Life Science Compliance Update

June 16, 2015

Media Using Medicare Part D Data and Open Payments To Put a “Spotlight on Potential Conflicts”


In April, the Centers for Medicare and Medicaid Services (CMS) released over thirty Medicare Part D payment spreadsheets, containing millions of lines of data. Interested patients can download the document containing their doctor’s last name, and find out how often he or she prescribed particular drugs to Medicare patients.

We have speculated for some time now that the trove of Medicare data would be paired with Open Payments data, both by journalists and potentially the government. Modern Healthcare indeed recently published an article correlating the two, entitled “Drugmakers funnel payments to high-prescribing doctors.”

The article includes an interactive tool to search for physicians who prescribed $500,000 or more of a drug and received money from the drugmaker. One such entry is for a doctor who prescribed approximately $600,000 worth of a drug and received $24 from that drug’s manufacturer.

The article also includes a “spotlight on potential conflicts,” which parses out the ten highest-prescribing Medicare physicians who are listed in the general payments database in Open Payments as receiving at least $5,000 from drug companies in 2013.

The article’s takeaway is that “about 23% of the 400-plus providers who prescribed $1 million or more of one drug received money from the maker of the drug.” What is interesting—even taking into consideration the small meals or often vital consulting or education agreements deemed to be “funneling” of funds—is that 23 percent is quite a low figure if you consider that “[m]ore than 90% of physicians report having some type of business relationship with industry sources.” (Modern Healthcare).

The article targets the Open Payments data and prescribing habits of Dr. Vallerie McLaughlin, an expert in cardiovascular disease, and Director of the Pulmonary Hypertension Program at the University of Michigan. She prescribed $4.8 million of the pulmonary arterial hypertension (PAH) treatment, Tracleer, and received $40,000 in consulting, travel, and meal fees from the Tracleer’s manufacturer, Actellion. The article does provide some balance, including quotes from Dr. McLaughlin. “It's in the best interest of clinical-care delivery for biomedical companies to be advised by the knowledgeable, experienced experts,” McLaughlin states. “I have treated PAH patients and have been involved in clinical trials in PAH for 20 years.”

Unfortunately, however, the article and others like it may be a disincentive for experts such as Dr. McLaughlin, who work in a specialized and very important field, to educate their peers on their area of expertise. The article is unclear about who would be better qualified from an academic or professional standpoint to teach others about hypertension treatment. 

While there are certainly corrupt doctors who bill Medicare, the article’s implications that high prescribing doctors with payments in CMS’s Open Payments database are inherently unethical seems like the wrong approach. It not only has the potential to undermine the trust of patients in experts in a given specialty (which may lead to patients avoiding important treatments or not taking their medication), it also may silence doctors who should be educating their peers and patients on innovative new therapies. 

The article notes that CMS has "cautioned that payments to providers from drugmakers and biotechnology companies don't necessarily mean there is a conflict of interest." The agency states: “Information about financial relationships alone is not enough to decide whether they're beneficial or improper...[j]ust because there are financial ties doesn't mean that anyone is doing anything wrong. Transparency will shed light on the nature and extent of these financial relationships and will hopefully discourage the development of inappropriate relationships.”

With the second year of Open Payments data due out at the end of the month, articles that simply list the top paid doctors will continue to proliferate. However, the impact of industry-physician collaborations--which result in tangible patient benefits--should be similarly easy to communicate. 

June 11, 2015

AMSA Scorecard Provides Useful Conflicts of Interest Tool For Industry Compliance Professionals


AMSA Scorecard

Periodically since 2007, the American Medical Student Association (AMSA) has released a “Scorecard,” ranking medical schools on how strict their policies are regarding interactions between their students and faculty and the pharmaceutical and device industries. The AMSA Scorecard is decidedly anti-industry, but by consolidating all of the conflict of interest documents for schools around the country, the list is actually a very useful tool for compliance professionals who must be attentive to a wide range of university policies. 

This initial AMSA Scorecard graded medical schools simply on whether they had a policy regulating the interactions between their students and faculty and the pharmaceutical and device industries. In 2008, AMSA worked with the Pew Prescription Project, an initiative of the Pew Charitable Trusts, to develop an updated Scorecard, “which used a more rigorous and transparent methodology to assess the content of policies at medical schools throughout the country,” states AMSA. In 2014, the AMSA instituted “further changes to the scoring methodology that better assess the nuances of medical center and industry relationships.”  

Leading up to 2014, the "AMSA scorecard methodology working group reviewed the literature on conflicts of interest, including the recent recommendations published by the Pew Task Force on Medical Conflicts of Interest." As a result, AMSA changed the number of domains from 11 to 14 for medical schools, and 16 for teaching hospitals. AMSA focuses on conflict-of-interest policies directly related to industry marketing and education. While not addressed in the scorecard, "academic medical centers should also have robust policies to ensure the integrity of basic and clinical research," AMSA advises.

AMSA Scores

The domains AMSA rates are:

  1. Gifts from industry
  2. Meals from industry
  3. Industry-sponsored promotional speaking relationships
  4. Industry support of ACCME-accredited CME
  5. Attendance of industry-sponsored promotional events
  6. Industry-funded scholarships and awards
  7. Ghostwriting and honorary authorship
  8. Consulting and advising relationships
  9. Access of pharmaceutical sales representatives
  10. Access of medical device representatives
  11. Conflict of interest disclosure
  12. Existence of an adequate conflict-of-interest medical school curriculum
  13. Extension of COI policies to adjunct/courtesy faculty and affiliated hospitals/clinics
  14. Enforcement and sanctions of policies

For teaching hospitals, AMSA also scores on pharmaceutical samples and P&T committees. 

How Does AMSA score these domains?

Some of AMSA's decisions about "model" policies are worth noting (click on the image for a clearer view). 

AMSA Examples


On the topic of continuing medical education, hospitals get a “1” if they follow standards laid out by the Accreditation Council for Continuing Medical Education (ACCME). AMSA states: “Studies (of course they don't state what those studies are) have shown that industry funding of continuing medical education programs tends to bias topic choices and content in favor of the sponsors’ products and therapeutic areas.” Thus, to achieve a “model” policy ranking according to the AMSA scorecard, the policy would have to state “that industry funding is not accepted for the support of accredited CME courses except in certain clearly defined circumstances.”  Whatever AMSA defines them.

Other domains are similarly strict. For example, on the subject of pharmaceutical sales representatives, a “3” score would mean sales reps are not allowed any access to any faculty or trainees in academic medical centers or affiliated clinical entities. 

View AMSA's criteria for their various scores here


Leading institutions such as the Mayo Clinic, Cleveland Clinic, and Ohio State University’s Wexner Medical Center, just to name a few, are given B ratings by the AMSA. While the score itself is not of much help to compliance professionals, AMSA  has put together a comprehensive and helpful resource for anyone who has to monitor and keep track of a potentially long list of COI policies at various medical centers and teaching hospitals. As pharmaceutical and device manufacturers must track and report virtually all of their interactions with physicians and teaching hospitals in a public database under the Sunshine Act, the industry must remain mindful of academic policies and various issues related to their collaborations with the entities. 


April 15, 2015

U.S. Spent $374 Billion on Prescription Drugs Last Year, Up 13%; Increase Largely Due To Hep C Cures and Limited Generic Competition

Sales incentives

The U.S. healthcare system spent $373.9 billion on prescription drugs in 2014, up 13.1 percent from the year before, and the highest rate of spending growth since 2001, according to a report by IMS Institute for Healthcare Informatics.

View the full report, including IMS video commentary here.

A number of factors point to the fact that this dramatic increase is not so much a trend, but an anomaly.

"2014 was a remarkable year," Murray Aitken, executive director of the IMS Institute. "We're probably not going to see it again."

Last year saw the FDA approve a near-record 42 novel medicines, including 18 for rare diseases--those that affect fewer than 200,000 Americans. Ten of the new drugs were designated as breakthrough therapies, for conditions including multiple sclerosis, various cancers, and hepatitis C.

“The availability of new hepatitis C treatments and very few products losing patent protection” account for the surge, states Aitken. “Sovaldi was the biggest drug launch in history and accounted for about $8 billion, or 2 of the 13 percent increase.” Furthermore, in 2013, patients were holding off on hep C treatments in anticipation of Gilead Sciences’ cure due out in 2014. This also added to the drastic year over year increase. Over 161,000 patients started treatment for hepatitis C in 2014, “more than four times the previous peak and nearly ten times more than in the previous year as spending on widely adopted new treatments totaled $12.3Bn,” states the IMS report.

As for patent protections, health systems save when from patent protected branded products to generics. “Typically this saves around 15-30 billion a year,” Aitken notes, and “in 2014, that number was only 12 percent.”

Another reason for the spike can be attributed to the Affordable Care Act’s impact on health coverage. Furthermore, on the Medicare side, Aitken states that the “number of Medicare Part D prescriptions reached almost $1 billion in 2014.”

The report also points out some interesting aspects related to Medicaid, which they note was the “leading driver of retail prescription growth in the first year of expanded coverage under the Affordable Care Act."

  • Overall Medicaid prescriptions increased 16.8% in 2014, accounting for 70% of the growth in retail prescription demand
  • Medicaid prescriptions increased 25.4% in states that expanded Medicaid coverage, and 2.8% in states that did not expand Medicaid coverage
  • Nearly a quarter of exchange plan patients and 9% of Medicaid patients may have been previously uninsured

However, while the Affordable Care Act significantly increased the number of insured, the ACA was less of a factor than expected on drug spending, accounting for only about $1 billion of the spending growth, Aitken said. He does not see the Affordable Care Act causing much of an increase in spending down the road either, as 2014 marked the greatest influx of newly insured--the amount may grow in the future, but at a much slower rate. 


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