Life Science Compliance Update

January 15, 2016

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.

December 18, 2015

AMA Adds Twenty Schools to Their Accelerating Change in Medical Education Consortium

With medicine and health care delivery in the United States constantly changing in new and exciting ways, the American Medical Association is focused on trying new, innovative ways to ensure the physicians and health care professionals of the future are receiving a medical education that is keeping pace with the changes.

In 2013, the AMA created the Accelerating Change in Medical Education Consortium, with eleven founding schools: Indiana University School of Medicine; Mayo Medical School; New York University School of Medicine; Oregon Health & Science University School of Medicine; Pennsylvania State University College of Medicine; The Brody School of Medicine at East Carolina University; The Warren Alpert Medical School of Brown University; University of California, Davis, School of Medicine; University of California, San Francisco, School of Medicine; University of Michigan Medical School; and Vanderbilt University School of Medicine.

Over the last two years, consortium schools have been focused on incorporating new technology with health care reforms and helping prepare tomorrow's physicians thrive in today's medical community. They have been developing flexible, competency-based pathways; working with health care delivery system in novel ways; making technology work for learning; and envisioning the master adaptive learner.

In November of 2015, the American Medical Association selected twenty schools to join the eleven founding members of the Accelerating Change in Medical Education Consortium, broadening the impact of the consortium to 18,000 medical students, who will provide care for 31 million patients each year.

The goal of the consortium is to improve care for patients with multiple chronic conditions and to develop advance simulations and telemedicine, specific to the needs to rural and remote communities.

The twenty new schools were chosen from over one hundred applicants, all of which offered proposals that would significantly change medical education and were vying for a $75,000 annual grant for assistance in aligning medical education with the twenty-first century health care system.

The twenty new schools are: A.T. Still University of Osteopathic Medicine in Arizona; Case Western Reserve University School of Medicine; Dell Medical School at the University of Texas at Austin; Eastern Virginia Medical School; Emory University School of Medicine; Florida International University Herbert Wertheim College of Medicine; Harvard Medical School; Morehouse School of Medicine; Ohio University Heritage College of Osteopathic Medicine; Pritzker School of Medicine at the University of Chicago; Rutgers Robert Wood Johnson Medical School; Sidney Kimmel Medical College at Thomas Jefferson University; Sophie Davis School of Biomedical Education/City College of New York; University of Connecticut School of Medicine; University of Nebraska College of Medicine; University of North Carolina School of Medicine; University of North Dakota School of Medicine and Health Sciences; University of Texas Rio Grande Valley School of Medicine; University of Utah School of Medicine; and University of Washington School of Medicine.

These schools will build upon programs and models that were created by the eleven founding schools and were chosen based upon how their proposals would align with and enhance the original eleven schools' programs and how feasible nationwide implementation is.

Some of the initiatives that the twenty new schools will focus on are: working on expanding the patient-navigator model to develop medical students' ability to work as part of Interprofessional teams in patient-centered medical home practices; implementing a leadership curriculum that will cover all four years of medical school; focusing on the social and behavioral social determinants of health to provide a longitudinal and Interprofessional community-based experience for medical students; reorganizing their entire curriculum to utilize new active-learning models and create a mastery-oriented culture; and developing and implementing strategies to nurture excellent communicators who will use technology to support information exchange and empathetic interactions with individuals and diverse groups in multiple settings for preventive health, health maintenance, and health care delivery purposes.

The American Medical Association recognizes that no one single organization has all the answers; that it will take a collaborative approach to bring systemic change to the future of health care in this country.

More information on the consortium can be found at www.changemeded.org.

November 19, 2015

American Medical Association House of Delegates Joins Prescription Drug Price Debate Calling for Price Control Measures on Pharmaceutical Products and Banning DTC

At this week's American Medical Association (AMA) House of Delegates meeting in Atlanta the AMA adopted recommendations that put them in direct odds with the life science industry. Including recommendations to endorse a ban on direct-to-consumer advertising, pharmaceutical price transparency, direct negotiation of drug prices by CMS and cutting the exclusivity period of biologic drugs.

Drug Pricing

On Tuesday November 17th, The AMA House of Delegates voted to adopt several recommendations in support of regulating drug pricing, including a recommendation that the AMA encourage the Federal Trade Commission to limit anticompetitive behavior by pharmaceutical companies attempting to reduce competition from generic manufacturers through manipulation of patent protections and abuse of regulatory exclusivity incentives.

The AMA had previously agreed to encourage cost transparency, but this session, the House of Delegates agreed to refine that further, stating cost transparency would be encouraged between pharmaceutical companies, pharmacy benefit managers and health insurance companies.

The AMA has also agreed to support several different legislative proposals. One, if legislation comes up to shorten the patent exclusivity period for biologics, the AMA would throw their support behind that. The AMA would also support legislation that gives the Secretary of the Department of Health and Human Services authority to directly negotiate contracts with manufacturers of covered Part D drugs, and work toward eliminating Medicare prohibition on drug price negotiation.

A speaker from PhRMA present at the AMA meeting raised concerns about these changes, highlighting a difference in statutory interpretation of the Affordable Care Act pertaining to market versus data exclusivity of biologics. The AMA House of Delegates talked their way around that difference and stated that they intend to reduce the market exclusivity that an innovator biological has relative to a follow-on biosimilar, not as PhRMA suggested, relative to a competing innovator biological.

The AMA has launched a Directive to Take Action to convene a task force of AMA Councils, state medical societies and national medical specialty societies to develop principles to guide advocacy and grassroots efforts aimed at addressing pharmaceutical costs and improving patient access and adherence to medically necessary prescription drug regimens.

Lastly, relating to drug pricing, the AMA will launch an advocacy campaign in an attempt to engage physicians and patients in local and national advocacy initiatives to bring attention to the rising price of prescription drugs and put forward solutions. The AMA is hoping to have a report for the 2016 Interim Meeting on the progress of this campaign.

Direct to Consumer Advertising

On Monday, November 16, the AMA House of Delegates passed a measure showing AMA support for a ban on direct-to-consumer (DTC) advertising for prescription drugs and implantable medical devices. The AMA states that this measure was adopted in an attempt to make prescription drugs more affordable and address member concerns about "the negative impact of commercially-driven promotions and the role that marketing costs play in fueling escalating drug prices."

The AMA released a press release stating that this new policy "recognizes that the promotion of transparency in prescription drug pricing and costs will help patients, physicians and other stakeholders understand how drug manufacturers set prices. If there is greater understanding of the factors that contribute to prescription drug pricing, including the research, development, manufacturing, marketing and advertising costs borne by pharmaceutical companies, then the marketplace can react appropriately."

The AMA wishes to support a ban on DTC advertising because, according to Reference Committee K, the United States is only one of two countries in the world that allows DTC advertising and they believe that ultimate goal of advertising is to drive choice and demand for product, not to educate potential patients and their caregivers. Some physicians at the meeting opined that the "proliferation of ads is driving demand for expensive treatments when cheaper alternatives exist." The AMA Reference Committee K does understand, however, that some patients may be prompted to visit a physician based on their increased awareness of a specific drug mentioned in DTC advertising.

The AMA, however, did not go as far as rescinding its policy on DTC advertising, Policy H-105.988. While Reference Committee K asked for the rescission of Policy H-105.988, the House of Delegates denied the request, instead referring the recommendation for a decision, meaning this rescission issue can come up again in future meetings. Policy H-105.988 was last brought up for discussion at the AMA's annual meeting in 2007, when it was reaffirmed.

Policy H-105.988 outlines eleven guidelines for product-specific DTC advertisements, including: the advertisement should be indication-specific and enhance consumer education; the advertisement should convey a clear, accurate, and responsible health education message by providing objective information about the benefits and risks of the drug or implantable medical device for a given indication; the advertisement should present information about warnings, precautions, and potential adverse reactions associated with the drug or implantable medical device product in a manner such that it will be understood by a majority of consumers; and the advertisement should be targeted to age-appropriate audiences. The policy also requires, among other things, that the FDA approve all DTC advertisements to ensure compliance with FDA regulations and consistency with FDA-approved labeling. The policy also mandates that the AMA support the concept that when companies engage in DTC, they assume an increased responsibility for the informational content and an increased duty to warn consumers.

According to John Kamp, the Executive Director of the Coalition for Healthcare Communication, DTC advertising plays an important role in the healthcare system and lays out the following points in support of DTC:

• DTC helps patients and caregivers recognize symptoms and possible solutions for health issues.  Indeed, one of the AMA dissenters to the new policy pointed out the role of early antidepressant advertising to help patients recognize their difficulty and seek medical help.

• DTC currently is the most aggressively regulated advertising available. This is clear from the careful and lengthy side effect disclosures in every broadcast ad. Eliminating these ads would keep consumers in the dark about both the benefits and side effects of medicines.

• Numerous studies have demonstrated that patients who seek out information and have robust conversations with their doctors are more likely to adhere to directions and achieve better health results.

• PhRMA and its members closely follow a DTC advertising code of self-regulation that emphasizes full and fair balanced information, as well as a delay in the commencement of consumer advertising until professionals have had an opportunity to learn about new drugs.

PhRMA spokeswoman Tina Stow also spoke out against these decisions by the AMA, stating that the goal of DTC advertising is "providing scientifically accurate information to patients so they are better informed about their healthcare and treatment options. Research shows that accurate information about disease and treatment options makes patients and doctors better partners."

This decision by the AMA is an interesting one, in that physicians have for a long time expressed dismay at patients who bring up therapeutic recommendations they see on TV. It has been suggested that the proposed ban would be considered a violation of the first amendment. Only passing reference during the physician's discussion at the House of Delegates was the acknowledgement to how DTC has helped patients identify symptoms and ultimately increased visits to physician offices.

Resolutions Adopted by the AMA House of Delegates November 2015

Support legislation that gives the Secretary of the Department of Health and Human Services authority to directly negotiate contracts with manufacturers of covered Part D drugs, and work toward eliminating

Medicare prohibition on drug price negotiation.

Support Legislation to Shorten Patent Exclusivity for Biologic Drugs

Encourage cost transparency between pharmaceutical companies, pharmacy benefit managers and health insurance companies

Encourage FTC to Limit "Anti Competitive" Behavior in the Pharmaceutical industry

Support Legislation Banning Direct to Consumer Advertising

Convene a task force of AMA Councils, state medical societies and national medical specialty societies to develop principles to guide advocacy and grassroots efforts aimed at addressing pharmaceutical costs and improving patient access and adherence to medically necessary prescription drug regimens.

AMA will monitor pharmaceutical company mergers and acquisitions, as well as the impact of such actions on drug prices

Conclusion

These adopted recommendations by the AMA House of Delegates represent a change in direction for the AMA which will put them at odds with the life science industry and its employees. There is a real issue with increases in generic drug prices and some prices being quite high, a dialog should be pursued, it is unclear that the path AMA is taking will in the end get them what their patients are demanding, which are better cures at a reasonable cost.

It also seems as though the AMA is planning to continue this increased scrutiny on the pharmaceutical industry by "monitor[ing] pharmaceutical company mergers and acquisitions, as well as the impact of such actions on drug prices." We will keep up with any additional changes the AMA makes with regard to the pharmaceutical industry.

Reference Documents

Reference Committee J -annotated - Pharma Pricing Section

Reference Committee K - annotated DTC Ban

 

Newsletter


Preview | Powered by FeedBlitz

Search


 
Sponsors
February 2016
Sun Mon Tue Wed Thu Fri Sat
1 2 3 4 5 6
7 8 9 10 11 12 13
14 15 16 17 18 19 20
21 22 23 24 25 26 27
28 29