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CMS Proposes Changes to the Stark Law Advisory Opinion Regulations

Posted in Fraud and Abuse, Hospitals and Institutions, Legislation and Public Policy, Providers

On July 29, the Centers for Medicare & Medicaid Services (CMS) published the CY 2020 Medicare Physician Fee Schedule Proposed Rule. Buried amongst the fee schedule provisions, the proposed rule includes key changes to the Stark Law advisory opinion regulations. Previously, CMS had requested  public comment on how to address unnecessary burden created by the Stark Law.

The proposed rule, among other things, would give CMS more discretion to determine if an advisory opinion request is accepted. The rule would also shorten the timeframe for reviewing most advisory opinions. Additionally, the CMS is proposing to eliminate the current requirement that a certification by the requestor as to the truthfulness of its submissions be necessary. Traditionally, CMS has excluded legal reliance on an advisory opinion by third parties. The proposed rule would expand this to allow any individuals or entities who are parties to the arrangement (but not specific requestors) to rely upon the advisory opinion.

These changes would significantly impact advisory opinions in the Stark Law context. Comments to the proposed rule, must be filed by September 27, 2019.

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