Friday, April 25, 2014

More Clouds Than Sunshine in Harrisburg



If you follow @CME_Scout on Twitter, you know I like to report on the latest news and trends that affect how we do our jobs in the continuing medical education (CME) space.

So last week I chose to pay the $129 registration fee to attend the annual meeting of accredited CME providers hosted by the Pennsylvania Medical Society (PAMED) in Harrisburg. Here’s a quick recap, written for Linda, a CME colleague in Media who didn't have time to go.

The 8:15 a.m. overview was short on specifics of areas of non-compliance and areas for improvement, as promised on the original agenda. Instead, Barbara Dugan, associate director for CME at the Pennsylvania Medical Society (PAMED), followed a revised agenda and spent a great deal of time on a participatory exercise aimed at familiarizing attendees with ACCME's simplification initiative. (See photo 1 below.) We received a good, color-coded handout in our packets related to this topic. To me, ACCME simplification is long overdue. As a board-certified editor, I've often found the wording of ACCME criteria to be obscure and redundant.


 
Photo 1: Participatory exercise related to simplified ACCME criteria


Photo 2: Example of a simplified ACCME criterion




Photo 3: A key terminology change



The 9:45 a.m. presentation on the Sunshine Act was given by Sterling North, director of continuing professional development at Geisinger Health System, and Justine Rubino, certification supervisor at University of Pittsburgh Medical Center (UPMC). They used slides developed by Barbara Barnes, MD, MS, associate vice chancellor at UPMC and vice president for sponsored programs, research support, and CME at UPMC.

North's presentation raised more questions than it answered. North, by his own admission, is not an expert on this topic and could not answer many questions from the floor, at least not in a convincing manner. "I don't want to be an expert on the Sunshine Act, quite frankly," North told us. "Here's another thing that we're being faced with . . . I'm not an expert, I'm dealing with this just like you guys are."

For example, Barnes' slide deck did not emphasize the fact that honoraria paid to faculty of ACCME-accredited educational activities are exempt from reporting under the act. This seems like it would have been important information to include, given the fact that the audience for the day-long meeting consisted of accredited CME providers from around the state. This point did come up during Q&A however, because I asked about it. Leslie Howell, director of CME, training, and physician leadership programs for PAMED, confirmed that faculty honoraria for ACCME-accredited programs are exempt from reporting, but added there is a complicating wrinkle: what about programs accredited indirectly, through state medical societies? According to Howell, the majority of accredited CME providers in the United States fall into this category. Howell recommended taking a hard line on this issue, insisting that providers accredited directly by the ACCME and those accredited indirectly through their state medical societies all report data annually through the same PARS portal and are therefore all a part of the same system, so the exemption holds.

Barnes' slide deck was moderately helpful in other areas. Here are 4 highlights of what she considers the implications for CME:

1. Payments to teaching hospitals for commercial support and exhibits will be reportable.
2. It is likely some companies will also report for non-teaching hospitals (there is nothing to prevent them from doing this).
3. Although it is not required, companies may try to report "directed" payments to physicians in accredited CME activities for honoraria and meals.
4. Payments to hospitals and directed payments to physicians for meals and speaking will be reportable for non-CME activities.

Questions from the floor reflected physicians' concern regarding what conclusions may be drawn from these data once released to the public. Another person wondered how the ACCME's definition of "commercial interest" aligns with the federal government's definition under the new open payments system. There was also considerable discussion of whether medical trainees (residents) are covered, and whether physicians who are no longer seeing patients are covered.

Ms. Rubino offered her perspective that drug companies do not seem to understand the law. There is a common theme of wanting to overreport, and they seem to collect a great deal of information they don't need. There is also a great deal of variation among companies with respect to the information they are gathering. Her job within a centralized office at UPMC allows her to survey a wide range of agreements with many commercial supporters and she sees "no consistency" on key points such as meals and types of participants required to report. "It's not standard by any means," Rubino said.

One of the most helpful parts of the presentation was provided by Ms. Rubino, who distributed a handout containing examples of language taken from actual letters of agreement (LOAs) that UPMC has executed with various commercial supporters and exhibitors.  She gave us 6 examples from LOAs and 2 examples from exhibits. The most egregious example of overreporting given was example 6, in which the commercial interest informed UPMC that the following data would be collected for each "transfer of any value" to a U.S. physician:

1 address
2 professional type
3 specialty
4 NPI#
5 state license number
6 state of license
7 non-US license
8 date of payment
9 total amount of payment
10 currency of payment
11 form of payment
12 nature of payment
13 expense type
14 product
15 therapeutic area
16 city, state, and country of travel

Pretty amazing, eh? Seems like Big Pharma may be trying to make a virtue out of necessity here, gathering as much physician data as possible since this is required by the Sunshine Act anyway, with the hopes of being able to use the data for other purposes, perhaps sales and marketing and direct mail, at a later date. The vibe in the room full of many hospital-based physicians was one of disbelief, mistrust, anger, and frustration.

Which reminds me: the meeting was aimed at directors, coordinators, and chairs of CME from both accredited and non-accredited community hospitals and medical specialty societies in Pennsylvania. There appeared to be roughly 60 people in attendance, including faculty and presenters. (See photo 5)

Photo 5: Meeting room setup. Leslie Howell sits at far left.


The "Leading from the Middle" presentation by Donald Hess, MD, MPH, was interesting, engaging, offbeat, and a little too long. Linda didn't ask about it so I won't elaborate. Same for the fish bowl exercise in problem-based learning.

The final panel discussion consisted mostly of elderly physicians quizzing a bright, young, and obviously competent hospital CME director on how she produces short e-learning modules on a variety of topics using Adobe Captivate software and how she then attempts to measure changes in physician competence and patient outcomes afterwards.

The wrap-up and final Q&A got bogged down in the nitty-gritty details of CME committee work and, in my view, missed any mention of the elephant in the room: What is being done to save vibrant and effective CME at local community hospitals in Pennsylvania, which are so obviously on the brink of extinction?