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05-02-2013 | Article

CMS releases long-delayed Sunshine Act rule

Abstract

CMS Rule

medwireNews: In reaching a long-awaited decision, the Centers for Medicare and Medicaid (CMS) finalized a rule that would enable the public to gain knowledge of any financial relationships that exist between drug and device manufacturers and specific healthcare providers.

As part of the Affordable Care Act (ACA) initiative to inject transparency into the healthcare market, the rule, known as National Physician Payment Transparency Program: Open Payments, settles how manufacturers of drugs, devices, biologics, and medical supplies that are covered by Medicare, Medicaid, or the Children's Health Insurance Program report to the CMS about payments or "transfers of value" that are made to physicians and teaching hospitals.

The CMS will create a public website where they will post the financial data. The website will also include disclosures from manufacturers and group purchasing organizations (GPOs) of any physician ownership or investment interests.

"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, CMS deputy administrator for Program Integrity, in a statement. "Disclosure of these relationships allows patients to have more informed discussions with their doctors."

Data collection will begin on August 1, 2013 to allow for sufficient preparation and will continue through December of 2013. Data for that time period will be provided to the CMS by March 2014, whereupon the CMS will release the data on a public website by September 30, 2014 after reported information is reviewed and necessary corrections are made.

The rule also drew lines with regard to speaking engagements by stipulating that speakers will be required to meet accreditations or certification and standards of various medical associations. Additionally, drug or device companies cannot directly pay or select speakers for the event or "provide the third party (such as a continuing education vendor) with a distinct, identifiable set of individuals to be considered as speakers for the continuing education program."

"We believe this reporting strategy appropriately separates accredited and certified continuing education from unaccredited and noncertified continuing education, so that consumers can better understand the nature of the payment received by a covered recipient," the agency noted in the rule. "We also believe that educational speaking engagements should be separated from all other speaking engagements, promotional or otherwise."

The American Medical Association (AMA) President issued a response to the rule, saying that the AMA will "carefully review" it while emphasizing the importance of physician's relationships with the pharmaceutical industry being "transparent and focused on benefits to patients."

By Peter Sergo, medwireNews Reporter