Re-Mapping the Fraud and Abuse Landscape: Understanding Proposed Reforms

In October 2019, the Department of Health and Human Services (HHS) released two proposed rules that include some of the most significant changes in at least a decade to the regulations governing fraud and abuse in federal healthcare programs, including Medicare and Medicaid. The first proposed rule, published by the HHS Office of Inspector General (OIG), focuses primarily on the AKS. The second, published by the Centers for Medicare & Medicaid Services (CMS), is centered on the Physician Self-Referral Law, known as the Stark Law. Both include a number of new protections for value-based arrangements, as well as many other substantive changes that materially loosen existing restrictions.

What larger healthcare goals are fueling the proposed revisions to AKS and Stark? What safe harbors and exceptions are introduced in the proposed rules? And what would the potentially transformational changes mean for healthcare organizations? In a new webinar, Manatt Health provides the answers. Key topics include:

  • The background of the proposed rules, including the HHS objective driving the amendments
  • The ways the new rules support value-based care and remove regulatory barriers to care coordination, patient engagement and data sharing among providers
  • The shared set of defined terms around value-based care that OIG and CMS are proposing—and where their definitions diverge
  • The six new AKS safe harbors for value-based enterprise (VBE) participants, including what each is designed to protect and promote—and what additional safeguards are included
  • The three new Stark exceptions for VBE participants—and how they reduce regulatory requirements in return for taking on added financial risk
  • Proposed protections for cybersecurity and electronic health records (EHR)
  • Other AKS and Stark additions and modifications to align with updates in other laws, clarify existing ambiguities, adjust policies and implement technical corrections

Robert D. Belfort, Partner, Manatt Health
Julian Polaris, Associate, Manatt Health

Date and Time
Thursday, February 13, 2020

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This program does not constitute legal advice, nor does it establish an attorney-client relationship. Views expressed by presenters are strictly their own and should not be construed to be the views of Manatt or attributed to Manatt.



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