* Rule requires disclosure of manufacturers' ties to
* Medtronic, Pew want final rule adopted before Jan. 1
* Delays spawn concern about unnecessary costs, confusion
WASHINGTON, Nov 28 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
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.