CMS delays changes to Stark Law, anti-kickback regulation

The Centers for Medicare & Medicaid Services (CMS) is delaying the publication of a final rule aimed at changing an anti-kickback regulation and making adjustments to Stark Law regulations until August 2021.

According to an entry in the National Register, the proposed rule was supposed to be implemented this month, but CMS is delaying the move because regulators are “still working through the complexity of the issues raised by comments received on the proposed rule.”

As previously reported, the proposed rules were released in October 2019 and were aimed at removing regulatory barriers to coordinated care and value-based care as part of the U.S. Department of Health and Human Services’ (HHS) “regulatory sprint to coordinated care.”

The Stark Law prohibits physicians from making referrals for certain healthcare services payable by Medicare if the physician or an immediate family member holds a financial stake and stops any entity from billing Medicare for services that derive from a prohibited referral, according to a fact sheet distributed by CMS.

While the law was implemented at a time when healthcare was almost exclusively based around the fee-for-service model, both Medicare and private payers are increasingly moving toward a value-based pay model, for which the Stark Law has been unable to keep up, according to HHS officials.

The proposed rule is a package of reforms which seek to modernize the regulations which interpret Stark Law while still protecting Medicare from bad actors while also supporting the necessary evolution of the American healthcare delivery and payment systems.

CMS says the new rule would create permanent exceptions in the law for value-based arrangements, citing a 2018 request for information which showed industry stakeholders felt the steep consequences of not complying with the Stark Law are so dire, doctors and other providers are discouraged from entering into arrangements that improve quality, increase efficiency, and lower costs.

The rule, according to HHS, would “unleash innovation” by allowing doctors and other providers to design and take part in value-based arrangements without fear their actions would violate the Stark Law.

The new exception would also include a series of safeguards aimed at ensuring the Stark Law continues to protect against over-utilization.

The new rule would also provide much-needed guidance on several key requirements that must be met so that physicians and providers can comply with the Stark Law.

It would also create new exceptions to protect non-abusive, beneficial arrangements between physicians and other healthcare providers which would provide new flexibility for arrangements such as donation of cybersecurity technology that safeguards the integrity of the healthcare system in both fee-for-service and value-based arrangements.