Rocky Rollout of Sunshine Act— The Open Payments Program for Physicians.

Another Accountable Care Act initiative with website problems!

For many years now, many public policy concerns have been expressed about the huge amounts of money that pharmaceutical companies and medical device manufacturers give directly to physicians and academic medical centers. An old drug detail-man in Kentucky once told me his company gave Cadillacs to the highest prescribers of his drugs. I doubt that things are that blatant anymore, but so much money flows into individual and departmental pockets that it is difficult to assemble members for expert panels of the FDA, CDC, or other policymaking organizations who are not receiving money from drug and device makers. Full disclosure was supposed to solve the problem, but that does not work. The Open Payments initiative is part of a larger movement for greater transparency and accountability. I plan to write more about this, including my own experience over the years interacting with Pig Pharma and Big Devices.

Clinical departments and medical schools refer to this income stream as “quality of life money.” What started as a courtesy $100 speaking fee for something we used to do for free turned into multiple $1000s per talk and 5-figure or higher yearly income supplements for being on speaker panels, for research of different degrees of sophistication, or for acting as “consultants or advisors.” [Full disclosure– I was once a player. It’s an interesting story.]  Naturally, as other physicians do, I believed that I was too smart or above the fray to be influenced by such payments. Of course, this is the same argument our legislators make about accepting political contributions. However, to believe that money does not influence our behavior is also to assume that we are not human. The pharmaceutical and device companies know better and would not give away their money unless they thought they were getting what they paid for.

Many see conflict of interest.
Recognizing, at the very least, the appearance of a conflict of interest, a number of states passed laws that made such payments public. A number of drug companies had to release their payments to providers as part of various settlements with the federal government. There have been published reports based on such available earlier disclosures but these represent only a highly selected part of the total.  (The link allows searches of such payment information.) The recent Accountable Care Act extended a requirement for transparency nationwide. This portion of the ACA was named the Sunshine Act. It is administered by the good folks at the Centers for Medicaid and Medicare Services (CMS) who refer to it as the Open Payments Program. The responsibility for reporting payments to physicians and academic medical centers falls on the pharmaceutical and device companies. Oversimplifying, and with a number of slippery exceptions, any gift over $10 must be reported to a national database. The required reporting of payments has been going on for some months now, and the results were originally targeted to be made public at the end of September. Physicians had until to the end of August to review the information submitted with a promised opportunity to correct any errors.

So far, so not-so-good.
To test the waters, and in anticipation of the public release, I signed as a physician to the system yesterday to see if any money had been given to me! [There should not have been a penny!] The results were not auspicious. If I were still in practice, this is the kind of bureaucratic intrusion that would have had me pulling out my hair prematurely.

The first step was to sign-in to a personal CMS account. From my name, Social Security number, date of birth, and address, I was easily identified. Curiously, I did not need to enter my “unique provider number” by which the information will presumably be made available to the public. Reasonably, I was required to prove that I was who I said I was which meant answering questions about my previous social and financial life that was checked against one of the big credit-rating companies.  I passed, but even with a step-by-step instructions from the AMA, the whole process took more than 30 minutes and left me to consider that if I had better computer-hacking skills, this database would be a treasure indeed. The real kicker was that when I clicked the button to see who might have been giving me money, I was told without explanation that the data review function was not available– and this with only three weeks to prove that no contributions have come my way! As I write this, the entire CMS website pertaining to the Open Payments Program appearts to have been shut down.

I should not have been surprised.
A little search on the web confirmed that there have been problems with implementation. At least one physician found that his payments were being co-mingled with another’s. I have no idea how big the problem might be. CMS immediately shut down the data review site. It is still down as I write this. We physicians are promised that the timetable for review and public release will be extended by at least as long as it takes for a fix. Nevertheless, that the initiative is starting out in such a flawed manner does not inspire confidence. Transparency only works if the information disclosed is accurate and verifiable.

Things might get even more confusing.
Even in recent months, CMS is considering changes to the rules and the type of payments that are excludable from reporting. A controversial exclusion (at least to drug companies and sponsors of Continuing Medical Education) is that the money that industry pays to sponsor CME should be reportable, even when delivered through a third-person bagman. I agree with the CMS, but tremendous political pressure is being applied to keep the exclusion in place. Such contributions are supposed to be “hands-off” and non-influential but it doesn’t work that way. A CME exclusion is a loophole big enough to drive an entire industry through. It is part of “native advertising” for Big Pharma and Big Devices.

Their hearts were in the right places.
I do not argue against the intent of the new law. I believe the flow of money from big Pharma and Big Devices has corrupted both the medical and academic marketplaces. When I was Chairman of University Hospital’s statutory Pharmacy and Therapeutics Committee, my members unanimously recommended that drug company representatives be required to register when they entered the hospital, and to do so only during normal business hours. We had learned that drug-reps were coming in late at night and were actually attending resident’s rounds, bringing food, and also giving advice on specific patients! Our intent was to supervise their otherwise unlimited 24-hour exposure to our students and residents. This was standard practice at many hospitals and should have been a non-controversial recommendation. [I was so naive!] The initiative was scuttled by the then Chairperson of a major clinical department whose statement in public was “that the relationship between doctors and drug companies is mutually beneficial and should not be changed.” Another clinical chairman said much the same thing and our recommendation went down in flames of demoralization. These were are the people who were training our next generation of physicians. I have many other such stories to tell.

This is a story I want to write more about. Every prior release of previously secret information about hospital charges, hospital quality and safety, or payments to hospitals and physicians has been followed by a rash of analytic reports that took the public by surprise. The same thing will surely happen when CMS finally gets around to publishing its Open Payments database. (Hopefully the data will be reasonable accurate.) CMS asserts that it is not prohibiting any of the reportable financial relationships, but that it believes they should be made transparent. I could not agree more.  It is now being reported that the simple possibility of disclosure has already caused a sharp fall in the amount that physician speakers are being paid!  Disclosure of financial relationships with drug companies is a mandatory part of the informed consent in clinical research trials. Similar disclosure is also appropriate in routine clinical practice. It is an intrinsic part of fully informed consent.

Peter Hasselbacher, MD
President, KHPI
Emeritus Professor of Medicine, UofL
August 11, 2014

One thought on “Rocky Rollout of Sunshine Act— The Open Payments Program for Physicians.”

  1. Last week, CMS put their Sunshine Act database back online. I need to learn more, but there was indeed some sort of problem, or “bug” such that data from physicians with similar names was co-mingled. It appears that CMS is prepared to publish the data publicly nearly on schedule. Curiously, it will omit up to one third of the filings from drug and device manufacturers for which the data is suspect! I still do not understand why existing physician unique identifier numbers were not used. So far the process is not inspiring great confidence. I will have to get back to this topic later.

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