Medtronic ($MDT) is lobbying hard to speed up the launch of a new federal regulation that would mandate device and drug manufacturers, among others, to annually reveal any financial ties they have with teaching hospitals or physicians.
Reuters reports that the public interest group Pew Charitable Trusts is also pushing hard for the adoption of the new rule, ideally by year-end. The Centers for Medicare and Medicaid Services is developing the regulation as part of the Affordable Care Act. But Medtronic and Pew, in a letter to CMS, said the so-called "sunshine" provision has taken too long to launch, and that the delays are confusing and expensive for the industry, according to the story.
Too long, you ask? A preliminary version of the new rule was first published almost a year ago. CMS is helping to roll-out various provisions of the health reform law, and the White House Office of Management and Budget only began reviewing the final version of the regulation this week--the last stop before the regulation becomes official. Initially, details were supposed by be finalized by October 1, 2011, with requirements that companies start collecting payment information starting Jan. 1, 2012. Companies are also supposed to start submitting that data to the U.S. Department of Health and Human Services (of which CMS is a part) by March 31, 2013. But Medtronic and Pew noted in their letter that the delay in establishing details of the law make the data submission deadlines unworkable.
The "sunshine" provision, as Reuters explains, is designed to avoid conflicts of interest among caregivers and researchers. It will require device- and drugmakers, biologics manufacturers and medical suppliers to disclose annually any payments or gifts they make to teaching hospitals and physicians.
- read the Reuters story
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