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.
viewpoints
Eighth Circuit Adopts Stricter But-For Causation Standard for False Claims Act Claims based on Anti-Kickback Violations
August 18, 2022 | Blog | By Kevin McGinty, Rachel Yount
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.
OIG Issues Favorable Opinion on Federally Qualified Health Center’s Smartphone Loan Program
May 6, 2022 | Blog | By Rachel Yount, Jean D. Mancheno
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).
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.
OIG Issues Another Favorable Advisory Opinion on Treatment-Based Patient Incentives
March 15, 2022 | Blog | By Rachel Yount
OIG Approves Online Retailer’s Discount Program
January 25, 2022 | Blog | By Rachel Yount
Removing Barriers to Second Chances
January 24, 2022 | Article
OIG Reiterates its Longstanding Concern about Joint Ventures between Health Care Providers/Suppliers and Referral Sources
December 1, 2021 | Blog | By Rachel Yount
OIG Revises and Renames the Provider Self-Disclosure Protocol
November 10, 2021 | Blog | By Karen Lovitch , Rachel Yount
OIG Issues Favorable Advisory Opinion on Hospital’s Warranty Program for Joint Replacement Procedures
September 20, 2021 | Blog | By Rachel Yount
PhRMA Updates its Code on Interactions with Health Care Professionals in Response to the OIG's Special Fraud Alert on Speaker Programs
August 17, 2021 | Blog | By Rachel Yount, Cody Keetch, Joe Ort
The changes to the PhRMA Code are undoubtedly in response to a November 16, 2020, Special Fraud Alert from the Department of Health and Human Services’ Office of the Inspector General (OIG), on “fraud and abuse risks associated … speaker programs.” (For additional information on the OIG’s Special Fraud Alert, please see our November 25, 2020 blog post.) Speaker programs are a common practice in the industry and generally entail pharmaceutical and medical device companies retaining health care professionals (HCPs) to speak or present to educate their peers on the companies’ drugs or devices.
News & Press
How New Kickback Rules Benefit Health Care Industry: Part 1
December 18, 2020
How New Kickback Rules Benefit Health Care Industry: Part 2
December 18, 2020
Events & Speaking
Healthcare Regulatory Considerations for Patient Incentives: AKS and CMPL Compliance, Safe Harbors, Exceptions
Strafford CLE
Virtual Webinar
Reducing Patient Leakage by Directing Physician Referrals, AKS Safe Harbors, and Stark Law Exceptions
Strafford
Online Event
HHS’s Holiday Gift to the Health Care Industry: Historic Changes to the Anti-Kickback Statute and Stark Law Regulations
View the Webinar Recording
Publications
Co-author, What Is...The Anti-Kickback Statute?, Second Edition, Published by the American Bar Association (2022)
Read lessRecognition & Awards
Recognized by The Legal 500 United States for Healthcare: Service Providers (2021)
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)