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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

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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Listen to our team discuss key takeaways from the weeklong summit and how industry trends are impacting business practices.

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In our annual Health Care Enforcement Year in Review & Outlook report, we examine the data and explore health care enforcement trends and likely targets of government scrutiny for 2022 and beyond.
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As we noted, Centers for Medicare & Medicaid Services (“CMS”) recently proposed its Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rules (“Proposed Rule”) that would increase consumer protections and reduce health care disparities in Medicare Advantage (“MA”) and Part D. In the Proposed Rule, CMS proposes major modifications to its regulations governing Dual Eligible Special Needs Plans (“D-SNPs”), which are MA products specifically for individuals who are dually eligible for Medicare and Medicaid. These changes are informed by the success of CMS’ Financial Alignment Demonstration and Medicare-Medicaid Plans (“MMPs”). In fact, under the Proposed Rule, CMS is proposing that many key characteristics of MMPs be incorporated into D-SNPs. CMS is also proposing to update the definitions of Fully Integrated Dual Eligible Special Needs Plans (“FIDE SNPs”) and Highly Integrated Dual Eligible Special Needs Plans (“HIDE SNPs”) to incorporate successful characteristics of MMPs and to better clarify and differentiate these terms.
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Our previous blog post on pending California privacy legislation included a prediction that has since materialized: Governor Newsom signed the Genetic Information Privacy Act (“GIPA”) on October 6, 2021, and the law will go into effect on January 1, 2022. GIPA establishes a number of mechanisms to close the existing gap in the protection of genetic information under the current framework of federal and state privacy laws. As discussed in our earlier post, GIPA contains a robust penalty structure, but it includes a number of carve-outs and does not apply to entities already subject to regulation under other health information privacy laws. Notably, GIPA does not reduce or eliminate obligations under other laws, including California’s more broadly applicable consumer privacy laws, such as the CCPA and breach notification statute, as recently amended by AB 825. Given Governor Newsom’s former concern about GIPA’s interference with mandatory COVID-19 testing reporting, the law also does not apply to tests that are conducted exclusively to diagnose whether an individual has a specific disease.
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When it comes to the privacy of health information, California belongs to the select group of states that have implemented broad consumer privacy protections above and beyond those provided by the federal Health Insurance Portability and Accountability Act (HIPAA) and the Federal Trade Commission Act (FTCA). This year, the state’s ongoing legislative efforts to protect the health information of its residents included: Assembly Bill 1436 (AB 1436) which if enacted would have revised California’s existing Confidentiality of Medical Information Act (CMIA), and Senate Bill 41 (SB 41), which if enacted will create the new Genetic Information Privacy Act (GIPA). As further discussed below, only SB 41 is moving forward, and if signed by Governor Newsom GIPA will go into effect on January 1, 2022.
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A recent settlement agreement between a clinical laboratory and the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) to resolve potential HIPAA Security Rule violations proves to be a cautionary tale for covered health care providers everywhere. There are two key lessons to note. First, a monetary penalty or fine may the least financially burdensome consequence of HIPAA non-compliance, because corrective action plans (CAPs) can be extremely costly. Second, in the context of a health care transaction, such as a merger or acquisition, non-compliance by one party to the transaction can prompt enforcement against the other party and even that party’s future business partners. This is the case even if the non-compliance preceded closing.
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As we previously reported, President Biden signed into law a $1.9 trillion dollar stimulus bill, the American Rescue Plan Act (ARPA). This historic legislative package provides much needed relief to millions of Americans impacted by the COVID-19 pandemic and essential resources to address the ongoing public health emergency. Among other things, the ARPA allocates funds to the Department of Health and Human Services (HHS) for COVID-19 testing, contract tracing, vaccines, supplies, and other related treatment. To alleviate the strain of the COVID-19 pandemic on America’s public health care system, it includes funding for rural health providers, community health centers, and skilled nursing facilities, and makes important modifications to the Medicare and Medicaid programs. This post summarizes the Medicaid provisions contained in the ARPA and their proposed changes to the Medicaid program.
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News & Press

Press Release Thumbnail Mintz

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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