The COVID-19 pandemic is producing even more evidence that proposed changes to Stark Law and Anti-Kickback Statute regulations can't come soon enough. But the rule changes, which are designed to encourage better care, could be delayed, also thanks to the coronavirus outbreak.
For years, the healthcare industry has warned regulators that providers are hesitant to engage in value-based arrangements or coordinate care, in part, because they're worried about running afoul of federal fraud and abuse rules. So federal officials in October proposed a wide range of changes to physician self-referral and safe harbor regulations to improve care coordination and encourage providers to take part in value-based arrangements, among other things.
Providers were broadly supportive of the new exceptions and safe harbors put forward by CMS and HHS' Office of Inspector General, but they adamantly opposed the addition of price transparency requirements.
Then the COVID-19 outbreak derailed HHS' plans for regulatory reform. HHS originally called their efforts to reform physician self-referral and safe harbor regulations a "sprint," but the pandemic has dramatically slowed the rulemaking process, said former OIG official Tony Maida, now a partner with McDermott, Will & Emery.
"COVID-19 has sucked up all of the oxygen," said former CMS official Don Romano, now a healthcare lawyer with Foley & Lardner.
CMS responded to the pandemic by waiving several Stark Law requirements, including broad waivers of fair market value requirements, to enable providers and other covered entities to better coordinate and deliver care during the public health emergency. OIG followed suit, saying it wouldn't go after providers for remunerations protected by 11 of CMS' 18 Stark Law waivers.
Throughout the pandemic, the waivers have allowed for "the sharing of resources without running afoul of fraud and abuse laws like the Stark Law and the Anti-Kickback Statute," said Mollie Gelburd, associate director of government affairs for the Medical Group Management Association.