Dive Brief:
- CMS has pushed back publishing a final rule that would ease anti-kickback regulations on providers by a year. Hospitals and devicemakers generally back the effort to update the rules.
- The deadline to finalize the rule proposed on Oct. 17, 2019, is now Aug. 31, 2021. Originally, the rule relaxing stipulations of the decades-old Stark Law was expected this month. It's unclear how the extension affects OIG's tandem rule slacking similar regulations outlined in the Federal Anti-Kickback Statute and the Civil Monetary Penalties Law.
- CMS chalked up the delay to the need to detangle thorny issues raised by healthcare companies in their comments. "We are still working through the complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date," Wilma Robinson, HHS deputy executive secretary, wrote in a notice on the change dated Monday. CMS did not respond to requests to clarify what issues are tying up the rule.
Dive Insight:
Industry groups, including hospitals and devicemakers, have said the Stark Law and Anti-Kickback Statute, passed decades ago in an attempt to deter physicians from referring patients to other locations or for services that would financially benefit them, are outdated and burdensome. Providers say the proposed changes are long overdue, citing longstanding concerns the laws hinder efforts to coordinate patient care across different sites and episodes.
The proposed rule, if finalized, would sharply ease federal anti-kickback regulations in a bid to help providers use value-based payment arrangements, reflecting the growing shift away from fee-for-service reimbursement and siloed care models.
The rule clarified exemptions from the physician self-referral law for certain value-based payment arrangements among physicians, providers and suppliers. Specifically, it applies to models with a specific patient population, where one of the entities takes on full financial risk for providing Medicare Part A and Part B for the first six months. The payments can either be capitated or global.
Doctors would be required to pay back a fourth of payments if they don't meet financial goals.
The proposed rule also introduced a new exemption for certain arrangements under which a doctor receives limited payment for items and services that he or she provides, and another that would allow hospitals and medical device manufacturers to donate cybersecurity tools and other related software to doctors without fear of retribution.
AdvaMed had called the proposed changed "crucial steps" toward value-based care.
Other comments on the proposed rule from the hospital and physician community were generally supportive of the changes, though some organizations, including the American Hospital Association and Walmart, thought the feds didn't go far enough. Hospital groups argued the exceptions should be expanded to include private payers, along with Medicare and Medicaid and the definition of value-based arrangements should be broadened, along with some other clarifications.
Per the Social Security Act, agencies have to maintain a regular timeline for publishing final regulations, normally within three years of the draft. However, they are allowed to extend the original deadline, if they justify the change.
Shannon Muchmore contributed reporting.