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Scope and effect of rules regarding transparency, disclosure unknown
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It is always a challenge to balance the competing interests of trust generated by transparency and disclosure against personal privacy.
For example, I would consider it an overreaching invasion of privacy if our government required every physician to publicly disclose in full detail his or her federal tax return every year on a public site (although I expect this to be the law a decade from now). Such a disclosure would clearly meet the needs of transparency regarding any and all revenues received from any company so long as the tax return was complete and accurate, but it would also disclose other facts — for example, details of charitable giving, gifts to family members, or investment patterns and losses that might create much personal turmoil for many individuals if disclosed to all.
We saw this controversy play out in the last presidential election. Does the public really need and deserve to know every financial detail going back decades of every elected official, including those just running for office? Some thought yes and some no. The two competing virtues, transparency and privacy, are important and, of necessity, in conflict. We must preserve and ideally enhance the level of trust that the public places in individual physicians and the medical profession as a whole. Trust is critical to the doctor-patient covenant; it is precious, important and, according to many, eroding. It is amazing the amount of trust a patient must place in a doctor in sight-threatening or life-threatening situations.
What does the patient need to know about his or her doctor to strengthen that level of trust, which is critical to a successful outcome? We all agree the patient deserves to know that the doctor has completed the appropriate training and has the degrees, licensure and hospital/ASC privileges to perform or prescribe the required treatment. All physicians will without objection provide documentation of these basic facts. Most today believe that the patient deserves to know of any disciplinary action or malpractice settlements, and while no doctor will openly and proudly share such details with their patients, this information is in most cases available from disciplinary agencies or searchable on the Web. Increasingly we are also being asked to disclose case volumes: “Doctor, how many LASIK procedures have you done and how many do you do each month or year?” Some sophisticated and type A compulsive patients want to see detailed outcomes analyses including complication rates, and some thoughtful institutions and practices are proactively collecting this data to use as a positive in their marketing.
As electronic medical records become universal, we can expect individual doctor and institution outcomes to be published along with the cost required to achieve that outcome. The patient of the future can be expected to want to know how many cataracts you performed each of the last 5 years, what percentage of your patients were 20/40 or better uncorrected on day 1 and best corrected at 1 month, your incidence of vitreous loss, secondary surgical intervention within 3 months of surgery and infection rate. They will also want to know how long it takes to get an appointment in your office, how long the wait time and total appointment time averaged, and what a randomly selected series of 100 patients thought of you as a physician and as a person and the quality of the total office experience your practice provided.
The public and our government, which now pays for more than half the health care in America, will in the future almost certainly demand this information be readily available to every potential patient to assist in selecting a preferred provider. If you are a physician in the military, Public Health Service or Veterans Administration, one of the larger health care provider groups such as Kaiser Permanente or Cleveland Clinic, or even a private entity such as TLC Vision, you are already fully accustomed to this in detail analyses of both the objective and patient-reported satisfaction outcomes you generate as an individual against a national benchmark and each of the other providers in your organization.
The new Sunshine Act is only the beginning, as transparency and disclosure for the practicing physician is in the earliest stages, and it is going to progressively increase in scope every year. Why does the federal government want to know every detail of your interaction with industry? Is it really for the patient? I say every detail because a threshold of $10 for required reporting will certainly include even trivial interactions, such as a cup of coffee.
In the case of the federal Sunshine Act, I do not believe the driver is transparency and disclosure for the patient because those of us who work in states with Sunshine Acts in place have found little patient interest in the numbers being reported. In Minnesota, a leader in transparency and disclosure, as a university-based surgeon, my exact income was published on a website in the Minneapolis and St. Paul newspapers every year. Today, as a private ophthalmologist, my practice-derived income is confidential (for now), but my exact consulting, teaching honorarium and royalty-based income are reported on a similar website annually in both Twin Cities newspapers. To date, from a patient perspective, it has generated little interest.
The driver for the new regulations is, in my opinion, the government’s desire to know, as it is highly motivated to learn every detail of how industry interacts with and markets to physicians because it believes this marketing influences physician prescribing behavior. And protest as we might, the data in most studies support this position. The primary concerns of the government and our patients today are cost, access and quality of care. The government believes that a deeper understanding of the relationship between industry and physicians will ultimately help it reduce costs.
For this reason, it is demanding a full reporting of all such interactions, down to those as trivial as $10 in value. It is possible that a few inappropriate larger financial relationships between an individual physician and industry will be discovered in the process. But the many multimillion dollar settlements and compliance agreements already in place have created a very careful, cautious and in some cases stifling overview of physician consultant, educator or inventor interactions with industry, and irregularities in this area are becoming rare. A simple lecture that even mentions any drug or device requires as many as 20 to 30 signatures of approval at a major strategic, including several with legal degrees behind their names, before it can be delivered to the intended audience. So, in my opinion, the target is the smaller day-to-day interactions between individual practicing physicians and the industry that provides the products and services they use every day to run their offices and treat their patients.
At a $10 threshold, it is hard to imagine an actively practicing physician or surgeon who will not be listed on the federal Sunshine Act website when published in 2014, and it will be the rare patient, in my opinion, who will be searching this site to learn that his or her doctor was provided a lunch while learning the details of how best to use a new surgical procedure or drug. But the aggregate data generated will provide a great deal of information to the government that, once analyzed, will be used to reduce the influence of industry and their marketing on physician product selection. The exact outcome of this process is unknown, but I expect a continuing trend toward generic product usage, a reduction in new product development as the costs of compliance grow, an increasing reluctance by the major health care strategics to take the risks required to develop new drugs and devices increase, and a reduction in investment by industry in physician education. Some would argue these four trends are already powerfully in place. As I strive to put my patients’ needs first, which is also most every physician’s primary goal, it is not clear to me and many of my colleagues that any of these four trends is at all in patients’ best interest.
For the physician of the future: Be prepared for a level of transparency and disclosure about your practice and personal life that would have been inconceivable even a decade ago. The impact of these changes on future physician recruitment, physician satisfaction and, for the baby boomer physician, retention in practice is unknown. It is hard to imagine that they will be a positive. An appropriate level of transparency and disclosure is reasonable and deserving of support, but overdone it can be expected to damage the medical device, pharmaceutical and services industry, physicians and even the patients it purports to protect. In the case of the Sunshine Act, I am very fearful of the ever-present “law of unintended consequences.”