On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the "Stark Law"), which has not been significantly updated since it was enacted in 1989. According to CMS, "The final rule supports the CMS 'Patients over Paperwork' initiative by reducing the unnecessary regulatory burdens on physicians and other healthcare providers while reinforcing the Stark Law's goal of protecting patients from unnecessary services and being steered to less convenient, lower quality, or more expensive services because of a physician's financial self-interest. Through the Patients over Paperwork initiative, the final rule opens additional avenues for physicians and other healthcare providers to coordinate the care of the patients they serve-allowing providers across different healthcare settings to work together to ensure patients receive the highest quality of care. In addition, as part of the Regulatory Sprint to Coordinated Care, CMS worked closely with the Department of Health and Human Services Office of Inspector General in finalizing policies that advance the transition to a value-based healthcare delivery and payment system that improves the coordination of care among physicians and other healthcare providers in both the federal and commercial sectors." The final rule sets forth an effective date of 60 days after the date of display in the Federal Register for all but one provision (which is effective January 1, 2022).
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