February 14, 2013

Health Care Market Sunshine Rule Issued

The Centers for Medicare & Medicaid Services (CMS) has issued a long-anticipated final rule to increase public awareness of financial relationships between physicians and teaching hospitals and those who manufacture drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid, or CHIP.  The rule is required by the federal Affordable Care Act and reflects concerns that payments from manufacturers to physicians and teaching hospitals can introduce conflicts of interest that influence research, education, and clinical decision-making in ways that compromise clinical integrity and patient care and lead to increased health care costs.

The rule requires manufacturers to report, and CMS to publish online, specified transfers of “anything of value” (a broad term that is not further defined) they make to physicians and teaching hospitals. It also requires manufacturers and group purchasing organizations to make annual disclosures when physicians or their family members hold ownership or investment interests in them.
CMS will start collecting data August 1 and must have a public website up and running by September 30, 2014.  Its first posting will cover reports received between August and December 2013.  Interested parties will get a chance to review the data and make corrections before the information goes online. Non-compliant manufacturers and purchasing organizations are subject to civil fines of up to $1,150,000 per year.