Dozens of policymakers pushed HHS and the Office of Management and Budget to finalize and broaden proposals to revamp anti-kickback and self-referral laws that currently inhibit care coordination, they wrote in a letter Tuesday.
More than 70 congressional members supported a wide range of changes that aim to facilitate more data sharing between providers and incentive pay under CMS-approved care models, among other proposals that are slated for final action this August. They also asked the administration to consider safe harbor provisions for device manufacturers; manufacturers, distributors or suppliers of durable medical equipment, prosthetics, orthotics or supplies; laboratories; and pharmaceutical manufacturers.
"Previous letters led by various members signed below have provided examples of ways these entities can improve care for patients, and we continue to believe that excluding particular entities will limit the positive impact of the proposed changes," the letter reads. Policymakers also urged HHS and OMB to adopt the rules as soon as possible to help providers manage the COVID-19 pandemic.
Officials and providers argue that the Stark law, which was originally implemented in 1989 to prevent physicians from profiting off referrals to Medicare providers that they or a family member had a financial stake in, has deterred them from participating in payment models where physicians and hospitals share the financial rewards for cost-effectively delivering higher quality care.
Carving out permanent exceptions for certain value-based arrangements via safe harbor provisions that eliminate potential financial penalties could pave the way for broader participation, stakeholders commented.
But employers, among others, are worried that avoiding physician self-referral penalties at any level risk 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 that have mirrored the intention of the proposed updates to the fraud and abuse laws, but they will end alongside the national and public health emergencies. Meanwhile, the pandemic has dramatically slowed the rulemaking process.
Significant changes to the Stark law would likely require another notice-and-comment period, similar to the proposed rules last fall. While HHS has more flexibility to carve out additional safe harbor exceptions under the Anti-Kickback Statute, neither CMS or OIG is likely to move forward with additional rule changes, experts said.