Life Science Compliance Update

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May 14, 2013

NEJM Article: Massachusetts Payment to Physicians Sites Old Statistics to Support Anti Industry Bias

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Over the last several years, we have covered the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC), enacted in 2009.  Subsequently, the Massachusetts legislature rolled back some of the reporting requirements last fall.  And we recently noted that Massachusetts saw a 3% drop in payments to physicians in 2011.  

Consequently, several researchers—led by Aaron S. Kesselheim, M.D., J.D., M.P.H.—recently published a viewpoints article in the New England Journal of Medicine (NEJM) analyzing the distribution of industry payments to Massachusetts physicians.  The authors maintain that “relationships between pharmaceutical manufacturers and health care professionals remain controversial.”  For example, “meals and continuing medical education (CME) programs have been criticized for being promotional and have been linked to non–evidence-based prescribing practices.” 

This assertion is clearly outdated, incorrect, and biased.  First, the Accreditation Council for Continuing Medical Education (ACCME) has strict Standards for Commercial Support (SCS) that prohibit any CME programs from being promotional in any way, and explicity prohibit the involvement of any commercial supporter at any point in a CME program.  Moreover, the ACCME conducts regular compliance audits of CME providers and CME programs to ensure compliance with such standards and physicians are able to submit complaints of any inappropriate promotion or potential violations.   

Furthermore, the ACCME has the highest level of standards for accreditation that strongly require and demand the use of evidence-based materials and scientific literature in creating and presenting an accredited CME program, independent from any commercial support.  Clearly the authors are not familiar with either standards. 

Moreover, the authors ignore significant and overwhelming literature which shows that commercial support of CME does not influence or create any bias in such educational programs.  See Cleveland Clinic; Medscape, and UCSF.  In fact, we have cited numerous surveys showing that physicians overwhelmingly value commercial support of CME.  For example, a recent survey showed that 98% of respondents said CME/CE activities provided them with information that has helped them improve patient care. In addition, almost 60% believe the information that they gathered from accredited CME has helped them reduce the cost of the care they provide.  

Another survey showed that 89% of physicians valued industry providing research grants to doctors, hospitals, and medical schools.  Of those responding to the survey, 76% of participants said they attended an industry sponsored education program and about 9 in 10 attendees say information provided at educational programs is up-to-date and timely, useful, and reliable.  More than half of attendees said they often gain knowledge or skills helpful in their practice. 

The author’s suggestion that CME is not evidence based is also problematic.  We have written numerous times that CME, including commercially supported programs, have improved patient outcomes in areas such as multiple sclerosis, hypertension, COPD, ICU patients, improved taking of family history by physician assistants, Sepsis, healthcare-associated infections, reduction in CT scans, and several other areas.   

To bolster the appearance of a “problem” with physician-industry relationships, the authors use evidence of relationships from 2004, almost a decade ago, to estimate that “83% of physicians received gifts from industry.”  Such data is not only 10 years old, but also predates the PhRMA and AdvaMed Codes, changes in the AMA’s ethical policies, rules and standards, and much of the federal guidance and regulations from FDA and HHS-OIG.   

They attempt to use newer data from 2009, which showed “71% of physicians received gifts” but it is unclear exactly how they could have received such “gifts” when federal law (anti-kickback statute), the AMA, and industry trade groups ban them.  Likely, the research did not capture detailed data such as meals, reprints etc., and instead classified all payments as “gifts.”  They also cite to “social science” research which suggests that “gifts” of any value may influence prescribing decisions, however, such research never used patient measure outcomes.  Moreover, no research to our knowledge has ever shown negative patient outcomes from doctors who collaborate with industry. 

To the contrary, research has shown that practitioners who restrict access to sales reps are slower to adjust to negative news about a drug on the market.   

Methods 

Nevertheless, the authors used data from the Massachusetts database to calculate industry payments to physicians, make comparisons, and evaluate trends from July 2009 through December 2011 (the most current data available).  The Massachusetts database lists the name, address, and professional license number of each physician, the manufacturer, and the amount and purpose of the payment.  The purpose is categorized by the reporting company as one of the following eight types, with names and descriptors set by the state:  

  1. compensation for bona fide services (including consulting and participation in speaker’s bureaus);
  2. food;
  3. grants and educational gifts;
  4. CME programs, third-party conferences, or meetings;
  5. education and training;
  6. marketing studies (payments in conjunction with research “other than genuine research”);
  7. charitable donations (excluding free samples); or
  8. “other.”  

The researchers recognized that the federal Sunshine Act has similar descriptors for the “nature of payment” category, but that the ones currently used in Massachusetts are of limited value, since the dominant category of “compensation for bona fide services” encompasses “legitimate scientific as well as more controversial marketing relationships.” 

The researchers also matched each physician to a medical specialty using a publicly available data set managed by the state medical licensing board from February 2013 (historical data were not available) and compared the distributions received by various specialties. 

Findings  

The 30 months’ worth of data included 32,227 reported payments to 11,734 Massachusetts physicians, for a total of $76.7 million.  Of those payments, $17.1 million occurred in the last 6 months of 2009, $30.3 million in 2010, and $29.3 million in 2011.  In 2010, a total of 6530 physicians appeared in the database, as compared with 5921 in 2011. The average total payment per physician over the course of a year increased slightly, from $4,637 in 2010 to $4,944 in 2011. 

The most common form of payment was food.  During the 30 months, there were 14,251 payments for a total of $2.4 million (median, $100; interquartile range [IQR], $69–$164).  The number of food payments shrank from 5253 in 2010 (for a total of $858,031) to 4131 in 2011 ($811,292).  

Compensation for bona fide services was the payment type with the highest value. The 8432 payments in this category accounted for $67.3 million, or 88% of total expenditures (median, $2,750; IQR, $1,000–$6,560).  Such payments were made 3072 times in 2010, and the number remained stable in 2011 (2990). 

According to physicians’ specialty distributions, the researchers found that 25% of currently licensed Massachusetts physicians (8439 of 33,446) received at least one payment between July 2009 and December 2011.   

  • Primary care was among the specialties least likely to receive payments: non-specialist internists (19%),
  • Pediatricians (12%), and family practitioners (21%)
  • Urologists (61%),
  • Gastroenterologists (57%),
  • Rheumatologists (51%), and
  • Cardiologists (46%)  

The highest average per-physician amounts paid over the full 30-month period were received by orthopedic surgeons ($18,446) and physicians in various specialties within internal medicine, including endocrinology ($17,407), infectious diseases ($15,922), and pulmonology ($13,027).  

The distribution of types of financial relationships also varied among specialties. For example, compensation for bona fide services accounted for more than 90% of the payments for orthopedic surgeons, psychiatrists, and most internal medicine specialists, whereas general internists received larger shares of their payments in the form of food (8%) and grants or educational gifts (5%), and obstetricians received 11% of their total amounts as education or training.   

The analysis revealed decreases in overall payments and numbers of physicians appearing in the database between 2010 and 2011, with a slight increase in the average payment amount — when fewer physicians received payments from drug and device companies, the remaining financial relationships became a bit more lucrative. 

One explanation may be that relatively high proportions of physicians in Massachusetts are affiliated with academic medical centers and health systems that now have policies preventing physicians from accepting certain types of gifts of any value; institutions that have taken such actions include: 

  • Boston University School of Medicine–Boston Medical Center (2007),
  • the University of Massachusetts (2008),
  • Partners HealthCare (2009),
  • Tufts University School of Medicine (2010), and
  • Harvard Medical School (2010).  

While payments for meals decreased due to the original July 2009 law, the repeal in the fall of 2012 will likely cause an increase in such meals, although there is no explicit definition of what “modest” industry-sponsored “meals and refreshments” are. 

Ultimately, journal articles such as this are evidence of what the future holds once CMS begins to publish payments under the Sunshine Act.  Articles such as this emphasize the critical need for having a “healthy dialogue” about physician-industry relationships to ensure that patients and the public understand their importance. 

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