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
Webinar Recording: Historic Changes to HHS's Anti-Kickback Statute and Stark Law Regulations
December 17, 2020 |Webinar
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
Webinar Recording: Historic Changes to HHS's Anti-Kickback Statute and Stark Law Regulations
December 17, 2020 | Webinar | By Karen Lovitch, Rachel Yount
In this webinar, Karen Lovitch and Rachel Yount reviewed the sweeping changes and provided practical examples as to how the industry can take advantage of the 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.
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HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part IV: Changes to Existing Safe Harbors and Stark Law Exceptions
December 11, 2020 | Blog | By Karen Lovitch, Bridgette Keller, Rachel Yount
As you know, we have been parsing through the HHS rules that finalize important changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations, which go into effect January 19, 2021. Today, we are taking a look at changes to existing AKS safe harbors and Stark Law exceptions, and, an extra add-on: a new Stark Exception for Limited Remuneration to a Physician. Mintz is also hosting a webinar during which we will review the key provisions from the final rules and provide practical examples of how the industry can take advantage of these significant changes. We hope you can join us.
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HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part III: Value-Based Arrangements
December 7, 2020 | Blog | By Nili Yolin, Rachel Yount, Michelle Caton
This third post in our multi-part series on the final rules examines the three new AKS safe harbors and four new Stark Law exceptions that offer protection for value-based arrangements. The primary goal of these final rules is to reduce regulatory barriers and advance the health care industry’s transition to value-based care. Value-based care, often referred to as pay-for-performance, is a payment model that offers health care providers and suppliers financial incentives to meet certain performance measures that improve quality of care or appropriately reduce costs, as opposed to traditional fee-for-service or capitated payments healthcare reimbursement.
Plus, we have prepared easy-to-read comparison charts breaking down the current, proposed, and final regulations. These comparison charts offer a quick way to get up to speed on these voluminous final rules and their many historic changes to the AKS and Stark Law.
Read more
Plus, we have prepared easy-to-read comparison charts breaking down the current, proposed, and final regulations. These comparison charts offer a quick way to get up to speed on these voluminous final rules and their many historic changes to the AKS and Stark Law.
HHS Finalizes Highly Anticipated Final Rules Amending Anti-Kickback Statute and Stark Law Regulations, Part II: Beneficiary Inducement
December 1, 2020 | Blog | By Karen Lovitch, Ellyn Sternfield, Rachel Yount, Jane Haviland
While health care entities often want to provide free or discounted items or services to patients (e.g., free transportation, co-payment waivers, free supplies), these free or discounted items or services pose risk under both the federal Anti-Kickback Statute (AKS) and the civil monetary penalty rules regarding beneficiary inducements (Beneficiary Inducements CMP), so minimizing risk when providing such items or services is important. Fortunately, as announced last week, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule making sweeping changes to the regulations implementing the AKS and the Beneficiary Inducements CMP, many of which will result in greater flexibility and reduced administrative burdens for the health care industry.
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HHS Finalizes Highly Anticipated Final Rules Amending Anti-Kickback Statute and Stark Law Regulations
November 23, 2020 | Blog | By Karen Lovitch, Rachel Yount
On November 20, 2020, the Department of Health & Human Services (HHS) finalized significant changes to 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 (Beneficiary Inducements CMP). The final rules are part of HHS’s Regulatory Sprint to Coordinated Care and are designed to offer the health care industry more flexibility and to reduce the regulatory burden associated with the AKS and the Stark Law, particularly with respect to value-based arrangements and care coordination. Offering a number of industry-friendly changes, the final rules will have a far-reaching impact on the health care industry.
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DOJ Announces the First Open Payments Program / Sunshine Act Enforcement Action
November 3, 2020 | Blog | By Rachel Yount
On October 29, 2020, the Department of Justice (DOJ) announced the first publicly-available settlement involving alleged violations of CMS’s Open Payments Program, otherwise known as the Sunshine Act. The $9.2 million settlement resolved allegations that Minnesota-based medical device manufacturer Medtronic USA Inc. violated (i) the Anti-Kickback Statute (AKS) and the False Claims Act (FCA) by paying kickbacks to a South Dakota neurosurgeon, Wilson Asfora, M.D., and (ii) the Open Payments reporting requirements by failing to accurately report payments it made to Asfora to the Centers for Medicare & Medicaid (CMS). While this settlement is the first public enforcement action involving Open Payments violations, more enforcement actions may be expected in the near future.
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West Virginia Hospital Enters into a $50 Million Settlement to Resolve Allegations over Excessive Compensation Paid to Referring Physicians
September 16, 2020 | Blog | By Laurence Freedman, Rachel Yount
On September 9, 2020, the Department of Justice (DOJ) announced a $50 million settlement with Wheeling Hospital, Inc. of West Virginia to resolve False Claims Act allegations that Wheeling Hospital violated the Anti-Kickback Statute (AKS) and Stark Law. The settlement resolved False Claims Act allegations that were triggered by a qui tam lawsuit brought by a former vice president of Wheeling Hospital who oversaw hospital operations and physician engagements. According to the relator's complaint, Wheeling Hospital, under its former management, paid several physicians annual compensation in excess of a million dollars based on the volume or value of their referrals.
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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.
Read more
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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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