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Stephnie A. John

Associate

[email protected]

+1.212.692.6257

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Stephnie focuses her practice on advising clients across the health care industry on regulatory, transactional, and compliance matters. She serves as regulatory counsel to private equity firms and other investors in transactions involving a range of health care targets, including health care systems and other health care providers, PBMs, pharmacies, nurse staffing companies, and laboratories. She regularly advises pharmacies, PBMs, third party payors, digital health companies, value-based contracting entities, and care providers on regulatory matters. With her previous experience at a state Medicaid agency and the Medicare Appeals Council, she is able to strategically advise clients on regulatory and compliance issues relating to Medicare and Medicaid.

Prior to joining Mintz, Stephnie was an attorney advisor at the Office of General Counsel of the DC Department of Health Care Finance. Stephnie provided DC’s Medicaid agency with legal and compliance counsel and defended it in administrative proceedings, including provider appeals of Medicaid payment suspensions based on allegations of fraud and pharmacy overpayment recoupments identified by state Medicaid audit. During the COVID-19 pandemic, Stephnie helped to ensure the agency’s compliance with the CARES Act. Earlier, Stephnie was an associate at Healthcare Legal Solutions, LLC, where she reviewed hospital and health care providers’ medical claims and billing practices, drafted administrative appeals on behalf of providers, and strategized with clients to ensure compliance with Medicare and Medicaid regulations and reduce payment denials.

While attending George Washington University School of Law, Stephnie was managing editor of the Federal Circuit Bar Journal. She also served as a legal extern for the Medicare Appeals Council, housed under the Departmental Appeals Board at the Department of Health and Human Services, and clerked for two law firms in the Washington metropolitan area.

Not admitted to practice law in New York.  Admitted to practice only in the District of Columbia.

viewpoints

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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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Read about criticism of the Biden administration’s proposal exploring the use of “march-in rights” granted under the Bayh-Doyle Act (the Act) to seize pharmaceutical patents if the administration believes that a pharmaceutical product is not available to the public at a reasonable price.

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Read about updates to the Medicare Drug Price Negotiation Program being considered by CMS, including changes to the 2027 negotiation process, plus industry response to draft guidance and drug makers’ softened perspective on the IRA’s impact.
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Read about the 2025 redesign of the Medicare Part D program pursuant to the Inflation Reduction Act of 2022 and how those changes impact Medicare Part D plan sponsors, beneficiaries, and manufacturers.

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States are increasingly exercising regulatory oversight of health care transactions by enacting laws requiring prior notice or approval of certain health care transactions. Currently, 15 states have enacted health care transaction review laws applicable to for-profit transactions. On Wednesday, March 20, 2024, Mintz members Daniel A. Cody, Deborah A. Daccord, and Karen S. Lovitch engaged in an insightful discussion with Lois Johnson, General Counsel of Massachusetts Health Policy Commission, to discuss the latest developments surrounding these laws and gain valuable insight from Ms. Johnson’s expertise, as Massachusetts was one of the first states to implement a health care transaction review process. The highlights of this informative conversation are summarized below, and the webinar can be viewed here.

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Read about the Biden administration’s backing of draft guidance to government agencies weighing the enforcement of march-in rights, which can allow federal agencies to require patent licenses to be given to third parties if a product was developed or conceived with federal funding assistance.

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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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Read about key Inflation Reduction Act provisions taking effect this year related to the Medicare Drug Price Negotiation Program, Medicare Part D benefits, and more.

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On October 10, 2023, the Drug Enforcement Administration (DEA) published another temporary rule extending the COVID-era telemedicine flexibilities that allow physicians and other prescribers to prescribe controlled substances without an in-person evaluation.  With just over a month to go before the expiration of the first set of flexibilities, the DEA announced that the telemedicine flexibilities, which have been in place since March 2020, will be extended through the end of 2024 in order to give the agency more time to consider feedback received in response to the proposed rule, which was announced in March of this year.  As a reminder, under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, providers may not prescribe controlled substances without an in-person visit, unless an exception applies.  The COVID public health emergency triggered one such exception, which lead to the telehealth flexibilities. 

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News & Press

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A Mintz team led by Richard Gervase, Member and Chair of the firm’s Royalty & Revenue Interest Financing Transactions Group, advised global investment firm Sixth Street in a non-dilutive, senior secured credit facility of up to $475 million for Apellis Pharmaceuticals. Apellis received $375 million in funding at close, with ability to access an additional $100 million under the facility at the Company’s option prior to September 2025, subject to the satisfaction of certain conditions.

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Recognition & Awards

  • Summer Public Interest Fellow, South Asian Bar Association (2015)

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Involvement

  • Legal Counsel, Dil to Dil, a nonprofit organization dedicated to South Asian mental health advocacy
  • Member, American Health Law Association
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