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Rachel E. Yount

(she/her/hers)

Of Counsel

[email protected]

+1.202.434.7427

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Rachel’s practice involves a variety of regulatory, compliance, and transactional matters for a broad range clients across the health care industry, including health care systems, managed care organizations, pharmacies, device and pharmaceutical manufacturers, long-term and post-acute care providers, and private equity firms investing in the health care industry. 

Rachel combines her industry knowledge and her deep understanding of the complex legal frameworks regulating the health care industry to provide her clients with practical, strategic guidance that supports innovation and business objectives. She is particularly well versed in the federal anti-kickback statute, the Stark Law, state fraud and abuse laws, beneficiary inducement prohibitions, provider-based rules, Medicare and Medicaid program requirements, and the federal Physician Payments Sunshine Act. She routinely advises clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices.

Rachel regularly advise clients on the regulatory framework for value-based health care, including new and evolving CMS-sponsored payment models (e.g., ACO REACH, Medicare Shared Savings Program, Kidney Care Choices). She is particularly adept at assisting health care companies in navigating the anti-kickback statute safe harbors and Stark Law exceptions for value-based care.

Rachel frequently assists with implementing effective health care compliance programs for clients in various health care sectors, including pharmaceutical manufacturers, health systems, and managed care organizations, to name a few. She has assisted both with developing brand new compliance programs for health care companies just starting out and maturing existing compliance programs to support health care companies’ efforts to expand.

On the transactional side, Rachel frequently serves as health care regulatory counsel in both M&A transactions and private equity investments, involving managed care organizations, pharmacies, and a range of health care providers. She has experience in complex due diligence, contracting matters, identifying fraud and abuse risks, and advising on regulatory issues relevant to the target.

Previously, Rachel was a compliance attorney with Sentara Healthcare, a health care system with 12 acute care hospitals and more than 300 sites of care in Virginia and North Carolina. Focusing on the physician contracting process, Rachel developed strategic solutions to operational problems and provided legal support for compliance issues across the system. Her in-house experience informs her pragmatic, business-savvy counsel to health care industry clients.

Rachel is frequently invited to speak on health care fraud and abuse, compliance, and other health law matters. She is also an editor of and frequent contributor to the firm’s Health Care Viewpoints.
 

Experience

  • Served as health care regulatory counsel to TPG Capital as part of its joint acquisition of OneOncology with AmericsourceBergen.
  • Served as health care regulatory counsel to JP Morgan and Goldman Sachs in connection with the financing and bond offerings relating to the purchase of athenahealth by Bain Capital and Hellman & Friedman.
  • Served as health care regulatory counsel to The Rise Fund in connection with its acquisition of Blue Cloud Pediatric Surgery Centers.
  • Conducted the due diligence and provided state and federal regulatory research and analysis in connection with TPG’s acquisition of Convey Health Solutions, a specialized health care technology company that provides health plan administration, supplemental benefits administration, and consulting services to health plans.
  • Served as health care regulatory specialist for a private equity-backed radiology services provider in multiple practice acquisitions.
  • Provided health care regulatory counsel in connection with a population health manager’s sale of a minority equity stake in its subsidiary to a large health care system.
  • Served as the Interim Chief Compliance Officer at CareSource, an Ohio managed care organization offering Medicaid, Medicare, and Marketplace plans.
  • Acted as special counsel for the initial public offering of Blued, China’s largest LGBT dating app and surrogacy facilitator.
  • Represented a health care provider in a self-disclosure to CMS for potential Stark Law violations.
  • Represented a health care provider under investigation by the Department of Justice for alleged violations of the anti-kickback statute and Stark Law.
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viewpoints

On November 20, 2020, the Department of Health & Human Services (HHS) finalized significant changes to the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (commonly known as the Stark Law), and the civil monetary penalty rules regarding beneficiary inducements (Beneficiary Inducements CMP). The final rules are part of HHS’s Regulatory Sprint to Coordinated Care and are designed to offer the health care industry more flexibility and to reduce the regulatory burden associated with the AKS and the Stark Law, particularly with respect to value-based arrangements and care coordination. Offering a number of industry-friendly changes, the final rules will have a far-reaching impact on the health care industry.
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On October 29, 2020, the Department of Justice (DOJ) announced the first publicly-available settlement involving alleged violations of CMS’s Open Payments Program, otherwise known as the Sunshine Act. The $9.2 million settlement resolved allegations that Minnesota-based medical device manufacturer Medtronic USA Inc. violated (i) the Anti-Kickback Statute (AKS) and the False Claims Act (FCA) by paying kickbacks to a South Dakota neurosurgeon, Wilson Asfora, M.D., and (ii) the Open Payments reporting requirements by failing to accurately report payments it made to Asfora to the Centers for Medicare & Medicaid (CMS). While this settlement is the first public enforcement action involving Open Payments violations, more enforcement actions may be expected in the near future.
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On September 9, 2020, the Department of Justice (DOJ) announced a $50 million settlement with Wheeling Hospital, Inc. of West Virginia to resolve False Claims Act allegations that Wheeling Hospital violated the Anti-Kickback Statute (AKS) and Stark Law. The settlement resolved False Claims Act allegations that were triggered by a qui tam lawsuit brought by a former vice president of Wheeling Hospital who oversaw hospital operations and physician engagements. According to the relator's complaint, Wheeling Hospital, under its former management, paid several physicians annual compensation in excess of a million dollars based on the volume or value of their referrals.
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On Wednesday, August 26th, the Centers for Medicare & Medicaid Services (CMS) issued a notice extending the deadline to finalize significant proposed changes to the Physician Self-Referral Law (commonly known as the Stark Law) announced last year. CMS published the proposed rule on October 17, 2019 in tandem with a companion proposed rule issued by Department of Health and Human Services (HHS) Office of Inspector General (OIG) with equally sweeping changes to the Anti-Kickback Statute (AKS). Both rules were issued as part of CMS’s Regulatory Sprint to Coordinated Care and offer a number of industry-friendly changes designed to reduce regulatory burden associated with the Stark Law and the AKS and allow for increased adoption of value-based arrangements.
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The Department of Justice (DOJ) has announced its first criminal securities fraud prosecution related to COVID-19, and it involves health care fraud as well. Mark Schena, president of Arrayit Corporation, a publicly traded medical technology company, faces criminal charges in connection with false and fraudulent claims submitted for allergy and COVID-19 testing. The complaint charges Schena with one count of securities fraud and one count of conspiracy to commit health care fraud. From 2018 to present, Arrayit, under Schena’s direction, allegedly submitted or caused the submission of over $5.9 million in Medicare claims and over $63 million in private insurance claims for allergy and COVID-19 tests that were not medically necessary, were not provided as claimed, or were tainted by the payment of kickbacks and bribes.
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In an effort to increase access to COVID-19 testing for Medicare and Medicaid beneficiaries, the Centers for Medicare & Medicaid Services (CMS) has issued a second round of regulatory waivers that includes relaxed Medicare requirements for ordering COVID-19 diagnostic laboratory tests, flexibility for Medicaid coverage requirements of COVID-19 tests, and Medicare coverage of COVID-19 serology tests to identify antibodies.
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On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued blanket waivers to the Stark Law that permit certain arrangements between physicians and health care providers implemented in response to COVID-19 that would otherwise violate the Stark Law. The waivers, which are numerous and fairly broad, offer health care entities significant flexibility to combat COVID-19 in ways that may have otherwise violated the Stark Law, such as the ability to pay physicians hazard pay and provide personal protective equipment to physicians at a price that is below fair market value (FMV). Importantly, the waivers only apply to remuneration and referrals related to COVID-19 purposes.
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In response to the nationwide COVID-19 emergency, state boards of pharmacy across the country are authorizing waivers of specific provisions of pharmacy laws and implementing policies to address potential staffing shortages and emergency dispensing of pharmaceuticals. Here's a high-level overview of the various actions being taken by state boards of pharmacy.
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Rachel Yount discusses the proposed new safe harbor that would protect patient engagement and support arrangements designed to improve quality, efficiency of care, and health outcomes.
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Drug prices continue to be a hot button issue in American politics.  While many of the Trump Administration’s efforts to curb increasing drug prices stalled in 2019, a number of state legislatures have adopted drug price transparency laws in recent years.  Since 2015, Vermont, Nevada, California, Maryland, Louisiana, New York, Oregon, Colorado, Connecticut, Maine, Texas, and Washington have all adopted drug pricing transparency laws.  These laws are designed to incentivize manufactures to lower drug prices by requiring them to report information about drug price increases and their justification for how drug prices are set.  We have been tracking and summarizing these laws, and you can find our summary here. 
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News & Press

News Thumbnail Mintz
Mintz Member and Chair of the firm’s Health Law Practice Karen S. Lovitch and Associate Rachel E. Yount co-authored a two-part Law360 expert analysis series that examined key provisions of the U.S. Department of Health and Human Services’ final rules amending the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law — commonly known as the Stark Law — and the civil monetary penalty rules regarding beneficiary inducements, and provided practical examples of how the industry can take advantage of these significant changes.
News Thumbnail Mintz
Mintz Member and Chair of the firm’s Health Law Practice Karen S. Lovitch and Associate Rachel E. Yount co-authored a two-part Law360 expert analysis series that examined key provisions of the U.S. Department of Health and Human Services’ final rules amending the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law — commonly known as the Stark Law — and the civil monetary penalty rules regarding beneficiary inducements, and provided practical examples of how the industry can take advantage of these significant changes.
News Thumbnail Mintz
In an article published by Bloomberg Law, Mintz Associate Rachel Yount was quoted discussing the easing of state pharmacy laws surrounding COVID-19 and the benefit of getting out-of-state help when needed.
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Publications

Co-author, What Is...The Anti-Kickback Statute?, Second Edition, Published by the American Bar Association (2022)

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Recognition & Awards

  • Recognized by The Legal 500 United States for Healthcare: Service Providers (2021)

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Involvement

  • Member, American Health Lawyers Association (2011-present)
  • Member, Health Law Section, American Bar Association (2016-present)
  • Vice Chair, Health Law Committee of the Young Lawyers Division, American Bar Association (2017-2018)
  • Member, Health Care Compliance Association (2014-2016)
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