Life Science Compliance Update

August 23, 2017

AMA and ACCME Announce Simplification of Credit and Accreditation Systems

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On August 1, 2017, the American Medical Association (AMA) and the Accreditation Council for Continuing Medical Education (ACCME) announced that they have adopted a final proposal to simplify and align their expectations for accredited continuing medical education (CME) activities certified for AMA PRA Category 1 Credit.

The final proposal follows a call for comment on the proposed simplification in April 2017, when the vast majority of those who responded endorsed the proposal and agreed that it would give them sufficient opportunity to innovate and evolve their CME programs. The proposal was then adopted by both the AMA and the ACCME and the organizations are now working together to develop a list of frequently asked questions and other resources to assist members with implementation.

This simplification is expected to encourage both innovation and flexibility in CME while ensuring that activities meet education standards and are free from commercial influence. The simplification aims to permit accredited CME providers to introduce and blend new instructional practices and learning formats that are appropriate to the learners and the setting – as long as they follow the AMA’s seven core requirements.

The core requirements are aligned with ACCME accreditation requirements—and do not represent any new rules for accredited providers. In addition, the AMA has simplified and reduced its learning format requirements to provide more flexibility for CME providers. To further encourage innovation in educational design and delivery, CME providers may design and deliver an activity that uses blended or new approaches to driving meaningful learning and change. For these activities, the provider can designate credits on an hour-per-credit basis using their best reasonable estimate of the time required to complete the activity.

“The simplification and alignment will encourage innovation and experimentation in CME, so that educators are free to respond nimbly to their learners’ changing needs while staying true to core principles for educational excellence and independence. We celebrate this collaborative effort with our AMA colleagues and thank our community of accredited CME providers for their high level of engagement in this process. We look forward to our continued work together to drive quality in clinicians’ lifelong learning and improve care for the patients we all serve,” said Graham McMahon, MD, MMSc, President and CEO, ACCME.

“Recognizing the need to better align the AMA and ACCME’s requirements for CME accreditation and reaccreditation, we believe that our newly adopted proposal will support the evolution of CME to better meet the needs of educators, physicians, and the patients they serve,” said Susan Skochelak, MD, AMA Group Vice President for Medical Education. “We look forward to continuing our work with ACCME on a more streamlined system that benefits providers and patients alike.”

In addition to collaborating on the simplification and alignment, the AMA and ACCME produced a shared glossary of terms and definitions to help clarify terminology for accredited CME providers and learners, developed as part of their alignment efforts and in response to requests from CME providers.

July 17, 2017

CME Continues to Grow and Evolve

Accme

The Accreditation Council for Continuing Medical Education (ACCME®) recently released the ACCME Data Report: Growth and Evolution in Continuing Medical Education — 2016. The 2016 report includes data from a community of over 1,800 accredited continuing medical education (CME) providers that offer physicians and healthcare teams an array of resources to promote quality, safety, and the evolution of healthcare.

Key Report Takeaways
The report highlights the fact that CME is a vibrant – and growing – community. Last year, ACCME along with more than 1,800 accredited CME providers offered close to 159,000 educational activities, comprising more than one million hours of instruction and interactions with 27 million health care professionals.

Since 2015, the number of educational events has increased 7% while hours of instruction increased by 9% and interactions with clinicians increased by 5%. Even more impressive, the number of activities and interactions have increased each year since 2010, despite some consolidation among CME providers.

The numbers of physician interactions have either increased over the years, or remained stable. The number of interactions with non-physician health care professionals such as nurses, physician assistants, and pharmacists shows steady growth.

Accredited CME providers represent a range of organizations from national physician membership organizations to rural hospitals. Some specialize in local, community-based health issues, others focus on national and international health priorities, and others advance interprofessional continuing education (IPCE) and team-based care. The ACCME recently began accrediting organizations outside the US, and this report includes their data as well.

The geographic distribution and diversity of CME providers means that clinicians and teams have access to education where they live and work that addresses local, national, and international healthcare priorities.

“Every day, across the country, clinicians can choose from more than 3,000 hours of accredited CME. Accredited CME is a tremendous resource — offering clinicians, educators, and health leaders the power and capacity to address many of the challenges we face in our changing healthcare environment,” said Graham McMahon, MD, MMSc, President and CEO, ACCME.

In his introduction to the report, Dr. McMahon also noted,

I’m delighted about the growth because it means that clinicians are increasingly engaged in education that promotes quality, safety, and the evolution of healthcare. Behind the numbers in the ACCME Data Report are educators who work every day to engage clinicians where they live, work, and learn. CME providers are creating “educational homes” that tackle health challenges while nurturing the professional development — and passion — of clinicians and teams.

He continues,

As this report demonstrates, accredited CME aims at changing more than knowledge—CME providers design and evaluate activities for meaningful change in skills, performance, and patient health outcomes. Organizations ranging from small, rural hospitals to national institutions such as the Food and Drug Administration and Centers for Medicare & Medicaid Services have recognized the value of accredited CME in advancing public health imperatives.

Dr. McMahon created a video introduction to the data, which can be found here.

Excel tables with data used to create reports can be found here.

ACCME Data Report Addendum can be found here.

ACCME Data Report Addendum Excel tables can be found here

 

June 16, 2017

California "Gift" Ban Bill Amended to Drop Fines and Requires Accreditation for Education Events

Californiastatecapitol

California has not been known to be the most “business friendly” state in the union in recent history. We recently wrote about legislation passed in the California state senate that was intended to restrict pharmaceutical companies from giving gifts and incentives to medical professionals. The bill prohibits drug manufacturers from offering or giving a gift to a health care provider.

The bill also prohibits a manufacturer or an entity on behalf of a manufacturer from providing a fee, payment, subsidy, or other economic benefit to a health care provider in connection with the provider’s participation in research. Exempts the annual direct salary support for principal investigators and other health care professionals for the purposes of a bona fide clinical trial from this provision.

The Bill was amended in the California assembly on June 13, 2017, to remove the penalty provisions. The bill passed in the assembly does not allow the Attorney General to bring an action seeking injunction relief, costs, attorney fees and a civil penalty up to $10,000 for each violation of the law, nor does it allow the Attorney General to

investigate and obtain remedies as are granted to the Director of Consumer Affairs pursuant to Chapter 4 (commencing with Section 300) of Division 1 of the Business and Professions Code.

Additionally, as those provisions were dropped, the amended legislation would ban doctors from participating as faculty or speakers in events that are not accredited by the Accreditation Council for Continuing Medical Education (ACCME) – or a comparable organization.

The legislation, as written, specifically lists monetary benefits that shall be excluded from the prohibition, and therefore, considered to be permitted notwithstanding the passage of this bill. Some of those include:

  • Samples of a prescribed product or reasonable quantities of an over-the-counter drug, an item of medical food as defined in Section 360ee of Title 21 of the United States Code, or infant formula as defined in Section 321 of Title 21 of the United States Code, that are provided to a health care provider for free distribution to patients.
  • The provision, distribution, dissemination, or receipt of peer-reviewed academic, scientific, or clinical articles or journals and other items that serve a genuine educational function provided to a health care provider for the benefit of patients.
  • Scholarship or other support for medical students, residents, and fellows to attend a significant educational, scientific, or policymaking conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship or other support is selected by the association.
  • Rebates and discounts for prescribed products provided in the normal course of business.
  • Labels approved by the federal Food and Drug Administration for prescribed products.
  • The provision to a free clinic of financial donations or of free prescription drugs, over-the-counter drugs, biological products, combination products, medical food, or infant formula.
  • Prescribed products distributed free of charge or at a discounted price pursuant to a manufacturer-sponsored or manufactured-funded patient assistance program.
  • Fellowship salary support provided to fellows through grants for manufacturers of prescribed products, provided that all of the following conditions are satisfied:

(1) The grants are applied for by an academic institution or hospital.

(2) The institution or hospital selects the recipient fellows.

(3) The manufacturer imposes no further demands or limits on the institution’s, hospital’s, or fellow’s use of the funds.

(4) Fellowships are not named for a manufacturer and no individual recipient’s fellowship is attributed to a particular manufacturer of prescribed products.

Industry Reaction

The Biotechnology Innovation Organization (BIO) states that their member companies know the importance of basing relationships with health care practitioners on high standards of ethics and professional conduct, which is why they strictly adhere to federal statutes, regulations, and internal policies already in place. BIO is concerned that this bill could encumber important interactions between biopharmaceutical manufacturers and health care practitioners.

The Pharmaceutical Research and Manufacturers of America (PhRMA) writes that this bill is unnecessary because current law already addresses interactions between health care practitioners and drug manufacturers, public disclosures are already required, and they know of no problem that has surfaced recently which would give rise to more legislation in this area.

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