(Final letter with responses to 3 calls for comment Sept 10 205)

Ctierney

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• Publié par: Suib
• Nombre de lectures: 23
• Langue: English

Extrait

September 10, 2008


Murray Kopelow, MD
Chief Executive
Accreditation Council for Continuing Medical Education
515 N. State Street, Suite 1801
Chicago, Illinois 60654

RE: ACCME Policy Announcements and Calls for Comment

Dear Dr. Kopelow:

The American Academy of Family Physicians (AAFP) is pleased to offer a response to
the proposed policy changes to the Accreditation Council for Continuing Medical
Education (ACCME) Standards for Commercial Support. In this response we will reflect
three perspectives — that of family physicians across the U.S. who seek quality,
unbiased continuing medical education (CME); that of a professional medical specialty
society; and that of an ACCME-accredited provider of CME.

First, AAFP affirms that ACCME is now, and should remain, the leading national multi-
specialty entity that develops and disseminates CME rules and regulations. A strong
ACCME is in the best interest of both physicians and the patients they serve. We also
assert that the AAFP carefully monitors our adherence to the ACCME’s 2004 Standards
for Commercial Support, as well as other pertinent laws, regulations, ethical codes,
guidelines and considerations that inform our ability to ensure the identification,
disclosure, and resolution of real or perceived conflicts of interest and/or bias, and are
proud to have earned the designation of “Accreditation with Commendation” from the
ACCME in 2001 and again in 2007. However, the AAFP disagrees with several premises
or solutions set forth by ACCME in its June and August 2008 calls for comment on the
following three matters:










I. The ACCME Will Ensure Current Processes of Attaining Commercial Support
Will Not Undermine the Independence of Continuing Medical Education.

II. The ACCME Believes that Due Consideration be Given to the Elimination of
Commercial Support of Continuing Medical Education Activities

III. ACCME Proposes Additional Features of Independence in Accredited
Continuing Medical Education


I. The ACCME Will Ensure Current Processes of Attaining Commercial Support
Will Not Undermine the Independence of Continuing Medical Education.

ACCME proposes that “Accredited providers must not receive communications from
commercial interests announcing or prescribing any specific content that would be a
preferred, or sought-after, topic for commercially supported CME … deliver that content.”

AAFP agrees with ACCME that independence of CME must be assured; but AAFP
objects to further restrictions in communications between accredited providers and
commercial interests regarding various practical topics for consideration that pertain to
the financial support but not the educational content of CME. AAFP believes that the
current ACCME guidelines for interactions between accredited providers and
commercial interest are sufficiently effective in assuring independence, and that further
restrictions on communication could jeopardize best practices in patient care by
restricting or slowing the translation of medical research into education and practice.

As an ACCME-accredited provider and the country’s first national CME accreditor, AAFP
appreciates the fact that ACCME will update its criteria and expectations on a regular
basis to support continuous improvement in the provision of CME. In fact, AAFP has
adopted ACCME’s criteria for AAFP-provided CME, and we require that CME providers
seeking AAFP CME credit likewise comply with ACCME policies and standards for
commercial support. We agree on the importance of rigorously applied safeguards to
assure CME independence, such as the identification, disclosure, and resolution of real
or potential conflicts of interest. We remain committed to ensuring that AAFP-provided
CME and AAFP-accredited CME is objective and relevant; not influenced inappropriately
by external support or other factors that would introduce bias in a manner that could
jeopardize the appropriate translation of science into research, education, and practice.
We regularly and rigorously verify that AAFP CME is designed and conducted in a
manner that supports improvements in professional competence, practice performance,
and ultimately, patient outcomes.


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AAFP disagrees, however, with ACCME’s proposed additional restrictions in interactions
between accredited providers of CME and industry; they are both unnecessary and
operationally impractical. Professional medical specialty societies seeking funding must
be allowed to communicate, directly when appropriate, with industry about matters of
mutual interest which may at times include discussion of broad therapeutic topics for
educational content, or scientific evidence for the incidence and burden of various
diseases and conditions. Likewise, external supporters, whether commercial, private
foundations, government agencies, or other entities, must be allowed to convey in broad
terms what activities they are willing to fund. No evidence has been disseminated by
ACCME or others to show that such broad conversations lead to ‘… guidance, either
nuanced or direct …’ in a manner that inappropriately influences CME.

II. The ACCME Believes that Due Consideration be Given to the Elimination of
Commercial Support of Continuing Medical Education Activities

ACCME proposes that “…if the following (four) conditions were all met, then the
commercial support of individual activities would be in the public interest and could
continue to be allowed.”
1. When educational needs are identified and verified by organizations that do not
receive commercial support and are free of financial relationships with industry
((e.g., U.S. government agencies), and
2. If the CME addresses a professional practice gap of a particular group of
learners that is corroborated by bona fide performance measurements (e.g.,
National Quality Forum) of the learners’ own practice; and
3. When the CME content is from a continuing education curriculum specified by a
bona fide organization, or entity, (e.g., AMA, AHRQ, ABMS, FSBM); and
4. When the CME is verified as free of commercial bias.

AAFP views ACCME’s proposal of such a list as problematic in principle, and as
operationally impractical. In particular, we disagree with items 1 and 3 in ACCME’s list of
conditions for allowance of commercial support.

Regarding item 1, educational needs: The identification and verification of educational
needs is core to the organizational mission of professional medical specialty societies.
Specifically, a cornerstone of AAFP’s mission is to educate our members — practicing
family physicians, family medicine residents and medical students – this is one of the
four strategic objectives of the organization. AAFP serves as its members’ steward and
advocate, and is thus uniquely positioned to best know and understand physician
members’ educational needs and learning or performance practice gaps. Thus AAFP
strongly objects to ACCME’s suggestion that such educational needs are better
understood by U.S. government agencies. It is a false premise that U.S. government

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agencies are free of financial relationships with industry, as indicated by the prevalence
of lobbying that occurs regularly in our nation’s capital.

Regarding item 2, measurable performance practice gaps: AAFP agrees with ACCME
that CME should address learners’ professional practice gaps as corroborated by bona
fide performance measurements. We agree that the National Quality Forum is one, but
not the only, organization from which such performance measurements may be set forth.

Regarding item 3, CME curriculum: AAFP does not question the valuable contributions
that ABMS, AHRQ, and FSMB make in regards to the advancement and assurance of
quality medical research, education and practice, but AAFP strongly disagrees with
ACCME’s designation of those organizations as the bona fide entities for specification of
CME content or curriculum. Should such a list exist, it must explicitly acknowledge the
unequivocal role and responsibility of professional medical specialty societies in
determining or overseeing specialty-specific CME curriculum. As noted in ACCME’s
2007 annual report (published August 28, 2008), Physician Membership Organizations
currently provide over 23% of all of ACCME-accredited CME in the United States.
Whatever approach is adopted to ensure that physicians are properly trained must
include a major role for these medical specialty societies, including the identification and
verification of educational needs, and the specification of educational curriculum.

Regarding item 4, freedom from commercial bias: AAFP agrees with the ACCME’s
commitment to verify CME is free from bias – whether due to commercial support or due
to any other means by which bias may arise. However, AAFP has not found evidence in
our own experience as an ACCME-accredited provider and as an accreditor, that
commercially supported certified CM