Life Science Compliance Update

June 03, 2016

Using Massachusetts Physician Payment Data Prescribing Patterns Under Attack (Again)

Prescribing practices of physicians are once again under attack. And, once again, the attacks leave consumers, patients, and their families feeling confused. This time, the confusion is a result of a study done by researchers from Harvard Medical School and published in JAMA Internal Medicine which found that "medical industry payments to physicians in Massachusetts are associated with higher rates of prescribing brand-name drugs that treat high cholesterol."

Right off the bat, there are some interesting things to note relating to the study. First of all, the study only looked at physicians in Massachusetts, a relatively small state. Second, the study only focused on the prescribing of brand-name drugs for high cholesterol, a relatively small portion of total branded drugs prescribed since the largest players have since gone generic. These are not suggested to discredit the research, but instead, to help put it in perspective.

However, even acknowledging those realities, it is always beneficial to read through the entire study to ascertain the methods, the reasoning, and, if possible, the true results of the study, to best understand the study and the points behind it.

Design, Setting, and Participants

The study used cross-sectional linkage of Part D Medicare prescriptions claims data with the Massachusetts physician payment database. The database includes all licensed Massachusetts physicians who wrote prescriptions for statins that were paid for under the Medicare drug benefit in 2011.

Study Results

Among the 2444 Massachusetts physicians in the Medicare prescribing database in 2011, 899 (36.8%) received some form of industry payments. The most frequent payment was for company sponsored meals, accounting for 71.1% of payments.

Statins accounted for 1,559,003 prescription claims, 22.8% of which were for brand name drugs. According to the study, physicians with no industry payments listed had a median brand name prescribing rate of 17.8%. For every $1,000 received in payments, the brand name statin prescribing rate increased by a statistically insignificant .1%.

However, interestingly, payments for educational training were associated with a 4.8% increase in the rate of brand name prescribing. While that percentage is more significant than the overall percentage mentioned above, it is still not that significant. As we have mentioned before, and continue to opine on, we do not believe that physicians becoming more educated about certain drugs is typically a bad thing. The more they learn, they more they know and can understand how individual drugs can help their patients and what kind of side effects they need to be looking for.

Using the foregoing figures, the researchers concluded that industry payments to physicians are associated with higher rates of prescribing brand-name statins.


As we have all know, and the Harvard researchers even stated, correlation does not equal causation. Simply because there is a correlation between receiving payments (such as a company sponsored meal) and prescribing rates does not mean that one is caused by the other. Even if it is a true causation, physicians who attend company sponsored meals learn more about the drug, and therefore feel more comfortable prescribing it, than a physician who does not have the benefit of that knowledge. Further, the correlation they are trying to bring to bear is a one in one thousand percent, a statistically insignificant amount.

Most patients likely prefer to have a physician who knows exactly what they are prescribing, and a physician who knows which individual patients may be someone who benefits from the name-brand drug, instead of the generic. In the case of statins not all patients can tolerate all statins some patients who have problems taking one statin often can use another statin and several of those statins that utilize different pathways are still branded products.

The study's limitations included the possible inaccuracy of the reporting of payments and prescriptions covered outside of Medicare. Further, they could not determine "which physicians received payments from a specific company and analyze their prescribing of that company's products."

April 14, 2016

NEJM: What Do I Need to Learn Today – The Evolution of CME

Graham McMahon, MD, MMSc, the President and CEO of the Accreditation Council for Continuing Medical Education, has written an article for the New England Journal of Medicine about the evolution of continuing medical education (CME). The article, "What Do I Need to Learn Today? – The Evolution of CME," asks for clinicians, educators, healthcare institutions, and regulators to contribute to the continuing transformation of CME.  He also suggests that CME be included as a significant asset for regulatory efforts such as MOC and the Merit-Based Incentive Payments System.

Dr. McMahon stated that such a continued transformation will serve to "expand the opportunities for educational innovation that improves physician practice and ultimately benefits patient care and the health of our country." To help the transformation, Dr. McMahon recommends that clinicians become more aware of their individual strengths and weaknesses and choose CME activities that can help them grow and become better clinicians.

In order to meet the learning needs of clinicians in today's healthcare environment, it is imperative for educators to design CME activities that focus on the learners, rather than the teachers, and incorporate opportunities for interaction and reflection. Interprofessional continuing education (IPCE) gives physicians the opportunity to build the competencies needed for team-based practice. Patients should be active in their care and should be viewed as part of the healthcare team; including patients as CME speakers can work to engage physicians' hearts as well as their minds.

Part of the problem today, as outlined in the article by Dr. McMahon, is that information is "ubiquitous," meaning that the simple exchange of information has little value, and that in order to truly learn and understand something, shared wisdom and the opportunity to engage in practice-relevant problem solving is crucial. Dr. McMahon realizes that once physicians see and understand that they are actively (and actually!) learning, they embrace future activities that allow them that same learning opportunity.

As stated by Dr. McMahon,

Education that's inadequate, inefficient, or ineffective, particularly when participation is driven by mandates, irritates physicians who are forced to revert to "box-checking" behavior that's antithetical to durable, useful learning.

It is important that going forward, regulators begin to focus on educational outcomes, not the process, and work to create other conditions that maximize flexibility and innovation in CME. The ACCME's collaboration with the American Board of Internal Medicine (ABIM) to simplify the integration of Maintenance of Certification (MOC) and CME, is an example of regulatory authorities working together to reduce the burden placed on physicians, helping to promote lifelong learning.

Dr. McMahon also points out that "If more regulatory authorities recognize the value of education in driving clinical practice and quality improvement and allow educational activities to count for multiple requirements, they can reduce the burden on physicians and promote lifelong learning. For example, participation in CME could be designated as a method for meeting the clinical practice improvement expectations of Medicare’s new Merit-Based Incentive Payment System."

Each year, the accredited CME community collectively provides nearly 150,000 activities. Accredited CME activities are required to be evidence-based and free of any commercial bias or influence. The more involved healthcare leaders, educators, and learners, become in the process, the more CME can do to promote performance, quality improvement, collegiality, and public health.

April 12, 2016

JAMA: Research Parasites Wanted

As reported, earlier this year, a top medical journal ignited a backlash by referring to "research parasites", also known as people who did not personally run a clinical trial or collect data but "use another group's data for their own ends, possibly stealing from the research productivity planned by the data gatherers." The New England Journal of Medicine quickly backtracked, as we noted, and clarified its support of data sharing.

Four days after jointly submitting the editorial piece with Dan Longo, M.D., Jeffrey Drazen, M.D., stated the Journal's support and noted it is "committed to data sharing in the setting of clinical trials." He went on to comment that he believes "there is a moral obligation to the people who volunteer to participate in these trials to ensure that their data are widely and responsibly used" and that "researchers who analyze data collected by others can substantially improve human health." In the walk back, he concludes by bringing up data sharing through collaboration, signaling that such form of data sharing may be palatable to more than just the "data socialists" who want to take your hard-researched data a mere six months after the publication of your findings.

Now, research published in the Journal of the American Medical Association (JAMA) suggests there are not enough of these so-called data parasites. The study found that although more than 3000 trials are available to investigators through open data platforms, only 15.5% had been requested by a limited number of researchers. Most proposals focused on nonprespecified subgroups or predictors of response rather than validation of study results. The reasons speculated for underutilization of clinical trials data include lack of knowledge about these resources, possibly due to lack of publication of results from proposals, or lack of funding to support analyses.

In an accompanying editorial, the editors of JAMA argue that sharing data has two principle purposes: to verify the original analysis and hypothesis generation. "It has the potential to advance scientific discovery, improve clinical care, and increase knowledge gained from data collected in these trials. As such, data sharing has become an ethical and scientific imperative," they wrote.

They also outline that researchers intentionally or inadvertently do not always report important findings from their investigations, citing a report involving clinical data. However, offering all possible data available for reexamination and replication of analyses can help ensure that the publications have fidelity to the trial plan. Perhaps more important, they write, are the study participants. The article cites the International Committee of Medical Journal Editor's position that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk.

Increasing, data sharing is actually being mandated by trial sponsors and has been supported by numerous groups like the Institute of Medicine/National Academy of Medicine, European Medicines Agency, and ICMJE. Journals and funders, they write, must find common ground to ensure data sharing occurs, but note it is easier to call for data sharing than to actually create a system that protects the privacy of patients and is also efficient, effective, and fair to the investigators who collected the data.

The editorial explains that three issues must be addressed for such a system to be successful. First, the shared data must be deidentified for the protection of individual study participants. Second, a system of sharing data must be efficient. Finally, the system must be fair and respect the investment and contributions of the trial investigators.


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