"Sunshine" bill sets $100 trigger for disclosing drug industry pay to doctors

The proposal would let states regulate such income even further. Reflecting a growing trend, two universities and a specialist group announce new conflict-of-interest policies.

By — Posted Feb. 23, 2009

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Physicians who receive $100 or more from drugmakers or device manufacturers over the course of a year would have those payments posted to the Web under bipartisan Senate legislation introduced in January.

The new bill is stricter than a version of the measure circulated last year that received support from industry and organized medicine groups, including the Pharmaceutical Research and Manufacturers of America and the American Medical Association.

The reintroduced legislation, known as the Physician Payments Sunshine Act, came amid another round of disclosure and conflict-of-interest policies announced by doctors and academic health systems.

Sen. Chuck Grassley (R, Iowa) co-sponsored the bill. He has led a wide-ranging inquiry into academic physician researchers who received millions in industry payments but allegedly failed to report the income as required by the National Institutes of Health and their universities.

"Shedding light on industry payments to physicians would be good for the system," Grassley said. "Transparency fosters accountability, and the public has a right to know about financial relationships."

The bill requires reporting of virtually every kind of industry compensation to doctors, ranging from small gifts to royalties and consulting income. Drug samples and short-term device loans would not be reported.

The 2008 revised version of the Sunshine Act that the AMA, PhRMA, the American Academy of Family Physicians and others endorsed did not require public disclosure until annual doctor payments hit the $500 aggregate mark. The AMA-endorsed version also preempted any state disclosure laws, whereas the 2009 bill allows states to enact "additional requirements." Six states have industry-pay disclosure laws, and Texas politicians are considering similar legislation.

The new sunshine bill is "carving out a federal standard and saying states can fill in the gaps," said Sharon Treat, a state representative in Maine and executive director of the National Legislative Assn. on Prescription Drug Prices. "The federal rules are the floor, not the ceiling."

The bill also would require drug companies or device makers that are not publicly traded to disclose any ownership interest held by physicians or their immediate family members. Industry firms that knowingly fail to report payments could face up to $1 million in fines.

Concerns about reporting

The AMA did not comment on the 2009 Sunshine Act. AAFP President Ted Epperly, MD, said the new bill's requirements may be too burdensome.

"Transparency is good," he said. "What we're all trying to find is what exactly is the right balance on this. It strikes us that the 2009 version has gotten even more restrictive. ... Has this gone too far? I'd say we believe [financial conflicts] can be managed appropriately and we need to work together to do that, but if it's overly onerous it almost discourages creativity and innovation."

PhRMA Senior Vice President Ken Johnson said in a statement that the trade group is reviewing the bill. "Any federal legislation should establish a uniform, national reporting standard that preempts state marketing reporting or disclosure laws."

The bill was referred to the Senate Finance Committee, where Grassley is the ranking Republican. Even as Congress considers a disclosure mandate, many medical organizations are tightening their disclosure and financial-conflict policies.

In early February, Harvard Medical School in Boston adopted policy that sets limits on faculty or their family members' ownership in firms sponsoring doctors' research. The policy bars holding more than $30,000 in stock in companies or any equity, or receiving more than $20,000 in consulting or other fees from research sponsors.

The North American Spine Society recently required participants at its professional meetings of physicians and PhDs specializing in spine care to disclose dollar amounts of all industry relationships they held in the prior year.

University of Iowa Health Care, a 1,420-physician health system, also announced a stricter financial-conflict plan in January. Among other things, the new policy bars faculty, staff and trainees from seeking, accepting or giving patients product samples under the theory that the free drugs improperly influence prescribing habits.

"As physicians, we are fiduciaries of patient care," said Jean E. Robillard, MD, University of Iowa Health Care's vice president of medical affairs. "And when patients come here they believe they'll get the best care at the lowest cost possible and get the right medications. We have to tell patients when there are conflicts of interest and eliminate any conflicts we can eliminate."

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Reporting drug industry payments

The Physician Payments Sunshine Act of 2009 would require drugmakers, device manufacturers and other medical suppliers to report annually any "payment or transfer of value" to individual physicians. If the aggregate amount exceeds $100, the physician's name and the value and kind of payments would be posted publicly on a Web site.

Publicly listed payments

  • Charitable contributions made on physician's behalf
  • Compensation for nonconsulting services
  • Consulting fees
  • Continuing medical education speaker or faculty fees
  • Current or prospective ownership or investment interests
  • Education
  • Entertainment
  • Food
  • Gifts
  • Grants
  • Honoraria
  • Research
  • Royalties or licenses
  • Travel

Not listed publicly

  • Anything physicians receive in their roles as patients
  • Devices loaned for less than 90 days for physicians to evaluate
  • Discounts
  • Dividends or profits from stock ownership in publicly traded industry firms
  • Educational materials that directly benefit patients or are intended for patient use
  • In-kind items used for providing charity care
  • Items or services provided under contractual warranty
  • Product samples intended for patient use

Source: Bill text

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External links

North American Spine Society Disclosure Policy (link)

Physician Payments Sunshine Act of 2009 (link)

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