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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

The Department of Health and Human Services’ Office of Inspector General (OIG) announced on April 24, 2023 that it will soon issue long overdue updates to its compliance program guidance documents (CPGs).  First introduced in 1998, the CPGs are a series of voluntary guidance documents, each tailored to a specific segment of the health care industry. While the CPGs include important insights on specific risk areas and how to apply the seven elements of an effective compliance program to particular types of health care entities, they are ripe for modernizing. OIG will publish a General CPG (GCPG) applicable to all individuals and entities involved in the health care industry by the end of 2023, followed by industry-specific CPGs (ICPGs) in 2024. Of note, the OIG announced that its first two ICPGs will address Medicare Advantage and Skilled Nursing Facilities (SNFs), perhaps signaling the OIG’s priorities. The OIG’s updates to the CPGs are part of the OIG’s Modernization Initiative first announced in September 2022.
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The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or preventive care services. The proposed arrangement involves an in-home colorectal cancer screening company’s proposal to provide gift cards of up to $75 to encourage patients to return their samples for their colorectal cancer screening. Though the OIG noted that the gift cards implicate the federal Anti-Kickback Statute (AKS) and the Beneficiary Inducements CMP because they would influence patients to receive reimbursable services from the requestor, the OIG concluded that the arrangement presented a minimal level of risk.  
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The Stark Law’s Self-Referral Disclosure Protocol (SRDP) will include a new Group Practice Information Form for physician practices to report any noncompliance arising from not fully satisfying the Stark Law’s definition for a “group practice,” effective March 1, 2023. The Centers for Medicare & Medicaid Services (CMS) intends for the changes to reduce regulatory burden and streamline the disclosure process.
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As Accountable Care Organizations (ACOs) and providers gear up for the start of the new ACO REACH Model in 2023, CMS recently issued helpful policy updates to the model’s benefit enhancements (BEs). Under BEs, CMS waives certain Medicare payment requirements for services provided to REACH beneficiaries through the REACH ACO’s participant providers and preferred providers. REACH ACOs can opt to use one or more of the BEs, which are designed to create flexibility in managing REACH beneficiaries’ care. REACH ACOs have full control over which providers participate in any BE. As discussed below, CMS recently announced updates to two of the model’s BEs – the 3-Day Skilled Nursing Facility (SNF) Rule Waiver and the Nurse Practitioner (NP) Services.   
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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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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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