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Rachel E. Yount

(she/her/hers)

Associate

[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 assists with implementing effective health care compliance programs for clients in various health care sectors, including managed care organizations, health systems, and pharmaceutical manufacturers, 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. During a three-month secondment from Mintz, she also served as the interim chief compliance officer for a nonprofit managed care organization that offers Medicaid, Medicare Advantage, and Marketplace health plans.

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.

An active member of the American Bar Association’s Health Law Section, Rachel assisted in drafting several revisions to the group’s reference guide, Health Care Fraud and Abuse: Practical Perspectives, and organized and moderated a panel of senior government attorneys for an ABA networking event. She is frequently invited to speak on health care 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 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

The Centers for Medicare & Medicaid Services (CMS) recently announced changes to the Medicare Shared Savings Program (MSSP) designed to improve equity within the MSSP and increase the percentage of Medicare beneficiaries in accountable care arrangements. The changes are included in the Calendar Year 2023 Physician Fee Schedule final rule (Final Rule), which is scheduled for publication on November 18, 2022.
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A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase patients’ awareness of the Open Payments database so they can make informed decisions about drugs and devices prescribed by their physician. This blog post provides an overview of the Open Payments Program, what exactly California's AB 1278 entails, and the implications of the law come January 2023 and January 2024. 
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On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of over-the-counter (OTC) drugs to Medicare Part D in violation of the False Claims Act (FCA).  Because Medicare Part D only covers prescription drugs, the pertinent drugs were not eligible for Medicare reimbursement. The conduct at issue under this settlement is a relatively novel basis for FCA liability, but we may see similar government enforcement actions in the future as the federal government actively encourages drug manufacturers to “switch” prescription drugs to OTC status in order to enhance their accessibility and reduce costs. This blog post provides an overview and analysis of the settlement. 
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In a significant win for False Claims Act (FCA) defendants, the Eighth Circuit recently reversed a district court decision that defendants violated the FCA premised on violations of the Anti-Kickback Statute (AKS). The Eighth Circuit adopted a stricter but-for causation standard for FCA claims based on AKS violations, holding that, in order to prevail on these claims, the government must prove that FCA defendants would not have submitted claims for particular items or services to Medicare or Medicaid absent the illegal kickbacks.
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On April 27, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services issued Advisory Opinion No. 22-08 (AO 22-08), which addresses an existing arrangement of a federally qualified health center (FQHC) (hereafter, Requestor) that loans limited-use smartphones to enable existing patients’ access to Requestor’s telehealth platform (the Arrangement).  The Arrangement’s purpose is described as increasing access to telehealth services and combating isolation by allowing patients to talk and text with others, including during the COVID-19 public health emergency (PHE).
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OIG Approves Physician-Owned Medical Device Company

April 28, 2022 | Blog | By Rachel Yount

On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the Company’s products hold a majority ownership interest.  The Company manufactures medical device products that may be ordered by the physician owners and a physician spouse of one of the physician owners. This blog post analyses the Advisory Opinion and recommends risk-mitigation strategies for PODs and other health care entities with physician ownership, particularly entities where physician-owners are a considerable source of revenue. 
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The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued another favorable Advisory Opinion on patient incentives (e.g. gift cards or cash equivalents) given as part of patients’ treatment plans. Though the OIG reiterated its concern that cash and cash equivalents given to patients can present substantial fraud and abuse risks, the OIG concluded that the arrangement presented a minimal level of risk.
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OIG Approves Online Retailer’s Discount Program

January 25, 2022 | Blog | By Rachel Yount

On January 19, 2022, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding an online retailer’s proposal to make its discount programs available to Medicaid beneficiaries. Currently, lower-income individuals are eligible for the retailer’s discount programs based on their enrollment in a number of assistance programs (e.g. Supplemental Security Income, Supplemental Nutrition Assistance Program), and the retailer proposes Medicaid enrollment as another category of eligibility.
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Removing Barriers to Second Chances

January 24, 2022 | Article

Mintz initiated many pro bono projects to combat systemic racism after the murder of George Floyd, including organizing Massachusetts Criminal Offender Record Information sealing clinics with the Lawyers Clearinghouse and conducting research for a Boston-based nonprofit into how housing authorities around the country evaluate applicants with open criminal charges.
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On November 22, 2021, the Office of Inspector General for the Department of Health and Human Services (OIG) posted a negative Advisory Opinion regarding a proposed joint venture (JV) for the provision of therapy services (Proposed Arrangement) between an existing therapy services provider (Therapy Services Provider) and the owner of long-term care facilities (LTC Owner). This Advisory Opinion is yet another example of OIG guidance reiterating its view that joint ventures formed between entities in the position to provide health care items or services and entities in the position to refer business can present risk under the federal Anti-Kickback Statute (AKS).
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News & Press

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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.
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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.
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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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Rachel E. Yount

(she/her/hers)

Associate

Washington, DC