Are You Aware of the Changes to Stark and Anti-Kickbacks?

The Department of Health and Human Services (HHS) published two final rules in an attempt to reduce regulatory barriers to care coordination.

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One of the final rules was issued by the Centers for Medicare and Medicaid Services (CMS). This rule, called Modernizing and Clarifying the Physician Self-Referral Regulations, modifies the Stark Law.

The final rule provides exceptions to the law for some value-based compensation arrangements and has an exception for certain arrangements where a physician receives remuneration for items or services provided by the physician.

The rule also has an exception for cybersecurity donations.

The CMS rule also modified the exception for Electronic Health Record services.

The HHS Office of Inspector General (OIG) issued the other rule, entitled Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements.

The new OIG regulations were created to facilitate better coordination for patients, value-based care, and improved cybersecurity. The rule allows remote patient monitoring.

The rule also clarifies how medical device manufacturers and durable medical equipment companies can participate in protected care coordination arrangements that involve digital health technology. It lowers the level of financial risk parties must assume to qualify under the new safe harbor.

The OIG final rule is available here and the CMS final rule is available here.

Have you read the final rules? How will they impact your practice or business? Let us know by commenting below!

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