The Centers for Medicare and Medicaid Services (CMS) recently announced a final rule implementing Section 6002 of the Affordable Care Act (the “National Physician Payment Transparency Program: Open Payments”). The final rule, commonly called the “Sunshine” rule, will make information publicly available about payments or other transfers of value from applicable manufacturers to physicians and teaching hospitals (“covered recipients”), and about physician (or immediate family members of a physician) ownership or investment interests in applicable manufacturers and group purchasing organizations (GPOs).

Under this rule, applicable manufacturers must report annually to the Health and Human Services Secretary all payments or transfers of value (including gifts, consulting fees, research activities, speaking fees, meals, and travel) from applicable manufacturers to covered recipients. Applicable manufacturers and GPOs must also report ownership and investment interests held by physicians (or their immediate family members) in such entities. This reported information will be posted on a publicly available website.

Key Definitions:

• Applicable manufacturers—entities operating in the United States that either produce or prepare at least one drug, device, biologic, or medical supply that is covered by Medicare, Medicaid, or Children’s Health Insurance Program (CHIP), and entities under common ownership with applicable manufacturers.
• Applicable GPOs—entities operating in the United States that purchase, arrange for, or negotiate the purchase of covered drugs, devices, biologics, or medical supplies for a group of individuals or entities.
• Teaching hospital—any hospital that receives indirect medical education, direct graduate medical education, or psychiatric hospital Insurance Medical Exam (IME).

The law does not require applicable manufacturers or GPOs to report ownership or investment interests held by teaching hospitals.

Data collection will begin on August 1, 2013. Applicable manufacturers and GPOs will report data for August-December 2013 to CMS by March 31, 2014. CMS will release the data publicly by September 30, 2014. For additional details, please see the final rule at
federalregister.gov/public-inspection.