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

Cheryl Clark, for HealthLeaders Media, December 15, 2011

"However, if the practice group includes five physicians, then the per-covered recipient cost is $5 (regardless of whether all five physicians actually consumed any of the food provided), so the payment would not need to be reported."

Group purchasing organizations covered by the proposed rule are broadly defined as any entity that purchases and arranges for, or negotiates the purchase of covered drugs, devices, biologicals or medical supplies in the U.S. whether they purchase them directly or for resale or distribution.

The reporting requirements also are proposed to exclude:

  • Transfers of value less than $10, unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient exceeds $100 in a calendar year.
  • Product samples that are not intended to be sold and are intended for patient use.
  • Educational materials that directly benefit patients or are intended for patient use.
  • The loan of a covered device for a short-term trial period, not to exceed 90 days, to permit evaluation of the covered device by the covered recipient.
  • Items or services provided under a contractual warranty, including the replacement of a covered device, where the terms of the warranty are set forth in the purchase or lease agreement for the covered device.
  • A transfer of anything of value to a covered recipient when the covered recipient is a patient and not acting in the professional capacity of a covered recipient.
  • Discounts, including rebates.

CMS says it will accept comments on the proposed rule until Feb. 17.


Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.
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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."