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Hassan Shaikh

Associate

[email protected]

+1.202.434.7375

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Hassan’s practice focuses on advising a broad range of clients—including health plans, pharmacy benefit managers, rebate aggregators, providers, and private equity firms—in contract negotiations, complex industry transactions, and compliance and regulatory matters. He regularly counsels plans, PBMs, rebate aggregators, and providers on regulatory, operational and contracting matters; and often advises clients on compliance with the anti-kickback statute and corporate practice of medicine prohibitions.

Hassan leverages his prior experience  representing private equity firms in various acquisitions, restructurings, and growth equity transactions to provide reasoned and pragmatic solutions to a wide range of client needs. 

Prior to joining Mintz, Hassan was an associate with a large, international law firm in New York City, and then later, with a boutique law firm in Los Angeles.

Hassan received his J.D. from Duke Law School, where he was an editor of the Duke Journal of Constitutional Law and Public Policy. He received his B.S.Ed and MPH from Baylor University, with a concentration in health education.

viewpoints

In ‘Third Edition: Q2 2024’ of the Mintz IRA Update, we cover updates to the Medicare Drug Price Negotiation Program being considered by CMS, developments in litigation challenging the program, the consequences and costs of redesigning the Part D program, opposition to the use of march-in rights to lower drug prices, and the growing use of state prescription drug affordability boards.

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On July 9, 2024, the Federal Trade Commission (FTC) Office of Policy Planning released an Interim Staff Report titled Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies. The Interim Staff Report reflects the FTC’s work since it began its 6(b) study of PBMs in June 2022.  Mintz’s Health and Antitrust teams actively monitor federal and state regulatory and legislative developments in the PBM space, including those from the FTC. In this Special Edition of the PBM Policy and Legislative Update, the Mintz Health team partnered with our Antitrust colleagues to analyze the Interim Staff Report including Commissioner Melissa Holyoak’s dissenting statement.  We also highlight upcoming Congressional testimony by CEOs of the three largest PBMs, as well as media reports of a forthcoming FTC action related to PBM insulin rebate practices.

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Mintz is pleased to present its quarterly publication, PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from October through December 2023 that affects the PBM industry and will specifically highlight (i) federal legislative and enforcement updates, (ii) state legislative updates and litigation, (iii) other industry news, and (iv) Inflation Reduction Act (IRA) updates.

 

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In this edition of the Mintz IRA Update, we cover the status of the negotiations underway between CMS and manufacturers pursuant to the Medicare Drug Price Negotiation Program and current legal challenges to the program, other drug pricing–related IRA initiatives, the IRA’s small biotech exemption, implications associated with removing the average manufacturer price cap on Medicaid rebates, and the Biden administration’s proposed draft guidance on patent “march-in” rights.

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Mintz’s PBM & Pharmacy practice is proud to present the Mintz IRA Update, a regular publication that delves into the spectrum of developments under the Inflation Reduction Act of 2022 (“IRA”) impacting the health care industry.

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Though the flurry of state PBM-focused legislation slowed down with the summer recess, there has still been plenty of noteworthy PBM news. This roundup focuses on state Medicaid enforcement activities involving Centene and provides a brief overview of recent legislative activity.

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MintzRx is a regular newsletter providing you with everything you need to know to stay abreast of the legal, regulatory, and industry developments across the pharmaceutical supply chain.

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2022 continues to see a surge in state-led PBM enforcement efforts. This roundup provides a brief summary of Louisiana’s complaint against United Healthcare and OptumRx related to its Medicaid program and recent state legislative actions.

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As we noted in our last PBM Regulatory Roundup, there has been a wave of state regulation focused on PBM practices in the wake of Rutledge and Webhi. However, PBMs are also facing federal reform efforts. The Pharmacy Benefit Manager (PBM) Transparency Act of 2022 (the Act) was recently proposed in the U.S. Senate and intends to incentivize “fair and transparent” PBM practices, prohibit spread pricing and claw backs of payments to pharmacies, and empower the Federal Trade Commission (FTC) and state attorneys general in enforcement actions to stop “unfair and deceptive” PBM business practices.

At the same time, government watchdogs are also taking action: on June 7, 2022, the FTC announced that it would launch an inquiry into vertically integrated PBMs, and the Office of the Inspector General (OIG) for the Department of Health and Human Services expects to release a report in 2022 following completion of its analysis of Medicaid Managed Care Organization (MCO) PBM pricing.

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News & Press

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Associate Hassan Shaikh spoke to Law360 in an article discussing Michigan’s new Pharmacy Benefit Manager (PBM) licensing requirements set to commence in 2024.

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Theresa CarnegieLauren Moldawer, and Hassan Shaikh co-authored an article published by Law360 on the Inflation Reduction Act's Medicare drug pricing negotiation program.

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In a recent installment of Law360 Pulse’s “Ask a Mentor” column, Managing Member of Mintz’s Washington, D.C. Office and Chair of the firm’s Health Law, Communications, Antitrust & ML Strategies Division Susan Berson, who regularly mentors firm attorneys, and Associate Hassan Shaikh, who transitioned from a private equity mergers and acquisitions practice to a health care regulatory role, offered retooling tips to associates.
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Publications

  • Co-author, Assessing College Students' Use of Campus Recreation Facilities Through Individual and Environmental Factors, Recreational Sports Journal, (October 2018)
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Involvement

  • Member, American Bar Association
  • Member, American Health Law Association
  • Member, Health Care Compliance Association
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