Life Science Compliance Update

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.

May 10, 2017

ABIM and ACCME Increase CME and QI Opportunities for Physicians

ABIM_rotating-01

The American Board of Internal Medicine (ABIM) and the Accreditation Council for Continuing Medical Education (ACCME) have expanded their collaboration to recognize more accredited continuing medical education (CME) for Maintenance of Certification (MOC). With this expansion, accredited providers are now able to register activities that meet ABIM’s requirements for Medical Knowledge and/or Practice Assessment MOC.

ABIM and ACCME expanded their collaboration to increase the number and diversity of accredited CME activities that earn both CME credit and MOC points in support of physicians participating in lifelong learning and quality improvement to make a meaningful difference in patient care.

While ABIM has extended its decision to not require Practice Assessment in its MOC program through December 31, 2018, MOC points are still available to physicians who complete Practice Assessment activities.

Additionally, using the online CME Finder tool, physicians can choose from over 3,000 accredited CME activities that count for ABIM MOC.

Richard J. Baron, MD, President and CEO of ABIM, noted, "In less than two years, ABIM’s collaboration with ACCME has resulted in over 3.3 million MOC points earned by more than 68,000 physicians for accredited CME activities they are already doing to stay current and improve the care they provide. As our collaboration expands we want to offer physicians even more choice and convenience for how they fulfill ongoing education and certification requirements. With this expansion, many new types of activities that combine lifelong learning and quality improvement will also be available for dual credit."

A Simpler, Unified Process

Accredited CME providers can now use the ACCME Program and Activity Reporting System (PARS) to register CME activities that are offered in any format, similar to what they have been doing for Medical Knowledge activities. Activities may be registered for a single type of ABIM MOC credit or for combinations of credit types, including Medical Knowledge and Practice Assessment, so long as they meet the guidelines described in the ABIM MOC Assessment Recognition Program Guide.

Building on Success

The expansion builds on the ongoing success of the ABIM/ACCME collaboration. Since the collaboration’s launch in 2015, the number and diversity of accredited CME activities that count for ABIM MOC has increased substantially, as has learner participation. More than 240 accredited CME providers registered over 7,000 activities that count for ABIM MOC in PARS.

Graham McMahon, MD, MMSc, President and CEO of ACCME, stated, "We celebrate the expansion of our collaboration with ABIM, because it will generate many more opportunities for accredited CME providers to support physician engagement in education that focuses on quality and safety improvement. Since its inception in 2015, our collaboration has succeeded in making a real and meaningful difference to physicians and educators who are working every day to improve healthcare in their communities. I look forward to building on that success and continuing to work together with ABIM, accredited CME providers, and physicians to leverage the power of education to optimize care for the patients we all serve."

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