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.
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
Final Rules Amending the Anti-Kickback Statute and Stark Law Regulations: Part 1
February 16, 2021 |Podcast
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.
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
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
CMS Announces One-Year Delay in Finalizing Highly Anticipated Stark Law Reform
August 27, 2020 | Blog | By Karen Lovitch, Rachel Yount
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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DOJ Announces Criminal Charges against Lab Executive Accused of Fraudulently Promoting COVID-19 Tests
June 11, 2020 | Blog | By Karen Lovitch, Rachel Yount
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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CMS Relaxes Medicare and Medicaid Ordering Requirements for COVID-19 Testing and Finalizes Coverage of Antibody Testing
May 1, 2020 | Blog | By Karen Lovitch, Rachel Yount
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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CMS Releases Several Stark Law Waivers for Use during the COVID-19 National Emergency
April 1, 2020 | Blog | By Theresa Carnegie, Rachel Yount
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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Boards of Pharmacy Nationwide Respond to COVID-19 Pandemic
March 26, 2020 | Blog | By Rachel Yount
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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HHS Proposed Changes to AKS and Stark Law: Patient Engagement and Support Safe Harbor
February 20, 2020 | Video | By Rachel Yount
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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Growing Number of States Enact Drug Pricing Transparency Laws
January 23, 2020 | Blog | By Rachel Yount
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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HHS Proposes Sweeping Changes to AKS and Stark Law, Part 6: Proposed Changes to the AKS Related to Beneficiary Inducement
December 18, 2019 | Blog | By Karen Lovitch, Rachel Yount, Jane Haviland
As reported previously, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published two proposed rules that seek to implement wholesale changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). This final post in our blog series focuses on a proposed new safe harbor that would protect patient engagement and support arrangements designed to improve quality, efficiency of care, and health outcomes. The OIG is also proposing modifications to the existing safe harbor for local transportation and a new safe harbor for remuneration provided in connection with certain payment and care delivery models developed by the Centers for Medicare & Medicaid Innovation Center or by the Medicare Shared Savings Program. Lastly, the OIG is codifying an existing statutory safe harbor for Accountable Care Organization (ACO) beneficiary incentives and an existing statutory exception to the Civil Monetary Penalty (CMP) rules on beneficiary inducement for telehealth technology related to in-home dialysis services.
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HHS Proposes Sweeping Changes to AKS and Stark Law, Part 5: Proposed Changes to Key Stark Law Requirements and Numerous Stark Law Exceptions
November 21, 2019 | Blog | By Karen Lovitch, Rachel Yount
As we previously reported, the Department of Health & Human Services (HHS) recently issued two proposed rules intended to reduce the regulatory burden associated with the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). Although the rules’ main focus is on value-based arrangements, the proposed rule issued by the Centers for Medicare & Medicaid Services (CMS) also includes a number of provider-friendly changes and clarifications to the Stark Law. As discussed below, CMS is proposing several changes to key Stark Law requirements as well as modifications to existing Stark Law exceptions.
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CMS Finalizes Changes Expanding the Scope of the Open Payments Program
November 18, 2019 | Blog | By Brian Dunphy, Rachel Yount
On November 15, 2019, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule. Perhaps most importantly, CMS broadened the list of Covered Recipients. Starting for data collection for CY 2021, manufacturers will be required to track and report payments and transfers of value made to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. CMS also added three new nature of payment categories – debt forgiveness, long-term medical supply or device loan, and acquisitions. CMS also consolidated the two payment categories for continuing education programs – accredited/certified and unaccredited/non-certified – into one payment category for all continuing education programs. Lastly, in a move expected to impose a substantial burden on medical device manufacturers, CMS added a reporting requirement for the ‘device identifier’ component of the unique device identifier for devices and medical supplies.
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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
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