Life Science Compliance Update

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. 


June 02, 2015

CMS Releases 2013 Medicare Payment Data for Hospitals and Physicians


Yesterday, the Centers for Medicare and Medicaid Services (CMS) announced the release of utilization and payment data for both Medicare hospital services (inpatient and outpatient) and for physicians and suppliers. This is the third year the hospital data was released and the second year that the physician and supplier data was released. Indeed, the big troves of healthcare data keep coming. On April 30, CMS published information on 2013 Medicare Part D payments. At the end of this month, on June 30, CMS is scheduled to release the first full year of pharmaceutical and medical device transfers of value made to physicians and teaching hospitals as part of the Physician Payments Sunshine Act. 

“Data transparency facilitates a vibrant health data ecosystem, promotes innovation, and leads to better informed and more engaged health care consumers,” said Niall Brennan, CMS chief data officer and director of the Office of Enterprise and Data Analytics in the accompanying press release. “CMS will continue to release the hospital and physician data on an annual basis so we can enable smarter decision making about care that is delivered in the health care system.” 

Physician and Supplier Payment Data

The physician and supplier payment data (available here) consists of information on services and procedures provided to patients for over 950,000 providers who received $90 billion in Medicare payments. CMS notes that the data allows for “comparisons by physician, specialty, location, types of medical services and procedures delivered, Medicare payment, and submitted charges.” 

CMS spotlighted physician specialty. As you can see from the following chart, cardiologists, for example, had higher average costs per provider for medical services in 2013 than hematology/oncologists and less than ophthalmologists. CMS, however, added an important addition to this year's dataset: 

Medicare Specialty list

Indeed, responding to criticism last year--in which many of the top physicians in the database had the cost of expensive drugs attributed to them as essentially profits by certain news outlets--CMS this year separately outlined payments to physicians for services and for the cost of drugs. This distinction matters. The doctor who received the most from Medicare, for instance, was Anne Greist, who co-founded the Indiana Hemophilia & Thrombosis Center in 1998. "Greist received more than $28 million, but $27.9 million of it was simply passed through her to pharmaceutical companies for expensive drugs," notes USA Today.

The American Medical Association said yesterday that it is "committed to transparency that improves patient care." However, the AMA said the 2013 release, despite improvements in clarity of drug pricing, "does not provide enough context to prevent the types of inaccuracies, misinterpretations and false assertions that occurred the last time the administration released Medicare Part B claims data." We outlined additional concerns with that database here

The top one percent of billers in 2013 received 17.5 percent of all payments in 2013, notes Nasdaq's coverage. "That same cluster of doctors and other individual providers received 16.6% of the program's payments in 2012, figures show."

Bloomberg wrote that Medicare paid at least 3,900 individual health-care providers $1 million or more in 2013. "On average, doctors were reimbursed about $74,000, though five received more than $10 million," they noted. 

A number of news articles have picked out the physicians with the highest Medicare payments; see USA Today

Hospital Utilization and Payment Data- Inpatient and Outpatient

As far as the hospital data (inpatient data available here; outpatient available here), CMS notes that “payment data consists of information for 2013 about the average amount a hospital bills for services that may be provided in an inpatient stay or outpatient visit.” The data includes information for services provided in connection with the 100 most frequently billed Medicare inpatient stays and for 30 selected outpatient procedures. The data covers more than 3,000 hospitals across the country.

According to CMS's hospital billing data, joint replacements are the most commonly performed procedure, costing $6.6 billion in 2013. Among the other most common conditions are life-threatening infections, known as septicemia, costing $5.6 billion; heart failure and shock costing about $3.5 billion; and types of pneumonia, costing about $3.8 billion. View CMS's fact sheet about this data set. Modern Healthcare has also compiled a useful chart outlining the procedures generating the most payments here

CMS has released hospital charge data for three years now, first in 2011. This allows for a comparison of changes on a yearly basis, for example, the changes in the average charges for a given procedure.  For instance, major joint replacement grew from $50,116 to $52,249 or a rate of 4.3% 2011 to 2012, and grew from $52,249 to $54,239, a rate of 3.8%, from 2012 to 2013.  The data also allows for analyses of disparities and variances in what different hospitals charge for the same procedure. 



Preview | Powered by FeedBlitz


July 2015
Sun Mon Tue Wed Thu Fri Sat
1 2 3 4
5 6 7 8 9 10 11
12 13 14 15 16 17 18
19 20 21 22 23 24 25
26 27 28 29 30 31