Life Science Compliance Update

June 16, 2017

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

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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

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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."

April 27, 2017

ACCME Announces New Logo and Provider Marks

ACCME

The Accreditation Council for Continuing Medical Education (ACCME) has introduced a new logo, tagline, and color palette that emphasize the lifelong journey of learning and celebrate the continued trajectory of the continuing medical education (CME) community. New marks are also available for CME providers to communicate their accreditation status.

The initiative is part of the ACCME’s efforts to build visibility for the CME community and communicate the value of accreditation and accredited CME. The new visual identity is designed to convey the transformation in accredited CME to better meet the needs of clinicians and teams where they live, work, and learn. It also reflects the ACCME’s evolving role as coach – in addition to regulator – aiming to support, inspire, and motivate the community of educators to achieve its full potential.

The shape of the logo is intended to suggest upward movement and expansion, while the clean lines reflect the precision and accuracy of accreditation, built on the ACCME’s solid foundation. The colors were chosen to show growth and a nurturing environment for education.

“Our new logo represents our aspirations for accredited CME. Working with our community of healthcare leaders, educators, clinicians, and patients, we are leveraging the power of education to advance quality in medicine and optimize care, health, and wellness—today and in the years to come,” said Todd Dorman, MD, Chair, Board of Directors, ACCME.

“Our new logo and tagline capture the role of learning in promoting wellness for all of us. As a physician and CEO of the ACCME, I’m optimistic and excited about our future, as we work together to expand the flexibility, inclusiveness, and diversity of education— with the aim of improving care for the patients and communities we all serve,” said Graham McMahon, MD, MMSc, President and CEO, ACCME.

Dr. McMahon and the ACCME staff discuss the meaning of the new logo and tagline in this video.

Marks for Accredited Providers

The new provider marks are adaptations of the ACCME logo, and serve to create a recognizable, consistent visual identity. The marks serve as a message from accredited CME providers to clinicians: continuing education is relevant to your needs, evidence-based, effective, and independent of commercial influence.

Providers directly accredited by the ACCME System and those accredited by ACCME Recognized Accreditors are welcome to use these updated marks beginning immediately. However, use of these marks is optional. More information for providers about how to use the marks is available here.

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