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About the same time that the Centers for Medicare and Medicaid Services was botching the rollout of healthcare.gov, the agency also announced its successful creation of two mobile apps designed to help doctors keep track the stuff they get from drug makers. It lets doctors electronically tabulate (and report to the Feds) each consulting fee, pen, and jelly doughnut that they receive, right on their iPhone.
The aim of this de rigueur is to help doctors comply with a new federal law passed as part of the Affordable Care Act. Starting this year, drug and medical device companies must report to CMS nearly every transaction they have with individual doctors and how much the physicians received. CMS will post the data on a searchable, public website that goes live September 2014.
The “Physician Sunshine Act” is as much a response to the past marketing excesses of the drug and device makers as a reflection of the retreating stature of the American doctor. Aspects of medical practice that were once firmly the domain of professional bodies are now subject to federal tinkering. This has profound implications for doctors and patients alike who have firmly ceded vital autonomy.
The Sunshine Act mandates that medical product companies report to the Federal government any payment or “items of value” that total $10 or more and are provided to an individual physician over the course of one year. The law also applies to “indirect transfers.” For example, when a drug company pays money to a marketing firm and then expects the group to provide something of value to doctors.
Physician groups like the American Medical Association celebrated the new restrictions. Doctor groups supported the Sunshine Act on a belief that doctors’ receipt of drug industry money leaves an impression that physicians have financial conflicts. They worry that these perceptions undermine patient confidence.
But professional medical societies should also ponder how the rise of these kinds of state and federal laws represents a failing of their responsibility to act as stewards of the occupation’s standards. This sort of federal regulation represents an enduring change in how Washington views the entire profession. Other professions (journalism, financial services) impose rules and limits on consulting work and outside payments. But perhaps no other profession is subject to federal limits and reporting requirements that are as profound as those now imposed on physicians.
One of the central tenets of professional autonomy and responsibility is the act of self-regulation. There’s a historical expectation that prestige professions like law, medicine, and accounting weren’t just afforded certain privileges merely by virtue of their specialized knowledge. It’s also their commitment to certain principles of impartial service that prompted society to entrust these professions. There was a time when the Hippocratic oath meant something tangible. Now the only professional currency that counts is what gets codified into federal regulation.
Nowadays, few can argue that medical societies still provide an adequate measure of regulatory supervision over doctors and their professional activities. The imposition of laws like the Sunshine Act is the consequence. The full-throated endorsement that this legislation received from medical societies is the clearest admission of failings of these groups to provide any measure of self-regulation. Today, medical “professional” societies exist largely to lobby Washington over doctor pay under Medicare. Most everything else they do supports that enterprise.
Underneath the imposition of the Sunshine Act is a far more troubling revelation: Washington has little faith in American physicians, and sees a need and a license to regulate just about every aspect of medical practice, even trinkets doctors receive. There’s a clear view that doctors can’t be trusted to have any financial interactions with drug and device makers, no matter how small or simple these transactions. A free mug is as likely to influence a physician’s judgment as a $50,000 consulting fee.
There’s no doubt that a small number of doctors took excessive payments from medical product companies. This money may have influenced some doctors. Nor is it debatable that some manufacturers acted badly, using fancy trips and large payments to try and influence the prescribing decisions. Many of the most egregious behaviors constituted kickbacks, and were already illegal under existing laws.
As full implementation of the Sunshine Act begins, the law’s provisions are already having some predictable but regrettable consequences to the broader enterprise of medicine and science. Because monetary and criminal penalties attach to lapses in compliance, drug and device companies are interpreting the provisions with no frills. They are often lumping valuable scientific consulting work with sales and marketing activities (like paid speeches given to other doctors) that the law’s architects always viewed with more suspicion. I have seen my own scientific consulting relationships constrained or curtailed as a result of this law.
Companies are ending a lot of very useful dealings. For example, the number of investigator-sponsored studies (where drug companies pay doctors to do small scale, exploratory clinical studies) has plummeted. Barred from recognizing the full economic value of their expertise through consulting work, some providers will seek other endeavors where their skills will be put to less useful purposes.
In Washington, American medicine is sick. The Sunshine Act is a mark of both the symptom and the disease. It’s the culmination of a more protracted failure of American medicine to self regulate, opening the way to far-reaching Federal oversight. It’s the demise of American medicine. At least there’s an app for that.
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