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June 27, 2019

Issue Spotlight

Funding boost needed to close treatment gap for patients with opioid use disorder

The nation's opioid epidemic is worsening as policy, regulatory and especially insurance barriers continue to block access to treatment, AMA President-elect Susan R. Bailey, MD, told Congress.

"The good news is that we know that there are policy and clinical interventions that work and have a direct impact on saving lives and improving care," Dr. Bailey testified last week at a House Oversight and Reform Committee hearing. "The bad news is there is a huge gap in access to treatment. It is estimated that less than 35% of adults with opioid-use disorder had received treatment for it in 2018."

Progress continues on multiple fronts. As shown in the AMA Opioid Task Force's 2019 progress report, physicians have significantly lowered the number of opioid prescriptions they write and there are rising numbers of doctors registering with and using their state prescription drug monitoring program, getting certified to provide in-office buprenorphine and prescribing naloxone for at-risk patients.

Medical societies in several states have used the AMA's model legislation to remove commercial and Medicaid prior authorization barriers to medication-assisted treatment (MAT).

"This progress, however, has not led to an overall reduction in mortality or a measurable increase in positive patient outcomes," Dr. Bailey said. Progress has also been stalled by barriers to evidence-based treatment. These include payer practices that delay or deny care, reluctance to use MAT, stigma and lack of sufficient treatment facilities, and addiction medicine specialists.

But, most of all, there is a lack of financial support.

"Even if all the barriers discussed above were eliminated, there still would not be enough treatment due to lack of funding," Dr. Bailey said. While the AMA was pleased with the more than $10 billion appropriated in the 2018 and 2019 federal budgets, it falls short given the enormity of the task. "Given the unprecedented nature of the current epidemic, much more funding will be needed to reverse and end this epidemic," she told the committee.

What's next? The Comprehensive Addiction Resources Emergency (CARE) Act, introduced in both the House and the Senate, would authorize $100 billion over 10 years.

"We believe the CARE Act, through policy and funding, is a major step forward in addressing the opioid epidemic," Dr. Bailey said. "The CARE Act is intended to fill the current funding gap and sets up a framework to do so."

Dr. Bailey said she was pleased to see AMA-suggested language in the CARE Act giving grant-funding preference to states that have prohibited prior authorization or step therapy for MAT.

"The AMA believes this language will help to incentivize those states that have not yet removed prior authorization to do so," Dr. Bailey said.
In addition, she said the other side of the crisis needs to be addressed: Improving access to evidence-based, multimodal pain care and increasing access and the affordability of nonopioid pain-care alternatives.

Learn more at the AMA's End the Epidemic website.

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National Update

Congress begins consideration of surprise billing legislation

On June 24, the Senate Committee on Health, Education, Labor and Pensions (HELP) released an updated version of S. 1895, the "Lower Health Care Costs Act," which was considered by the Committee on June 26. Though the bill contains numerous commonsense proposals for lowering the cost of health care, there are significant negative consequences for physicians contained in Title I of the bill, "Ending Surprise Medical Bills." Earlier versions of the bill had contained several options for addressing the impact on patients of medical bills from out-of-network providers, including an untested concept referred to as an "in-network guarantee" as well as allowing disputes between insurers and providers to be settled in through "baseball-style" arbitration. The final committee bill, however, included a mandate that insurers pay out-of-network physicians at the median in-network rate, with no additional patient cost-sharing allowed. This restriction would apply to all out-of-network physician services at in-network facilities, including freestanding emergency departments, ambulatory surgical centers, critical access hospitals, laboratories, radiology clinics and others when the care was provided in an emergency (or for active labor), or where non-emergency services were provided by physicians not generally selected by patient such as anesthesiologists, pathologists, radiologists, on-call specialists and consultants. It would also apply to out-of-network services furnished after an enrollee has been stabilized but declines to consent to pay out-of-network amounts.

HELP Committee Chairman Lamar Alexander (R-TN) hopes to take the legislation up on the Senate floor before the August congressional recess and use the savings generated by the bill to pay for other federal spending priorities.

While virtually all physician organizations support limiting patient costs to their in-network amount in cases where patients did not have the opportunity to select their physician, there are serious potential implications from a government mandate to pay in-network median rates. Plans will have little incentive to offer fair contacts to physicians when they are guaranteed not to have to pay those physicians more than in-network rates for out-of-network care. Physicians with contracts above a plan's in-network rates will likely see those contracts canceled or face demands for significant rate concessions to remain in-network. Those actions would have the secondary effect of further depressing median in-network amounts and threatening access to care.

Physician organizations, including the AMA, have been calling on Congress to pass legislation based on the successful model in New York that has significantly curtailed surprise billing complaints by instituting a "baseball-style" independent dispute resolution system whereby a neutral arbiter chooses between the amount offered by the plan and the amount billed by the physician. Not only is this proven system efficient, it has encouraged more reasonable plan offers and curtailed outlier billing. Such a proposal was introduced on June 26 as H.R. 3502, the "Protecting People from Surprise Medical Bills Act," by Rep. Raul Ruiz, MD (D-CA), Rep. Phil Roe, MD (R-TN) and over 30 other cosponsors including Rep. Larry Bucshon, MD (R-IN), Rep. Brad Wenstrup, DPM (R-OH), Rep. Ami Bera, MD (D-CA), former U.S. Department of Health and Human Services (HHS) Secretary Rep. Donna Shalala (D-FL), Rep. Joe Morelle (D-NY) who authored the NY law, and Rep. Van Taylor (R-TX).

Physicians respond to health information exchange framework proposals

The AMA has submitted a set of comments and recommendations to the Office of the National Coordinator for Health Information Technology (ONC) on the second draft of its Trusted Exchange Framework and Common Agreement (TEFCA). ONC's proposed framework is meant to provide a single "on-ramp" to nationwide interoperability, enable health care teams to better find and use patient medical records and support patients' access to their own information. The AMA expressed its appreciation for ONC's continued involvement of the physician community in developing a nationwide information exchange network. However, the AMA has identified several areas that need more attention before a final version of the TEFCA is released.

While more work needs to be done, the AMA is very supportive of the ongoing efforts by organizations like Carequality and the Sequoia Project to improve information exchange. ONC must take more consideration in minimizing or eliminating proposals that would duplicate and disrupt existing exchanges between participants of health information networks. Fundamentally, the TEFCA should address real, material gaps between currently existing exchanges—with a focus on reducing costs and aiding physicians in finding more complete and accurate medical records.

The AMA urged ONC to take the necessary time for a comprehensive review of its own interoperability policies. This includes recent information blocking and electronic health record (EHR) certification proposals, as well as ensuring alignment between other federal agencies within HHS. In line with congressional intent, the AMA recommends ONC take a practical approach with the TEFCA, initially establishing a nationwide information exchange for the purposes of treatment and patient access to information. The AMA reiterated its position that any framework must also strengthen patient privacy and be resilient to cyber-attacks.

The AMA also urges ONC to maintain the voluntary nature of the TEFCA, specifically that physicians cannot be deemed "information blockers" if they determine that participation under the TEFCA is not optimally serving their patients or not possible due to technical or cost limitations. ONC should restrict mandatory or de facto mandatory participation requirements imposed by EHR vendors, payers or other federal agencies.

President signs executive order on health care price transparency

On June 24, President Trump signed an executive order directing federal agencies to take steps to improve health care price transparency. The order lists five major points:

  • HHS will issue regulations requiring hospitals to disclose actual charge and negotiated payment rate information in an easy-to-read format.
  • A regulatory framework will be proposed to require health care providers and insurers to disclose cost of care information, including out-of-pocket costs, to patients before services are provided.
  • Federal agencies will collaborate on a comprehensive quality roadmap for consolidating consumer-centered quality metrics across all federal health care programs.
  • Access to de-identified health care claims data from all taxpayer funded programs will be expanded to enable health care transformation and facilitate research.
  • The Department of the Treasury is directed to expand the availability of health savings account options to include services like more preventive care and direct primary care arrangements.

As the various reports and proposals are released by federal agencies, the AMA will prepare detailed comments that reflect the interests of patients and their physicians.

AMA supports humanitarian standards for migrating families

The AMA signed on to a letter of support for H.R. 3239, the "Humanitarian Standards for Individuals in Customs and Border Protection Custody Act," along with 13 other health care organizations. H.R. 3239 takes important steps toward ensuring that appropriate medical and mental health screening and care is provided to all individuals, including immigrant children and pregnant women, in U.S. Customs and Border Protection (CBP) custody. The bill was recently introduced by Rep. Raul Ruiz, MD, and currently has 112 cosponsors, including the chairmen of the House Homeland Security and Judiciary Committees.

OMB seeks comments on changing a metric used to determine the federal poverty line

The Office of Management and Budget (OMB) sought comments on changing the inflation index used to calculate the federal poverty line – a change which may substantially cut eligibility for critical health care assistance programs.

More specifically, the AMA responded with a comment letter standing against a switch from the Consumer Price Index (CPI) to the Chained Consumer Price Index (C-CPI) to measure inflation when estimating the federal poverty line (more formally referred to as the Official Poverty Measure or poverty threshold). Making this change would result in the federal poverty line decreasing because inflation estimates based on the C-CPI are consistently lower than those based on the CPI. Because the current poverty guidelines depend on the federal poverty line to determine eligibility and coverage for various health care programs (including Medicaid, CHIP, and Medicare Low-Income Subsidy Program), making this change would, over time, substantially decrease the number of vulnerable patients that qualify for assistance from these critical programs.

Additionally, CPI reflects inflation for the entire U.S. population but studies have shown lower-income households face comparatively higher inflation. Because C-CPI consistently trends lower than CPI, it is likely that C-CPI would understate inflation even more so for these vulnerable groups and generate an even less representative federal poverty line.

CMS office hours will provide MACRA cost measure updates

Following AMA recommendations, the Centers for Medicare & Medicaid Services (CMS) and its contractor, Acumen LLC, are taking steps to improve transparency throughout the Medicare Access and CHIP Reauthorization Act (MACRA) cost measure development process. This is especially important because the episode-based cost measures under development include chronic condition and disease management measures that will affect physicians across multiple specialties. In addition, CMS and Acumen LLC are developing measures in the following clinical areas: dermatologic disease, general and colorectal surgery, and hospital medicine.

To provide an update and answer questions from specialty societies and other stakeholders about the initial cost measure clinical subcommittee meetings, CMS and Acumen will host office hours on July 2 from 3-4 p.m. Eastern time and July 10 from 5-6 p.m. Eastern time. The clinical subcommittees recently met to provide input on which cost measures to develop and about the composition of workgroups that will give detailed clinical input on specifications for each measure. Register for either office hour session at this link.

AMA adopts policy to integrate augmented intelligence in physician training

Furthering its efforts to transform the way future physicians are trained, the AMA adopted policy at its 2019 Annual Meeting aimed at incorporating augmented intelligence (AI) into medical education. The new policy identifies the steps needed to work toward educating physicians-in-training and physicians on how AI technology works and how to evaluate its applicability, appropriateness and effectiveness in caring for patients.

"To realize the benefits for patient care, physicians must have the skills to work comfortably with augmented intelligence in health care. Just as working effectively with electronic health records is now part of training for medical students and residents, educating physicians to work effectively with AI systems, or more narrowly, the AI algorithms that can inform clinical care decisions, will be critical to the future of AI in health care," said AMA Board Member S. Bobby Mukkamala, MD.

The AMA adopted policies on integrating AI into medical education, which include encouraging the development of AI education modules for physicians and physicians-in-training, addressing disparities in AI education that could impact patient care, and ensuring that physicians are involved in the development and implementation of educational materials on AI.

The new policy builds on the AMA's effort over the past six years to transform medical education to ensure future physicians have the skills they need to practice in modern and future health systems. Launched in 2013, the AMA's Accelerating Change in Medical Education initiative aims to incorporate the newest technologies, health care reforms and scientific discoveries that continue to alter what physicians need to know to practice in the evolving health care landscape.

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State Update

New York, Maine, Washington limit non-medical vaccine exemptions

On June 13, New York became the latest state to enact legislation eliminating non-medical exemptions from school vaccination requirements. Previously, parents in New York could cite religious objections in order to opt out of immunization requirements for school enrollment. The new law contains provisions that allow school age children who have begun the immunization process to attend school in Fall 2019 and the law becomes fully effective in June 2020. The Medical Society of the State of New York organized and led a group of 33 specialty societies, patient and public health advocates to support the bill.

New York is the third state to limit non-medical vaccine exemptions this year. In May, with strong support from the Maine Medical Association, Maine enacted a law to eliminate religious and philosophical exemptions for childhood vaccinations. Similarly, the Washington State Medical Association successfully advocated to strengthen Washington's vaccine laws, barring personal and philosophical objection to the measles, mumps, and rubella vaccine. These states follow California, which eliminated non-medical exemptions in 2015, and Mississippi and West Virginia, which have both disallowed non-medical exemptions for decades.

The AMA has long-supported eliminating all non-medical exemptions from required childhood vaccines and supported the legislation in Maine, New York and Washington.

In addition the AMA joined a sign-on letter to Congress on June 7 in support of the Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 (H.R. 2862). The bill authorizes the development of a national vaccination rate surveillance system at the Centers for Disease Control and Prevention, and allows data collected to be used to identify communities with low vaccination utilization or where vaccine misinformation may be targeted. It authorizes research grants to better understand vaccine hesitancy, attitudes towards vaccines, and develop strategies to address nonadherence to the recommended use of vaccines. Additionally, the bill authorizes an evidence-based public awareness campaign on the importance of vaccinations that would aim to increase vaccination rates and can be targeted at communities that have particularly low vaccination levels.

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Judicial Update

Court contemplates third party liability for physicians

The defendant, B.M.D (initials used due to confidentiality concerns), struck and killed Judith Schrope with her vehicle as Schrope was riding her bicycle on the right-hand side of a residential road. Through discovery, Vizzoni learned that B.M.D. was under the care of psychiatrist Stefan Lerner, MD at the time of the accident, being treated for "mild depression," and was prescribed at least six psychiatric medications. Discovery and testimony could not establish, however, that B.M.D. was experiencing any side effects from the medications at the time of the accident. On May 11, 2018, the trial court granted Dr. Lerner's motion for summary judgment on the argument that he owed no duty of care to Schrope because she was not a readily identifiable victim, and that "a therapist has no duty to warn unless he or she knows or should know their patient intends to harm a readily identifiable victim." (McIntosh v. Milano, 168 N.J. Super. 466, 489 Law. Div. 1979). While the court affirmed the trial court's dismissal of claims against Dr. Lerner, it found the reliance on McIntosh to be misplaced. The court went on to say that when a practitioner prescribes either appropriate or inappropriate medication that impairs the patient, the question is not whether the practitioner has a duty to act, but rather were the consequences of the act of prescribing medication foreseeable to the practitioner. While the ruling was in favor of Dr. Lerner, the court did not preclude the establishment of a duty of care between the physician and the cyclist, but rather that there was no evidence that the physician's treatment of the patient was a proximate cause of the accident.

The Litigation Center brief argued that physician's duty of care is to the patient – and in a few rare instances to identifiable third parties – and not to protect third parties that suffer injuries as a result of the negligence of their patients. The AMA has a strong interest in ensuring that the patient-physician relationship is not improperly intruded upon such that it would undermine patient care. Physicians should "never hesitate to provide patients with treatments that have inherent risks and potential side effects because of fear of liability to the public."  

Court allows evidence of a known risk in medical malpractice case

On Jan. 8, 2018 the AMA Litigation Center joined the Pennsylvania Medical Society, and various other amici, in submitting an amicus brief in the case Mitchell v. Shikora. On June 18, 2019 the Supreme Court of Pennsylvania ruled in favor of the Appellants, Evan Shikora, DO. This is a favorable ruling for the AMA Litigation Center and for physicians.

Dr. Evan Shikora was to perform a laparoscopic hysterectomy on Lanette Mitchell. Dr. Shikora began the operation by making an incision into Mitchell's abdomen; however, the initial incision severely cut Mitchell's colon causing Mitchell to wear an external ileostomy pouch for a short period. Mitchell filed a medical negligence action against Dr. Shikora, alleging that Dr. Shikora breached his duty of care by "failing to take reasonable precautions to prevent Mitchell from suffering complications, injuries and/or damages in connection with the surgery." Mitchell motioned to exclude evidence of her informed consent regarding the risks of the procedure, which included perforation of the colon, as well as evidence of the risks themselves, as irrelevant, unfairly prejudicial, or confusing. Relying on a Pennsylvania Supreme Court case, Brady v. Urbas (2015), the Court noted that "evidence about the risks of surgical procedures, in the form of either testimony or a list of such risks as they appear on an informed-consent sheet, may also be relevant in establishing the standard of care."

Ultimately, the majority opinion for the Court agreed with the Litigation Center brief in finding that simply because risk of complications is relevant to informed consent does not make it irrelevant to the standard of care. The decision supports the tenet that "injuries may occur in the absence of negligence," and that without the ability to admit evidence regarding the risks and complications of a surgical procedure, physicians would inappropriately be made strictly liable for patient harm.

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Other News

New AMA dashboard features top advocacy victories

A new advocacy dashboard  highlights progress the AMA has made on ending the opioid epidemic, fighting prior authorization, improving Medicare's Quality Payment Program (QPP), preserving competition in health care markets, improving access to digital health, promoting health equity and more. 

Inaugural recipient announced for the AMPAC Award for Political Participation

Last year, AMPAC launched the Award for Political Participation to recognize an AMPAC member who did outstanding work on behalf of medicine during the last election cycle. AMPAC received eight exceptional nominees from across the country, and the AMPAC Board of Trustees decided that Dr. Marilyn Heine would be the inaugural recipient for the award.

Dr. Marilyn HeineDr. Marilyn Heine wins the inaugural AMPAC Award for Political Participation.

Dr. Heine was recognized and presented her award at the AMPAC luncheon at 2019 AMA Annual Meeting in Chicago. In his remarks, AMPAC Chair Lyle Thorstenson, MD, stated that, "Dr. Heine worked tirelessly to help Congressman Brian Fitzpatrick, a pro-physician legislator, secure his re-election in one of the closest races in the country. She organized fundraisers, formed the 'Physicians for Brian Fitzpatrick' group and mobilized an impressive [get out the vote] GOTV campaign as election day was drawing near and in his supporting letter, Congressman Fitzpatrick stated that Dr. Heine played a vital role in his re-election."

Dr. Heine is a long-time member of the AMA Very Influential Physician (VIP) program and a dogged advocate for both her profession and her patients.

Value-based care: Taking the pulse of key stakeholders in health care

Tune into a new AMA-ReachMD podcast to hear stakeholder perspectives on current and future approaches to value in health care from the AMA's Vice President for Healthcare Quality, Kathleen Blake, MD, MPH, Sheila Savageau from General Motors, Mandy Cohen, MD, MPH, who is the North Carolina Secretary for Health and Human Services, and Michael Seres, CEO of 11Health.

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Upcoming Events

Rx Drug Abuse & Heroin Summit now accepting submissions

By Aug. 23: The Rx Drug Abuse & Heroin Summit is now accepting submissions for the 2020 meeting, taking place April 13-16 in Nashville, TN. The Rx Drug Abuse & Heroin Summit is the largest national collaboration of professionals from local, state and federal agencies, business, academia, clinicians, treatment providers, counselors, educators, state and national leaders, law enforcement/public safety, and advocates impacted by the opioid crisis. The summit will be accepting presentation proposals that accommodate the following formats:

  • Breakout Sessions (75 minutes, including a question and answer segment)
  • Posters (which will be featured in the exhibit hall and have designated poster presentation times where presenters will be required to stand by their posters)

The presentations should be tailored to provide stakeholders timely and relevant information for their particular fields. Submissions will be reviewed by the Rx Summit's National Advisory Board members, who represent multi-disciplinary interests. Submissions are due Aug. 23 11:59 p.m. Eastern time. For more information visit the submission site.

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