January 29, 2013

Lobbyists air concerns about doctor gift-disclosure rule at White House

From: RegWatch/The Hill’s Regulation Blog

By Megan R. Wilson

Lobbyists are lining up to meet with Obama administration officials about rules that would require medical companies to disclose financial relationships with doctors, according to records released by the White House.

The rules set forth by the Affordable Care Act reached the Office of Information and Regulatory Affairs (OIRA) in November — way behind schedule set by Congress. Interest groups and Congress have since called for the administration to speed the process along. OIRA has up to 90 days to conduct a review, giving it until Feb. 27.

However, the American Medical Association (AMA), in its most recent meeting, argued that significant changes still need to be made.

“We support the underlying goal of enhancing transparency,” the group said in a letter, but the rule “will result in the publication of misleading  information and impose costly and burdensome paperwork requirements on  physicians while shedding very little light on actual physician-industry interactions.”

The regulations stem from the Physician Payments Sunshine Act, which was passed  as part of the healthcare reform law and requires drug, device and biologic manufacturers to tell federal health officials about payments and gifts to doctors, among other disclosures. It would also establish a website to make the records public.

During the Jan. 17 meeting with Office of Management and Budget (OMB) and Department of Health and Human Services (HHS) officials, the AMA also argued that the reports could result in inaccurate information with no oversight and the implication that doctors are engaging in illegal or unethical activities.

“This perception has the potential to chill beneficial collaboration and information exchange between physicians and industry,” the group said in a letter to officials, posted on the OIRA website.

OIRA is required to list meetings it has with lobbyists involved in the regulatory process and often posts letters other written materials used in the meetings.

Last month, officials also met with the Union of Concerned  Scientists, the National Research Center for Women and Families, the Consumers Union and GE Healthcare. According to the OIRA website, individuals from OMB, HHS, OIRA and the White House Domestic Policy Council have been involved.

In the posted meeting materials, GE Healthcare provided a one-page recommendation for the implementation of the rule that mostly revolved around clarifying how items are reported — for example, using common or generic names of medical devices and drugs instead of clinical names. They also asked for more time to put the tracking databases into place.

But others would like to see the process move faster, claiming that it would help curb fraud in Medicare.

Earlier this month, AARP, the AFL-CIO and 17 other healthcare advocacy groups wrote a letter to OMB asking it to speed along the rule approval. The American Medical Student Association and the National Physicians Alliance wrote a similar letter to Jack Lew, President Obama’s chief of staff.

In addition, Sen. Chuck Grassley (R-Iowa), who co-authored the Physician  Payments Sunshine Act with former Sen. Herb Kohl (D-Wis.), wrote to Lew and pressured the administration to finalize the rules.

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