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Sandra Jarva Weiss
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Sandra Jarva Weiss
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Extensive Changes to Stark and Anti-Kickback Regulations

The Department of Health and Human Services OIG and CMS seek to modernize and clarify the Anti-Kickback and Stark Statutes

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) have issued two highly-anticipated and significant final rules (scheduled to be published today, December 2, 2020) that seek to modernize and clarify the Anti-Kickback Statute (AKS) and Physician Self-Referral Statute (Stark). These final rules are part of the HHS Regulatory Sprint to Coordinated Care Initiative which aims to remove certain regulatory barriers and administrative burdens that hindered the shift to a value-based health care system and the development by providers of innovative arrangements to improve the coordination of patient care. Both OIG and CMS emphasized that the final rules offer health care providers greater flexibility to coordinate and improve care while maintaining important safeguards against overutilization and inappropriate incentives. The final rules will go into effect on January 19, 2021.

The OIG and CMS worked together to develop these final rules. Although overall the two final rules are consistent, OIG and CMS did not completely align the AKS safe harbors and Stark exceptions set out in the final rules. Outlined below is a brief overview of the major provisions in the final rules.

New and Modified Stark Exceptions

  • Full financial risk exception in which the value-based enterprise assumes the full financial risk for the cost of all patient care for each covered patient for a specified time period
  • Meaningful downside financial risk exception where the physician is at meaningful downside financial risk (at least 10% of remuneration) for failure to achieve the value-based goals
  • Value-based arrangements exception regardless of the level of risk undertaken that permits both monetary and non-monetary remuneration between the parties

New and Modified Anti-Kickback Statute Safe Harbors

  • Care coordination arrangements to improve quality, health outcomes, and efficiency that does not require the participants to take on risk but protects only in-kind remuneration
  • Value-based arrangements with substantial downside financial risk (at least 5%)
  • Value-based arrangements with full financial risk for the cost of all items or services covered by a payor for each patient in the target population for a term of one year

We will provide more detailed descriptions of some of these new Stark exceptions and AKS safe harbors in future blog posts. If you have any questions concerning these final regulations or any related health care matters, please contact me at sjarvaweiss@norris-law.com.

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Sandra Jarva Weiss
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