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A Holiday Gift for the Health Care Industry? Value-Based Care and Related Final Rules for Stark, Anti-Kickback, and Civil Monetary Penalties Regulations

Introduction. On November 20, 2020, the U.S. Department of Health and Human Services Office of the Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) released their long-awaited final rules describing changes to the “safe harbor” regulations implementing the federal anti-kickback statute (the “AKS”), the beneficiary inducement provisions of the civil monetary penalty law (the “CMPL”), and the physician anti-self-referral law (“Stark”) and its exceptions. OIG’s final rulemaking (the “OIG Final Rule”) and the final rulemaking from CMS (the “CMS Final Rule”) each include three new provisions for value-based care arrangements presenting different financial risk profiles.

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Safeguarding American Innovation Act Moves Forward in Senate Republicans’ HEALS Package

Practices: Health Care

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Earlier this week, the Safeguarding American Innovation Act (SAIA) bill, spearheaded by Senators Ron Portman and Tom Carper, was re-introduced as part of the package of bills in the Senate Republicans’ proposed Health, Economic Assistance, Liability Protection and Schools (HEALS) Act for “Phase 4” economic relief for COVID-19. The SAIA was included in Senator Lindsay Graham’s bill, Restoring Critical Supply Chains and Security Act, which is focused on rebuilding a supply chain in the United States and protecting against national security threats perceived to be arising from the People’s Republic of China. As we wrote last month, the SAIA includes several controversial provisions that will have significant impact on universities, academic medical centers and others who receive federal research funding. Among other concerns, the SAIA bill would:

  • Lower the annual threshold for reporting foreign gifts from $250,000 to $50,000,
  • Direct changes to grant applications to enable “uniformity” rather than consistency, and
  • Expand the U.S. Code to criminalize investigators’ failure to disclose a broadly defined category of “outside compensation,” which may be unrelated to their U.S. government-funded activities.

With a foothold into the HEALS Act, the SAIA’s prospects for passage are stronger, but there is still a lot of negotiation with the House of Representatives required to complete the funding bill. Senator Portman advocated again for the bill on the Senate Floor yesterday. But given expressed opposition from advocates for universities and academic medical centers, prospects for passage remain uncertain.

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