Medtronic, Pew urge quick adoption of medical 'sunshine' rule

Wed Nov 28, 2012 6:12pm EST

* Rule requires disclosure of manufacturers' ties to doctors, hospitals

* Medtronic, Pew want final rule adopted before Jan. 1

* Delays spawn concern about unnecessary costs, confusion

WASHINGTON, Nov 28 (Reuters) - A major U.S. medical device maker and a leading public interest group are urging the U.S. government to move quickly to adopt a new rule requiring manufacturers to disclose their financial ties to physicians and teaching hospitals.

The so-called "sunshine" provision, part of President Barack Obama's healthcare reform law, has widespread support among industry and consumer groups. But advocates say lengthy delays in implementation are threatening to hamper its effectiveness with unnecessary costs and confusion.

"Many companies have already invested significant resources in preparing to comply with the sunshine provision," representatives from Medtronic Inc and the Pew Charitable Trusts said in a November 16 letter to Marilyn Tavenner, acting administrator of the Centers for Medicare and Medicaid Services, or CMS.

"We request that final regulations be released no later than December of this year," the letter said.

CMS officials were not immediately available to comment. The agency, part of the U.S. Department of Health and Human Services, helping to spearhead implementation of the Patient Protection and Affordable Care Act.

Pew released the letter on Wednesday, a day after the White House Office of Management and Budget began reviewing the final version of the regulation. A preliminary version was published December 19, 2011. OMB is the final stop in the federal rule-making process before regulations are finalized.

The sunshine rule would require manufacturers of drugs, medical devices, biologics and medical supplies covered by federal healthcare programs to report annually their payments and gifts to physicians or teaching hospitals.

Its objective is to avoid conflicts of interest that could influence research or care-delivery decisions to the detriment of clinical integrity and patients.

"Full implementation of this law will protect patients and help restore trust in our healthcare system," said the letter co-authored by Medtronic's ethics chief, Thomas Schumacher, and Pew's medical programs director, Allan Coukell.

The healthcare law required the administration to establish reporting procedures for manufacturers by October 1, 2011. The original deadlines also called for companies to begin collecting payment information on January 1, 2012, and submit the data to HHS by March 31, 2013.

"Delays in establishing procedures for the submission and public reporting of the required information have made these deadlines unfeasible," the letter noted.

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