CMS Rule Would Make Drug, Device Makers’ Payments to Docs Transparent

Cheryl Clark, for HealthLeaders Media , December 15, 2011

The Centers for Medicare & Medicaid Services late Wednesday released its 121-page proposed rule designed to reveal potential conflicts of interest between drug, biological and medical device companies and the physicians and teaching hospitals that prescribe and use them.

The proposed rule, also called the Physician Payment Sunshine Act, which was required by Section 6002 in the Affordable Care Act, would mean about 150 manufacturers of drugs, or biologics, 1,000 makers of medical devices or medical supplies, and 420 group purchasing organizations will be required to report payments, to physicians and teaching hospitals. Such payments are defined to include gifts, fees, meals and travel expenses.

"When people are faced with the difficult task of choosing the right doctor, they need all the information they can gather," CMS deputy administrator for Program Integrity Peter Budetti, MD, said in a statement.  "If your doctor is taking money from manufacturers of prescription drugs, suppliers of wheelchairs or other devices, you deserve to know about it.

"Disclosure of these relationships will discourage the inappropriate influence on clinical decision-making that sometimes occurs while still allowing legitimate partnerships," Budetti said.

The ACA specified that details of these transactions should be made publicly available and searchable on a federal website.

CMS missed its deadline by about 10 weeks. The proposed rule delays the start time from Jan. 1, as set forth in the Affordable Care Act, to after the final rule is published next year.

It defines eligible transfers of value as amounts of $10 or more. Covered teaching hospitals are defined as those that receive graduate medical education payments.

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3 comments on "CMS Rule Would Make Gifts to Docs Transparent"

Andre J. Pagliaro, MD (12/28/2011 at 9:10 PM)
Does the government list and detail all payments, gifts, etc.that any elected politician, or official is given? Or government employee's that are responsible for making decisions regarding government contracts, suppliers, etc. I would like to know if that transparency is present. For some reason it seems that "physicians" are considered so easily manipulated that a $10 dollar lunch, a pen, or perhaps a educational course (througth a company) will cause us to make choices that may not be in a patient's best interest. One should remember that our best interests are also those of the patient's. Good outcomes, satisfied patients, and lower complications benefit "all" involved in the practice of medicine. That hardly seems to be the case in government. Do they face their constituents on a daily basis? I think not. Congress and the U.S. Government, as a whole, has the lowest approval level of all time.

douglas wright (12/19/2011 at 12:34 PM)
so to be clear. if the hospital has a teaching program for radiologists and a rep picks up the $10 lunch tab in the cafeteria for the neurosurgeon, this should be reported??

Mintz Levin Member Tom Crane (12/15/2011 at 11:59 AM)
"This long-overdue regulation implements the so-called 'Sunshine Act', which requires a variety of disclosures of financial ties between pharmaceutical and medical device manufacturers and physicians and teaching hospitals. Because of the delays in issuing this proposed rule, CMS sensibly has decided to postpone the January 1, 2012 start date for data collection until a final rule is published. As with most voluminous regulations, CMS has made a number of key interpretations that will need to be closely reviewed. Importantly, in several areas CMS has decided that if manufacturers have disclosable financial arrangements with covered recipients, arrangements that are otherwise accepted, such as de minimus amounts, need to be disclosed as well. Similarly, if a medical device manufacturer has both disclosable devices (ones that are subject to pre-market approval) and exempt devices, it must disclose financial arrangements with covered recipients associated with all of its devices."




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