Dec 15 2011

CMS Releases Proposed “Sunshine” Rule

The Centers for Medicare & Medicaid Services (CMS) announced yesterday a proposed rule that implements the Affordable Care Act “sunshine” provisions. According to CMS, the proposed rule will increase public awareness of financial relationships between drug and device manufactures and certain health care providers. CMS intends that the increased transparency under the proposed rule will help reduce the potential for conflicts of interest that physicians at teaching hospitals might face as a result of their relationships with manufactures.

The proposed rule would require manufactures of drugs, devices, biological, or medical supplies covered by federal health care programs to report annually regarding certain payments or transfers of value provided to physicians or teaching hospitals. The proposed rule also requires certain manufactures and group purchasing organizations to report annually regarding certain physician ownership or investment interests.

The reported payment and ownership information will be published by the Secretary of Health and Human services on a public website. Violators of the reporting requirement will be subject to civil monetary penalties up to $150,000 annually for failing to report and $1,000,000 for knowingly failing to report.

Under the proposed rule, data collection need not begin until final regulations are released. However, CMS suggests that a required partial year data submission may be due March 31, 2013.

Comments on the proposed rule may be submitted to CMS until February 17, 2012. You may submit an electronic comment here. For more information on the proposed sunshine rule, including a description of the covered recipients, please review the CMS press release and fact sheet.