Posted on September 30, 2014 at 3:15 AM
by Craig Klugman, Ph.D.
Today, Tuesday, September 29, the Centers for Medicare and Medicaid Services will release most of the Open Payments database. The public will now have access to the monetary value of gifts, marketing, and payments for clinical testing made by the pharmaceutical industry to physicians. The database is being rolled out 12 days later than planned and with one-third of the 2013 data unavailable until June 2015: There have been some glitches including mix-up of names and wrong provider and license numbers entered.
The Open Payment database is a part of the Sunshine Act, a provision of the 2010 Affordable Care Act. Under this law, entries must include the name and address of the physician, amount and date of payments, the form of the payment, and the nature of the payment (is it for consulting, gifts, entertainment). All gifts and payments over $10 that do not directly benefit patients must be reported.
The goal is to increase transparency and reduce conflict of interest. Knowledge of payments should theoretically increase patient awareness of factors that may effect recommendations made by their physicians. Studies and reports demonstrate that pharmaceutical gifts and marketing visits impact physicians’ prescribing practices.
The American Medical Association supports the database but feels it has had some rollout problems and is not ready for release. Specifically, the AMA feels that a delay is necessary “to allow physicians adequate time to review and seek correction of inaccurate claims made by pharmaceutical companies, device manufacturers, and group purchasing organizations.” Physicians have to register with the database to be able to review any entries about them. The doctor then has 45-days to review and dispute an entry from its appearance.
Also, the AMA fears that the reporting requirements may create an undue burden on doctors. Physicians seem to share this concern. A private corporation’s survey released in January 2014 found that out of 1,025 physicians questioned, nearly half did not know the details of database reporting and 63% were concerned that a record of payments to them would be publicly available. Interestingly, 21% said that the database would cause them to end their relationships with pharmaceutical companies and another 43% said their connections to the companies would be effected.
The president and CEO of the Pharmaceutical Research and Manufacturers of America stated in a recent editorial that while his organization supports the Sunshine Act, it is concerned that the pubic may not understand the context of the monetary reports. He cites as an example that a person may not know a payment was for participation in a clinical trial for “an innovative cancer treatment or a family practice physician’s attendance at an industry-sponsored speaking event…” Nevermind whether either is geared toward improving patient care or outcomes.
One website stated the opposition to the database as: “Concerns over the pending Sunshine Act data release are fairly simple: doctors don’t want to be demonized in the press over either inaccurate payments or payments reflect beneficial collaborations with industry.” In other words, it’s potentially bad for business.
When I searched for everyday people’s reactions or discussion of the benefits to the public, I found very few articles. In May 2014, Newsweek published an article titled “The Sunshine Act Will Publicize Big Pharma’s Undue Influence on Doctor’s.” An article in a recent edition of the Chicago Tribune declared, “Feds to publicize gifts to doctors.” The crux of these articles is that industry-clinician collaborations are part of the health care system and can be fruitful. However, there are enough cases of poor ethical judgment and questionable relations that some sort of oversight is necessary. Perhaps, transparency may have avoided these problems.
The question becomes whether the reporting burden placed on manufacturers, organizations, and physician offices is balanced by the ability of the public to access this information. Will doctors have to go out of their way to not prescribe drugs from companies with which they interact? Will this compromise patient care?
Given the studies that show relations between industry and doctors effect prescribing practices, transparency would seem to be a tool against conflicts of interest if awareness alone is sufficient. The database may help even the playing a field a little bit. However, the role of policing these relations are in the hands of the consumer—I mean patient—who really has little power. The question is, how many patients will look up their physicians? How many fewer will question their physician’s prescription if the drug or device is from a firm with which he or she has a relationship? Can patients band together and strike to force a particular doctor to change her or his industry relations? Given limitations on physicians accepting new patients and insurance company networks limiting choice, is changing to a physician with a different set of conflicts really an option?
These questions are not philosophical ones, but ones that can be studied carefully by correlating the Open Payments database and databases of physician prescriptions—the industry has no problem with the latter because such information helps them to target physicians for marketing. I hope that someone in CMS is considering this necessary step.
The relationships between clinicians and device and drug manufacturers can be a productive one in furthering medical technology and innovation. Spending money on drug reps, dinners, and paying thought leaders to lead seminars does not necessarily forward that aim. Instead, it furthers the commercial interests in companies to produce profit (not health) and to acquire the loyalty of physicians who are the gatekeepers between products and the consumer (i.e. patient). According to a study published in BMJ, the financial ratio may be as much as $19 in marketing for every $1 spent on research.
This database is the minimum that can be done—making the information available. Whether people will access it and whether the information will be useful remains to be seen. Is disclosure alone enough to protect patients and change behavior? If, what the survey above suggests is accurate and the polled physicians follow through, then the existence of the database will encourage a large proportion of physicians to reflect on and perhaps change their relationship with industry. If that should happen then the database is an unqualified good.