The American Medical Association (AMA) House of Delegates has wrapped the 2016 interim meeting in Orlando. During the Nov. 12-15 meeting, the organization adopted a number of new policies and resolutions.


AMA Statement on the Future of Health Care Reform

"The AMA House of Delegates, reflecting more than 170 state and specialty medical societies from across the country, today reaffirmed its commitment to healthcare reform that improves access to care for all patients," said Andrew W. Gurman, MD, president of the American Medical Association.

Andrew W. Gurman, MD

"Using a comprehensive policy framework that has been refined over the past two decades, the AMA will actively engage the incoming Trump Administration and Congress in discussions on the future direction of healthcare. The AMA remains committed to improving health insurance coverage so that patients receive timely, high quality care, preventive services, medications and other necessary treatments.

"A core principle is that any new reform proposal should not cause individuals currently covered to become uninsured. We will also advance recommendations to support the delivery of high quality patient care. Policymakers have a notable opportunity to also reduce excessive regulatory burdens that diminish physicians' time devoted to patient care and increase costs.

"Healthcare reform is a journey involving many complex issues and challenges, and the AMA is committed to working with federal and state policymakers to advance reforms to improve the health of the nation."



AMA Supports Changing the Fundamentals of Drug Pricing

Value-based pricing is a viable cost-saving solution for challenging the current rationale for determining what patients pay for prescription drugs in the U.S. market, according to policy adopted by physicians at the AMA Interim Meeting. The new policy establishes guiding principles for AMA advocacy efforts aimed at changing the fundamentals of prescription drug pricing without compromising patient outcomes and access.

"The new AMA policy acknowledges the carte blanche approach to drug pricing needs to change to align with the health system's drive for high-quality care based on value," said AMA President Andrew W. Gurman, MD. "This transformation should support drug prices based on overall benefit to patients compared to alternatives for treating the same condition. We need to have the full picture to assess a drug's true value to patients and the health care system."

The new AMA policy seeks to blunt growing pharmaceutical spending rates by tying drug prices to an optimal balance of benefits and costs. The policy's adoption adds to the AMA's long-standing support for market-driven mechanisms to control pharmaceutical costs, while recognizing that improvements need to be made to ensure that the prescription drug market operates efficiently and effectively. In its continued push for transparency in drug prices, the AMA last month launched a grassroots campaign to hear patients' stories.

Brand name drug prices in the U.S. have spiked 98.2 percent since 2011. The average price of brand-name drugs rose 16.2 percent in 2015, according to Express Scripts. Prescription drug prices have been frequently cited as a main justification for higher health insurance premiums, and growing cost-sharing requirements. For patients with commercial health insurance, out-of-pocket costs for brand prescriptions have increased by more than 25 percent since 2010, according to IMS Institute for Healthcare Informatics. A Kaiser Health Tracking Poll released in October found that Americans rank high prescription drug costs among their top health care priorities.

As public and private payers move forward to tie drug prices to value, the AMA's support for these programs will be guided by the following principles:

• Value-based prices of pharmaceuticals should be determined by objective, independent entities;
• Value-based prices of pharmaceuticals should be evidence-based and be the result of valid and reliable inputs and data that incorporate rigorous scientific methods, including clinical trials, clinical data registries, comparative effectiveness research, and robust outcome measures that capture short- and long-term clinical outcomes;
• Processes to determine value-based prices of pharmaceuticals must be transparent, easily accessible to physicians and patients, and provide practicing physicians and researchers a central and significant role;
• Processes to determine value-based prices of pharmaceuticals should limit administrative burdens on physicians and patients;
• Processes to determine value-based prices of pharmaceuticals should incorporate affordability criteria to help assure patient affordability as well as limit system-wide budgetary impact; and
• Value-based pricing of pharmaceuticals should allow for patient variation and physician discretion.

"The AMA principles emphasize that efforts to price prescription drugs based on value should ultimately benefit patients and the health care system without stifling innovation in the pharmaceutical industry," said Gurman. "These initiatives should aim to ensure patient access to necessary prescription drugs and allow for patient variation and physician discretion. In addition, such initiatives should limit administrative burdens on physician practices and patients, and be evidence-based, transparent, objective and involve the input of practicing physicians and researchers."

In addition, new AMA policy emphasizes that pharmaceutical pricing mechanisms need to take into account a drug's public health value. The AMA supports direct purchasing of pharmaceuticals used to treat or cure diseases that pose unique public health threats, including hepatitis C. Direct purchase arrangements will guarantee prices for prescription drugs as well as volume for manufacturers. As such, lower prices can be achieved in exchange for a larger, guaranteed market for a drug.


AMA Adopts Policy to Urge Further Research into Detection and Prevention of CTE

The American Medical Association adopted new policies aimed at increasing research into the full continuum of head injuries, ranging from subconcussive impacts to chronic traumatic encephalopathy (CTE), a progressive degenerative condition of the brain found in athletes (and others) with a history of repetitive brain trauma. The new policy urges research into the detection, causes, and prevention of head injuries.

"With hundreds of thousands of Americans - including approximately 250,000 children under age 19 - sustaining concussions each year, it is vital that we research the full continuum of head impacts," said AMA Board member Willarda V. Edwards, MD. "Whether the concussion occurs during youth sports like football, soccer, and basketball or during a military deployment, the insidious symptoms of CTE are occurring eight or 10 years after the inciting event. Further research into the causes, prevention, and detection of CTE are critical, but we must begin this effort by understanding how to prevent it."

Detecting and diagnosing CTE before death is currently very difficult. The new policies adopted today encourage research efforts to develop diagnostic tools as well as to understand preventive measures that can protect against CTE.

During the opening session of the Interim Meeting on Saturday, the AMA honored Bennet I. Omalu, MD, MBA, MPH, with the Distinguished Service Award for his work discovering CTE in American football players. A Nigerian-American forensic pathologist, Omalu discovered CTE while working at the coroner's office in Allegheny County (Pittsburgh) in 2002. Omalu recognized brain abnormalities in several NFL players who had signs of personality changes or cognitive disorders before dying at an early age. He named the condition CTE, and described the abnormal accumulation of tau protein in the brains of these individuals.


AMA Adopts Ethical Guidance on Team-Based Health Care

As a patient's care now often lies in the hands of many collaborating healthcare professionals, the AMA has adopted ethical guidance for physicians as leader-members of care teams. Team-based healthcare models have emerged as the preferred method for providing coordinated, cost-effective, high-quality healthcare for patients.

Healthcare teams involve physicians, nurses, social workers and other health care professionals - all of whom play various clinical and administrative roles in the care of a single patient - at one or several sites of care. The AMA policy said by virtue of their thorough and diverse training, experience and knowledge, physicians have a distinct appreciation of the breadth of health issues and treatment options that enable them to integrate the diverse professional perspectives and recommendations of the team into an appropriate, coherent plan of care for the patient.

"Physician-led collaborative care has been proven time and again as an effective, consultative approach to providing high-quality medical care," said AMA Board Member Kevin W. Williams. "An effective team requires vision and direction of an effective leader and physicians are uniquely suited to serve as a clinical leader who will ensure that the team as a whole functions effectively and facilitates patient-centered decision-making."

As leaders within healthcare teams, physicians individually should:

• Model leadership by:
• understanding the range of their own and other team members' skills and expertise and roles in the patient's care;
• clearly articulating individual responsibilities and accountability;
• encouraging insights from other members and being open to adopting them; and
• mastering broad teamwork skills.
• Promote core team values of honesty, discipline, creativity, humility, and curiosity and commitment to continuous improvement.
• Help clarify expectations to support systematic, transparent decision making.
• Encourage open discussion of ethical and clinical concerns and foster a team culture in which each member's opinion is heard and considered and team members share accountability for decisions and outcomes.
• Communicate appropriately with the patient and family and respect their unique relationship as members of the team.
• As leaders within healthcare institutions, physicians individually and collectively should:
• Advocate for the resources and support healthcare teams need to collaborate effectively in providing high-quality care for the patients they serve, including education about the principles of effective teamwork and training to build teamwork skills.
• Encourage their institutions to identify and constructively address barriers to effective collaboration.
• Promote the development and use of institutional policies and procedures, such as an institutional ethics committee or similar resource, to address constructively conflicts within teams that adversely affect patient care.

According to the AMA's new ethical guidance, teams are defined by their dedication to providing patient-centered care, protecting the integrity of the patient-physician relationship, sharing mutual respect and trust, communicating effectively, sharing accountability and responsibility, and upholding common ethical values as team members.

The collaborative care guidance will be added to the Code of Medical Ethics, which was modernized recently after an eight year project to ensure physicians have useful and effective ethical direction that keeps pace with emerging demands, new technologies, changing patient expectations and shifting healthcare priorities.


AMA Urges Legislation to Ban Dangerous Coal-Tar Sealcoats

The AMA has adopted a new policy aimed at reducing or ending the use of common coal-tar-based sealcoats that are used and applied on pavement and playgrounds across the country. The new policy advocates for legislation either to ban the use of pavement sealcoats containing polycyclic aromatic hydrocarbons (PAH) or to mandate the use of sealcoat products with minimal PAH. According to the International Agency for Research on Cancer, PAH compounds have been proven to be carcinogenic, mutagenic, and teratogenic to humans.

"Whether they are sending their children to a playground or repairing a driveway, Americans are potentially being exposed to harmful carcinogens in coal-tar-based sealcoats," said AMA Board member Albert J. Osbahr III, MD. "Even if one's exposure is limited, as sealcoats erode over time, PAHs leach into the water, soil, and air, finding their way into sediment and eventually into aquatic wildlife. We must take action to either eliminate the use of PAH altogether or dramatically reduce its concentration in coal-tar sealcoats."

Studies show that individuals with lifelong exposure to coal-tar sealcoat-treated pavements and playgrounds have a 38-fold higher risk of cancer. Already, Washington, Minnesota, Washington, D.C., and counties, townships and municipalities in many other states, including Michigan, have banned the use of coal-tar sealcoats. Alternatives to coal-tar-based sealcoats, including asphalt, acrylic, or latex sealcoats, have low or no PAHs and are available at a similar cost.

Support for Efforts to Promote Environmental Sustainability and Halt Global Climate Change

As climate change continues to affect public health across the world, the AMA adopted policy in support of initiatives that promote environmental sustainability and efforts to halt global climate change. The policy also calls for aiding physicians in adopting environmentally-sustainable programs in their practices and sharing these concepts with their patients and communities.

"Scientific surveys have shown clear evidence that our patients are facing adverse health effects associated with climate change. From heat-related injuries and forest fire air pollution, to worsening seasonal allergies and storm-related illness and injuries, it is important that we make every effort to put environmentally friendly practices in place to lessen the harmful impact that climate change is having on patient health across the globe," said AMA Board Member Willarda V. Edwards, M.D.

Endorse Important Framework to Promote Firearm Safety

Endorsing recommendations made by other leading groups of health care professionals to reduce firearm-related injuries and deaths, the AMA backed the proposals, which track existing AMA policies intended to reduce the public health consequences of firearms. The specific recommendations - originally made by seven health groups and one legal group in 2015 - include universal background checks of gun purchasers, elimination of physician "gag laws," restrictions on the manufacture and sale of military-style assault weapons and large-capacity magazines for civilian use, and research to support strategies for reducing firearm-related injuries and deaths. The health professional organizations also advocate for improved access to mental health services.

"Improper use of firearms has created a public health crisis," said Dr. Barbara L. McAneny, the former chair of the AMA Board of Trustees. "Only by collaborating with others in a multidisciplinary approach can we reduce firearm-related injuries and death."

The recommendations originally appeared in the publication, "Firearm-Related Injury and Death in the United States: A Call to Action from 8 Health Professional Organizations and the American Bar Association."

The groups responsible for making the recommendations last year were: the American Academy of Family Physicians, American Academy of Pediatrics, American College of Emergency Physicians, American Congress of Obstetricians and Gynecologists, American College of Physicians, American College of Surgeons, and American Psychiatric Association, and the American Public Health Association. The American Bar Association, acting through its

Standing Committee on Gun Violence, confirms that none of these recommendations conflict with the Second Amendment or previous rulings of the U.S. Supreme Court.

Each year, nearly 34,000 people die as a result of firearm-related violence, suicides and accidents in the United States.

Parity in Reproductive Health Insurance Coverage for Same-Sex Couples

In recognition that same-sex couples have sometimes been denied access to insurance benefits that cover fertility service, the AMA adopted policy aimed at promoting parity in reproductive health insurance coverage for same-sex couples. The new policy adds to established AMA policy supporting measures providing same-sex households with the same rights and privileges to health care, health insurance, and survivor benefits, as afforded opposite-sex households.

"Regardless of the insurance industry's rationale for doing so, denying fertility coverage to same-sex couples is discriminatory," said AMA Board Member Maya A. Babu, M.D., M.B.A. "Our new policy recognizes that disparities exist in some health insurers' policies that are unfair for same-sex households and supports measures to ensure all households are afforded the same access to insurance coverage for fertility services."

Improved Access to Mental Health Services at Colleges, Universities

The AMA adopted new policies to improve mental health services at colleges and universities. The new policies support strategies to improve accessibility to care and reduce the stigma of mental health issues. The AMA also urged colleges and universities to emphasize to students and parents the importance, availability, and efficacy of mental health resources, and to develop mechanisms of care that support timely and affordable access.

"Depression, anxiety, suicidal thoughts, and sadly, suicide are common among young people at colleges and universities. The lack of resources and stigma associated with seeking help can prevent students from getting the mental health care they need," said AMA Board member William E. Kobler, M.D. "By improving access to care, colleges and universities will make it easier for young people to focus on their own well-being and give them a greater chance for success on campus."

Expanded Training Opportunities to Treat Opioid Use Disorders

The AMA adopted new policy that bolsters efforts to address the rate of death due to drug overdose, which reached an unprecedented 14.7 per 100,000 in 2014. Specifically, the policy calls for expansion of and funding for residency and fellowship training opportunities to provide clinical experience to treat opioid use disorders.

"The AMA supports efforts to confront the opioid and prescription drug epidemic so physicians who are on the front lines have the ability to best meet patient needs," said AMA board member Jesse M. Ehrenfeld, M.D. "With an unprecedented need for treatment of opioid use disorders, it is critical that we do all we can to expand residency and fellowship training opportunities so patients have increased access to the treatment they need."

Preventing Exploitation of Restricted Drug Distribution Systems

Responding to the need for greater competition and choice in the pharmaceutical marketplace, the AMA adopted policy to prevent brand name drug manufacturers from potentially exploiting legitimate safety protocols to block generics drugs from entering the market.

Drug manufacturers can be required by the Food and Drug Administration (FDA) to establish Risk Evaluation & Mitigation Strategies (REMS) to ensure that the benefits of certain prescription drugs outweigh their risks. Such REMS can result in the creation of restricted distribution systems to stringently control the allocation of drug products that may pose potential health risks. In addition, pharmaceutical companies may establish controlled distribution channels for their products for other purposes. Misuse of this safety protocol jeopardizes competition in the pharmaceutical industry by allowing brand name drug manufacturers to block access to test samples that generic drug manufacturers need to help satisfy FDA approval requirements.

"Drug safety is a notable concern of the AMA, but drug manufactures should not be allowed to misuse restricted distribution mechanisms to block competition from rival drug makers," said AMA Board Member William A. McDade, M.D., Ph.D. "To encourage competition and choice, the AMA supports measures that require prescription drug manufacturers to seek FDA and Federal Trade Commission approval before establishing a restricted distribution system."

The new AMA policy also supports the mandatory provision of samples of approved out-of-patent drugs upon request to generic manufacturers seeking to perform bioequivalence assays. The AMA will also continue working on measures that expedite the FDA approval process for generic drugs.

Support for Voluntary Inclusion of Gender Identity, Sex, Sexual Orientation Options in Electronic Health Records

To improve patient health, the AMA approved policy supporting the voluntary inclusion of a patient's biological sex, current gender identity, sexual orientation, and preferred pronoun(s) in medical documentation and related forms, including EHRs. An estimated 700,000 transgender individuals, in addition to others who identify with a nonconforming gender identity, live in the United States. Their physicians will benefit from more complete, culturally sensitive patient history records. The AMA also will advocate for collection of patient data that is inclusive of sexual orientation/gender identity for the purposes of research into patient health.

"The addition of this voluntary recordkeeping will benefit patients by giving their physicians more accurate personal health information. This is a step to ease the unique obstacles that keep the transgender population from receiving healthcare," said Dr. Carl A. Sirio, a member of the AMA Board of Trustees.

Appropriate Use of Genetic Testing and Access to Counseling Services

As the number of genetic and genomic testing options available to physicians and patients grows, the AMA adopted new policy to support the appropriate use of genetic and genomic testing technologies and to promote patient access to genetic counseling services. The new policy calls for supporting the development and dissemination of guidelines with best practice standards for pre- and post-test genetic counseling. The policy also calls for research on issues in medical genetics, including genetic specialist workforce levels, physician preparedness in providing genetic testing and counseling services, and the impact of genetic testing and counseling on patient care and outcomes.

"The AMA supports the appropriate use of genetic testing and counseling, and we encourage physicians to make themselves familiar with the latest testing and counseling services available that could benefit their patients," said AMA Board member Albert J. Osbahr, III, M.D. "The policy adopted furthers the AMA's work over the past decade to ensure that physicians have access to the resources and support they need to appropriately integrate personalized medicine services into practice to precisely target treatment and improve health outcomes."

In July, the AMA launched an online program aimed at educating physicians and other health care professionals on the benefits and limitations of genetic testing and when it is appropriate to incorporate it into their practices. The 12-module series called, "Precision Medicine for Your Practice," will be released individually over the next year and will be available online at the AMA Education Center. The modules focus on applications of genetic testing, which include expanded carrier screening, targeted therapy in oncology, genomic sequencing, cardiogenomics, neurogenomics, pharmacogenomics and ethics in precision medicine.

Strengthening Policy on Interoperability of Electronic Health Records

The AMA bolstered its policy on the interoperability of health care records by ensuring that physicians who are not affiliated with hospitals or health organizations are not impaired by data blocking. The AMA has long advocated for interoperability of electronic health records and for legislation and regulations to prohibit health care organizations and networks from blocking the electronic availability of clinical data.

"Just because physicians are not affiliated with a hospital does not mean that they should not have access to patients' records," said Dr. Russell W. Kridel, a member of the AMA Board of Trustees. "Timely, safe and optimal care depends on physicians' ability to access electronic health records. A cornerstone of interoperability is that data is accessible to physicians, regardless of their connection to a hospital or health organization."