Life Science Compliance Update

April 14, 2016

NEJM: What Do I Need to Learn Today – The Evolution of CME

Graham McMahon, MD, MMSc, the President and CEO of the Accreditation Council for Continuing Medical Education, has written an article for the New England Journal of Medicine about the evolution of continuing medical education (CME). The article, "What Do I Need to Learn Today? – The Evolution of CME," asks for clinicians, educators, healthcare institutions, and regulators to contribute to the continuing transformation of CME.  He also suggests that CME be included as a significant asset for regulatory efforts such as MOC and the Merit-Based Incentive Payments System.

Dr. McMahon stated that such a continued transformation will serve to "expand the opportunities for educational innovation that improves physician practice and ultimately benefits patient care and the health of our country." To help the transformation, Dr. McMahon recommends that clinicians become more aware of their individual strengths and weaknesses and choose CME activities that can help them grow and become better clinicians.

In order to meet the learning needs of clinicians in today's healthcare environment, it is imperative for educators to design CME activities that focus on the learners, rather than the teachers, and incorporate opportunities for interaction and reflection. Interprofessional continuing education (IPCE) gives physicians the opportunity to build the competencies needed for team-based practice. Patients should be active in their care and should be viewed as part of the healthcare team; including patients as CME speakers can work to engage physicians' hearts as well as their minds.

Part of the problem today, as outlined in the article by Dr. McMahon, is that information is "ubiquitous," meaning that the simple exchange of information has little value, and that in order to truly learn and understand something, shared wisdom and the opportunity to engage in practice-relevant problem solving is crucial. Dr. McMahon realizes that once physicians see and understand that they are actively (and actually!) learning, they embrace future activities that allow them that same learning opportunity.

As stated by Dr. McMahon,

Education that's inadequate, inefficient, or ineffective, particularly when participation is driven by mandates, irritates physicians who are forced to revert to "box-checking" behavior that's antithetical to durable, useful learning.

It is important that going forward, regulators begin to focus on educational outcomes, not the process, and work to create other conditions that maximize flexibility and innovation in CME. The ACCME's collaboration with the American Board of Internal Medicine (ABIM) to simplify the integration of Maintenance of Certification (MOC) and CME, is an example of regulatory authorities working together to reduce the burden placed on physicians, helping to promote lifelong learning.

Dr. McMahon also points out that "If more regulatory authorities recognize the value of education in driving clinical practice and quality improvement and allow educational activities to count for multiple requirements, they can reduce the burden on physicians and promote lifelong learning. For example, participation in CME could be designated as a method for meeting the clinical practice improvement expectations of Medicare’s new Merit-Based Incentive Payment System."

Each year, the accredited CME community collectively provides nearly 150,000 activities. Accredited CME activities are required to be evidence-based and free of any commercial bias or influence. The more involved healthcare leaders, educators, and learners, become in the process, the more CME can do to promote performance, quality improvement, collegiality, and public health.

April 05, 2016

2015 Front Line of Healthcare Report – CME and Conferences are a More Frequently Utilized Source of Information

Bain & Company, Inc. has published their Front Line of Healthcare Report 2015, a report that focuses on the shifting United States healthcare landscape by the numbers.

Bain & Company took a natural survey of 632 physicians across specialties and 100 hospital procurement administrators in the United States in an attempt to update their 2011 Physician Attitudes Survey. To highlight the idea that the dynamics of change vary substantially across different regions of the country, Bain oversampled two regions with distinct market characteristics (Massachusetts and Mississippi/Alabama). Bain found that in states like Massachusetts, the pace of change is faster because of several factors in play: more competition among payers and provider organizations, and an activist policy and regulatory environment that promotes change.

Since the report is focused on the shifting United States healthcare landscape, the report opens with a brief infographic that includes a variety of information on just how much the landscape is changing. For example, of physicians who have changed employment in the past five years, almost three-fourths, 72%, now work in large management-led organizations. Additionally, it was noted that in the last three years, the percentage of surgeons who state that procurement officers influence most of the purchasing decisions for devices has more than doubled, and 65% of physicians say that formularies limit their prescribing decisions.

Bain found that CE and conferences were a much more influential to physicians than their interviews in 2011 with a 23% increase in the utilization of CE as a source of information. Physicians are relying more and more on CME to help them figure out what to do next for their patients. Other sources of information that increased included Key Opinion Leaders (16%), Manufacturer Websites (9%) and Academic Journals (7%) big losers included Colleagues (-10%), Pharmacists (-18%) and Sales Reps (-26%). One could hypothesized that systems integration has actually lead to less communication between colleagues and discussions with pharmacists. In large systems physicians have quota's to meet and patient discussions are happening less and less with colleagues. In the same vein sales reps have been continuing to lose access especially to physicians who join integrated health systems as time is a huge commodity in those systems.

Financing and Delivery of Healthcare

Even though healthcare costs have slowed, per capita costs do not seem to have decreased. Organizational shifts and the trend toward consolidation and more professionally managed organizations have produced many changes, including: increasing the use of standardized clinical protocols and electronic medical records, more objective metrics for measuring clinical performance, payment models that put providers at risk for outcomes, and a shift in physicians' perceptions of their own cost responsibility.

When physicians were asked about their change in use of analytic and clinical tools over time, they responded that over the last two years alone, their use of electronic medical records (EMRs) has nearly tripled, and use of treatment protocols more than doubled. Bain also found that physicians who work in management-led systems of care tend to be significantly less likely to recommend their organization to others than those in physician-led organizations. One explanation could be that physicians in management-led organizations also report having less knowledge of their organization's mission and being less engaged in the organization's activities.

Direct Impact on MedTech and Pharma

These changes in healthcare affect the entire supply chain, and as delivery systems continue growing larger and more complex, decisions become more focused on outcomes and economics.

While centralized purchasing in healthcare organizations is not new, Bain found that there is an increasing use of preferred vendor lists by procurement departments, which is quickly reducing the number of available products and putting lower-share players at risk. It is estimated that forty percent of surgeons no longer use a particular product because it is no longer available at their hospital.

The decline in physician autonomy is also affecting the pharmaceutical sector, with the exception of selected specialties that are highly differentiated and require drugs with a high-impact nature (i.e. oncology).

These shifts in decision-making power also have an effect on where physicians and surgeons obtain information about new products. For decades, sales representatives have been a common and highly valued source of information. Today, however, physicians are relying more on manufacturer websites, academic journals, and conferences. In Bain's recent survey, only 41% of physicians reported sales reps as being one of their top three sources of information about a new drug, compared to 56% three years ago. This holds true for medical devices as well, with 48% of surgeons reporting that sales reps are an important source of information, down from 59% three years ago.

However, those figures vary widely from state to state, as well as physician demographics. Of surgeons in Alabama and Mississippi, 69% rate sales reps as one of their top sources of information, compared with only 31% in Massachusetts. More experience physicians, orthopedic surgeons, and cardiologists, also report a higher reliance on sales representatives, as do self-employed physicians.

What Does This Mean?

With the purchase of drugs and devices becoming more competitive and centralized in hospitals and drug benefit plans, it is important for sales representatives to adapt to serve a more complex customer. To meet the likely challenges ahead, manufacturers will need to develop more sophisticated and flexible go-to-market models that reflect both regional and practice differences. The pharmaceutical, device, and MedTech companies that come out ahead will be those that can achieve flexibility while minimizing the complexity of their operating model. Manufacturers should also recognize that category leadership will likely continue to matter more than range in a company's portfolio when it comes to both loyalty and advocacy.

March 17, 2016

New Canadian CME Standards for Commercial Support

Canada has created new standards for industry involvement with accredited CME programs. Three professional organizations, including the College of Family Physicians of Canada and its counterpart for surgeons, have been responsible for sanctioning educational events for doctors in Canada. Previously, each organization was responsible for its own ethical standards on CME events, which resulted in significant variations across different parts of the country, for different events.

The new guidelines, known as the National Standard for Support of Accredited CPD Activities (the Standard) were developed with input from multiple Canadian physician organizations and committees, and apply in all situations where financial and in-kind support is accepted to contribute to the development, delivery and/or evaluation of accredited CPD activities.

Adherence to the Standard will be mandatory for approval of all accredited CPD activities included within the Canadian national/provincial CME/CPD accreditation systems for physicians. The standards of individual accrediting systems may be more stringent that the Standard, but may not be less stringent.

There will be a twenty-two month transition phase from March 1, 21016 in Canada to allow organizations to align to the new standard, which will officially launch on January 1, 2018. During the transition phase, stakeholders are encourage to become familiar with the Standard and prepare their own implementation plans to align their organization's operating procedures. The new Standard will guide the ability of CPD providers and other stakeholders to: prevent commercial influence on CPD; outline a clearly defined role for sponsors of CPD activities; and standardize the development and delivery of CPD activities for both family and specialist physician audiences.

The Standard includes seven elements and twenty-nine sub-elements, including: Independence, Content Development, Conflict of Interest, Receiving Financing and In-Kind Support, Recognizing Financial and In-Kind Support, Managing Commercial Promotion, and Unaccredited CPD Activities. Some of the new Standards go beyond current Accreditation Council for Continuing Medical Education (ACCME) requirements, as outlined below.


New Canadian Standards


Conflict of Interest/Disclosure of Relevant Commercial Interests

Must disclose all relationships with for-profit and not-for-profit organizations within the past two years

Within the past twelve months

Sponsors participation in CPD program decisions

Representatives of a sponsor or any organization hired by a sponsor cannot participate in decisions related to CPD program elements

Must ensure that decisions were made free of the control of a commercial interest.

CPD provider obligations

Must ensure that their interactions with sponsors meet professional and legal standards, including the protection of privacy, confidentiality, copyright, and contractual law regulations

No comparable obligations.

Unaccredited CPD activity listings

Unaccredited CPD activities cannot be listed or included within activity agendas, programs or calendars of events (preliminary and final)

No Comparable obligations

Content Development

Those who are responsible for developing or delivering content must be informed about: the identified needs of the target audience; the need to ensure that the content and/or materials presented provide (where applicable) a balanced view across all relevant options related to the content area; the intended learning objectives for the activity; ensuring that the description of therapeutic options utilize generic names (or both generic and trade names) and not reflect exclusivity and branding.

Similar to the Standards for Commercial Support™

Commercial Bias Requirements

The content or format of a CME activity or its related materials must promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest

Similar to the Standards for Commercial Support™

CME Mission Statement

Not applicable.

ACCME requires that the provider have a mission statement that includes the expected results articulated in terms of competence, performance, or patient outcomes as a result of the program


Not applicable.

CME provider should build bridges with other stakeholders through collaboration and cooperation

Managing Commercial Promotion

Product-specific advertising, promotional materials, or branding strategies cannot be included on, appear within, or be adjacent to: any educational materials, slides, abstracts and handouts used as part of an accredited CPD activity; activity agendas, programs or calendars of events (preliminary and final); any webpages or electronic media containing educational material.

Product promotion material or product-specific advertisement of any type is prohibited in or during CME activities. Advertising and promotional materials may face the first or last pages of printed CME content as long as these materials are not related to the CME content they face and are not paid for by supporters of the CME activity.


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