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Revisiting the Sunshine Act

New rules will take effect soon. Will they have an impact? Yes and no -- and I care more about the no.

February 4, 2013

On Friday, the Federal Register will publish first-ever rules requiring the public reporting of physician and university payments and investment information by companies providing drugs, biologicals, and medical supplies and devices. Data collection will begin this summer, and first reporting will occur approximately one year after the rules go into effect.

The rules, required by the Physician Payment Sunshine Act, part of the Affordable Care Act, constitute a form of conflict of interest regulation, and will become part of 42CFR. As in all conflict of interest policy related to scientific research, it has been both necessitated by failures of ethics and to adequately self-regulate, and resisted and lobbied against by powerful, interested actors.  Experience on financial conflict of interest suggests this is not a good combination for meaningful, effective, enforceable ethics policy. How do these new rules stack up?

Certainly, the fact that they exist at all is a tremendous first step toward providing information that offers the potential to better understand physician, and in many cases researcher and institutional, relationships with industry; financial influences on physician and researcher decision making; and conditions that impact not only the diffusion of new drugs and devices but also their costs. The data must be published on a public website, an important achievement in transparency that has been unobtainable or delayed in other areas, such as reporting of financial conflicts on research grants.

So I began reading the final rule(s) with the cynicism of long experience. But I have to say, overall, whoever was in charge of this did as good a job as they could. Granted, there was fairly consistent counter-pressure to efforts to weaken the final rule, and it and the delays (the rule and the beginning of reporting have been delayed by more than a year) received media considerable media attention. This surely had an impact on final decisions, and such public airing is crucial. But credit is due to the writers of the final rule. Their decisions and explanations of their decisions differ markedly in tone and approach to what I’ve seen in other conflict of interest rule making (for example, the widely disparaged rules on objectivity in federal research finalized in 2011). They were unusually and explicitly sensitive to the potential for loopholes, and were firm in their commitment to the intent of the legislation, particularly in dealing with the very tricky, in policy making, job of definitions and their scope. Particularly important in this regard is holding the line on the definition of physician to those who hold a license whether a practicing or not, which allows it to comprise researchers, and on a broad, non-exclusionary definition of research.

Overall, and given the constraints, the thoroughness and intelligence, indeed the knowingness, with which this final rule is written is a breath of fresh air. And who knew 287 pages of policy could be fun to read? Thank you, CMS, for this day-making gem in response to the suggestion by some commenters that physicians be able to opt out of having their name appear on a public website:

“We believe that a physician who wants to opt out should simply refuse all payments or other transfers of value from manufacturers, and will, accordingly, not be included on the public website (unless they hold ownership or investment interests in an applicable manufacturer or applicable GPO). (pp 38-39).

Simple, isn’t it. A choice. I could not have said it better myself.

Unfortunately, though, the constraints I mentioned resulted in something of a double standard, and what may be a fatal flaw.  While I recognize the importance of this rule for individual practicing physicians and individuals providing services for drug and device companies, it is actually of paramount importance for research and other system-level concerns, including continuing medical education (CME).

So I was deeply disappointed (and my old cynicism fully restored) by what I consider to be a waiver to the earlier tough definitions of who is a physician and what is research—and the unraveling of much of the good that might have been done in the name of transparency and trust in the research enterprise.  The rule grants a significant delay—four years—for reporting payments for a broad swath of research. It is done in response to the tired and always evidence-free claim—the excuse de jour in academic-industry relations—of “confidentiality of proprietary information.” There is nothing about the reporting that would expose anything proprietary or undermine any competitive relation. And if one could be convinced there were (show me), there would be ways to protect that while simultaneously publishing relevant information. But unfortunately the lobbying at the legislative stage put limits on what could be done in the final rule, assuming the CMS wanted to.

Also, the penalties—while I am glad there are some—are too low. For many pharmaceutical and device companies, they are the equivalent of pocket change. Even amounts much greater would be considered a cost of doing business, as many civil penalties always are. Better they lose some of the privileges the government is in a position to grant, or take away. In addition, large CME providers have been given a pass, opening up a rather large lacuna in influence control.

So, overall this final rule strikes me as two rules—one for the little guys, another for the biggies. It does a great job at the low-hanging fruit.  But it leaves the hard-to-reach stuff rotting on the vine. Universities have, as ever, been granted a reprieve from public scrutiny in their research relations with industry. We will have to wait a good five years to find out just how big a one. Assuming, of course, the website, the details of which are still to be developed, is not further eviscerated by those who don’t want you to know.





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