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Stark and AKS Final Rules Will Facilitate Donations of EHR and Cybersecurity Technology and Services | McDermott Will & Emery


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On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Law. As part of these final rules, the agencies liberalized the requirements under the existing exception and safe harbor for donations of electronic health record items and services, and created a new exception and safe harbor to allow donations of cybersecurity technology and related services.
IN DEPTH
On November 20, 2020, the US Department of Health & Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) (Stark Rule) and the Anti-Kickback Statute (AKS) and Beneficiary Inducement Civil Monetary Penalty Law (collectively, AKS Rule) in connection with HHS’s Regulatory Sprint to Coordinated Care. As part of t ....

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Breaking Down the New Stark Law and Anti-Kickback Statute Final Rules | Murtha Cullina


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In late November, the Centers for Medicare and Medicaid Services and the Office of the Inspector General released their final rules revising the Physician Self-Referral Law (the “
Stark Law”) and the Anti-Kickback Statute. The changes are sweeping and while they are generally designed to facilitate coordinated care, some of the changes will impact providers more broadly. Most provisions of the final rules are effective on January 19, 2021.  The following is a brief overview of the hundreds of pages of rules and commentary:
The Stark Law Final Rule
New Value-Based Exceptions: New exceptions were created to permit compensation arrangements in the context of value-based arrangements designed to coordinate and improve the quality of care for patients and to lower costs. ....

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CMS Releases Final Rules on Stark & AKS Final Rules


Tuesday, December 22, 2020
OVERVIEW
On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Law. As part of these final rules, the agencies liberalized the requirements under the existing exception and safe harbor for donations of electronic health record items and services, and created a new exception and safe harbor to allow donations of cybersecurity technology and related services.
IN DEPTH
On November 20, 2020, the US Department of Health & Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) (Stark Rule) and the Anti-Kickback Statute (AKS) and Beneficiary Inducement Civil Monetary Penalty Law (collectively, AKS Rule) in connection with HHS’s Regulatory Sprint to Coordinated Care. As part of the Stark R ....

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White Paper: CMS Finalizes Updates to the Stark Law to Reduce Regulatory Burdens and Provide Flexibility to Providers | K&L Gates LLP


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On 2 December 2020, the Centers for Medicare & Medicaid Services (CMS) published a Notice of Final Rulemaking in the
Federal Register (Final Rule),
1 modifying the regulations implementing the federal physician self-referral law (the Stark Law).
2 In the Final Rule, CMS largely finalizes many of the proposals set forth in the Proposed Rulemaking issued on 17 October 2019 (Proposed Rule),
3 with certain modifications. CMS has indicated that many of the changes to the Stark Law are intended to provide additional flexibility and reduce administrative burden to health care providers in structuring arrangements to comply with the Stark Law, driven by the Department of Health and Human Services’ initiative to accelerate the transformation of the health care system to better pay for value and promote care coordination, titled the “Regulatory Sprint to Coordinated Care.” The great majority of the final ....

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HHS Issues Final Cybersecurity Safe Harbor and Exception | Faegre Drinker Biddle & Reath LLP


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On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) each released a final rule (the Final Rules). The Final Rules were both formally published in the Federal Register on December 2, 2020. Among other updates, the OIG final rule established a new cybersecurity technology and services donation safe harbor under the Anti-Kickback Statute (the AKS Cybersecurity Safe Harbor
1), and the CMS final rule established a similar exception to the Stark Law (the Stark Cybersecurity Exception ....

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