Some pretty big news came out last week while I was in San Diego for our West Coast Life Sciences Meeting Management Forum: The Centers for Medicare & Medicaid Services announced a proposed rule designed to increase public awareness of financial relationships between drug and device manufacturers and certain healthcare providers, as required by the Sunshine Act provision of healthcare reform.

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.

It’s mid-May, so it must be time for the latest American Medical Association Council on Ethical and Judicial Affairs report on financial relationships between industry and CME. I’ll leave it to others to weigh in on it at this point (here’s Tom Sullivan’s take) because, quite frankly, I’m getting a little tired of writing about it.

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).

The state of Massachusetts (where I just so happen to live) has one of the strictest policies of any state around the interactions between healthcare providers and pharmaceutical companies. Earlier this week MassBio hosted the 2010 Gubernatorial Candidates Forum, featuring candidates Charlie Baker, Tim Cahill and Governor Deval Patrick, who debated the Mass. gift ban, among other topics. Here’s the gift ban clip:

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.

Update: Dr. Kopelow is going to talk with me this afternoon. I know he likely won’t be able to give me many details, but I look forward to hearing whatever he can say, and will share it with you as soon as I can.

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.

I sense the hand of my former editor and ACCME’s director of communications, Tamar Hosansky, in the new e-newsletter from ACCME called, not surprisingly, The ACCME Report (link goes to pdf download).

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.

From the Accreditation Council for CME:

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.

The Alliance for Continuing Medical Education in conjunction with the

Accreditation Council for Continuing Medical Education is putting on a

live webinar on “ACCME‘s Revised Accreditation Model and Updated Accreditation Criteria” on November 20 at 2 p.m. ET, and again on November 27 at the same time. To register, click here , click on Professional Development and Educational Opportunities and follow the link for Upcoming Webinars. The Alliance also says:

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.

The Accreditation Council for CME has put the presentation Murray Kopelow, MD, made at the National Task Force on CME Provider/Industry Collaboration available here on its Web site. While he delivered it with panache, he didn’t say much about the new criteria for ACCME accreditation that isn’t already contained in the FAQs released earlier. Still, it makes for some interesting reading.

Steven Irizarry, JD, Vice President of Government Relations of ML Strategies, LLC, former Senior Health Counsel to the Senate Special Committee on Aging, and former counsel to the Senate Health Education Labor Pensions (HELP) Committee, predicted at the National Task Force on CME Provider/Industry Collaboration conference that 2007 will be a big year for healthcare legislation. For example, he said the reauthorization of the Prescription Drug User Fee Act is “considered must-pass legislation, as is the Best Pharmaceuticals for Children’s Act.” He called these two pieces of legislation “locomotives,” or bills that have the energy and support to move on their own, as opposed to “boxcar” bills, which need to be hooked into a locomotive to get passed. There also are two competing bills related to drug trail results disclosure, the Fair Access to Clinical Trials Act, introduced by Sen.s Grassley and Dodd; and the Enhancing Drug Safety and Innovation Act of 2006, introduced by Sen.s Kennedy and Enzi. “While these two competing bills are quite different, they both contain key things about off-label issues,” he said.

The November elections could affect future healthcare legislation, he said. “Democrats have been more critical of the FDA and pharma. They won’t provide less scrutiny of the pharmaceutical industry.” His advice? “Get involved. Educate members of Congress and their staff, because they have no idea what CME is and what you do. If you don’t h ave a voice, no one will speak for you, or if they do, you may not like what they say.”

He also talked about possible new legal actions:

The Wednesday morning keynoters at the National Task Force on CME Provider/Industry Collaboration conference focused on Washington, D.C.’s view of CME. As John Kamp, PhD, JD, Coalition for Healthcare Communications said in his introductory remarks, “It’s all about the money in Washington.” I’d venture to say a lot of it is about the money elsewhere, but I’ll stick to the subject at hand for now.

Kamp explained that most of the dollars in the federal budget go to Social Security, Medicaid/Medicare/VA benefits, and the Department of Defense. “If you’re a member of Congress, you don’t save money on defense in a time of war. You don’t mess with Social Security, and you don’t mess with Medicaid/Medicare or VA benefits.” So where do our Congressmen and women look to save money? Kamp said, “The F word in Washington isn’t a four-letter one—it’s fraud. Fraud, waste, and abuse is what Washington looks to root out.”

He then introduced Dan Donovan, senior investigative council, U.S. Senate Committee on Finance. You know, the folks who recently sent out the letters to pharma companies asking them to detail all things related to CME, led by Sen. Chuck Grassley of Iowa. Fortunately, Dan started out on a reassuring note: “We’re not trying to kill CME.” He said that agencies under his committee’s jurisdiction range from the Department of Homeland Security to Social Security, but their main focus is on Health and Human Services. They work with DHHS, DOJ, U.S. attorneys, Medicaid fraud control, state attorneys general, whistleblowers, and companies that come in to rat out their competitors to root out fraud and abuse of the healthcare system. But hearings based on results are fairly rare, he said, due to the huge time and expenses involved. More often, the Finance Committee deals with request letters, such as the ones they sent out about educational grants (for background on these letters, click here, here, and here). “If we don’t get cooperation through letters, we turn to subpoenas and conduct interviews.”

He also flashed several quotes from U.S. Attorney Michael Loucks, including, “Our focus is going to continue to be on allegations in the pharmaceutical industry.” Loucks currently has 150 civil pharmaceutical cases pending in 35 districts nationwide, Donovan said, and he’s seeing an increasing growth in off-label promotion cases. “Given Medicare Part D, the focus will remain on the pharmaceutical industry,” he said.

So, what they’ve learned to date from the letters sent to pharma is that most companies are following the PhRMA Code and OIG Guidance. “The difficult part is teasing out what happens in reality as opposed to what’s on paper,” he said. The 23 pharma companies who received the letters spent $1.47 billion in 2004 on educational grants, a 20 percent increase over 2003, he said. “Substantial financing may compromise independence,” he warned. “When you review payments down to the $100 level, you can see reps in certain regions giving out $100 educational grants.”

He wrapped up by saying, “We would like to hear from you and better understand what you h ave to say about these issues.”