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 a frequent contributor to the firm’s Health care Viewpoints.
Education
- William and Mary Law School (JD)
- University of Tennessee (BA)
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.
Recognition & 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)
Recent Insights
Viewpoints
OIG Approves Physician-Owned Medical Device Company
April 28, 2022 |Blog
OIG Issues Another Favorable Advisory Opinion on Treatment-Based Patient Incentives
March 15, 2022 |Blog
News & Press
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.
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.
Events
Karen Lovitch and Rachel Yount will present on a Strafford CLE-webinar titled, "Reducing Patient Leakage by Directing Physician Referrals, AKS Safe Harbors, and Stark Law Exceptions." The panel will discuss whether and how healthcare systems are currently using directed referral requirements. The panel will also address how to implement referral requirements in compliance with the Stark Law.
Just in time for the holidays, the Department of Health & Human Services (HHS) gifted the health care industry with sweeping changes to the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (known as the Stark Law), and the civil monetary penalty rules regarding beneficiary inducements.
Viewpoints
OIG Issues Favorable Opinion on Federally Qualified Health Center’s Smartphone Loan Program
May 6, 2022 | Blog | By Rachel Yount, Jean D. Krebs
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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OIG Issues Another Favorable Advisory Opinion on Treatment-Based Patient Incentives
March 15, 2022 | Blog | By Rachel Yount
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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OIG Reiterates its Longstanding Concern about Joint Ventures between Health Care Providers/Suppliers and Referral Sources
December 1, 2021 | Blog | By Rachel Yount
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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OIG Revises and Renames the Provider Self-Disclosure Protocol
November 10, 2021 | Blog | By Karen Lovitch, Rachel Yount
For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other entities to voluntarily disclose and resolve instances of potential fraud involving federal health care programs, including potential overpayments and Anti-Kickback Statute (AKS) violations. The OIG originally published the SDP in 1998, and has since modified the SDP several times generally to make the SDP a more appealing option for providers and other health care entities.
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OIG Issues Favorable Advisory Opinion on Hospital’s Warranty Program for Joint Replacement Procedures
September 20, 2021 | Blog | By Rachel Yount
On September 15, 2021, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a hospital’s proposal to implement a program through which patients who experience complications after specific joint replacement procedures can receive free items and services to treat the complications. The OIG likened the program to a warranty for joint replacement procedures.
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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
On Friday, August 6, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA), the preeminent trade association representing pharmacies companies, announced revisions to its Code on Interactions with Health Care Professionals (PhRMA Code) that will become effective January 1, 2022. The PhRMA Code is a voluntary code for pharmaceutical companies, but its standards are considered to be best practices and are commonly adhered to by pharmaceutical and medical device companies. Moreover, some states (e.g. California, Massachusetts, Nevada, and the District of Columbia) require pharmaceutical companies to adopt a code consistent with the PhRMA Code.
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.
Read more
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.
Combatting Patient Leakage by Directing Physician Referrals: What is Permitted under the Stark Law?
July 29, 2021 | Blog | By Karen Lovitch, Rachel Yount
For many health care systems, patient leakage – when patients leave a health care system’s network in favor of out-of-network providers – is a rampant problem that results in substantial lost revenue. While sometimes patient leakage is just a result of patient choice, often the issue lies with employed or contracted physicians referring patients for services outside the network. Many health care systems may be wary of including in their physician contracts requirements that physicians refer patients exclusively within the network (otherwise known as directed referral requirements) based on concerns with interfering with physicians’ medical judgment and/or the common misconception that the Stark Law prohibits directed referral requirements.
To the contrary, the Stark Law actually permits directed referral requirements, provided that certain conditions are met. CMS recently enacted changes to the Stark Law regulations, effective January 19, 2021, that provide additional clarity on how health care providers can permissibly use directed referral requirements. These recent changes have seemingly triggered new awareness and interest in how health care systems can utilize directed referral requirements to combat patient leakage.
Read more
To the contrary, the Stark Law actually permits directed referral requirements, provided that certain conditions are met. CMS recently enacted changes to the Stark Law regulations, effective January 19, 2021, that provide additional clarity on how health care providers can permissibly use directed referral requirements. These recent changes have seemingly triggered new awareness and interest in how health care systems can utilize directed referral requirements to combat patient leakage.
News & Press
How New Kickback Rules Benefit Health Care Industry: Part 1
December 18, 2020
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.
How New Kickback Rules Benefit Health Care Industry: Part 2
December 18, 2020
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.
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.
Events
Speaker
Oct
27
2021
Reducing Patient Leakage by Directing Physician Referrals, AKS Safe Harbors, and Stark Law Exceptions
Strafford
Online Event
Speaker
Dec
17
2020
HHS’s Holiday Gift to the Health Care Industry: Historic Changes to the Anti-Kickback Statute and Stark Law Regulations
View the Webinar Recording