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Pharma and physicians worry about getting sunburned by the Sunshine Act.
With the payment data collection date rapidly approaching (August 1, 2013), soon to be affected parties are scrambling to interpret, or reinterpret, just what exactly the Physician Payment Sunshine Act will require. The tone of the discussion has moved from shoulder-shrugging semantic hilarity—'Is candy a snack or a meal?' or 'What's the fair market value of a cup of coffee?'—to wide-eyed anxiety and direct pleas to regulators.
At the end of April, James Madara, EVP and CEO of the American Medical Association, argued in a letter to the Centers for Medicare & Medicaid Services (CMS) that handing out peer-reviewed articles from scientific journals does not represent a transfer of value, or a payment, since most physicians already have subscriptions, or institutional access to most scientific journals. Reprints, therefore, should be excluded from the reporting process.
FDA already regulates pharma's dissemination of reprints to physicians, to prevent inappropriate promotion or marketing, wrote Madara. The Sunshine Act's additional paperwork requirements associated with "fairly and accurately reporting on reprints for articles that are widely available for free to physicians could chill such exchanges of information." After the burn comes the chill; will CMS provide some aloe for reprint "transfers of value" after the fact, or hand out sunscreen by way of a reprints exclusion before August 1?
A panel of experts at last month's Drug Information Association (DIA) meeting all agreed that physicians don't want to see their names show up on a pharma payments list, simply because they chose to read a reprint from a scientific journal. One option, according to the panel, is to send a link to the journal article, and hope the physician either has a subscription, or ponies up the reading fee (which could be anywhere from $10 to $30 for a single article). Without specific guidance from CMS, however, any approach is an educated guess about what will appease regulators. Monica Kwarcinski, executive director, medical services, at Purdue Pharma, said her company is planning to report the copyright clearance cost for each journal article disseminated.
Questions from the audience were dead serious; gone were the jokey lamentations about the difficulty of justifying physician green fees in Hawaii, or even whether a USB flash drive is an okay gift for a doc when it has patient education materials on it. One audience member wanted to know how he should value a journal supplement, as opposed to a reprint. Another wondered what would happen when a physician who did not request a reprint shows up on a list with a "value" next to his name. A third wanted to know how to value journal reprints bought in bulk, with unknown recipients.
CMS will surely have to clarify its needs at some point. It's easy to say that legislation like the Sunshine Act is incomplete, that it doesn't answer critical questions about the specifics of what it's requiring. But if the Act and guidance were three times as long and twice as specific, it would be criticized as unwieldy and overwhelming (over 900 pages!), and even then, politicians wouldn't have anticipated a debate on whether candy is a snack or a meal.
Regardless of what industry leaders think of regulators, Congress and the current administration, it must be assumed that companies doing everything they can to obey new laws will be given the benefit of the doubt if they fall short, but can show they meant well. For those who hope to skirt new regulations and continue bad practices by focusing on conflicting minutia or minor obfuscations instead of the guiding spirit of the law, your flabbergasted expression won't be enough to stop the penalties from piling up. With the sun coming out it's important to sweat the small stuff, but not to a fault. CMS isn't looking to burn everyone.
Ben Comer is Pharm Exec's Senior Editor. He can be reached at firstname.lastname@example.org.