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HHS proposes changes to Stark Law and AKS: 4 things to know

On October 9, 2019, the United States Department of Health and Human Services (HHS) proposed some of the largest changes to the Stark Law, which guides physician self-referrals, and the Anti-Kickback Statute (AKS) discussed in decades. The proposals are part of the government’s broader attempt to encourage coordinated care efforts.

The HHS and Centers for Medicare and Medicaid Services (CMS) have recognized that some of these regulations hinder relationships between medical providers. As such, the agencies have made the following proposals to better encourage coordinated care:

  • Modifications to compensation rules under Stark Law. The HHS’ proposal includes changes to the compensation exceptions listed within the Stark Law. These changes include exceptions for value-based care arrangements and limited remuneration to a physician. The relationship must satisfy certain criteria to be eligible for the exception.
  • Changes to definitions to establish “bright line rules” under Stark Law. The agency also recommends new definitions to help establish clear rules. Terms that may be addressed include commercial reasonableness and fair market value.
  • Expansion and modification of safe harbors offered under AKS. HHS also proposed the addition of three safe harbors available for medical professionals who are entering a value-based arrangement. The agency has also considered increased flexibility within existing safe harbor protections.
  • Addition of CMPL exceptions within AKS. The government may also include exceptions within the Beneficiary Inducement Civil Monetary Penalty Law (CMPL) for certain telehealth technologies.

The proposals are now open for public feedback. The proposed rules will likely be open for discussion through the end of the year. If passed, the rules could reduce the risk of federal investigation and allegations of wrongdoing when physicians work together to provide patient care.

We will provide updates on the progress of these proposed changes as they become available.

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