Letter to CMS urging the release of the Sunshine Act final regulations

Marilyn Tavenner

Acting Administrator

Centers for Medicare & Medicaid Services

Department of Health and Humans Services

Room 445-G

Hubert H. Humphrey Building

200 Independence Ave, SW

Washington, DC 20201

Dear Ms. Tavenner:

As members of the Patient, Consumer, and Public Health Coalition, we strongly urge CMS to release the Sunshine Act final regulations as quickly as possible.  Earlier this year (February 2012), we submitted comments on the draft regulations and we are still waiting for the final rule, which is more than a year late and should not be delayed any longer.  Public interest groups and members of Congress agree that it is past time to release the regulations and start collecting information on industry payments to healthcare providers.

Recently, a Washington Post editorial included the Physician Payments Sunshine (PPSA) Act rules in its list of regulations the White House should have already acted on.  The editorial stated, “the health-care reform law stipulated that final rules for a sunshine provision on drug-company payments to physicians and teaching hospitals were to be issued by October 2011. They still have not been.”[1]

An Institute of Medicine (IOM) report (Conflict of Interest in Medical Research, Education, and Practice) stated that, “The public needs to be able to trust that physicians’ decisions are not inappropriately influenced by their financial relationships with industry.”[2] The Sunshine Act directly addresses that issue.  Its purpose is to restore trust in the medical profession and to protect patients and public programs.  The Administration should release the regulations immediately so this important patient safety and consumer protection legislation can be implemented.

The PPSA regulations (CMS-5060-P, RIN 0938-AR33) are designed to increase accountability and transparency in our health care system.  It is not possible to ensure that physicians’ decisions involving prescription drugs and medical devices are based on the best available science, but it is possible to make sure that patients are aware of the financial incentives that their physicians have received from drug and device makers.

American Medical Women’s Association

Annie Appleseed Project

Connecticut Center for Patient Safety

Jacobs Institute of Women’s Health

National Research Center for Women & Families / Cancer Prevention and Treatment Fund

Truth in Medicine

THE TMJ Association

Union of Concerned Scientists



For more information, contact Paul Brown at (202) 223-4000 or pb@center4research.org

[1] Editorial November 8, 2012).  Lawmakers face a torrent of delayed decisions, Washington Post.  http://www.washingtonpost.com/opinions/lawmakers-face-a-torrent-of-postponed-decisions/2012/11/08/5994f11c-278a-11e2-b4f2-8320a9f00869_story.html

[2] Institute of Medicine (April 2009). Conflict of Interest in Medical Research, Education, and Practice.  http://www.iom.edu/~/media/Files/Report%20Files/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice/COI%20report%20brief%20for%20web.pdf

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