Portions of
two of these opinions have been vacated. See Gloucester Cnty. Sch. Bd. v. G.G. ex rel. Grimm, 137 S. Ct. 1239
(2017) (vacating court of appeals’ decision in light of agency guidance); Doe ex rel. Doe v. Boyertown Area Sch.
Dist., 897 F.3d 518, 533-36 (3d Cir. 2018) (superseding opinion omitting portion of original opinion discussed
in the petition, which was vacated on rehearing); cf. Doe, 893 F.3d 179, slip op. 23-31 (vacated opinion).
62 Bostock v. Clayton County, 723 Fed. Appx. 964 (11th Cir. 2018), cert granted, No. 17-1618 (U.S. Apr. 22,
2019); Altitude Express, Inc. v. Zarda, 883 F.3d 100 (2d Cir. 2018), cert granted, No. 17-1623 (U.S. Apr. 22,
2019); Equal Employment Opportunity Commission v. R.G. & G.R. Harris Funeral Homes, Inc., 884 F.3d 560 (6th
Cir. 2018), cert granted, No. 18-107 (U.S. Apr. 22, 2019),
https://www.supremecourt.gov/orders/courtorders/042219zor 9olb.pdf.
63 See DOJ, Title IX Legal Manual (August 6, 2015), https://www.justice.gov/crt/title-ix.
40
under Title VII will likely have ramifications for the definition of “sex” under Title IX, and
for the cases raising sexual orientation or gender identity claims under Section 1557 and
Title IX which are still pending in district courts. 64
e. HHS’s Inconsistency with Other Federal Agencies
From 1972 to the present, no Title IX regulation from any agency explicitly defined
“sex” to include “gender identity.” All of the Title IX regulations of all agencies which
adopted such regulations – including, as noted above, HHS’s Title IX regulations – use the
term in a binary and biological sense, and include phrases such as “male and female,” and
“one sex” and “the other sex.”65 Currently, HHS is the only Federal agency with a regulation
defining “sex” under Title IX (in its Section 1447 Regulation) as inclusive of gender identity.
However, starting in 2012, two other agencies—the Department of Justice (DOJ), and the
Department Education (ED)—took enforcement actions, issued guidance, or took litigating
positions that discrimination on the basis of sex under certain anti-discrimination statutes
included “gender identity.” See ED, Office for Civil Rights, Questions and Answers in Title IX
64 Compare Etsitty v. Utah Transit Auth., 502 F.3d 1215 (10th Cir. Sept. 20, 2007) (Title IX does not prohibit
gender identity discrimination); and Texas v. United States, 201 F. Supp. 3d 810 (N.D. Tex. Aug. 21, 2016) with
Doe ex rel. Doe v. Boyertown Area Sch. Dist., 893 F.3d 179 (3d Cir.), slip op. 23-31, vacated on reh’g, 897 F.3d
515 (3d Cir.), and superseded by 897 F.3d 518 (3d Cir. 2018); Whitaker ex rel. Whitaker v. Kenosha Unified Sch.
Dist. No. 1 Bd. of Educ., 858 F.3d 1034, 1046-1054 (7th Cir. 2017) (interpreting Title IX and Equal Protection
Clause), cert. dismissed, 138 S. Ct. 1260 (2018); and G.G. ex rel. Grimm v. Gloucester Cnty. Sch. Bd., 822 F.3d 709,
720-723 (4th Cir. 2016), vacated and remanded, 137 S. Ct. 1239 (2017).
65 See, e.g., Department of Education Title IX regulation at 34 CFR § 106.2(s), § 106.7, § 106.17(b)(2), §
106.21(c)(4), § 106.31(c), § 106.32(b)(2) and (c)(2), § 106.33, § 106.37(a)(3), § 106.41(b) and (c), §
106.55(a), § 106.58(a) and (b), § 106.60(b), and § 106.61; Department of Justice Title IX regulation at 28 CFR
§ 54.105, § 54.130, § 54.230(b)(2), § 54.235(b)(3), § 54.300(c)(4), § 54.400(c), § 54.405(b)(2) and (c)(2), §
54.410, § 54.430(a)(3), § 54.450(b) and (c)(2), § 54.520(a), § 54.535(a) and (b), § 54.545(b), and § 54.550.
See also DOJ Coordination and Compliance Division, Title IX Regulations by Agency,
https://www.justice.gov/crt/fcs/Agency_Regulations#2.
41
and Single Sex Elementary and Secondary Classes and Extracurricular Activities (2014) 66;
ED and DOJ joint Dear Colleague Letter on Transgender Students (May 13, 2016) (Title IX
guidance); Complaint, United States v. McCrory, No. 5:16-cv-238-BO (M.D.N.C. filed May 9,
2016) (DOJ Title IX lawsuit challenging a North Carolina law concerning transgender access
to intimate facilities at State university). The Department proposed (and then finalized) its
definition to be consistent with the policy positions, sub-regulatory guidance, and
enforcement actions of ED and DOJ. 67
The earlier interpretations have now been taken under review, dismissed,
preliminarily enjoined, or revoked outright. See Franciscan Alliance, Inc., et al. v. Burwell, et
al., 227 F. Supp. 3d 660, 696 (N.D. Tex. 2016) (nationwide preliminary injunction against
the Section 1557 regulation); Texas, et al. v. United States, et al., 201 F. Supp. 3d 810, 836
(N.D. Tex. 2016) (preliminarily enjoining ED’s Title IX interpretation); Dear Colleague
Letter (Feb. 22, 2017) (ED and DOJ’s withdrawal of the May 13, 2016 Dear Colleague
Letter); Stipulated Joint Notice of Dismissal, United States v. State of North Carolina, No.
1:16-cv-425 (M.D.N.C. May 4, 2017) (dismissing, with prejudice, the DOJ lawsuit
challenging the North Carolina law).
As noted above, in Franciscan Alliance, DOJ submitted a brief on behalf of HHS, in
response to plaintiffs’ motions for summary judgment, on April 5, 2019. The brief stated
66 http://www2.ed.gov/about/offices/list/ocr/docs/faqs-title-ix-single-ex201412.pdf.
67 See 81 FR at 31388-31389.
42
that Section 1557’s prohibition on sex discrimination “unambiguously excludes
discrimination on the basis of gender identity.”68
The Department proposes to repeal the novel definition of “sex” in the Section 1557
regulation in order to make the Department’s regulations implementing Title IX through
the Section 1557 Regulation more consistent with the Title IX regulations of other Federal
agencies. The Department further believes this proposed rule avoids different
interpretations of the same statute by multiple agencies, and promotes consistent
expectations and enforcement.
f. Need for Consistency with the Department of Justice on Implementation and
Enforcement of Nondiscrimination Laws
In 1980, the President delegated to the Attorney General the responsibility to lead
the coordination of consistent and effective implementation of cross-cutting
nondiscrimination laws, including Title VI, Title IX, and Section 504. 69 The Department,
along with each other Executive Agency, is required to cooperate with DOJ and issue its
implementing regulations consistent with the requirements prescribed by the Attorney
General, unless prohibited by law.70
In court briefs and otherwise on behalf of the United States, DOJ has stated that the
ordinary meaning of the word “sex” for purposes of Federal nondiscrimination laws does
Alliance, No. 7:16-cv-00108-O, p. 11 (N.D. Tex, filed April 5, 2019).
69 Executive Order 12250, Leadership and Coordination of Nondiscrimination Laws, Secs. 1-201(a) through
(c), 45 FR 72995 (Nov. 2, 1980).

70Executive Order 12250 at Secs. 1-401 through 1-402.
43
not encompass sexual orientation or gender identity. On April 5, 2019, DOJ filed a brief on
behalf of HHS in the Franciscan Alliance case stating that “the relevant provisions of Title IX
and Section 1557 unambiguously exclude gender-identity discrimination.” 71 Similarly, in a
July 26, 2017 amicus curiae brief in a Second Circuit case regarding the prohibition of sex
discrimination in employment under Title VII of the Civil Rights Act of 1964, DOJ stated,
“‘[i]n common, ordinary usage in 1964—and now, for that matter—the word ‘sex’ means
biologically male or female.’”72
Consistent with this position, a few months later, the Attorney General issued a
memorandum stating that “‘sex’ is ordinarily defined to mean biologically male or female”
and that “Congress has confirmed this ordinary meaning by expressly prohibiting, in
several other statutes, ‘gender identity’ discrimination, which Congress lists in addition to,
rather than within, prohibitions on discrimination on the basis of ‘sex’ or ‘gender.’” 73 The
memorandum concluded, “Title VII’s prohibition on sex discrimination encompasses
discrimination between men and women but does not encompass discrimination based on
gender identity per se, including transgender status. Therefore, as of the date of this
memorandum … the Department of Justice will take that position in all pending and future
matters….”
72 See also DOJ Brief for the United States as Amicus Curiae, p. 4, in Zarda v. Altitude Express, Inc., 883 F.3d 100
(2d Cir. July 26, 2017) (quoting dissent in Hively v. Ivy Tech Community College, 853 F.3d 339, 362 (7th Cir.
2017)); DOJ Brief in Support of Defendants’ Motion to Dismiss at 2-6, U.S. Pastor Council v. EEOC, No. 4:18-cv-
00824-O (N.D. Tex. Dec. 17, 2018).
73 Memorandum of the Attorney General (Oct. 4, 2017),
https://www.justice.gov/ag/page/file/1006981/download.
44
DOJ also took that position on October 24, 2018, when it submitted a brief to the U.S.
Supreme Court in another Title VII case in which a petition for a writ of certiorari was filed.
DOJ argued that “Title VII does not define the term ‘sex,’ so the term should ‘be interpreted
as taking [its] ordinary, contemporary, common meaning.’ When Title VII was enacted in
1964, ‘sex’ meant biological sex; it ‘refer[red] to [the] physiological distinction[ ]’ between
‘male and female.’ Title VII thus does not apply to discrimination against an individual
based on his or her gender identity. Notably, Congress has specifically prohibited
discrimination based on ‘gender identity’ in other statutes, as a separate protected category
in addition to ‘sex’ or ‘gender.’ It has not included similar language in Title VII as originally
enacted in 1964 or in any amendment in the 54 years since.” 74
Nevertheless, because the Section 1557 Regulation’s gender identity provisions
remain, public confusion persists. To ensure that its civil rights regulations are consistent
with the views of the Department of Justice, other Federal agencies, and internally, the
Department proposes to repeal the definition of “on the basis of sex” that had been adopted
in its Section 1557 Final Rule. Because of the likelihood that the Supreme Court will be
addressing the issue in the near future,75 the Department declines, at this time, to propose
74 DOJ, Brief for the Federal Respondent in Opposition to Petition for Writ of Certiorari in R.G. & G.R. Harris
Funeral Homes, Inc. v. Equal Employment Opportunity Commission, et al., No. 18-107, 16-18 (Oct. 2018)
(citations omitted).
75 See Bostock v. Clayton County, 723 Fed. Appx. 964 (11th Cir. 2018), cert granted, No. 17-1618 (U.S. Apr. 22,
2019); Altitude Express, Inc. v. Zarda, 883 F.3d 100 (2d Cir. 2018), cert granted, No. 17-1623 (U.S. Apr. 22,
2019); Equal Employment Opportunity Commission v. R.G. & G.R. Harris Funeral Homes, Inc., 884 F.3d 560 (6th
Cir. 2018), cert granted, No. 18-107 (U.S. Apr. 22, 2019),
https://www.supremecourt.gov/orders/courtorders/042219zor 9olb.pdf.
45
its own, definition of “sex” for purposes of discrimination on the basis of sex in the
regulation.
g. Sensitive Balancing of Competing Interests at the Local Level
The adoption of a definition of “sex” in the Section 1557 Regulation may stifle the
ability of States, local governments, and covered entities to set their own policies and
balance multiple competing interests on questions related to gender dysphoria. Because
Title IX and Section 1557 get their constitutional authority from the Spending Clause,
according to the Supreme Court, it is appropriate that it be exercised with respect for State
sovereignty:
[L]egislation enacted pursuant to the spending power is much in the nature

of a contract: in return for federal funds, the States agree to comply with
federally imposed conditions. The legitimacy of Congress’ power to legislate
under the spending power thus rests on whether the State voluntarily and
knowingly accepts the terms of the “contract.” See Steward Machine
Co. v. Davis, 301 U. S. 548, 585-598 (1937); Harris v. McRae, 448 U. S. 297
(1980). There can, of course, be no knowing acceptance if a State is unaware
of the conditions or is unable to ascertain what is expected of it. Accordingly,
if Congress intends to impose a condition on the grant of federal moneys, it
must do so unambiguously. Cf. Employees v. Department of Public Health and
Welfare, 411 U. S. 279, 285 (1973); Edelman v. Jordan, 415 U. S. 651 (1974).
By insisting that Congress speak with a clear voice, we enable the States to
exercise their choice knowingly, cognizant of the consequences of their
participation.
Pennhurst State School and Hospital v. Halderman, 451 U.S. 1, 17 (1981); see also National
Federation of Independent Business v. Sebelius, 567 U.S. 519, 588 (2012) (“Congress has no
authority to order the States to regulate according to its instructions. Congress may offer
the States grants and require the States to comply with accompanying conditions, but the
States must have a genuine choice whether to accept the offer”) (opinion of Roberts, C.J.,
46
joined by Breyer and Kagan, JJ.). The Department’s broad reinterpretation of “sex” under
Title IX affected States’ ability to accept these restrictions knowingly as they came long
after states became heavily reliant on the continued receipt of Federal funds subject to Title
IX requirements.
This proposed rule would significantly restore the ability of States to establish
policies in this area, based on their weighing the competing interests at stake. This
proposed rule is not intended to remove any protection that Congress has provided by
statute, including Title IX, or to deny States the ability to provide protections that exceed
those required by Title IX. Rather, the proposed rule would ensure that the Department’s
Title IX and corresponding Section 1557 regulations follow the will of Congress with
respect to the States by not expanding Title IX’s definition of “sex” beyond the statutory
bounds.
C. The Costs of the Final Rule Were Unnecessary and Unjustified.
The Department has determined that the Section 1557 Regulation imposed
substantially larger regulatory burdens than predicted, a result inconsistent with the
policies of this Administration. In his first day in office, President Donald Trump issued
Executive Order 13765, identifying it as Administration policy to “minimize the
unwarranted economic and regulatory burdens of the [Patient Protection and Affordable
Care] Act, and prepare to afford the States more flexibility and control to create a more free
and open healthcare market.” This Executive Order states that “the Secretary of Health and
Human Services (Secretary) and the heads of all other executive departments and agencies
47
(agencies) with authorities and responsibilities under the [PPACA] shall exercise all
authority and discretion available to them to waive, defer, grant exemptions from, or delay
the implementation of any provision or requirement of the [PPACA] that would impose a
fiscal burden on any State or a cost, fee, tax, penalty, or regulatory burden on individuals,
families, healthcare providers, health insurers, patients, recipients of healthcare services,
[or] purchasers of health insurance.” President Trump has also issued two further
Executive Orders directing executive agencies to relieve the regulatory burden and reduce
regulatory costs across the Federal government. 76
1. The Section 1557 Regulation Imposed Substantially Higher Regulatory Costs Than
Predicted.
The Department has concluded, based on its independent assessment of the
evidence, that the costs and burdens imposed by the Section 1557 Regulation are
substantially larger than originally anticipated. The Final Rule requires covered entities to
post and disseminate to beneficiaries, enrollees, and the public, detailed notices of
nondiscrimination that include information on how individuals with disabilities may
receive auxiliary aids and services and how LEP individuals may receive translated
documents or oral interpretation. 45 CFR § 92.7. The Department estimated that this notice
requirement would impose approximately $3.6 million of costs in the first year of
compliance and zero for the following four years. In calculating this cost, the Department
76Executive Order 13771 on Reducing Regulation and Controlling Costs (Jan. 30, 2017); Executive Order
13777 on Enforcing the Regulatory Reform Agenda (Feb. 24, 2017); see also Executive Order 13563 on
Improving Regulation and Regulatory Review, 76 FR 3821 (Jan. 21, 2011).
48
counted the employee time required to initially download, print, and post notices in public
areas, but did not count the recurring costs of paper, ink/toner, and additional postage for
the required initial or subsequent mailings of these notices. 81 FR 31453, 31458.
The Final Rule additionally requires covered entities to provide to beneficiaries,
enrollees, and others, “taglines” describing the availability of free language assistance
services. The Final Rule requires these taglines be written in “at least the top 15 languages”
spoken by LEP individuals in the relevant State or States. 45 CFR § 92.8(d)(1). The
Department estimated that the taglines requirement would cost the same as the notice of
nondiscrimination requirement, namely, $3.6 million in the first year and zero over the
following four years. 81 FR 31453, 31458. Again, as with notices, the Department counted
the employee time required to initially download, print, and post taglines, but did not count
the recurring costs of paper, ink/toner, and additional postage for the required initial or
subsequent mailings of taglines. 81 FR 31453.
The Department did not fully appreciate the volume of mail inserts the combined
notice and tagline provisions would require. The Final Rule requires notices of
nondiscrimination and taglines be appended to all “significant” publications and
communications (bigger than a postcard or brochure) sent by covered entities to
beneficiaries, enrollees, applicants, or members of the public. 45 CFR § 92.8(f)(1). The Final
Rule’s preamble explained that “significant communications” include “not only documents
intended for the public . . . but also written notices to an individual, such as those pertaining
to rights or benefits.” 81 FR 31402. Many health insurance issuers reasonably interpreted
49
the Section 1557 Regulation as requiring that they provide the notice and taglines to their
subscribers in nearly every written communication, including every time the issuer
processes a claim and, as a consequence, issues a beneficiary an Explanation of Benefits.
Many of these matters were discussed in DOJ’s 2002 and HHS’s 2003 LEP guidance
documents. The LEP guidance documents flagged concerns about “unrealistic”
interpretations of translating written materials into languages when recipients serve
communities in large cities or across the country and serve LEP persons who speak dozens
and sometimes over 100 different languages. 67 FR 41455, 41463 (June 18, 2002) (DOJ
guidance); 68 FR 47311, 47319 (Aug. 8, 2003) (HHS guidance). Furthermore, with the
recognition that there could be large numbers of documents in need of translation into
dozens of languages, the LEP guidance documents advised that recipients could start with
several of the more frequently encountered languages and set benchmarks for continued
translations into the remaining languages over time. 67 at 41463 (DOJ); 68 FR at 47319
(HHS). By contrast, the Section 1557 Regulation set an effective date of July 18, 2016—only
60 days after promulgation of the final rule. The Section 1557 Regulation used the vague
term “significant” to identify documents to which providers must append translated tagline
notices. See 45 CFR § 92.8(g). However, the Department’s long-standing LEP guidance
discussed translation of “vital” documents, with the acknowledgement that “[c]lassifying a
document as vital or non-vital is sometimes difficult” because the health care context is so
fact-specific, depending on “the importance of the program, information, encounter, or
50
service involved, and the consequence to the LEP person if the information in question is
not provided accurately or in a timely manner.” 68 FR at 47318 (HHS guidance).
In practice, the notices and taglines requirement results in the inclusion of one to
two sheets of paper (which may be double-sided) per each significant communication
mailed by a covered entity.
Data collected from covered entities, and the Department’s independent analysis,
illustrate the financial impact of the notice and tagline requirements. One covered health
insurance issuer, which sends over 42 million Explanations of Benefits for one of its health
plans to enrollees each year, states that it was required to add 2-5 pages of disclosure
content to each letter or document, and estimates the incremental cost of printing, paper,
and postage alone to be approximately $8 million per year. 77 That covered health insurance
issuer also reported that another of its health plans, which communicates with enrollees 50
to 90 times per year, estimated that it is spending approximately $14 million annually on
printing and postage for notice and tagline requirements.78 A third plan reported that its
costs for taglines were $802,000 for the last quarter of 2016 and were projected to be $2.4
million in 2017.79 Another large plan estimates it will spend $4-5 million per year to
comply with these requirements.80
A pharmacy benefit managers (PBM) trade association has reported similar effects
of the Section 1557 Regulation. It estimates that PBMs process over three billion
77 Source: Aetna health plan representatives (April 13, 2017).

78 Source: Aetna health plan representatives (May 1, 2017).
79 Source: Aetna (April 10, 2017).
80 Source: UnitedHealth Group (April 10, 2017).
51
prescriptions per year, with each prescription requiring multiple “significant”
communications be sent to beneficiaries (such as explanations of benefits, refill reminders,
drug safety information, and other notices), many of which are sent by mail. The trade
association estimates that this amounts to between 1 and 4.8 billion notices and taglines
mailed per year at approximately $0.50 to $1 in additional printing and postage costs per
communication. Thus, according to the trade association, these requirements have cost
PBMs from $500 million to nearly $5 billion per year. 81 The high costs that health insurance
issuers, health plans, and the members of a PBM trade association have reported about the
costs resulting from the notice and tagline provisions of the Final Rule prompted the
Department to reevaluate the requirement and its associated benefits and burdens.
As discussed further in the Regulatory Impact Analysis of this proposed rule, and
based on the Department’s independent analysis, the Department concludes that its
original assessment of $7.2 million in one-time notice and tagline-related costs
underestimated the actual costs associated with including nondiscrimination notices and
taglines in significant communications and publications.
The Department now estimates that the burden from the notice and taglines
requirement ranges from $147 million (low-end) to $1.34 billion dollars (high-end) in
annual costs before accounting for electronic delivery, as described below. These estimates
are a function of multiplying the low and high per-unit cost of including a
nondiscrimination notice and tagline insert ($0.035/per unit to $0.32/per unit) by the
81 Source: Pharmaceutical Care Management Association (May 2, 2017).
52
volume of significant communications and publications to which covered entities are
required to attach the notice and taglines. The Regulatory Impact Analysis explains the
calculations underlying these estimates in detail. The Department uses an average of the
low- and high-end estimates, and adjusts for electronic delivery, to arrive at an average
savings of $0.632 billion per year which totals approximately $3.16 billion over five years.
The Regulatory Impact Analysis explains the assumptions, rationale, and calculations for
this weighted average.
2. The Section 1557 Regulation’s Burdens Are Not Justified by Need.
The Department does not believe that the regulatory burdens of the Section 1557
Regulation, either as originally anticipated or as now more correctly estimated, are
justified. The Department stated in the Final Rule that, apart from burdens related to the
Final Rule’s definition of discrimination “on the basis of sex” and provisions concerning
language access plans,82 “we do not anticipate that covered entities will undertake new
actions or bear any additional costs in response to the issuance of the regulation” because
the Final Rule applies “pre-existing requirements” that have applied to regulated entities
“for years.” 81 FR 31446. Indeed, the Department noted in the preamble to the Final Rule
82Language access plans are meant to assist covered entities in fulfilling their obligations to provide LEP
individuals meaningful access to services provided by the covered entity. Although the Final Rule did not
require covered entities to develop a language access plan, the Rule stated that the development and
implementation of a language access plan is a factor the Director “shall” take into account when evaluating
whether an entity is in compliance with Section 1557. 45 CFR § 92.201(b)(2). The Department anticipated
that 50% of covered entities would develop and implement a language access plan following issuance of the
Final Rule. 81 FR at 31454.
53
that, following the passage of Section 1557 in 2010, the Department’s Office for Civil Rights
(OCR) complaint workload had increased only “slightly.” 81 FR 31458.
These facts call into question the need for both the $942 million in costs to the
public over five years that the Department originally anticipated, 81 FR 31459, and the
additional approximately $3.2 billion in notice and tagline compliance costs of which the
Department is now aware.
Several factors suggest that the extraordinary burdens imposed by the notice and
tagline requirements in particular are not justified by need. First, those requirements are
difficult for covered entities to implement because of other differing and overlapping
requirements already imposed by the Federal government (with respect to Federal health
care programs such as Medicare), and by many States (with respect to State-regulated
health insurance), concerning language access. 83
83 E.g., 42 U.S.C. 300gg-15(b)(2) and 300gg-19(a)(1)(B) (requiring standards for ensuring that the Summaries
of Benefits and Coverage and certain notices are provided in a culturally and linguistically appropriate
manner); 42 U.S.C. 1396d(p)(5)(A) (requiring HHS to distribute to States an application form for Medicare
cost-sharing in English and 10 non-English languages); 26 CFR § 1.501(r)-4(a)(1), (b)(5)(ii) (requiring a
hospital organization to translate certain documents, among other requirements, to qualify for a tax-exempt
status with respect to a hospital facility); 42 CFR § 422.2262(a)(1)-(2) and § 422.2264(e) (setting forth
Medicare Advantage marketing requirements, which include requiring Medicare Advantage organizations to
translate marketing materials into non-English languages spoken by 5% or more of individuals in a plan
service area), § 423.2262(a)(1)-(2) and § 423.2264(e) (setting forth Medicare Part D marketing
requirements, which include requiring Part D plan sponsors to translate marketing materials into non-
English languages spoken by 5% or more of individuals in a plan service area); 45 CFR § 155.205(c)(2)(iii)(A)
(Marketplaces must post taglines on their websites and include taglines in documents “critical for obtaining
health insurance coverage or access to health care services through a QHP”); 45 CFR § 147.136(e)(2)(iii) and
(e)(3), and § 147.200(a)(5) (requiring taglines in languages in which 10% of individuals with limited English
proficiency (LEP) county-wide are exclusively literate on internal claims and appeals notices and on an
issuer’s Summary of Benefits and Coverage); 42 CFR § 435.905(b)(3) (requiring individuals to be “informed
of the availability of language services . . . and how to access . . . [them] through providing taglines in non–
English languages indicating the availability of language services”); 42 CFR § 457.340(a) (applying certain
Medicaid requirements, including § 435.905(b)(3), which requires individuals to be “informed of the
54
Second, the Department has heard from multiple stakeholders that the repetitive
nature of the notices and taglines in communications and publications dilutes the message
contained in significant communications to the point that some recipients may be
disregarding the information entirely.84
Third, the Department has learned that many beneficiaries of Federal and other
health programs do not want to receive extra pages of information they have seen many
times before out of environmental concerns or annoyance. 85 Aetna, one of the largest
health insurance issuers in the United States, surveyed 322 enrollees by showing them a
sample document with 4 pages of taglines; 75% of the enrollees reacted negatively
(referring to the taglines as “wasteful,” “confusing,” “unintelligible,” “incomprehensible,”
“inefficient,” among others), 50% said they would be less likely to carefully read documents
from their insurer if they had taglines, and about one third said they would be less likely to
open mail from an insurer if taglines were included in each document. 86
Fourth, the Department has received little evidence of more beneficiaries seeking
language assistance as a result of the requirements that caused these increased burdens.
Health plans report, anecdotally, that there has been no increase in the number of calls to
availability of language services . . . and how to access . . . [them] through providing taglines in non–English
languages indicating the availability of language services”); 210 Illinois Cons. Stat. 87/1 (Illinois Language
Assistance Act).
84 Sources: Aetna, “Member Reactions to 1557 Taglines” (Apr. 2017); American Health Insurance Plans and
Blue Cross Blue Shield Association (May 5, 2017); Pharmaceutical Care Management Association (May 2,
2017).
85 Sources: Aetna (May 1, 2017); Pharmaceutical Care Management Association (Mar. 27, 2017); American
Health Insurance Plans and Blue Cross Blue Shield Association (May 5, 2017).
86 Source: Aetna, “Member Reactions to 1557 Taglines” (Apr. 2017).
55
their language lines requesting oral interpretation or written translation services since the
notice and tagline requirements became effective in October 2016. 87 One plan reported
lower numbers after the tagline requirement—it received 98,800 calls during the period
between January and March 2016, but only 91,800 during the same time period in 2017. 88
Since the Final Rule, some pharmacy benefit managers report having received a handful of
calls to their anti-discrimination grievance line, some have noticed an increase in their
translation line call volume, some have noticed no change in call volume, and others have
seen a decrease, but they report that, as a group, they have received significantly more
complaints about providing too many notices, as compared to requests for translation
assistance.89
Fifth, the Department has found little evidence showing that repeatedly mailing all
beneficiaries taglines with 15 or more languages is an efficient use of covered entities’
resources when the overwhelming majority of beneficiaries speak English (with Spanish
being a distant second). According to Census statistics, as of 2015, over three-quarters
(79%) of the U.S. population over age 18 speaks only English at home, followed by Spanish
(12.5%).90 Additionally, of persons selecting a language preference when registering for
coverage on the HealthCare.gov platform for 2017, 89.93% selected English, followed by
87 Sources: Pharmaceutical Care Management Association (Mar. 27, 2017); American Health Insurance Plans
and Blue Cross Blue Shield Association (May 5, 2017).
88 Source: Aetna (May 1, 2017).
89 Source: Pharmaceutical Care Management Association (Mar. 27, 2017).
90 U.S. Census Bureau, American FactFinder, “B16007: Age by Language Spoken at Home for the Population 5
Years and Over,” 2011 – 2015 American Community Survey (2017),

https://factfinder.census.gov/bkmk/table/1.0/en/ACS/16_5YR/S1601/0100000US.
56
8.36% who selected Spanish.91 This data suggests that, for the large majority of people who
receive them, the required language tagline mailings provide little to no benefit (and
potentially impose burdens) because they are already proficient English speakers with
little need for, and no entitlement under the law to, translation services.
Sixth, confusion over the notices has resulted in an increased volume of mistaken
inquiries on the Department’s public phone line.92 OCR’s toll-free phone number, available
to file civil rights complaints, is listed at the bottom of the Notice of Nondiscrimination. See
Appendix A to Part 92 (Sample Notice Informing Individuals About Nondiscrimination and
Accessibility Requirements and Sample Nondiscrimination Statement: Discrimination Is
Against the Law). However, recipients of the notices often misunderstand it to be the phone
number to call when they have questions to ask their health insurance issuer or health care
provider. The majority of phone calls to the OCR complaint line do not concern civil rights
matters at all. This experience indicates that many members of the public do not fully read
the non-discrimination notice or are confused because it is attached to other information
sent to them by their providers or issuers. The result has been a significant waste of OCR
resources with respect to its complaint line and a commensurate waste of time for callers.
91 CMS, “Race, Ethnicity, and Language Preference in the Health Insurance Marketplaces 2017 Open
Enrollment Period,” (April 2017), https://www.cms.gov/About-CMS/Agency-
Information/OMH/Downloads/Data-Highlight-Race-Ethnicity-and-Language-Preference-Marketplace.pdf.
California and New York were not included in the analysis as they do not use the HealthCare.gov platform.
92 Between November 26, 2018 and April 2, 2019, OCR’s Call Center received 983 calls on the complaint line
from individuals who actually wanted to speak to their insurance company, not OCR, in order to raise billing
questions, report a change of address, request a replacement insurance card, seek a reimbursement check, or
make a payment.
57
The Department’s proposal to substantially replace the Section 1557 Regulation
with the existing framework for protection of civil rights laws, while expressly addressing
language access issues in this proposed rule, will better strike the balance between the
government’s interest in ensuring meaningful access to covered healthcare programs for
LEP individuals and the burdens imposed on regulated entities in support of that interest.
III. Nondiscrimination in Health Programs or Activities
This proposed rule would substantially replace the Section 1557 Regulation. The
provisions proposed for retention, revision, and repeal are as follows:
A. Provisions of the Proposed Section 1557 Rule at 45 CFR Part 92
The proposed rule would more faithfully fulfill the Department’s congressional
mandate. In Section 1557 of the PPACA, Congress applied long-standing nondiscrimination
requirements to any health programs or activities that receive Federal financial assistance,
or programs or activities administered by an Executive agency under Title I of the PPACA
or any entity established under such Title I. It did so by cross-referencing the categories of
protected classifications listed in those longstanding civil rights laws, namely,
discrimination on the basis of race, color, national origin, sex, age, or disability. To ensure
compliance, Congress dictated that “[t]he enforcement mechanisms provided for and
available under” such laws “shall apply for purposes of violations of” Section 1557. The
Department now proposes to fulfill this Congressional mandate by applying the
enforcement mechanisms already provided for, and available under, existing statutes and
their implementing regulations, including the rights and remedies under such laws.
58
Based on its review, and the preliminary injunction issued by the court in Franciscan
Alliance that held parts of the Final Rule exceeded the Department’s authority under the
PPACA, the Department has determined that (in addition to exceeding its statutory
authority) parts of the regulation are duplicative, unduly burdensome, and confusing to the
regulated community. This proposed rule, accordingly, would substantially replace 45 CFR
Part 92 with provisions in keeping with the plain language of Section 1557, while
continuing to codify certain provisions regarding covered entities’ obligations with respect
to language and disability access. This will ensure better compliance with the mandates of
Congress, avoid further litigation, relieve regulatory burdens, reduce confusion, reduce
uncertainty about the scope of Section 1557, promote substantive compliance, and improve
the consistency of regulatory requirements between entities required to comply with the
civil rights laws as a result of Section 1557 and those directly subject to only to the
underlying civil rights laws.
The proposed rule would be divided into two subparts: Subpart A on General
Provisions (consistent with the current regulation), and Subpart B on Specific Applications
to Health Programs or Activities. The Department proposes to replace §§ 92.1 through 92.3,
92.5, 92.6, and 92.101 of the current rule with provisions addressing Section 1557’s
purpose, nondiscrimination requirements, scope of application, enforcement mechanisms,
relationship to other laws, and meaningful access for LEP individuals.
The Department’s proposal does not change the provision to submit assurances of
compliance with Section 1557 at § 92.5, designated as § 92.4. In addition, the Department
59
would retain, but redesignate (to adjust to the proposed restructuring in the rule) the
provisions on voluntary acceptance of language assistance services (§ 92.201(g)), effective
communication for individuals with disabilities (§ 92.202), accessibility of buildings and
facilities (§ 92.203), accessibility of information and communication technology (§ 92.204),
and the requirement to make reasonable modifications (§ 92.205).
Although the proposed rule would eliminate the definitions section in the Section
1557 Regulation, the Department proposes to retain many key definitions explicitly in
other sections or through incorporation by reference to relevant statutes or regulations.
For example, as discussed below, proposed § 92.3 (Scope of application) will define the
scope of “health program or activity.” Proposed § 92.3 also effectively defines “covered
entities” similar to the Final Rule by clarifying that the rule applies to: (1) every health
program or activity, any part of which is receiving Federal financial assistance (including
credits, subsidies, or contracts of insurance) provided or made available by the
Department; (2) any program or activity administered by the Department under Title I of
the PPACA; or (3) any program or activity administered by any entity established under
such Title. Furthermore, consistent with the text of Section 1557, proposed § 92.2 and §
92.3 provide that “Federal financial assistance” includes credits, subsidies, or contracts of
insurance.
The proposed rule uses the same characteristics as are included in the definitions of
“qualified interpreter” for an LEP individual and of “qualified translator” in describing the
requirements that an interpreter and translator, respectively, should meet (but omits the
60
word “qualified” which is implied by the context). See proposed § 92.101(b)(3)(i) & (ii).
The proposed rule also retains nearly verbatim, as requirements with respect to the
provision of language access services, the characteristics used to define “language
assistance services.” See proposed § 92.101(b)(2).
Additionally, the proposed rule retains most of the disability-rights related
definitions from the current rule either explicitly, such as the definitions of “disability” and
“information and communication technology;” by using the definition to describing the
requirements or characteristics of the entity, such as when describing a “qualified
interpreter” for an individual with a disability; or by referencing underlying regulations or
statutes, such as for technical accessibility standards and definitions.
In other cases, some terms are clear enough to obviate the need for further
definition given the context of the proposed rule including terms such as “age,” “individual
with limited English proficiency,” “qualified bilingual/multilingual staff,” or “individual
with a disability.” In these examples, OCR will continue to interpret the phrases naturally
and consistent with the Final Rule.
The Department will also continue to abide by terms defined in the definitions
sections of the implementing regulations for the underlying statutes. In fact, the
Department believes it is generally more appropriate to rely on individual definitions
applicable to individual statutes incorporated into Section 1557 as opposed to picking one
standard (or creating a new one) and making it applicable in all cases, as under the Final
Rule.
61
This proposed section describes the core substantive requirements of compliance
with Section 1557 under the proposed regulation. Namely, the Department proposes to
provide that, except as otherwise provided by Title I of the PPACA, an individual shall not
be excluded from participation in, be denied the benefits of, or be subjected to
discrimination under, any health program or activity, any part of which is receiving Federal
financial assistance (including credits, subsidies, or contracts of insurance) provided by the
Department, or under any program or activity administered by the Department under such
Title, or under any program or activity administered by any entity established under such
Title, on any grounds prohibited under the following statutes:
(1) Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.) (race, color,
national origin);
(2) Title IX of the Education Amendments of 1972 (20 U.S.C. 1681 et seq.) (sex);
(3) the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.) (age); or
(4) Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794) (disability).
The cross-reference to existing civil rights statutes does not change the prohibited
grounds of discrimination, but applies them, to the extent they did not already apply, to the
health care context. Thus, for example, the cross-referencing of Title IX (which prohibits
sex discrimination in education programs or activities) in Section 1557 and in the proposed
regulation means that sex discrimination, as defined by Title IX, is prohibited in health
programs or activities to which this proposed part applies, not merely health programs or
63
activities related to education. This proposed section would replace current § 92.2 in its
entirety.
In keeping with the text of Section 1557, proposed § 92.2 would apply to health
programs or activities receiving Federal financial assistance, “including credits, subsidies,
or contracts of insurance.”
Although Section 1557 prohibits discrimination by any program “administered by
an Executive Agency,” the Final Rule itself acknowledged the difficulty of the Department
enforcing the rule with respect to programs administered by other agencies. 93 Many other
agencies have their own rules implementing the underlying statutes incorporated in
section 1557. See, e.g. 65 FR 52857 (Title IX common rule for 21 Federal agencies). HHS,
therefore, proposes to continue the general limitation on the rule’s scope found in the Final
Rule, specifically, that the proposed rule not assert or encompass enforcement jurisdiction
over entities receiving Federal financial assistance administered by another agency under
Section 1557.
The current regulation, however, departed from this general principle by defining
Federal financial assistance to include assistance that HHS “does not have primary
responsibility for administering,” but merely “plays a role” in providing or administering.
81 FR 31384; 45 CFR § 92.4. This gloss goes beyond the text of Section 1557, which, in
relevant part, only covers certain programs or activities “administered” by the Department,
93In the preamble to the Final Rule, the Department acknowledged its limited ability to regulate programs
covered by other agencies. 81 FR at 31379 (“Drafting a rule applicable to health programs and activities
assisted by other Departments would pose numerous challenges”).
64
not any program in which the Department “plays a role in administering.” In keeping with
the text of Section 1557, the proposed regulation would not retain the “plays a role”
language. As a result, the proposed rule would no longer cover issuers of Exchange plans
solely on the basis that HHS plays a role in administering tax credits, also administered by
the Internal Revenue Service. 94 Exchange plans, however, may still be subject to
antidiscrimination enforcement by the Department under Section 1557 on other grounds,
or under other antidiscrimination authorities. For example, qualified health plans (QHPs)
sold on the Exchanges established under Title I of the PPACA are subject to Section 1557,
and the issuers of QHPs are subject to regulation by the Department’s Center for Consumer
Information and Insurance Oversight, of the Centers for Medicare & Medicaid Services.
The Department seeks specific comment on the proposed elimination of the “plays a
role” language.
The Final Rule applies to “every health program or activity administered by the
Department; and every health program or activity administered by a Title I entity.” 45 CFR
§ 92.2. But Section 1557, with respect to the administration of programs by the Department
and PPACA’s Title I entities, does not include the term “health.” Rather Section 1557 applies
to “any program or activity” administered by the Department or any entity established
under Title I of the PPACA.
94In the preamble to the Final Rule, the Department acknowledged its limited ability to regulate programs
covered by other agencies. 81 FR at 31379 (“Drafting a rule applicable to health programs and activities
assisted by other Departments would pose numerous challenges”). Additionally, the Department has not
applied the Final Rule to the risk adjustments program (Section 1343 of the PPACA), and does not propose to
do so in this proposed rule. See also 45 CFR § 153.310 (risk adjustment administration).
65
The Department added the health limitation to the current rule because it did not
believe Section 1557 was intended to apply to every program or activity administered by
every Executive agency whether or not it had any relation to health. Accordingly, the
preamble to the Final Rule stated it covered health programs administered by CMS, HRSA,
CDC, Indian Health Service (IHS), and SAMHSA (for example, IHS tribal hospitals and clinics
operated by the Department and the National Health Service Corps) but not any human
services programs administered by the Department. 81 FR 31446. The Department
continues to believe that Congress did not provide such expansive coverage, but believes
that Section 1557 itself already provides a meaningful limitation without resort to inserting
the word “health” when Congress did not do so, Section 1557 specifies that it applies to any
program or activity administered by the Department (or other Executive Agency) “under
this title,” meaning Title I of the PPACA. To be consistent with the text as passed by
Congress, the proposed § 92.2 would apply to any program or activity administered by the
Department under Title I of the PPACA and any program or activity administered by any
entity established under such Title. Entities established under Title I of the PPACA include
the health insurance exchanges established pursuant to the PPACA. Such exchanges
currently include the 12 State Exchanges, 5 State Exchanges on the Federal platform, and
34 Federally-facilitated Exchanges. Title I additionally establishes, among other things,
State advisory councils concerning community health insurance (section 1323).
The Department seeks public comment on the impact of this language, including on
mechanisms for identifying affordable health insurance coverage options (Sec. 1103), the
66
wellness program demonstration project (Sec. 1201, adding Public Health Service (PHS)
Act Section 2705(l)), and the provision of community health insurance options (Sec. 1323).
Proposed “45 CFR § 92.3 Scope of application.”
This proposed section would clarify that the scope of application of the proposed
rule would be consistent with the Civil Rights Restoration Act (CRRA), which defined the
scope of the underlying civil rights laws based on whether or not an entity receiving
Federal financial assistance is or is not principally engaged in the business of providing
health care.
Proposed § 92.3 clarifies the scope of entities covered by the rule by specifying that
the rule applies to: (1) any health program or activity, any part of which is receiving
Federal financial assistance (including credits, subsidies, or contracts of insurance)
provided by the Department; (2) any program or activity administered by the Department
under Title I of the PPACA; or (3) any program or activity administered by any entity
established under such Title. Furthermore, as provided in Section 1557 of the PPACA 95 and
in proposed § 92.2, the Department interprets “Federal financial assistance” in the
proposed rule to apply to credits, subsidies, or contracts of insurance.
With respect to entities receiving Federal financial assistance, the current regulation
defines the operation of a “health program or activity” to cover “all [] operations” of such
entities when they are principally engaged in providing or administering “health services
9542 U.S.C. 18116(a) (Section 1557 applies to recipients of Federal financial assistance for contracts of
insurance).
67
or health insurance coverage or other health coverage.” 45 CFR § 92.4. The CRRA, however,
defined “program or activity” under Title VI, the Rehabilitation Act, the Age Act, and Title IX
to cover all the operations of entities only when they are “principally engaged in the
business of providing education, health care, housing, social services, or parks and
recreation.” Pub. L. 100-259, 102 Stat. 28 (Mar. 22, 1988) (emphasis added).
“Health insurance” is distinct from “health care.” Compare 5 U.S.C. 5371 (“‘health
care’” means direct patient-care services or services incident to direct patient-care
services”) with 42 U.S.C. 300gg-91 (“The term ‘health insurance coverage’
means benefits consisting of medical care (provided directly, through insurance or
reimbursement, or otherwise and including items and services paid for as medical
care) under any hospital or medical service policy or certificate, hospital or
medical service plan contract, or health maintenance organization contract offered by
a health insurance issuer.”).96 The Final Rule, however, went beyond the CRRA by covering
all the operations of entities that are principally engaged in providing “health insurance
coverage or other health coverage,” even if they are not principally engaged in the business
of providing “health care,” despite there being nothing in Section 1557 indicating any
abrogation – or extension – of the CRRA. 97
96 See also 45 CFR § 160.103 (HIPAA administrative simplification) (“Health care means care, services, or
supplies related to the health of an individual. Health care includes, but is not limited to, the following: (1)
Preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care, and counseling, service,
assessment, or procedure with respect to the physical or mental condition, or functional status, of an
individual or that affects the structure or function of the body; and (2) Sale or dispensing of a drug, device,
equipment, or other item in accordance with a prescription.”).
97 The preamble to the Final Rule acknowledges the relevance of the CRRA, 81 FR at 31386, but does not
explain how the provision of “health care” covers the provision of “health insurance, even if only part of the
health program or activity receives such assistance.”
68
Therefore, to provide further clarity on these issues and return to the CRRA’s
statutory text, proposed § 92.3 would explicitly incorporate the CRRA standard. The
Department also believes this approach is an appropriate interpretation of the phrase
“health program or activity.” If an entity is principally engaged in the business of health
care, the Department proposes to interpret Section 1557 so that all operations of that
entity would be deemed part of any “program or activity” it engages in, any part of which
receives Federal financial assistance. If, on the other hand, an entity is not principally
engaged in the business of health care, the Department proposes to interpret Section 1557
so that only the operation for which it receives Federal financial assistance is part of the
“program or activity.”
Specifically, the proposed section would set forth the general applicability standard
from Section 1557: that it applies to any health program or activity, any part of which is
receiving Federal financial assistance administered by the Department, including credits,
subsidies, or contracts of insurance, or under any program or activity that is administered
by the Department or any entity established under Title I of the PPACA.
Further, the Department proposes that § 92.3 provide that the regulation would
cover all of the operations of any entity that receives Federal financial assistance from the
Department and that is principally engaged in the business of providing health care, as part
of a “health program or activity.” For any entity not principally engaged in the business of
providing health care, “health program or activity” under the proposed regulation would
69
apply to such entity’s operations only to the extent any such operations receive Federal
financial assistance.
Finally, the proposed section would clarify that, for purposes of the rule, an entity
principally or otherwise engaged in the business of providing health insurance shall not, by
virtue of such provision, be considered to be principally engaged in the business of
providing health care.
The proposed regulation would not apply to entities that do not receive Federal
financial assistance from the Department. Likewise, as discussed above concerning the
CRRA, the Department proposes that where entities receive Federal financial assistance but
are not principally engaged in the business of providing health care, the regulation would
not apply to the components or activities of those entities that do not receive Federal
financial assistance. If an entity, such as a health insurance issuer, receives Federal financial
assistance from the Department to further a health program or activity but is not
principally engaged in the business of providing health care, the proposed regulation
would apply to the entity’s specific operations which receive Federal financial assistance
from the Department, but it would not apply to the entity’s entire operations. 98 Thus, for
example, the proposed rule would generally not apply to short term limited duration
insurance (STLDI) because, as the Department understands it, providers of STLDI are
98Compare with Grove City College v. Bell, 465 U.S. 555(1984) (holding that receipt of Federal financial aid
does not automatically trigger institution-wide coverage under Title IX) abrogated in part by the CRRA.
70
either (1) not principally engaged in the business of health care, or (2) not receiving
Federal financial assistance with respect to STLDI plans specifically. 99
Under the proposed section, examples of entities principally engaged in the business
of providing health care would include hospitals, nursing facilities, hospices, community
health centers, and physical therapists. Examples of recipients of Federal financial
assistance from the Department for health programs or activities would include
laboratories, medical schools, and nursing schools. Examples of recipients of Department
assistance for contracts of insurance would include Medicare Part C (Medicare Advantage).
The proposed rule would not apply to Medicare Part B (except to the extent
participation in a health care program is required for engaging in other operations), 100 or
self-funded group health plans under the Employee Retirement Income Security Act of
1974 (ERISA), Federal Employees Health Benefits (FEHB) Program, or STLDI plans because
(or to the extent) such programs do not receive Federal financial assistance from HHS
and/or the entities operating them are not principally engaged in the business of providing
health care as discussed above.
99 The Public Health Service Act expressly excludes STLDI from its definition of “individual health coverage,”
and the PPACA does not deem short term limited duration insurance to be qualifying coverage under the
PPACA’s minimum essential coverage requirements. 42 U.S.C. 300gg–91(b)(5); 26 U.S.C. 5000A; see also 83
FR 38212 (Aug. 3, 2018) (rule clarifying definition of short-term, limited-duration insurance to Departments
of Treasury, Labor, and Health and Human Services regulations at 26 CFR § 54.9801-2, 29 CFR § 2590.701-2,
and 45 CFR § 144.103).
100 The Department believes that the Federal financial assistance does not include Medicare Part B under the
Social Security Act. See 2 CFR § 200.40(c) (Uniform Administrative Requirement, Cost Principles, and Audit
Requirements for Federal Awards); 45 CFR § 75.502(h) (Uniform Administrative Requirement, Cost
Principles, and Audit Requirements for HHS Awards).
71
The Department seeks public comment on issues related to the scope of coverage
under the proposed rule, including whether it should define “health care” in the rule
according to the statutes cited above defining the term, whether it should define “recipient”
according to the current rule or by incorporation by reference to definitions in the
underlying statutes, and whether such a definition of recipient should include
subrecipients.
Proposed “45 CFR § 92.4 Assurances.”
The Department contemplates retaining current § 92.5, requiring covered entities to
submit an assurance of compliance with Section 1557 to the Department without change,
but proposes to redesignate it as § 92.4. Subsection (a) requires applicants for the
Department’s Federal financial assistance for health programs or activities, health
insurance issuers seeking certification to participate in an Exchange, and States seeking
approval to operate State Exchanges to submit assurances that the health program or
activity will comply with Section 1557 and its regulation. Subsection (b) clarifies that
assurances of compliance with Section 1557 apply to the period during which Federal
financial assistance is extended, or the applicable property is used, owned or possessed.
Subsection (c) requires that assurances with Section 1557 must be contained in covenants
running with applicable property, interest, and land transfers from the Department. The
source of these provisions is the Department’s Section 504 regulations, and while Section
72
504 regulations have more detail, they do not have major substantive requirements that
differ from their Title IX, Title VI, or Age Act regulations.101
The Department proposes to retain the assurance provisions and identify “Section
1557” on a consolidated assurance form with Title VI, Title IX, Section 504, and the Age Act
to include major applicable civil rights laws and require all applicable covered entities to
submit the assurance. The Department believes keeping Section 1557 on a consolidated
form ensures that the insurance industry and States are aware that these Federal civil
rights laws currently apply to them.
The Department seeks comment on whether it is appropriate to retain the
requirement to submit an assurance of compliance with Section 1557 to the Department,
or whether it unnecessarily duplicates requirements in the underlying regulations to
provide such assurances of compliance to the Department.
Proposed “45 CFR § 92.5 Enforcement mechanisms.”
This proposed section would ensure that even under the proposed rule’s repeal of
certain provisions of the Section 1557 Regulation, the enforcement mechanisms provided
for, and available under, Title VI of the Civil Rights Act of 1964, Title IX of the Education
Amendments of 1972, the Age Discrimination Act of 1975, or Section 504 of the
Rehabilitation Act of 1973, and the Department’s implementing regulations, shall apply for
purposes of enforcement of Section 1557. Other than as proposed in the conforming
amendments discussed in Part IV, the proposed rule would not repeal or otherwise amend
101 Compare 45 CFR § 84.5 (Section 504) with 45 CFR § 86.4 (Title IX); § 80.4(a) (Title VI), § 91.33 (Age Act).
73
the regulations implementing and enforcing Title VI at 45 CFR Parts 80 and 81, Title IX at
45 CFR Part 86, Section 504 at 45 CFR Parts 84 and 85, and the Age Act at 45 CFR Parts 90
and 91.
The proposed § 92.5 also designates the Director of the Department’s Office for Civil
Rights to receive complaints, conduct compliance reviews, and otherwise investigate and
take enforcement actions with respect to allegations of discrimination in violation of
Section 1557 under this part.102
Proposed “45 CFR § 92.6 Relationship to other laws.”
The Department proposes § 92.6, to define the relationship of the regulation to
other laws with more specificity than the current sections titled “Application” (§ 92.2) and
“Relationship to other laws” (§ 92.3). The Department proposes to combine the substance
of these two sections into a new § 92.6. It would set forth the text of Section 1557(b) nearly
verbatim, and state that nothing in the proposed regulation shall be construed to invalidate
or limit the rights, remedies, procedures, or legal standards available to individuals
aggrieved under Title VI of the Civil Rights Act of 1964, Title VII of the Civil Rights Act of
1964, Title IX of the Education Amendments of 1972, the Age Discrimination Act of 1975,
or Section 504 of the Rehabilitation Act of 1973, or to displace additional protections under
State antidiscrimination laws.
102 The Office of Personnel Management (OPM) handles of claims alleging discrimination in the Federal
Employees Health Benefits (FEHB) Program. OPM is charged by Federal statute with offering FEHB plans as a
fringe benefit of Federal employment and, in that role, approves benefit designs and premium rates, sets rules
generally applicable to FEHB carriers, adjudicates and orders payment of disputed health claims, and adjusts
policies as necessary to ensure compliance with nondiscrimination standards.
74
The proposed section would also specify that the proposed regulation not be
applied in a manner that conflicts with or supersedes exemptions, rights, or protections
contained in several civil rights statutes, including those just mentioned, the Architectural
Barriers Act of 1968,103 the Americans with Disabilities Act of 1990 (as amended by the
Americans with Disabilities Act Amendments Act of 2008), 104 Section 508 of the
Rehabilitation Act of 1973,105 and statutes protecting conscience and religious freedom.
Although the Section 1557 Regulation incorporated exemptions to Title VI, Section
504, and the Age Act,106 it did not incorporate abortion,107 religious,108 and other109
exemptions contained in Title IX. The Final Rule considered the question of explicitly
incorporating the Title IX religious exemption in the Section 1557 Regulation, but declined,
instead providing that, “[i]nsofar as the application of any requirement under this part
103 42 U.S.C. 4151 et seq.

104 42 U.S.C. 12181 et seq.
105 29 U.S.C. 794d.
106 See 45 CFR § 92.101(c) (The exceptions applicable to Title VI apply to discrimination on the basis of race,
color, or national origin under this part. The exceptions applicable to Section 504 apply to discrimination on
the basis of disability under this part. The exceptions applicable to the Age Act apply to discrimination on the
basis of age under this part. These provisions are found at §§ 80.3(d), 84.4(c), 85.21(c), 91.12, 91.15, and
91.17–.18 of this Subchapter.”)
107 “Nothing in this title shall be construed to require or prohibit any person, or public or private entity, to
provide or pay for any benefit or service, including the use of facilities related to an abortion….” Pub. L. 100-
259, 102 Stat. 28 (Mar. 22, 1988) (codified at 20 U.S.C. 1688).
108 20 U.S.C. 1681(a)(3) (providing that the prohibition of discrimination on the basis of sex “shall not apply to
an educational institution which is controlled by a religious organization if the application of this subsection
would not be consistent with the religious tenets of such organization”); see also 45 CFR § 86.12 (Title IX
exemption for educational organizations controlled by religious organizations).
81 FR 31435 (HHS declines to include a religious exemption in Section 1557).
109 20 U.S.C. 1681(a)(6)(B) (Title IX exemption for voluntary youth service organizations); 1686 (separate
living facilities); 45 CFR § 86.33 (exemption for separate toilet, locker room, and shower facilities).
75
would violate applicable Federal statutory protections for religious freedom and
conscience, such application shall not be required.”
The Franciscan Alliance court stated that the Department’s failure to incorporate
statutory exemptions “nullifies Congress's specific direction to prohibit only the ground
proscribed by Title IX.” Franciscan Alliance, 227 F. Supp. 3d at 690-691 (citations omitted).
The Franciscan Alliance court held that there was a likelihood that plaintiffs would prevail
on the claim that “[t]he Rule's failure to include Title IX's religious exemptions renders the
Rule contrary to law.” 110
In its April 5, 2019, brief in Franciscan Alliance, DOJ, on behalf of HHS, stated that the
prohibition on sex discrimination under Section 1557 “unambiguously includes Title IX’s
exemptions, including those addressing religion and abortion.” 111 This statement
represents the Department’s own further consideration of this issue, guided by DOJ’s
pronouncements on Title VII and Title IX. The Department believes that its enforcement of
Title IX, and its enforcement of Section 1557 (to the extent it incorporates Title IX), must be
constrained by the statutory contours of Title IX, which include explicit abortion and
religious exemptions and which should be set forth more clearly than in the Final Rule. 112
In the Department’s view, Section 1557 did not override any statutes protecting
conscience or civil rights, and the exemptions thereto, and it is appropriate to specify that
110 227 F. Supp. 3d at 690-91.

112 As discussed further below, HHS also proposes to amend its underlying Title IX regulation to include the
statutory abortion and religious exemptions explicitly.
76
the Section 1557 Regulation will not be implemented in violation of those laws. Indeed,
Section 1303 of the PPACA states that nothing in the PPACA shall be construed to require
qualified health plans to cover abortions as an essential health benefit (42 U.S.C.
18023(b)(1)(A)(i)) and “[n]othing in this Act shall be construed to have any effect on
Federal laws regarding—(i) conscience protection; (ii) willingness or refusal to provide
abortion; and (iii) discrimination on the basis of the willingness or refusal to provide, pay
for, cover, or refer for abortion or provide or participate in training to provide abortion”
(42 U.S.C. 18023(c)(2)(A)). With respect to Section 1303 of the PPACA, this language is
contained in a provision labeled “NO EFFECT ON FEDERAL LAWS REGARDING ABORTION”
and is in a section that dealing with “special rules” about abortion. However, the language
(“conscience protections”) is not limited to abortion.
In light of the PPACA’s text and structure and the experience of the Franciscan
Alliance litigation, the proposed section would incorporate by reference statutory
exemptions and protections concerning religious and abortion exemptions with greater
clarity than the Final Rule’s § 92.2(b)(2) which currently states that, “[i]nsofar as the
application of any requirement under this part would violate applicable Federal statutory
protections for religious freedom and conscience, such application shall not be required.”
This current provision would be amended and replaced by the proposed § 92.6
which provides that, “[i]nsofar as the application of any requirement under this part would
violate, depart from, or contradict definitions, exemptions, affirmative rights, or
77
protections provided by any of the[se] statutes [ ] . . . or any related, successor, or similar
Federal laws or regulations, such application shall not be imposed or required.”
Additionally proposed § 92.6 would explicitly identify and incorporate protections
from specific religious freedom, conscience, and nondiscrimination statutes—42 U.S.C.
18113 (Section 1553 of the Patient Protection and Affordable Care Act); 42 U.S.C. 2000bb et
seq. (the Religious Freedom Restoration Act, which applies to “all Federal law . . . unless
such law explicitly excludes such application”); 42 U.S.C. 238n (the Coats-Snowe
Amendment); 42 U.S.C. 300a-7 (the Church Amendments); the Weldon Amendment (e.g.,
Consolidated Appropriations Act of 2019, Pub. L. 115-245, Div. B, sec. 506(d) (Sept. 28,
2018)); and related conscience provisions in appropriations law (e.g., Consolidated
Appropriations Act of 2019, Pub. L. 115-245, Div. B. sec. 506) (Sept. 28, 2018)).
Proposed “Subpart B—Specific Applications”
Proposed “45 CFR § 92.101 Meaningful access for individuals with limited English
proficiency.”
The Department proposes to redesignate § 92.201, on providing meaningful access
for individuals with limited English proficiency (LEP), as § 92.101 and, as so redesignated,
to amend the provision to more closely align with the Department’s 2003 LEP guidance.
In proposed subsection (a), the Department sets forth the governing standard for
the provision of meaningful access to programs and activities receiving Federal financial
assistance based on the U.S. Supreme Court decision of Lau v. Nichols, 414 U.S. 563 (1974),
which interprets Title VI’s prohibition of discrimination on the basis of “national origin” in
78
the context of LEP individuals . Subsection (a) also incorporates language from the
Department of Justice’s and HHS’s LEP guidance documents. See 67 FR 41455 (June 18,
2002) (DOJ Guidance to Federal Financial Assistance Recipients Regarding Title VI
Prohibition Against National Origin Discrimination Affecting Limited English Proficient
Persons); 68 FR 47311 (Aug. 8, 2003) (HHS Guidance to Federal Financial Assistance
Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting
Limited English Proficient Persons).
Proposed paragraph (a) would adopt the standard from DOJ’s and HHS’s LEP
guidance by specifying that any entity operating or administering a health program or
activity subject to this rule shall take reasonable steps to ensure meaningful access to such
programs or activities by limited English proficient individuals. Because Section 1557
applies to a broader scope of entities than only recipients of federal financial assistance, the
Department proposes to use “entity” rather than “recipient” which retains the
nomenclature used in the current rule with respect to LEP access.
Adopting this language would apply the same standard to both health and human
services within the Department, and conform to the other Federal agencies who follow
DOJ’s LEP guidance, consistent with its civil rights coordinating authority. This standard is
also consistent with Department’s LEP guidance.113 This provision is proposed to replace
11368 FR 47312 (Aug. 8, 2003) (HHS LEP guidance) (stating that “Title VI and its implementing regulations
require that recipients take reasonable steps to ensure meaningful access by LEP persons.” See also 67 FR
41455 (June 18, 2002) (DOJ LEP Guidance); Executive Order 13166 on Improving Access to Services for
Persons with Limited English Proficiency, 65 FR 50121 (Aug. 16, 2000) (directing all Federal agencies to
develop LEP guidance consistent with DOJ’s LEP guidance).
79
the current rule’s provision which requires that reasonable steps to provide meaningful
access be provided to each LEP individual eligible to be served or likely to be
encountered.114
Proposed paragraph (b) would likewise adopt the four factors from the
Department’s existing LEP guidance to assist entities in determining the extent of a covered
entity's obligation to provide language assistance services. The Department proposes to
clarify that the starting point for OCR’s exercise of its enforcement discretion would be an
individualized case-by-case assessment that balances the following four factors: (1) the
number or proportion of LEP individuals eligible to be served or likely to be encountered in
the eligible service population; (2) the frequency with which LEP individuals come in
contact with the entity’s health program, activity, or service; (3) the nature and importance
of the entity’s health program, activity, or service; and (4) the resources available to the
entity and costs. 68 FR at 47314-15 (HHS guidance); accord 67 FR at 41459-60 (factors
from DOJ’s 2002 LEP guidance).115 By using the factors as written in the Department’s LEP
114 45 CFR § 92.201(a). But see 68 FR 47312, 47314 (Aug. 8, 2003) (HHS LEP guidance) (stating that
recipients may conclude that “in certain circumstances” recipient-provided language services are not
necessary).
115 The Department notes that, in both its LEP guidance and in the Department of Justice’s LEP guidance,
language in factor (1) also refers to LEP persons rather than individuals, refers to the number of those
persons served or encountered rather than those eligible to be served or likely to be encountered, and refers
to those served or encountered by the program or grantee rather than in the eligible service population. .
Likewise, language in factor (3) refers to the nature and importance of the program, activity, or service
provided by the program to people’s lives. The Department believes that these variations in descriptions of
the factors have the same meaning, but asks for comment on which formulation of these factors it should use
for purposes of this rulemaking.
80
Guidance, the proposed rule would use the same factors in health care that already apply to
all of the Department’s programs, including human services.
Although the current Section 1557 Regulation states that it applies to individuals
“eligible to be served or likely to be encountered,” 116 it did not explicitly address factors
such as the number or proportion of LEP individuals, the frequency of contact, the
resources available, or the costs identified in the Department’s LEP guidance. 117
Additionally the Final Rule newly required the OCR Director to take into account whether a
covered entity had developed and implemented an effective written language access plan
in evaluating compliance.118 By contrast, the HHS LEP Guidance had stated that
“[r]ecipients with very few LEP persons and recipients with very limited resources, may
choose not to develop a written LEP plan.” 68 FR 47320. The Department also stated in its
guidance that recipients have “alternative and reasonable ways to articulate” how they are
providing meaningful access to LEP individuals besides through written language access
plans. Id.
Because of these departures from the Department’s LEP guidance, the Department
anticipated that 50% of covered entities would develop language access plans subsequent
to the finalization of the Section 1557 Regulation, amounting to a total annualized cost of
$84.1 million over five years (undiscounted). 81 FR 31459.
116 45 CFR § 92.201(a).

117 But see 45 CFR § 92.201(b) (including a catchall allowing the Director to “take into account other relevant
factors”).
118 See 45 CFR § 92.201(a).
81
The Department seeks comment on this proposed provision with respect to how
health care providers would articulate their responsibilities under the proposed rule and
comment on any related costs or cost savings.
Next, the Department retains § 92.201(c) through (e) and (g) from the current rule,
but proposes to redesignate these provisions as § 92.101(b)(2) through (4) and (c), with
the proposed clarifying revision that these obligations, which are applicable to specific
language services, would apply only to the extent necessary to comply with the standard
articulated in (a) (which is consistent with the HHS LEP guidance), as informed by the
entity’s individualized assessment of the four factors. In general, language assistance
services, if required to be offered by an entity, must be no-cost, timely, and accurate. If the
standard requires an entity to offer translators or interpreters, they must also meet specific
minimum qualifications, including ethical principles, confidentiality, proficiency, effective
interpretation, and ability to use specialized terminology as necessary in the health care
setting. The proposed paragraph also provides a list of other types of “language assistance
services” to mirror the definition of the phrase under the current rule, with the exception of
taglines, which the Department no longer believes constitute the actual provision of a
service, as opposed to the notification of the availability of services.
Like the current rule, when interpretation services are required by the rule, the
proposed rule would prohibit an entity from requiring a LEP individual to bring his or her
own interpreter or rely on a minor child or accompanying adult to facilitate
communication, except under limited exceptions.
82
Finally, the Department proposes to redesignate § 92.201(f),which identified
specific technical and training requirements for use of video remote interpreting services
for LEP individuals, as § 92.101(b)(3)(iii), and, as so designated, to revise the provision. In
§ 92.201(f), the Department extended the application of the Americans with Disabilities Act
regulatory definition of “video remote interpreting services” which requires video that is
high quality, real-time, full-motion large, sharply delineated, and that does not transmit
blurry or grainy images. See 45 CFR § 35.160. Although individuals with hearing
impairments rely on accurately seeing sign language interpreters (and the proposed rule
retains these access standards for persons who are deaf or hard of hearing), foreign
language speakers can, in many circumstances, rely solely on a clear audio transmission for
effective communication. Given that equipment and training costs for more sophisticated
video remote interpreting technology can be more expensive than audio, 119 the
Department believes that additional video standards may not justify the costs, particularly
with respect to small providers.120
The Department seeks comment on the extent to which covered entities rely on
video remote interpreting for LEP individuals, circumstances where a clear video signal (as
119See Barb Jacobs, Anne M. Ryan, et al., Medical Interpreters in Outpatient Practice, 16:1 Annals of Family
Medicine 70-76 (Jan. 2018), https://doi.org/10.1370/afm.2154 (stating that costs can be “considerable,”
ranging from $1.25 to $3.00 per minute for audio interpreters, and $1.95 to 3.49 per minute for video
interpreters, sometimes with minimum number of minutes required per session. Setup costs for video remote
interpreting equipment vary, depending on whether a laptop, desktop, or cameras, speakers and
microphones are used”).
120 Christopher M. Burkle, Kathleen A. Anderson, et al., Assessment of the efficiency of language interpreter
services in a busy surgical and procedural practice, BMC Health Services Research 17:456 (2017),
https://doi.10.1186/s12913-017-2425-7 (“With increasing numbers of LEP patients over time along with
any new mandates for providing language assistance, the financial implications for many health care facilities
will likely continue to be a challenge”).
83
opposed to audio) would be necessary for effective communication, the applicable costs of
this service, and whether such standards improve the effectiveness of communication.
Consequently the Department proposes to repeal certain provisions on video standards for
remote language interpretation services, but retain the audio standards which require
clear, audible transmission of voices, use of quality video connection without lagging or
irregular pauses in transmission, and applicable training of staff to use the remote
interpreting technology.
Finally, paragraph (c), by retaining the provision currently found at § 42.201(g),
would clarify that Section 1557 does not require patients to accept the language access
services offered by a provider.
In its proposed revisions to its meaningful access requirements, the Department
attempts, in accordance with Supreme Court guidance, to strike an appropriate balance
with respect to the Title VI rights of LEP individuals and the burdens imposed on the
regulated community. The Department believes that its proposal – in what it proposes to
retain, and in what it proposes to revise – strikes the right balance and provides benefits
greater than the burdens imposed. The Department nevertheless seeks comment on
whether it has struck that proper balance with respect to benefits and burdens.
The Department seeks comment particularly in light of the proposed retention of
some provisions that impose requirements on covered entities under the Section 1557
Regulation (which govern health programs or activities) but not on entities who only
receive HHS funding for human services. Specifically, on whether there is or will continue
84
to be problems, confusion or further complexity in implementing the regulations arising
from differing standards, and if so, what could or should be done to address such
problems/issues, including the possibility of amending the Department’s Title VI
regulation.
The Department retains several key definitions with respect to LEP services. The
proposed rule incorporates, as requirements with respect to interpreters and translators,
the elements of the definitions of “qualified interpreter” for an individual with LEP and of
“qualified translator” in the text of the rule. See proposed § 92.101(b)(3). In other cases,
some terms are clear enough so as to not require a definition, such as “individual with
limited English proficiency.” In this example, OCR will continue to interpret the phrase as
under the Final Rule to mean “an individual whose primary language for communication is
not English and who has a limited ability to read, write, speak, or understand English.”
Similarly, OCR will continue to interpret the phrase “qualified bilingual/multilingual staff”
to mean a member of a covered entity’s workforce who is designated by the covered entity
to provide oral language assistance as part of the individual’s current, assigned job
responsibilities and who has demonstrated to the covered entity that he or she: (1) Is
proficient in speaking and understanding at least spoken English and the spoken language
in need of interpretation, including any necessary specialized vocabulary, terminology and
phraseology, and (2) is able to effectively, accurately, and impartially communicate directly
with LEP individuals in their primary languages.
85
The Department contemplates also continuing to abide by terms defined in the
definition section of the Title VI regulation where relevant to LEP issues.
Proposed “45 CFR § 92.102 Effective communication for individuals with
disabilities.”
The Department retains § 92.202 of the current rule, but proposes to redesignate it
as § 92.102. Subsection (a) requires that communications with individuals with disabilities
must include provision of appropriate auxiliary aids and services, bars requiring that
individuals with disabilities bring their own interpreters, sets minimum standards for
video remote interpreting and telephone relay services, exempts covered entities from
actions that result in a fundamental alteration in the nature of a service, program, or
activity or in undue financial and administrative burdens, and requires appropriate
timeliness, respect for privacy concerns, and independence of the individual with a
disability. Subsection (b) requires recipients of Federal financial assistance and State
Exchanges subject to Part 92 to provide appropriate auxiliary aids. These provisions are
drawn from regulations implementing Title II of the Americans with Disabilities Act, which
applies to any public entity,121 and which were promulgated by the Department of Justice.
See 28 CFR § 35.160 through § 35.164.
121“Public entity” includes State or local government; any department, agency, special purpose district, or
other instrumentality of a State or States or local government. 42 U.S.C. 12311; see also 28 CFR § 35.104(3).
The proposed rule instead uses “entity” with respect to provisions concerning disability rights, as it does with
other provisions concerning who or what is covered by the proposed rule.
86
As stated earlier, although the Department proposes to repeal the definitions
section, it would still apply many of the definitions that the Section 1557 Regulation
incorporated from the Americans with Disabilities Act (“ADA”) (42 U.S.C. 12101 et seq.) or
its regulations. The definitions incorporated from the ADA are the following: disability, 122
auxiliary aids and services,123 qualified interpreter,124 video remote interpreting,125
information and communications technology, 126 technical definitions and standards under
the ADA,127 and Uniform Federal Accessibility Standards as promulgated. 128 The
Department also proposes to retain the Current Rule’s definitions of “oral
transliterators”129 and “cued language transliterators.”130
The Department seeks comment on whether to propose an exemption from the
auxiliary aids and services requirement for covered entities with fewer than 15 employees.
The Department’s current Section 504 regulations permit the exemption, but allow the OCR
Director discretion to impose a requirement on recipients with fewer than 15 employees if
122 42 U.S.C. 12102 (The term "disability" means with respect to an individual—(A) a physical or mental
impairment that substantially limits one or more major life activities of such individual;
(B) a record of such an impairment; or (C) being regarded as having such an impairment.” 42 U.S.C.
12102(1)).
123 The list of auxiliary aids and services from 28 CFR § 35.104 is incorporated into the proposed rule at §
92.102(b)(1).
124 The description of a qualified interpreter from 28 CFR § 35.104 informs the description in the proposed
rule at § 92.101(b)(3).
125 The description of video remote interpreting at 28 CFR § 36.303(f) is incorporated by reference in the
proposed rule at § 92.102(b)(1)(i).

126 36 CFR § D1194.4.
127 Appendix D to 28 CFR part 36 and 28 CFR § 35.104.
128 49 FR 31528 (Aug. 7, 1984), https://www.access-board.gov/guidelines-and-standards/buildings-and-
sites/about-the-aba-standards/ufas.
129 The Section 1557 Rule defined “oral transliterators” as “individuals who represent or spell in the
characters of another alphabet”). 45 CFR § 92.4.

130 “Cued language interpreters” are defined as “individuals who represent or spell by using a small number of
handshapes”). 45 CFR § 92.4.
87
provision of auxiliary aids and services would not significantly impair the ability of the
recipient to provide the benefits or services. See 45 CFR § 84.52(d). The OCR Director
announced such a requirement in 2000. See Notice of Exercise of Authority Under 45 CFR
84.52(d)(2) Regarding Recipients With Fewer Than Fifteen Employees, 65 FR 79368 (Dec.
19, 2000). The Final Rule did not include the exemption because the Department believed
that imposing the requirement on all entities would promote “uniformity and consistent
administration of law.” 81 FR 31407.
Proposed “45 CFR § 92.103 Accessibility standards for buildings and facilities.”
The Department proposes to retain § 92.203 of the current rule, but to redesignate
it as § 92.103. Subsection (a) requires that new construction or alteration of buildings or
facilities subject to Section 1557 must comply with the 2010 ADA Standards for Accessible
Design by January 18, 2018. However, this paragraph allows departures from the 2010
ADA standards where other methods are permitted that provide substantially equivalent
or greater access to and usability of the building. Subsection (b) contains a safe harbor for
new construction or alteration of buildings or facilities subject to Section 1557, allowing
existing facilities which were only required to be compliant with the UFAS standards, 1991
ADA Standards, or the 2010 ADA Standards as of July 18, 2016, to be deemed compliant,
unless there is new construction or alteration after January 18, 2018. The source of these
provisions, Title III of the Americans with Disabilities Act, applies to any public or private
88
owner, lessor, or operator of a place of public accommodation, 131 any public or private
owner, lessor, or operator of commercial facilities,132 or private entities that offer
examinations or courses related to applications, licensing, certification, or credentialing for
secondary or postsecondary education, professional, or trade purposes. 133
The Department seeks comment on the appropriateness of applying the 2010 ADA
Standards’ definition of “public building or facility” to all entities covered under Section
1557, specifically with respect to benefits to individuals and disabilities or burdens on
private entities related to multistory building elevator134 and TTY135 requirements.
Proposed “45 CFR § 92.104 Accessibility of information and communication
technology for individuals with disabilities.”
as § 92.104. Subsection (a) requires covered entities to ensure that their health programs
or activities provided through information and communication technology are accessible to
individuals with disabilities, except when resulting in an undue financial or administrative
burden or fundamental alteration in the nature of an entity’s health program or activity.
131 42 U.S.C. 12812(a). See also 28 CFR § 35.102 (DOJ regulations apply to “all services, programs, and
activities provided or made available by public entities”).
132 42 U.S.C. 12183.
133 28 CFR § 36.102(a)(3).
134 Exception 1 of section 206.2.3 of the 2010 Standards exempts multistory buildings besides the
professional office of a health care provider owned by private entities from the requirement to provide an
elevator to facilitate an accessible route throughout the building. This exemption does not apply to public
entities.
135 The 2010 ADA Standards also specifies TTY requirements for public buildings different from private
buildings. Compare ADA 2010 Standard 217.4.3.1 (public buildings) with ADA 2010 Standard 217.4.3.2
(private buildings).
89
Subsection (b) requires effective communication over Federally-facilitated Exchange
websites and Department administered health programs or activities it administers.
The Department proposes to use the term “information and communication
technology” as defined in the Architectural and Transportation Barriers Compliance Board
(“U.S. Access Board”) regulations implementing Section 508 of the Rehabilitation Act (36
CFR Part 1194, Appendix A, E103.4). In the Final Rule, HHS stated that it would use the
terminology and its definition from the U.S. Access Board regulations. 81 FR at 31382. At
the time of the Final Rule’s promulgation, the Architectural and Transportation Barriers
Compliance Board regulations had been proposed but the rulemaking process had not
concluded. The proposed Section 1557 rule includes the updated citation and
nomenclature change from the now finalized U.S. Access Board regulation. 82 FR 5790 (Jan.
18, 2017) (Final Rule); 83 FR 2912 (Jan. 22, 2018) (technical edits).
Paragraph (b) states the requirements of Section 504 as applied to the Department
and Department-conducted or administered health programs or activities. See 29 U.S.C. 794
(Section 504); 45 CFR Part 85 (Section 504). However, in addition to Section 504, Section
508 of the Rehabilitation Act and its implementing regulations also apply to each Federal
department or agency. See 29 U.S.C. 794d; see also 45 CFR Part 85 (Section 504), 36 CFR
1194.1 & Apps. A, C & D.136 The Department seeks comment as to whether the Department
136When conformance to requirements in the Revised 508 Standards would impose an undue burden or
would result in a fundamental alteration in the nature of the ICT, conformance is required only to the extent
that it does not impose an undue burden or result in a fundamental alteration in the nature of the ICT. The
Section 1557 Regulation does not override the standards under Section 508 that concurrently apply to the
Department and Department-conducted health programs or activities.
90
should cross-reference Section 508 and its applicable implementing regulations in
proposed § 92.104.
Proposed “45 CFR § 92.105 Requirement to make reasonable modifications.”
as § 92.105. This section requires covered entities to make reasonable modifications to
policies, practices, or procedures when necessary, to avoid discrimination on the basis of
disability, except if the modification would fundamentally alter the nature of the health
program or activity. This provision is derived from regulations implementing Title II of the
Americans with Disabilities Act promulgated by the Department of Justice and imposed on
all public entities. See 28 CFR § 35.104.
The Department seeks comment whether this provision should be retained or
substituted with language conforming to the Department of Justice’s Section 504
coordinating regulations which state that covered entities “shall make reasonable
accommodation to the known physical or mental limitations of an otherwise qualified”
individual with a disability. See 28 CFR § 92.205. The Department also seeks comment
whether to include an exemption for “undue hardship.” See 45 CFR § 84.12 (HHS Section
504 regulation); 28 CFR § 92.205 (DOJ Section 504 coordinating regulation).
Request for Comments on Proposed 45 CFR § 92.102 through § 92.105
In retaining the requirements imposed in the Section 1557 Regulation through
Section 504 with respect to disability, the Department seeks to strike an appropriate
balance with respect to the Section 504 rights of individuals with disabilities and the
91
obligations imposed on the regulated community. With respect to the requirement for
regulated entities to provide assurances, the Department also seeks to strike an
appropriate balance. The Department believes that, in retaining all of these requirements, it
has struck that balance and provides benefits greater than the burdens it imposes. Even so,
the Department seeks comment on whether it has struck that proper balance by retaining
the provisions, and whether the benefits of these provisions exceed the burdens imposed
by them. The Department also seeks comment on whether, in light of the proposed
retention of such provisions, the requirements imposed on covered entities under the 1557
regulations differ from those entities who are only subject to the underlying civil rights
laws and regulations (e.g., the Department’s human services grantees), and whether there
is or will continue to be problems, confusion or further complexity in implementing the
regulations arising from any lack of consistency of the requirements imposed under the
regulations and, if so, what could or should be done to address such problems or issues.
The Department seeks comment on whether revisions should be made to these
provisions and whether they are adequately addressed in the underlying regulations (or
should be) or if additional cross references should be made.
B. Current Section 1557 Regulation Provisions Proposed for Repeal or Reconsideration
The proposed rule would repeal certain provisions of the Section 1557 Regulation
that conflict with, or unnecessarily duplicate, the statutory text of Section 1557, Federal
case law, the four statutes incorporated by Section 1557 (Title VI of the Civil Rights Act of
1964, Title IX of the Education Amendments of 1972, the Age Discrimination Act of 1975,
92
and Section 504 of the Rehabilitation Act of 1973), or their implementing regulations. The
proposal to repeal such provisions from the Section 1557 Regulation would leave in place
all of the substantive protections of Title VI of the Civil Rights Act of 1964, Title IX of the
Education Amendments of 1972, the Age Discrimination Act of 1975, and Section 504 of the
Rehabilitation Act of 1973 and the enforcement mechanisms of those statutes referenced at
proposed § 92.2. As discussed above, the Department does not propose to remove several
provisions prohibiting discrimination against individuals with disabilities: with respect to
effective communication, accessibility of buildings and facilities, accessibility of
information and communication technology, and the requirement to make reasonable
modifications. The Department also does not propose to repeal the provision on assurances
of compliance with Section 1557. A provision on language access services for LEP
individuals is retained (with proposed revisions), with the exception of the provisions on
taglines, notices of nondiscrimination, the use of language access plans, and video
standards, as described in the following section, as well as many duplicative provisions.
1. Taglines, Notices, Language Access Plans, and Video Interpretation Standards
The Department proposes to repeal in toto the Section 1557 provisions on
taglines,137 the use of language access plans,138 and notices of non-discrimination.139 The
137 See 45 CFR § 92.4 (definition of taglines), § 92.8(d) (posting of taglines), § 92.8(e) (languages of taglines), §
92.8(f) (tagline notices). § 92.8(g) (taglines in significant publications and communications); Appendix B to
45 CFR Part 92 (sample tagline).
138 45 CFR § 92.201(b)(2) (requiring the OCR Director to “take into account…whether a covered entity has
developed and implemented an effective written language access plan, that is appropriate to its particular
circumstances” in evaluation of compliance). 45 CFR § 92.201(b)(2).
139 45 CFR § 92.8; Appendix B to 45 CFR Part 92 (sample notice).
93
Department also proposes to replace the requirements for remote English- language video
interpreting services with comparably effective requirements with respect to audio-based
services.140 The current rule’s provisions were not justified by need, were overly
burdensome compared to the benefit provided, and created inconsistent requirements for
HHS funded health programs or activities as compared to HHS funded human services
programs or activities. The Department proposes to return to the language access standard
previously in place under the existing Title VI regulation as interpreted by the U.S. Supreme
Court and HHS and the Department of Justice in their LEP guidance documents. Other
Department regulations that require the provision of taglines in certain healthcare
140 45 CFR § 92.201(f).
94
contexts141 and do not otherwise track, reference, or rely on Section 1557 or its regulations
would not be impacted by the proposed repeal of the taglines provisions. 142
When it promulgated the Section 1557 Regulation, the Department did not discuss
all available Department data on the extent of voluntary compliance with HHS’s LEP 2003
guidance. In 2010, the Department’s Office of the Inspector General (OIG) published two
reports,143 which found that the vast majority of Medicare providers and plans in counties
with high proportions of LEP persons surveyed in 2009 conducted the assessment
141 E.g., 42 U.S.C. 300gg-15(b)(2) and 300gg-19(a)(1)(B) (requiring standards for ensuring that the
Summaries of Benefits and Coverage and certain notices are provided in a culturally and linguistically
appropriate manner); 42 U.S.C. 1396d(p)(5)(A) (requiring HHS to distribute to States an application form for
Medicare cost-sharing in English and 10 non-English languages); 26 CFR § 1.501(r)-4(a)(1), (b)(5)(ii)
(requiring a hospital organization to translate certain documents, among other requirements, to qualify for a
tax-exempt status with respect to a hospital facility); 42 CFR § 422.2262(a)(1)-(2) and § 422.2264(e) (setting
forth Medicare Advantage marketing requirements, which include requiring Medicare Advantage
organizations to translate marketing materials into non-English languages spoken by 5% or more of
individuals in a plan service area), § 423.2262(a)(1)-(2) and § 423.2264(e) (setting forth Medicare Part D
marketing requirements, which include requiring Part D plan sponsors to translate marketing materials into
non-English languages spoken by 5% or more of individuals in a plan service area); 45 CFR §
155.205(c)(2)(iii)(A) (Marketplaces must post taglines on their websites and include taglines in documents
“critical for obtaining health insurance coverage or access to health care services through a QHP”); 45 CFR §
147.136(e)(2)(iii) and (e)(3), and § 147.200(a)(5) (requiring taglines in languages in which 10% of
individuals with limited English proficiency (LEP) county-wide are exclusively literate on internal claims and
appeals notices and on an issuer’s Summary of Benefits and Coverage); 42 CFR § 435.905(b)(3) (requiring
individuals to be “informed of the availability of language services . . . and how to access . . . [them] through
providing taglines in non–English languages indicating the availability of language services”); 42 CFR §
457.340(a) (applying certain Medicaid requirements, including § 435.905(b)(3), which requires individuals
to be “informed of the availability of language services . . . and how to access . . . [them] through providing
taglines in non–English languages indicating the availability of language services”); 210 Illinois Cons. Stat.
87/1 (Illinois Language Assistance Act).
142 See, e.g., 45 CFR § 155.205(c)(2)(iii)(A) (deeming compliance with the LEP provisions of the Section 1557
regulation to constitute compliance with CMS’s LEP requirements).

143 HHS OIG, Guidance and Standards on Language Access Services: Medicare Providers (July 2010) (OIG
Providers Report), https://oig.hhs.gov/oei/reports/oei-05-10-00051.pdf (surveying 140 randomly selected

Medicare providers, such as hospitals and nursing homes, that directly supply health care services to
beneficiaries); HHS OIG, Guidance and Standards on Language Access Services: Medicare Plans (July 2010)
(OIG Plans Report), https://oig.hhs.gov/oei/reports/oei-05-10-00050.pdf (surveying 139 randomly selected
private companies that contract with CMS to provide health insurance under Medicare Advantage or
prescription drug coverage under Medicare Part D).
95
recommended in HHS’s guidance. 144 Additionally, in that 2010 report, 27% of providers
cited the cost of offering language services as an obstacle.145 The generally high rate of
voluntary action is one reason that the Department proposes to repeal some of the Final
Rule’s LEP mandates and replace them with the principles and factors of HHS’s LEP
guidance. The Department requests comment on these OIG reports, and requests other
surveys or reports, if available, with more current or comprehensive data, to evaluate the
level of voluntary compliance with the best practices identified in the Department’s LEP
guidance.
2. Redundant Provisions Duplicative of Pre‐Existing Regulations
The Section 1557 Regulation contains provisions that are duplicative of,
inconsistent with, or may be confusing in relation to the Department’s pre-existing Title VI,
Section 504, Title IX, and the Age Act regulations. In some cases, they may also be
duplicative of, inconsistent with, or confusing in relation to coordinating regulations
published by DOJ for Title VI and Section 504, applicable to recipients of Federal financial
assistance. See 28 CFR Parts 41 (Section 504) and 42 (Title VI).
144 OIG Providers Report at 34; OIG Plans Report at 29.

145 OIG Providers Report at 23.
96
These Section 1557 provisions relate to definitions;146 health insurance coverage;147
certain employee health benefits programs;148 notification of rights of beneficiaries under
civil rights laws;149 designation of responsible employees and adoption of grievance
procedures;150 access granted to OCR for review of covered entities’ records of
compliance;151 prohibitions on intimidation and retaliation;152 and remedial action and
voluntary action.153
The Department seeks comment on the provisions proposed for repeal, and which
of these, if any, should be preserved, in whole or part, in the rule, whether they are already
addressed in the underlying regulations (or should be), and with particular comments
requested about the following subjects:
⦁ Coverage of certain employee health benefit programs.
⦁ Designation of responsible employees and adoption of grievance procedures.
146 Compare 45 CFR § 92.4 (Section 1557) with 45 CFR § 80.13 (Title VI), § 85.3 (Section 504), § 86.2 (Title IX)
and § 91.12 (Age Act).
147 Compare 45 CFR § 92.207 (non-discrimination in health-related insurance and other health-related
coverage under Section 1557) with 45 CFR § 80.5 (health benefits under Title VI), § 84.43 (health insurance
under Section 504), § 84.52 (health benefits under Section 504), § 84.33 (rule of construction of Section 504
vis-à-vis validly obligated payments from health insurer); § 86.39 (health insurance benefits and services
under Title IX).
148 Compare 45 CFR § 92.208 (employer liability for discrimination in employee health benefit programs in
Section 1557) with 45 CFR § 86.56 (discrimination on the basis of sex in fringe benefits under Title IX). In
view of the current 1557 rulemaking, the enforcement Memorandum of Understanding (MOU) between OPM
and the Department, available at https://www.hhs.gov/sites/default/files/opm.pdf, would be moot if this
proposed rule were to become final. Moreover, because the MOU is akin to subregulatory guidance, it is
suspended during this rulemaking, consistent with Section V below.
149 Compare 45 CFR § 92.8 and Appendix A to 45 CFR Part 92 (Section 1557) with 45 CFR § 80.6 and Appendix
to Part 80 (Title VI), § 84.8 (Section 504), § 86.9 (Title IX) and § 91.32 (Age Act).
150 Compare 45 CFR § 92.7 and Appendix C to 45 CFR Part 92 (Section 1557) with 45 CFR § 84.7 (Section 504),
and § 86.8 (Title IX).

151 Compare 45 CFR § 92.303(c) (Section 1557) with 45 CFR § 91.31 (Age Act) and § 80.6(c) (Title VI).
152 Compare 45 CFR § 92.303(d) (Section 1557) with 45 CFR § 80.7(e) (Title VI) and § 91.45 (Age Act).
153 Compare 45 CFR § 92.6 (Section 1557) with 45 CFR § 84.6 (Section 504), § 86.3 (Title IX), and § 91.48 (Age
Act).
97
⦁ Notification of beneficiaries, enrollees, applicants, patients, and/or members of the
public of rights and responsibilities under civil rights laws.
IV. Need for Conforming Amendments
In conjunction with the proposed new provisions for the Section 1557 regulation,
the Department proposes to add provisions containing Title IX’s exemptions to its Title IX
Regulation in order to conform it to the statute, be consistent with the Section 1557
regulation, and reflect current law. This proposed rule would also amend regulations
governing certain HHS-funded or HHS-administered health programs covered by Section
1557 or Title IX in order to conform them to the scope of the changes defined by this
proposed rule.
A. Nondiscrimination in Education Programs or Activities
In conjunction with the proposed Section 1557 Regulation, the Department
proposes to conform the Title IX regulation to statutory exemptions consistent with the
Section 1557 regulation and current law. Although the Section 1557 Regulation
incorporated exemptions of Title VI, Section 504, and the Age Act, 154 it did not incorporate
the abortion and religious exemptions contained in Title IX. The Franciscan Alliance court
stated that the Department’s failure to incorporate statutory exemptions “nullifies
154See 45 CFR § 92.101(a)(6) (The exceptions applicable to Title VI apply to discrimination on the basis of
race, color, or national origin under this part. The exceptions applicable to Section 504 apply to
discrimination on the basis of disability under this part. The exceptions applicable to the Age Act apply to
discrimination on the basis of age under this part. These provisions are found at §§ 80.3(d), 84.4(c), 85.21(c),
91.12, 91.15, and 91.17–.18 of this Subchapter.”)
98
Congress's specific direction to prohibit only the ground proscribed by Title IX.” Franciscan
Alliance, 227 F. Supp. 3d at 690-691 (citations omitted).
In its April 5, 2019 brief in Franciscan Alliance, DOJ, on behalf of HHS, stated that the
prohibition on sex discrimination under Section 1557 “unambiguously includes Title IX’s
exemptions, including those addressing religion and abortion.” 155 To address the
Franciscan Alliance court’s holding and ensure a consistent and equitable enforcement
approach, HHS proposes to amend its Title IX regulation to include the statutory
abortion156 and religious157 exemptions.
The Final Rule did not include an affirmative religious exemption in the Section
1557 Regulation, but stated that “Insofar as the application of any requirement under this
part would violate applicable Federal statutory protections for religious freedom and
conscience, such application shall not be required.” The Franciscan Alliance court held that
there was a likelihood that plaintiffs would prevail on the claim that “[t]he Rule's failure to
include Title IX's religious exemptions renders the Rule contrary to law.” 158 After further
consideration of this issue, the Department concludes that any enforcement of Title IX by
the Department, and, therefore, any enforcement of Section 1557 to the extent it
156 “Nothing in this title shall be construed to require or prohibit any person, or public or private entity, to
provide or pay for any benefit or service, including the use of facilities related to an abortion….” Pub. L. 100-
259, 102 Stat. 28 (Mar. 22, 1988) (codified at 20 U.S.C. 1688).
157 20 U.S.C. 1681(a)(3) (providing that the prohibition of discrimination on the basis of sex “shall not apply to
an educational institution which is controlled by a religious organization if the application of this subsection
would not be consistent with the religious tenets of such organization”);
81 FR 31435 (HHS declines to include a religious exemption in Section 1557).
158 227 F. Supp. 3d at 690-671.
99
incorporates Title IX, must be constrained by the statutory contours of Title IX, which
include its abortion and religious exemptions, and must be set forth more clearly than
occurred in the Final Rule. Therefore, to comply with the Franciscan Alliance court’s
decision and Congress’s directives in Title IX and Section 1557, and to properly give effect
to religious liberty and conscience protections related to the provision of abortion services
provided explicitly under Title IX, the Department proposes to amend its Title IX regulation
to conform to the statute.
In the Final Rule, the Department stated that termination of pregnancy 159 was
included as a prohibited basis of discrimination on the basis of sex under the Section 1557
Regulation in order to “mirror” the text of the Department’s Title IX regulation. 81 FR at
31387 (May 19, 2016) (Section 1557 Final Rule); see also 80 FR at 54176 (Sept. 8, 2015)
(Section 1557 Proposed Rule). However, the Department did not incorporate relevant
abortion exemption language from the text of Title IX itself. 20 U.S.C. 1688. 160 As the
Franciscan Alliance court noted:
Title IX prohibits discrimination on the basis of sex, but . . . . categorically

exempts any application that would require a covered entity to provide
159 Although this proposed rule does not adopt a position on whether discrimination on the basis of
termination of pregnancy can constitute discrimination on the basis of sex, it does not mean that OCR could
not consider such claims of discrimination, such as discrimination on the basis of miscarriage or
discrimination on the basis of medical complications resulting from a termination of pregnancy.
160 The Civil Rights Restoration Act (CRRA) added the following language to Title IX, “Nothing in this chapter
shall be construed to require or prohibit any person, or public or private entity, to provide or pay for any
benefit or service, including the use of facilities, related to an abortion. Nothing in this section shall be
construed to permit a penalty to be imposed on any person or individual because such person or individual is
seeking or has received any benefit or service related to a legal abortion.” Pub. L. 100-259, 102 Stat. 28 (Mar.
22, 1988) (codified at 20 U.S.C. 1688). The CRRA also included a rule of construction stating that “No
provision of this Act or any amendment made by this Act shall be construed to force or require any individual
or hospital or any other institution, program, or activity receiving Federal funds to perform or pay for an
abortion.” Id. at Sec. 8.
100
abortion or abortion-related services. 20 U.S.C. § 1688. . . . Failure to

incorporate Title IX’s religious and abortion exemptions nullifies Congress’s
specific direction to prohibit only the ground proscribed by Title IX. That is
not permitted.
Franciscan Alliance, 227 F. Supp. 3d at 690-91.
Proposed “45 CFR § 86.18 Amendments to conform to statutory exemptions.”
To resolve the current litigation, avoid future litigation over the Department’s Title
IX and Section 1557 regulations, and give effect to the statutory abortion exemption
provisions adopted by Congress and relevant rules of construction adopted by Congress,
the Department proposes to amend its Title IX regulations at 45 CFR Part 86 to add a new
Section 86.18.
In proposed paragraph 86.18(a), the Department seeks to codify the abortion
exemption to Title IX. The Department proposes to use the text Congress added to Title IX
by means of the CRRA – which states that “Nothing in this chapter shall be construed to
require or prohibit any person, or public or private entity, to provide or pay for any benefit
or service, including the use of facilities, related to an abortion,” Pub. L. 100-259, 102 Stat.
28 (Mar. 22, 1988) (codified at 20 U.S.C. 1688) – as the basis of the regulatory text, making
the appropriate changes to reflect the difference between the statute and the implementing
regulations.
Proposed paragraph 86.18(b) would set forth the rule of construction in Title IX, as
added by the CRRA. The Department again proposes to base the regulatory text on the
language of the rule of construction adopted by Congress: “No provision of this Act or any
amendment made by this Act shall be construed to force or require any individual or
101
hospital or any other institution, program, or activity receiving Federal funds to perform or
pay for an abortion.” Id. at Sec. 8.
In proposed paragraph 86.18(c), the Department proposes to incorporate other
relevant laws that may impact the application of the Title IX abortion exemption. This
paragraph would incorporate the laws cited by the Franciscan Alliance court: the Religious
Freedom Restoration Act,161 the Weldon Amendment,162 the Coats-Snowe Amendment, 163
and the Church Amendments.164 See 227 F. Supp. 3d at 690-91. The Department also
proposes to reference the First Amendment to the U.S. Constitution, the Hyde
Amendment,165 the Helms Amendment,166 and Section 1303 of the Patient Protection and
Affordable Care Act.167 The Department concludes that all of these statutes establish
Congressionally required parameters that may apply to the Department’s interpretation,
implementation, and enforcement of Title IX. 168
The Department requests comment on proposed § 86.18.
B. Proposed Conforming Amendments
The Department proposes to amend certain regulations that identify “sexual
orientation” or “gender identity” as prohibited bases of discrimination for certain
Department health programs or activities, to the extent that the regulations are not based
161 42 U.S.C. 2000bb-1.

162 E.g., Pub. L. 114–113, Div. H, sec. 507(d), 129 Stat. 2242, 2649 (2015).
163 42 U.S.C. 238n.
164 42 U.S.C. 300a-7.
165 E.g., Consolidated Appropriations Act, 2019, Pub. L. 115–245, Div. B, sec. 506(a).
166 E.g., Continuing Appropriations Act, 2019, Pub. L. 115–245, Div. C, sec. 7018.
167 42 U.S.C. 18023.
168 To the extent the law is found in an appropriations rider, it applies to the Department’s interpretation,
implementation, and enforcement of Title IX every year that it is enacted.
102
on independent statutory authority which expressly provides such prohibition. As stated
above, Congress through Section 1557 adopted certain nondiscrimination requirements for
health programs or activities, any part of which receive Federal financial assistance or
programs or activities administered by an Executive agency under Title I of the PPACA or
by an entity established under such Title by cross-referencing the grounds for
discrimination prohibited by longstanding civil rights laws—namely, race, color, national
origin, sex, age, or disability. Neither Section 1557 nor any of those longstanding civil rights
laws reference sexual orientation or gender identity.
Moreover, as noted in the preamble to the Final Rule, the current regulation does
not treat “an individual’s sexual orientation status alone [a]s a form of sex discrimination
under Section 1557,” 81 FR at 31390. It is the position of the United States government that
Title VII, which is read consistent with or carries over to Title IX when determining the
scope of discrimination on the basis of “sex,” “does not reach discrimination based on
sexual orientation.” DOJ Brief for the United States as Amicus Curiae, Zarda v. Altitude
Express, Inc., No. 15-3775 (2d Cir. July 26, 2017). It is also the position of the United States
government that “Title VII’s prohibition on sex discrimination . . . does not encompass
discrimination based on gender identity per se, including transgender status.”
Memorandum of the Attorney General (Oct. 4, 2017). 169 As discussed above, on April 5,
2019, DOJ filed a brief in Franciscan Alliance v. Azar on behalf of HHS, reiterating the U.S.
169Memorandum of the Attorney General, (Oct. 4, 2017),

https://www.justice.gov/ag/page/file/1006981/download.
103
Government’s position about Title VII, and stating that “the [Section 1557] Rule’s
prohibitions of discrimination on the basis of gender identity and, without the
accompanying statutory protections, termination of pregnancy are substantively unlawful
under the APA.”170
This proposed rule, thus, seeks to amend regulations that identify sexual orientation
or gender identity as prohibited bases for discrimination for certain Department funded or
administered programs covered by Section 1557 in order to conform them more closely to
the prohibited bases for discrimination authorized by Section 1557, and encompassed in
the proposed § 92.2, and to conform them with government policy. The provisions
proposed to be conformed are:
⦁ 45 CFR § 155.120(c)(ii) and § 155.220(j)(2), nondiscrimination provisions
concerning how States and Exchanges carry out PPACA requirements and how agents or
brokers market to individuals they assist with Exchange enrollment or related applications.
⦁ 45 CFR § 147.104(e), nondiscrimination provision concerning marketing or
benefit design practices of health insurance issuers under the PPACA.
⦁ 45 CFR § 156.200(e) and § 156.1230(b)(3), nondiscrimination provision
concerning the administration of qualified health plans (QHP) by issuers and concerning
marketing and other conduct by QHP issuers engaged in direct enrollment of applicants
under the PPACA.
Alliance, No. 7:16-cv-00108-O, at 5 (filed April 5, 2019).
104
⦁ 42 CFR § 460.98(b)(3) and § 460.112(a), nondiscrimination provisions concerning
organizations operating Programs for All-inclusive Care of the Elderly (PACE) programs
and participants receiving PACE services under Medicare.
⦁ 42 CFR § 438.3(d)(4), § 438.206(c)(2), and § 440.262, nondiscrimination
provisions concerning Medicaid beneficiary enrollment, and promotion and delivery of
access and services.
Additionally, the Department proposes to amend its Title IX regulation at 45 CFR §
86.31 to remove any potential ambiguity or conflict concerning the current regulation’s
prohibition of discrimination “in the application of any rules of appearance.” Currently, the
Department is the only Federal agency with Title IX regulatory language prohibiting
discrimination “against any person in the application of any rules of appearance.” 171 45 CFR
§ 86.31(b)(5) (retained from the predecessor 1975 HEW regulation). While “rules of
appearance” does not appear in Title IX and was never defined in any agency’s Title IX
regulations, the phrase may cause confusion in the public about Title IX’s coverage and
compliance responsibilities and has already led to at least one lawsuit. 172 Because this
language is not in current regulations of any other agencies, the proposed edit would
eliminate the potential for conflicting and inequitable Federal agency enforcement of Title
171 See, e.g., 47 FR 32527 (July 28, 1982) (Department of Education Title IX regulation); 65 FR 52858 (Aug. 30,
2000) (common rule adopted by twenty agencies), 66 FR 4627 (Feb. 20, 2001) (common rule adopted by
Department of Energy); 82 FR 46656 (Oct. 6, 2017) (U.S. Department of Agriculture adopting common rule).
None of these agency Title IX rules contain any language concerning “rules of appearance.”
172 See Complaint, Peltier et al. v. Charter Day School, No. 7:16-CV-30-H, No. 160 (E.D.N.C. Mar. 30, 2017)
(citing “rules of appearance” in Department of Agriculture’s Title IX regulation to challenge a school’s girls'
dress code for “subject[ing] them to archaic sex stereotypes about what constitutes appropriate behavior and
conduct”); but see 82 FR 46655 (Oct. 6, 2017) (by adopting the Title IX common rule, the Department of
Agriculture no longer contains language about “rules of appearance”).
105
IX. See Jespersen v. Harrah’s Operating Co., No. 03-15045 (9th Cir. Apr. 14, 2006) (en banc)
(finding sex-specific uniform, appearance and grooming standards did not violate Title VII’s
prohibition on sex discrimination).
C. Technical Amendments
Several technical amendments are proposed to the Department’s Section 1557 and
Title IX regulations. The Department makes a nomenclature change to replace “State-based
MarketplaceSM” with “State Exchange” to conform the proposed rule to CMS regulations. See
45 CFR § 155.20. The Department also makes a nomenclature change from “electronic and
information technology” to “information and communication technology” 173 and updates
the regulatory cross-reference in this definition from the Access Board’s former 508
Standards (36 CFR 1194.4) to its revised 508 Standards (36 CFR Part 1194, Appendix A,
E103.4). The Department also inserts cross-references to ADA 2010 Standards, 1991
Standards, and UFAS in the regulatory text concerning accessibility for individuals with
disabilities.
The Department proposes to make a conforming amendment to § 86.2, which
defines Title IX for purposes of the regulation as certain enumerated provisions in the U.S.
Code. When the Department updated its Title IX regulation in 2005 in order to conform to
the 1987 CRRA, the Department failed to add all relevant statutory citations, including 20
173Although the Section 1557 Regulation uses the term “electronic and information technology” (EIT) in §
92.204, the Department stated that it would update its nomenclature to the U.S. Access Board’s then-
proposed new term “information and communication technology” (ICT) upon finalization of the U.S. Access
Board regulation. 81 FR 31382 (Section 1557 Final Rule). See also 82 FR 5790 (Jan. 18, 2017) (Access Board
ICT Final Rule).
106
U.S.C. 1688, which requires neutrality with respect to abortion. Compare 70 FR 24314 (May
9, 2005) with Pub. L. 100-259, 102 Stat. 28 (Mar. 22, 1988) (CRRA). The Department’s Title
IX regulation should encompass all relevant provisions of the statute it is regulating and,
accordingly, the Department proposes to edit § 86.2 include references to 20 U.S.C. 1687
and 1688 to correct the omission.
The enforcement section in the Department’s Title IX regulation currently only
addresses applicable procedures for the interim period between Title IX’s “effective date
and the final issuance of a consolidated procedural regulation applicable to Title IX and
other civil rights authorities.” 45 CFR § 86.71. The proposed rule would address current
enforcement procedures by adopting the same language from the Title IX common rule,
which incorporates Title VI procedures.
The proposed rule would also make nomenclature change to the Title IX regulation
by replacing “United States Commissioner of Education” with the official’s current title,
“Secretary of Education.” See 45 CFR § 86.2(n).
V. Interim Treatment of Subregulatory Guidance
Because the enforcement mechanisms of the underlying four civil rights statutes in
Section 1557 are already enshrined in the Department’s free standing regulations, and
implemented and enforced by the Department’s Office for Civil Rights, existing sub-
regulatory guidance not inconsistent with this rulemaking would not be impacted by this
rulemaking. Other subregulatory guidance may, however, be inconsistent with the
107
Department’s interpretation of Section 1557 and Title IX, and its requirement to comply
with court orders.
Upon publication of this notice of proposed rulemaking, the Department will, as a
matter of enforcement discretion, suspend all subregulatory guidance issued before this
proposed rule that interprets or implements Section 1557 (including FAQs, 174 letters,175
and the preamble to the current Section 1557 Regulation) that is inconsistent with any
provision in this proposed rule (including the preamble) or with the requirements of the
underlying civil rights statutes cross-referenced by Section 1557 or their implementing
regulations. This suspension may be revoked wholly or partially at any time before
finalization of this proposed rule and will be lifted automatically if this proposed rule is
withdrawn. This suspension is consistent with the Attorney General’s memorandum of
November 16, 2017, stating that, for the Department of Justice, “guidance may not be used
as a substitute for rulemaking and may not be used to impose new requirements on entities
174 After publishing the Final Rule, OCR issued guidance explaining that anything printed on an 8.5” x 11”
sheet of paper is considered “significant,” and, thus, must include the tagline notice. See OCR, Question 23,
General Questions about Section 1557 (May 18, 2017), https://www.hhs.gov/civil-rights/for-
individuals/section-1557/1557faqs/index.html; see also OCR, Sample Covered Entity Tagline Informing
Individual with Limited English Proficiency of Language Assistance,
https://cms-drupal-hhs-prod.cloud.hhs.gov/sites/default/files/sample-ce-tagline-english.pdf.
This documents are examples of sub-regulatory guidance that must be suspended under this proposed rule.
See also OCR, Sample Notice Informing Individuals About Nondiscrimination and Accessibility Requirements
and Sample Nondiscrimination Statement,
https://cms-drupal-hhs-prod.cloud.hhs.gov/sites/default/files/sample-ce-notice-english.pdf;
OCR, Frequently Asked Questions to Accompany the Estimates of at Least the Top 15 Languages Spoken by
Individuals with Limited English Proficiency under Section 1557 of the Affordable Care Act, (Sept. 1, 2016),
https://www.hhs.gov/civil-rights/for-individuals/section-1557/1557faqs/top15-languages/index.html.
175 On July 12, 2012, the OCR Director first announced in a correspondence addressed to a single member of
the public that OCR was accepting and investigating complaints of discrimination on the basis of “actual or
perceived sexual orientation or gender identity” under Section 1557 of the PPACA. OCR Transaction Number
12-00800 (July 12, 2012).
108
outside the Executive Branch. Nor should guidance create binding standards by which the
Department will determine compliance with existing regulatory or statutory
requirements.”176 It is also consistent with the Associate Attorney General’s memorandum
of Jan. 25, 2018, indicating that Department of Justice litigators cannot use noncompliance
with guidance documents as the basis for proving violations of law in affirmative civil
enforcement cases and may not use its enforcement authority to convert agency guidance
documents into binding rules.177
VI. Regulatory Impact Analysis
The Department has examined the impacts of the proposed rule as required by
Executive Order 12866 on Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993);
Executive Order 13563 on Improving Regulation and Regulatory Review, 76 FR 3821 (Jan.
21, 2011); Executive Order 13132 on Federalism, 64 FR 43255 (Aug. 4, 1999); Executive
Order 13175 on Tribal Consultation, 65 FR 67249 (Nov. 6, 2000); Executive Order 13771
on Reducing Regulation and Controlling Costs, 82 FR 9339 (Jan. 30, 2017); the
Congressional Review Act (Pub. L. 104-121, sec. 251, 110 Stat. 847 (Mar. 29, 1996)); the
Unfunded Mandates Reform Act of 1995, Pub. L. 104-4, 109 Stat. 48 (Mar. 22, 1995); the
Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164 (Sept. 19, 1980); Executive Order
13272 on Proper Consideration of Small Entities in Agency Rulemaking, 67 FR 53461 (Aug.
16, 2002); Executive Order 12250, Leadership and Coordination of Nondiscrimination
176 Memorandum of the Attorney General, “Prohibition on Improper Guidance Documents.”

https://www.justice.gov/opa/press-release/file/1012271/download.
177 Memorandum of the Associate Attorney General, “Limiting Use of Agency Guidance Documents In
Affirmative Civil Enforcement Cases.” https://www.justice.gov/file/1028756/download.
109
Laws, 45 FR 72995 (Nov. 2, 1980), and the Paperwork Reduction Act of 1995, 44 U.S.C.
3501, et seq.
A. Executive Orders 12866 and Related Executive Orders on Regulatory Review
Executive Order 12866 directs agencies to assess all costs and benefits of available
regulatory alternatives and, if regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental, public health and
safety effects; distributive impacts; and equity). Executive Order 13563 is supplemental to,
and reaffirms the principles, structures, and definitions governing regulatory review as
established in, Executive Order 12866.
As discussed below, the Department has estimated that the proposed rule will have
an effect on the economy greater than $100 million in at least one year in fact it will result
in greater than $100 million in savings. Thus, it has been concluded that this proposed rule
is economically significant. It has therefore been determined that this proposed rule is a
‘‘significant regulatory action’’ (albeit of a deregulatory nature) under Executive Order
12866. Accordingly, the Office of Management and Budget (OMB) has reviewed this
proposed rule.
1. Summary of the Proposed Rule
Through Section 1557 of the PPACA, Congress applied certain long-standing civil
rights nondiscrimination requirements to any health programs or activities that receive
Federal financial assistance, and any programs or activities administered by an Executive
agency under Title I of the PPACA or by an entity established under such Title. It did so by
110
cross-referencing the discriminatory grounds prohibited by those longstanding civil rights
laws, namely, discrimination on the basis of race, color, national origin, sex, age, or
disability, in an array of Federally funded and administered programs or activities. To
ensure compliance, Congress dictated that “[t]he enforcement mechanisms provided for
and available under” such laws “shall apply for purposes of violations of” Section 1557. The
proposed rule would, thus, eliminate most of the provisions in the current Section 1557
Regulation and return to the enforcement mechanisms provided for, and available under,
those existing statutes and the Department’s implementing regulations. Specifically, the
Department proposes to repeal the provisions which interpret Federal law inconsistently
with Federal court opinions or impose burdens that unjustifiably exceed anticipated
benefits. These include: the Section 1557 Regulation’s inclusion of novel definitions;
language access plan provisions; provisions that set forth new requirements for tagline
notices, notices of nondiscrimination, and grievance procedures; application of theories
and remedies available under a subset of civil rights laws to all of them, without analysis of
whether such theories and remedies were available under all such civil rights laws; and,
provisions based on legal theories that were inconsistent with (or, at a minimum,
unnecessarily duplicated) provisions of long-standing regulations of the underlying civil
rights laws cited in Section 1557. Consistent with this approach to the Section 1557
Regulation, the Department proposes to retain certain language and disability access
provisions, as well as the assurance of compliance requirements. The proposed rule
empowers the Department to continue its robust enforcement of civil rights laws by
111
additionally making it clear that the substantive protections of Title VI of the Civil Rights
Act of 1964, Title IX of the Education Amendments of 1972, the Age Discrimination Act of
1975, and Section 504 of the Rehabilitation Act of 1973, remain in full force and effect. 178
The Department also proposes to make certain conforming changes to regulations across
the Department, and to update its underlying Title IX regulation to adopt statutory
amendments, in light of the failures noted by the district court in Franciscan Alliance.
2. Need for the Proposed Rule
The Department proposes to substantially replace the Section 1557 Regulation,
while retaining certain LEP, disability, and assurances of compliance provisions, in order to
better comply with the mandates of Congress, relieve approximately $3.6 billion in undue
regulatory burdens, further substantive compliance, reduce confusion, and clarify the scope
of Section 1557.
As stated above, the proposed rule is needed in part because two Federal district
courts have determined that the Department exceeded its authority in promulgating parts
of the regulation and have enjoined or stayed it from applying those parts. By substantially
repealing most of the Section 1557 Regulation, the Department would revert to statutory
interpretations more consistent with the law and with the United States Government’s
official position on certain of the underlying civil rights statutes, and ultimately allow the
Federal courts, in particular, the U.S. Supreme Court, to resolve any dispute about the
178While Section 1557 does not incorporate nondiscrimination provisions by reference to Title VII, it
provides that nothing in Title I of the PPACA is to be construed as invalidating or limiting the rights, remedies,
procedures, or legal standards available under certain civil rights laws, including Title VII. 42 U.S.C. 18116(b).
112
proper legal interpretation of such statute and, thus, on Section 1557 of the Affordable Care
Act.
Additionally, the Department has determined that the Final Rule is duplicative and
confusing, has imposed substantial unanticipated burdens, and that its anticipated and
unanticipated burdens are not justified.
The Department initially estimated the costs from the Section 1557 Regulation at
over $942 million across the first five years. 81 FR at 31458-31459. This figure, however,
underestimated actual five year costs by at least $2.6 billion, according to the Department’s
current estimates. Most of this expense is derived from the taglines requirement, which
amounts to an annual burden of approximately $147 million (low-end) to $1.34 billion
dollars (high-end), before accounting for electronic delivery, for an average annual burden
of $0.632 billion per year, and an average five year burden of $3.16 billion after accounting
for electronic delivery, as further described in this Regulatory Impact Analysis. Based on
the Department’s re-examination of the burden on regulated entities, the Department has
preliminarily determined that the potential public benefits of imposing such requirements
are outweighed by the large costs those requirements impose on regulated entities and
other parties.
3. Consideration of Regulatory Alternatives
The Department carefully considered several alternatives, including the option of
not pursuing any regulatory changes, but rejected that approach for several reasons.
113
First, not pursuing any regulatory changes would be inconsistent with the
Administration’s policies to appropriately reduce regulatory burden, in general, with
respect to individuals, businesses and others, and resulting from PPACA specifically. Not
pursuing any regulatory change would also be inconsistent with a nationwide preliminary
injunction in place against the Department with respect to the inclusion, in the Section
1557 Regulation, of gender identity and termination of pregnancy in the definition of
discrimination on the basis of sex.
Second, Federal courts have reached varying conclusions concerning a number of
legal positions taken by the Department in the Section 1557 Regulation. The Northern
District of Illinois dismissed a plaintiff’s claim that the Department created a new
enforcement legal standard, because the “plain and unambiguous” statutory text of Section
1557 expressly incorporated four distinct enforcement mechanisms. Briscoe v. Health Care
Serv. Corp., 281 F. Supp. 3d 725, 738 (N.D. Ill. 2017) (dismissing a Section 1557 claim for
sex discrimination using a disparate impact standard); but see Rumble v. Fairview Health
Servs., No. 14-cv-2037 (SRN/FLN) (D.Minn. Mar. 16, 2017) (declining to determine the
specific standard on motion to dismiss, rejecting implication Congress meant to create a
“new anti-discrimination framework completely ‘unbound by the jurisdiction of the four
referenced statutes,’” but concluding Congress “likely” intended a single standard to avoid
“patently absurd consequences”). In addition, Federal courts in California, New York, and
Iowa did not recognize disparate impact claims for sex discrimination under Section 1557,
because such claims are not cognizable under Title IX. See Condry v. UnitedHealth Group,
114
No. 3:17-cf-00183-VC (N.D. Calif. June 27, 2018) (Slip. Op. at 7); Weinreb v. Xerox Business
Services, 323 F. Supp. 3d 501, 521 (S.D.N.Y. 2018); York v. Wellmark, Inc., No. 4:16-cv-
00627-RGE-CFB, Slip. Op. at *30 (S.D. Iowa Sep. 6, 2017). Another court in Pennsylvania
indicated that there is no disparate impact claim for discrimination on the basis of race
under Section 1557 because such claims are unavailable under Title VI. See Southeastern
Pennsylvania v. Gilead, 102 F. Supp. 3d 688 (E.D. Pa. 2015); but see Callum v. CVS Corp., 137
F. Supp. 3d 817 (D.S.C. 2015).
Third, the Department believes that the status quo would not address, much less
remedy, public confusion regarding complainants’ rights, and covered entities’ legal
obligations. The Department believes that revisiting the rule will address inconsistences
between the Department’s underlying regulations and with the regulations and actions
taken by other components of the Department. As applied to sex discrimination claims, the
Department currently employs a definition of discrimination on the basis of sex under
Section 1557 and, thus, under Title IX that varies from the practice of other Departments.
Moreover, revising the Section 1557 Regulation will allow the Department to resolve
current and future complaints of sexual orientation and gender identity discrimination in a
manner consistent with other agencies’ enforcement efforts under Title IX. If the
Department uses interpretations of Title IX that differ from other Departments, and that
diverges from the legal interpretation of the U.S. Government, as set forth by DOJ, it would
lead to inconsistent outcomes across complainants and covered entities, with the problem
being especially acute in cases involving a single covered entity being investigated with
115
respect to the same allegations by multiple Departments that come to different conclusions
on effectively the same question.
The Department also considered adding “gender identity” and “sexual orientation”
to a definition of “sex” or “on the basis of sex” under Title IX. The Department concluded it
is inappropriate to do so at this time, in light of the government position on the meaning of
discrimination on the basis of sex under Title VII and cases on which the U.S. Supreme
Court has granted petitions for writs of certiorari to resolve similar questions in the
context of Title VII. As a policy matter, the Department believes State and local entities are
better equipped to address issues of gender dysphoria or sexual orientation and the
sometimes competing privacy interests with sensitivity, especially when young children or
intimate settings are involved. The Department’s position will not bar covered entities from
choosing to grant protections for sexual orientation and gender identity that are not
required by, but do not conflict with, any other Federal law. 179 The Department has also
determined that more complex forms of regulation, such as economic incentives or
performance objectives, are neither appropriate nor feasible solutions to the problem to be
solved.
179Policies of covered entities that result in unwelcome exposure to, or by, persons of the opposite biological
sex where either party may be in a state of undress—such as in changing rooms, shared living quarters,
showers, or other shared intimate facilities—may trigger hostile environment concerns under Title IX. United
States v. Virginia, 518 U.S. 515, 550 n.19 (1996) (“Admitting women to [an all-male school] would
undoubtedly require alterations necessary to afford members of each sex privacy from the other sex in living
arrangements”); Fortner v. Thomas, 983 F.22d 1024, 1030 (11th Cir. 1993) (“[M]ost people have a special
sense of privacy in their genitals, and involuntary exposure of them in the presence of people of the other sex
may be especially demeaning or humiliating.”).
116
The Department also considered simply repealing the Section 1557 Regulation in
toto and not issuing a replacement regulation. Such an approach would be consistent with
the Administration’s goals of reducing the regulatory burden on covered entities and is
allowed under Section 1557, since that provision does not require the Department to issue
implementing regulations. However, the Department is committed to vigorous
enforcement of civil rights and nondiscrimination laws as directed by Congress.
Additionally, it believes that certain provisions—such as those addressing the assurance of
compliance with Section 1557, effective communication and accessibility for individuals
with disabilities, and certain language access services—address applications of civil rights
laws without the statutory or legal conflicts or excessive regulatory burdens entailed by
other provisions of the current Rule.
The Department considered retaining the provision on visual standards for video
remote interpreting services for LEP individuals. However, the burden of requiring covered
entities to provide video technology training and utilize expensive software does not
appear to be justified based on minimal benefit to language speakers who can effectively
communicate when there is clear audio transmission through the remote interpreting
service.
Accordingly, the Department believes it is appropriate to clarify how the Office for
Civil Rights would enforce the PPACA’s nondiscrimination protections by replacing the
Section 1557 Regulation with regulatory provisions (1) explicitly applying the enforcement
mechanisms provided under the civil rights statutes and related implementing regulations
117
cited by Section 1557 to the health contexts identified in Section 1557, (2) vesting
enforcement authority under Section 1557 with the Director of the Office for Civil Rights,
and (3) specifying how Section 1557 enforcement shall interact with existing laws – while
retaining certain language and disability access provisions and the assurances provision.
With respect to the requirement that covered entities provide nondiscrimination
notices and taglines, the Department considered keeping the requirement but limiting the
frequency of required mailings to one per year to each person served by the covered entity.
To estimate the cost of this option, the Department adopted the base assumptions
described in this Regulatory Impact Analysis regarding the number of covered entities and
the average unit cost associated with the low-end and high-end costs of a notice and tagline
mailing (materials, postage, and labor).180 The Department adjusted the volume of mailings
based on the average number of individuals served by each covered entity.181 The
Department assumed the same covered entity compliance rate for the insurance industry
as under this Regulatory Impact Analysis but assumed an increased compliance rate for
non-insurers (assuming 30% instead of 10%) to reflect that more entities would likely
comply with the requirements if the burden were to be significantly reduced to one mailing
per customer/patient per year. Based on this method, the estimated total cost of this
180The average of the low ($0.035) and high ($0.32) unit costs is $0.18 per notice and tagline mailing.
181The estimated volume is expected to vary based on covered entity type. For instance, each of the 180
health insurance issuers serve 685,138 individuals on average, based on the number of insured individuals
(123 million), which equates to 685,138 mailings per issuer. Each of the 185,649 physicians’ offices serve
1,703 individuals, based on the average number of individuals (316 million) associated with 990 million
physicians visits. On average, each covered entity serves about 3,000 persons per entity, which equates to
3,000 mailings per entity, based on 820 million persons served by 275,002 covered entities.
118
alternative is approximately $63 million per year. Although this option poses a significantly
reduced burden, the Department believes the costs under this alternative still outweigh the
benefits because such mass multi-language taglines mailings would still be received
overwhelmingly by English speakers and because the requirement to issue non-
discrimination notices would be largely duplicative of non-discrimination notice
requirements that already exist under Section 1557’s underlying civil rights regulations. 182
The Department invites comment on its proposed approach, as well as the other
approaches considered by the Department.
4. Considerations for Cost‐Effective Design
In this proposed rule, the Department proposes to substantially replace most of the
Section 1557 Regulation, so as to significantly reduce the regulatory burden of compliance
and to return to the pre-existing understanding of the underlying nondiscrimination
obligations imposed by the civil rights laws referenced by Section 1557.
In the preamble to the Final Rule, the Department observed there were pre-existing
requirements under Federal civil rights laws that, “except in the area of sex discrimination,”
applied to a large percentage of entities covered by the Final Rule. 81 FR at 31446. Thus, in
the Final Rule the Department concluded it did not expect covered entities to undertake
additional costs with respect to the prohibitions on discrimination on the basis of race,
color, national origin, age, or disability discrimination, “except with respect to the
voluntary development of a language access plan.” Id.
182 See 45 CFR § 80.6(d) (Title VI), § 84.8 (Section 504), § 86.9 (Title IX), § 91.32 (Age Act).
119
By proposing to repeal the Section 1557 Regulation’s novel definition of sex
discrimination and to eliminate the notices, taglines, visual standards in video remote
interpreting services for LEP individuals, language access plans, and duplicative grievance
procedures requirements, the proposed rule would also allow covered entities the freedom
to order their operations efficiently, flexibly, and in a cost-effective manner.
Accordingly, returning to the familiar pre-existing requirements and eliminating
novel requirements not contemplated nor allowed by Section 1557 is a cost-effective way
of (1) removing the unjustified burdens imposed by the Section 1557 Regulation; (2)
reducing confusion among the public and covered entities; (3) promoting consistent,
predictable, and cost-effective enforcement; and (4) creating space for innovation in the
provision of compliant services by covered entities (including flexible and innovative
language access practices and technology), while faithfully and vigorously enforcing
Section 1557’s civil rights protections.
5. Methodology for Cost‐Benefit Analysis
For purposes of this Regulatory Impact Analysis (RIA), the proposed rule adopts the
list of covered entities and other costs assumptions identified in the 2016 RIA for the Final
Rule. The use of assumptions from the 2016 rulemaking in the present RIA, however, does
not mean that the Department adopts those assumptions in any respect beyond the
purpose of estimating (1) the number of covered entities that would be relieved of burden,
and (2) cost relief. For example, the 2016 rulemaking based several cost estimates on an
expansive definition of Federal financial assistance, which significantly impacted the
120
number of covered entities currently burdened by the Final Rule; thus, it is appropriate to
use that definition for estimating cost relief.183 Such use, however, should not be
interpreted as an endorsement or acceptance of the definitions for any other purpose.
Moreover, the existing definition of Federal financial assistance under the Section 1557
Regulation is proposed to be repealed in this NPRM.
The Department also does not “carry over” every assumption from the 2016 Section
1557 Regulation for this NPRM’s RIA calculation purposes. Most notably, the Department
no longer considers its prior estimates of costs imposed due to the current Section 1557
Regulation’s taglines requirement accurate or valid, and provides a more thorough and
accurate estimate for purposes of this NPRM.
Cost savings result from the repeal of (1) the provision on the incentive for covered
entities to develop language access plans and (2) the provisions on notice and taglines. In
addition, the Department quantitatively analyzes and monetizes the impact that this
proposed rule may have on covered entities’ voluntary actions to re-train their employees
on, and adopt policies and procedures to implement, the legal requirements of this
proposed rule. The Department analyzes the remaining benefits and burdens qualitatively
because of the uncertainty inherent in predicting other concrete actions that such a diverse
scope of covered entities might take in response to this proposed rule. The Department
183The Department seeks public comment in particular on one aspect of the Final Rule where there was no
estimate of the number of impacted entities: the number of religious organizations that provide health
services and receive Federal financial assistance from the Department. The Department seeks public
comment to better estimate the impact of the proposed rule on such religious entities, and the impact of any
applicable religious exemptions that might change the effect of the proposed rule on those entities.
121
requests all relevant information or data that would inform a quantitative analysis of
proposed reforms that the Department qualitatively addresses in this RIA.
6. Cost‐Benefit Analysis
a. Overview
In 2016, the Department estimated $942 million 184 in costs (over five years) for the
Section 1557 Regulation due to impacts on personnel training and familiarization,
enforcement, posting of nondiscrimination notices and taglines, and revisions in covered
entity policies and procedures. 81 FR at 31446, and 31458-31459 (at Table 5). As stated
earlier, the Department estimated in its 2016 rulemaking that these costs would arise
primarily from requirements imposed by the Section 1557 Regulation with which covered
entities were not already complying.185 The Department specifically identified the Final
Rule’s interpretation of sex discrimination to cover gender identity and sex stereotyping, 186
and the Final Rule’s consideration of language access plans for compliance purposes, as
provisions triggering the imposition of new costs.187 See 81 FR at 31459 – Table 5.
184 Throughout the regulatory impact analysis in the Section 1557 Regulation, the 2016 estimates used 2014
dollars unless otherwise noted.
185 81 FR at 31446 (“to the extent that certain actions are required under the final rule where the same
actions are already required by prior existing civil rights regulations, we assume that the actions are already
taking place and thus that they are not a burden imposed by the rule”).
186 81 FR at 31455 (“Although a large number of providers may already be subject to State laws or
institutional policies that prohibit discrimination on the basis of sex in the provision of health services, the
clarification of the prohibition of sex discrimination in this regulation, particularly as it relates to
discrimination on the basis of sex stereotyping and gender identity, may be new.”).
187 Although the Final Rule did not require covered entities to develop a language access plan, the Rule stated
that the development and implementation of a language access plan is a factor the Director “shall” take into
account when evaluating whether an entity is in compliance with Section 1557. 45 CFR § 92.201(b)(2).
Therefore, the Department anticipated that 50% of covered entities would be induced to develop and
implement a language access plan following issuance of the Final Rule. 81 FR at 31454.
122
In 2016, the Department estimated that the Final Rule’s nondiscrimination notice
requirement would impose approximately $3.6 million in one-time additional costs on
covered entities. 81 FR at 31469. Regarding these requirements, the Department stated:
“We are uncertain of the exact volume of taglines that will be printed or posted, but we
estimate that covered entities will print and post the same number of taglines as notices
and therefore the costs would be comparable to the costs for printing and disseminating
the notice, or $3.6 million.” 81 FR at 31469. Thus, the total notice and tagline cost was
estimated at $7.2 million in the first year and was predicted to go down to zero after year
one despite the regulatory requirement for covered entities to provide notices and taglines
to beneficiaries, enrollees, and applicants by appending notices and taglines to all
“significant publications and significant communications” larger than postcards or small
brochures. Compare 81 FR at 31458 (Table 5), with 45 CFR § 92.8.
For reasons explained more fully below, the 2016 estimate of $7.2 million in one-
time costs stemming from the notice and taglines requirement was a gross
underestimation, and thus this proposed rule’s elimination of those requirements would
generate a large economic savings of approximately $3.6 billion over five years based on
the proposed repeal of the notice and taglines provision.
123
controversy over the meaning of Section 1557. The Department solicits comment regarding
the nature and magnitude of such ongoing costs incurred by covered entities.
The proposed rule would also carry intangible benefits, most important of which is
that covered entities would enjoy increased freedom to adapt their Section 1557
compliance programs to most efficiently address their particular needs, benefiting both
covered entities and individuals. The value of knowledge of civil rights is difficult to
quantify. Covered entities would be free under the proposed rule to implement policies and
procedures that comply with Federal civil rights laws in creative, effective, and efficient
ways that are tailored to the covered entities and the communities that they serve.
The Section 1557 Regulation likely induced many covered entities to conform their
policies and operations to reflect gender identity as protected classes under Title IX. The
Department anticipates that, as a result of the proposed rule, some – but not all – covered
entities may revert to the policies and practices they had in place before the agency actions
that created confusion regarding Title IX’s definition of discrimination on the basis of
sex.188 Such a reversion may naturally entail amending organizational nondiscrimination
policies and training materials, and communicating those changes to employees. The
process of voluntarily reverting to previous practices would cost covered entities some
time and money. In addition, the Department believes that, under the proposed rule, some
covered entities would no longer incur labor costs pursuant to the Section 1557 Regulation
188Covered entities located in jurisdictions that prohibit sexual orientation and gender identity
discrimination under State or local laws likely already have policies, training, or grievance procedures
concerning sexual orientation and gender identity and likely would not change their policies under the
proposed rule.
125
associated with processing grievances related to sex discrimination complaints as they
relate to gender identity under Title IX because such claims would not be cognizable under
the proposed rule.
The Department, however, is uncertain as to the total number of covered entities
that would change their policies and grievance processes to reflect the understanding of
sex discrimination set forth in this proposed rule. It anticipates that such changes would be
influenced by a number of factors, including applicable State and local laws, along with the
covered entities’ experiences in implementing the previous definition. Accordingly, the
Department, at this time, cannot estimate the number of covered entities that would revert
to the previous interpretation of “sex” under their internal policies and operations and the
related cost and benefits from such change in behavior. The Department solicits public
comments and data on this question.
Consequently, the Department also lacks the data necessary to estimate the number
of individuals who currently benefit from covered entities’ policies governing
discrimination on the basis of gender identity who would no longer receive those benefits
as a consequence of the rule—notwithstanding that nothing in the rule precludes covered
entities from continuing such policies voluntarily. The Department seeks comments on this
question.
The Department also solicits comments regarding this and other intangible benefits
that would be conferred by this proposal.
c. Baseline Assumptions
126
The following discussion identifies the economic baseline from which the
Department measures the expected costs and benefits of the proposed rule. Its baseline
includes the cost estimates in the Final Rule, in addition to data it has gathered since the
Final Rule was implemented, as described in more detail below.
Key assumptions include the following: (1) the Final Rule triggered significant
voluntary activity on the part of covered entities, generating both costs and benefits; (2)
covered entities were already complying with civil rights laws and related regulations that
were in effect before the Final Rule and, thus, the proposed rule does not impose any new
burden by reaffirming the requirements of those laws; (3) the projected costs from the
Final Rule for years 1 and 2 have been incurred, and the projected costs from years 3, 4,
and 5 have not been incurred; (4) repeal of the Final Rule’s notice and taglines
requirements would not affect notice or tagline requirements required by Centers for
Medicare & Medicaid Services guidance or regulations that do not reference, rely on, or
depend upon the taglines requirements of the Final Rule; (5) a relatively small percentage
of physicians and hospitals currently append notices and taglines to billing statements sent
to patients, while all insurance companies append notices and taglines to their
explanations of benefits statements; and (6) covered employers are more likely to train
employees who interact with the public than those who do not.
d. Covered Entities
(1) Entities Covered By Section 1557
127
The Final Rule and the proposed rule replacing Section 1557 apply to any entity that
has a health program or activity, any part of which receives Federal financial assistance
from the Department, any program or activity administered by the Department under Title
I of the PPACA, or any program or activity administered by an entity established under
such Title. Covered entities under the current rule’s definition 189 include:
(a) Entities with a Health Program or Activity, Any Part of Which Receives Federal
Financial Assistance from the Department
The RIA for the Final Rule stated that the Department, through agencies such as the
Health Resources and Services Administration (HRSA), the Substance Abuse and Mental
Health Services Administration (SAMHSA), the Centers for Disease Control and Prevention
(CDC), and the Centers for Medicare & Medicaid Services (CMS), provides Federal financial
assistance through various mechanisms to health programs or activities of local
governments, State governments, and the private sector. An entity may receive Federal
financial assistance from more than one component in the Department. For instance,
Federally qualified health centers receive Federal financial assistance from CMS by
participating in Medicaid programs and may also receive Federal financial assistance from
HRSA through grant awards. Because more than one funding stream may provide Federal
financial assistance to an entity, the examples we provide may not uniquely capture entities
189As noted above, we use the list and number of covered entities and other figures from the 2016 Final
Rule’s RIA in this RIA for the sake of consistency and convenience, but such use does not mean that we adopt
or accept any of the underlying analysis, definitions, or assumptions from the Final Rule’s RIA for any other
purpose related to this proposed rule.
128
that receive Federal financial assistance from only one component of the Department.
Under the Final Rule, the covered entities consisted of the following:
(i) Entities receiving Federal financial assistance through their participation in
Medicare (excluding Medicare Part B) or Medicaid (about 133,343 facilities). 190 Examples
of these entities cited in the 2016 RIA include:
⦁ Hospitals (includes short-term, rehabilitation, psychiatric, and long-term)
⦁ Skilled nursing facilities/nursing facilities (facility-based and freestanding)
⦁ Home health agencies
⦁ Physical therapy/speech pathology programs
⦁ End stage renal disease dialysis centers
⦁ Intermediate care facilities for individuals with intellectual disabilities
⦁ Rural health clinics
⦁ Physical therapy—independent practice
⦁ Comprehensive outpatient rehabilitation facilities
⦁ Ambulatory surgical centers
⦁ Hospices
⦁ Organ procurement organizations
⦁ Community mental health centers
⦁ Federally qualified health centers.
190CMS, Provider of Service file (June 2014), https://www.cms.gov/Research-Statistics-Data-and-

Systems/Downloadable-Public-Use-Files/Provider-of-Services/POS2014.html.
129
(ii) Laboratories that are hospital-based, office-based, or freestanding that receive
Federal financial assistance through Medicaid payments for covered laboratory tests
(about 445,657 laboratories with Clinical Laboratory Improvement Act certification).
(iii) Community health centers receiving Federal financial assistance through grant
awards from HRSA (1,300 community health centers).191
(iv) Health-related schools in the United States and other health education entities
receiving Federal financial assistance through grant awards to support 40 health
professional training programs that include oral health, behavioral health, medicine,
geriatric, and physician’s assistant programs.192
(v) State Medicaid agencies receiving Federal financial assistance from CMS to
operate CHIP (includes every State, the District of Columbia, Puerto Rico, Guam, the
Northern Marianas, U.S. Virgin Islands, and American Samoa).
(vi) State public health agencies receiving Federal financial assistance from CDC,
SAMHSA, and other HHS components (includes each State, the District of Columbia, Puerto
Rico, Guam, the Northern Marianas, U.S. Virgin Islands, and American Samoa).
(vii) Qualified health plan issuers receiving Federal financial assistance through
advance payments of premium tax credits and cost-sharing reductions (which include at
least the 169 health insurance issuers in the Federally-facilitated Exchanges receiving
191 HRSA, Justification of Estimates for Appropriation Committee For Fiscal Year 2016, 53,
http://www.hrsa.gov/about/budget/ budgetjustification2016.pdf.
192 HRSA, Justification of Estimates for Appropriation Committee For Fiscal Year 2016, 53,
http://www.hrsa.gov/about/budget/ budgetjustification2016.pdf.
130
Federal financial assistance through advance payments of premium tax credits and cost
sharing reductions and at least 11 health insurance issuers operating in the State
Exchanges).193
(viii) Physicians receiving Federal financial assistance through Medicaid payments,
‘‘meaningful use’’ payments, and other sources, but not Medicare Part B payments;
Medicare Part B payments to physicians are not Federal financial assistance. The Medicare
Access and CHIP Reauthorization Act amended Section 1848 of the Act to sunset
‘‘meaningful use’’ payment adjustments for Medicare physicians after the 2018 payment
adjustment.
In the 2016 rulemaking, the Department estimated that the Final Rule likely covers
almost all licensed physicians because they accept Federal financial assistance from
sources other than Medicare Part B. Many physicians participate in more than one Federal,
State, and local health program that receives Federal financial assistance, and many
practice in several different settings which increases the possibility that they may receive
payments constituting Federal financial assistance.
For the sake of consistency and convenience, the Department uses the 2016 RIA
estimate of the number of physicians receiving Federal financial assistance. As the 2016
RIA noted, based on 2010 Medicaid Statistical Information System data (the latest
available), about 614,000 physicians accept Medicaid payments and are covered under
193Qualified Health Plans Landscape Individual Market Medical (2015),

https://data.healthcare.gov/dataset/2015-QHP-Landscape-Individual-Market-Medical/mp8z-jtg7.
131
Section 1557 as a result.194 This figure represents about 69% of licensed physicians in the
United States when compared to the 890,000 licensed physicians reported in the Area
Health Resource File.195 In addition, physicians receiving Federal payments from non-Part
B Medicare sources will also come under Section 1557. The 2016 RIA noted that, as of
January 2014, 296,500 Medicare-eligible professionals had applied for funds to support
their ‘‘meaningful use’’ technology efforts. 196 Adding the approximately 614,000 physicians
who receive Medicaid payments to the 296,500 physicians who receive meaningful use
payments yields over 900,000 physicians potentially reached by Section 1557 because they
participate in Federal programs other than Part B of Medicare. Because physicians can
receive both Medicaid and meaningful use payments, and these figures are not adjusted for
duplication, the 900,000 result is best interpreted as an upper bound.
When the Department compared the upper bound estimated number of
physicians participating in Federal programs other than Medicare Part B (over 900,000) to
the number of licensed physicians counted in HRSA’s Area Health Resource File
(approximately 890,000), and allowing for duplication in both the Medicare/Medicaid and
HRSA numbers,197 the Department concluded in the 2016 RIA that almost all practicing
194 John Holahan and Irene Headen, Kaiser Commission on Medicaid and the Uninsured, Medicaid Coverage
and Spending in Health Reform: National and State-by-State Results for Adults at or Below 133% FPL (2010),
https://kaiserfamilyfoundation.files.wordpress.com/2013/01/medicaid-coverage-and-spending-in-health-
reform-national-and-state-by-state-results-for-adults-at-or-below-133-fpl.pdf. Estimates are based on data
from FY 2010 MSIS.
195 HRSA, Area Health Resource Files (2015), http://ahrf.hrsa.gov.
196 Mynti Hossain and Marsha Gold, Mathematical Policy Research Inc.: Prepared for The Office of the National
Coordinator for Health Information Technology, HHS, Monitoring National Implementation of HITECH: Status
and Key Activity Quarterly Summary (Jan. to Mar. 2014), http://www.healthit.gov/sites/default/
files/globalevaluationquarterlyreport januarymarch2014.pdf.
197 The Area Health Resource File itself double counts physicians who are licensed in more than one State.
132
physicians in the United States are reached by Section 1557 because they accept some form
of Federal remuneration or reimbursement apart from Medicare Part B.
The Department invites the public to submit information regarding physician
participation in health programs or activities that receive Federal financial assistance.
(b) Programs or Activities Administered by the Department under Title I of the PPACA
This proposed rule applies to programs or activities administered by the
Department under Title I of the PPACA. Such programs or activities include temporary high
risk pools (section 1101), temporary reinsurance for early retirees (section 1102),
Department mechanisms for identifying affordable health insurance coverage options
(section 1103), the wellness program demonstration project (section 1201, adding Public
Health Service (PHS) Act 2705(l)), the provision of community health insurance options
(section 1323), and the establishment of risk corridors for certain plans (section 1342).
(c) Entities Established under Title I of PPACA
This proposed rule applies to the health insurance exchanges established under
Title I of PPACA. Such exchanges currently include the 12 State Exchanges, 5 State
Exchanges on the Federal platform and 34 Federally-facilitated Exchanges. 198 Title I
additionally establishes State advisory councils concerning community health insurance
(section 1323) and certain reinsurance entities under the transitional reinsurance program
(section 1341).
198CMS, State-Based Exchanges for Plan Year 2018 (Nov. 13, 2018),
https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/state-marketplaces.html.
133
(2) Entities Covered by Title IX
Title IX applies to recipients of Federal financial assistance for education programs
or activities. 20 U.S.C. 1681. The population of applicable covered entities is defined by the
term “recipient” in the Department’s Title IX regulations. The population includes any State
or political subdivision thereof, or any instrumentality of a State or political subdivision
thereof, any public or private agency, institution, or organization, or other entity, or any
person, to whom Federal financial assistance is extended directly or through another
recipient and that operates an education program or activity that receives such assistance,
including any subunit, successor, assignee, or transferee thereof. See, e.g., 45 CFR § 86.2.
Under the definition of program or activity, recipients of Federal financial assistance within
the scope of Title IX may include colleges, universities, local educational agencies,
vocational education systems, or other entities or organizations principally engaged in the
business of providing education. See, e.g., 45 CFR Part 86, App. A (cross-referencing
Appendix B to 45 CFR Part 80).
e. Cost Savings from Eliminating Notice and Taglines Requirement
The Department’s baseline for calculating the savings from repealing the notice and
taglines requirement includes approximately $0.632 billion in additional average annual
costs from the requirement that were not considered in the 2016 rulemaking. It is
important to note that, while industry estimates prompted the Department to reassess the
burdens imposed by the Final Rule, the Department conducted and relied upon its own cost
analysis in developing the RIA for this proposed rule.
134
The Final Rule assessed $7.1 million for covered entities and $70,400 for the Federal
government in combined annual costs for printing and distributing nondiscrimination
notices and taglines, with the costs being apportioned roughly equally between notices and
taglines. 81 FR at 31453. As explained in detail below, the Department estimates the
combined notice and taglines requirement actually costs covered entities hundreds of
millions of dollars per year, as explained in this analysis.
The Final Rule requires covered entities to include a notice and taglines for any
“significant” document or publication, but did not define the term “significant.” 45 CFR §
92.8(f)(1)(i).199 Thus, covered entities have reasonably interpreted this provision to
require a notice and taglines to accompany many communications from covered entities,
including annual benefits notices, medical bills from hospitals and doctors, explanations of
benefits from health insurance companies or health plans, and communications from
pharmacy benefit managers.
Covered entities such as plan administrators and pharmacy benefit managers have
reasonably interpreted this guidance to require a notice and taglines for an extraordinary
amount of mailed communications, including every auto-ship refill reminder, formulary
notice, and specialty benefit letter. Further, some other entities that operate in multiple
States have interpreted the Final Rule as requiring them to include taglines for as many as
60 languages, or to include that many taglines in mailed communications due to the cost or
199After publishing the Final Rule, OCR issued guidance explaining that any significant publication printed on
an 8.5 x 11 sheet of paper is not considered small sized and, thus, must include a minimum of 15 taglines. See
OCR, Question 23, General Questions about Section 1557 (May 18, 2017), https://www.hhs.gov/civil-
rights/for-individuals/section-1557/1557faqs/index.html.
135
technical barriers to customizing mailing inserts on a State-by-State basis and, thus, have
incurred costs to send up to an additional two double-sided pages of notices with each
communication.200
To estimate the volume of notices and taglines that accompany an annual benefits
notice, we began with the approximately 300 million persons in the United States who have
health insurance,201 or approximately 91% of the U.S. population. The Department then
assumed that the annual notice of benefits (that includes a notice and taglines) is sent to
each policyholder, not to each individual member of a covered household, such as covered
children. Of the total U.S. population, 306 million individuals belong to 117.7 million
households. For the data set relied on, a “household” includes “all the people who occupy a
housing unit. . . . The occupants may be a single family, one person living alone, two or more
families living together, or any other group of related or unrelated people 202 who share
living arrangements.”203 By implication, 17.3 million individuals do not belong to a
200 Although OCR has issued guidance stating that a covered entity may identify the top 15 languages spoken
across all the States that the entity serves, see https://www.hhs.gov/civil-rights/for-individuals/section-
1557/1557faqs/aggregation_tagline/index.html, evidence of notices that some covered entities shared with
OCR suggests covered entities with beneficiaries in multiple States may issue more comprehensive tagline
notices exceeding 15 languages, likely because of reasonable interpretations of the relevant provisions of the
Final Rule.
201 Calculated by subtracting total uninsured population (28.1 million as of 2016), see
https://www.census.gov/library/publications/2017/demo/p60-260.html, from the total U.S. Population

(327,350,075 as of March 14, 2018), see https://www.census.gov/popclock.
202 The calculations do not take into account households where two or more unrelated persons have
individual coverage, and thus receive separate annual notices at the same household. The Department
believes, however, that this exclusion has only a minor impact on the overall figures but welcome comments
on whether they should be included.
203 U.S. Census Bureau, American Community Survey and Puerto Rico Community Survey 2016 Subject
Definitions 76, https://www2.census.gov/programs-

surveys/acs/tech docs/subject definitions/2016 ACSSubjectDefinitions.pdf (defining “household” under
“Household Type and Relationship”).
136
household,204 and live in group quarters.205 The Department assumed that the percentage
of the U.S. population that is uninsured, 9%, is the same percentage of U.S. individuals
belonging to U.S. households that are uninsured. To calculate the number of annual benefits
notices, the Department added the total number of individuals that do not belong to a
household (17.3 million) to the total number of households (117.7 million), and discounted
the sum (135 million) by 9% to exclude those individuals who are not insured. The total
number of annual notices of benefits that include a nondiscrimination notice and taglines is
therefore approximately 123 million (approximately 91% of 135 million).
To estimate the volume of notices and taglines that accompany auto-reenrollment
communications from the health insurance Exchanges, the Department assumes the
Exchanges send these communications to the 11.8 million individuals enrolled in the
individual market.206 It assumes that the Exchanges send out approximately 1.5 notices per
person per year. This accounts for the annual re-enrollment communication plus additional
204 The Department subtracted 306 million individuals belonging to a household from the total US population
in of 323.4 million individuals. See U.S. Census Bureau,
https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?src=bkmk (relied on 2016
population nationally).
205 U.S. Census Bureau, American Community Survey and Puerto Rico Community Survey 2016 Subject
Definitions 76, https://www2.census.gov/programs-

surveys/acs/tech_docs/subject_definitions/2016_ACSSubjectDefinitions.pdf (“People not living in
households are classified as living in group quarters.”). “Group quarters include . . . college residence halls, . . .
skilled nursing facilities, . . . correctional facilities, and workers’ dormitories.” U.S. Census Bureau, 2016
American Community Survey/Puerto Rico Community Survey Group Quarters Definitions, 1
https://www2.census.gov/programs-surveys/acs/tech_docs/group_definitions/2016GQ_Definitions.pdf.
206 See CMS, Health Insurance Exchanges 2018 Open Enrollment Period Final Report (Apr. 3, 2018),
https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-04-
03.html.
137
communications Exchanges will send for special enrollment periods. Thus, the total
estimated volume of notices and taglines attributable to the Exchanges is 17.7 million.
To estimate the volume of notices and taglines that accompany hospital bills and
explanations of benefits sent by insurance companies (or health plans) for hospital
admissions, the Department first estimated the total number of hospital bills and
explanation of benefits that would be sent to patients annually. There are 35,158,934
million hospital admissions per year. 207 For the purpose of this estimate, the Department
assumes that each admission generates three bills from one hospital visit—each of which
would include a notice and tagline document, for a total of 105,476,802 bills (35,158,934
admissions times three bills per admission).208 The Department assumes that 10% of the
105,476,802 bills will have a notice and tagline document attached, for a total of
10,547,680 notice and tagline documents.
For patients who were insured upon admission to the hospital, in addition to the
three hospital bills they would receive (on average), they would receive three associated
explanations of benefits from their insurer or health plan, each of which would also include
notice and tagline documents. If more than three service providers bill a patient for a
hospital visit, then the savings associated with this patient encounter would be greater
than estimated due to the additional notice and tagline documents that the insurer would
207 CDC, Chartbook on Long-Term Trends in Health (2016),

http://www.cdc.gov/nchs/data/hus/hus16.pdf#317.
208 The Department presumes one hospital visit likely will generate a bill from the physician and two bills
from any combination of services, such as anesthesia, ambulance service, imaging/radiology, or laboratory or
blood work.
138
send with each additional explanation of benefits beyond the initial three assumed. If less
than three service providers bill for a hospital visit, then the savings would be less due to
the decreased volume of notice and tagline documents that the insurer would send given
that the insurer would send fewer than three explanation of benefits. Given that
approximately 91% of the U.S. population is insured, the Department estimates that
approximately 32,104,054 admissions of the 35,158,934 million hospital admissions are
associated with insured patients (91% of 35,158,934 million hospital admissions). 209 This
assumption does not account for variation in health care consumption between the insured
and uninsured populations. It is possible that more hospital admissions are attributable to
the uninsured than the insured population. If such is the case, the Department’s estimate
for the number of notices and taglines attributable to explanations of benefits would be
lower. Further, this estimate does not account for outpatient hospital visits, which would
increase the volume of notices and taglines.
As discussed further below, the Department assumes 100% of insurance companies
are compliant with the notice and taglines requirement. Thus, approximately 96 million
notice and tagline documents are attributable to the explanations of benefits sent by
insurers (32,104,054 admissions times three explanation of benefits). Using rounded
https://www.census.gov/library/publications/2017/demo/p60-260.html, from the total U.S. Population in

2016 (323,405,935), see https://www.census.gov/popclock. The Department also notes that Gallup recently
conducted a study that shows that 12.2% of the U.S. Population is uninsured. See Zac Auter, U.S. Uninsured
Rate Steady at 12.2% in Fourth Quarter of 2017 (Jan. 16, 2016),
http://news.gallup.com/poll/225383/uninsured-rate-steady-fourth-quarter-2017.aspx?g source=Well-
Being&g medium=newsfeed&g campaign=tiles.
139
values, approximately 107 million additional notices and taglines (96 million plus 11
million) are related to hospital admissions.
To estimate the volume of notices and taglines that accompany doctor’s bills and
explanations of benefits from a physician’s visit, the Department relied on data showing
that individuals visit a doctor approximately 990 million times each year. 210 Given that
approximately 9%211 of Americans are uninsured, the Department assumes (and
subtracting an estimated 5% for uninsured patients who do not visit the doctor, except in
an emergency), 95% of individuals who see doctors every year are insured in some form.
The Department assumes that each visit to a compliant doctor’s office will generate at least
one bill from the doctor and at least one explanation of benefits from the health insurance
company. As explained below, it also assumes that 10% of doctors and 100% of insurance
companies comply with the notice and taglines requirement. Thus, approximately 99
million notices and taglines are attributable to doctors billing the patients directly and
approximately 941 million are attributable to explanations of benefits sent by insurers
which results in a total of 1.04 billion additional notices and taglines related to physician
visits. The Department seeks comment on these cost estimates, the frequency of
210 CDC, Ambulatory Care Use and Physician Office Visits (2016),
https://www.cdc.gov/nchs/fastats/physician-visits.htm. As noted above, the Department relies on the 2016
RIA assumption that virtually all doctors receive Federal financial assistance and, thus, are subject to the
2016 Final Rule.
https://www.census.gov/library/publications/2017/demo/p60-260.html, from the total U.S. Population in

2016 (323,405,935), see https://www.census.gov/popclock.
140
communications to which taglines and notices are sent, and how often insurers mail (other
otherwise, provide copies in person or via electronic delivery) documents to the ensured.
Because experience and substantial feedback from health care insurers suggests a
very high degree of compliance with the notice and taglines requirements concerning
documents such as explanations of benefits, the Department has presumed 100%
compliance for purposes of this RIA. Anecdotal evidence, however, suggests that hospital
and physician compliance with the notice and tagline requirements in the documents
discussed above is not standard industry practice. The Department estimates that, at most,
10% of such covered entities include notices and taglines in their significant mailed
communications with patients. While, according to the 2016 RIA, most hospitals and
physicians are covered entities under Section 1557, the Department believes their failure
to adopt notices and taglines as a standard billing and communication practice may be due
to the fact the notice and taglines requirement in the Final Rule mentions a duty to notify
“beneficiaries, enrollees, applicants, and members of the public” and does not explicitly
mention “patients.” 45 CFR § 92.8(a). Additionally, the preamble to the Final Rule explained
that the notice and taglines requirement covered communications “pertaining to rights or
benefits” which insurance companies have universally interpreted as applying to
significant numbers of communications they send to beneficiaries. 81 FR at 31402. For
these reasons, the Department’s calculations presume a 10% compliance rate for hospitals
and physicians and a 100% compliance rate by health insurance companies concerning the
141
notice and taglines requirement as it relates to bills and explanations of benefits,
respectively.
To estimate the volume of notices and taglines that accompany pharmacy-related
communications, the Department relied on estimates from the Pharmaceutical Care
Management Association, which, due to the nature of its organization, obtained an
estimated number of impacted beneficiaries from its member organizations.
Approximately 173 million beneficiaries are being impacted annually by the notice and
taglines requirement, and these beneficiaries receive between 6 and 28 communications
per year with an accompanying notice and taglines. The Department relied the average of
this estimate (17 communications per year per beneficiary) to determine that 2.9 billion
prescription-related communications (e.g., communications from pharmacy benefit
managers) are sent each year.212
The Department seeks comment on these calculations. In particular, it requests that
commenters identify significant communications sent by covered entities that include a
notice and taglines that have not been considered by this analysis, as well as the estimated
annual volume for such communications. The Department also seeks comment on whether
the estimates in this RIA for covered communications (communications subject to the
notice and taglines requirement) by health insurance companies or pharmacy benefit
managers are reasonable. The Department also seeks comment on the cost burden of, how
many entities utilize, how many beneficiaries opt for receipt of, and the expected
212 Source: Pharmaceutical Care Management Association (May 2, 2017).
142
effectiveness to LEP individuals of, providing non-paper notices or taglines relevant
communications related to prescriptions or explanations of benefits. The Department also
seeks comment from small, community, and independent providers and pharmacy benefit
managers about notices of availability of language assistance services for LEP individuals.
To calculate the costs of the notice and taglines requirement, the Department
assumes that the underlying communication to which a nondiscrimination notice and
taglines document is attached is a communication that is on average three sheets of paper
or less. Combined with the nondiscrimination notice and taglines (which constitute another
1-4 sides of a page, that is, 1 sheet single-sided213 to 2 sheets of paper double-sided), the
total number of sheets of paper that would be transmitted is equivalent to 4-5 sheets of
paper or less. The associated costs of the notice and taglines requirement are (1) materials,
(2) postage, and (3) labor. Because of the uncertainty around some of the estimates, we
report ranges for some values in this analysis.
For materials, the Department assumes that materials (paper and ink) per notice
and taglines mailing insert will cost between $0.025 and $0.10. The Department assumes
that low materials cost would be $0.025 to print a 1-page notice and taglines on a single
sheet of paper single-sided, and the high materials cost of $0.10 to print a 4-page notice and
taglines on 2 sheets of paper double sided. The Department seeks comment on its estimate
213Although this cost-benefit analysis assumes a lower-bound estimate that a notice of nondiscrimination and
15 taglines may be printed on one side of one sheet of paper, HHS believes that a notice of that length is likely
noncompliant with the current Section 1557 rule requirement to be posted “in conspicuously-visible font
size.” See also OCR, Sample Notice Informing Individuals About Nondiscrimination and Accessibility
Requirements and Sample Nondiscrimination Statement: Discrimination is Against the Law (printed on two
sides of one sheet of paper), https://www.hhs.gov/sites/default/files/sample-ce-notice-english.pdf.
143
of the length of the materials, including whether the required notice and taglines could
have fit on one side of one page only, and how often entities did so in compliance with the
requirement, as opposed to using 2-4 sides of a page.
For postage, the Department estimates that the additional weight of the notice and
tagline inserts result in a range of no incremental postage costs (low-end) to $0.21 per
mailing (high-end). For instance, if an underlying communication is three sheets of paper
or less, a covered entity’s inclusion of one double-sided page (or shorter) of notice and
taglines insert would likely weigh one ounce or less (approximately four letter-sized pages
weigh one ounce).214 Consequently, in this scenario, the notice and taglines insert would
not increase the total weight of the mailing beyond the one ounce of postage that a covered
entity would already expect to incur. If, however, a covered entity included 2 sheets of
paper double-sided containing the nondiscrimination notice and taglines, added to a
communication of three sheets of paper or more, , the total weight of the mailing would
likely be at least five sheets of paper, and therefore over one ounce. The marginal cost of
postage for each ounce is $0.21.215 The Department seeks comment on whether and how
often the required notice and tagline inserts are inserted in larger mailings so as not to
implicate the higher end of the estimated incremental postage costs.
214 See “How Many Sheets of Paper Fit in a 1 Ounce Envelope for Mailing Purposes,”
https://www.reference.com/business-finance/many-sheets-paper-fit-1-ounce-envelope-mailing-purposes-
84ba93a60789c2e1.
215 See U.S. Postal Service Postage Rates, https://www.stamps.com/usps/current-postage-rates/
144
For labor, the Department estimates the burden to download, print, and include
these notices and taglines with all significant communications for an office clerk
(Occupation Code No. 43-9061) with a mean hourly wage of $16.92/hour 216 plus an
additional $16.92/hour in fringe benefits, or $33.84/hour for labor costs. 217 Based on
experience, entities can manually fold and insert notices and taglines into envelopes at a
rate of approximately 360 per hour. Entities that use commercial machines can fold and
insert notices and taglines as fast as 5,400 envelopes per hour. 218 The Department uses the
median of 2,520 notices and taglines that can be folded and placed into an envelope in an
hour. Under these assumptions, the unit labor cost per notice and taglines mailing is $0.01,
or $56.2 million per year.
Considering materials, postage and labor, the per-unit cost for the notice and
taglines insert ranges from $0.035 at the low-end (for one single-sided sheet of paper of
notice and taglines) and $0.32 at the high-end (for two double-sided sheets of paper of
notice and taglines) if the Department assumes that the average underlying mailer is 3
sheets of paper. In addition, the Department estimates that some of these costs would be
mitigated absent regulatory action, due to transitions to electronic delivery for some
216 BLS, Occupational Employment and Wages (May 2018),

https://www.bls.gov/oes/2018/may/oes nat.htm.
217 CMS estimates that the labor costs would be a one-time cost of $16,244 for Medicaid managed care and a
one-time cost of $9,669 for CHIP managed care. The Department assumes for its calculations that the labor
costs for the notice and tagline provisions are not one-time but are ongoing costs associated with the value of
office clerks’ time printing and including the notices and taglines with significant publications and significant
communications.
218 See, e.g., Pitney Bowes, Relay Mid to High Volume Inserter Systems,
https://www.pitneybowes.com/us/shipping-and-mailing/inserters-sorters-printers/relay-mid-high-
volume-inserting-systems.html.
145
communications affected by the rule. The Department estimates electronic delivery would
reduce costs of affected communications by approximately 10-20% absent regulatory
action, shifting linearly from 10% in the first year to 20% in the fifth year following
implementation. Electronic delivery would eliminate postage costs, but may merely shift
the costs of paper and printing from the entity providing the communication to the
consumer/beneficiary/patient, given that some consumer/beneficiary/patient recipients
of electronic communications will print them out and incur costs for the paper and ink
associated with doing so. The Department has not included such
consumer/beneficiary/patient costs in its estimates, but requests comments on this issue,
including on whether there is a higher likelihood of electronic use than assumed here.
The Department averages the low and high-end estimates to determine a primary
estimate of annual cost savings, which results in average savings of approximately $0.632
billion per year after adjusting for electronic delivery.
These cost estimates are based on the Department’s own research and extensive
feedback from covered entities. It invites comment on these estimates, in particular the
average numbers of pages sent by covered entities and the costs for publishing and
distributing notices and taglines that may be borne by covered entities or types of
transactions that it has not identified in this discussion.
With repeal of the Final Rule requirements, the Department assumes that two other
regulatory requirements for taglines would also be fully repealed because they depend on,
or refer to, the Final Rule for authority for the tagline requirement. The first is the
146
The average of the low and high end estimates yields a primary estimate of annual
savings of approximately $0.632 billion after accounting for electronic delivery. The
Department assumes that the nine other CMS regulations or guidelines requiring taglines
will continue to be in effect, and the cost of complying with these CMS requirements would
need to be subtracted from the total savings that the Section 1557 Regulation’s rescission
generates for the health care sector as set forth in Table 2. These requirements include (1)
Group Health Plans and Health Insurance Issuers requirements 219; (2) Navigator
requirements220; (3) Non-Navigator Assistance Personnel requirements 221; Medicaid
requirements222; Medicaid Managed Care requirements223; CHIP requirements224; CHIP
Managed Care requirements225; Hospitals Qualifying for Tax-Exempt Status
requirements226; and Medicare Advantage (Part C) and Prescription Drug Plans (Part D)
requirements.227 Because the Department’s previous rulemaking on these CMS tagline
requirements did not attempt to estimate these costs, it invites comment on cost
implications here.
Other burdens imposed by the Final Rule’s notice and taglines requirements are
real, but difficult to quantify.
219 45 CFR § 147.136(e)(2)(iii) and (e)(3), and § 147.200(a)(5).

220 45 CFR § 155.215(c)(4).
221 45 CFR § 155.215(c)(4).
222 42 CFR § 435.905(b)(3).
223 42 CFR § 438.10(d)(2) through (3), (d)(5)(i) and (iii), and (j).
224 42 CFR § 457.340(a).
225 42 CFR § 457.1207.
226 26 CFR § 1.501(r) through 1(b)(24)(vi).
227 Medicare Marketing Guidelines § 30.5.1, https://www.cms.gov/Medicare/Health-
Plans/ManagedCareMarketing/FinalPartCMarketingGuidelines.html.
148
The vast majority of recipients of taglines do not require translation services. For
example, according to Census statistics, as of 2015, over three-quarters (79%) of the U.S.
population over age 18 speak only English at home, followed by Spanish (12.5%). 228
Additionally, of persons selecting a language preference when registering for coverage on
the HealthCare.gov platform for 2017, 89.93% selected English, followed by 8.36% who
selected Spanish.229 These data points indicate that, for the large majority of people who
receive them, the required language tagline mailings provide little to no benefit because
they are already proficient English speakers with little need for, and no entitlement under
the law to, translation services.
The Department has received many communications from beneficiaries and
advocacy groups complaining about the excessive amount of paperwork they receive.
These individuals and groups have explained that few people read the notice and taglines
and most ignore the last pages of lengthy health documents. These complaints make us
concerned that the Section 1557 Regulation has resulted in “cognitive overload,” such that
228 U.S. Census Bureau, B16007: Age by Language Spoken at Home for the Population 5 Years and Over, 2011 –
2015 American Community Survey (American FactFinder) (2017),
https://factfinder.census.gov/bkmk/table/1.0/en/ACS/16 5YR/S1601/0100000US. See also Kimberly
Proctor, Shondelle M. Wilson-Frederick, et al., The Limited English Proficient Population: Describing Medicare,
Medicaid, and Dual Beneficiaries, 2.1 Health Equity 87 (May 1, 2018),
http://online.liebertpub.com/doi/10.1089/heq.2017.0036 (identifying Spanish as the language of the largest
majority of limited English proficient speakers in Medicaid and Medicare, according to the 2014 American
Community Survey).
229 CMS, Race, Ethnicity, and Language Preference in the Health Insurance Marketplaces 2017 Open Enrollment
Period (April 2017), https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-

Highlight-Race-Ethnicity-and-Language-Preference-Marketplace.pdf. States that that do not use the
HealthCare.gov platform, such as California and New York, were not included in this report.
149
individuals experience a diminished ability to process information when inundated with
duplicative information and paperwork.
Additionally, documents that contain a significant number of pages that recipients
do not value will induce annoyance or frustration due to perceived wasting of time,
ignorance of the customers’ actual needs or language abilities, waste of economic
resources, or insensitivity to environmental concerns. These frustrations, though difficult
to quantify are reasonable to expect, given the large volume of health care communications
with notice and taglines that most Americans receive. It is also reasonable to expect that
repeated mailings of taglines to people who do not want them may negatively impact their
likelihood to read truly significant documents from their insurers or doctors, and may
negatively impact health outcomes in some cases.
The Department seeks comment on whether and how the Final Rule’s notice and
taglines requirements impose costs on covered entities and other downstream entities and
individuals.
f. Costs Arising from Removal of Notice and Taglines Requirement
Repealing the notice and taglines requirement may impose costs, such as decreasing
access to, and utilization of, health care for non-English speakers by reducing their
awareness of available translation services. Even so, such an impact is expected to be
negligible. Reports from covered entities suggest, anecdotally, that utilization of translation
services did not appreciably rise after the Final Rule’s imposition of notice and taglines
150
requirements.230 Furthermore, the Section 1557 requirement added 47 languages to
existing language access requirements, which only increased access to 0.4% of the entire
U.S. population. This is after broadly defining “limited English proficiency” to include those
who speak English “well” but not “very well.”231 The Department’s Office for Civil Rights
also produced a list of the top 15 languages in each State; however 26 of the languages on
OCR’s list are not spoken by even 0.004 percent of the population. In some States,
especially those with sparser populations, health insurance issuers must provide tagline
services in languages spoken by very few people in the State. For instance, in Wyoming,
issuers must provide translation notices in Gujarati and Navajo in every significant
communication sent to beneficiaries to account for approximately 40 Gujarati speakers and
39 Navajo speakers; in Montana issuers must provide notices to account for approximately
80 speakers of Pennsylvania Dutch; and in Puerto Rico, issuers must provide taglines
notices to account for approximately 22 Korean speakers and 22 French Creole
speakers.232 In addition, the Section 1557 Regulation omitted some languages, like
Hungarian, spoken by significant numbers of people in more densely populated States.
230 Source: Aetna (May 1, 2017).

231 See HHS OCR, Frequently Asked Questions to Accompany the Estimates of at Least the Top 15 Languages
Spoken by Individuals with Limited English Proficiency under Section 1557 of the Affordable Care Act,
Question 2 (Sept. 1, 2016), https://www.hhs.gov/civil-rights/for-individuals/section-1557/1557faqs/top15-
languages/index.html (using 2013 year estimates). See U.S. Census Bureau, Language Spoken at Home by
Ability to Speak English for the Population 5 Years and Over,
https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ACS 14 5YR B16001&
prodType=table (2016 year estimates).
232 OCR, Resource for Entities Covered by Section 1557 of the Affordable Care Act, Estimates of at Least the
Top 15 Languages Spoken by Individuals with Limited English Proficiency for the 50 States, the District of
Columbia, and the U.S. Territories (Aug. 2016), https://www.hhs.gov/sites/default/files/resources-for-
covered-entities-top-15-languages-list.pdf.
151
Regulations under Section 504 of the Rehabilitation Act require the provision of
auxiliary aids and services in health programs or activities that receive Federal financial
assistance. 45 CFR § 84.52(d). Because the notice requirement under the Final Rule
requires frequent mailed notification of the availability of auxiliary aids and services,
repealing the notice of nondiscrimination requirement may result in additional societal
costs, such as decreased utilization of auxiliary aids and services by individuals with
disabilities due to their reduced awareness of such services. This impact may be limited,
however, because the Section 504 regulations already require recipients of Federal
financial assistance employing fifteen or more persons provide notice to participants,
beneficiaries, applications, employees, and other interested persons of the availability of
such aids and services. 45 CFR § 85.12 and § 84.22(f).
Additionally, an unknown number of persons are likely not aware of their right to
file complaints with the Department’s Office for Civil Rights and some unknown subset of
this population may suffer remediable grievances, but will not complain to OCR absent
notices informing them of the process.
g. Cost Savings from Changes to Language Access Plan Provisions
Although the Final Rule did not require covered entities to develop a language
access plan, the Rule stated that the development and implementation of a language access
plan is a factor the Director “shall” take into account when evaluating whether an entity is
in compliance with Section 1557. 45 CFR § 92.201(b)(2). Therefore, the Department
152
anticipated that 50% of covered entities would develop and implement a language access
plan following issuance of the Final Rule. 81 FR at 31454.
OCR estimated that the burden for developing a language access plan is
approximately three hours of medical and health service manager staff time in the first
year, and an average of one hour of medical and health service manager staff time per year
to update the plan in subsequent years. The value of an hour of time for people in this
occupation category, after adjusting for overhead and benefits, is estimated to be $109.36
based on Bureau of Labor Statistics (BLS) data for 2018. 233 The Department estimated that
approximately 269,141 entities could potentially make changes and develop language
access plans, as part of the requirement to take reasonable steps to provide meaningful
communication with LEP individuals (calculated by reducing the total number of entities
(275,002) by the number of hospitals and nursing care facilities that were already subject
to language access plan requirements under Medicare Part A (5,861). The Department
further assumed that only 50% of the identified entities would actually make changes to
implement a language access plan. These assumptions imply that the total cost of
developing language access plans will be approximately $44.1million (269,141 entities
multiplied by 50% of entities multiplied by 3 hours per entity multiplied by $109.36 per
hour) in the first year and approximately $14.7 million (269,141 entities multiplied by 50%
of entities multiplied by 1 hour per entity multiplied by $109.36 per hour) per year in
233BLS, Occupational Employment and Wages (May 2018),

https://www.bls.gov/oes/2018/may/oes nat.htm.
153
subsequent years. In making these calculations, the Department assumes sunk costs cannot
be recovered by this rule, and therefore that initial language access plan development costs
described above cannot be recovered.
By repealing the provision of the Final Rule regarding the Language Access Plans,
the Department estimates an annual savings are $14.7 million.
h. Cost Savings Attributed to Covered Entities’ Handling of Certain Grievances
The proposed rule proposes to repeal the requirement for each covered entity with
15 or more employees to have a compliance coordinator and a written grievance procedure
to handle complaints alleging violations of Section 1557. The Department estimates that,
under the proposed rule, covered entities would no longer have to incur certain labor costs
associated with processing grievances related to sex discrimination complaints as they
relate to gender identity and sex-stereotyping as defined under the Final Rule because such
definitions would be repealed and no longer binding under the proposed rule. This
proposed repeal would not, however, affect the independent obligations of Section 1557
covered entities to comply with Federal regulations under Section 504 and Title IX to have
written processes in place to handle grievances alleging certain disability and sex
discrimination claims, respectively.234
234See, e.g., 45 CFR § 84.7(a) (HHS regulations implementing Section 504) (requiring a written process in
place for handling grievances alleging disability discrimination), § 86.8(a)(HHS regulations implementing
Title IX) (requiring a written process in place for handling grievances alleging sex discrimination).
154
For the sake of consistency and convenience, the Department uses the methodology
from the 2016 Final Rule as a foundation for estimating the projected savings of this
proposed rule provision.
The 2016 Final Rule estimated that, in years three through five of the Final Rule’s
implementation, covered entities with 15 or more employees would incur $85.5 million in
costs annually to handle Section 1557 grievances. 81 FR at 31458. This estimate assumed
that covered entities would experience an average increase in grievances equal to OCR’s
projected long-term increase in caseload of about 1%. 81 FR at 31376. The 2016 Final Rule
monetized this 1% increase in caseload as a labor cost equivalent to 1% of the annual
median wage for a medical and health service manager (occupation code 11-9111). 81 FR
at 31376. The Department continues to assume that OCR’s increase in caseload attributed
to the 2016 Final Rule reasonably informs the increase in grievance processing that
covered entities experience.
Based on OCR’s tracking of Section 1557 complaints received from promulgation of
the Final Rule (May 18, 2016) until present, OCR predicts that its long-term caseload would
have increased 5% rather than 1% as originally predicted. Further, OCR believes roughly
60% of this increase (which equals 3% of the overall increase) would have been
attributable to discrimination claims based on the Final Rule’s definition of sex
discrimination with respect to gender identity and sex stereotyping. The Department uses
the phrase “would have” with regard to OCR’s caseload because, as described above, the
155
Department has been enjoined by a Federal court from enforcing claims based on the Final
Rule’s novel definition of sex discrimination.
The Final Rule asserted that private parties have the right to challenge a violation of
Section 1557 or the Final Rule in Federal court, independent of OCR enforcement or
involvement. 45 CFR § 92.302(d). In the preamble to the Final Rule, the Department
estimated that the ability for private parties to sue under the Final Rule would result in
covered entities bearing increased compliance costs. 81 FR at 31395 (“the presence of a
coordinator and grievance procedure enhances the covered entity’s accountability and
helps bring concerns to prompt resolution, oftentimes prior to an individual bringing a
private right of action.”). The injunction does not apply to suits filed by private parties.
Although the Supreme Court has recognized a private right of action for some civil
rights statutes enforced by the Department, with the proposed rule change, the Department
would no longer assert that a private right of action exists for parties to sue covered
entities for any and all alleged violations of the proposed rule. The Department would no
longer take a position on that issue in its regulations, leaving the matter as primarily one
for the courts to decide. Additionally, by virtue of rescinding the definitions from the
regulatory text, the proposed rule would remove the expansive inclusion of gender identity
and sex stereotyping in the definition of sex discrimination as substantive grounds for a
private right of action alleging such violations by covered entities. As a result, a certain
number of covered entities that are currently incurring grievance-related costs related to
these claims may no longer incur such costs under the proposed rule.
156
For reasons set forth above, the Department estimates that covered entities have
experienced a 3% increase in grievance claims over the long term concerning gender
identity and sex stereotyping claims as set forth under the Final Rule and that, under the
proposed rule, they would no longer have to process such claims under the grievance
procedures required under the Final Rule. However, due to voluntary policies or more
stringent State requirements, the Department expects that 50% of covered entities would
likely continue to accept and handle grievances alleging discrimination based on gender
identity and sex stereotyping as set forth under the Final Rule, notwithstanding that this
proposed rule would eliminate those provisions. Consequently, the Department estimates
that only approximately half of the 3% increase in caseload, or about 1.5%, will be realized
as annual savings by covered entities. The annual savings in labor attributed to a 1.5%
decrease in grievance caseload is $123.4 million. This value represents 1.5% of the annual
median wage of a medical and health service manager ($199,472 fully loaded) multiplied
by the 41,250 covered entities with 15 or more employees.
i. Additional Costs for Training and Familiarization under Proposed Rule
To comply with the proposed rule, the Department anticipates that some covered
entities may incur costs to re-train employees in order realize potential longer term costs
savings from the deregulatory aspects of this proposed rule change, for example, provisions
eliminating the need for certain grievance procedures described in the preceding section.
The Department assumes that employers are most likely to train employees who interact
with the public, and will therefore likely train between 40% and 60% of their employees, as
157
the percentage of employees that interact with patients and the public varies by covered
entity. For purposes of the analysis, the Department assumes that 50% of the covered
entity’s staff will receive one-time training on the requirements of the regulation. It uses
the 50% estimate as a proxy, given the lack of certain information as described below. For
the purposes of the analysis, the Department does not distinguish between employees
whom covered entities will train and those who obtain training independently of a covered
entity.
(1) Number of Covered Entities That May Train Workers
The Final Rule estimated that 275,002 covered entities would train their employees
on the Rule’s requirements in general (including training regarding language access
provisions), and used that 275,002 figure as the basis for calculating costs to covered
entities arising specifically out of the Rule’s prohibition on discrimination on the basis of
sex. See 81 FR at 31450. HHS assumes, for purposes of this analysis, that the Final Rule’s
estimation was an accurate and reasonable basis for calculating costs arising out of the
Final Rule’s prohibition of sex discrimination. However, HHS seeks comment on the
accuracy of these assumptions and calculations.
Table 3—Number of Health Care Entity Firms Covered by Rule

Number
NAIC Entity type
of firms
62142 Outpatient mental health and substance abuse centers 4,987
621491 HMO medical centers 104
621492 Kidney dialysis centers 492
621493 Freestanding ambulatory surgical and emergency centers 4,121
621498 All other outpatient care centers 5,399
6215 Medical and diagnostic laboratories 7,958
158
6216 Home health care services 21,668

6219 All other ambulatory health care services 6,956
62321 Residential intellectual and developmental disability facilities 6,225
6221 General medical and surgical hospitals 2,904
6222 Psychiatric and substance abuse hospitals 411
6223 Specialty (except psychiatric and substance abuse) hospitals 373
6231 Nursing care facilities (skilled nursing facilities) 8,623
44611 Pharmacies and drug stores 18,852
6211 Offices of physicians 185,649
524114 Insurance Issuers 180
Navigator grantees 100
Total Entities 275,002
(2) Number of Individuals Who Will Receive Training
The first category of health care staff that may receive training comprises health
diagnosing and treating practitioners. This category includes physicians, dentists,
optometrists, physician assistants, occupational, physical, speech and other therapists,
audiologists, pharmacists, registered nurses, and nurse practitioners. The BLS occupational
code for this grouping is 29-1000 and the 2018 reported count for this occupational group
is approximately 5.4 million with average loaded wages of $98.04 per hour.
The second category of health care staff that the Department assumes will receive
training comprises degreed technical staff (Occupation code 29-2000) and accounts for 3.1
million workers with average loaded wages of $46.52 per hour. Technicians work in almost
every area of health care: x-ray to physical, speech, psychiatric, dietetic, laboratory,
nursing, and records technicians, to name but a few areas.
The third category of health care staff that the Department assumes will receive
training comprises non-degreed medical assistants (Occupation code 31-0000), and
159
includes psychiatric and home health aides, orderlies, dental assistants, and phlebotomists.
Health care support staffs (technical assistants) operate in the same medical disciplines as
technicians, but often lack professional degrees or certificates. The Department refers to
this workforce as non-degreed compared to medical technicians who generally have
degrees or certificates. There are approximately 4.1 million individuals employed in these
occupations with average loaded wages of $31.14 per hour.
The fourth category of health care staff that the Department assumes will receive
training is health care managers (approximately 0.4 million based on BLS data for
occupation code 11-9111) with average loaded wages of $109.36 per hour. Because the
Department assesses costs of familiarization with the regulation for one manager at each
entity, it assumes that those managers will have already become familiar with the
regulation and will not need additional training.
The fifth category of health care staff that the Department assumes will receive
training is office and administrative assistants—Office and Administrative Support
Occupation (Occupation code 43-0000). These workers are often the first staff patients
encounter in a health facility and, because of this, covered entities might find it important
that staff, such as receptionists and assistants, receive training on the regulatory
requirements. Approximately 2.8 million individuals were employed in these occupations
in health facilities in 2018 with average loaded wages of $36.50 per hour. The Department
assumes that outreach workers are included in the five categories listed above, especially
in the manager category.
160
(3) Total Cost of Training
The Final Rule estimated that covered entities would incur $420.7 million in
undiscounted costs to train employees on the requirements of the Rule, distributed roughly
evenly over the first two years after the Final Rule’s effective date. 81 FR at 31458. This
conclusion presumed covered entities were already periodically training employees on
their obligations under Section 1557, but that the Final Rule’s new sex discrimination
requirements would induce covered entities to engage in additional “comprehensive
training.” 81 FR at 31447.
For the purposes of this regulatory impact analysis, the Department assumes covered
entities would face similar costs to retrain the workforce on the proposed rule’s
requirements.235 However, because some covered entities will avoid incurring training
expenses when they are not required to (and they will not be under the proposed rule), and
because several States with large populations already prohibit gender identity
discrimination in health care, the Department further assumes that only 50% of covered
entities would modify their policies and procedures to reflect the changes in the proposed
rule. The Department further assumes that the same percentage, 50%, of covered entities,
or 137,501, would train their employees to reflect the changes in the proposed rule. As in
the Final Rule, the Department assumes that approximately half of the employees at these
235Training costs in the Final Rule relied upon 2014 wages. See, e.g., 81 FR at 31451 (estimating the median
hourly wage for occupation code 29-1000 at $36.26, unloaded, at
https://www.bls.gov/oes/2014/may/oes nat.htm#29-0000https://www.bls.gov/oes/tables.htm (OES Data:
May 2014).https://www.bls.gov/oes/2014/may/oes nat.htm#29-
0000https://www.bls.gov/oes/2014/may/oes nat.htm#29-0000).
161
covered entities will engage in an average of an additional hour of training, and that this
will occur in the first year of implementing this rule. These assumptions imply total
training costs of $235.9 million. The Final Rule’s calculations of training costs did not
anticipate any ongoing training costs after year one – either in the form of annual refresher
training for returning employees or training for new employees. The Department now
believes that covered entities likely incur such costs, but assumes that equal costs would
also be incurred under the proposed rule. Therefore, HHS has excluded ongoing training
costs from the calculation of the baseline and from the calculation of the projected costs of
the proposed rule, because such training has a net zero effect on projected costs. HHS
solicits comment on the foregoing assumptions and calculations of the costs of training
under the Final Rule and the proposed rule.
j. Additional Costs for Revising Policies and Procedures
As discussed above, the Department anticipates that 50% of covered entities, or
approximately 137,501 entities, would choose to revise their policies or procedures to
reflect this proposed rule’s clarification of the application of Section 1557 (if finalized as
proposed), while other covered entities may retain their policies to ensure compliance with
State or local laws. The Department assumes that it would take, on average, three to five
hours for a provider to modify policies and procedures concerning the Section 1557
proposed rule. The Department selects four hours, or the midpoint of this range, for the
analysis. HHS further assumes that an average of three of the hours would be spent by a
mid-level manager equivalent to a front-line supervisor (Occupation code 43–1011), at a
162
cost of $57.06 per hour236 after adjusting for overhead and benefits, and an average of one
hour would be spent by executive staff equivalent to a general and operations manager
(Occupation code 11–1021), at a cost of $119.12 per hour 237 after adjusting for overhead
and benefits. HHS solicits comment on the accuracy of these assumptions. The total cost for
the estimated 137,501 covered entities to make their policies and procedures consistent
with the proposed rule’s clarification of discrimination on the basis of sex is estimated to be
approximately $39.9 million following implementation of this rule.
The above estimates of time and number of entities that would choose to revise their
policies under the regulation are approximate estimates based on general BLS data. Due to
the wide range of types and sizes of covered entities, from complex multi-divisional
hospitals to small neighborhood clinics and physician offices, the above estimates of time
and number of entities that would choose to revise their policies under the regulation is
difficult to calculate.
k. Other Costs Due to Reversion to Previous Practices
The Final Rule may have prompted covered health care providers to institute
operational changes beyond their nondiscrimination policies and procedures. HHS solicits
comment on providers’ experience with the efficiency or cost-effectiveness of any such
operational changes made in response to the Final Rule. To the extent that such changes
required more than a de minimis cost to implement, providers that choose to revert to
236 BLS, Occupational Employment and Wages, May 2018, https://www.bls.gov/oes/2018/may/oes nat.htm.
237 Id.
163
previous practices may incur more than a de minimis cost in making that reversion.
However, as such changes would likely be voluntary, HHS assumes that providers would
make such changes because they determined them to be cost-effective. HHS solicits
comment on the accuracy of this assumption.
l. Other Benefits or Costs
The Final Rule’s regulatory impact analysis did not include an economic cost-benefit
analysis of the impact of the regulation on health insurance benefit design. The Department
lacks sufficient data on how much burden the Final Rule has placed on the development
and operation of insurance benefits policies, and, thus, is unable to fully assess the benefit
of removing this requirement. The Final Rule was intended to impact benefit design by
applying Section 1557’s nondiscrimination requirements to denial, cancellation, limitation,
refusal to issue, refusal to renew, or categorical exclusion of certain benefits related to
gender identity. A Federal court, however, enjoined application of the Final Rule in this
manner on a nationwide basis immediately before the start of the first plan year after the
Final Rule came into effect, thus, OCR has not enforced the Final Rule’s benefit design
provisions as they relate to coverage of gender identity-related treatments.
The Department does not know what effect the Final Rule, in conjunction with the
court injunction, has had on benefit design with respect to coverage of gender identity-
related treatments. It, therefore, does not have enough information to estimate effects from
the proposal to repeal of the Final Rule’s benefit design requirements. The Department
believes, however, that because a Federal court enjoined enforcement of the Section 1557
164
Regulation before the start of the first plan year in which the current rule would have
applied, that beneficiaries of the expanded gender identity provisions could not have
developed a reliance interest on the enjoined parts of the rule. The Department seeks
comments on the effective date of repeal of the gender identity benefit design provisions.
Additionally, aside from benefit design questions, the Department seeks comment
and documentation of cases where, despite the preliminary injunction barring OCR from
enforcing the provisions, persons would not have received treatments or procedures
related to gender identity or termination of pregnancy, but for the Final Regulation’s
gender identity and termination of pregnancy provisions.
The Department does not estimate any cost savings related to decreased OCR
enforcement of gender identity related claims under the proposed rule because the
injunction has generally prevented OCR enforcement of such claims to date and the
proposed rule would thus merely reflect the status quo and not result in additional cost
savings related to OCR enforcement expenditures.
Continued enforcement of Section 1557 includes vindication of legal rights, the
benefits of which are difficult to quantify. The proposed rule would continue to prohibit
covered entities from discriminating against patients and beneficiaries on the basis of their
race, color, national origin, disability, age, or sex. OCR will continue to vigorously enforce
civil rights in order to help guarantee more access to health care and concomitant
improved health outcomes—but these benefits are difficult to estimate given that many of
the prohibitions encompassed by the proposed rule, as with the Final Rule, have been in
165
place at the Federal level for many years or have been otherwise required by State or local
law. We welcome comments on these issues.
7. Impact on State, Local, and Tribal Entities under Executive Orders 12866, 13132, and
13175
a. State and Local Governments
Executive Order 13132 establishes certain requirements that an agency must meet
when it issues a proposed rule (and subsequent Final Rule) that imposes substantial direct
requirement costs on State and local governments, preempts State law, or otherwise has
federalism implications. Executive Order 13132, 64 FR 43255 (Aug. 4, 1999). The
Department does not believe that this rulemaking would (1) impose substantial direct
requirements costs on State or local governments; (2) preempt State law; or (3) otherwise
have federalism implications. Section 1557 itself provides that it shall not be construed “to
supersede State laws that provide additional protections against discrimination on any
basis described in subsection (a) [of Section 1557].” 42 U.S.C. 18116(b).
The proposed rule maintains the full force of Federal civil rights laws’ protections
against discrimination, but does not attempt to impose a ceiling on how those protections
may be observed by States. State and local jurisdictions would continue to have the
flexibility to impose additional civil rights protections.
The Department believes that there would be reduced costs to State and local
entities, by repealing wasteful Federal mandates and giving States more flexibility to
address the needs of LEP individuals or other regional-specific issues.
166
The Department believes that the proposed change to its Title IX regulations would
not have a substantial direct effect on the States, on the relationship between the national
government and the States, on the distribution of power and responsibilities among the
various levels of government, or on tribal self-government or sovereignty. The proposed
rule would not subject Title IX funding recipients to new obligations, but rather would
relieve potential burden on the States or tribes that could have resulted from the prior
interpretation of Title IX by HHS. The proposed rule would allow States and tribes to adopt
or continue to provide nondiscrimination protections on the basis of sexual orientation and
gender identity in State, local, and tribal law. Therefore, the Department has determined
that the proposed rule would not have sufficient federalism implications to warrant the
preparation of a federalism summary impact statement under Executive Order 13132, and
that the rule would not implicate the requirements of Executive Orders 12866 and 13175
with respect to tribes.
b. Tribal Governments
Executive Order 12866 directs that significant regulatory actions avoid undue
interference with State, local, or tribal governments, in the exercise of their governmental
functions. Executive Order 12866 at § 6(a)(3)(B). 238 Executive Order 13175 further directs
that Agencies respect Indian tribal self-government and sovereignty, honor tribal treaty
and other rights, and strive to meet the responsibilities that arise from the unique legal
relationship between the Federal Government and Indian tribal governments. Executive
238 As stated in the preceding section, the proposed rule does not have federalism implications.
167
Order 13175 at § 2(a). The Department does not believe that the proposed rule would
implicate the requirements of Executive Orders 12866 and 13175 with respect to tribal
sovereignty, and solicits comments from tribal representatives and tribal members on this
conclusion and all other provisions of this proposed rule as they relate to tribes.
8. Avoidance of Inconsistent, Incompatible, or Duplicative Regulations
Executive Order 12866 requires the Department to avoid issuing regulations that are
inconsistent, incompatible, or duplicative with other regulations that it has issued or that
have been issued by other Federal agencies. Executive Order 12866 at §1(b)(10). Section
1557 itself requires avoidance of duplication by providing that the enforcement
mechanism under specifically identified civil rights laws “shall apply for purposes of
violations” of Section 1557. 42 U.S.C. 18116(a). 239 The preamble to the Final Rule
repeatedly stated that, with the exception of issues concerning notices, sex discrimination,
and language access plans, it was merely applying civil rights protections that were already
applicable and familiar to covered entities. See 81 FR at 31446. (“It is important to
recognize that this final rule, except in the area of sex discrimination, applies pre-existing
requirements in Federal civil rights laws to various entities, the great majority of which
have been covered by these requirements for years.”); 81 FR at 31464 (“For the most part,
because this regulation is consistent with existing standards applicable to the covered
entities, the new burdens created by its issuance are minimal.”).
239For the applicable enforcement mechanisms, see 45 CFR Parts 80 and 81 (Title VI), 85 (Section 504), 86
(Title IX), 90 and 91 (Age Act).
168
With regard to the current Section 1557 Regulation’s notice and taglines
requirement, covered entities are already subject to dozens of regulations concerning
multi-language taglines or notices concerning an individual’s right to have documents
translated. For example, CMS imposes tagline requirements on health insurance
marketplaces, qualified health plan issuers, group health plans and health insurance
issuers, navigators, non-navigator assistance personnel, Medicaid, Medicaid managed care,
Children’s Health Insurance Program, Medicare Advantage, and Medicare Part D. 240
24045 CFR § 147.136(e)(2)(iii) and (e)(3) and § 147.200(a)(5) (requiring group health plans and QHP issuers
to post taglines in languages in which 10% of individuals with LEP county-wide are exclusively literate on
internal claims and appeals notices, and requiring QHP issuers to post on its Summary of Benefits and
Coverage), § 155.215(c)(4) (requiring Navigators and non-Navigator personnel in States with Marketplaces
operated by HHS to “[p]rovide oral and written notice to consumers with LEP, in their preferred language,
informing them of their right to receive language assistance services and how to obtain them”); 42 CFR
§ 435.905(b)(3) (Medicaid regulations requiring individuals to be “informed of the availability of language
services . . . and how to access . . . [them] through providing taglines in non–English languages indicating the
availability of language services”); § 438.10(c)(5)(i) through (ii) (Medicaid managed care regulations
requiring taglines until July 1, 2017); § 438.10(d)(2) through (3), (d)(5)(i), (d)(5)(iii) and (d)(5)(j) (Medicaid
managed care regulations requiring taglines on “all written materials for potential enrollees” in the prevalent
non-English languages in the State and requiring notification that “oral interpretation is available for any
language and written translation is available in prevalent languages” during the rating period for contracts
with managed care entities beginning on or after July 1, 2017), § 457.340(a) (applying certain Medicaid
requirements to the Children’s Health Insurance Program, including § 435.905(b)(3), which requires
individuals to be “informed of the availability of language services . . . and how to access . . . [them] through
providing taglines in non–English languages indicating the availability of language services”), 457.1207
(applying certain Medicaid managed care requirements to Children’s Health Insurance Program managed
care, including § 438.10(c)(5)(i)-(ii) until the State fiscal year beginning on or after July, 1, 2018), §
438.10(d)(2)-(3), (d)(5)(i), (iii), (j) (applying certain Medicaid managed care requirements to Children’s
Health Insurance Program managed care, in the State fiscal year beginning on or after July, 1, 2018); CMS,
2017 Medicare Marketing Guidelines, § 30.5.1, § 100.2.2, § 8, § 80-8 (Jun. 10, 2016),
https://www.cms.gov/Medicare/Health-
Plans/ManagedCareMarketing/Downloads/2017MedicareMarketingGuidelines2.pdf (providing a CMS Multi-
Language Insert” for certain Medicare Advantage Plan’s and Medicare Part D Plan Sponsors’ marketing
materials meeting the percentage translation threshold in § 422.2264(e) and § 423.2264(e) of Title 42 of the
CFR). As discussed in the RIA section of this NPRM, we presume 45 CFR 155.205(c)(2)(iii)(A) (requiring
Marketplaces and QHP issuers to post taglines on their websites and documents “critical for obtaining health
insurance coverage or access to health care services through a QHP”) and other provisions that depend or
refer to 45 CFR Part 92 for their tagline requirements would no longer apply if this proposed rule is finalized.
169
Furthermore, a Department of Treasury regulation imposed tagline requirements for
hospital organizations to qualify for tax-exempt status. 241 Additionally, in 2003, the
Department issued guidance under Title VI of the Civil Rights Act of 1964, setting forth a
flexible four-factor framework to assess the necessity and reasonableness for providing
written translation for LEP individuals. 242 Finally, the PPACA itself provides that each
summary of benefits and coverage provided by issuers—perhaps the single most important
health insurance-related document a person receives—must be “presented in a culturally
and linguistically appropriate manner.” 42 U.S.C. 300gg–15(b)(2).
Substantially replacing many provisions of the Final Rule as proposed, including
removing the notice and taglines requirements, would eliminate significant redundancies
identified above, while maintaining vigorous enforcement of existing Federal civil rights
statutes.
B. Executive Order 13771 on Reducing and Controlling Regulatory Costs
This proposed rule is expected to be an E.O. 13771 deregulatory action. The
Department estimates that this proposed rule would generate $532 million in net
annualized savings at a 7% discount rate (discounted relative to year 2016, over a
perpetual time horizon, in 2016 dollars).
241 See 79 FR 78954 (Dec. 31, 2014) (finalizing rule requiring the plain language summary of the financial
assistance policy for hospital organizations to qualify as tax exempt, to indicate, if applicable, whether the
summary, the financial assistance policy, and the application for such assistance are available in other
languages).
242 Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin
Discrimination Affecting Limited English Proficient Persons, 68 FR 47315 (Aug. 8, 2003) (HHS LEP Guidance).
170
Furthermore, Executive Order 13765 states that “the Secretary of Health and Human
Services (Secretary) and the heads of all other executive departments and agencies
(agencies) with authorities and responsibilities under the [PPACA] shall exercise all
authority and discretion available to waive, defer, grant exemptions from, or delay the
implementation of any provision or requirement of the [PPACA] that would impose a fiscal
burden on any State or a cost, fee, tax, penalty, or regulatory burden on individuals,
families, healthcare providers, health insurers, patients, recipients of healthcare services,
[or] purchasers of health insurance.” Executive Order 13765, 82 FR 8351, 8351 (Jan. 24,
2017). In implementing Section 1557 of the PPACA, the Section 1557 Regulation imposed
significant regulatory burdens on covered entities, including States, healthcare providers,
and health insurers, without corresponding benefits for patients or beneficiaries. By
proposing to substantially replace the Final Rule with a regulation that requires compliance
with pre-existing civil rights laws, the Department is acting in accordance with Executive
Order 13765 in exercising its authority and discretion to address the fiscal burdens on
States, and the regulatory burdens imposed on individuals, families, healthcare providers,
health insurers, patients, and recipients of healthcare service. The proposed rule would
particularly reduce the economic burden imposed on health care providers and insurers
required to provide taglines under the Final Rule. Decreasing the burden on these
providers and insurers will allow them to pass along some of the cost savings to
individuals, families, patients, and beneficiaries of insurance to whom they provide services
or coverage. Additionally, eliminating the taglines requirement will alleviate burdens on
171
patients and insurance beneficiaries that neither need nor want to receive repeated tagline
mailings.
C. Congressional Review Act
The Congressional Review Act (CRA) defines a ‘‘major rule’’ as ‘‘any rule that the
Administrator of the Office of Information and Regulatory Affairs (OIRA) of the Office of
Management and Budget finds has resulted in or is likely to result in—(A) an annual effect
on the economy of $100,000,000 or more; (B) a major increase in costs or prices for
consumers, individual industries, Federal, State, or local government agencies, or
geographic regions; or (C) significant adverse effects on competition, employment,
investment, productivity, innovation, or on the ability of United States-based enterprises to
compete with foreign-based enterprises in domestic and export markets.’’ 5 U.S.C. 804(2).
Based on the analysis of this proposed rule under Executive Order 12866, this proposed
rule, if finalized as proposed, is expected to be a major rule for purposes of the
Congressional Review Act because it proposes cost savings of over $100 million. The
Department will comply with the CRA’s requirements to inform Congress if applicable.
D. Unfunded Mandates Reform Act
The proposed rule is not subject to the Unfunded Mandates Reform Act because it
falls under an exception for regulations that establish or enforce any statutory rights that
prohibit discrimination on the basis of race, color, religion, sex, national origin, age,
handicap, or disability. 2 U.S.C. 1503(2).
172
E. Regulatory Flexibility Act and Executive Order 13272 on Proper Consideration of
Small Entities in Agency Rulemaking
The Regulatory Flexibility Act (RFA) requires agencies to analyze regulatory options
that would minimize any significant impact of a rule on small entities. Pub. L. 96-354, 94
Stat. 1164 (Sept. 19, 1980) (codified at 5 U.S.C. 601 through 612). The RFA requires an
agency to describe the impact of a proposed rulemaking on small entities by providing an
initial regulatory flexibility analysis, unless the agency expects that the proposed rule will
not have a significant economic impact on a substantial number of small entities, provides a
factual basis for this determination, and proposes to certify the statement. 5 U.S.C. 603(a),
605(b). If an agency must provide an initial regulatory flexibility analysis, this analysis
must address the consideration of regulatory options that would minimize the economic
impact of the proposed rule on small entities. 5 U.S.C. 603(c).
For purposes of the RFA, small entities include small businesses, nonprofit
organizations, and small governmental jurisdictions. HHS considers a rule to have a
significant impact on a substantial number of small entities if it has at least a three percent
impact of revenue on at least five percent of small entities.
Based on its examination, the Department has preliminarily concluded that this
proposed rule does not have a significant economic impact on a substantial number of
small entities. The preamble to the Final Rule discussed the character of small entities
impacted by the Final Rule in detail. 81 FR at 31463-31464. Although the proposed rule
would affect numerous small entities, it does not create new or expanded requirements,
173
and, for all the reasons stated in the RIA, it will be reducing economic burdens on such
entities overall. The proposed changes to Title IX would not impose any new substantive
obligations on Federal funding recipients and, in fact, would provide regulatory clarity and
relief for any small entities previously subject to several of the policies and requirements
imposed by the Department.
To the extent the proposed rule imposes economic costs, it is limited to entities’
voluntary choices to revise their policies and procedures and conduct training, and we
believe these costs are well below those required to have a significant impact on a
substantial number of small entities. In addition, the majority of the costs associated with
this proposed rule are proportional to the size of entities, meaning that even the smallest of
the affected entities are unlikely to face a substantial impact.
For these reasons, the Secretary certifies that the proposed rule will not have a
significant impact on a substantial number of small entities.
Executive Order 13272 on Proper Consideration of Small Entities in Agency
Rulemaking reinforces the requirements of the RFA and requires the Department to notify
the Chief Counsel for Advocacy of the Small Business Administration if the proposed rule
may have a significant economic impact on a substantial number of small entities under the
RFA. Executive Order 13272, 67 FR 53461 (Aug. 16, 2002). Because the economic impact of
the proposed rule is not significant under the RFA, the Department is not subject to
Executive Order 13272’s notification requirement.
F. Executive Order 12250 on Leadership and Coordination of Nondiscrimination Laws
174
Pursuant to Executive Order 12250, the Attorney General has the responsibility to
“coordinate the implementation and enforcement by Executive agencies of…Title IX of the
Education Amendments of 1972 (20 U.S.C. 1681 et seq.)” Executive Order 12250 at sec. 1-
2(b), 45 FR 72995 (Nov. 2, 1980). Furthermore, Executive Order 12250 requires the
Attorney General to “review… proposed rules… of the Executive agencies in order to
identify those which are inadequate, unclear or unnecessarily inconsistent.” Id. at sec. 1-
202. The proposed rule has been reviewed and approved by the Attorney General pursuant
to Executive Order 12250.
G. Paperwork Reduction Act
The Department has determined that the proposed rule does not impose additional
reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995, 44
U.S.C. 3501 et seq. If the rule is finalized as proposed, OCR will update and revise its burden
analysis by removing the burden associated with the posting of a nondiscrimination notice
and taglines, development and implementation of a language access plan, and designation
of a compliance coordinator and adoption of grievance procedures for covered entities
with 15 or more employees. OCR is seeking Paperwork Reduction Act approval for this
reporting requirement via an update to HHS Form 690 (Consolidated Civil Rights
Assurance Form)243 separate from this rulemaking.
VII. Effective Date
243 See HHS OCR, Assurance of Compliance Portal, https://ocrportal.hhs.gov/ocr/aoc/instruction.jsf.
175
Because this proposed rule would relieve significant regulatory burdens, particularly
the tagline requirements, the Department proposes that the effective date be 60 days after
publication of the Final Rule.
VIII. Request for Comment
The Department seeks comment on all issues raised by the proposed regulation.
Specifically, in addition to issues on which it has already requested comments, above, the
Department requests comment on:
⦁ The financial impact of the proposed rule on the health care sector, with any
detailed supporting information, facts, surveys, audits, or reports;
⦁ Whether, and if so how, the proposed rule addresses clarity and confusion over
compliance requirements and rights of protected classes;
⦁ Whether the Final Rule’s grievance procedures have achieved any significant
mitigation of the costs of litigation over the new requirements created by the Final Rule;
⦁ Whether, and if so, how new and developing technologies can assist covered
entities with their compliance obligations and enhance access to quality health care;
⦁ The costs incurred for design of health benefits, with any detailed information facts,
surveys, audits, or reports;
⦁ The costs to provide nondiscrimination notices and taglines, specifically including
the marginal labor, material, postage, and depreciation costs for printing and mailing
additional sides and sheets of paper (including extra postage), the volume of such notices
176
or mailings, and the impact of such notices or mailings on the utilization of language access
services with any detailed supporting information, facts, surveys, audits, or reports;
⦁ The prevalence of health care entities that operate and beneficiaries that reside in
more than one State, with any detailed supporting information, facts, surveys, audits, or
reports;
⦁ The amount of marketing, enrollment, and benefits communications delivered or
mailed per year, with any detailed supporting information, facts, surveys, audits, or
reports;
⦁ Unaddressed discrimination on the basis of race, color, national, and origin, sex,
disability, and age as applied to State and Federally-facilitated Exchanges, with any detailed
supporting information, facts, surveys, audits, or reports;
⦁ Whether covered entities seek guidance on best practices for compliance with
Section 1557, such as for civil rights assurances signed by recipients of Federal financial
assistance, and notices of civil rights posted in areas such as employee break rooms;
⦁ The costs of coming into compliance or remaining in compliance with a Federal
prohibition of discrimination on the basis of gender identity or sexual orientation under
Title IX, and with any detailed supporting information, facts, surveys, audits, or reports;
⦁ Whether the proposed LEP provisions are practical, effective, fiscally responsible,
reasonable, responsive to the particular circumstances relevant to health care programs or
activities, and capable of being readily implemented;
177
⦁ Whether HHS’s Title VI regulations at 45 CFR Part 80 should be amended to
address the Lau v. Nichols precedent applicable to LEP individuals under any program or
activity receiving Federal financial assistance from HHS;
⦁ Whether HHS’s Section 504 regulations at 45 CFR Part 85 should be amended to
address effective communication, accessibility standards for buildings of facilities,
accessibility of electronic information technology, and the requirement to make reasonable
modifications for otherwise qualified individuals with disabilities under any program or
activity receiving Federal financial assistance from HHS; and
⦁ Whether the proposed provisions on language assistance services adequately
balance an LEP individual’s meaningful access to effectively participate in the covered
health program or activity with the resources available and costs to the covered entity.
List of Subjects
45 CFR Part 86
Civil rights, Colleges and universities, Employment, Administrative practice and
procedure, Buildings and facilities, Education of individuals with disabilities, Education,
Educational facilities, Educational research, Educational study programs, Equal educational
opportunity, Equal employment opportunity, Graduate fellowship program, Grant
programs—education, Individuals with disabilities, Investigations, Reporting and
recordkeeping requirements, Sex discrimination, State agreement program, Student aid,
Women.
45 CFR Part 92
178
Administrative practice and procedure, Age discrimination, Civil rights,
Discrimination, Elderly, Health care, Health facilities, Health insurance, Health programs or
activities, Individuals with disabilities, National origin, Nondiscrimination, Reporting and
recordkeeping requirements, Sex discrimination.
Proposed Rule
For the reasons set forth in the preamble, the Department of Health and Human
Services proposes to revise 45 CFR Parts 86 and 92 as follows:
PART 86—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS
OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE
1. The authority citation for part 86 is revised to read as follows:
Authority: 20 U.S.C. 1681 through 1688; Civil Rights Restoration Act of 1987, Pub. L. No.
100-259, 102 Stat. 28 (Mar. 22, 1988).
2. Add § 86.18 to read as follows:
§ 86.18 Amendments to conform to statutory exemptions.
(a) Nothing in this part shall be construed to force or require any individual or
hospital or any other institution, program, or activity receiving Federal Funds to perform
or pay for an abortion.
(b) Nothing in this part shall be construed to require or prohibit any person, or
public or private entity, to provide or pay for any benefit or service, including the use of
179
facilities, related to an abortion. Nothing in the preceding sentence shall be construed to
permit a penalty to be imposed on any person or individual because such person or
individual is seeking or has received any benefit or service related to a legal abortion.
(c) This part shall be construed consistently with, as applicable, the First
Amendment to the Constitution, Title IX’s religious exemptions (20 U.S.C. 1681(a)(3) and
1687(4)), the Religious Freedom Restoration Act (42 U.S.C. 2000b et seq.), and provisions
related to abortion in the Church Amendments (42 U.S.C. 300a-7), the Coats-Snowe
Amendment (42 U.S.C. 238n), Section 1303 of the Patient Protection and Affordable Care
Act (42 U.S.C. 18023), and appropriation rider provisions relating to abortion, to the extent
they remain in effect or applicable, such as the Hyde Amendment (e.g., Consolidated
Appropriations Act, 2019, Pub. L. 115–245, Div. B, sec. 506-507), the Helms Amendment
(e.g., Continuing Appropriations Act, 2019, Pub. L. 116–6, Div. F, Titl III), and the Weldon
Amendment (e.g., Consolidated Appropriations Act, 2019, Pub. L. 115–245, Div. B, sec.
507(d)).
PART 92—NONDISCRIMINATION ON THE BASIS OF RACE, COLOR, NATIONAL ORIGIN,
SEX, AGE, OR DISABILITY IN HEALTH PROGRAMS OR ACTIVITIES RECEIVING
FEDERAL FINANCIAL ASSISTANCE AND PROGRAMS OR ACTIVITIES ADMINISTERED
BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES UNDER TITLE I OF THE
PATIENT PROTECTION AND AFFORDABLE CARE ACT OR BY ENTITIES ESTABLISHED
UNDER SUCH TITLE
180
Authority: 42 U.S.C. 18116; 5 U.S.C. 301; Civil Rights Restoration Act of 1987, Pub. L.
No. 100-259, 102 Stat. 28 (Mar. 22 1988); 42 U.S.C. 2000d et seq. (Title VI of the Civil Rights
Act of 1964, as amended); 29 U.S.C. 794 (Section 504 of the Rehabilitation Act of 1973, as
amended); 20 U.S.C. 1681 et seq. (Title IX of the Education Amendments of 1972, as
amended); 42 U.S.C. 6101 et seq.; (Age Discrimination Act of 1975, as amended); Lau v.
Nichols, 414 U.S. 563 (1974).
4. Revise subpart A of part 92 as follows:
a. Redesignate § 92.5 as § 92.4;
a. Add new §§ 92.1, 92.2, 92.3, 92.5, and 92.6;
b. Remove and reserve §§ 92.7 and 92.8; and
c. Revise § 92.4 as redesignated.
The redesignations, revisions, and additions read as follows:
Subpart A–General Provisions
Sec.
92.1 Purpose.
92.2 Nondiscrimination requirements.
92.3 Scope of application.
92.4 Assurances.
92.5 Enforcement mechanisms.
92.6 Relationship to other laws.
§ 92.1 Purpose.
The purpose of this part is to provide for the enforcement of Section 1557 of the
Patient Protection and Affordable Care Act, 42 U.S.C. 18116, prohibiting discrimination
181
under any health program or activity receiving Federal financial assistance, or under any
program or activity administered by an Executive agency, or by any entity established,
under Title I of such law, on the grounds of race, color, national origin, sex, age, or
disability, except as provided in Title I of such law (or any amendment thereto). Section
1557 requires the application of the enforcement mechanisms under Title VI of the Civil
Rights Act of 1964 (42 U.S.C. 2000d et seq.), Title IX of the Education Amendments of 1972
(20 U.S.C. 1681 et seq.), the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.), and
Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794) for purposes of violations of
Section 1557 and this part.
§ 92.2 Nondiscrimination requirements.
(a) Except as provided in Title I of the Patient Protection and Affordable Care Act (or
any amendment thereto), an individual shall not, on any of the grounds set forth in
subsection (b), be excluded from participation in, be denied the benefits of, or be subjected
to discrimination under any health program or activity, any part of which is receiving
Federal financial assistance (including credits, subsidies, or contracts of insurance)
provided by the U.S. Department of Health and Human Services; or under any program or
activity administered by the Department under such Title; or under any program or
activity administered by any entity established under such Title.
(b) The grounds are the grounds prohibited under the following statutes:
(1) Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.) (race, color,
national origin);
182
(2) Title IX of the Education Amendments of 1972 (20 U.S.C. 1681 et seq.) (sex);
(3) the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.) (age); or
(4) Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794) (disability).
§ 92.3 Scope of application.
(a) Except as otherwise provided in this part, this part applies to
(1) Any health program or activity, any part of which is receiving Federal financial
assistance (including credits, subsidies, or contracts of insurance) provided by the
Department;
(2) Any program or activity administered by the Department under Title I of the
Patient Protection and Affordable Care Act; or
(3) Any program or activity administered by any entity established under such Title.
(b) As used in this part, “health program or activity” encompasses all of the
operations of entities principally engaged in the business of providing health care that
receive Federal financial assistance as described in paragraph (a)(1). For any entity not
principally engaged in the business of providing health care, the requirements applicable to
a “health program or activity” under this part shall apply to such entity’s operations only to
the extent any such operation receives Federal financial assistance as described in
paragraph (a)(1).
(c) For purposes of this part, an entity principally or otherwise engaged in the
business of providing health insurance shall not, by virtue of such provision, be considered
to be principally engaged in the business of providing health care.
183
§ 92.4 Assurances.
(a) Assurances. An entity applying for Federal financial assistance to which this part
applies shall, as a condition of any application for Federal financial assistance, submit an
assurance, on a form specified by the Director of the Department’s Office for Civil Rights,
that the entity's health programs or activities will be operated in compliance with Section
1557 and this part. A health insurance issuer seeking certification to participate in an
Exchange or a State seeking approval to operate a State Exchange to which Section 1557 or
this part applies shall, as a condition of certification or approval, submit an assurance, on a
form specified by the Director of the Department’s Office for Civil Rights, that the health
program or activity will be operated in compliance with Section 1557 and this part. An
applicant or entity may incorporate this assurance by reference in subsequent applications
to the Department for Federal financial assistance or requests for certification to
participate in an Exchange or approval to operate a State Exchange.
(b) Duration of obligation. The duration of the assurances required by this subpart is
the same as the duration of the assurances required in the Department's regulations
implementing Section 504 at 45 CFR 84.5(b).
(c) Covenants. When Federal financial assistance is provided in the form of real
property or interest, the same conditions apply as those contained in the Department's
regulations implementing Section 504 at 45 CFR 84.5(c), except that the nondiscrimination
obligation applies to discrimination on all bases covered under Section 1557 and this part.
§ 92.5 Enforcement mechanisms.
184
(a) The enforcement mechanisms provided for, and available under, Title VI of the
Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.), Title IX of the Education Amendments of
1972 (20 U.S.C. 1681 et seq.), the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.), or
Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), including under the
Department’s regulations implementing those statutes, shall apply for purposes of
violations of § 92.2 of this part.
(b) The Director of the Office for Civil Rights has been delegated the authority to
enforce 42 U.S.C. 18116 and this part, which includes the authority to handle complaints,
initiate and conduct compliance reviews, conduct investigations, supervise and coordinate
compliance within the Department, make enforcement referrals to the Department of
Justice, in coordination with the Office of the General Counsel and the relevant component
or components of the Department, and take other appropriate remedial action as the
Director deems necessary, in coordination with the relevant component or components of
the Department, and as allowed by law to overcome the effects of violations of 42 U.S.C.
18116 or of this part.
§ 92.6 Relationship to other laws.
(a) Nothing in this part shall be construed to invalidate or limit the rights, remedies,
procedures, or legal standards available to individuals aggrieved under Title VI of the Civil
Rights Act of 1964 (42 U.S.C. 2000d et seq.), Title VII of the Civil Rights Act of 1964 (42
U.S.C. 2000e et seq.), Title IX of the Education Amendments of 1972 (20 U.S.C. 1681 et seq.),
the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.), or Section 504 of the
185
Rehabilitation Act of 1973 (29 U.S.C. 794), or to supersede State laws that provide
additional protections against discrimination on any basis described in § 92.2 of this part.
(b) Insofar as the application of any requirement under this part would violate,
depart from, or contradict definitions, exemptions, affirmative rights, or protections
provided by any of the statutes cited in paragraph (a) or provided by the Architectural
Barriers Act of 1968 (42 U.S.C. 4151 et seq.); the Americans with Disabilities Act of 1990, as
amended by the Americans with Disabilities Act Amendments Act of 2008 (42 U.S.C. 12181
et seq.), Section 508 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794d), the
Coats-Snowe Amendment (42 U.S.C. 238n), the Church Amendments (42 U.S.C. 300a-7), the
Religious Freedom Restoration Act (42 U.S.C. 2000bb et seq.), Section 1553 of the Patient
Protection and Affordable Care Act (42 U.S.C. 18113), Section 1303 of the Patient
Protection and Affordable Care Act (42 U.S.C. 18023), the Weldon Amendment
(Consolidated Appropriations Act, 2019, Pub. L. 115-245, Div. B sec. 209 and sec. 506(d)
(Sept. 28, 2018)), or any related, successor, or similar Federal laws or regulations, such
application shall not be imposed or required.
5. Revise subpart B of part 92 by:
a. Redesignating § 92.201 of Subpart C as § 92.101;
b. Redesignating § 92.202 of Subpart C as § 92.102;
c. Redesignating § 92.203 of Subpart C as § 92.103;
d. Redesignating § 92.204 of Subpart C as § 92.104;
e. Redesignating § 92.205 of Subpart C as § 92.105; and
186
f. Revising § 92.101 as redesignated.
The revisions and additions read as follows:
Subpart B–Specific Applications to Health Programs or Activities
Sec.
92.101 Meaningful access for individuals with limited English proficiency.
92.102 Effective communication for individuals with disabilities.
92.103 Accessibility standards for buildings and facilities.
92.104 Accessibility of information and communication technology.
92.105 Requirement to make reasonable modifications.
§ 92.101 Meaningful access for individuals with limited English proficiency.
(a) Any entity operating or administering a health program or activity subject to this
part shall take reasonable steps to ensure meaningful access to such programs or activities
by limited English proficient individuals.
(b) Specific Applications.
(1) Enforcement Discretion. In evaluating whether any entity to which subsection (a)
applies has complied with subsection (a), the Director of the Department’s Office for Civil
Rights may assess how such entity balances the following four factors:
(i) The number or proportion of limited English proficient individuals eligible to be
served or likely to be encountered in the eligible service population;
(ii) The frequency with which LEP individuals come in contact with the entity’s
health program, activity, or service;
(iii) The nature and importance of the entity’s health program, activity, or service;
and
187
(iv) The resources available to the entity and costs.
(2) Language assistance services requirements. Where subsection (a), in light of the
entity’s individualized assessment of the four factors set forth in (b)(1), requires the
provision of language assistance services, such services must be provided free of charge, be
accurate and timely, and protect the privacy and independence of the individual with
limited English proficiency. Language assistance services may include
(i) Oral language assistance, including interpretation in non-English languages
provided in-person or remotely by a qualified interpreter for an individual with limited
English proficiency, and the use of qualified bilingual or multilingual staff to communicate
directly with individuals with limited English proficiency; and
(ii) Written translation, performed by a qualified translator, of written content in
paper or electronic form into languages other than English.
(3) Specific requirements for interpreter and translation services.
(i) Where subsection (a), in light of the entity’s individualized assessment of the four
factors set forth in (b)(1), requires the provision of interpreter services, they must be
provided by an interpreter who
(A) Adheres to generally accepted interpreter ethics principles, including
client confidentiality;
(B) Has demonstrated proficiency in speaking and understanding at least spoken
English and the spoken language in need of interpretation; and
188
(C) Is able to interpret effectively, accurately, and impartially, both receptively and
expressly, to and from such language(s) and English, using any necessary specialized
vocabulary, terminology and phraseology.
(ii) Where subsection (a), in light of the entity’s individualized assessment of the
four factors set forth in (b)(1), requires the provision of translation services for written
content (in paper or electronic form), they must be provided by a translator who
(A) Adheres to generally accepted translator ethics principles, including client
confidentiality;
(B) Has demonstrated proficiency in writing and understanding at least written
English and the written language in need of translation; and
(C) Is able to translate effectively, accurately, and impartially to and from such
language(s) and English, using any necessary specialized vocabulary, terminology and
phraseology.
(iii) If remote audio interpreting services are required to comply with subsection
(a), in light of the entity’s individualized assessment of the four factors set forth in (b)(1),
the entity to which Section 1557 applies (as defined in § 92.3 of this part) shall provide
(A) Real-time, audio over a dedicated high-speed, wide-bandwidth video connection
or wireless connection that delivers high-quality audio without lags or irregular pauses in
communication;
(B) A clear, audible transmission of voices; and
189
(C) Adequate training to users of the technology and other involved individuals so
that they may quickly and efficiently set up and operate the remote interpreting services.
(4) Restricted use of certain persons to interpret or facilitate communication. If an
entity is required by subsection (a), in light of the entity’s individualized assessment of the
four factors set forth in (b)(1), to provide interpretation services, such entity shall not
(i) Require an individual with limited English proficiency to provide his or her own
interpreter;
(ii) Rely on an adult accompanying an individual with limited English proficiency to
interpret or facilitate communication, except
(A) In an emergency involving an imminent threat to the safety or welfare of an
individual or the public, where there is no qualified interpreter for the individual with
limited English proficiency immediately available;
(B) Where the individual with limited English proficiency specifically requests that
the accompanying adult interpret or facilitate communication, the accompanying adult
agrees to provide such assistance, and reliance on that adult for such assistance is
appropriate under the circumstances;
(iii) Rely on a minor child to interpret or facilitate communication, except in an
emergency involving an imminent threat to the safety or welfare of an individual or the
public, where there is no qualified interpreter for the individual with limited English
proficiency immediately available; or
190
(iv) Rely on staff other than qualified bilingual/multilingual staff to communicate
directly with individuals with limited English proficiency.
(c) Acceptance of language assistance services is not required. Nothing in this section
shall be construed to require an individual with limited English proficiency to accept
language assistance services.
§ 92.102 Effective communication for individuals with disabilities.
(a) Any entity operating or administering a program or activity under this part shall
take appropriate steps to ensure that communications with individuals with disabilities are
as effective as communications with others in such programs or activities, in accordance
with the standards found at 28 CFR 35.160 through 35.164. Where the regulatory
provisions referenced in this section use the term “public entity,” the term “entity” shall
apply in its place.
(b) A recipient or State Exchange shall provide appropriate auxiliary aids and
services, including interpreters and information in alternate formats, to individuals with
impaired sensory, manual, or speaking skills, where necessary to afford such persons an
equal opportunity to benefit from the service in question.
(1) Auxiliary aids and services include
(i) Interpreters on-site or through video remote interpreting (VRI) services, as
defined in 28 CFR 35.104 and 36.303(f); note takers; real-time computer-aided
transcription services; written materials; exchange of written notes; telephone handset
amplifiers; assistive listening devices; assistive listening systems; telephones compatible
191
with hearing aids; closed caption decoders; open and closed captioning, including real-time
captioning; voice, text, and video-based telecommunication products and systems, text
telephones (TTYs), videophones, and captioned telephones, or equally effective
telecommunications devices; videotext displays; accessible information and
communication technology; or other effective methods of making aurally delivered
information available to individuals who are deaf or hard of hearing; and
(ii) Readers; taped texts; audio recordings; Braille materials and displays; screen
reader software; magnification software; optical readers; secondary auditory programs;
large print materials; accessible information and communication technology; or other
effective methods of making visually delivered materials available to individuals who are
blind or have low vision.
(2) When an entity is required to provide an interpreter under subsection (b), the
interpreting service shall be provided to individuals free of charge and in a timely manner,
via a remote interpreting service or an onsite appearance, by an interpreter who
(i) Adheres to generally accepted interpreter ethics principles, including client
confidentiality; and
(ii) Is able to interpret effectively, accurately, and impartially, both receptively and
expressively, using any necessary specialized vocabulary, terminology and phraseology.
(3) An interpreter for an individual with a disability for purposes of this section can
include, for example, sign language interpreters, oral transliterators (individuals who
192
represent or spell in the characters of another alphabet), and cued language transliterators
(individuals who represent or spell by using a small number of handshapes).
(c) Disability means, with respect to an individual, a physical or mental impairment
that substantially limits one or more major life activities of such individual; a record of such
an impairment; or being regarded as having such an impairment, as defined and construed
in the Rehabilitation Act, 29 U.S.C. 705(9)(B), which incorporates the definition of disability
in the Americans with Disabilities Act (ADA), as amended (42 U.S.C. 12102 et seq.). Where
this part cross-references regulatory provisions that use the term ‘‘handicap,’’ ‘‘handicap’’
means ‘‘disability’’ as defined in this section.
§ 92.103 Accessibility standards for buildings and facilities.
(a) Each facility or part of a facility in which health programs or activities are
conducted that is constructed or altered by or on behalf of, or for the use of, a recipient or
State Exchange shall comply with the 2010 Standards, if the construction or alteration was
commenced on or after July 18, 2016, except that if a facility or part of a facility in which
health programs or activities are conducted that is constructed or altered by or on behalf
of, or for the use of, a recipient or State Exchange, was not covered by the 2010 Standards
prior to July 18, 2016, such facility or part of a facility shall comply with the 2010
Standards if the construction was commenced after January 18, 2018. Departures from
particular technical and scoping requirements by the use of other methods are permitted
where substantially equivalent or greater access to and usability of the facility is provided.
All newly constructed or altered buildings or facilities subject to this section shall comply
193
with the requirements for a “public building or facility” as defined in section 106.5 of the
2010 Standards.
(b) Each facility or part of a facility in which health programs or activities under this
part are conducted that is constructed or altered by or on behalf of, or for the use of, a
recipient or State Exchange in conformance with the 1991 Standards at appendix D to 28
CFR part 36 or the 2010 Standards shall be deemed to comply with the requirements of
this section and with 45 CFR 84.23(a) and (b) with respect to those facilities, if the
construction or alteration was commenced on or before July 18, 2016. Each facility or part
of a facility in which health programs or activities are conducted that is constructed or
altered by or on behalf of, or for the use of, a recipient or State Exchange in conformance
with UFAS shall be deemed to comply with the requirements of this section and with 45
CFR § 84.23(a) and (b), if the construction was commenced before July 18, 2016 and such
facility was not covered by the 1991 Standards or 2010 Standards.
(c) For purposes of this part:
(1) “1991 Standards” refers to the 1991 Americans with Disabilities Act Standards
for Accessible Design at appendix D to 28 CFR part 36.
(2) “2010 Standards” refers to the 2010 ADA Standards for Accessible Design, as
defined in 28 CFR 35.104.
(3) “UFAS” refers to the Uniform Federal Accessibility Standards as promulgated in
49 FR 31528 (Aug. 7, 1984).
§ 92.104 Accessibility of information and communication technology.
194
(a) Entities required to comply with § 92.2, unless otherwise exempted by this part,
shall ensure that their health programs or activities provided through information and
communication technology are accessible to individuals with disabilities, unless doing so
would result in undue financial and administrative burdens or a fundamental alteration in
the nature of the health programs or activities. When undue financial and administrative
burdens or a fundamental alteration exist, the covered entity shall provide information in a
format other than an electronic format that would not result in such undue financial and
administrative burdens or a fundamental alteration, but would ensure, to the maximum
extent possible, that individuals with disabilities receive the benefits or services of the
health program or activity that are provided through information and communication
technology.
(b) A recipient or State Exchange shall ensure that its health programs or activities
provided through websites comply with the requirements of Title II of the Americans with
Disabilities Act (42 U.S.C. 12131 through 12165).
(c) For purposes of this part, “information and communication technology” (ICT)
means information technology and other equipment, systems, technologies, or processes,
for which the principal function is the creation, manipulation, storage, display, receipt, or
transmission of electronic data and information, as well as any associated content.
Examples of ICT include computers and peripheral equipment; information kiosks and
transaction machines; telecommunications equipment; customer premises equipment;
195
multifunction office machines; software; applications; websites; videos; and, electronic
documents.
§ 92.105 Requirement to make reasonable modifications.
Any entity to which Section 1557 applies (as defined in § 92.3 of this part) shall
make reasonable modifications to its policies, practices, or procedures when such
modifications are necessary to avoid discrimination on the basis of disability, unless the
covered entity can demonstrate that making the modifications would fundamentally alter
the nature of the health program or activity. For the purposes of this section, the term
“reasonable modifications” shall be interpreted in a manner consistent with the term as set
forth in the regulation promulgated under Title II of the Americans with Disabilities Act, at
28 CFR 35.130(b)(7).
6. Remove and reserve subparts C and D of part 92.
7. Remove and reserve appendices A, B, and C to part 92.
Proposed Conforming and Technical Amendments
For the reasons set forth in the preamble, the Department of Health and Human
Services proposes to revise 42 CFR parts 438, 440, and 460, and 45 CFR parts 86, 147, 155,
and 156 as follows:
TITLE 42—PUBLIC HEALTH
PART 438—MANAGED CARE
1. The authority citation for part 438 continues to read as follows:
Authority: 42 U.S.C. 1302.
196
2. Amend § 438.3 by revising paragraph (d)(4) to read as follows:
§ 438.3 Standard contract requirements.
* * * * *
(d) * * *
(4) The MCO, PIHP, PAHP, PCCM or PCCM entity will not discriminate against
individuals eligible to enroll on the basis of race, color, national origin, sex, or disability and
will not use any policy or practice that has the effect of discriminating on the basis of race,
color, or national origin, sex, or disability.
* * * * *
3. Amend § 438.206 by revising paragraph (c)(2) to read as follows:
§ 438.206 Availability of services.
* * * * *
(c) * * *
(2) Access and cultural considerations. Each MCO, PIHP, and PAHP participates in the
State’s efforts to promote the delivery of services in a culturally competent manner to all
enrollees, including those with limited English proficiency and diverse cultural and ethnic
backgrounds, disabilities, and regardless of sex.
* * * * *
PART 440—SERVICES: GENERAL PROVISIONS
Authority: 42 U.S.C. 1302.
197
5. Amend § 440.262 to read as follows:
§ 440.262 Access and cultural conditions.
The State must have methods to promote access and delivery of services in a
culturally competent manner to all beneficiaries, including those with limited English
proficiency, diverse cultural and ethnic backgrounds, disabilities, and regardless of sex.
* * * * *
PART 460—PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
Authority: Secs. 1102, 1871, 1894(f), and 1934(f) of the Social Security Act (42
U.S.C. 1302, 1395l, 1395eee(f), and 1396u–4(f)).
7. Amend § 460.98 by revising paragraph (b)(3) to read as follows:
§ 460.98 Service delivery.
* * * * *
(b) * * *
(3) The PACE organization may not discriminate against any participant in the
delivery of required PACE services based on race, ethnicity, national origin, religion, sex,
age, mental or physical disability, or source of payment.
* * * * *
8. Amend § 460.112 by revising paragraph (a) to read as follows:
§ 460.112 Specific rights to which a participant is entitled.
198
(a) Respect and nondiscrimination. Each participant has the right to considerate,
respectful care from all PACE employees and contractors at all times and under all
circumstances. Each participant has the right not to be discriminated against in the delivery
of required PACE services based on race, ethnicity, national origin, religion, sex, age, mental
or physical disability, or source of payment.
* * * * *
TITLE 45—PUBLIC WELFARE
PART 86—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS
OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE
Authority: 20 U.S.C. 1681 through 1688; Civil Rights Restoration Act of 1987, Pub.
L. No. 100-259, 102 Stat. 28 (Mar. 22, 1988).
10. In § 86.2, revise paragraph (a) by adding “1687, 1688” after “1686.”
11. In § 86.2(n), remove the words “United States Commissioner of Education” and add, in
their place, the words “Secretary of Education.”
12. Amend § 86.31 by revising paragraph (b) to read as follows:
§ 86.31 Education programs or activities.
* * * * *
(b) Specific prohibitions. Except as provided in this subsection, in providing any aid,
benefit, or service to a student, a recipient shall not, on the basis of sex:
199
(1) Treat one person differently from another in determining whether such person
satisfies any requirement or condition for the provision of such aid, benefit, or service;
(2) Provide different aid, benefits, or services or provide aid, benefits, or services in
a different manner;
(3) Deny any person any such aid, benefit, or service;
(4) Subject any person to separate or different rules of behavior, sanctions, or other
treatment;
(5) Apply any rule concerning the domicile or residence of a student or applicant,
including eligibility for in-State fees and tuition;
(6) Aid or perpetuate discrimination against any person by providing significant
assistance to any agency, organization, or person which discriminates on the basis of sex in
providing any aid, benefit or service to students or employees;
(7) Otherwise limit any person in the enjoyment of any right, privilege, advantage,
or opportunity.
* * * * *
13. Revise § 86.71 to read as follows:
§ 86.71 Enforcement procedures.
For the purposes of implementing this Part, the procedural provisions applicable to
Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d) are hereby adopted and
incorporated herein by reference. These procedures may be found at 45 CFR 80.6 through
80.11 and 45 CFR part 81.
200
* * * * *
PART 147—HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND
INDIVIDUAL HEALTH INSURANCE MARKETS
Authority: 42 U.S.C. 18021, 18031, 18041, 18044, 18054, 18061, 18063, 18071, and
18082, 26 U.S.C. 36B, 31 U.S.C. 9701.
15. Amend § 147.104 by revising paragraph (e) to read as follows:
§ 147.104 Guaranteed availability of coverage.
* * * * *
(e) Marketing. A health insurance issuer and its officials, employees, agents and
representatives must comply with any applicable State laws and regulations regarding
marketing by health insurance issuers and cannot employ marketing practices or benefit
designs that will have the effect of discouraging the enrollment of individuals with
significant health needs in health insurance coverage or discriminate based on an
individual’s race, color, national origin, present or predicted disability, age, sex, expected
length of life, degree of medical dependency, quality of life, or other health conditions.
* * * * *
PART 155—EXCHANGE ESTABLISHMENT STANDARDS AND OTHER RELATED
STANDARDS UNDER THE AFFORDABLE CARE ACT
* * * * *
201
Subpart B—GENERAL STANDARDS RELATED TO THE ESTABLISHMENT OF AN
EXCHANGE
16. The authority citation for Part 155 continues to read as follows:
Authority: 42 U.S.C. 18021 through 18024, 18031 through 18033, 18041 through
18042, 18051, 18054, 18071, and 18081 through 18083.
17. Amend § 155.120 by revising subsection (c)(ii) to read as follows:
§ 155.120 Non-interference with Federal law and non-discrimination standards.
* * * * *
(c) * * *
(ii) Not discriminate based on race, color, national origin, disability, age, or sex.
* * * * *
18. Amend § 155.220 by revising paragraph (j)(2)(i) to read as follows:
§ 155.220 Ability of States to permit agents and brokers to assist qualified
individuals, qualified employers, or qualified employees enrolling in QHPs.
* * * * *
(j) * * *
(2) * * *
(i) Provide consumers with correct information, without omission of material fact,
regarding the Federally-facilitated Exchanges, QHPs offered through the Federally-
facilitated Exchanges, and insurance affordability programs, and refrain from marketing or
conduct that is misleading (including by having a direct enrollment website that HHS
202
determines could mislead a consumer into believing they are visiting HealthCare.gov),
coercive, or discriminates based on race, color, national origin, disability, age, or sex;
* * * * *
PART 156—HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE
CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES
Authority: 5 U.S.C. 552; 42 U.S.C. 300jj-11 and 300jj-14.
20. Amend § 156.200 by revising paragraph (e) to read as follows:
§ 156.200 QHP issuer participation standards.
* * * * *
(e) Non‐discrimination. A QHP issuer must not, with respect to its QHP, discriminate
on the basis of race, color, national origin, disability, age, or sex.
21. Amend § 156.1230 by revising subsection (b)(3) to read as follows:
* * * * *
§ 156.1230 Direct enrollment with the QHP issuer in a manner considered to be
through the Exchange.
* * * * *
(b) * * *
(3) The QHP issuer must provide consumers with correct information, without
omission of material fact, regarding the Federally-facilitated Exchanges, QHPs offered
through the Federally-facilitated Exchanges, and insurance affordability programs, and
203
refrain from marketing or conduct that is misleading (including by having a direct
enrollment website that HHS determines could mislead a consumer into believing they are
visiting HealthCare.gov), coercive, or discriminates based on race, color, national origin,
disability, age, or sex.
* * * * *
Dated: _____________
_________________________________________
Alex M. Azar II
Secretary,
Department of Health and Human Services.
204

Proposed Transgender and Abortion Rule

Uploaded by

Copyright:

Available Formats

Proposed Transgender and Abortion Rule

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Proposed Transgender and Abortion Rule

Uploaded by

Copyright:

Available Formats

*This HHS‐approved document is being submitted to the Office of the Federal Register (OFR) for publication and has

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Docket No.: [INSERT DOCKET NUMBER]

Nondiscrimination in Health and Health Education Programs or Activities

ACTION: Proposed rule.

SUMMARY: The Department of Health and Human Services (“the Department”) is

billions of dollars in undue regulatory burdens, further substantive compliance, reduce

origin, sex, age, and disability.

DATES: Submit comments on or before [INSERT DATE 60 DAYS AFTER DATE OF

PUBLICATION IN THE FEDERAL REGISTER].

AA11, by any of the following methods:

• Federal eRulemaking Portal. You may submit electronic comments at

http://www.regulations.gov by searching for the Docket ID number [INSERT DOCKET

NUMBER]. Follow the instructions at http://www.regulations.gov online for submitting

comments through this method.

change to http://www.regulations.gov, including any personal information provided, and

receive on Federal Register documents, we are not able to provide individual

Building is not readily available to persons without Federal government identification,

or Excel; however, we prefer Microsoft Word.

comment period will not be accepted.

Docket: For complete access to background documents or posted comments, go to

http://www.regulations.gov and search for Docket ID number [INSERT DOCKET NUMBER].

FOR FURTHER INFORMATION CONTACT: Luben Montoya, Supervisory Civil Rights

B. Litigation Challenging the Section 1557 Regulation

Proposed “45 CFR § 92.102 Effective communication for individuals with

h. Cost Savings Attributed to Covered Entities’ Handling of Certain

A. Background on Section 1557 and Its Rulemaking

or activity that is administered by an executive agency under Title I of the PPACA or by an

Services (“Secretary”) to promulgate regulations implementing Section 1557’s

input on regulations under Section 1557. 78 FR 46558. Thereafter, on September 8, 2015,

requirements on covered entities.5 80 FR 54172.

81 FR 31376.6 As noted above, Section 1557 bars discrimination on grounds prohibited

declined to include discrimination on the basis of sexual orientation. 81 FR at 31390 (“OCR

individual’s sexual orientation status alone is a form of sex discrimination.”). As explained

regarding language assistance services, multi-language “taglines,” and nondiscrimination

after January 1, 2017. 45 CFR § 92.1.

regulatory burden on individuals, families, healthcare providers, health insurers, patients,

recipients of healthcare services, purchasers of health insurance, or makers of medical

devices, products, or medications.” 82 FR 8351 (Jan. 24, 2017).

B. Litigation Challenging the Section 1557 Regulation

Lawsuits challenging the regulations followed promulgation of the Final Rule. On

3:16-cv-432 (D.N.D. filed Dec. 28, 2016). 7

Section 1557 Regulation’s prohibition against discrimination on the basis of “gender

order to be “thorough and well-reasoned,” and on that basis temporarily stayed

enforcement of Section 1557's prohibitions against discrimination on the bases of gender

nationwide preliminary injunction, or the orders in Franciscan Alliance, Religious Sisters of

Mercy, or Catholic Benefits Association, staying proceedings. On May 2, 2017, the

controversial rules and regulations at issue.”14

relevant provisions of Title IX and Section 1557 unambiguously exclude gender-identity

Alliance, No. 7:16-cv-00108-O (filed April 5, 2019).

to the contrary, thereby prohibiting conduct the statute permits.” Id.

C. Summary of the Proposed Rule

relieve billions of dollars in undue regulatory burdens, further substantive compliance,

addition, to resolve confusion raised by the Section 1557 Regulation’s reliance on an

outdated version of the Department’s Title IX regulation, the Department proposes to

amend its Title IX regulation to implement statutory amendments made by Congress to

submit assurances of compliance, certain provisions concerning language access for

The Department further proposes to make limited conforming amendments to ten

provisions in relevant Department regulations.