If you aren’t already familiar with the issues involved in this aspect of the proposed Sunshine Act, I would urge you do get up to speed (resources: here and here). And do it today, because the deadline to respond to the HHS is tomorrow, February 17. This could really affect your business, so please check into it and let HHS know what you think. (Submit comments here.)

Update: I forgot to mention that the Alliance for Continuing Education in the Health Professions also has weighed in on this issue (download a PDF of its response here). Not surprisingly, the Alliance has many of the same objections to this proposal as the CME Coalition. To quote from the Alliance letter to CMS:

“These potential consequences include: (1) reluctance on the part of physicians to serve as faculty or even to participate in industry-supported CME because the reporting requirements could result in the incorrect perception that these individuals are receiving some direct benefit from industry support; (2) burdensome reporting requirements for CME providers who already operate with limited resources and tight margins and would be required to determine the value of benefits that accrue to covered recipients attending CME programs; and (3) a reluctance on the part of commercial supporters to fund CME activities due to the difficulty in calculating, tracking and reporting the indirect benefit of their support on faculty and participants.”

From a pharmaceutical/device meeting manager’s perspective (which I got last week in spades, being surrounded by these good folks), no one seemed to be anticipating it making much of a difference in their lives. The biggest issue for them was CMS’s delaying the collection of data on physician spend from Jan. 1, 2012, until after final regulations are issued.

I heard over and over again that if they weren’t already tracking physician and other healthcare worker spend as a requirement of a corporate integrity agreement, they have been working since healthcare reform passed to get a system up and running. In fact, a survey of the forum’s participants found that 88 percent had a system already to track their spend on physicians and other healthcare professionals, and 76 percent were either already testing their system or were confident that their system was ready to roll with the new year.

But that’s about as far as I’ve had time to get with CMS’ announcement. I’m not sure whether it’s a blessing (so thankful someone’s keeping on top of all this!) or a curse (ain’t no way I can keep up with the flow of information the dude puts out, much less beat him to the punch, so I have to live with being continually scooped!), but Tom Sullivan has been churning and burning all this up on his Policy and Medicine blog. Keep in mind that he comes at it from a pro-collaboration perspective, but he provides a great overview of possible affects this announcement could have on the CME community. Some posts to check out:

Physician Payment Sunshine Act: CMS Proposed Rule - Impact on Continuing Medical Education, Medical Societies and Patient Organizations

Physician Payment Sunshine Act: CMS Proposed Regulations — Public Posting, Data Submission and Correction

Physician Payment Sunshine Act: CMS Proposed Regulations Delayed Reporting for Clinical Trials, Penalties and Preemption

Physician Payment Sunshine Act: CMS Proposed Regulations – The Cost for Sunshine

Physician Payment Sunshine Act: CMS Proposed Rule Overview

Physician Payment Sunshine Act: CMS Releases Proposed Regulations

Update:Daniel Carlat, MD, has a different take on how the new rules could affect CME (namely, he’s ecstatic that the language could include faculty honoraria in reportable income) on his Carlat Psychiatry blog.

Want some background?

CEJA Report Sent Back Again

CEJA Releases Fourth Funding Report

AMA Again Rejects CEJA Report

CEJA Report Recommedations: Rejected Again

CEJA Report Misses the Mark

CEJA Report: Close, but No Cigar

Etc., etc., etc. Hopefully this time around it won’t be another remake of Groundhog Day.

On a semi-related note, I read an article in The Boston Globe over the weekend that I found both interesting and kind of troubling, seeing as the CME world relies so heavily on disclosure and transparency to manage conflicts of interests. Called Deeply Conflicted, it talks about some recent research that finds that “Coming clean about conflicts of interest … can promote less ethical behavior by advisers. And though most of us assume we’d cast a skeptical eye on advice from a doctor, stockbroker, or politician with a personal stake in our decision, disclosure about conflicts may actually lead us to make worse choices.” As is almost always the case with we humans, it’s more complicated than we’d like to think, though how disclosure works for CME does seem to be the best-case scenario for it being effective (handled by a third party, with discloser and disclosed-to being peers).

It sounds like all three — including Governor Patrick, who backed the ban initially — think it needs to be either modified or outright removed. Then again, candidates say all kinds of things during an election cycle, and it can vary depending on the audience. We’ll have to wait and see what happens with this one, but if it did get weakened or eliminated, it would be the first step backward in pharma-HCP-interaction regulation I’ve heard of in recent years.

OK, I admit I was a little miffed to learn we had been scooped on our own turf by The New York Times when that venerable paper reported that the Accreditation Council for CME was going to be publicly outing accredited providers who were found to be in violation of its accreditation criteria. But really, shame on me for not jumping on the story first, I thought.

But now I am doubly miffed. After waiting for weeks for an interview, then at least some e-mailed comments, yesterday ACCME Chief Executive Murray Kopelow, MD, declined to discuss with me at all what he had already told the Times, much less answer any follow-up questions I sent. They did issue a statement last week that, to me anyway, didn’t say a whole lot (here’s the best I could do to provide an update, based on the information in the statement).

I understand that his hands are tied due to the nature of the organization, which answers to many masters, but it makes me think that the ACCME’s new approach to transparency is going to be one of those one-step-forward, two-steps-back type of things.

On one hand, ACCME wants to open up its processes and let people comment, as it did last spring when it issued a request-for-comment on four proposals it was considering. On the other hand, in this case anyway, it sounds as if ACCME doesn’t want to publicly specify—except in very general terms—what the board is even deliberating until the deliberation is done. Except to The New York Times, of course. But now ACCME’s lack of willingness to talk about what it already said makes me think it is backing off from those statements as well.

Any time the ACCME sneezes, the entire CME community gets pneumonia, and questions were flying around the Alliance for CME listservs after the Times article came out. If an accredited provider is found to be noncompliant, would it be required to notify learners and provide corrective materials? Who would have to pay for it? How would it work? A lot of people seemed to jump the gun and, as this community is wont to do, start sweating the details before any decision is finalized. It would be nice to know if in fact this is something people need to start thinking about or not. It also could be a good argument against increased transparency, if all that transparency is going to do is cause unnecessary stress if the board decides not to go this route.

But it would be nice to at least be given the sense that the community’s input is important to the board’s decision-making process. While I’m still miffed, I’m putting my faith in the ACCME and hoping that one of the next steps it will make as soon as the board issues its decisions on whatever specific policies it is deliberating will be another call for comments—before it hands down any final decisions.

Among the topics in the first issue:

The ACCME Program & Activity Reporting System

ACCME Submits Additional Testimony to the Senate Special Committee on Aging (Someone remind me to add a link to this when our cover story, which so happens to be on the hearing this summer, goes online)

The 2009 Robert Raszkowski, MD, PhD, ACCME Hero Award winners–congratulations to George Mejicano, MD, MS; Ronald Murray, EdD; J. Brian O’Toole, PhD; and David Swee, MD

And a whole lot more. This is a great idea–I’ll look forward to seeing it in my in-box every third week of the month.

The ACCME has updated its website with two News Releases. One release announces a new collaborative relationship with the National Association of Medical Staff Services (NAMSS) to support NAMSS members and ACCME accredited providers especially as it relates to the integration and fulfillment of ACCME‘s Updated Accreditation Criteria. For more information on this collaborative effort, please visit www.accme.org and view the news release “ACCME to Collaborate with NAMSS” or click here.



The other release informs the CME community that the ACCME has been asked to provide the U.S. Senate Finance Committee with information regarding continuing medical education. For more information on the Senate Finance Committee‘s request, please visit www.accme.org and view the news release “ACCME to Provide U.S. Senate Finance Committee with Information Regarding CME” or click here.

Each ACCME accredited provider is entitled to ONE complimentary registration on November 20 or 27, paid by the ACCME. To receive this discount, please click Non-Member and then enter the ACCME Provider ID in the Registration Discount Code box on the Check Out page. Additional registrations may be purchased.

The speaker, of course, will be Murray Kopelow, MD, Chief Executive of the ACCME. Bruce Bellande, PhD, of the Alliance for CME will

moderate.