Breaking news: On August 16, 2013, a major pharmaceutical company provided a lunch buffet of some kind—unconfirmed reports indicate deli sandwiches—for the medical staff of a doctor’s office. The Diet Coke was described as “flat,” sources familiar with the matter reveal. The quality of the corned beef, reputed to be “New York’s finest,” could not be determined at press time. One high-value target demanded, and was given access to, a brownie. Updates will be posted as the story develops.
Those are the sort of revelations I expect we’ll see at the end of this month. That’s when the 2013 physician payment data collected as per the so-called Sunshine Act is slated to be released—nine to 14 months after the fact, which is considered breakneck speed for a federal agency but woefully outdated by everyone else.
Is there any value in knowing what happened between doctors and industry a year ago, especially when so much of it is mundane? CMS seems to think so. Fasten your seat belts—I expect this to be about as juicy as the opening of Al Capone’s vault.
Fun in the Sun
The Sunshine Act stipulates that payments of $10 or more from industry to a doctor must be disclosed to CMS and, eventually, to the public. But even payments below $10 must still be tracked; if the cumulative annual total is $100 or more, that triggers a report too.
After a few false starts, the law went into effect early last year. Data on transactions from August 1 to December 31, 2013 will be released to the public on September 30, 2014; the site will be updated annually on June 30 thereafter.
I can think of at least two reasons why the Sunshine Act would offend me if I were in your shoes.
First, the fundamental premise of the Act is to assume that you can be bought—that your clinical decisions are susceptible to influence from relationships cultivated with industry, even if there’s no direct quid-pro-quo arrangement. Any person with a good code of ethics would find that inherently offensive, but especially a doctor sworn to put patients’ best interest first.
Secondly, the Act might interfere with the care you provide, by driving a wedge between industry and practitioners. Manufacturers need doctors to give them feedback on their products, and clinicians need the expertise of a drug or device’s creators to make the best possible use of it in practice. Those goals are served by open, unfettered dialog.
If doctors get spooked by the negative connotations that surround a public “outing” of their business dealings, or manufacturers (who face stiff penalties for noncompliance) feel they must walk on eggshells in the presence of doctors, routine communication will dry up. It might also jeopardize research programs and educational initiatives that rely on industry support. Who benefits then?
Lastly, consider how arbitrary implementation seems to be.
If you request data on a drug’s performance and the company provides article reprints that have monetary value, those could trigger a report if they cross the $10/$100 threshold. Anything that constitutes a “transfer of value” must be tracked. But professional samples, product rebates and patient education materials don’t. Promotional items at an exhibit booth don’t need to be tracked because they’re made available to all. But if given during a one-on-one visit, they do.
Confused? No worries. CMS has published a handy “user guide” to answer your questions. It weighs in at a svelte 359 pages. Brave souls can find it here: www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Downloads/Open-Payments-User-Guide-%5BJune-2014%5D.pdf.
With even the most humdrum physician/industry relations being tracked, you’re subject to Sunshine whether you know it or not. And all this assumes that patients will even bother to look for the data.
Good Intentions, Bad Policy
Certainly, there are legitimate concerns about industry influence in medicine, and guidelines regarding disclosure of financial interest are both necessary and welcome. They’re also already the norm. Adding another layer of cumbersome oversight and reporting brings clouds, not sunlight.