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These excerpts taken from the WBMD 10-K filed Feb 27, 2009. Regulation
and Accreditation of Continuing Medical Education
Activities and information provided in the context of an
independent medical or scientific educational program, often
referred to as continuing medical education or “CME,”
usually are treated as non-promotional and fall outside the
FDA’s jurisdiction. The FDA does, however, evaluate CME
activities to determine whether they are independent of the
promotional influence of the activities’ supporters. To
determine whether a CME provider’s activities are
sufficiently independent, the FDA looks at a number of factors
related to the planning, content, speakers and audience
selection of such activities. To the extent that the FDA
concludes that such activities are not independent, such content
must fully comply with the FDA’s requirements and
restrictions regarding promotional activities.
Table of Contents
Medscape, LLC distributes online CME to physicians and other
healthcare professionals and is accredited by the Accreditation
Council for Continuing Medical Education (ACCME), which oversees
providers of CME credit. MedscapeCME
(www.medscapecme.com) is the Web site through which
Medscape, LLC distributes online CME. If any CME activity that
Medscape, LLC provides is considered promotional, Medscape, LLC
may face regulatory action or the loss of accreditation by the
ACCME. Supporters of CME activities may also face regulatory
action, potentially leading to termination of support.
Medscape, LLC’s current ACCME accreditation expires at the
end of July 2010. In order for Medscape, LLC to renew its
accreditation, it will be required to demonstrate to the ACCME
that it continues to meet ACCME requirements. If Medscape, LLC
fails to maintain its status as an accredited ACCME provider
(whether at the time of such renewal or at an earlier time as a
result of a failure to comply with existing or additional ACCME
standards), Medscape, LLC would not be permitted to accredit CME
activities for physicians and other healthcare professionals.
Instead, Medscape, LLC would be required to use third parties to
provide such CME-related services. That, in turn, could
discourage potential supporters from engaging Medscape, LLC to
develop CME or education related activities, which could have a
material adverse effect on our business.
Medscape, LLC’s CME activities are planned and implemented
in accordance with the Essential Areas and Policies of the ACCME
and other applicable accreditation standards. ACCME’s
standards for commercial support of CME are intended to ensure,
among other things, that CME activities of ACCME-accredited
providers, such as Medscape, LLC, are independent of
“commercial interests,” which are now defined as
entities that produce, market, re-sell or distribute health care
goods and services, excluding certain organizations.
“Commercial interests,” and entities owned or
controlled by “commercial interests,” are ineligible
for accreditation by the ACCME. The standards also provide that
accredited CME providers may not place their CME content on Web
sites owned or controlled by a “commercial interest.”
In addition, accredited CME providers may not ask
“commercial interests” for speaker or topic
suggestions, and are also prohibited from asking
“commercial interests” to review CME content prior to
delivery.
From time to time, the ACCME revises its standards for
commercial support of CME. As a result of certain past ACCME
revisions, we adjusted our corporate structure and made changes
to our management and operations intended to allow Medscape, LLC
to provide CME activities that are developed independently from
those programs developed by its sister companies, which may not
be independent of “commercial interests.” We believe
that these changes allow Medscape, LLC to satisfy the applicable
standards.
In June 2008, the ACCME published for comment several proposals,
including the following:
Table of Contents
The comment period for these proposals ended on
September 12, 2008. The comments submitted to the ACCME
indicated significant backing from the medical profession for
commercially-supported CME and, accordingly, we believe that it
is unlikely that a proposal for complete elimination of such
support would be adopted. However, we cannot predict the
ultimate outcome of the process, including what other
alternatives may be considered by ACCME as a result of comments
it has received. The elimination of, or restrictions on,
commercial support for CME could adversely affect the volume of
sponsored online CME programs implemented through our Web sites.
During the past several years, educational activities, including
CME, directed at physicians have been subject to increased
governmental scrutiny to ensure that sponsors do not influence
or control the content of the activities. For example, the
U.S. Senate Finance Committee conducted an investigation of
the sponsorship of CME activities, including an examination of
the ACCME’s role in ensuring that CME activities are
independent from the influence of their supporters. In response,
pharmaceutical companies and medical device companies have
developed and implemented internal controls and procedures that
promote adherence to applicable regulations and requirements. In
implementing these controls and procedures, supporters of CME
may interpret the regulations and requirements differently and
may implement varying procedures or requirements. These controls
and procedures:
In addition, future changes to laws, regulations or
accreditation standards, or to the internal compliance programs
of supporters or potential supporters, may further discourage,
significantly limit, or prohibit supporters or potential
supporters from engaging in educational activities with Medscape
LLC, or may require Medscape LLC to make further changes in the
way it offers or provides educational activities.
Regulation and Accreditation of Continuing Medical Education Activities and information provided in the context of an independent medical or scientific educational program, often referred to as continuing medical education or “CME,” usually are treated as non-promotional and fall outside the FDA’s jurisdiction. The FDA does, however, evaluate CME activities to determine whether they are independent of the promotional influence of the activities’ supporters. To determine whether a CME provider’s activities are sufficiently independent, the FDA looks at a number of factors related to the planning, content, speakers and audience selection of such activities. To the extent that the FDA concludes that such activities are not independent, such content must fully comply with the FDA’s requirements and restrictions regarding promotional activities.
Table of ContentsMedscape, LLC distributes online CME to physicians and other healthcare professionals and is accredited by the Accreditation Council for Continuing Medical Education (ACCME), which oversees providers of CME credit. MedscapeCME (www.medscapecme.com) is the Web site through which Medscape, LLC distributes online CME. If any CME activity that Medscape, LLC provides is considered promotional, Medscape, LLC may face regulatory action or the loss of accreditation by the ACCME. Supporters of CME activities may also face regulatory action, potentially leading to termination of support. Medscape, LLC’s current ACCME accreditation expires at the end of July 2010. In order for Medscape, LLC to renew its accreditation, it will be required to demonstrate to the ACCME that it continues to meet ACCME requirements. If Medscape, LLC fails to maintain its status as an accredited ACCME provider (whether at the time of such renewal or at an earlier time as a result of a failure to comply with existing or additional ACCME standards), Medscape, LLC would not be permitted to accredit CME activities for physicians and other healthcare professionals. Instead, Medscape, LLC would be required to use third parties to provide such CME-related services. That, in turn, could discourage potential supporters from engaging Medscape, LLC to develop CME or education related activities, which could have a material adverse effect on our business. Medscape, LLC’s CME activities are planned and implemented in accordance with the Essential Areas and Policies of the ACCME and other applicable accreditation standards. ACCME’s standards for commercial support of CME are intended to ensure, among other things, that CME activities of ACCME-accredited providers, such as Medscape, LLC, are independent of “commercial interests,” which are now defined as entities that produce, market, re-sell or distribute health care goods and services, excluding certain organizations. “Commercial interests,” and entities owned or controlled by “commercial interests,” are ineligible for accreditation by the ACCME. The standards also provide that accredited CME providers may not place their CME content on Web sites owned or controlled by a “commercial interest.” In addition, accredited CME providers may not ask “commercial interests” for speaker or topic suggestions, and are also prohibited from asking “commercial interests” to review CME content prior to delivery. From time to time, the ACCME revises its standards for commercial support of CME. As a result of certain past ACCME revisions, we adjusted our corporate structure and made changes to our management and operations intended to allow Medscape, LLC to provide CME activities that are developed independently from those programs developed by its sister companies, which may not be independent of “commercial interests.” We believe that these changes allow Medscape, LLC to satisfy the applicable standards. In June 2008, the ACCME published for comment several proposals, including the following:
Table of ContentsThe comment period for these proposals ended on September 12, 2008. The comments submitted to the ACCME indicated significant backing from the medical profession for commercially-supported CME and, accordingly, we believe that it is unlikely that a proposal for complete elimination of such support would be adopted. However, we cannot predict the ultimate outcome of the process, including what other alternatives may be considered by ACCME as a result of comments it has received. The elimination of, or restrictions on, commercial support for CME could adversely affect the volume of sponsored online CME programs implemented through our Web sites. During the past several years, educational activities, including CME, directed at physicians have been subject to increased governmental scrutiny to ensure that sponsors do not influence or control the content of the activities. For example, the U.S. Senate Finance Committee conducted an investigation of the sponsorship of CME activities, including an examination of the ACCME’s role in ensuring that CME activities are independent from the influence of their supporters. In response, pharmaceutical companies and medical device companies have developed and implemented internal controls and procedures that promote adherence to applicable regulations and requirements. In implementing these controls and procedures, supporters of CME may interpret the regulations and requirements differently and may implement varying procedures or requirements. These controls and procedures:
In addition, future changes to laws, regulations or accreditation standards, or to the internal compliance programs of supporters or potential supporters, may further discourage, significantly limit, or prohibit supporters or potential supporters from engaging in educational activities with Medscape LLC, or may require Medscape LLC to make further changes in the way it offers or provides educational activities. | EXCERPTS ON THIS PAGE:
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