Physician Payments Sunshine Act Final Rule
On February 1, 2013, the Centers for Medicare and Medicaid Services (“CMS”) issued a final rule to implement the requirements of section 6002 of the Affordable Care Act (commonly referred to as the “Physician Payments Sunshine Act”) (the “Act”). The final rule sets forth:
- the requirements for applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or the Children's Health Insurance Program (also known as “CHIP”) to report annually to the Secretary of Health and Human Services (the “Secretary”) certain payments or other transfers of value to physicians and teaching hospitals
- the requirements for applicable manufacturers and applicable group purchasing organizations (GPOs) to report certain information regarding the ownership or investment interests held by physicians or the immediate family members of physicians in such entities;
- the civil monetary penalties for failure to report payments or other transfers of value, or physician ownership or investment interests, including clarification of the instances when the penalties will be imposed.
- the processes for the review, dispute, and correction period when applicable manufacturers, applicable GPOs, covered recipients, and physician owners or investors are provided the opportunity to review, dispute, and propose corrections to reported payments or other transfers of value, or ownership or investment interests, attributed to them;
- the information required to be published by the Secretary on the publicly available website, as well as the usability of the public website; and
- the statutory requirements for the pre-emption of State laws that require disclosure of the same type of information as the Act.
The final rule is effective 60 days after the date of its publication in the Federal Register (February 8, 2013), and requires applicable manufacturers and applicable GPOs to begin to collect the required data on August 1, 2013 and report the data to CMS by March 31, 2014.