Life Science Compliance Update

August 12, 2015

The Unintended Consequences of Public Reporting

Complications
     ProPublica Surgeon Scorecard Ad

A major concern surrounding ProPublica’s recently released “Surgeon Scorecard” is that rating physicians in a public database solely on complication rates may discourage surgeons from operating on high-risk patients. The fear, it turns out, is a legitimate one. A study published this month in the Journal of the American College of Cardiology examined the effect that public reporting of procedural outcomes has on heart attack patients. The authors looked at two states, Massachusetts and New York, which mandate the public reporting of hospital outcomes of percutaneous coronary intervention (PCI) for myocardial infarction (MI). PCI, commonly known as an angioplasty, is a widely used procedure to open blood vessels that lead to the heart during or soon after a heart attack.

The investigators used the Nationwide Inpatient Sample to examine whether patients who were hospitalized for MI were more or less likely to go through PCI in states with public reporting compared to regional comparator states. Second, they looked at the impact of public reporting on patients with MI overall. The study found that in Massachusetts and New York, patients presented with MI were much less likely to undergo PCI than in non-reporting states. Further, this was disproportionately concentrated in patients with the highest risk: older patients and those with ST-segment MI (a severe heart attack) or cardiac arrest or cardiogenic shock. Cardiogenic shock, for example, is a severe condition where the heart suddenly cannot pump enough blood to meet the body’s needs—if treated immediately, about half of patients survive. 

More importantly, the study noted that patient health suffered in public reporting states. The study found that  patients with MI in reporting states had higher risk-adjusted in-hospital mortality rates than those in non reporting states. The study found that this was observed primarily in patients who did not receive PCI in the public reporting states. 

The results, while observational, strongly suggest that interventional cardiologists are shying away from difficult cases where a patient has a high risk of complication, including death, despite treatment. Under the PCI public reporting metric, providers aren't dinged if they choose to operate only on the patients with the greatest likelihood of survival. 

C. Michael Gibson, an interventional cardiologist, Harvard Professor, and founder of WikiDocs, posed this question that clearly frames the issue at hand: 

Heart Attack tweet


Clearly, if a patient wants a better chance at survival, PCI treatment is the way to go. However, the public reporting methodology and other transparency initiatives focus exclusively on complications. ProPublica's recently released Surgeon Scorecard, for example, defines complications as "readmissions related to the surgery" and deaths during the initial surgical stay. However, it does not show the negative effects of NOT doing a surgery.

Much of the pushback on ProPublica's search tool is that it positions itself as a comprehensive grading system and that patients will make actual healthcare decisions based on whether their surgeon falls in a green, yellow, or red category (i.e. "Making the Cut: Why Choosing the Right Surgeon Matters Even More Than You Know.")

This is an example of how a surgeon is ranked--this one performed over one hundred prostate removals. 

Surgeon's rate

ProPublica's Surgeon Scorecard has experienced pushback from the surgery community. An article on Kevin MD, which is worth a read, takes aim at how ProPublica defines “complication rate.” Here is a sample from the article:

So the 84-year-old patient three weeks out from hip replacement who is admitted through the ER with “increasing confusion” due to insomnia and overuse of narcotic pain meds is a red mark against the orthopedic surgeon.  Urinary tract infection two weeks after spinal surgery in a patient with known BPH.  The anxious 27-year-old lady readmitted at midnight two days after a LC because of refractory nausea.  The 49-year-old male who develops chest pains ten days after lumbar fusion surgery.  All these are reportable offenses that don’t necessarily have anything to do with the quality of said procedure performed.

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Public reporting and efforts at increasing the transparency of surgical procedures have a laudable goal in mind of guiding patients to the best care. While it is easier to point out the flaws in a reporting system than come up with a perfect methodology, the public reporting of PCI study shows that true patient harm can result if the reporting metrics continue unchanged.  Further, a fundamental criticism of the Surgeon Scorecard is how it is being framed by ProPublica. Their ad campaign seemed like more "click-bait scare tactic" rather than a true patient tool. The scorecard could actually cause people who need surgery to avoid it altogether, and it points to surgeons as the enemy (watch this "teaser" video). 

The authors of the public reporting outcomes study conclude that moving forward, “public reporting of outcomes should balance the benefits of transparency and accountability against the potential influence of physician risk aversion.” Dr. Robert Yeh, one of the authors, notes that perhaps one improvement would be to exclude certain high-risk individuals, such as cardiac arrest patients, from public reporting (see his interview here). While it is very difficult, and potentially impossible, to find a metric that accounts for all the internal and external variables that take place when a patient goes in for a surgical procedure, the study hopefully guides reporting policies away from particularly problematic unintended consequences. 

 

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

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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. 

 

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