Things are getting colder here in New England, and we’d been hoping for a little more Sunshine in October. That’s when HHS was supposed to issue rules implementing the Physician Payment Sunshine provisions of health reform.

The urgency was summed up by co-sponsor Sen. Chuck Grassley (R-Iowa) back in 2009: “Transparency fosters accountability, and the public has a right to know about financial relationships. Patients rely on their doctors’ advice. Taxpayers spend billions every year on prescription drugs and medical devices through Medicare and Medicaid. They also fund tens of billions of dollars of medical research each year, and the doctors conducting that research have a big influence on the practice of medicine.” For the last several months, Senators Grassley and Kohl (D-Wisconsin) have been urging HHS to issue regulations as quickly as possible to meet this need.

The Sunshine provisions require drug, device, biologics and medical supply makers to start submitting information to HHS on their payments to physicians, teaching hospitals and group purchasing organizations (GPOs) this January. That information must be available to the public on September 30, 2013 through a searchable online database.

We are increasingly worried that HHS delays could interfere with the process of collecting the most accurate, consistent and understandable reports from manufacturers, and that we and other interested parties will not have time to weigh in on the reporting framework that HHS proposes. Because of these concerns, we submitted a letter on October 20 to HHS Secretary Sebelius, along with Consumers Union, the Pew Health Group and industry itself – PhRMA, BIO and AdvaMed.

Early this spring, Community Catalyst shared our informal recommendations with HHS on how the systems could be set up to be most effective. We based our thinking on our experience with state disclosure laws and industry disclosures resulting from lawsuits and government investigations. Our top concerns are that:

  • Reporting categories be defined in a specific, unambiguous, and mutually exclusive manner, so that data tells a clear picture of what these financial relationships are
  • The public disclosure website be useful to all users, including lay consumers, physicians whose payments are being reported, and researchers interested in studying trends and impacts of financial relationships with industry
The Sunshine statute itself is much more specific than the state disclosure laws that it will replace. (Note: states can still collect other information not required by Sunshine, such as payments to nurse practitioners.) For instance, the Sunshine provisions lay out 14 descriptors for the “nature” of a payment, including, in brief: consulting fee; compensation other than consulting; honoraria; gift; entertainment; food; travel; education; research; charitable contribution; grant; royalty or license; ownership interest; and speaking for serving as faculty. States and industry data bases use many fewer, often ambiguous categories.

However, we have urged HHS to refine these definitions in regulation so that there is no confusion over how a company should report its payments. And physicians and teaching hospitals deserve to have the payment categories carefully described so they aren’t misinterpreted. The public needs clarity to assess whether certain payments might or might not affect the care they are receiving.

There are concerns by some over how the Sunshine disclosures will relate to other public sources of information on industry payments. These types of issues were front and center last week at a conference we attended on conflicts of interest, put on by the American Society of Law, Medicine and Ethics. The Sunshine law requires industry to report their payments to physicians and teaching hospitals, but physicians themselves must make disclosures about their industry financial ties to many sources, including academic medical centers, medical journals, NIH and FDA panels. There is the potential for confusion and misinterpretation of the data. Despite the challenges, Robert Steinbrook, MD from Dartmouth, and former deputy editor of NEJM, concluded in his presentation on COI and medical journals, that with the Sunshine provisions, “there should be additional opportunities to better control conflicts of interest in Medicine.”

Indeed, we believe the Sunshine provisions can set a national standard that will help in harmonizing all disclosure requirements and provide a useful cross check for physician self-reports.

— Marcia Hams, Director, Prescription Access and Quality Community Catalyst