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April 18, 2019

Issue Spotlight

FDA and CDC issue clarifications on opioid prescribing guidelines

The Centers for Disease Control and Prevention (CDC) issued a clarification that its 2016 CDC Guideline for Prescribing Opioids for Chronic Pain "does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm." The CDC letter highlighted that it is currently supporting multiple research projects to evaluate the impact of the CDC Guideline, including whether it has led to unintended consequences. The CDC letter highlighted that its recommendations on opioid dose strength "focuses on initiation."

The AMA continues to advocate against the misapplication of CDC guideline by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit patients' medical access to opioid analgesia.

In a separate move, the U.S. Food and Drug Administration (FDA) issued a statement indicating it will provide updated labeling information regarding opioid analgesic tapering.

"With overdoses and deaths continuing to plague communities across the country, the AMA welcomes the FDA's decision to include tapering guidance on the labels of prescription opioids," said AMA President Barbara L. McAneny, MD. "This patient-centric approach will encourage discussions between patients and physicians on whether a decrease in dose or discontinuation of the opioid is the best approach. If so, the patient and physician should discuss how to safely decrease dosages. The FDA notes that there is no standard tapering schedule suitable for all patients. The right approach depends on conversations between patients and physicians, including a decision to maintain the patient on a current dose if the benefits outweigh the risks."

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National Update

Congress urged to address causes of surprise billing

On April 16, the AMA sent a letter to the House Committees on Ways and Means, Energy and Commerce, and Education and Labor, as well as the Senate Health, Education, Labor and Pensions Committee and Finance Committee, urging the committees and Congress to protect patients from unanticipated, or "surprise," medical bills by examining the full range of situations that cause patients to receive medical bills that their health insurance plan will not cover. These situations include health insurance market concentration and narrow provider networks that increase the likelihood patients may receive care from an out-of-network provider, particularly in emergency situations. The letter also discusses the consequences when health insurance plans shift costs to patients by denying care through utilization management (including prior authorization), mental and substance abuse payment disparities, retroactive denials, and formulary changes.

The AMA emphasized that remedies must protect patients from costs that should have been covered by their health insurer, and instead focus on creating a process that relies on unbiased claims data where providers and insurers can reach a fair payment amount for out-of-network care in situations where a patient cannot choose the provider. The letter cites a survey that a clear majority of patients who have experienced a surprise bill place responsibility on their health care insurance plan rather than on physicians.

New bill aims to lower maternal and infant mortality, reduce racial disparities in health outcomes

The AMA has joined other health organizations in supporting legislation to address the troubling rates of maternal mortality, morbidity and infant mortality in the United States. The Mothers and Offspring Mortality and Morbidity Awareness Act or "MOMMA Act," (S. 916/H.R. 1897) was reintroduced by Senators Richard Durbin (D-IL), Tammy Duckworth (D-IL) and Representative Robin Kelly (D-IL). More women die from pregnancy-related complications in the United States than in any other developed country, and the rate of maternal deaths continues to rise. Major disparities in maternal mortality exist, with black women being three to four times more likely than white women to die during pregnancy or shortly after birth. Moreover, for every maternal death that occurs, an estimated 100 other women suffer severe complications of pregnancy or childbirth.

The MOMMA Act seeks to lower the country's rising maternal and infant mortality rates and reduce racial disparities in health outcomes by:

  • Expanding coverage under Medicaid and the Children's Health Insurance Program, as well as the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), through a longer post-partum period for women
  • Improving coverage and access to doulas
  • Improving and scaling best practices for maternity care
  • Improving implicit bias and cultural competency training among health care providers.

The legislation also would bolster federal efforts to support states in collecting, standardizing and sharing maternal mortality and morbidity data.

Proposed coverage expansion will increase access to ambulatory blood pressure monitoring

In response to a 2018 joint request from the AMA and the American Heart Association (AHA), the Centers for Medicare & Medicaid Services (CMS) agreed to review its national coverage policy for ambulatory blood pressure monitoring (ABPM). It has now proposed to expand the covered indications for ABPM to include use in diagnosing patients with suspected masked hypertension and informing their treatment plans.

Masked hypertension occurs when office blood pressure measurement is normal but ABPM is elevated. The proposed coverage decision notes CMS has now concluded that ABPM has benefits beyond only ruling out white-coat hypertension—it is an essential tool in managing hypertension to reduce mortality and improving other health outcomes for Medicare patients. The AMA and AHA are encouraged by the proposal to expand coverage to additional indications. AMA is reviewing the details of the proposed coverage decision and will submit comments to CMS.

Click here to review the proposed coverage decision memo. Public comments will be accepted until May 9.

AMA supports prescription drug rebate proposals, cautions against unintended consequences

On April 8, the AMA submitted comments on a proposed rule seeking changes to the current safe harbors for prescription drug rebates. With the proposed rule, the administration seeks to eliminate safe harbor protections for prescription drug price reductions (including rebates and other discounts) paid by drug manufacturers to health plans and/or pharmacy benefit managers (PBM) contracting with health plans administering Medicare Part D plans or with Medicaid managed care organizations (MCO).

The administration is also proposing to create a new safe harbor for prescription drug price reductions paid directly to beneficiaries at the point of sale. This proposal would essentially eliminate the current system of PBM-negotiated rebates and ensure that patients taking drugs for which discounts are available are able to directly benefit from those discounts. The proposed rule also includes some additional transparency requirements for PBMs in the Part D/Medicaid MCO space, proposing that certain fees included in contracts with manufacturers are clearly disclosed.

The AMA supports changes to the prescription drug rebate system that would allow patients to directly benefit from any price reductions negotiated with manufacturers. However, the AMA also urged the U.S. Department of Health and Human Services (HHS) to consider the potential of unintended consequences for all beneficiaries, including the potential for increased premiums in Part D plans, no meaningful reductions in drug list prices, a decrease in amount of price reductions offered and increased drug spending by Medicaid programs.

The prescription drug rebate proposal is the latest of several proposals put forth by the Trump administration looking at prescription drug spending and prices. The AMA continues to work closely with the administration to ensure policy changes have a meaningful impact on patient out-of-pocket costs and maintain access to critical treatments.

FDA issues discussion paper on regulation of artificial intelligence/machine learning-based software

The FDA released its first discussion paper and request for feedback on a proposed regulatory framework for artificial intelligence/machine learning-based software (AI/ML) as a medical device. The proposal builds on the FDA's ongoing work to modernize the regulatory framework for software as a medical device (SaMD), including non-AI/ML-based software.

For SaMD, the FDA is proposing a precertification program for software manufacturers that could ultimately result in streamlined review of software products created by manufacturers gaining precertification status, similar to the TSA Pre-Check program for travelers. The AI/ML-based software discussion paper proposes to utilize the precertification program as the regulatory pathway for certain types of continuously learning artificial intelligence-based products, but with additional considerations for this type of software product.

Much like the precertification proposals, this discussion paper does not represent guidance or binding regulatory changes from the FDA. The AI/ML-based software discussion paper represents only the FDA's current thinking and seeks feedback from interested stakeholders to help further develop the framework. The AMA is carefully evaluating this discussion paper and the potential considerations for physicians in any new regulatory framework for software products of this type. The FDA is seeking comment by June 3.

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State Update

District of Columbia, New Jersey take steps to save lives, reverse the opioid epidemic

State officials in the District of Columbia and New Jersey recently took significant steps to improve patient care for persons with an opioid use disorder, including removing prior authorization for MAT. The Medical Society of the District of Columbia (MSDC) and the AMA commended Mayor Muriel Bowser, Department of Health Care Finance Director Wayne Turnage and Medicaid Director Melisa Byrd.

Similarly, the AMA commended the actions by New Jersey Gov. Phil Murphy and state Human Services Commissioner Carole Johnson. "Now it's time for commercial health insurance companies to follow suit and remove prior authorization for medication assisted treatment," said Patrice A. Harris, MD, MA, Chair AMA Opioid Task Force and President-elect of the AMA.

Massachusetts bans conversion therapy, protects LGBTQ youth

On April 8, Massachusetts Gov. Charlie Baker signed into law a bill that prohibits the practice of conversion therapy on minors. Massachusetts is the 16th state to enact such a ban. Conversion therapy refers to any form of interventions which attempt to change an individual's sexual orientation, sexual behaviors, gender identity or gender expression. Underlying this practice is the harmful assumption that homosexuality and gender dysphoria are mental disorders that should be treated. Evidence has shown it is a coercive practice that may cause long-term psychological harm, particularly to young patients.

The AMA opposes the use of conversion therapy and joined the Massachusetts Medical Society in supporting the legislation. Under the new law, licensed health care professionals are prohibited from engaging in sexual orientation and gender identity change efforts with a patient less than 18 years of age. The prohibition does not apply to interventions that facilitate a patient's coping, social support, identity development, or address unlawful conduct or unsafe sexual practices. 

For more information about AMA advocacy for the LGBTQ community, visit the AMA website.

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Other News

Physician Compare supplemental 30-day preview period is open

This is the first year Quality Payment Program (QPP) performance information will be publicly reported, and due to AMA feedback, CMS has re-opened the preview period to allow physicians additional time to review their data before it is publicly reported. All Merit-based Incentive Payment System (MIPS)-eligible clinicians and groups should check their performance information by logging into the Quality Payment Program website.

The supplemental 30-day preview period opened on March 28 and closes April 27. CMS has included the latest 2017 performance information that is available for public reporting. Even if a physician previously did not have performance information to preview, there may be updated performance information to preview now. All clinicians and groups are advised to login to the QPP website and check their most current performance information. In year two of the QPP and moving forward, a standard 30-day preview period is expected, but the AMA will continue to advocate for an extended preview period.

To preview your performance information:

For additional assistance with accessing the QPP website, or obtaining your HARP user role, contact the QPP service center at QPP@cms.hhs.gov. To learn more about the 2017 QPP performance information and 2016 clinician utilization data that are available for preview, download the following documents from the Physician Compare Initiative page:

If you have any questions about Physician Compare, public reporting, or the supplemental 30-day preview period, please contact PhysicianCompare@Westat.com.

New resources available to assist with privacy laws related to the opioid crisis

The National Center of Excellence for Protected Health Information (CoE-PHI) provides clear guidance and strategies to improve application of federal health privacy laws by physicians and other staff working in mental health, substance use disorder and school settings, and to improve access to accurate information among consumers and families. It has updated its resource center with tools that address important anti-discrimination protections for individuals with substance use disorder, including people who receive medication-assisted treatment (MAT) for opioid use disorder. These documents are meant to assist in the interpretation and application of PHI laws and regulations as they relate to the opioid crisis.

The AMA is a member of the National Advisory Group for the CoE-PHI, funded by the Substance Abuse and Mental Health Services Administration. AMA will continue to advise the CoE-PHI by relaying physician concerns and pain points related to privacy, as well as suggest ways that the CoE-PHI can provide guidance and education that is meaningful to physicians.

Help for physicians in unwinding contractual agreements

The AMA has compiled expert resources to help physicians unwind existing arrangements with hospitals, health systems or large group practices that are owned or controlled by health systems or payers.

The resource addresses billing practices, potential limitations on patient relationships, professional liability coverage, noncompete provisions, practice infrastructure and governmental or payer-reporting obligations. The AMA also offers a model checklist to guide physicians who are considering unwinding an existing relationship, as well as a snapshot of the topline issues to address.

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Upcoming Events

2019 Rx Drug Abuse and Heroin Summit

Apr. 22-25: The Rx Drug Abuse & Heroin Summit is the largest and most-recognized conference committed to addressing the opioid crisis. Government officials, first responders, law enforcement personnel, clinicians, physicians, nurses, educators, public health and prevention officials, and families and people in recovery are represented. The conference agenda is designed with timely and relevant information to address what is working in prevention, treatment and law enforcement. AMA Trustee S. Bobby Mukkamala, MD, will be representing the AMA, giving a presentation April 24, "Moving slowly to treatment: policymaker, payer and physician leadership to end the epidemic."

The 2019 Summit returns to the Hyatt Regency in Atlanta.

Visit www.rx-summit.com to explore the agenda and register.

Webinar on a follow-up study about payment models

April 24: Learn how findings from a new RAND Corp./AMA study, "Effects of Health Care Payment Models on Physician Practice in the U.S." can help guide practices' efforts to successfully adapt to changes required by complex alternative payment models (APM) in a new webinar. Register now for the webinar at 1:00 p.m. Eastern time.

DEA National Prescription Drug Take Back Day

April 27: The National Prescription Drug Take Back Day addresses a crucial public safety and public health issue. According to the 2017 National Survey on Drug Use and Health, 6 million Americans misused controlled prescription drugs. The study shows that a majority of abused prescription drugs were obtained from family and friends, often from the home medicine cabinet. The U.S. Drug Enforcement Agency's (DEA) Take Back Day events provide an opportunity for Americans to prevent drug addiction and overdose deaths. Visit the Take Back Day website to find the closest collection site.

Thriving in practice webinar: A physician's APM journey

May 22: A long-time physician will share her practice's journey through the phases of transformation and how both the struggles and the triumphs have prepared the practice team for operating and succeeding in an APM. Register now for the webinar at 1:00 p.m. Eastern time.

The campaign trail starts here: Register for AMA Campaign School by June 21

Open to AMA members, their spouses, medical students, residents and state medical association staff who want to become more involved in campaigning process, the 2019 AMPAC Campaign School will be held Sept. 26-29 at the AMA offices in Washington, D.C. The Campaign School is designed to provide participants with the skills and strategic approach they need to run a successful political campaign.

During the two-and-a-half day in-person portion of the program, under the direction of AMA political experts, participants will be broken into campaign staff teams to run a simulated congressional campaign using what they have learned during group sessions on strategy, vote targeting, social media, advertising and more. Faculty, materials and all meals during the meeting are covered by the AMA. Participants are responsible for the registration fee and hotel accommodations at the Hyatt Regency Washington on Capitol Hill.

The deadline to register is June 21. For more information or to apply visit: www.ampaconline.org/apply or contact politicaleducation@ama-assn.org.

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