Life Science Compliance Update

May 05, 2015

ACCME Updates Disclosure Policy For Commercial Support

*CME Providers may now use hyperlinks to link to disclosure information

*Also, starting May 1: All commercial logos must be removed from educational materials and disclosures in accordance with last year's decision

 

Accme

The Accreditation Council for Continuing Medical Education (ACCME) now allows for accredited CME providers to use tabs and hyperlinks to transmit disclosure information to learners at educational activities. ACCME notes that this revised policy does not affect the actual disclosure requirements under the Standards for Commercial Support, just the method for disclosure. Furthermore, one year after ACCME modified its logo policy, no educational material or disclosures should contain a commercial logo or slogan. Materials may still state the name, mission, and areas of clinical involvement of commercial interests.

Updated: 5/5/2015: We previously indicated that starting May 2015, there is "no longer an exception" to the new logo policy for materials that existed at the time of ACCME's April 2014 policy. ACCME has indicated that there was never a specific exception for these materials, only an extended timeframe for accredited providers to come into compliance with the new rules. CME providers were told that they did not need to discard their current materials and reprint them without a logo, but that they were expected to make the changes by May 2015 into all current and future CME materials. ACCME states: "After May 2015, the ACCME will begin to find providers in noncompliance if logos of ACCME-defined commercial interests are included with disclosure of commercial support."

ACCME requires all commercial support to be disclosed in a specific manner, in accordance with their Standards for Commercial Support (SCS):

ACCME SCS: Disclosure Relevant to Potential Commercial Bias

  • Standard 6.1: An individual must disclose to learners any relevant financial relationship(s), to include the following information: The name of the individual; The name of the commercial interest(s); The nature of the relationship the person has with each commercial interest.
  • Standard 6.2: For an individual with no relevant financial relationship(s) the learners must be informed that no relevant financial relationship(s) exist.  
  • Standard 6.3: The source of all support from commercial interests must be disclosed to learners. When commercial support is "in-kind‟ the nature of the support must be disclosed to learners.  
  • Standard 6.4: 'Disclosure' must never include the use of a corporate logo, trade name or a product-group message of an ACCME-defined commercial interest.  
  • Standard 6.5: A provider must disclose the above information to learners prior to the beginning of the educational activity.  

"In a continuing effort to simplify compliance expectations and make them consistent across activity types, the ACCME has decided to allow accredited CME providers to use tabs, links, or other electronic mechanisms to transmit disclosure information to learners for CME activitiesm" states ACCME. Previously, CME providers were restricted from using methods such as electronic tabs or links and had to "use a method that ensured learners passed through electronic disclosure information before engaging in an activity."

"Now, CME providers can make electronic disclosure information available via an electronic tab or link, just as they have always been able to make disclosure available via a tabbed section in a printed syllabus."

"Regardless of the method, the ACCME expects—as it always has—that disclosure information will be delivered prior to the beginning of the CME activity and will be clearly marked, accessible, and useful for learners," ACCME advises. 

As noted in Standard 6.4, last year, ACCME elected to disallow the use of company logos on educational materials and disclosure information. ACCME CEO and President, Dr. Murray Kopelow, discussed the modifications in a webinar, noting that a CME provider's "acknowledgment of commercial support as required by Standards 6.3 and 6.4 may state the name, mission, and areas of clinical involvement of an ACCME-defined commercial interest but may not include corporate logos and slogans."

He stated that this change is effective immediately but does not apply to currently printed existing materials. CME providers "do not need to throw them out and reprint them, but you do need to make all of these changes and incorporate this new policy by May 2015 into your printed materials and your Internet presentations of continuing medical education."

Kopelow also clarified: 

I want to emphasize that this change only applies to mixing educational materials and logos and only applies to mixing disclosure of commercial support and logos; it applies to nothing else. It is not relevant to when a speaker mentions a brand name in your educational materials or if you're using a device to teach accredited continuing medical education and that device has a logo or brand on it. You don't have to remove that logo from the device.

 

April 29, 2015

“Encouraging Continuing Medical Education For Physicians” Incorporated Into Newly Updated 21st Century Cures Discussion Draft

Notable updates to January's Draft include bipartisan concessions: New provisions to increase NIH funding; removal of provisions for increased exclusivity periods. 

Ladd email

Today, the House Energy and Commerce Committee released an updated discussion draft of 21st Century Cures legislation (view the legislative text, whittled from 400 pages to 199 pages since January); a section-by-section explainer; and a 1-page summary). “The yearlong 21st Century Cures listening session explored the complete cycle of cures – from the discovery of clues in basic science, to the development of new treatments, to the delivery of those cures, and back again to further discovery,” the House notes in the press release for the new bill.

Unlike January’s release of the draft, which Democrats did not formally endorse, today's document  is issued as a bipartisan bill by Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO), Full Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX).

Concessions: NIH Funding In; Market Exclusivity Out

One of the most notable new aspects of the bill—clearly evidenced as the lead off provision—is that the 21st Century Cures bill would raise NIH funding to $31.8 billion in 2016 and to $34.85 billion in 2018. The bill would also create an NIH Innovation Fund of $2 billion per year to support “precision medicine” and “young emerging scientists.”

Another important change is the absence of provisions which extended the marketing exclusivity. The January version of the bill included a 15-year marketing exclusivity for “dormant therapies,” defined as medicine that “is being investigated or is intended to be investigated for an indication to address one or more unmet medical needs…”  The old bill also sought more exclusivity for “New Therapeutic Entities” and “Orphan Products.” View Title 1, Subtitles L, M, and N in the old bill’s language, not found in the new version. 

Encouraging Continuing Medical Education for Physicians

Most interesting to Policy and Medicine readers likely concerns the status of the continuing medical education provision in the new bill. The language is updated considerably from the first go-round. 

Subtitle C—Encouraging Continuing Medical Education for Physicians:Exempting from manufacturer transparency reporting certain transfers used for educational purposes.  

Updates to the Sunshine Act reporting requirements are included in red. 

Transparency Reports and Reporting of Physician Ownership or Investment Interests, Sec. 1128G. [42 U.S.C. 1320a-7h]

(B) Exclusions.—An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:

  • (iii) Educational materials that directly benefit patients or are intended for patient use, including peer-reviewed journals, journal reprints, journal supplements, and medical textbooks;
  • (xiii) In the case of a covered recipient who is a physician, an indirect payment or transfer of value to the covered recipient 
    • (I) for speaking at, or preparing educational materials for, an educational event for physicians or other health care professionals that does not commercially promote a covered drug, device, biological, or medical supply; or
    • (II) that serves the sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event.

This language is much clearer than previously set forth. CME Coalition Senior Advisor, Andy Rosenberg, was encouraged by the language in the new bill, and commended the bipartisan effort set forth in the 21st Century Cures initiative.  

Sharing Off-Label Data and Social Media

Also of note, the original draft's provision encouraging FDA to consider a new regulatory approach to social media has been dropped from the final bill. This could be in recognition of the fact that FDA has agreed to align their guidances concerning scientific exchange with the First Amendment. 

This new bill includes an important section entitled "Facilitating Dissemination of Health Care Economic Information," which offers some regulatory leniency concerning communications with payors and formulary committees. This is especially significant given the more prominent decision-making role payors play in the current health care environment. 

Other Highlights in the Bill 

The Energy and Commerce Committee ran down a short list of provision highlights in the bill, which, in addition to increasing the flow of funds to NIH, also:

  • Incorporate the patient perspective in the discovery, development, and delivery process.
  • Foster development of treatments for patients facing serious or life-threatening diseases.
  • Repurpose drugs for serious or life-threatening diseases and conditions.
  • Modernize clinical trials.
  • Break down barriers to increased collaboration and data sharing among patients, researchers, providers, and innovators.
  • Help the development of personalized and precision medicines so the right patient can receive the right treatment at the right time.
  • Provide for continued work in the telehealth space.
  • Advance a truly interoperable health care system.
  • Provide clarity for developers of software products used in health management and medical care.

We will continue to cover this important legislation as it makes its way through Congress. 

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