January 19, 2021

Volume XI, Number 19

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January 19, 2021

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January 18, 2021

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What to Expect: HHS Issues Final Rules on Stark, AKS & CMP Laws

The U.S. Department of Health and Human Services (“HHS”) recently issued two corresponding final rules amending the implementing regulations of the Physician Self-Referral Law (“Stark Law”), the Anti-Kickback Statute (“AKS”), and the Civil Monetary Penalties Law (“CMP”). Both rules are part of HHS’s examination of federal regulations that potentially impede health care providers’ efforts to transition to value-based care and improve coordination of patient care in Federal health care programs and the commercial sector. Most of the amended regulations are effective on January 19, 2021.

In general, CMS made the following revisions to the Stark Law:

  • Created new exceptions for value-based arrangements

  • Created a new exception for arrangements where a physician receives a limited amount of remuneration for items or services provided

  • Created a new exception for donations of cybersecurity technology and related services

  • Clarified important definitions, such as “commercially reasonable,” “volume or value” and “fair market value”

The Office of Inspector General (OIG) added six new safe harbors and modified four safe harbors to the AKS. Three of the new AKS safe harbors pertain to value-based arrangements that foster better coordinated and managed patient care. The AKS Final Rule also modified existing safe harbors related to electronic health records items and services, personal services and management contracts, warranties and local transportation.

Last, OIG amended the definition of “remuneration” in the CMP rule that interprets and incorporates a new statutory exception to the prohibition on beneficiary inducements for “telehealth technologies” furnished to certain in-home dialysis patients.

 

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© Steptoe & Johnson PLLC. All Rights Reserved.National Law Review, Volume X, Number 346
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Joshua L. Stearns ASSOCIATE Louisville Health Law Construction
Associate

As a student-athlete on the University of Louisville football team, Josh learned how to work as part of a team, think analytically in stressful situations, and respect the importance of self-discipline and details.  In his legal practice, Josh takes the lessons he learned on the field and puts them to work for his clients. His clients have needs in health care, corporate law, business transactions, and construction.  Growing up in Kentucky, Josh is proud to work with organizations who share his vision for improving the local community, especially his health care clients. Those clients...

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Charles A. Sinsel, Steptoe Johnson, Corporate Transactions Lawyer, Employment recruitment Attorney
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Charles "Chark" Sinsel concentrates his practice in the areas of health care, corporate law, business transactions, and contracting. Mr. Sinsel represents health care entities, including hospitals, nursing homes, behavioral health providers, medical and dental practices, in a variety of transactions, including acquisitions, corporate restructuring, leasing, employment, recruitment, income guarantees, independent contractor (services) arrangements and group purchasing arrangements. Mr. Sinsel serves as leader of the Firm's Health Care Team.

 

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Kristen Wilson Steptoe Johnson Law Firm Wheeling, WV Professional Liability Litigation Attorney
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Clients know that Kristen Andrews Wilson will help them understand and navigate the complex and complicated healthcare landscape.  Kristen’s clients include hospitals, nursing homes, and long-term care facilities, as well as independent healthcare providers.  Kristen’s practice is a unique combination of litigation avoidance via counseling and defense via litigation, when necessary.  In addition to her medical malpractice litigation practice, Kristen has experience with federal and state healthcare regulatory compliance, as well as business transactions involving...

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Aleah M. Schutze Health Care Attorney Steptoe & Johnson Louisville, KY
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Aleah Schutze knew from a  young age that she wanted to pursue a career in healthcare and obtained a Master’s Degree in Public Health. Her decision to attend law school was born out of an altruistic desire to help more people by helping healthcare entities fulfill their individual missions.  Continuing to build her healthcare acumen, Aleah spent three years as the Associate General Counsel and Deputy General Counsel for Res-Care, Inc. (now BrightSpring Health Services), the largest diversified health and human services provider in the U.S. In that role, she gained experience in providing...

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