On March 23, 2010, Section 6409 of the Patient Protection and Affordable Care Act (ACA) was signed into law. Section 6409(a) of the ACA required the secretary of the Department of Health and Human Services, in cooperation with the inspector general of the Department of Health and Human Services, to establish a Medicare self-referral disclosure protocol that would set forth a process to enable health care providers and suppliers to self-disclose actual or potential violations of the physician self-referral statute (Section 1877 of the Social Security Act).
Section 1877 of the Social Security Act, is also known as the physician self-referral law and commonly referred to as the “Stark Law.” The Stark Law prohibits a physician from making referrals for certain designated health services (DHS) payable by Medicare or Medicaid to an entity with which he (or an immediate family member) has a financial relationship (ownership, investment or compensation), unless an exception applies; prohibits the entity from presenting or causing to be presented claims to Medicare or Medicaid (or billing another individual, entity, or third party payer) for those referred services; and establishes a number of specific exceptions. It also grants the secretary the authority to create regulatory exceptions for financial relationships that do not pose a risk of program or patient abuse.
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