Life Science Compliance Update

April 26, 2017

AMA and ACCME Announce Call for Comment on Proposal

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Yesterday, the American Medical Association (AMA) and the Accreditation Council for Continuing Medical Education (ACCME) issued a call for comment on their joint proposal to simplify and align their expectations for accredited continuing medical education (CME) activities that offer the AMA PRA Category One CreditTM. The proposal for alignment attempts to encourage innovation and flexibility in accredited CME, while continuing to ensure that activities meet educational standards and are independent of commercial influence.

The proposal is aimed at allowing accredited CME providers to introduce and blend new instructional practices and learning formats that are appropriate to their learners and the setting, provided that they abide by the seven core requirements found within the proposal. Those seven core requirements are aligned with ACCME requirements and do not represent any new rules for accredited providers. Found in the proposal, the AMA simplified and reduced its learning format requirements to provide more flexibility for CME providers.

Under the proposal, 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.

Graham McMahon, MD, MMSc, President and CEO of ACCME, noted,

We celebrate this collaborative effort with our AMA colleagues and the opportunity to advance the evolution of CME. This proposal reflects the values of our CME providers and supports their aspirations to engage in education that makes a meaningful difference in clinician practice and patient care. We want to do everything we can to 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 thank accredited CME providers for their participation in this process and look forward to their feedback on our proposal and to our continued work together to drive quality in postgraduate medical education and improve care for the patients and communities we all serve.

Susan Skochelak, MD, AMA Group Vice President for Medical Education, was also pleased with the proposal, stating,

Based on the feedback we received from the CME community during listening sessions, we recognize the need to better align the AMA and ACCME’s requirements for CME accreditation and reaccreditation. We believe that our proposal will support the evolution of CME to better meet the needs of educators, physicians, and the patients they serve. We want to hear from the CME community to make sure the proposal addresses their feedback. We encourage CME providers to submit their comments to the proposal so we can continue to evolve to a more streamlined system that meets their needs. 

Following the call for comment period, the AMA and ACCME will analyze the feedback and determine whether to make modifications to the proposal and glossary. Once finalized, the resulting new process will be integrated into the existing accreditation and reaccreditation processes.

If any of our readers wish to comment on the proposal, you may do so here. Comments will be accepted through Thursday, May 25, 2017, at 5:00 pm CST. If you are unable to meet that deadline, but wish to provide constructive comments, email info@accme.org to request an extension.

The Murky Future of Physician Owned Distributorships (“PODs”)?

On January 9, 2017, a physician was sentenced for his role in a criminal health care fraud scheme totaling approximately $2.8 million and focused on False Claims Act (FCA) related allegations concerning  this physicians’ participation in very complex and elaborate physician-owned distributorships (PODs). PODs are described by the government as physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their patients at hospitals or ambulatory surgical centers. In recent years, PODs have been subjected to heightened regulatory scrutiny and oversight because of the potential for abuse, fraud, and conflicts of interest; as a result, the future of PODs remains highly uncertain.

When someone says PODs, it is natural to think of a sci-fi movie. For the life sciences industry, PODs have another connotation; physician-owned distributorships. Physician-owned distributorships are “physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their patients at hospitals or ambulatory surgical centers.”

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April 25, 2017

AMA Releases Satisfaction and Stress Survey Results of Physicians

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At the end of March 2017, the American Medical Association (AMA) released survey findings that explored the experiences, perceptions, and challenges that are currently facing physicians in the current healthcare environment.

1,200 physicians, residents, and medical students (400 of each) participated in the online survey, which when respondents knew they would become physicians, who encouraged them down that path, what challenges they face professionally, and whether they are satisfied with their career choice.

According to the survey, nine in ten physicians are satisfied with their career choice, despite challenges common to each career stage. Three quarters of medical students, residents, and physicians said that helping people is a top motivator for pursuing their career and sixty-one percent of all respondents said they would encourage others to enter the field of medicine. Personal experiences as a patient, volunteer, and with family members played a role – across career stages – in realizing one’s calling to practice medicine. Additionally, seventy-three percent of respondents knew before they reached the age of twenty and/or graduated college that they wanted to be physicians, and nearly a third knew before by the age of twelve.

“Physicians may be discouraged at times, but almost every single one of us remains confident in our decision to enter medicine and continues to be driven by our desire to help our patients,” said Andrew W. Gurman, M.D., AMA president. “As an organization, the AMA is constantly striving to deliver resources that empower physicians to maximize time with their patients and help them succeed at every stage of their medical lives. Understanding the challenges physicians face, as well as their motivations for continuing on, is critical to fulfilling that mission.”

The AMA survey, which was conducted in February 2017, found administrative burden, stress, and lack of time were among the top three challenges of respondents. For residents, however, long hours and on-call schedules were also among their top challenges. More than half of students – fifty-three percent – indicated that stress was one of their top three challenges.

Despite these challenges, only thirteen percent of all respondents indicated they had regularly questioned their decision to practice medicine – and more than half of those cited burnout as their top reason for questioning.

These survey findings are released as the AMA launches a comprehensive brand initiative that strives to demonstrate to physicians, residents and medical students the many ways the AMA listens, supports and empowers them to succeed throughout their unique journeys with timely and relevant resources.

The brand initiative is expected to reach physicians through print, digital and social media platforms. It is intended to recognize and celebrate the core reasons that physicians choose the profession while also highlighting the broad array of initiatives and resources the AMA provides in support of physicians.

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