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Nov. 1, 2018

Issue Spotlight

A note from the AMA President

We have redesigned this week's issue of Advocacy Update to deliver more of the news you need right to your inbox, keeping you up to date on the issues affecting physicians and medical practice at the national and state levels as well as in the courts. In addition to the new look, we are now including direct links to individual stories so that you can get to the news you want, faster.

Keep an eye out for new features in upcoming issues that celebrate physicians moving medicine, highlight the wins that improve patient care and tout the power of organized medicine.

We'd love to hear your thoughts as we continue to update and improve this newsletter. Please send us your feedback—what you would like to see more of and what you think is missing.

Thank you for subscribing and for your membership.

Barbara L. McAneny, MD

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National Update

Trump administration announces new proposal to lower drug prices

On Oct. 25, the administration announced a new plan to lower prices paid by Medicare for physician-administered drugs paid under Part B. The new "International Price Index Model for Part B" would create a payment system where certain included drugs would be reimbursed at the lower levels paid for those drugs by other countries. Also, private third-party vendors would contract with physicians and hospitals to supply drugs included in the plan.

The Centers for Medicare & Medicaid Services (CMS) would then reimburse vendors for the drugs with prices capped at a predetermined level based on prices in the international market. Physicians and hospitals would still bill for a drug-administration fee. They would also be paid a flat "add-on" fee that will equate to 6 percent of the historical average sales price for the drug in question.

The proposal was released as an Advance Notice of Proposed Rule Making (ANPRM) and at this point is largely conceptual. CMS anticipates a formal proposed rule to be issued this spring with a final rule possibly taking effect in 2020.

The agency is currently seeking feedback on many questions included in the ANPRM that it plans to consider prior to entering the formal rulemaking process. While appreciative of the administration's work to move toward lower drug prices for patients, the AMA has questions about this proposal and will be working closely with CMS to provide feedback.

Physicians oppose prolonged detention of migrant families  

The AMA submitted comments to the secretaries of the departments of Homeland Security (DHS) and Health and Human Services (HHS) in response to a proposed rule titled, "Apprehension, Processing, Care, and Custody of Alien Minors and Unaccompanied Alien Children." The AMA stated its opposition to the DHS-HHS proposal to expand long-term detention of migrating families. The AMA has policy specifically opposing the expansion of family immigration detention in the U.S.

The proposed rule seeks to dismantle the Flores Settlement Agreement (FSA), a decades-old court settlement put in place to ensure the safety and proper care of children in immigration detention. The FSA set strict national standards for the detention, treatment and release of all minors (both accompanied and unaccompanied minors) in immigration custody. The FSA generally requires that children be held in the least-restrictive setting appropriate for a child's needs and that they be released without unnecessary delay to a parent, designate of the parent or responsible adult as deemed appropriate.

The proposed rule seeks to undermine the FSA by allowing minors with their parents to be detained in DHS-licensed family detention facilities for the entirety of their immigration proceedings. The AMA voiced concern about the proposed rule's potential negative impact on immigrant children and their parents or caregivers and urged the administration to withdraw the proposed rule.

The AMA urged the administration to give priority to supporting families and protecting the health and well-being of the children within those families, stating: "Prolonged detention of migrant children and their parents is not a solution to the earlier immigration issue created by the administration's zero-tolerance policy which led to the forced separation of thousands of children from their parents and caregivers at the U.S. border."

The AMA urges FTC to act on insulin prices

The AMA expressed strong concern to the Federal Trade Commission (FTC) in an Oct. 26 letter about the sharp rise in insulin prices among manufacturers. The AMA urged the agency to monitor insulin pricing and assess whether anti-competitive actions were driving higher insulin prices.

The AMA asked that the FTC recommend enforcement action against manufacturers that were engaged in anti-competitive practices to the U.S. Department of Justice. In the letter, the AMA cited lawsuits filed in 2017 against insulin manufacturers on behalf of patients that noted there were "rapid and lockstep price increases of more than 150 percent."

New Medicaid model addresses maternal opioid use

The Center for Medicare and Medicaid Innovation has announced a new delivery model, Maternal Opioid Misuse (MOM), aimed at expanding access to comprehensive care for opioid-use disorder (OUD) among pregnant and postpartum women and their infants. The model is designed to foster coordination of medical care and all the other services needed to support maternal health and recovery.

Morbidity and mortality related to OUD has been growing rapidly among pregnant and postpartum women. The MOM model will award cooperative agreements in up to 12 states that will support state Medicaid agencies and health care professionals working to address fragmentation in the care of pregnant and postpartum Medicaid patients with OUD. Medical societies interested in potentially working with state Medicaid programs as "care delivery partners" in the MOM model can register to learn more through webinars scheduled for Nov. 8 and Dec. 6.

Physicians provide comments on EHR reporting program

The 21st Century Cures Act, signed into law December 2016, directs the HHS secretary to establish an electronic health record (EHR) reporting program to engage stakeholders and gather information about EHR performance to help physicians better choose products. EHR developers will be required, as a condition of their products' certification, to submit reporting criteria on EHR usability, interoperability and security. The Office of the National Coordinator for Health Information Technology (ONC), the HHS agency responsible for regulating EHRs, recently released a request for information to gather physician and end-user feedback on how best to structure the EHR reporting program.

The AMA provided extensive feedback, encouraging ONC to focus the program's goals on:

  • Increasing the expectation that EHR vendors must respond to and focus on their customers' needs, rather than simply comply with federal EHR program requirements
  • Coupling EHR performance, functionality and cost with physician satisfaction, burden and frustration as a key domain for measuring and comparing EHRs
  • Capturing EHR reporting information without further burdening physicians or their staff, be automated wherever possible, and deliver value to those being measured
  • Requiring comprehensive, consistent and comparable reporting requirements for all EHR developers, with attention to product cost, safety and security
  • Leveraging industry standards and frameworks for measuring and scoring an EHR's usability assessment—such as those developed by the AMA, Pew and MedStar Health
  • Including information on EHRs' capability to connect to regional and state health information exchanges, registries, and prescription drug monitoring programs
  • Reducing physician burden by utilizing EHR developer-submitted reporting information as an alternative, supplement or direct replacement for reporting programs like Promoting Interoperability

AMA urges OIG to create value-based anti-kickback safe harbor

In a comment letter responding to the "Request for Information regarding the Anti-Kickback Statute, and Beneficiary Inducement Civil Monetary Penalty," the AMA urged the Office of Inspector General (OIG) to create a new value-based anti-kickback safe harbor to facilitate coordinated care and to promote well-designed alternative payment models (APMs). AMA calls for the safe harbor to be broad, covering both the development and operation of a model to allow physicians to transition to an APM, and to provide adequate protection for the entire care delivery process—including downstream care partners.

The AMA also recommended that OIG create an anti-kickback safe harbor for the sharing of cybersecurity tools and resources. The AMA stressed that any cybersecurity safe harbor be easy to understand, interpret and enforce so that donors and recipients can readily distinguish permissible activities from those that violate the anti-kickback statute. The AMA suggested that the current EHR safe harbor may act as template for a new cybersecurity safe harbor.

Other recommendations from the AMA include:

  • Allowing personal services and management contracts that reward value and allow for incentive payments for efficient and better care
  • Expanding the warranty safe harbor to include bundled payments
  • Making the EHR safe harbor permanent and include covering replacement technology
  • Creating policy guidance that meeting the promoting access to care Civil Monetary Penalty (CMP) exception gets Anti-Kickback Statute protection
  • Establishing a new CMP exception from remuneration to allow for beneficiary incentives for adherence and management activities
  • Asking for policy guidance to waive cost-sharing when the amount is nominal (i.e., when reasonable collection efforts cost more than would be collected)

AMA urges changes to the QIO appeals process

The AMA sent a letter regarding the lack of recourse for providers or patients who are unhappy with the outcome of the CMS Quality Improvement Organization (QIO) appeals process. The Oct. 22 letter was in response to physicians' concerns that the QIO appeals process, and particularly redeterminations, lacks fairness and is singularly focused on a final determination providing no opportunity for further discussion or appeal. The AMA urged CMS to require QIOs to give both parties appropriate notification and to provide the same opportunity to comment during reconsiderations of initial decisions.

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State Update

2018 Health Workforce Mapper now available

An updated version of the AMA Health Workforce Mapper is now available. This interactive tool helps medical associations, legislators or regulators, researchers and others identify underserved patient care areas and understand trends and gaps in patient access to care essential to pursuing a proactive scope of practice advocacy agenda.

In addition to illustrating the geographic locations of the health care work force in each state—including physician specialties and subspecialties—the tool provides population health data by geographic location. The Population Health Explorer feature offers data on a variety of population health factors, including health care access and quality, health behaviors such as smoking and alcohol use, demographics, and social environment factors. This feature enables users to not only see where the physicians of the country practice, but overlay where the patients are located, and the factors that influence their health and access to care.

Here's how some state medical associations and national medical specialty societies have used the tool to aid their advocacy efforts:

"We've used it to show the distribution of psychiatrists, psychologists, nurse practitioners and naturopaths in scope battles. We've also used it to show that states who have passed scope legislation have no different distribution of labor (rural is still sparse for access.)"

"Helpful to show legislators the distribution of practitioners in their districts. Helps link up telemedicine and collaborative care."

"We have used it to help advocate for funding for our medical education and GME program expansions. We've been able to show legislators that additional funding—particularly for rural training tracks—would add providers to their communities."

"We used the mapper to create a poster for a hearing to fight against a bill to grant advanced practice registered nurses independent practice."

For information please contact AMA's Advocacy Resource Center at ARC@ama-assn.org.

MMA holds lawmakers accountable on opioid epidemic

In a richly detailed report, the Maine Medical Association evaluated its state's progress in reversing the opioid epidemic by matching the 2016 goals and objectives with progress made as of April 2018. With few exceptions, the state has considerable work to do, according to the report's findings. For example, Maine's physicians and other health care professionals have reduced opioid prescribing by 32 percent between 2013 and 2017, but little or only moderate progress has been made on measures established by the state with respect to treatment. This includes little progress to improve access to the full continuum of substance-use treatment for adolescents in all counties in Maine. There was also little progress in reducing the stigma, shame, and cultural barriers around substance-use disorder for women who are pregnant and/or who are the primary caregiver for a child under the age of six. In addition, there is only moderate progress toward filling gaps in publicly funded treatment options, prioritizing integrated medication-assisted treatment across all regions and districts.

For questions about the report, please contact MMA EVP Gordon Smith at gsmith@mainemed.com

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Judicial Update

Physicians have immunity for good-faith psychiatric discharges

One day after being discharged from involuntary commitment in a mental health facility, a Maryland man killed himself—a sequence of events that everyone fears.

But psychiatrists acting in good faith in their decision-making in such cases have immunity from medical liability in the event of adverse outcomes, Maryland's highest court has ruled.

The opinion not only allows physicians to make good-faith clinical decisions, but protects patients' civil liberties because physicians won't err on the side of involuntary confinement for fear of being sued.

"All that is required for immunity is that the assessment [for release] be done in good faith following the process and applying the criteria in the statue," the Court of Appeals of Maryland said in its decision in Bell v. Chance.

The justices' opinion echoed many of the arguments that the Litigation Center of the American Medical Association and State Medical Societies, and the Maryland State Medical Society made in an amicus brief. The organizations filed the brief in support of the physician in the case, Leroy C. Bell Jr., MD, and his employer, Bon Secours Hospital Baltimore Inc.

Read more at AMA Wire®

Should abortion rights extend to unaccompanied migrant minors?

A federal appeals court will determine whether a government agency can establish barriers for unaccompanied migrant children seeking abortions.

A federal district court earlier this year stopped government interference with access to services, ruling that the U.S. Health and Human Services Department's Office of Refugee Resettlement (ORR) cannot establish an anti-abortion policy that unduly burdens these minors' right to abortion.

The question went before the court after ORR—which can make all medical decisions for unaccompanied alien children in place of their parents—issued a memo and follow-up communication to federal grantee organizations that provide shelter and services for the unaccompanied alien children. The agency said that unless it is an emergency:

  • The grantee organizations must contact ORR about any minor who may require an abortion.
  • Grantee organizations could not take any action that facilitates an abortion without ORR's director.
  • Grantee organizations could only provide "pregnancy services and life-affirming options counseling."

The lower court said ORR established the policy without statutory or regulatory authority.

ORR appealed the decision in Azar II v. Garza to the U.S. District Court Appeals for the District of Columbia Circuit, which heard oral arguments on the case in September.

The Litigation Center of the American Medical Association and State Medical Societies joined the American College of Obstetricians and Gynecologists and a half-dozen physician organizations supporting the guardian ad litem for a pregnant unaccompanied alien minor who filed the class action lawsuit on behalf of that child and others. The amici are asking the court to uphold the lower court decision.

Read more at AMA Wire.

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Other News

How physicians are responding to new payment models

Physician payment models are becoming more complex and the pace of change is increasing, creating challenges for physician practices that might hamper their ability to improve the quality and efficiency of care despite their willingness to change, according to a new joint study by the RAND Corporation and the American Medical Association. The study is a follow-up to a similar one conducted in 2014 to assess how physician practices were responding to alternative payment models.

Researchers from RAND examined 31 physician practices in six geographic markets to describe the effects of alternative health care payment models on physician practices. Whenever possible, researchers re-interviewed the same physicians and practice leaders that participated in the previous study. The findings are intended to help guide system-wide efforts by the AMA, which sponsored and co-authored the study, and other health care stakeholders to improve alternative payment models and to help physician practices successfully adapt to the changes.

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Upcoming Events

Register now for both 2019 advocacy conferences
Registration is now open for the 2019 AMA State Advocacy Summit (formerly the State Legislative Strategy Conference) and the National Advocacy Conference. Register for both events today and get 20 percent off. SAS will be held Jan. 10-12 in Scottsdale, Arizona, and NAC will be held Feb. 11-13 at the Grand Hyatt in Washington, D.C.

Nov. 15: Delivering climate-smart health care webinar
In this webinar emergency medicine experts will explore the health impacts of climate change and opportunities to advance solutions that address human health and our health system. Participating physicians can earn one CME credit per webinar. Nov. 15 at 1 p.m. EST. Register now.

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