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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.

viewpoints

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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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Mintz IRA Update — Inaugural Edition

September 20, 2023 | Blog | By Theresa Carnegie, Tara E. Dwyer, Mitchell Clough, Xavier Hardy, Stephnie John, Bridgette Keller, Lauren Moldawer, Pat Ouellette, Hassan Shaikh

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Transforming Primary Care: CMS Launches Making Care Primary (MCP) Model

August 8, 2023 | Blog | By Rachel Yount, David Gilboa, Stephnie John

The Centers for Medicare & Medicaid Services (CMS) announced a new primary care model—the Making Care Primary (MCP) Model—geared towards smaller, independent primary care practices and organizations that want to participate independently in value-based care initiatives. The MCP Model will be tested in eight states - Colorado, Massachusetts, Minnesota, New Mexico, New Jersey, New York, North Carolina, and Washington.
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In a resounding unanimous 9-0 decision, the Supreme Court rejected the argument that a defendant’s subjective belief is irrelevant under the False Claims Act (FCA) when evaluating whether a defendant “knowingly” submitted a false claim to the government for payment. On June 1, 2023, the Court issued its highly anticipated opinion in the consolidated cases U.S. ex rel. Schutte v. SuperValu, Inc. and U.S. ex rel. Proctor v. Safeway, Inc. (SuperValu) and addressed the question of whether a defendant is liable under the FCA if its conduct is consistent with an “objectively reasonable” interpretation of ambiguous statutory or regulatory language. Justice Thomas, writing for the Court, held that an “objectively reasonable” interpretation does not provide a complete legal defense to liability under the FCA. Rather, a defendant meets the FCA’s intent (scienter) requirement if the defendant’s subjective beliefs indicate it had knowledge that its submission of claims was “false or fraudulent,” regardless of whether the defendant’s conduct could be supported by a later “objectively reasonable” interpretation of the ambiguous legal or regulatory issue. Further, the Court articulated new standards for what might constitute “deliberate ignorance” or “reckless disregard” under the “knowledge” prong of the FCA.
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Mintz Health Law: What We Are Grateful For

January 11, 2023 | Podcast | By Bridgette Keller

Bridgette Keller speaks with the Mintz Health Law team about what they are grateful for as they look back on a year of client service, mentorship, and working together as a team.
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Nurse and health care professional staffing shortages during the COVID-19 pandemic resulted in a significant increase in the use of temporary health care professional staffing. Shortages have also lead to the increase in the use of travel nurses, causing state lawmakers to prioritize regulation of health care staffing agencies. This post provides an overview of recently enacted and proposed state legislation requiring licensure or registration of health care staffing companies and/or nursing pools.
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MintzRx Newsletter — Your Prescription for the Pharmaceutical Supply Chain

October 3, 2022 | Article | By Theresa Carnegie, Tara E. Dwyer, Xavier Hardy, Stephnie John, Bridgette Keller, Lauren Moldawer, Pat Ouellette, Hassan Shaikh

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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Senate Democrats Pass Long-Awaited Drug Pricing Reforms in Budget Reconciliation Bill

August 10, 2022 | Blog | By Bridgette Keller, Stephnie John

On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022 (the Reconciliation Bill). In addition to climate and tax provisions, the Reconciliation Bill includes a revised drug pricing reform package that Democrats had approved last month. In this post, we review what passing the long-awaited drug pricing reforms means for Medicare recipients and for drug prices in the United States.
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At the end of March 2022, the Centers for Medicare & Medicaid Services (CMS) released guidance to drug manufacturers and states on reporting Medicaid Best Price under value based purchasing (VBP) arrangements (Medicaid Best Price Guidance or Guidance).  This Guidance follows CMS’ final rule issued on December 31, 2020 (Final Rule) responding to criticism that Medicaid Best Price requirements are hindering the use of VBP arrangements.  The Final Rule and Guidance will go into effect on July 1, 2022, allowing manufacturers to report multiple best prices for VBP arrangements so long as the manufacturer offers the VBP arrangement to state Medicaid programs. This blog post will begin with a “101” on the Medicaid Best Price Policy, and then delve into an overview of the Final Rule, including the surrounding criticism from stakeholders; summarize the Medicaid Best Price Guidance; and discuss the potential impact of this change on states and manufacturers
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Health Law Diagnosed — Key Takeaways from the 6th Annual Pharmacy & Pharmaceutical Industry Summit

April 7, 2022 | Podcast | By Stephnie John, Bridgette Keller, Hassan Shaikh

The latest episode of Mintz’s Health Law Diagnosed podcast covers key takeaways from our 6th Annual Pharmacy & Pharmaceutical Industry Summit.
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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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