Comments to CMS on Sunshine Implementation

Dear Ms. Tavenner:

The Pew Health Group of The Pew Charitable Trusts welcomes the opportunity to submit comments regarding the Centers for Medicare & Medicaid Services' (“CMS”') proposed rule for Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests.¹

The Pew Charitable Trusts is an independent, non-profit organization that applies a rigorous, analytical approach to improve public policy, inform the public and stimulate civic life. Based on data, science and non-partisan research, the Pew Health Group (“Pew”) works to reduce hidden risks to the health, safety, and well-­being of American consumers. The Pew Prescription Project worked to promote transparency of financial relationships between pharmaceutical and medical device makers and health care providers.

We are pleased CMS is working toward implementing the provisions of the Physician Payments Sunshine Act signed into law as section 6002 of the Patient Protection and Affordable Care Act. The Physician Payments Sunshine Act has the support of consumer and industry groups and leaders within the medical profession. Implementation will bring transparency to the financial relationships between physicians and pharmaceutical and medical device companies. The Institute of Medicine has said that these financial relationships “present the risk of undue influence on professional judgments and thereby may jeopardize the integrity of scientific investigations, the objectivity of medical education, the quality of patient care, and the public's
trust in medicine.”

Pew was closely involved in the development of the Physician Payments Sunshine Act and in working to ensure its inclusion in the Patient Protection and Affordable Care Act. We have also supported the development and implementation of analogous state transparency laws. We look forward to continuing to work with CMS toward a successful implementation of this important new program.

Pew's main goals in commenting on the proposed rule are to ensure timely implementation and to promote the interest of full transparency by ensuring that data is collected, reported, and published in the most complete, consistent and accurate manner possible. 

Our first goal is to ensure timely implementation. The statute calls for data collection beginning on January l, 2012. Although we are not advocating for retroactive data collection, swift implementation of this provision is crucial to meet the aims of the statute.

The purpose of the Physician Payments Sunshine Act is to make information available and understandable to consumers and the public. In the interest of collecting and publishing complete and accurate data, we believe that CMS should (1) carefully define nature of payment categories and remove the proposed “other” category, which could be used to serve as a “catch all” and thereby obfuscate the true nature of payments; (2) provide more clarification on the rules regarding indirect payments, especially indirect research payments; and (3) provide more information regarding how reported data will be presented and accessed from the public Website.

. . .

The goal of the Physician Payments Sunshine Act is to protect consumer by ensuring transparency in industry-physician relationships. Swift implementation is crucial to begin to work toward achieving the goal of complete transparency. Effective transparency is possible only if the rules clearly define what information must be reported, when the reports are due, and how the reported data will be published in the public website, as required by the statute.

Thank you for your consideration of our comments. Should you have any questions, please contact me at 202.540.6466 or [email protected].

Sincerely,

Allan Coukell
Director of Medical Programs, Pew Health Group

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1 Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests. 76 Fed. Reg. 78742 (December 19, 2011).