Senators Charles Grassley and Herb Kohl are two of the legislative champions of the Physicians Payment Sunshine Act, which was included in the Affordable Care Act (ACA) last year. They recently sent a letter to the Centers for Medicare and Medicaid Services (CMS), expressing “severe disappointment” about a major missed deadline that puts timely implementation of the legislation at risk.
We at PostScript join in their disappointment that regulations on the Sunshine Act have not yet been released by the CMS. We also appreciate the attention the Senators’ letter gives to the role for consumers and consumer advocates – these rules are ultimately for the benefit of health care consumers. We have a personal stake in knowing our physician’s potential conflicts of interest because payments from industry may affect decisions they make about our care, the affordability of our treatment and ultimately of our insurance premiums.
A Minneapolis Star Tribune editorial said it well:
“Some might be tempted to applaud the delay of any new industry regulations. That’s shortsighted. The Sunshine Act will require public disclosure of the large sums sometimes paid to medical professionals by industry. That collaboration is important for medical innovation, but there are also concerns about whether money influences doctors when it comes time to choose between new products and older drugs or devices. Payment information should be easily accessible so that patients can weigh for themselves if medical providers have their best interests at heart.”
To date, the independent, non-profit newsroom ProPublica has done their share to get the ball rolling. Combining industry disclosures required by Department of Justice lawsuits concerning illegal marketing (Pfizer, Novartis, Eli Lilly, Johnson & Johnson, etc), ProPublica has created an online database of payments to doctors from the 12 companies whose “combined prescription drug sales amounted to about 40 percent of the U.S. market in 2010.”
ProPublica has also helped journalists understand and publicize the importance of these payments through an ongoing series of news articles about industry payments to doctors. But as ProPublica notes, “physician payments from potentially hundreds of drug and device companies operating in the United States are still secret for the time being.” The Sunshine Act will not only provide transparency of payments by all companies, but make disclosures more detailed and consistent.
In April, CMS hosted an open door meeting by phone, where industry and consumers weighed-in on some important definitions that the Department of Health and Human Services (HHS) must clarify through regulation. For instance, how will industry draw the line between education and marketing? What kinds of research payments can be delayed, and which can’t? How the agency defines certain types of payments will have real impacts upon how the data is reported, and how useful it will be to consumers and others researching the effects of these payments. So the agency has its hands full.
Community Catalyst knows from our other work on many aspects of the ACA that HHS and CMS have their hands full implementing the biggest expansion in health care coverage and other improvements to the U.S. health care system in more than forty years. However, the Sunshine Act rules also need to come out soon, so the industry has ample time to implement systems to track all their payments starting January 1, 2012.
Here is a refresher on the timing of the Sunshine Act provisions:
- Spring/Summer 2011: The Secretary of Health and Human Services was “required to consult with the Inspector General, affected industry, consumers, consumer advocates and other interested parties to ensure that the information made available to the public is presented in the appropriate context.”
- October 1, 2011: Deadline for regulations that establish the procedures for applicable manufacturers to submit information, as well as procedures for making such information available to the public.
- January 1, 2012: Manufacturers begin collecting data for calendar year 2012. Duplicative state laws preempted (see Pew Prescription Project fact sheet).
- March 31, 2013: Manufacturers submit information to CMS on payments for calendar year 2012.
- April 1, 2013: Report to Congress on information collected from industry.
- August 16, 2013: Manufacturers and recipients have opportunity to review and correct posting prior to publication of the data, subject to subsection (c)(1)(D). Review period under (c)(1)(C)(ix) – cannot delay posting date.
- September 30, 2013: CMS to publish information on public, searchable website, and to send their first reports to states.
More about Sunshine? Check out the Sunshine Act Guide.
– Anna Dunbar-Hester, Program Associate and
Wells Wilkinson, Director Prescription Access Litigation