The federal government gave healthcare providers a gift this holiday season. The United States Department of Health and Human Services (HHS) recently announced changes to the Stark Law and the Anti-Kickback Statute (AKS). These changes, according to the feds, will reduce regulatory barriers that hinder efforts toward coordinate care. Ultimately, the HHS states the changes will lead to increased flexibility, allowing for value-based arrangements between providers that will benefit patients.
The move is a part of the agency’s broader effort, the Regulatory Spring to Coordinated Care. Deputy secretary of the HHS, Eric Hargan, states the changes are “historic” and will break down barriers to “patient-centered, value based healthcare innovation.”
What do healthcare providers need to know about these changes?
Two federal offices published final rules that will impact this push toward coordinated care. First, the HHS Office of Inspector General (OIG) issued the final rule “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements” on November 20, 2020. One key change: the inclusion of three new safe harbors. These include care coordination arrangements that will improve the quality of care, outcome and efficiency for the patient that do not require those involved to assume risk and value-based arrangements with varying levels of risk.
On that same day, the Centers for Medicare and Medicaid Services (CMS) issued the final rule “Modernizing and Clarifying the Physician Self-Referral Regulations,” specifically updating the Stark Law. The new rule results in permanent exceptions to the Stark Law that reduce the risk of the harsh consequences that inhibited physicians from working together.
Although these changes will remove barriers, it is important to note that the feds were careful to clarify that safeguards remain to provide meaningful protection against overutilization and other harms. As such, medical professionals should tread carefully — the laws are not gone, just updated.