Feds delay Stark law updates until next August

FEDERAL REGULATORS gave themselves until August 2021 to publish updates to physician self-referral rules.

The proposed rule, issued last October in conjunction with suggested changes to anti-kickback regulations, aims to spur more data-sharing between providers and suppliers and create more incentives to participate in alternative pay models, among other things. A fi nal rule was due out this August. The COVID-19 pandemic delayed the process, and HHS in an Aug. 26 notice said it was still “working through the complexity of the issues raised by comments received on the proposed rule.”

Providers criticized the delay, claiming COVID-19 emphasized the need for the regulatory rework.

“The reforms, which would allow independent physicians to participate fully in value-based payment models, were important before the COVID-19 pandemic, but are even more significant now,” the Digestive Health Physicians Association said in a statement, adding that the changes would “level the playing field and protect private practices” in an era of consolidation.

More than 70 members of Congress wrote HHS the day before the notice came out asking that they finalize the proposed rules soon, as well as consider safe harbor provisions for device manufacturers; distributors or suppliers of durable medical equipment, prosthetics, orthotics or supplies; laboratories; and pharmaceutical manufacturers.

Industry groups argue that the Stark law deters participation in alternative payment models. Carving out permanent exceptions for certain value-based arrangements could pave the way for broader participation, stakeholders told HHS in comments on the proposed rules.

But employers, among others, are worried that avoiding physician self-referral penalties could boost fraud without encouraging participation in value-based payments. It could even undermine the government’s efforts to get providers to take on more risk if doctors and hospitals can get the exception with relatively low levels of risk, they cautioned.

Regulators have implemented waivers amid COVID-19 mirroring the intention of the proposed rules, but they will end alongside the national and public health emergencies.

Significant changes to the Stark law would likely require another comment period. While HHS has more flexibility to carve out additional safe harbor provisions under the Anti-Kickback Statute, neither CMS or OIG is likely to move forward with additional rule changes, experts said. ●