Final Sunshine Regs: Physicians Win Some, Lose Some

February 06, 2013

The medical profession caught a few breaks in the long-awaited final version of federal "sunshine" regulations that require drug and medical device makers to disclose what they give physicians in the way of money, food, and coffee mugs.

In general, however, the fine print promises to make the lives of many physicians a little more complicated.

The Affordable Care Act (ACA) calls for disclosing "transfers of value" by drug and device makers to spotlight possible conflicts of interest that may compromise education, research, and clinical decision making, all to the detriment of patient care, as officials with the Centers for Medicare & Medicaid Services (CMS) put it. Final regulations released February 1 spell out exactly what these companies must do.

One break for physicians is that payments to speakers at accredited continuing medical education (CME) events need not be reported, even though a drug or device company funded the CME activity. The payment is off the radar as long as the manufacturer does not select the speaker or pay him or her directly (that role belongs to the CME provider).

In December 2011, CMS originally proposed making such payments reportable. Organized medicine objected, saying that the world of CME is already well policed to root out conflicts of interest and that the regulations would scare off physicians and industry from accredited CME activities.

Electronic Pizza Records?

CMS also loosened the rules on how food — lavished on physicians and their medical practices by industry — must be accounted for. For example, a drug company's buffet line at a bustling medical conference will not count as a transfer of value, and the cost of a drug representative pizza lunch at a group practice will be assigned strictly to those who wolf down the slices — physicians and medical assistants alike. (Under the proposed version, a $100 pizza lunch for a 5-physician practice was automatically divvied up as $20 for each physician, whether or not any of them partook.)

But there is no getting away from complications: CMS advises physicians that if they do not want to receive drug representative meals and have them reported under the sunshine regulations, they "simply should make clear to applicable manufacturers that they do not accept them." In other words, give notice. It is up to the manufacturers, after all, to track who eats what.

However, CMS also says that physicians may need to maintain their own records of what they receive or do not receive in case drug and device makers get it wrong. The agency estimates that it will take a medical practice employee about 5 hours a year to do the sunshine bookkeeping for a single physician, who will need about 1 hour on average to review it.

"We Do Not Have the Resources"

The ACA requires drug and device makers to report any transfer of value to a physician that is worth $10 or more. It can be a speaker's fee or honoraria, a research grant, or an in-kind item or service such as food, travel, lodging, and entertainment. Transfers less than $10 — think a Starbucks latte — are not reportable unless they add up to more than $100 over the course of 1 year. Excluded altogether are product samples, educational materials meant for patients, and short-term loans of medical devices.

Drug and device makers also must reveal whether a physician or his or her family members have an ownership stake in the company beyond publicly traded stock.

CMS has laid out a timetable for this exercise in transparency. On August 1, drug and device makers should begin compiling information on transfers of value to physicians during the last 5 months of 2013. They must forward this data to CMS by March 31, 2014. The agency, in turn, will release the data in a searchable format on a public Web site by September 30, 2014.

The American Medical Association and other medical societies have worried that erroneous information about how much physicians receive from drug and device makers could hurt their reputations and careers. Anticipating that problem, the ACA gives physicians and industry 45 days to review the data for mistakes and submit any corrections before CMS posts it online. Under the final regulations, if a physician and a manufacturer disagree about what changed hands, CMS will publish the manufacturer's data but flag it as disputed. The data can be revised on the CMS Web site, but only at 12-month intervals.

Organized medicine had asked CMS to dispense with the 45-day period for review and correction and instead update its Web site on a year-round basis as manufacturers and physicians resolve data differences. The agency replied in its final regulations that "we do not have the resources to make continual changes to the Web site."

Ignorance of Sunshine Requirements Widespread

A recent survey of more than 1000 physicians by the information technology company MMIS shows that much of the medical profession is unfamiliar with the ACA's sunshine provisions even though they have been in the news for several years. More than half said that they did not know that the law requires drug and device makers to report how much they are giving physicians in money, goods, and services, according to an MMIS press release issued yesterday.

That news came as a rude shock, because 63% of those surveyed told MMIS that they are "deeply concerned" that these payments will be available in a public, searchable database. Twenty-one percent said that they will severe a relationship with a company that submits inaccurate information to CMS.