Proposed rules issued Oct. 9 by HHS' Office of Inspector General and CMS aim to limit the reach of the federal Anti-Kickback Statute and Stark Law. The rules include proposals for various value-based care arrangements to qualify for exceptions to Stark Law and the Anti-Kickback Statute.
Five things to know:
1. HHS said the rules would ease the compliance burden for healthcare providers and help eliminate some of the roadblocks to value-based arrangements. "Our proposed rules would be an unprecedented opportunity for providers to work together to deliver the kind of high-value, coordinated care that patients deserve," HHS Secretary Alex Azar said in a news release.
2. The rule proposed by CMS would create safe harbor exceptions to Stark Law for certain value-based models. It would also extend exceptions to certain other arrangements, such as donations of cybersecurity technology.
3. The rule issued by the OIG proposes new safe harbors under the Anti-Kickback Statute. The rule would provide safe harbors for remuneration exchanged between participants in value-based arrangements with substantial downside financial risk and in connection with Medicare ACOs, CMS-sponsored care models and care coordination agreements to improve quality, health outcomes and efficiency.
4. The American Medical Association and the American Hospital Association applauded the proposals. "When healthcare providers are able to work together to coordinate care, it is patients that benefit the most," said AHA President and CEO Rick Pollack in a release. "For far too long, a group of out-of-date regulations has created unnecessary roadblocks to the kind of collaboration and coordination that enables caregivers to meet all of their patients' healthcare needs, whether in the hospital, the doctor's office or their own homes."
5. The agencies will accept comments on the proposed rules for 75 days after publication in the Federal Register.
Access the proposed rule from CMS here.
Access the proposed rule from the OIG here.
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