On December 2, the Department of Health and Human Services will publish two final rules intended to reduce regulatory barriers to care coordination. The rules provide greater flexibility for healthcare providers to participate in value-based arrangements and to provide coordinated care for patients. The final rules also ease compliance burdens for healthcare providers and other stakeholders, while maintaining strong safeguards to protect patients and programs from fraud and abuse.
In the final rule “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements,” the HHS OIG addresses stakeholder concerns that the federal Anti-Kickback Statute and the civil monetary penalties law unnecessarily limit the ways in which healthcare providers can coordinate care with and for federal healthcare program beneficiaries.
The final rule clarifies how medical device manufacturers and durable medical equipment companies may participate in protected care coordination arrangements that involve digital health technology, and the final rule lowers the level of “downside” financial risk parties must assume to qualify under the new safe harbor for value-based arrangements that involve substantial downside financial risk. The rule also broadens the new safe harbor for cybersecurity technology and services to protect cybersecurity-related hardware.
In addition, the Centers for Medicare and Medicaid Services is issuing the final rule “Modernizing and Clarifying the Physician Self-Referral Regulations.” This rule clarifies and modifies existing policies to ease unnecessary regulatory burden on physicians and other healthcare providers while reinforcing the physician self-referral law’s (the Stark Law) 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.
