The U.S. Department of Health and Human Services (HHS) announced proposed changes to modernize and clarify the regulations that interpret the Physician Self-Referral Law (also called the "Stark Law") and the Federal Anti-Kickback Statute. The changes, which are intended to eliminate current barriers to provide care to patients under value-based care arrangements, are addressed in two proposed rules issued by the Office of the Inspector General (OIG) and Centers for Medicare and Medicaid Services (CMS), respectively.

The proposed changes to the Federal Anti-Kickback Statute issued by the OIG would offer flexibility for beneficial innovation and improved coordinated care through things like outcome-based payment arrangements that reward improvements in patient health. According to the OIG, the changes would also make it easier for physicians and other health care providers to ensure they are complying with the law by offering specific safe harbors for these arrangements.

Start Law changes proposed by CMS include new value-based exceptions intended to acknowledge that incentives are different in a value-based health care payment system vs. a volume-based system. For example, the proposed rule would permit physicians and other health care providers to design and enter into value-based arrangements without fear of violating the law. The exceptions would apply regardless of whether the arrangement relates to care furnished to people with Medicare or other patients. Proposed changes were informed by comments received from the ACC and other stakeholders in response to a 2018 request for information.

Additionally, the proposed Stark Law changes offer guidance on how to determine if compensation meets the fair market value requirement, and provide clarity and guidance on a number of other technical compliance requirements intended to reduce administrative burden. The proposed rule also seeks comments on the role of price transparency in the context of the Stark Law and whether to require cost-of-care information at the point of a referral for an item or service.

According to HHS, examples of activities that could currently be difficult to fit under existing protections, but could potentially be protected by both proposals if finalized, include:

• Shared data analytics services between a specialty physician practice and a primary care physician practice to coordinate care and better manage the care of their shared patients
• Hospitals and physicians could work together in new ways to coordinate care for patients being discharged from the hospital, including using shared data analytics systems and remote monitoring technology use to improve health outcomes and prevent unnecessary emergency room visits and readmissions
• Use of free, smart pillboxes and home health aides to help with medication adherence
• A local hospital could improve its cybersecurity and the cybersecurity of nearby providers through the donation of free cybersecurity software to each physician that refers patients to its hospital

The rules will be open for a 75-day comment period ending on Dec. 31. ACC Advocacy leaders and staff will be taking a closer look at both and submitting comments during this timeframe. The ACC will also be advocating for policies to promote the successful transition to value-based payments, such as revisions to the Stark Law, at the annual Legislative Conference taking place Nov. 3-5 in Washington, DC.

Keywords: ACC Advocacy, Physician Self-Referral, Centers for Medicare and Medicaid Services, U.S., Medication Adherence, Physicians, Primary Care, Medicaid, Medicare, Emergency Service, Hospital

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