No Delay for Sunshine Data Disclosure

October 1, 2014
Jill Wechsler

Jill Wechsler is ACT's Washington Editor

Applied Clinical Trials

The federal Open Payments program went live Sept. 30.

The federal Open Payments program went live Sept. 30—even though 40% of the data is “de-identified," i.e., not linked to an individual recipient due to problems in identifying physicians receiving payments from pharmaceutical and medical device companies. Officials at the Centers for Medicare and Medicaid Services (CMS) said that the information would be fully identified next year after the doctor identification process is fixed.

Medical societies and drug and medical device manufacturers had urged CMS to delay the launch of the program for fear that the public would be confused by the incomplete information—instead of gaining transparency into financial transactions between medical product makers and health professionals.

The compromise adopted by CMS is to post de-identified data for 40% of the 4.4 million individual payment transactions valued at nearly $3.5 billion. Despite its limitations, the de-identified data can be used to calculate aggregate totals by industry payer, type of payment, and physician specialty.

In addition, about 10% of the data was not released at all, as expected by the program. The vast majority of the withheld reports qualify for up to a 4-year delay allowed for payments to physicians involved in conducting research; 9% of the data withheld involves disputes that could not be fully resolved in the period provided to physicians to review and challenge industry submissions.

Context needed

Biopharma companies continue to be concerned about the lack of context provided for the payment information and minimal explanation of how relationships between industry and physicians are not always illicit, but can foster innovation and help health care providers learn about new medical therapies and important safety information. An even greater fear, as expressed by Jim Greenwood, president of the Biotechnology Industry Organization, is that third parties will “attempt to misuse the data.”

A prime example of such approaches is the statement from America’s Health Insurance Plans (AHIP) that while these payments are “not nefarious in every case,” they are “a perfect symbol for the misaligned incentives of our health care system.” 

Clearly, Open Payments is a work in process. CMS administrator Marilyn Tavenner described the initial posting as “only the first phase of the Open Payments program,” and that additional data and tools will be made available in “coming weeks.” Shantanu Agrawal, director of CMS’ Center for Program Integrity, which manages the program, explained that 40% of records are de-identified because CMS was unable to match physician information submitted by the payer to national provider information databases. He expressed optimism that disclosure of financial relationships could both discourage “inappropriate” payments and also “identify relationships that lead to the development of beneficial new technologies.”

Allan Coukell of the Pew Charitable Trusts acknowledged that the Open Payments website is not yet fully functional, and that the initial release of such extensive data inevitably will have errors and technical problems. But he and others are pleased that the program has been launched and that stakeholders will work with CMS to fix the problems. The hope is that the information will indicate which financial relationships between manufacturers and doctors are necessary and beneficial and generate new knowledge and advances patient care—and which merely add to health care costs and create conflicts of interest.

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