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Letter to The Honorable Kathleen Sebelius Secretary U.S. Department of Health and Human Services

Letter

By:
Date:
Location: Washington, DC

Sen. Chuck Grassley and Sen. Herb Kohl are asking the federal government to move forward in implementing new physician payment sunshine provisions. The senators said some drug and medical device makers are preparing to meet the new requirements but in the absence of clear guidance from the federal government, are preparing payment data in non-uniform ways, causing the material to be difficult for the public to use.

Kohl is chairman of the Senate Special Committee on Aging and Grassley is ranking member of the Senate Committee on Finance. They sponsored the Physician Payment Sunshine Act, which became law as part of the health care overhaul enacted this year. The new provisions require drug and medical device manufacturers to disclose to the Department of Health and Human Services anything of value given to physicians, such as payments, gifts, honoraria or travel above certain minimum thresholds. The goal is to inform consumers in case they want to consider the role such payments or gifts play in the provision of medical care. The senators said the information will be collected in 2012 but some companies are preparing now, and greater guidance from the agency would help the utility of the information for the public.

The text of the senators' letter follows here.

November 4, 2010

The Honorable Kathleen Sebelius
Secretary
U.S. Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20001

Dear Secretary Sebelius:

As Chairman of the Senate Special Committee on Aging and Ranking Member of the Senate Committee on Finance, respectively, it is our duty to ensure that Americans have access to affordable prescription medication. It is in this interest that we have worked together to examine various operations and activities of the pharmaceutical industry, including payments made to physicians for consulting activities, presentations and speeches, participation in Continuing Medical Education and conferences, and research.

As you know, the Physician Payments Sunshine Act requires drug and medical device manufacturers to disclose to the Department of Health and Human Services (the Department) anything of value given to physicians, such as payments, gifts, honoraria or travel above certain minimum thresholds. Companies would also be required to report additional information, including the name of the physician, the value and date of the payment of gift, and its purpose. This information would be collected by the Department beginning on March 31, 2013 and then made available to the public starting on September 30, 2013.

To prepare for compliance with the new legislation, some companies, manufacturers, universities and even the National Institutes of Health (NIH) have developed individual policies to increase disclosure on the nature of relationships between doctors and pharmaceutical companies or medical device makers. While we believe these initial actions are a promising beginning, we are concerned that the variation in individual disclosure policies is creating confusion within the industry and the public. For example, both academic institutions and manufacturers are releasing payment data about the same transactions, but with different levels of granularity addressing different time periods. As a result, the information appears to conflict and is therefore difficult for the public to use. Prompt federal guidance is urgently needed to ensure the same information is disclosed in the same way, and is meaningful.

We need to ensure a smooth path toward increasing disclosure, eliminating conflicts, and ultimately providing patients with the tools they need to make informed health choices. To that end, we urge the Department to promptly designate an agency that will oversee the creation and operation of the database. Ideally, this agency will have the vision and dedication to ensure that this database is complete, easy to find and use, and enhances the integrity of the American health care system.

So that we may better monitor this process, we also request that you provide a briefing to the staff of the Finance and Aging Committees allowing them an opportunity to participate in the Department's decision-making on issues including, but not be limited to: who is responsible for implementation; who is accountable for insuring that the database is operational in a timely manner; and what is the timeline the Department is following to implement the disclosure and publication requirements contained in PPACA.

Thank you for your prompt attention to this important matter. We look forward to the Department providing the briefing before the end of the year.

Sincerely,

Chuck Grassley Herb Kohl


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