COVID-19 slows sprint to reform Stark law, anti-kickback rules

HHS LAST OCTOBER kicked off a self-described “sprint” to overhaul physician self-referral and safe harbor regulations. Then came COVID-19 and virtually all rulemaking came to a standstill.

“COVID-19 has sucked up all of the oxygen,” said former CMS official Don Romano, now a healthcare lawyer with Foley & Lardner.

But that doesn’t mean reforms are completely abandoned.

Within HHS and across the industry, there’s still a desire to see the decades-old Stark law and AntiKickback Statute regulations updated to spur greater use of value-based payment models.

So where do things stand?

Temporary relief

CMS responded to the pandemic by waiving several Stark law requirements, including broad waivers of fair market value requirements. HHS’ Office of Inspector General followed suit, saying it wouldn’t go after providers for remunerations protected by 11 of CMS’ 18 Stark law waivers.

The pandemic put a spotlight on many of the care coordination problems that experts say could be addressed through permanent rulemaking.

Lessons learned

Although the temporary waivers showed how relaxed rules could work, CMS has limited power to create new exceptions under the Stark law. Any significant changes would need to go through a notice-and-comment period, just like rules proposed last fall.

The OIG, on the other hand, has more flexibility to make changes because it has broad authority under the AntiKickback Statute to establish new safe harbors.

Social contract

Experts suggest the OIG might be more willing to ease rules that industry insiders say limit providers’ ability to collaborate around social determinants of health. For instance, providers are now banned from offering Medicare or Medicaid beneficiaries payments or in-kind benefits that are likely to influence them “to order or receive items or services from a particular provider,” according to the OIG.

Out of time?

HHS might not sign off on the rule changes until next year because of competing priorities with mandatory deadlines like Medicare’s physician fee schedule.

Maybe not

Political appointees in the Trump administration may push to finalize the physician selfreferral and safe harbor regulations before November’s election to deliver a policy win for the president and cement their legacies.

Making it matter

Whenever the changes come, they won’t move the dial on changing care delivery unless providers more fully commit to value-based payment. And while the COVID-19 crisis has been all-consuming for the past several months, there’s “a coalescing around” the need to accelerate the move to valuebased payment post-COVID, said Chet Speed, chief policy officer at the American Medical Group Association.

“It’s financially probably a safer place to be in case another pandemic like this breaks out,” he said. ●