On Nov. 15, 2019, the Centers for Medicare and Medicaid Services (CMS) issued a final rule updating its advisory opinion regulations, codified at 42 C.F.R. Sections 411.370 through 411.389. The updated regulations liberalize and improve CMS’ process for issuance of advisory opinions on the application of the federal physician self-referral law (Stark Law). These regulatory changes went into effect Jan. 1.
Background
Under the CMS advisory opinion process, parties can seek guidance on whether a physician’s referrals for certain designated health services payable by Medicare to an entity with which he (or an immediate family member) has a financial relationship are prohibited under the Medicare program by Section 1877 of the Social Security Act. The purpose of the advisory opinion process is to provide a binding opinion concerning the application of Section 1877 of the act to specific factual situations.
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