This the first attempt to significantly modernize and clarify regulations around the self-referral law since it was enacted in 1989.
The Centers for Medicare & Medicaid Services (CMS) has issued the final rule aimed at modernizing and clarifying the regulations pertaining to the Medicare physician self-referral law, or Stark Law.
According to a news release, the final rule creates permanent exceptions to the law for value-based care arrangements. It allows physicians to design and enter into value-based arrangements without fear that their legitimate activities will run afoul of the law. These exceptions will apply whether these arrangements relate to care for a Medicare patient or otherwise.
The final rule also provides additional guidance on several requirements that must be met to ensure compliance with the Stark Law such as how physician compensation from another provider generally must be at fair market value. The rule lays out how to determine if the compensation meets the requirement, the release says.
It also provides clarity and guidance on a range of other technical compliance requirements which intend to reduce administrative burdens that can drive up cost, according to the release.
The full text of the final rule can be found here.
Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association (MGMA), says that the organization appreciates the move, but the U.S. Department of Health and Human Services (HHS) should have gone farther.
“In particular, we support the new value-based arrangement exception to the Stark Law, which will provide some group practices with greater protection when entering into care coordination arrangements,” Gilberg says. “While HHS endeavored to make improvements to key terms that impact physician compensation arrangements, the final rule could have gone further to reduce the overall complexity and regulatory intrusion into group practice operations.
“Despite countless rulemakings, each of which identified legitimate problems with Stark Law regulations and attempted to fix them, the regulatory scheme has grown in complexity to the point where it is beyond comprehension to the average physician or practice administrator.”