CMS issues ‘sunshine rule’ on industry-practitioner relationships

March 12, 2013

The Centers for Medicare & Medicaid Services (CMS) announced Feb. 1, 2013, a new rule designed to increase public awareness of any financial relationships existing between drug or medical device manufacturers and health care providers.

The “National Physician Payment Transparency Program: Open Payments” initiative is one of several measures authorized under the Affordable Care Act (ACA) to encourage greater transparency in the health care market, according to the CMS.

The new “sunshine rule” finalizes ACA provisions that require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the federal Children’s Health Insurance Program (CHIP) to report payments or other transfers of value they make to physicians and teaching hospitals to the CMS.

The CMS then will post that data to a public website.

The AOA Ethics and Value Committee is studying the new rule and plans to issue a “white paper” on the new reporting program before it takes effect late this summer.

In addition to manufacturers, the rule will apply to group purchasing organizations (GPOs), which the CMS emphasizes will have to disclose physician ownership or investment interests.

The new reporting program is intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers.

“You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need,” said Peter Budetti, M.D., CMS deputy administrator for Program Integrity. “Disclosure of these relationships allows patients to have more informed discussions with their doctors.”

Manufacturers and GPOs, as well as the physicians and teaching hospitals, will have an opportunity to review and correct reported information prior to its publication.

In order to give applicable manufacturers and applicable GPOs sufficient time to prepare, data collection will begin Aug. 1, 2013. Applica-ble manufacturers and GPOs will report the data for August through December 2013 to the CMS by March 31, 2014, and the CMS will release the data on a public website by Sept. 30, 2014.

The CMS is developing an electronic system to facilitate the reporting process. The final rule can be downloaded at https://www.federalregister.gov/public-inspection.

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