Matthew O'Donnell

At The Regulatory Review, Penn Medicine Chief Privacy Officer Lauren Steinfeld C’89 discusses regulatory compliance in the context of data privacy and health care. Steinfeld argues that health care faces new legal requirements, industry standards, and rapidly changing technology, and that each new development requires strategies to manage risk and seize opportunity. In the case of new rules, health care providers must assess—and if necessary, change—existing internal policies and procedures, training, systems, and more to comply. New technologies also must be understood, she argues, because some may introduce new vulnerabilities and others may provide new opportunities for protecting patient data. https://lnkd.in/ekt4ENf3

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“New York’s New Pharmacy Regulations: Major Win for Independent Pharmacies and Consumers”—Learn more in this Health Care Controversies Team alert authored by Brad Gallagher and Linda Clark, co-leaders of Barclay Damon’s Health Care Controversies Team, and Amanda Rhodes, associate. Click here to read the alert: https://lnkd.in/gdtrvM9J #Alert #HealthCare #MarketConductRegulations #PharmacyRegulations #IndependentPharmacies #NYS #DFS #PharmacyBenefitManager #PBM #PharmacyContracting #AuditRequirements #HealthCareLaw #PharmacyLaw

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Will AstraZeneca’s Novel Argument Beat Back KS’ #ContractPharmacy Law? #AZ includes a novel state law-based challenge in its claims against the state’s #340B contract #pharmacy law. Can it succeed where other Constitutional and preemption arguments have failed? Maybe. The KS #Constitution: The state Constitution generally provides that "[njo bill shall contain more than one subject." This "One-Subject Rule” prevents what’s referred to as “'logrolling”—the practice of pressuring a legislator to vote for one proposal by combining it with another, unrelated proposal. The Claim: AZ argues that, the CP law, which was passed as part of a broad appropriations bill, is a classic “2 subjects” problem. Standing?: Claims can only be asserted by someone who has been directly harmed in a concrete way by the alleged wrong. Since this is a legislative rule, I would have thought that a private party would not have standing to assert this claim—that the claim, if it was to be brought by anyone, would have to brought by a legislator. But AZ’s complaint says otherwise. Private parties, like AstraZeneca, the complaint says, “have standing to challenge legislative enactments under the ‘one-subject rule.’” According to AZ, the state “Supreme Court [has] found standing because a cognizable injury can be inferred… as a result“ of the violation. Why I Like This Claim: I can’t speak to the relative merit of this argument, but I sure do like the concept of it. It gives the court a way of avoiding the entire debate about the interaction of the #340B statute and the state law—but still find in favor of AZ. With courts having already upheld comparable laws passed in Arkansas and Louisiana, this claim might be the best way to minimize the impact of those prior decisions in this KS challenge. “Procedural” challenges, like these, can be particularly effective, obligating the court to put aside what it might think about the substantive merits or their policy implications, and focus narrowly on a purely “technical” issue. We shall see what we shall see. #pharmacists #lifesciences #Protect340B

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Exciting News for Pharmacies and Patients! 🏥📢 There's a new law in town, meant to help pharmacies, pharmacists and the communities they serve in Pennsylvania. HB 1993 grants the Pennsylvania Insurance Department (PID) the authority to regulate PBM practices and contains several important protections that will benefit Pennsylvanians, resulting in lower out-of-pocket costs for prescription medication. This legislation aims to: - Increase transparency and accountability  - Cut costs  - Support local pharmacies News release in comments. #HealthcareReform #PharmacyAccess #PatientCare #OrderInsite #HB1993 #PharmacySupport

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NEW Legal Briefing!!! On September 27, 2024, New York Governor Kathy Hochul signed into law an amendment to the New York Public Health Law that prohibits pharmacy benefit managers (“PBMs”) from penalizing New York pharmacies for providing customers with information relating to the costs of prescription medications and reimbursement rates.  For more information on these updated regulations, visit lawpf.com, or click on the link below.

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A couple weeks ago, I had the privilege of visiting the #pharmacypodcastnetwork studios to discuss leadership. Many are quick to recognize outstanding leaders in pharmacy, yet few are learning the leadership skills necessary to learn lead their teams and patients well. Give it a listen and let me know what you think. #forpharmacy #forpharmacists #pharmacists #pharmacyleadership #leadwell #EveryoneDeservesToBeLedWell #KeepPharmacistsImproving

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Another 340B Court Fight: Do CPs Really Take Title and Act as Agents? Sanofi has filed suit under the Freedom of Information Act demanding that #HRSA release portions of the MANY contract #pharmacy agreements it has. #Sanofi is looking for info showing whether CPs actually comply with the stated premises of HRSA’s CP guidance. This suit could be a watershed event in #drug makers’ attempts to undermine the replenishment model and to build the case that HRSA is not a credible source of #oversight. Background: HRSA’s CP guidance is built on the flawed premise that those transactions don’t constitute prohibited diversion because the CEs “retain title” at all times to #340B drugs and because the CPs are merely “acting as agents” of the CEs in dispensing drugs. The Dispute: In 2021, Sanofi filed a FOIA request with HRSA demanding copies of the CP agreements it has. HRSA refused, citing the FOIA exemptions for a 3rd party’s confidential and proprietary info. Sanofi responds by saying that a blanket assertion of an objection is improper—that HRSA should redact any C&P information and disclose information going to title and agency, which it says is not C&P. S harps on the point that HRSA did NOT rely on the exemption for “investigatory materials”, which S (correctly) deduces means that HRSA isn’t investigating ANY of these arrangements (that’s pretty damning in and of itself). Why This Matters: 340B Report gives 1 important reason: S is seeking to demonstrate in a to be filed ADR complaint that CEs using the replenishment model (virtually all CEs that use CPs) are not complying with HRSA guidance and therefore engaged in diversion. But I think that may be missing the forest for the tree. The biggest threat right now to manufacturers are the state CP laws and the 8th Circuit’s decision that at least the Arkansas law was not “in conflict” with federal law. The 8th got to that conclusion by PRESUMING that ALL CEs “retained title” of CP drugs and that ALL CPs acted as the “agents” of CEs. This FOIA request could cripple that premise, potentially leading other courts of appeals hearing other challenges to other state laws refuse to follow the 8th. What Will Happen? Hard to predict. The DC federal court, which hears these FOIA cases, is overwhelmed by them, and, generally, fairly sympathetic to the agencies. Still, most of the judges there try to find some “middle ground“ approach that allows for the release of some materials, which is the tact that S is taking. On the question of “agency”, that issue is usually addressed in an entirely “boilerplate“ clause at the end of a contract. It’s one of the most common contract provisions there is. I could see a court saying that there’s nothing C&P about such “boilerplate”. If so, that alone would be a huge win. 2 Wins Already: No matter how the case goes, S has 2 wins already. See the comment for these 2 wins—it’s the best part of my write up. #lifesciences #pharmacist #pharmacies #Protect340B

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8 Reasons Drug Makers HATE the #340b #ADR Rule Reason 1: Audit Burdens HRSA dresses the rule up as creating an “equitable” process and “equal access” for all stakeholders, but then fails to reduce manufacturer audit burdens, virtually guaranteeing that they will be unable to access ADRs. Reason 2: Biased Panels OPA renders the ADR process a “rubber stamp” exercise by limiting panel participation to its own employees. Although a panel member cannot have participated in the “specific” dispute at issue, there is no prohibition on panel members having participated in the creation of the underlying policy or the exact same issue with respect to a different covered entity—built in bias. Reason 3: No Procedural Standards HRSA eliminates the requirements for the Federal Rules of Civil Procedure and Evidence to apply, while failing to specify ANY standards in their place. Indeed, there isn’t even a right to an in-person hearing. Reason 4: No Minimum Claim Requirement The agency removes any clear minimum amount in controversy requirement, potentially subjecting a drug maker to an endless barrage of ADRs over trivial disputes. Reason 5: Time Frames Compromise the Defense Although time extensions can be granted, on a discretionary basis, the time frames to respond to an initial complaint and to respond to discovery demands are ridiculously short (30 and 20 days, respectively). Where drug makers are forced to act in incredibly short periods, OPA gives itself at least a year to come to a decision—and it can extend even that time frame as it chooses. Reason 6: Absurd Discovery Obligations The drug maker has responsibility to provide, under the preamble, discovery from its “agents”, purportedly including “wholesalers or other third parties”, without any legal standard for “agency” being identified. The reg is even WORSE, dropping any reference to “agency” and saying that the obligation applies to “any wholesaler or other third party that may facilitate the sale or distribution of its drugs to covered entities”. So, absurdly, under that language, drug makers would have to produce information from wholly independent entities—whether or not they had a contract with them and whether or not any contract was entered into before the ADR Rule was issued. It’s literally impossible to comply with this provision—a fool’s errand. Reason 7: Phantom Review Although the Rule references a mechanism for the Secretary to address an adverse panel determination, that “process” is limited to a statement that the Secretary only has 30 days to do so, underscoring that there is no there there. Reason 8: Cherry Picked “Purpose“ Reference #OPA repeats the cherry picked “scarce resources” line in discussing 340B’s purpose, ignoring the rest of the legislative history, such as the provisions showing an intent to limit discounts only to those entities providing “direct care” to “large numbers” of the underinsured and the uninsured. The Rule is a (bad) joke.

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ICYMI: Our annual Transparency in Coverage report has been released. This report outlines data on claims, denials, and appeals for health insurers doing business in Pennsylvania. We examine this type of data to minimize patient health service and treatment denials and identify and alleviate any issues in this process. Read more at https://lnkd.in/eWDkZWbk.

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This is a reminder that because pharma has the rebates and the product, they are complicit in allowing continued #AntiPatient calculus. Somehow we’ve accepted that healthcare can be secret with its prices, contracts, and more. Imagine trying to buy office supplies, and the Office Depot, Uline, or whoever the supplier is said that they won’t give you prices. That’s the insanity patients and employers face. We can justify it by saying, “Oh, all prices are confidental…” Not the way they are in healthcare. There are consumer protection laws that if, for instance, the broccoli you are buying at the grocery store scans at a higher price than advertised, you get a lower price. In healthcare, the bill comes, it isn’t itemized, and it’s after the service has occurred. And, if the organization has a contract for a price, you as the patient must file legal action because you aren’t a party to the contract. #Healthcare #Insanity #JustAnotherDay

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𝐀𝐏𝐑𝐱 𝐄𝐕𝐏 & 𝐆𝐞𝐧𝐞𝐫𝐚𝐥 𝐂𝐨𝐮𝐧𝐬𝐞𝐥 𝐌𝐢𝐠𝐮𝐞𝐥 𝐑𝐨𝐝𝐫𝐢𝐠𝐮𝐞𝐳 𝐂𝐚𝐥𝐥𝐬 𝐟𝐨𝐫 𝐅𝐓𝐂 𝐭𝐨 𝐁𝐫𝐞𝐚𝐤𝐮𝐩 𝐏𝐁𝐌𝐬 Today the Federal Trade Commission held an open commission meeting on the recently released preliminary report of its highly anticipated 6(b) study into PBM practices. During the meeting, independent pharmacists, physicians, and pharmacy and patient advocates commented on the impact of PBM abuses on their patients and businesses. APRx EVP & General Counsel Miguel Rodriguez highlighted additional items for the commission’s consideration, including diminishing pharmacy access and one-sided non-negotiable contract terms that govern every aspect of a pharmacy’s business, making it nearly impossible for independent pharmacies and their patients to thrive. Read the report: https://lnkd.in/eXEbpeFx #PBMs #FTC #PBMReform

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DKI Health discussed recent trends related to access to medicines and the influence patients can have on these decisions during today's presentation at the Chief Patient Officer Summit (#CPOsummit) in Boston! Our presentation was led by Jamie Culp, Market Access Director, and Philip Gattone, CEO of National Bleeding Disorders Foundation. For more information on DKI Health's work in market access and patient engagement, contact us: [email protected] #DKImpact #MarketAccess #PatientAdvocacy

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Join Shields' very own Champ Burgess at the Becker's Healthcare Chief Pharmacy Officer Summit on November 13th for a panel discussion titled “Dealing with Expensive Drugs, GLP-1s and More: What Pharmacy Leaders Need to Know.” Champ will share valuable insights on managing high-cost medications and the latest in pharmacy innovation. Don’t miss this opportunity to learn from industry leaders and gain strategies to tackle some of today’s biggest challenges in pharmacy. #ElevatingSpecialtyPharmacy #ShieldsRx #BeckersCPOSummit

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#HRSA Punts on the “Patient Definition”—Again The Final #340b #ADR Rule punts on the patient definition, even though #drug makers pressed for clarity. Where manufacturers hoped that HRSA would leverage the Rule to fix the damage done by the Genesis case, the agency categorically refused. Having failed to appeal the Genesis case, HRSA has now missed a ready made opportunity to limit the resulting damage. #Drug Makers Press: As HRSA acknowledged in summarizing the comments, “[m]any manufacturers …objected to the lack of an explicit definition in the proposal for the terms ‘patient’ or ‘diversion’”. In offering that summary, however, OPA carefully avoided any reference to the Genesis case or the court’s decision, which held that Genesis need not have been responsible for the prescription of a drug to claim a discount on it. Without referencing the source of drug maker concerns, HRSA did state that manufacturers specifically asked the agency to “revise and clarify its current [1996 patient definition] guidance”. Drug makers tied the “patient definition” issue to the need “to strengthen administration of the 340B Program, including the 340B ADR process and the parties' ability to work together to resolve disputes in good faith”—all items clearly at the core of the proposed rule Having None of It: Despite the Genesis problem, HRSA slapped the drug maker request for clarification to the side. “Revision of the 1996 patient definition guidance,” HRSA flatly declared, “is outside the scope of this rule.” That answer is incredibly unsatisfying, reflecting an utter failure to use an available regulatory power to address a core threat to the program. What Did HRSA Say?: Not much. Instead of giving guidance on what the material connection must be between a patient, a CE, and a discounted drug, HRSA fell back on a description of its intended procedure: “When a #diversion claim is presented before a 340B ADR Panel, the Panel will follow the 340B statute and all applicable regulations, and consider 340B policies and guidance documents”. Interestingly, that statement doesn’t include any reference to case law, such as the Genesis case. Drug makers hope that omission is telling. But, putting that to the side, HRSA merely offered “[e]xamples of a diversion claim that may be submitted” to ADR. Specifically, HRSA referenced “(1) transferring of covered outpatient drugs to a patient where there was no record of the individual's health care or no provider relationship or (2) transferring covered outpatient drugs to an individual who is an inpatient”. In other words, by offering these “examples”, HRSA stuck to obvious scenarios, steering clear of any of the Genesis issues, whether a CE must be responsible for the prescription or at least for the treatment of the underlying condition. Bottom Line: The Rule could have plugged the gaping hole in the current “patient definition”, but HRSA took a pass, abdicating its regulatory responsibility.

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The evidence is stacking up on the ways many hospitals are violating the 340B program. Here’s one example that’s getting more attention lately: Illegal duplicate discounting.    Under federal law, a medicine cannot be purchased at the lower 340B price AND also receive a Medicaid rebate.    Yet government watchdogs have found it’s happening at an alarming rate. Between FY 2012 and FY 2019, GAO found more than 400 violations of the law.   And it is leading to higher prices for patients, employers and taxpayers.    Despite the clear legal prohibitions, HRSA and CMS have failed to put an end to illegal duplicate discounting.    If these agencies won’t do their job and put a stop to it, they shouldn’t interfere with manufacturers implementing their own reasonable business practices to address the issue.

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📢 Legislation Alert: The Pharmacists Fight Back Act! We're excited to see Representative Jake Auchincloss taking a strong stance against predatory drug pricing with the introduction of the bipartisan Pharmacists Fight Back Act. This crucial legislation aims to protect consumers from unfair pricing practices and ensure that affordable medications are accessible to all. At AffirmedRx, we wholeheartedly support initiatives like this that align with our mission to bring transparency and fairness to the pharmacy benefit management industry. Our commitment to Building Trust Through Transparency means we go beyond industry norms to provide clear, upfront pricing and prioritize the well-being of our members over profits. Together, let's push for a healthcare system where transparency isn't just an option, but a standard. Learn more about how AffirmedRx is leading the charge in transforming pharmacy benefits management for the better. #PharmacyBenefits #DrugPricing #HealthcareReform #Transparency #AffirmedRx Read the full article here: https://lnkd.in/eYH_9dVH

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Pennsylvania takes action on PBMs and scope of practice #PBM #PBMReform #drugprices #pharmacy #independentpharmacy https://lnkd.in/eD5gH4ew

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🌟 Say hello to Katie Laskin, PharmD, BCSCP, FNHIA, CNSC, IgCP, Senior Pharmacy Specialist at Yale New Haven Health Home Infusion! In this installment of our Innovators of Home Infusion series, Katie shares her passion for mentoring future leaders in home infusion. With nearly two decades of experience, she emphasizes the importance of continuous learning and adaptability in this ever-evolving field. Katie is actively advocating for expanding Medicare coverage to improve patient access to home infusion services. Curious to learn more about Katie's impactful work and vision for patient-centered care? Check out the full blog post in the comments below!👇#InnovatorsOfHomeInfusion #NHIAFellow2024

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