Life Science Compliance Update

January 22, 2016

CME Saves in Overall Healthcare Cost

We have long been vocal proponents of Continuing Medical Education (CME) and the benefits it provides to both the medical community and patients around the country. Recently, a study was published in the Journal of Outcome Measurement in Continuing Healthcare Education to help further prove the benefit of CME, by showing that CME actually prevented over $20 million in HIV-related healthcare costs. The study was a collaboration between HealthHIV, Bristol-Myers Squibb, Medscape, and CMEology.

 Study Background

The study estimated the economic impact that happens when physicians and healthcare providers applied learning from a CME activity to recognize and treat HIV earlier. A series of live and online CME courses were developed to enhance knowledge and competence in how to test for, and treat, HIV in a clinical or primary care setting. The CME activity, known as HIV in the Primary Care Setting: Screening, Access to Expert Care, and Treatment Initiation was conducted to: apply recommendations and procedures for primary care practice treatment teams in screening, diagnosing, counseling, and treating patients with HIV; develop integrated systems for linking patients with newly diagnosed HIV/AIDS to an appropriate care setting; describe recommendations in current HIV treatment guidelines for initiating therapy and monitoring patients who are on an initial regimen; and evaluate important factors in the decision to become an expert HIV caregiver.

 The study used a mathematical model to estimate decreased transmission of HIV from an increased awareness of the infection and from an earlier initiation of antiretroviral therapy. An increased awareness of the infection helps to control infection rates because someone who is known to have HIV is less likely to take actions that would transmit the virus to others.  

 According to the study, estimated costs averted were $10,731,517 when testing-related awareness led to decreased transmission rates while earlier initiation of antiretroviral therapy (351-500 CD4 cells/uL versus 201-350 CD4 cells/uL) was estimated to have prevented nearly $11,685,686 in healthcare costs. Initiating antiretroviral therapy at 351-500 CD4 cells/UL instead of < 200 resulted in a cost savings of a staggering $39,521,676.

 Study Results

Participants in the CME workshops were primarily primary care physicians and nurses. Participants who completed both the pre-activity and the post-activity case vignettes showed a significant increase in answering questions correctly and demonstrating an improved competence in the goals of the activity.

 According to Derek Dietze, MA, FACEHP, CHCP, President of Improve CME, LLC and Editor in Chief of The Journal of Outcome Measurement in Continuing Healthcare Education, "Estimated costs averted from decreased transmission (based on early testing) and from earlier antiretroviral therapy demonstrated very substantial impact of the education. Studies on the economic impact of continuing medical education are few and far between, yet results and the analysis reported in this issue suggest tremendous potential."

While little is known about the economic impact of continuing medical education in the HIV setting, this recent study solidifies the value CME provides to internal and external stakeholders, policy makers, and society. By modeling the economic outcomes, this study showed that the implementation of learning would be expected to be associated with substantial cost savings. The data and results of the study suggest that CME-related learning has a strong influence on even a small number of learners, leading to a considerable impact on the economic aspects of HIV care by saving costs that are related to healthcare utilization.

Other HIV Courses

A relatively recent survey found that 34% of primary care providers are not aware of Pre-Exposure Prophylaxis (PrEP) as a way to prevent HIV. The FDA approved PrEP in 2012 and the CDC issued a formal guidance on how to properly use it in 2014.

As a "highly effective" prevention strategy, it is important that healthcare providers know about it and know how to properly use it. Given that CME has such an excellent effect on providers and their knowledge of HIV-related treatment, perhaps next, more CME courses should be developed that can focus on HIV prevention.

January 15, 2016

The College of Family Physicians of Canada and Commercial Support for CME

Once again, the fact that the pharmaceutical industry helps financially support continuing medical education programs is in the spotlight. This time, the spotlight focuses on the College of Family Physicians of Canada (CFPC), where a small group of physicians are reiterating all of the partially misleading, and somewhat nonsensical, sound bites we have heard time and time again. Instead of again focusing on those accounts, we will instead focus on the good work the CFPC is doing, and the actions they have taken as a result of a 2010 Task Force review.

In 2010, the College of Family Physicians of Canada established a Task Force to review the CFPC's relationship with the healthcare and pharmaceutical industries (HPI), and to make recommendations about the College's relationship with HPI.

Task Force Results

The Task Force recognized the importance of industry financial assistance, and therefore made some of the following recommendations to the CFPC, some of which have been taken under advisement, and others that have been implemented. This is by no means a complete list of precautions the CFPC takes, but an overview.

Conflict of Interest (COI)

The Task Force recommended that the CFPC set out explicit and defined conflicts of interest in the CFPC's relationships with the HPI. Additionally, the Task Force recommended that where the scope and responsibilities of CFPC positions are broad, a judgment must be made to confirm if a disclosed COI rises to the level of preventing the individual from carrying out high-level roles such as Committee Chair, Section Chair, CFPC Executive, and Chapter Executive.

Financial Relationships

The CFPC must be explicit about, and in control of, the financial relationships it undertakes with HPI. For one, sponsorship terms must be publicly declared and requests to initiate or continue a sponsorship relationship must be assessed for impact on the CFPC's reputation. Additionally, the sponsorship of any food or other "gifts" from accredited educational activities will not be linked back to the HPI.

Access to Information

Several of these recommendations related to the CFPC website, and recommended that the website be used to post information related to the disclosure of relationships with HPI for members to review, as well as some public information on how the CFPC manages their relationships with the HPI.

CFPC Pushback

Dr. Jennifer Hall, the president of the CFPC, and Dr. Francine Lemire, the executive director and chief executive officer of the CFPC, together wrote a well thought-out response to the critics, focusing on how critical private sponsorship of continuing professional development is to Canadian physicians. As they state, "unlike medical undergraduate or residency education, continuing education receives almost no public funding." This lack of funding makes it difficult for physicians to afford and attend the continuing education courses required, and as such, the pharmaceutical industry has stepped in to fill the void in the funding vacuum.

Doctors Hall and Lemire set the record straight when they state that the CFPC Board has considered, on more than one occasion, whether to eliminate the healthcare and pharmaceutical industry-supported program, and that they have not done so because doing so might result in less high-quality opportunities for Canadian physicians to learn.

The CFPC has taken steps to mitigate the influence of pharmaceutical companies on the annual scientific program at Family Medicine Forum, as well as clearly articulate what counts as education versus what is considered to be marketing. The CFPC has changed their vetting guidelines and requirements for prospective exhibitors for their annual Family Medicine Forum in order to ensure transparency and clarity about the exhibitors' relationships with the healthcare and pharmaceutical industry.

Additionally, at the 2016 Family Medicine Forum, the Exhibit Hall will be clearly labeled "marketplace" so attendees are "acutely aware" that exhibitors are marketing their products and services in there. CFPC even went one step further, allowing attendees who are disinterested in any of the exhibitor's products and services to avoid the marketplace altogether by placing food and meals in a different location, away from the Exhibit Hall.

Lastly, Doctors Hall and Lemire highlighted the fact that the CFPC's peer-reviewed journal, Canadian Family Physician, carefully screens all advertisements and has a strict policy on the proximity of ads relative to editorial content.

In addition to the restraints already in place, the Task Force helped the CFPC to come to the conclusion that creating a continuing professional development program development fund might be a potential way to support the development, dissemination, and evaluation of accredited educational activities. This fund would include contributions in the form of subscriptions to access high-quality continuing professional development or unrestricted donations to the Research and Education Foundation.

Conclusion

In short, most patients enjoy knowing that the doctor who is taking care of them and their family has fulfilled continuing medical education requirements, and that the physician has knowledge about the most recent developments in healthcare. Industry support of the continuing education of the physicians who take care of our families is one of the main reasons we have such a thriving healthcare industry and a contributor to long life expectancy. High-quality continuing medical education is crucial to the continuation of such success, and industry financial support is just one of the important ways the success will continue.

AMA House of Delegate Recommendations on Maintenance of Certification and Licensure

During November's American Medical Association (AMA) House of Delegates (HOD) meeting in November, many resolutions and recommendations were adopted, some of which we have previously touched upon.

In addition to the aforementioned HOD actions relating to price control measures on pharmaceutical products and banning direct to consumer advertising, the AMA House of Delegates also adopted some changes recommended by the Council on Medical Education Report. Council on Medical Education Report 2 reviewed and consolidated existing AMA policy on Maintenance of Certification (MOC), Osteopathic Continuous Certification (OCC) and Maintenance of Licensure (MOL) to ensure that the policies are current and coherent.

AMA Principles on Maintenance of Certification (MOC)

The AMA voted to amend Policy H-275.924, Maintenance of Certification. Some of the changes made were for clarification purposes, such as the change that now requires any changes to the MOC process for a given medical specialty board to occur no more frequently than the "intervals used by that specialty board" for MOC. Previously that requirement had used "intervals used by each board" for MOC, possibly creating some confusion as to whether the longest interval by any specialty board controlled, or the interval used by the specialty board in question.

A new statement was added into the policy, #10. The new statement reads,

"In relation to MOC Part II, our AMA continues to support and promote the AMA Physician's Recognition Award (PRA) Credit system as one of the three major credit systems that comprise the foundation for continuing medical education in the U.S., including the Performance Improvement CME (PICME) format; and continues to develop relationships and agreements that may lead standards accepted by all U.S. licensing boards, specialty boards, hospital credentialing bodies and all other entities requiring evidence of physician CME."

MOC's importance was also clarified, with the AMA now saying that MOC is

"but one component to promote patient safety and quality. Health care is a team effort, and changes to MOC should not create an unrealistic expectation that lapses in patient safety are primarily failures of individual physicians."

Another change made was the addition of the following statement, "Our AMA will include early career physicians when nominating individuals to the Boards of Directors for ABMS member boards."

Additionally, the AMA has also advocated policy so that physicians with lifetime board certification are no longer required to seek recertification and no qualifiers or restrictions should be placed on diplomats with lifetime board certification recognized by the ABMS related to their participation in MOC.

Members of the AMA House of Delegates are encourage to increase awareness of these, and other proposed changes to physician self-regulation, through their specialty organizations and other professional member groups.

AMA Principles on Maintenance of Licensure (MOL)

The AMA House of Delegates recommended a new chunk of requirements be added to these principles.

One new requirement reflects the aforementioned change in MOC above. The new requirement asks that the AMA:

"Continue to support and promote the AMA Physician's Recognition Award (PRA) Credit system as one of the three major CME credit systems that comprise the foundation for continuing medical education in the U.S., including the Performance Improvement CME (PICME) format, and continue to develop relationships and agreements that may lead to standards accepted by all U.S. licensing boards, specialty boards, hospital credentialing bodies, and other entities requiring evidence of physician CME as part of the process for MOL."

Additionally, the AMA is to advocate that if state medical boards move forward with a more intense or rigorous MOL program, each state medical board shall be required to accept evidence of successful ongoing participation in the ABMS MOC and AOA-Bureau of Osteopathic Specialists (AOA-BOS) Osteopathic Continuous Certification (OCC) to have fulfilled all three components of the MOL, if performed.

The AMA will also advocate for acceptance by state medical boards of programs created by specialty societies as evidence that the physician is participating in continuous lifelong learning. The AMA will also encourage state medical boards to allow physicians to choose which programs they participate in to fulfill their MOL criteria.

Lastly, the AMA agreed to oppose any MOL initiative that creates barriers to practice, is administratively unfeasible, is inflexible with regard to how physicians practice (clinically or not), does not protect physician privacy, or is used to promote policy initiatives about physician competence.

An Update on Maintenance of Licensure

The AMA is also set to amend Policy D-275.957. The AMA has agreed to continue to monitor the evolution of Maintenance of Licensure (MOL), continue its active engagement in discussions regarding MOL implementation, and report back to the House of Delegates on the issue. The AMA will also continue to review published literature and emerging data as part of the Council on Medical Education's efforts to review MOL issues and work with the Federation of State Medical Boards (FSMB) to study whether principles of MOL are important factors in a physician's decision to retire or if they have a direct impact on the U.S. physician workforce.

The AMA will also encourage the FSMB to continue working with individual state medical boards to accept physician participation in the American Board of Medical Specialties MOC and the AOA-BOS OCC as meeting the requirements for MOL and also to develop alternatives for physicians who are not certified or recertified, and advocate that MOC or OCC not be the only pathway to MOL for physicians.

The AMA will also continue to encourage rigorous evaluation of the impact on physicians of any future proposed changes to MOL processes, including cost, staffing, and time.

Maintaining Medical Specialty Board Certification Standard

Policy H-275.926 will be amended to signify AMA's opposition of discrimination against physicians based solely on lack of ABMS or equivalent AOA-BOS board certification. The AMA also opposed discrimination that may occur against physicians involved in the board certification process, including those who are in a clinical practice period for the specified minimum period of time that must be completed prior to taking the board certifying examination.

The AMA is also encouraging member boards of the ABMS to adopt measures aimed at mitigating the financial burden on residents related to specialty board fees and fee procedures, including ideas like shorter preregistration periods, lower fees, and easier payment terms.

Rescinded Policies

The AMA will rescind a list of policies, including: H-275.923, Maintenance of Certification/Maintenance of Licensure; H-275.944, Board Certification and Discrimination; H-405.974, Specialty Recertification Examinations; and D-275.971, American Board of Medical Specialties – Standardization of Maintenance of Certification Requirements. Most of these rescinded policies contained ideas mentioned above that were added to other policies and standards.

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