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VOLUME 31, NO. 7
                                        Almanac
                                       A Monthly Member Benefit of the Alliance                                       J U LY 2 0 0 9



PACME 2009 Report:                                               accreditation body representatives then responded to the
                                                                 audience feedback on a number of grey zone issues that might
                                                                 put funders or CME providers at risk for compliance violations.
Grey Zones in Compliance                                         Breakout buzz groups, in which small groups discussed and
                                                                 then presented their conclusions regarding acceptable levels of
Issues in Pharma Med-Ed and                                      communication between CME funders and CME providers,
                                                                 formed a third component of this session. Dialogue with the
Marketing Departments                                            reactor panel continued during this stage of the session as well.
                                                                    Among the grey zone topics considered were:
Pesha Rubinstein, BA, CCMEP, Senior Director,
                                                                 • Issues around promotional events at CME activities (eg, a
CME, Education Outcomes Science                                    medical society planning an annual conference approaches
    Nearly 100 attendees convened on May 7–8, 2009, for the        an industry funder of CME marketing department for: general
Pharmaceutical Alliance for Continuing Medical Education           support, product theaters, satellite symposia, meeting rooms
(PACME) Second Annual Spring Summit in Philadelphia. Of those      specifically for health care provider [HCP]-industry funder
participating in the conference, approximately 50% were from       representative interaction, or receptions/breaks)
the pharmaceutical/device/biotech environment (hereafter         • Whether provider type (eg, academic medical center versus
referred to as industry funders), 25% were from medical            MECC) mattered in regard to the level of risk posed to the
education communications companies (MECC), and the                 funder or to the activity
remainder were from other CME provider groups that included      • Acceptable levels of communication from an industry funder
hospital/health care systems, medical specialty societies, and     to CME providers, particularly in regard to requests for
state medical societies.                                           proposals (RFPs)
    The first session of day one of the conference was titled
Compliance Continuous Improvement Working Session,               • Acceptable levels of communication from a CME provider to
facilitated by Mike Saxton, MEd, FACME, CCMEP, Senior              an industry funder.
Director, Medical Education Group, Pfizer Inc, and Pamela L.        Through their ARS responses, attendees clearly identified those
Mason, BS, CCMEP, FACME, Director, Medical Education Grants      activities that were in violation of the Accreditation Council for
Office, AstraZeneca. The fact that this session opened the       Continuing Medical Education (ACCME) Standards of
conference indicated its critical importance to the PACME        Commercial SupportSM (SCS) and that posed the greatest
planning committee. Through audience response system (ARS)       compliance risk to the funder. When issues were more in the
interactions, attendees provided feedback on general questions   grey zone, participant ARS responses were distributed more
and case scenarios featuring communication between industry      widely across a five-point scale. See Figure 1 to view responses
funders of CME and CME providers. A reactor panel of             to perceived compliance risk if a medical society were to request


Inside                                                           Educational Opportunities

➤ REALITY CME: YOUR GUIDE TO WHICH WAY IS UP! [4]                Alliance 35th Annual Conference
                                                                 January 27–30, 2010
➤ SECOND ANNUAL PACME SPRING SUMMIT: MEETING
                                                                 Establishing Continuing Medical Education as a Pathway to Better
  ROUNDUP [4]
                                                                 Patient Care
➤ CALENDAR OF EVENTS [8]                                         Hilton® New Orleans Riverside
                                                                 New Orleans, Louisiana

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support from a pharmaceutical company marketing department           both departments. There was even a suggestion that the same
to support an area for HCP-industry engagement (when one-on-         lawyers should consult both departments, so that employees in
one detailing rooms are set up outside an exhibit hall).             both departments would understand the need for compliance
    Two main points of view emerged from the exercises in            and the repercussions of compliance violations.
compliance risk, one from the pharmaceutical/device/                    PACME participants could conclude from the presentation that
biotechnology company’s medical education perspectives, the          well-defined policies were in order for pharmaceutical/device/
other from a government regulator’s. Saxton defined the              biotechnology marketing departments as well as for their medical
pharmaceutical/device/biotechnology medical education                education departments. Guidance for any communication
community’s internal point of view when he summarized a buzz         between CME industry funders and CME providers as well as
session, “We need to have criteria-based decision making.”           between pharmaceutical/device/biotechnology marketing and
Specific criteria regarding acceptable levels of communication       promotional funding recipients would need to be made with an
between funders and providers could help reduce compliance           eye to how the press and government regulators could perceive
risk in the grant-awarding process. Peter H. Vlasses, PharmD,        both types of grant awarding processes.
BCPS, FCCP, Executive Director, Accreditation Council for
Pharmacy Education (ACPE), expressed the external point of           Participants and Panel Weigh In
view during a reactor panel response. He posed the question,             The presentation format—ARS input, reactor panel
“Will it pass the Grassley test?” as the question industry funders   commentary, buzz group breakout presentations with reactor
and CME providers needed to ask when deciding whether an             panel dialogue—made for an interactive session of high interest.
activity was clearly identifiable as an educational or a                 The scenario of a medical society approaching a
promotional activity. [For reference, Vlasses was referring to the   pharmaceutical company’s marketing department for general
ranking Republican of the Senate Finance Committee, Senator          support of an annual conference garnered an ARS response of
Charles Grassley, who spearheaded an inquiry into drug               63% of the audience who perceived it as presenting no, low, or
company grants for medical education.]                               moderate risk. However, during the buzz group and reactor
    A point of emphasis in this session was that pharmaceutical/     panel dialogue, attendees discovered that general support can
device/biotechnology company marketing departments must be           put both the medical society and the industry funder at risk. The
as well-versed as medical education departments in how               Journal of the American Medical Association (JAMA) April 2009
promotional material differs from CME. Scrutiny from government      article, by Rothman et al,1 was invoked by a number of speakers
regulators or the press is done with an eye toward criticizing       during this topic discussion. Kristin Rand, JD, Group Manager,
corporate, not departmental, integrity. With compliance risk         Independent Medical Education, Genentech, in representing her
occurring in the areas of marketing and in accredited medical        buzz group, commented that the general support idea is an issue
education, training in promotion versus CME needs to occur in        of concern. She asked, “How would that be affected by the
                                                                     proposed Sunshine Act?” and added that the passage of this act
                                                                     could engender a process for identifying who got what money
Figure 1: Perceived Compliance Risk If a
                                                                     from where and for what purpose. From a compliance point of
          Marketing Department Were to Support
                                                                     view she remarked that funding requests should not be general;
          Detailing Outside an Exhibit Hall
                                                                     rather they should indicate exactly what the funds are for, meet
    Responses                                                        specific criteria, and be associated with a documentation
                                                                     process. Moderator Saxton also put forth that academic medical
 Percent Count Answer Options
                                                                     centers that pool grant money awarded for research should
  13%          8      None—can not imagine a circumstance            consider devising criteria that specify what the money will be
                      when this would not be appropriate             used for.
  30%        19       Low—almost always consider this                    Reactor panelist Mindi McKenna, PhD, Director, Division of
                      appropriate                                    CME, American Academy of Family Physicians (AAFP) remarked,
  33%        21       Moderate—depends on circumstances              “General support includes accredited education, product-specific
                                                                     information, and patient education. It is incumbent upon all of us
    8%         5      Medium—would likely not do this                to use standardized language for clarity inside our own
  16%        10       High—definitely would not do this              community, for Congress, the public, and anywhere else.” With
                                                                     respect to requests for both promotional opportunities and
 100%        63       Totals
                                                                     commercial support, another reactor panelist, Kate Regnier, MA,

2 • Visit the Alliance website at www.acme-assn.org                             Almanac • Alliance for CME • Volume 31, No. 7 • July 2009
MBA, Deputy CEO, ACCME, reminded the audience that                  are generally known among all CME stakeholders, including
Standards were already established to deal with this issue.         industry funders and CME providers, it was interesting to note
Regnier referred participants to the fourth standard of the         how specific scenarios challenged attendees’ SCS understanding
ACCME SCS and said, “This Standard requires accredited              and interpretation. The ends of the spectrum—what is clearly
providers to keep requests for commercial support separate from     acceptable and what is clearly unacceptable—are much clearer
requests for promotional opportunities. Combining such requests     than the middle. No one CME provider type was identified by
or providing promotional opportunities in exchange for              PACME attendees as being more SCS-savvy than another, and a
commercial support is prohibited by the ACCME Standards of          number of the case scenarios involved SCS violations by medical
Commercial Support.”                                                societies and academic medical centers.
    Another hot topic of discussion involved how an industry           What clearly emerged from this session was that there needs
funder’s medical education department may communicate with          to be more clarity among all CME stakeholders as to what
the CME provider community, and comments focused particularly       constitutes CME and what constitutes promotional efforts. The
on the RFP. All attendees voted that an RFP that prescribed         AAFP’s McKenna succinctly summed up the Thursday morning
content regarding a specific drug’s mechanism of action or an       exercise by pointing out, “We all [need to] tackle the potential
update on a specific drug’s use was high risk, and should not be    confusion between education and promotion . . . clarify who in
issued or considered. Perceived risk plummeted when the             each other’s [organizations] to approach for what, and . . .
scenarios involved an industry funder interested in supporting      respect the synergies but distinctions between our roles as
independent medical education (IME) that concerned:                 commercial supporters, CME providers, and health care
1. A current update on treatment options for diabetes               providers. We have a responsibility to clarify this . . . [ultimately]
                                                                    to contribute to the timely translation of research into practice to
2. The clinical (disease) area
                                                                    serve patient needs.”
3. A practice gap of patient nonadherence to treatment plan as
                                                                    Reference
    measured by the HbA1c blood test.
                                                                    1. Rothman DJ, McDonald WJ, Berkowitz CD, et al. Professional medical
    RFP posting inspired a number of comments ranging from             associations and their relationships with industry: a proposal for controlling
select a few providers to disseminate as widely as possible.           conflict of interest. JAMA. 2009;301(13):1367–1372.
One industry funder medical education representative
contributed that his group received direction from its legal
department that advised as broad a dissemination of the RFP as                            Points for Practice
possible as the company’s strategy for minimizing compliance
risk. RFPs for this funder are distributed to the ACCME’s list of      • All CME stakeholders should periodically review the
accredited providers. A medical education representative from            ACCME SCS and ensure that their policies and
another industry supporter made the argument to send an RFP to           practices are in compliance with these requirements.
a selected few CME providers, since broadly disseminated RFPs
use up CME provider resources in writing up grant requests.            • CME providers should avoid requesting general
Jann Balmer, PhD, Director of CME, University of Virginia School         support from industry funders and instead should
of Medicine, and Alliance President, countered that this                 clearly define CME funding requests from promotional
approach might suggest that the funder is compromising the               funding requests.
CME activity’s independence. “If you are picking the same
providers over and over again it creates a pattern in terms of         • Academic medical centers that pool funding for
disseminating the information. I’d prefer that you open up the           research should be scrupulous in ensuring that these
RFP process and then take them on a first come, first served             monies be used as intended and should be able to
basis,” she said.                                                        provide documentation as evidence.

                                                                       • Industry funders can minimize compliance risk by
Summary
                                                                         developing decision-making criteria to support CME
    The 2009 PACME Spring Summit session titled Compliance
                                                                         funding awards; criteria-based decision-making should
Continuous Improvement Working Session offered a number
                                                                         rule both industry funded independent education and
of stimulating challenges and opportunities for discussion to its
                                                                         marketing department grant awards.
attendees. Although the ACCME’s SCS, now adopted by the
ACPE and the American Nurses Credentialing Center (ANCC),

Almanac • Alliance for CME • Volume 31, No. 7 • July 2009                                     Visit the Alliance website at www.acme-assn.org • 3
www.NFEInitiative.org
                                                                          Second Annual PACME Spring
               Reality CME                                                Summit: Meeting Roundup
                                                                          Pesha Rubinstein, BA, CCMEP, Senior Director,
               Your Guide to Which Way is Up!
                                                                          CME, Education Outcomes Science
Question
                                                                          Performance CME and Ethics: Major PACME Themes
    What are some methods for disclosing speaker relationships
                                                                             Two major themes characterized the Second Annual PACME
to learners?
                                                                          Spring Summit. The first general theme was the importance of
Answer                                                                    improving medical education through the greater adoption of
    Accredited CME providers utilize a number of ways to disclose         measurement processes and metrics analyses, while the second
the relevant financial relationships (or not) of CME faculty to the       general theme focused on the ethics of industry-supported CME
learners prior to the CME activity taking place, which includes           that often make headlines: compliance risks, lack of transparency
printing the disclosure information in the first few pages of the         regarding payments from industry that are perceived to create
course syllabus—probably the most common method for                       conflicts of interest (COI), and the confusion that exists in our
documenting said disclosure for live courses. For enduring                government and the general public about the difference between
materials, providers should force the learner through this disclosure     CME and promotional material. Underlying discussions of both
information to maximally ensure their review of this information. In      topics was the need for funders and grant recipients to advertise
other words, for online and other forms of electronic media, simply       the successes of industry-supported CME by clarifying to the
providing a link to the disclosure information is not adequate. For       academic and lay press the contribution that industry makes to
regularly scheduled series (RSS), the disclosure information could be     education that results in improved patient outcomes.
printed on the RSS session flier that is distributed to learners, typed
at the top of the RSS session sign-in sheet, or displayed on a            Would You Approve This Grant Request?
PowerPoint® slide as learners enter the meeting room. Whatever                Frank Berry, BS, Director, Department of CME, Maryland
method is used, however, it must be in evidence in the activity file.     State Medical Society, kicked off a session on integrating
    That said, remember that CME providers are responsible for            ACCME Criteria in grant applications. He linked the Level 3
disclosing the relevant financial relationships of all individuals in     criteria to the first 15, and described criteria 16–22 as “being
a position to the control the content of the CME activity, so do not      engaged with the environment.” The Level 3 criteria are the
forget communicating the course director, members of the                  “push from the nest that allow the provider to fly into the full
planning committee, and staff disclosure information to learners          health care environment.”
prior to the activity taking place, and be clear what role the                Attendees then reviewed actual grant proposals, broke off in
individual has in the CME activity. An example:                           small groups to assess whether they were submitted by CME
                                                                          providers capable of delivering as Level 3 providers, and made
Planner/Faculty Disclosures                                               presentations to a reactor panel. The three proposals described:
Jane Doe, MD, Course Director/Faculty                                     1. Bridging gaps in diabetes care in a Latino community
   Doctor Jane Doe has indicated she has no financial relation-
                                                                          2. A diabetes Performance Improvement (PI) initiative
ships to disclose relevant to the content of this CME activity.
                                                                          3. A PI initiative in colorectal cancer.
John Doe, MD, Planner
   Doctor John Doe has indicated he is a consultant for ABC               Interestingly, several comments emerged from all the groups
Pharma Company.                                                           critiquing the three proposals:
Jonis Doe, Administrative Staff                                           • “Too-dense writing”
   Ms. Jonis Doe has indicated she has no financial relationships         • “How the relevance of PI would be communicated to
to disclose relevant to the content of this CME activity.                     clinicians was missing”
Joseph Doe, MD, Faculty                                                   • “Missing format rationale”
   Doctor Joseph Doe has indicated he is an advisory board                • “Despite CME provider’s assurance, lack of confidence it has
member for XYZ Pharma Company.                                                the ability to achieve those outcomes”
              By Debra L. Gist, MPH, FACME, Assistant Editor              • “Would this pass the Grassley test?”

4 • Visit the Alliance website at www.acme-assn.org                                  Almanac • Alliance for CME • Volume 31, No. 7 • July 2009
One industry funder representative related that her               excoriated in the press, the FDA is requiring it in certain
organization was not reviewing grants side by side with the           instances. Werble believes that eventually the FDA may require
ACCME Updated Accreditation Criteria, but she predicted that          pharmaceutical companies to support CME, and not just
as time moved on, CME provider level would have more of an            speaker’s bureaus, in REMS cases.
effect on decision-making.
                                                                      Demonstrating the Value Proposition for Support of
                                                                      CME in Your Institution
  The Level 3 criteria are the “push from
                                                                          With an increasingly regulated environment, and Office of the
  the nest that allow the provider to fly                             Inspector General (OIG) policy prohibiting marketing influence in
  into the full health care environment.”                             CME, a challenge for pharmaceutical/device/biotechnology
                                                                      company educational grants departments is to validate and justify
                              —Frank Berry                            the value they bring to their own organizations. Walter Wolyniec,
                                                                      MSc, President, Confluent Healthcare Solutions, and Hilary
                                                                      Schmidt, PhD, of sanofi-aventis, offered tips to industry leaders on
What’s Around the Corner for CME in Political and                     how to define the expectations and outcomes for CME support.
Legislative Realms                                                        Pharma funders were particularly interested in this session,
    The Institute of Medicine’s (IOM’s) Conflicts of Interest in      having responded through use of the ARS on day one that
Medical Research, Education, and Practice, released the               Demonstrating value of IME to the company was the biggest
week before the meeting, was invoked in a number of Summit            challenge in starting and enhancing the IME/CME group (see
presentations, but particularly in the session on political and       Figure 2).
legislative issues impacting CME. Facilitator Destry Sulkes, MD,          This session took a novel approach and incorporated the point
Alliance Board Member, recalled that the 1999 IOM report, To          of view of a sanofi-aventis marketing representative, Laura Fields,
Err is Human, ultimately led to the National Quality Forum’s          PharmD, Associate VP, Metabolism Marketing, who commun-
Never Events. Both he and faculty presenter Damon Marquis,            icated by telephone with PACME 2009 attendees about lessons
MA, MS, of the Society of Thoracic Surgeons, informed                 the marketing division has learned from CME colleagues. Fields
attendees that IOM documents turn into policy and procedure.          listed the following lessons that CME has taught the marketing
Marquis strongly recommended that attendees read the entire           teams: the incorporation of more sophisticated education
report. He commented that the IOM recommends reforming the            approaches that reach physicians, higher level outcomes made
financing system for CME, and predicts that although industry         possible only through practical, hands-on, interactive workshops,
support will not go away, it will most certainly change.
    Faculty for this session considered recent changes in the US      Figure 2: What Is/Was Your Biggest Challenge
Food and Drug Administration (FDA) due to the new                               in Starting and Enhancing Your
administration. Cole Werble, Senior Executive Editor of the                     IME/CME Group? (For All Attendees)
publisher of The Pink Sheet, analyzed what he dubbed the FDA’s
“headline crisis.” Werble provided the audience with a rundown            Responses
of the issues that have eroded the FDA’s credibility, including the    Percent Count Answer Options
agency’s approval of Avandia, Plan B, and contaminations of               1%        1      Obtaining head count
tomatoes and pistachios. He commented that the FDA needs to be
perceived once more as a defender of the public health, and             32%        25      Securing grant budget funding
predicted that once it achieves that goal, it will engage more            4%        3      Internal training
actively again in drug approvals. He pointed out that Risk              39%        30      Demonstrating value of IME to the
Evaluation and Mitigation Strategies (REMS) required by the FDA                            company
for some drugs will allow industry to produce mini-buster rather
                                                                          6%        5      Overcoming barriers to risks in grant
than blockbuster drugs. Through the REMS programs, the FDA will
                                                                                           funding (eg, Senate Finance media)
actually require on-label speaker’s bureaus to ensure that
clinicians are educated as to the proper use of powerful drugs            0%        0      Other
that may have fatal side effects. Moderator John Kamp, JD, PhD,         18%        14      NA
of the Coalition for Healthcare Communication, pointed out the
                                                                       100%        78      Totals
paradox that as industry-funded promotional education is

Almanac • Alliance for CME • Volume 31, No. 7 • July 2009                                  Visit the Alliance website at www.acme-assn.org • 5
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and the need to publicize or publish results to change public                      This session’s panel featured a number of representatives from
perception. Like the policy commentators in the previous session,              various CME stakeholder environments. Nancy Davis, PhD,
Fields mentioned REMS and the FDA-mandated education that                      Executive Director, National Institute for Quality Improvement and
these drugs require. She remarked, "REMS presents a unique                     Education, pointed out that medical specialty societies are well-
opportunity for CME teams to deliver critical education to                     positioned to create performance-based CME, because their
preserve the benefit-risk of therapeutics, as mandated by the FDA.             clinical guidelines can generally be translated into performance
Third party outcomes metrics reports are provided to the FDA in                measures. This CME provider type has traditional educational
an area of education that they have deemed as being very                       delivery formats, but also has access to other modalities such as
important in dealing with risk.”                                               journals and state chapter activities. The specialty societies can
    Ratcheting up CME activities’ outcomes levels and the need to              help with the transition into the CME future by indexing
publish the results were two messages that clearly came through                educational content and implementing patient registries. She
in this session. Marketing management is used to hearing metrics               identified the Society of Thoracic Surgeons, the American
like the number of doctors reached and the number of                           College of Cardiology, and the American College of Chest
prescriptions written. Metrics such as the number of patients                  Physicians as organizations with effective registries in use. Davis
whose care has been improved is congruous with a                               noted that implementing performance-based CME positions
pharmaceutical/device/biotechnology company’s mission of                       specialty medical societies to effectively link CME with MOC for
improving health care and improving the bottom line. Publication               their members.
of successful educational interventions shows industry funder                      Bob Addleton, EdD, LPC, CCMEP, of the Physicians’ Institute
management the value of education, and makes it easier to justify              for Excellence in Medicine, shared his thoughts on future CME
CME support through grants down the road.                                      from the perspective of a state medical association. The
                                                                               Physicians’ Institute has 16 state medical society members,
The Future of CME                                                              representing 900 accredited providers. Addleton pointed to the
    Speculating on the future of CME is a standard topic at                    challenges of either not enough staff or lack of trained staff in this
conferences as well as in dialogue with colleagues, and the                    setting. There was a murmur of commentary when Addleton
discussion at this conference gave attendees the opportunity to                informed the crowd that 15 Missouri providers had announced
reflect on accomplishments achieved and changes yet to come.                   they would no longer be offering accredited education due to
Through the ARS, Maureen Doyle-Scharff, MBA, FACME, of                         their lack of human and financial resources. Moving from the old
Pfizer Inc, obtained attendee feedback indicating that 92% of the              way of doing CME to a higher-level CME would remain the
funders indicated they would be more likely to support a grant                 challenge of this poorly funded provider setting. Addleton
that included a budget to measure the activity’s impact on health              advised, “Hospital-based CME people . . . need to rebrand
care quality or patient outcomes. Fifty-one percent of the funding             themselves from the people who are in charge of the meeting
community in attendance voted that it would be appropriate to                  logistics to those who become advisors to physicians.”
fund grant requests only if they included post-initiative publication
of outcomes in a peer-reviewed journal.
    Doyle-Scharff also posed questions that in the years before                   “Hospital-based CME people . . . need
maintenance of certification (MOC) requirements might have                        to rebrand themselves from the people
been unthinkable. She asked whether attendees could imagine a
world where:
                                                                                  who are in charge of the meeting
• The ACCME doesn’t exercise as much control as it                                logistics to those who become advisors
    currently does                                                                to physicians.”
• American Medical Association Physician Recognition Award                                                —Bob Addleton
    (AMA PRA) Category 1 creditTM doesn’t have the same value
    as it does today                                                              Destry Sulkes, MD, commented, “The idea of technology
• Licensing bodies don’t care about AMA PRA Category                           adding to CME’s impact in the future is a big no-brainer.” He
    1 credit                                                                   pointed out that the push for technology in improving health care
• AMA PRA Category 1 credit is one of many kinds of credit                     was set up in the previous administration, and that President
    that learners can apply toward their MOC or maintenance of                 Obama’s selection of David Blumenthal, MD, MPP, as head of the
    licensure (MOL).                                                           Office of the National Coordinator for Health Information


6 • Visit the Alliance website at www.acme-assn.org                                          Almanac • Alliance for CME • Volume 31, No. 7 • July 2009
Technology will advance our ability to see robust health care data        and stratify information. Candid discussions about education
in real time. Sulkes briefly described the FDA’s Sentinel Initiative, a   versus promotion and an ethical code addressing COI need to
partnership linking databases from Centers for Medicare and               be part of future conversations on CME as well.
Medicaid Services, the Veterans Administration and Department of
Defense, and an array of private health care organizations, that
will be able to aggregate data across millions of Americans, resul-         “Prevention is one of the futures of the
ting in important data such as drug safety, hospitalizations and            health care industry.”
physician visits, all of which will contribute up-to-date information                                —Jann Balmer
that will influence US health policy. Sulkes commented that the
Sentinel Initiative will provide new data and new pathways for the
dissemination of up-to-date CME material in the years ahead.                 From the program presentations, attendees could conclude
    Alliance President, Jann Balmer, PhD, presented a detailed            that CME planning and educational effectiveness will be
summary of the future of CME and put the challenges of today’s            demonstrated by the publication of objective data related to
CME environment in the context of today’s health care                     improvements in patient care. There was a general consensus
environment. Challenges include:                                          among speakers that some form of a federally-legislated Sunshine
• A highly regulated environment due to the FDA and the OIG               Act, with mandated reporting of payments by industry to health
                                                                          care providers, will become policy—and that it would behoove
• New and evolving frameworks regarding ACCME processes                   industry funders to embrace and adapt to the concept of a more
  and review, MOC, MOL, and informatics and information                   transparent process.
  technology                                                                 The CME community has seen many changes over the past
• A greater general public awareness of CME and calls for                 few years that include education divisions separated out from
  greater transparency, improved ethical behavior, and more               marketing departments in pharmaceutical companies, funders’
  effective management of industry relations.                             transparency databases, and a broader acceptance of linking
    Balmer also offered some criticism regarding documentation            quality improvement with CME. CME providers have been
that satisfied ACCME requirements. “I have concerns that the              charged by the ACCME to be change agents. Clearly, CME
focus on accreditation documentation can and often does                   funders are ready to support CME activities provided by change
overshadow the important work of developing effective education           agents who can produce the data that objectively demonstrate
for our physician and health care professional audiences with the         improvements in patient care.
goal of improved performance and practice.” She proposed a                Additional Resources
future in which more monies could be spent on effective                   1. Berwick DM. What “patient-centered” should mean: confessions of an
education rather than on compliance tracking.                                extremist. Health Affairs. 2009;28(4):w555–w565.
    The Alliance president shared one idea for meeting the                2. Institute of Medicine. Conflict of Interest in Medical Research, Education, and
challenges in the current CME environment is for CME                         Practice. Washington, DC: The National Academies Press; 2009.
professionals to “design [activities] in a very purposeful manner,        3. US Department of Health and Human Services, Agency for Healthcare
which goes not only to diagnostics and therapeutics, but also to             Research and Quality, National Quality Measures Clearinghouse website:
                                                                             www.qualitymeasures.ahrq.gov.
preventive strategies. Prevention is one of the futures of the health
                                                                          4. Patient-Centered Primary Care Collaborative website: www.pcpcc.net.
care industry, which is the talk of the current administration.”
Balmer’s other suggestions included a patient-centric focus for           5. Institute for Healthcare Improvement website: www.ihi.org.
guidelines-based CME, and clinician self-assessment. Team-based
care would contribute to addressing challenges of the future, as
would professional education that addressed informatics and                                           Green Tip
taught health care practitioners about how to manage, analyze,                  When choosing a site for your next meeting, institute due
                                                                            diligence in finding out what, if any, green features they offer
                                                                            (such as recycling, water in pitchers instead of single use
      Share your thoughts on Alliance issues                                bottles, energy-efficient lighting). Negotiate to include
           by contacting the Board at:                                      additional green features in the contract (utilizing local food,
                                                                            no disposables).
          acmeboard@acme-assn.org.                                                                               —Submitted by Brooke Taylor



Almanac • Alliance for CME • Volume 31, No. 7 • July 2009                                          Visit the Alliance website at www.acme-assn.org • 7
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Calendar of Events
September 9-11, 2009                                October 14-16, 2009                                                January 27–30, 2010
NIQIE 2009                                          20th Annual Conference of the National Task                        Alliance for Continuing Medical Education
Mastering Continuous Performance Improvement            Force on CME Provider/Industry Collaboration                   35th Annual Conference
Intercontinental Chicago O'Hare                     Baltimore Marriott Waterfront, Baltimore, MD                       Establishing Continuing Medical Education as a
Rosemont (Chicago), IL                              www.ama-assn.org/go/cmetaskforce                                       Pathway to Better Patient Care
www.niqie.org                                                                                                          Hilton® New Orleans Riverside
                                                                                                                       New Orleans, LA
September 14-30, 2009                                                                                                  www.acme-assn.org
NC-CME Exam
www.nccme.org


                                                                  Alliance Almanac
  Almanac Editors                              2009 Board of Directors                                   Headquarters Office
  Jane Eckstein, MA—Editor-in-Chief            Jann T. Balmer, PhD, FACME, President*                    Paul D. Weber, MA—Executive Director*
  Marissa Seligman, PharmD—Associate Editor    Maureen Doyle-Scharff, MBA, FACME,                        Bernie Halbur, PhD, FACME—Professional Development
  Derek Dietze, MA—Assistant Editor               Secretary/Treasurer*                                        and Meeting Management Director
  Debra L. Gist, MPH, FACME—Assistant Editor   Sue Ann Capizzi, MBA, FACME, Past President*              Jay Brown, BA—Project Manager and Meeting Planner
  Robin Hendricks, MAdEd—Assistant Editor      Bob Addleton, EdD                                         James C. Leist, EdD, FACME—Staff Consultant
  Paul D. Weber, MA—Managing Editor            Winnie Brown, MPA                                         Diane Baker O’Hern—Professional Development Coordinator
  Mitch Pruitt—Production Editor               Nancy Davis, PhD                                          Marissa K. Green—Manager, Membership Information Services
                                               Barbara Huffman, MEd                                      Anne Marie Smith, BS—Staff Assistant
                                               Jack Kues, PhD                                            Debrah Fisher, BA—Manager of Member Services
  Almanac Editorial Board                      Damon K. Marquis, MA                                      Alison Skinner, BA—Executive Assistant
  Linda DuPont, BA                             George Mejicano, MD*                                      Jessica Romano, BS—Product Development/Marketing Specialist
  Paul Frisch, JD                              Greg Paulos, MBA                                          Jill Real, BS—Bookkeeper
  Paige Green, MEd                             Linda Raichle, PhD, FACME                                 Amy Guberman, MPM—Staff Consultant
  Kevin Heffernan                              Mark Schaffer, EdM                                        Megan Pace, BA—Administrative Assistant
  Kate Regnier, MBA                            Destry Sulkes, MD
  Tiffany Stepien, BS                                                                                    The Almanac is published monthly by the Alliance for CME,
                                                                                                         1025 Montgomery Highway, Suite 105, Birmingham, AL 35216;
  Brooke Taylor, MPH                           *Executive Committee                                      Phone: 205-824-1355; Fax: 205-824-1357; email: acme@acme-assn.org;
  NaBrina J. Webb, MBA                                                                                   ISSN#1076-3899. The views expressed in the Almanac are those of
  Betsy Woodall, PharmD                        © Copyright 2009 by the Alliance for Continuing Medical   the authors and are not intended to represent the views of the
                                               Education®. All rights reserved.                          Alliance or its membership.




Alliance for Continuing Medical Education®                                                                                                                Nonprofit Org.
1025 Montgomery Highway                                                                                                                                     US Postage
Suite 105                                                                                                                                                      PAID
Birmingham, AL 35216                                                                                                                                     Permit No. 2230
                                                                                                                                                          Birmingham, AL
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July 09 Almanac

  • 1. VOLUME 31, NO. 7 Almanac A Monthly Member Benefit of the Alliance J U LY 2 0 0 9 PACME 2009 Report: accreditation body representatives then responded to the audience feedback on a number of grey zone issues that might put funders or CME providers at risk for compliance violations. Grey Zones in Compliance Breakout buzz groups, in which small groups discussed and then presented their conclusions regarding acceptable levels of Issues in Pharma Med-Ed and communication between CME funders and CME providers, formed a third component of this session. Dialogue with the Marketing Departments reactor panel continued during this stage of the session as well. Among the grey zone topics considered were: Pesha Rubinstein, BA, CCMEP, Senior Director, • Issues around promotional events at CME activities (eg, a CME, Education Outcomes Science medical society planning an annual conference approaches Nearly 100 attendees convened on May 7–8, 2009, for the an industry funder of CME marketing department for: general Pharmaceutical Alliance for Continuing Medical Education support, product theaters, satellite symposia, meeting rooms (PACME) Second Annual Spring Summit in Philadelphia. Of those specifically for health care provider [HCP]-industry funder participating in the conference, approximately 50% were from representative interaction, or receptions/breaks) the pharmaceutical/device/biotech environment (hereafter • Whether provider type (eg, academic medical center versus referred to as industry funders), 25% were from medical MECC) mattered in regard to the level of risk posed to the education communications companies (MECC), and the funder or to the activity remainder were from other CME provider groups that included • Acceptable levels of communication from an industry funder hospital/health care systems, medical specialty societies, and to CME providers, particularly in regard to requests for state medical societies. proposals (RFPs) The first session of day one of the conference was titled Compliance Continuous Improvement Working Session, • Acceptable levels of communication from a CME provider to facilitated by Mike Saxton, MEd, FACME, CCMEP, Senior an industry funder. Director, Medical Education Group, Pfizer Inc, and Pamela L. Through their ARS responses, attendees clearly identified those Mason, BS, CCMEP, FACME, Director, Medical Education Grants activities that were in violation of the Accreditation Council for Office, AstraZeneca. The fact that this session opened the Continuing Medical Education (ACCME) Standards of conference indicated its critical importance to the PACME Commercial SupportSM (SCS) and that posed the greatest planning committee. Through audience response system (ARS) compliance risk to the funder. When issues were more in the interactions, attendees provided feedback on general questions grey zone, participant ARS responses were distributed more and case scenarios featuring communication between industry widely across a five-point scale. See Figure 1 to view responses funders of CME and CME providers. A reactor panel of to perceived compliance risk if a medical society were to request Inside Educational Opportunities ➤ REALITY CME: YOUR GUIDE TO WHICH WAY IS UP! [4] Alliance 35th Annual Conference January 27–30, 2010 ➤ SECOND ANNUAL PACME SPRING SUMMIT: MEETING Establishing Continuing Medical Education as a Pathway to Better ROUNDUP [4] Patient Care ➤ CALENDAR OF EVENTS [8] Hilton® New Orleans Riverside New Orleans, Louisiana For New Alliance Programs and Products Visit the Alliance Website: www.acme-assn.org
  • 2. For more information and Call for Data submission guidelines, visit www.cmexchange.org today! support from a pharmaceutical company marketing department both departments. There was even a suggestion that the same to support an area for HCP-industry engagement (when one-on- lawyers should consult both departments, so that employees in one detailing rooms are set up outside an exhibit hall). both departments would understand the need for compliance Two main points of view emerged from the exercises in and the repercussions of compliance violations. compliance risk, one from the pharmaceutical/device/ PACME participants could conclude from the presentation that biotechnology company’s medical education perspectives, the well-defined policies were in order for pharmaceutical/device/ other from a government regulator’s. Saxton defined the biotechnology marketing departments as well as for their medical pharmaceutical/device/biotechnology medical education education departments. Guidance for any communication community’s internal point of view when he summarized a buzz between CME industry funders and CME providers as well as session, “We need to have criteria-based decision making.” between pharmaceutical/device/biotechnology marketing and Specific criteria regarding acceptable levels of communication promotional funding recipients would need to be made with an between funders and providers could help reduce compliance eye to how the press and government regulators could perceive risk in the grant-awarding process. Peter H. Vlasses, PharmD, both types of grant awarding processes. BCPS, FCCP, Executive Director, Accreditation Council for Pharmacy Education (ACPE), expressed the external point of Participants and Panel Weigh In view during a reactor panel response. He posed the question, The presentation format—ARS input, reactor panel “Will it pass the Grassley test?” as the question industry funders commentary, buzz group breakout presentations with reactor and CME providers needed to ask when deciding whether an panel dialogue—made for an interactive session of high interest. activity was clearly identifiable as an educational or a The scenario of a medical society approaching a promotional activity. [For reference, Vlasses was referring to the pharmaceutical company’s marketing department for general ranking Republican of the Senate Finance Committee, Senator support of an annual conference garnered an ARS response of Charles Grassley, who spearheaded an inquiry into drug 63% of the audience who perceived it as presenting no, low, or company grants for medical education.] moderate risk. However, during the buzz group and reactor A point of emphasis in this session was that pharmaceutical/ panel dialogue, attendees discovered that general support can device/biotechnology company marketing departments must be put both the medical society and the industry funder at risk. The as well-versed as medical education departments in how Journal of the American Medical Association (JAMA) April 2009 promotional material differs from CME. Scrutiny from government article, by Rothman et al,1 was invoked by a number of speakers regulators or the press is done with an eye toward criticizing during this topic discussion. Kristin Rand, JD, Group Manager, corporate, not departmental, integrity. With compliance risk Independent Medical Education, Genentech, in representing her occurring in the areas of marketing and in accredited medical buzz group, commented that the general support idea is an issue education, training in promotion versus CME needs to occur in of concern. She asked, “How would that be affected by the proposed Sunshine Act?” and added that the passage of this act could engender a process for identifying who got what money Figure 1: Perceived Compliance Risk If a from where and for what purpose. From a compliance point of Marketing Department Were to Support view she remarked that funding requests should not be general; Detailing Outside an Exhibit Hall rather they should indicate exactly what the funds are for, meet Responses specific criteria, and be associated with a documentation process. Moderator Saxton also put forth that academic medical Percent Count Answer Options centers that pool grant money awarded for research should 13% 8 None—can not imagine a circumstance consider devising criteria that specify what the money will be when this would not be appropriate used for. 30% 19 Low—almost always consider this Reactor panelist Mindi McKenna, PhD, Director, Division of appropriate CME, American Academy of Family Physicians (AAFP) remarked, 33% 21 Moderate—depends on circumstances “General support includes accredited education, product-specific information, and patient education. It is incumbent upon all of us 8% 5 Medium—would likely not do this to use standardized language for clarity inside our own 16% 10 High—definitely would not do this community, for Congress, the public, and anywhere else.” With respect to requests for both promotional opportunities and 100% 63 Totals commercial support, another reactor panelist, Kate Regnier, MA, 2 • Visit the Alliance website at www.acme-assn.org Almanac • Alliance for CME • Volume 31, No. 7 • July 2009
  • 3. MBA, Deputy CEO, ACCME, reminded the audience that are generally known among all CME stakeholders, including Standards were already established to deal with this issue. industry funders and CME providers, it was interesting to note Regnier referred participants to the fourth standard of the how specific scenarios challenged attendees’ SCS understanding ACCME SCS and said, “This Standard requires accredited and interpretation. The ends of the spectrum—what is clearly providers to keep requests for commercial support separate from acceptable and what is clearly unacceptable—are much clearer requests for promotional opportunities. Combining such requests than the middle. No one CME provider type was identified by or providing promotional opportunities in exchange for PACME attendees as being more SCS-savvy than another, and a commercial support is prohibited by the ACCME Standards of number of the case scenarios involved SCS violations by medical Commercial Support.” societies and academic medical centers. Another hot topic of discussion involved how an industry What clearly emerged from this session was that there needs funder’s medical education department may communicate with to be more clarity among all CME stakeholders as to what the CME provider community, and comments focused particularly constitutes CME and what constitutes promotional efforts. The on the RFP. All attendees voted that an RFP that prescribed AAFP’s McKenna succinctly summed up the Thursday morning content regarding a specific drug’s mechanism of action or an exercise by pointing out, “We all [need to] tackle the potential update on a specific drug’s use was high risk, and should not be confusion between education and promotion . . . clarify who in issued or considered. Perceived risk plummeted when the each other’s [organizations] to approach for what, and . . . scenarios involved an industry funder interested in supporting respect the synergies but distinctions between our roles as independent medical education (IME) that concerned: commercial supporters, CME providers, and health care 1. A current update on treatment options for diabetes providers. We have a responsibility to clarify this . . . [ultimately] to contribute to the timely translation of research into practice to 2. The clinical (disease) area serve patient needs.” 3. A practice gap of patient nonadherence to treatment plan as Reference measured by the HbA1c blood test. 1. Rothman DJ, McDonald WJ, Berkowitz CD, et al. Professional medical RFP posting inspired a number of comments ranging from associations and their relationships with industry: a proposal for controlling select a few providers to disseminate as widely as possible. conflict of interest. JAMA. 2009;301(13):1367–1372. One industry funder medical education representative contributed that his group received direction from its legal department that advised as broad a dissemination of the RFP as Points for Practice possible as the company’s strategy for minimizing compliance risk. RFPs for this funder are distributed to the ACCME’s list of • All CME stakeholders should periodically review the accredited providers. A medical education representative from ACCME SCS and ensure that their policies and another industry supporter made the argument to send an RFP to practices are in compliance with these requirements. a selected few CME providers, since broadly disseminated RFPs use up CME provider resources in writing up grant requests. • CME providers should avoid requesting general Jann Balmer, PhD, Director of CME, University of Virginia School support from industry funders and instead should of Medicine, and Alliance President, countered that this clearly define CME funding requests from promotional approach might suggest that the funder is compromising the funding requests. CME activity’s independence. “If you are picking the same providers over and over again it creates a pattern in terms of • Academic medical centers that pool funding for disseminating the information. I’d prefer that you open up the research should be scrupulous in ensuring that these RFP process and then take them on a first come, first served monies be used as intended and should be able to basis,” she said. provide documentation as evidence. • Industry funders can minimize compliance risk by Summary developing decision-making criteria to support CME The 2009 PACME Spring Summit session titled Compliance funding awards; criteria-based decision-making should Continuous Improvement Working Session offered a number rule both industry funded independent education and of stimulating challenges and opportunities for discussion to its marketing department grant awards. attendees. Although the ACCME’s SCS, now adopted by the ACPE and the American Nurses Credentialing Center (ANCC), Almanac • Alliance for CME • Volume 31, No. 7 • July 2009 Visit the Alliance website at www.acme-assn.org • 3
  • 4. www.NFEInitiative.org Second Annual PACME Spring Reality CME Summit: Meeting Roundup Pesha Rubinstein, BA, CCMEP, Senior Director, Your Guide to Which Way is Up! CME, Education Outcomes Science Question Performance CME and Ethics: Major PACME Themes What are some methods for disclosing speaker relationships Two major themes characterized the Second Annual PACME to learners? Spring Summit. The first general theme was the importance of Answer improving medical education through the greater adoption of Accredited CME providers utilize a number of ways to disclose measurement processes and metrics analyses, while the second the relevant financial relationships (or not) of CME faculty to the general theme focused on the ethics of industry-supported CME learners prior to the CME activity taking place, which includes that often make headlines: compliance risks, lack of transparency printing the disclosure information in the first few pages of the regarding payments from industry that are perceived to create course syllabus—probably the most common method for conflicts of interest (COI), and the confusion that exists in our documenting said disclosure for live courses. For enduring government and the general public about the difference between materials, providers should force the learner through this disclosure CME and promotional material. Underlying discussions of both information to maximally ensure their review of this information. In topics was the need for funders and grant recipients to advertise other words, for online and other forms of electronic media, simply the successes of industry-supported CME by clarifying to the providing a link to the disclosure information is not adequate. For academic and lay press the contribution that industry makes to regularly scheduled series (RSS), the disclosure information could be education that results in improved patient outcomes. printed on the RSS session flier that is distributed to learners, typed at the top of the RSS session sign-in sheet, or displayed on a Would You Approve This Grant Request? PowerPoint® slide as learners enter the meeting room. Whatever Frank Berry, BS, Director, Department of CME, Maryland method is used, however, it must be in evidence in the activity file. State Medical Society, kicked off a session on integrating That said, remember that CME providers are responsible for ACCME Criteria in grant applications. He linked the Level 3 disclosing the relevant financial relationships of all individuals in criteria to the first 15, and described criteria 16–22 as “being a position to the control the content of the CME activity, so do not engaged with the environment.” The Level 3 criteria are the forget communicating the course director, members of the “push from the nest that allow the provider to fly into the full planning committee, and staff disclosure information to learners health care environment.” prior to the activity taking place, and be clear what role the Attendees then reviewed actual grant proposals, broke off in individual has in the CME activity. An example: small groups to assess whether they were submitted by CME providers capable of delivering as Level 3 providers, and made Planner/Faculty Disclosures presentations to a reactor panel. The three proposals described: Jane Doe, MD, Course Director/Faculty 1. Bridging gaps in diabetes care in a Latino community Doctor Jane Doe has indicated she has no financial relation- 2. A diabetes Performance Improvement (PI) initiative ships to disclose relevant to the content of this CME activity. 3. A PI initiative in colorectal cancer. John Doe, MD, Planner Doctor John Doe has indicated he is a consultant for ABC Interestingly, several comments emerged from all the groups Pharma Company. critiquing the three proposals: Jonis Doe, Administrative Staff • “Too-dense writing” Ms. Jonis Doe has indicated she has no financial relationships • “How the relevance of PI would be communicated to to disclose relevant to the content of this CME activity. clinicians was missing” Joseph Doe, MD, Faculty • “Missing format rationale” Doctor Joseph Doe has indicated he is an advisory board • “Despite CME provider’s assurance, lack of confidence it has member for XYZ Pharma Company. the ability to achieve those outcomes” By Debra L. Gist, MPH, FACME, Assistant Editor • “Would this pass the Grassley test?” 4 • Visit the Alliance website at www.acme-assn.org Almanac • Alliance for CME • Volume 31, No. 7 • July 2009
  • 5. One industry funder representative related that her excoriated in the press, the FDA is requiring it in certain organization was not reviewing grants side by side with the instances. Werble believes that eventually the FDA may require ACCME Updated Accreditation Criteria, but she predicted that pharmaceutical companies to support CME, and not just as time moved on, CME provider level would have more of an speaker’s bureaus, in REMS cases. effect on decision-making. Demonstrating the Value Proposition for Support of CME in Your Institution The Level 3 criteria are the “push from With an increasingly regulated environment, and Office of the the nest that allow the provider to fly Inspector General (OIG) policy prohibiting marketing influence in into the full health care environment.” CME, a challenge for pharmaceutical/device/biotechnology company educational grants departments is to validate and justify —Frank Berry the value they bring to their own organizations. Walter Wolyniec, MSc, President, Confluent Healthcare Solutions, and Hilary Schmidt, PhD, of sanofi-aventis, offered tips to industry leaders on What’s Around the Corner for CME in Political and how to define the expectations and outcomes for CME support. Legislative Realms Pharma funders were particularly interested in this session, The Institute of Medicine’s (IOM’s) Conflicts of Interest in having responded through use of the ARS on day one that Medical Research, Education, and Practice, released the Demonstrating value of IME to the company was the biggest week before the meeting, was invoked in a number of Summit challenge in starting and enhancing the IME/CME group (see presentations, but particularly in the session on political and Figure 2). legislative issues impacting CME. Facilitator Destry Sulkes, MD, This session took a novel approach and incorporated the point Alliance Board Member, recalled that the 1999 IOM report, To of view of a sanofi-aventis marketing representative, Laura Fields, Err is Human, ultimately led to the National Quality Forum’s PharmD, Associate VP, Metabolism Marketing, who commun- Never Events. Both he and faculty presenter Damon Marquis, icated by telephone with PACME 2009 attendees about lessons MA, MS, of the Society of Thoracic Surgeons, informed the marketing division has learned from CME colleagues. Fields attendees that IOM documents turn into policy and procedure. listed the following lessons that CME has taught the marketing Marquis strongly recommended that attendees read the entire teams: the incorporation of more sophisticated education report. He commented that the IOM recommends reforming the approaches that reach physicians, higher level outcomes made financing system for CME, and predicts that although industry possible only through practical, hands-on, interactive workshops, support will not go away, it will most certainly change. Faculty for this session considered recent changes in the US Figure 2: What Is/Was Your Biggest Challenge Food and Drug Administration (FDA) due to the new in Starting and Enhancing Your administration. Cole Werble, Senior Executive Editor of the IME/CME Group? (For All Attendees) publisher of The Pink Sheet, analyzed what he dubbed the FDA’s “headline crisis.” Werble provided the audience with a rundown Responses of the issues that have eroded the FDA’s credibility, including the Percent Count Answer Options agency’s approval of Avandia, Plan B, and contaminations of 1% 1 Obtaining head count tomatoes and pistachios. He commented that the FDA needs to be perceived once more as a defender of the public health, and 32% 25 Securing grant budget funding predicted that once it achieves that goal, it will engage more 4% 3 Internal training actively again in drug approvals. He pointed out that Risk 39% 30 Demonstrating value of IME to the Evaluation and Mitigation Strategies (REMS) required by the FDA company for some drugs will allow industry to produce mini-buster rather 6% 5 Overcoming barriers to risks in grant than blockbuster drugs. Through the REMS programs, the FDA will funding (eg, Senate Finance media) actually require on-label speaker’s bureaus to ensure that clinicians are educated as to the proper use of powerful drugs 0% 0 Other that may have fatal side effects. Moderator John Kamp, JD, PhD, 18% 14 NA of the Coalition for Healthcare Communication, pointed out the 100% 78 Totals paradox that as industry-funded promotional education is Almanac • Alliance for CME • Volume 31, No. 7 • July 2009 Visit the Alliance website at www.acme-assn.org • 5
  • 6. Go Where The Talent Is The Alliance for CME has created the CME Career Center to be your online resource for career connections in CME. Post your job and resume at http://careers.acme-assn.org. Major discounts for Alliance members! and the need to publicize or publish results to change public This session’s panel featured a number of representatives from perception. Like the policy commentators in the previous session, various CME stakeholder environments. Nancy Davis, PhD, Fields mentioned REMS and the FDA-mandated education that Executive Director, National Institute for Quality Improvement and these drugs require. She remarked, "REMS presents a unique Education, pointed out that medical specialty societies are well- opportunity for CME teams to deliver critical education to positioned to create performance-based CME, because their preserve the benefit-risk of therapeutics, as mandated by the FDA. clinical guidelines can generally be translated into performance Third party outcomes metrics reports are provided to the FDA in measures. This CME provider type has traditional educational an area of education that they have deemed as being very delivery formats, but also has access to other modalities such as important in dealing with risk.” journals and state chapter activities. The specialty societies can Ratcheting up CME activities’ outcomes levels and the need to help with the transition into the CME future by indexing publish the results were two messages that clearly came through educational content and implementing patient registries. She in this session. Marketing management is used to hearing metrics identified the Society of Thoracic Surgeons, the American like the number of doctors reached and the number of College of Cardiology, and the American College of Chest prescriptions written. Metrics such as the number of patients Physicians as organizations with effective registries in use. Davis whose care has been improved is congruous with a noted that implementing performance-based CME positions pharmaceutical/device/biotechnology company’s mission of specialty medical societies to effectively link CME with MOC for improving health care and improving the bottom line. Publication their members. of successful educational interventions shows industry funder Bob Addleton, EdD, LPC, CCMEP, of the Physicians’ Institute management the value of education, and makes it easier to justify for Excellence in Medicine, shared his thoughts on future CME CME support through grants down the road. from the perspective of a state medical association. The Physicians’ Institute has 16 state medical society members, The Future of CME representing 900 accredited providers. Addleton pointed to the Speculating on the future of CME is a standard topic at challenges of either not enough staff or lack of trained staff in this conferences as well as in dialogue with colleagues, and the setting. There was a murmur of commentary when Addleton discussion at this conference gave attendees the opportunity to informed the crowd that 15 Missouri providers had announced reflect on accomplishments achieved and changes yet to come. they would no longer be offering accredited education due to Through the ARS, Maureen Doyle-Scharff, MBA, FACME, of their lack of human and financial resources. Moving from the old Pfizer Inc, obtained attendee feedback indicating that 92% of the way of doing CME to a higher-level CME would remain the funders indicated they would be more likely to support a grant challenge of this poorly funded provider setting. Addleton that included a budget to measure the activity’s impact on health advised, “Hospital-based CME people . . . need to rebrand care quality or patient outcomes. Fifty-one percent of the funding themselves from the people who are in charge of the meeting community in attendance voted that it would be appropriate to logistics to those who become advisors to physicians.” fund grant requests only if they included post-initiative publication of outcomes in a peer-reviewed journal. Doyle-Scharff also posed questions that in the years before “Hospital-based CME people . . . need maintenance of certification (MOC) requirements might have to rebrand themselves from the people been unthinkable. She asked whether attendees could imagine a world where: who are in charge of the meeting • The ACCME doesn’t exercise as much control as it logistics to those who become advisors currently does to physicians.” • American Medical Association Physician Recognition Award —Bob Addleton (AMA PRA) Category 1 creditTM doesn’t have the same value as it does today Destry Sulkes, MD, commented, “The idea of technology • Licensing bodies don’t care about AMA PRA Category adding to CME’s impact in the future is a big no-brainer.” He 1 credit pointed out that the push for technology in improving health care • AMA PRA Category 1 credit is one of many kinds of credit was set up in the previous administration, and that President that learners can apply toward their MOC or maintenance of Obama’s selection of David Blumenthal, MD, MPP, as head of the licensure (MOL). Office of the National Coordinator for Health Information 6 • Visit the Alliance website at www.acme-assn.org Almanac • Alliance for CME • Volume 31, No. 7 • July 2009
  • 7. Technology will advance our ability to see robust health care data and stratify information. Candid discussions about education in real time. Sulkes briefly described the FDA’s Sentinel Initiative, a versus promotion and an ethical code addressing COI need to partnership linking databases from Centers for Medicare and be part of future conversations on CME as well. Medicaid Services, the Veterans Administration and Department of Defense, and an array of private health care organizations, that will be able to aggregate data across millions of Americans, resul- “Prevention is one of the futures of the ting in important data such as drug safety, hospitalizations and health care industry.” physician visits, all of which will contribute up-to-date information —Jann Balmer that will influence US health policy. Sulkes commented that the Sentinel Initiative will provide new data and new pathways for the dissemination of up-to-date CME material in the years ahead. From the program presentations, attendees could conclude Alliance President, Jann Balmer, PhD, presented a detailed that CME planning and educational effectiveness will be summary of the future of CME and put the challenges of today’s demonstrated by the publication of objective data related to CME environment in the context of today’s health care improvements in patient care. There was a general consensus environment. Challenges include: among speakers that some form of a federally-legislated Sunshine • A highly regulated environment due to the FDA and the OIG Act, with mandated reporting of payments by industry to health care providers, will become policy—and that it would behoove • New and evolving frameworks regarding ACCME processes industry funders to embrace and adapt to the concept of a more and review, MOC, MOL, and informatics and information transparent process. technology The CME community has seen many changes over the past • A greater general public awareness of CME and calls for few years that include education divisions separated out from greater transparency, improved ethical behavior, and more marketing departments in pharmaceutical companies, funders’ effective management of industry relations. transparency databases, and a broader acceptance of linking Balmer also offered some criticism regarding documentation quality improvement with CME. CME providers have been that satisfied ACCME requirements. “I have concerns that the charged by the ACCME to be change agents. Clearly, CME focus on accreditation documentation can and often does funders are ready to support CME activities provided by change overshadow the important work of developing effective education agents who can produce the data that objectively demonstrate for our physician and health care professional audiences with the improvements in patient care. goal of improved performance and practice.” She proposed a Additional Resources future in which more monies could be spent on effective 1. Berwick DM. What “patient-centered” should mean: confessions of an education rather than on compliance tracking. extremist. Health Affairs. 2009;28(4):w555–w565. The Alliance president shared one idea for meeting the 2. Institute of Medicine. Conflict of Interest in Medical Research, Education, and challenges in the current CME environment is for CME Practice. Washington, DC: The National Academies Press; 2009. professionals to “design [activities] in a very purposeful manner, 3. US Department of Health and Human Services, Agency for Healthcare which goes not only to diagnostics and therapeutics, but also to Research and Quality, National Quality Measures Clearinghouse website: www.qualitymeasures.ahrq.gov. preventive strategies. Prevention is one of the futures of the health 4. Patient-Centered Primary Care Collaborative website: www.pcpcc.net. care industry, which is the talk of the current administration.” Balmer’s other suggestions included a patient-centric focus for 5. Institute for Healthcare Improvement website: www.ihi.org. guidelines-based CME, and clinician self-assessment. Team-based care would contribute to addressing challenges of the future, as would professional education that addressed informatics and Green Tip taught health care practitioners about how to manage, analyze, When choosing a site for your next meeting, institute due diligence in finding out what, if any, green features they offer (such as recycling, water in pitchers instead of single use Share your thoughts on Alliance issues bottles, energy-efficient lighting). Negotiate to include by contacting the Board at: additional green features in the contract (utilizing local food, no disposables). acmeboard@acme-assn.org. —Submitted by Brooke Taylor Almanac • Alliance for CME • Volume 31, No. 7 • July 2009 Visit the Alliance website at www.acme-assn.org • 7
  • 8. PINPOINT YOUR PERFECT PROSPECTS WITH MULTIDIMENSIONAL LISTS (SM) FROM Alliance for CME Value Vendor for lists, featuring AMA Physicians For more information, see <mmslists.com>, e-mail <sales@mmslists.com>, or call 1-800-MED-LIST (633-5478) or 1-630-350-1717. Calendar of Events September 9-11, 2009 October 14-16, 2009 January 27–30, 2010 NIQIE 2009 20th Annual Conference of the National Task Alliance for Continuing Medical Education Mastering Continuous Performance Improvement Force on CME Provider/Industry Collaboration 35th Annual Conference Intercontinental Chicago O'Hare Baltimore Marriott Waterfront, Baltimore, MD Establishing Continuing Medical Education as a Rosemont (Chicago), IL www.ama-assn.org/go/cmetaskforce Pathway to Better Patient Care www.niqie.org Hilton® New Orleans Riverside New Orleans, LA September 14-30, 2009 www.acme-assn.org NC-CME Exam www.nccme.org Alliance Almanac Almanac Editors 2009 Board of Directors Headquarters Office Jane Eckstein, MA—Editor-in-Chief Jann T. Balmer, PhD, FACME, President* Paul D. Weber, MA—Executive Director* Marissa Seligman, PharmD—Associate Editor Maureen Doyle-Scharff, MBA, FACME, Bernie Halbur, PhD, FACME—Professional Development Derek Dietze, MA—Assistant Editor Secretary/Treasurer* and Meeting Management Director Debra L. Gist, MPH, FACME—Assistant Editor Sue Ann Capizzi, MBA, FACME, Past President* Jay Brown, BA—Project Manager and Meeting Planner Robin Hendricks, MAdEd—Assistant Editor Bob Addleton, EdD James C. Leist, EdD, FACME—Staff Consultant Paul D. Weber, MA—Managing Editor Winnie Brown, MPA Diane Baker O’Hern—Professional Development Coordinator Mitch Pruitt—Production Editor Nancy Davis, PhD Marissa K. Green—Manager, Membership Information Services Barbara Huffman, MEd Anne Marie Smith, BS—Staff Assistant Jack Kues, PhD Debrah Fisher, BA—Manager of Member Services Almanac Editorial Board Damon K. Marquis, MA Alison Skinner, BA—Executive Assistant Linda DuPont, BA George Mejicano, MD* Jessica Romano, BS—Product Development/Marketing Specialist Paul Frisch, JD Greg Paulos, MBA Jill Real, BS—Bookkeeper Paige Green, MEd Linda Raichle, PhD, FACME Amy Guberman, MPM—Staff Consultant Kevin Heffernan Mark Schaffer, EdM Megan Pace, BA—Administrative Assistant Kate Regnier, MBA Destry Sulkes, MD Tiffany Stepien, BS The Almanac is published monthly by the Alliance for CME, 1025 Montgomery Highway, Suite 105, Birmingham, AL 35216; Brooke Taylor, MPH *Executive Committee Phone: 205-824-1355; Fax: 205-824-1357; email: acme@acme-assn.org; NaBrina J. Webb, MBA ISSN#1076-3899. The views expressed in the Almanac are those of Betsy Woodall, PharmD © Copyright 2009 by the Alliance for Continuing Medical the authors and are not intended to represent the views of the Education®. All rights reserved. Alliance or its membership. Alliance for Continuing Medical Education® Nonprofit Org. 1025 Montgomery Highway US Postage Suite 105 PAID Birmingham, AL 35216 Permit No. 2230 Birmingham, AL Address Service Requested