Tips, News & Topics

Editor's Note: The following item was sent recently to all Colorado Accredited Sponsors by Anne Wilson, Manager of Accreditation, Colorado Medical Society. Note the valuable tip on how to add the newly required trade mark symbol to your accreditation statements.

This is also a good time to recall that the CME credit system is owned by the American Medical Association. Managers of CME programs are required to adhere to both the ACCME Standards and Elements and, in the matter of credits, the requirements of the AMA.

Hello CME providers.

The AMA has slightly reworded the second paragraph of the accreditation statement and included the new trade mark symbol ™.

So the accreditation/ designation statement should read:

(Name of the accredited sponsor) is accredited by the Colorado Medical Society to provide continuing medical education to physicians.

(Name of the accredited sponsor) designates this educational activity for a maximum of (number of credits) AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

As always the statement must be two separate paragraphs with no additions or deletions. It is not to be combined with any other statements. The accreditation/designation statement must appear on all flyers, brochures and electronic notices.

Just a tip......that tiny trademark symbol ™ can be found in Word by clicking on INSERT on your toolbar, then scroll down and click on SYMBOL. In the available symbols I have two ™ options (two different type styles). Click on the spot in your word document where you want the symbol inserted, click on the symbol and click on insert. Presto!

This change goes into effective immediately.

Thanks for your questions! -- Anne Wilson

QUESTIONS AND ANSWERS CONCERNING NEWLY ADOPTED STANDARDS FOR COMMERCIAL SUPPORT

1. Print out the Revised Standards
September 28 has come and gone, and the seven ACCME parents have adopted the revised Standards for Commercial Support unanimously. You can instantly obtain your very own copy of the new Standards by going to www.accme.org. On the home page find Popular Downloads and go to Standards for Commercial Support (third from the bottom of the list). Hit your print button.

2. Review a Lengthy List of Frequently Asked Questions Compiled Since Adoption of the Revised Standards became Official.
On the ACCME Home Page, www.accme.org, look for the tabs at the top of the page and click on Ask ACCME. At the bottom of the list that comes up, you will find six headings that begin, Standards for Commercial Support. The first one is about Independence, the second one is about Resolution of Personal Conflicts of Interest, and so on. All six are worth printing out. If you review and understand all of these Q and A s you should be in pretty good shape to comply with the Revised Standards.

DEALING WITH CHANGE: KEEP IT SIMPLE!

The references above give you the means to find out how the new commercial support standards are different from the old ones. There are many changes, but not all of them apply to all providers. It will be up to each provider to decide which changes will demand attention.

Don’t waste time thinking or writing about elements of the new standards that don’t apply to your program. And when you have selected which of the changes you need to work on, think simplicity, think efficiency. Meet the new requirements in the easiest possible way.

Take conflict of interest. It’s there to stop promotion of commercial interests in the process of educating physicians concerning commercial products. There are two tough new requirements: First, all people involved in planning and delivering a CME activity (not just speakers) must disclose their commercial connections. Second, if there are conflicts of interest, they must be resolved before the activity occurs.

Time consuming in an already overloaded work schedule? Discouraging? Not so bad if you keep it simple and efficient.

Collect disclosures once a year from your CME committee and any local regular planners or presenters. Continue as in the past to get disclosures from outside speakers. That should handle the expanded disclosure requirement.

The new standard abandons the assumption that physicians can deal with conflicts of interest if they are informed about them ahead of time. Now there must be mechanisms in place to “resolve” them. A pretty extreme resolution of conflicts of interest would be to exclude all folks with such conflicts from planning or delivering CME. Less extreme would be to establish a peer review group to deal with conflicts. Two or three physicians would agree to review the outlines of conflicted speakers and certify that their presentations appear to be scientifically objective and evidence based. Identified problems would be dealt with before the presentation. During the presentation, all participants could be asked to document their opinions concerning the objectivity of the presentation.

And, as in the past conflicts would be announced in advance along with how they were resolved.

These changes could easily be added to the provider’s written policies and procedures.

Visit the ACCME web site, www.accme.org, from time to time to read additional implementation suggestions straight from the horse’s mouth.

Kevin Bunnell, Ed.D., January, 2005

REPRESENTATIVE PETE STARK AND MEDICARE/MEDICAID

by Kevin P. Bunnell, Ed.D., FACME

Recently, several Colorado Continuing Medical Education (CME) programs have begun to feel the impact of a complex federal statute designed to fine tune the laws governing Medicare and Medicaid.

Sponsored by Representative Pete Stark, and known as the Stark Statute, the revisions focus on many aspects of Medicare/Medicaid.

The part of the Stark Statute that aims at fraud and abuse is of concern to CME folks. This part makes the assumption that CME is universally a benefit provided for physicians to encourage them to admit patients to the hospital or other institution sponsoring CME. The new law has been interpreted to impute a value of $25 to each CME event a physician attends with a limit of $300 per physician per year before the law assumes a conflict of interest potentially leading to charges of fraud and abuse.

I believe this is one of the most serious threats to CME that has occurred within memory. If CME is to be equated with fraud and abuse, it is difficult to see how our profession can survive.

Bruce Bellande, Executive Director of the Alliance for CME reports that the Alliance is in the process of finalizing plans for a campaign to address misperceptions about the mission of CME and to enhance the understanding that CME is educational and not intended to promote the products of any institution. Rather, its main value and purpose is to improve the practice of medicine, raise the quality of patient care, and upgrade the level of public health.

A proactive role for the Alliance in this matter is important to all of us in CME. But we must not be satisfied to let the matter rest there. We must all work to establish the principle that CME offered to change physicians’ clinical practice and thus to improve the public’s health, is not a violation of the Stark Statute.

Here are some thoughts about how to do this.

CME should be concerned primarily with the gaps between what is and what should be in health care practice. This approach to CME makes heavy demands on CME staffs and committees. But the results will be worth the effort. Indeed, the future of CME may depend on it.

Here are some examples of “Gap Oriented” problems that CME can address.

--Myocardial infarction patients admitted to Hospital X wait an average of eight hours before anticoagulation therapy is started.

--Only twenty percent of patients at Hospital Y report on their patient satisfaction questionnaires that their pain was satisfactorily controlled.

--Only twenty percent of diabetic patients at Hospital Z have their blood pressures controlled to the level of 120 systolic.

What does it take to deal with problems such as these?

First: Gap problems must be made credible through the use of hard data that clearly defines the problem, and provides a baseline against which progress through education can be measured.

Second: Gap problems can rarely be solved by a single educational activity. If the lag time between the admission of MI patients and the administration of anticoagulation therapy is to be significantly reduced, all of the several groups of health care professionals and managers who encounter such patients must be involved in planning and delivering corrective measures. Such an effort takes on the character of a CAMPAIGN with many kinds of initiatives that reaches all who may have an effect on the amount of time that elapses between admission and therapy.

Educational campaigns require strong liaisons among all involved groups to identify contributing problems and to plan and deliver corrective measures.

Third: The Gap approach to CME requires a continuous flow of clinical data. Not only must there be baseline data to define the problem. There must also be monitoring of progress in solving the problem, and ultimately data that clearly defines for all to see that the gap has been closed.

Ten years ago the state of clinical data systems made the reporting of progress in meeting clinical goals difficult. Today clinical data systems that function virtually in real time make such reporting much more possible. One of the effects of the Stark Statute may be to pressure hospitals that have been slow to upgrade their clinical data systems to do so immediately so they can demonstrate clearly the impact of their efforts to improve quality of care.

Fourth: CME professionals need to develop leadership skills in reporting the progress that results from their efforts. One reason that the Clark Statute has been so threatening to CME is that too many senior administrators see CME as a benefit provided by the hospital to “keep the docs happy”. They see it as a cost center that never produces enough income.

CME leaders who report quarterly, the hard data of clinical progress to their CME committees, and through them to their administrators and boards will surely be immune from fraud and abuse concerns. Who wouldn’t welcome the news that the average time between admission and start of anti coagulation therapy has gone from eight hours to forty five minutes---or that satisfactory pain control, as reported by patients, has gone from twenty percent to eighty percent—or that diabetic blood pressures controlled to a level of 120 systolic have gone from twenty percent to ninety two percent?

MM (Medical Meetings) Magazine Emerges as a Valuable Source of Information Concerning Current CME Issues

MM Magazine serves commercial interests that provide continuing medical education. As one would expect, it publishes ads for resorts that aspire to host medical meetings and covers issues related to conference management.

Recently, Editor, Tamar Hosansky and Executive Editor, Susan Pelletier have enriched the magazine's content to include thoughtful, penetrating, reporting concerning tough issues that face providers of CME, especially those that depend on commercial support. The June 2004 issue is an especially good example.

The issue opens with praise for the newly released ACCME Standards for Commercial Support.

The editors say "Cheers for New Standards" and report that key CME players such a Bruce Bellande, Executive Director of the Alliance for CME, are saying that the revised Standards have deleted most of the objectionable features of the first draft and are "...very specific on involvement in educational grants of a commercial supporter, and the separation of any promotion from education."

If the big CME names quoted in the MM article are right, final approval of the new Commercial Support Standards in October, by the seven sponsors of ACCME, should be a shoo in. See below for a comparison between the new and the old Standards, prepared by the Alliance staff.

Here's your chance to get a head start on compliance. The lead article in the June issue of MM is titled "Don't Relax Yet" Written by Hosansky and Pelletier, it pokes and probes the new Standards for soft spots that may need to be clarified by ACCME as they are implemented. My copy of the pages of this article are covered with hand written notes, signifying the thoroughness of the authors analysis of the Standards.

Those who want to know how rocky a road the Standards will travel as they are implemented, should beg. borrow or steal a copy of this issue of MM. Or better still, get on the mailing list.

CME professionals will be welcomed as subscribers. Email Cathy Kitlasz, Audience Marketing Manager, ckitlasz@primediabusiness.com.

MM Magazine is not just concerned with commercial support of CME. Other articles in the June issue of interest to CME folks are, "Intellectual Property Law and CME" by Steve Passin (speaker at CACME Annual Meeting this August) and Richard Krakowski. "Empower Your Team" (how to get the most out of your CME staff) by James Leist, Robert Kristofco and Joe Green. Also of interest is an article by Derek Dietze and Harold Magazine titled, Outcomes Measurement: Beyond the Basics".(How to write effective items for CME evaluation forms.)

Regularly Scheduled Conferences (RSCs) Come under the Accreditation Spotlight

Many hospital based CME programs consist mainly of Regularly Scheduled Conferences ( Grand Rounds, Tumor Conferences, etc). About a year ago ACCME issued a news release stating the procedures that should be followed by accredited sponsors as they administer such educational activities. Sponsors renewing their accreditation in the months ahead may expect to report how they assure that Regularly Scheduled Conferences are conducted according to the Essentials and Elements of accreditation.

The June 2004 issue of the Alliance Almanac (received by all members of the Alliance) contains a lead article analyzing the ACCME ( and hence, the Colorado Medical Society) expectations concerning documentation of RSCs.

Colorado accredited sponsors will probably encounter requirements for documentation of RSCs in the form of one or more questions under the Administration section of the reaccreditation application.

For more information, see the Almanac article, "Regularly Scheduled Conferences: Turning a Headache into an Opportunity by Beth Mullikin, University of Wisconsin. (Volume 26, No. 6, June 2004.) You can also go to www. accme.org>What's New>entry under 5/7/2003 for the text of the ACCME news release.

Alliance for CME Offers Comparison Between Old and New Standards for Commercial Support

On April 1, the Accreditation Council for CME (ACCME), adopted major changes in the Standards for Commercial Support. These are recommendations to the seven organizations that make up the Council (AMA, AAMC, AHA, etc.) They have until October 1, 2004 to vote the changes up or down.

The chances are that CME programs, including those accredited by the Colorado Medical Society, will be living by the revised standards by the first of next year.

The additions and deletions are substantial, and will require careful study by accredited sponsors if they are to be in compliance with the changes.

To help with the study process, the Alliance for CME has prepared a comparison between the old (1992) Standards for Commercial Support and the new Standards (2004). To view a printable copy of the comparison, go to the following Alliance for CME web address: http://www.acme-assn.org/files/SCS.htm.

Alliance Executive Director Sheds Light on the OIG Guidelines

So what’s this OIG business?
Those who depend on commercial support for their CME programs are seeing the effects of a determined effort to build a firewall between medical education and promotion of drug products. Many millions of dollars in fines have been imposed by the OIG on drug manufacturers who promote their products under the guise of medical education.

OIG stands for the Office of the Inspector General of the Department of Health and Human Services. It is this office that has, again brought to center stage the way CME programs obtain funding from commercial sources.

The Accreditation Council for CME (ACCME) has responded by proposing a new set of commercial support standards for accredited sponsors. These revised Standards, which are likely to be adopted by October 1, 2004, will also become the new Standards for Commercial Support of the Colorado Medical Society system of accreditation. Since these new Standards take into account the concerns of the Office of Inspector General, Colorado accredited sponsors of CME, who adhere to the new Standards should not have problems with sanctions by the OIG.

On the other hand, as the reprinted article below makes clear, large changes are occurring in how accredited sponsors obtain educational grants from commercial supporters.

Executive Director Bruce Bellande, PhD, of the Alliance for CME has been following closely this complex set of developments. In the May 2004 issue of the Alliance Almanac, Bruce has shared his conclusions concerning the forces that are beginning to impact on CME programs.
His article is reprinted here with his permission.

Since the release of the Office of Inspector General of the Health and Human Services Department (IOG-HHS) Compliance Program Guidelines for Drug Manufacturers, Alliance members have been asking about the impact of this guidance on the CME process.

Here are some answers to common questions:

• Electronic submission of proposals for educational grants will become the norm rather than letters requesting funding.
• Grantors will require that their letters of agreement (LOAs) must be executed rather than that of the CME provider because of internal legal requirements imposed by the company granting the funds. The Standards for Commercial Support (SCS) require a signed LOA between the accredited provider and the grantor of funding, but do not specify a format. CME providers must ensure that the LOA is in full compliance with the SCS before executing the LOA.
• Legal affairs departments within the granting companies have been given greater control and oversight of the awarding of grants, contents of the letter of agreement, and relationships between company employees and CME providers.
• In general, granting companies have increased the amount of funding they intend to grant in 2004.
• Granting companies will scrutinize proposals more carefully for compliance with CME requirements, including needs data relevant to the topic and effective educational design. They will be looking for evidence that documents delivery to the target audience, evidence-based content, and achievement of desired outcomes.
• The independence of CME providers will become a more and more important requirement for receiving funding. CME providers that are accredited and also offer non-accredited promotional activities will have to demonstrate clear separation (firewalls) between certified CME activities, and advertising and promotion of regulated products. Some companies may elect not to provide grants to non-accredited CME providers.
• The granting process will take more time to accomplish, due to submission to and review by grants committees, approval from legal counsel, and requests for additional documentation.