Healthy Skepticism Library item: 13712

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Publication type: news

Dombrowski C.
Grassley, Kohl Retool Physician Gift Reporting Bill To Defuse Opposition
FDALegislativeWatch.com 2008 May 20
http://www.fdalegislativewatch.com/2008/05/grassley-kohl-r.html

Full text:

Sens. Chuck Grassley, R-Iowa, and Herb Kohl, D-Wis., plan to add a state pre-emption provision to their Physician Payments Sunshine Act as they try to attach it to a Medicare bill being written by the Finance Committee.

The sunshine bill, S. 2029, would require drug and device companies to disclose their financial relationships with doctors in a national, publicly available registry operated by HHS (1“The Pink Sheet,” Sept. 24, 2007, p. 8).

In the new version of the bill, the senators would not only establish the national reporting program, but also direct that it override various state requirements, giving industry a single reporting standard (2“The Pink Sheet,” July 23, 2007, p. 17).

Other changes designed to make the measure more palatable to industry include a higher financial trigger level for gifts that must be reported and lower penalties for non-reporting.

PhRMA Favors National Reporting Standard

The Pharmaceutical Research and Manufacturers of America has not taken a position on S. 2029. But a May 13 statement by Senior VP Ken Johnson indicates that the changes contemplated by Kohl and Grassley are viewed favorably.

Any federal legislation designed to increase the transparency of industry/physician relationships “should establish a uniform, national reporting standard that pre-empts state marketing reporting or disclosure laws,” Johnson said.

Disclosure requirements should not impose “excessive burdens” on physicians or companies nor chill physician involvement in research, nor should they “inadvertently imply that these interactions are inappropriate,” Johnson added.

The Senate Finance Committee is expected to take up the Medicare package in June; Grassley is the top Republican on the panel.

That measure, designed to update government payments for physician services, is considered a priority for action this year and thus may become a vehicle for a number of health-related proposals, including one to alter payments for intravenous immune globulin (3“The Pink Sheet,” May 12, 2008, p. 32).

Finance Committee Chairman Max Baucus, D-Mont., however, is expected to oppose add-ons that could be controversial and impede passage. Kohl and Grassley’s changes could help defuse opposition by Baucus, as well as stakeholders.

They now plan to propose that reporting be required for payments to an individual recipient only if they exceed an aggregate of $500 during a calendar year. As initially introduced, all payments of more than $25 would have had to be reported.

Specifically excluded from reporting are certain educational materials and direct training, equipment loans, discounts and rebates, anything nominal in value, in-kind items used for charity care, individual payments of less than $25, product samples, and transfers to a physician who is a patient.

Other changes that would make the measure less burdensome are reporting on an annual rather than quarterly basis; delayed reporting of payments related to clinical trial funding until trial information must be posted; and, in the case of product development agreements, delayed reporting for up to two years or until FDA approval.

The revised bill would have lower penalties for failure to report — $1,000 to $5,000 per incident, with an annual cap of $50,000, instead of the previously proposed $10,000 to $100,000 per incident. The penalty for knowingly failing to report would be $5,000 to $50,000 per incident, with an annual cap of $250,000.

The proposal received support from Lilly CEO John Lechleiter, who said in a May 12 letter to Grassley that reporting payments to physicians is “an important step” in ensuring public understanding of how companies help physicians increase their knowledge about products and improve patient care. Last year, Lilly began reporting its educational grants and charitable contributions on a company Web site. Pfizer launched a Web site May 15 to report its educational grants to organizations (see 4following story).

In the House, the Gift Disclosure Act, H.R. 3023, was introduced March 13 by Rep. Peter DeFazio, D-Ore. (5“The Pink Sheet,” March 10, 2008, p. 23). The Medicare Payment Advisory Commission also is considering whether to recommend a national online gift reporting database.

This article is reprinted from “The Pink Sheet” – May 19, 2008