CMS releases long-overdue 'Sunshine Act' rule

The Centers for Medicare and Medicaid Services (CMS) released a final rule Friday that will expose financial relationships between doctors and industry in compliance with President Obama's healthcare law.

Pressure had been mounting for the Obama administration to release the final "Sunshine Act" regulations, which are more than one year overdue. Critics blamed the wait on election-year politics.

The rules will require drug, device and biologic manufacturers to annually report to CMS the payments and gifts they make to physicians and teaching hospitals. CMS, in turn, will create an online database that makes the disclosures easily accessible to the public. 

"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 Friday. "Disclosure of these relationships allows patients to have more informed discussions with their doctors."

The 287-page rule orders that industry players begin collecting their data on Aug. 1 and report it to CMS by March 31, 2014.

Payment categories will include consulting fees, honoraria, gifts, food, entertainment, travel and charitable contributions, among others. Industry players are required to report their payments if they are covered by any federal health program.

The rule also stated that it preempts similar state laws, creating the possibility of "cost-savings, since a single reporting system for reporting this information is less burdensome than multiple programs."

Sen. Chuck Grassley (R-Iowa), an author of the original bill, said in a statement that the new rule will "bring about accountability, and accountability will strengthen the credibility of medical research, the marketing of ideas, and, ultimately, the practice of medicine."

"I will stay vigilant about how this law is implemented, especially after the delays seen already," Grassley added.

The regulations outline a 45-day "review and correction" period for doctors to ensure the accuracy of any disclosures to CMS.

The American Medical Association (AMA) withheld judgment Friday, saying it would "carefully review" the rule.

"Our feedback during this rulemaking process was aimed at ensuring the new registry will provide a meaningful picture of physician-industry interactions and give physicians an easy way to correct any inaccuracies," said AMA President Jeremy Lazarus in a statement.

"As the rule is implemented, we will work to make sure physicians have up-to-date information about the new reporting process.”

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