On November 20, 2020, the Facilities for Medicare and Medicaid Companies (“CMS”) and the Workplace of Inspector Basic (“OIG”) promulgated much-anticipated and important remaining guidelines meant to “modernize” and “make clear” laws concerning the Doctor Self-Referral Legislation (“Stark Legislation Closing Rule”) and the Anti-Kickback Statute (“AKS Closing Rule”). Within the instant future, Sheppard Mullin will publish on this Healthcare Legislation Weblog a complete essential evaluation of each the Stark Legislation Closing Rule and the AKS Closing Rule and their sensible impacts.
The Stark Legislation Closing Rule
The Stark Legislation Closing Rule goals to advance the transition to a value-based healthcare supply and cost system that improves the coordination of care amongst physicians and different healthcare suppliers, throughout totally different healthcare settings, in each the federal and industrial sectors.
The Stark Legislation Closing Rule finalizes most of the provisions proposed within the October 17, 2019 proposed rule (“Stark Legislation Proposed Rule”), as analyzed in Sheppard Mullin’s earlier essential evaluation. Key adjustments to the Stark Legislation embody the next:
New steering on key Stark Legislation technical compliance necessities, such because the definition of “honest market worth”, “commercially affordable” preparations, and the amount or worth commonplace;
Extra new or revised definitions for key Stark Legislation phrases, corresponding to designated well being companies, doctor, referral, remuneration, and transaction, some importantly narrowing the Stark Legislation’s scope;
New exceptions for value-based preparations, designed to allow “physicians and different healthcare suppliers to design and enter into value-based preparations with out concern that legit actions to coordinate and enhance the standard of look after sufferers and decrease prices would violate the Stark Legislation,” and have the potential to guard a variety of preparations within the well being care business;
New exceptions for cybersecurity, each increasing the present exception for donations of digital well being file methods to expressly embody the donation of cybersecurity software program and companies, when associated to digital well being data, and a brand new exception for preparations involving the donation of cybersecurity know-how and associated companies; and
Updates to current Stark Legislation exceptions meant by CMS to facilitate higher entry and outcomes for sufferers by creating clearer paths for the suppliers that serve them to enter into and keep enhanced coordinated care preparations.
The AKS Closing Rule
The AKS Closing Rule, launched concurrently with the Stark Legislation Closing Rule, equally goals to take away limitations to coordinated and value-based care whereas facilitating acceptable safeguards to guard Federal well being care packages and sufferers.
The AKS Closing Rule implements seven new secure harbors, modifies 4 current secure harbors, and codifies one new exception below the Beneficiary Inducements Civil Financial Penalties Legislation (“CMPL”), as follows:
Three new secure harbors for remuneration exchanged as a part of Worth-Primarily based Preparations that foster higher coordinated and managed affected person care;
New secure harbors for Affected person Engagement and Assist, remuneration supplied in reference to CMS-Sponsored Fashions, donations of Cybersecurity Expertise and Companies, and for Accountable Care Group (“ACO”) Beneficiary Incentive Packages for the Medicare Shared Financial savings Program; and
Modifications to current secure harbors for the donation of Digital Well being Data Gadgets and Companies (to permit donations of associated cybersecurity know-how and to replace provisions concerning interoperability), for Private Companies and Administration Contracts, for Warranties, and for Native Transportation.
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