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Jan. 24, 2019

Issue Spotlight

Addressing the opioid epidemic in Colorado: Progress and opportunities

The AMA, Colorado Medical Society and Manatt Health recently released a report that shows Colorado has implemented meaningful reforms in response to the opioid epidemic though further steps are needed to save even more lives.

The Colorado spotlight analysis found that progress is being made to increase access to evidence-based treatment for substance use disorders, several pilot projects have improved care for patients with pain, and increased access to the opioid overdose-reversing drug naloxone has resulted in thousands of lives saved.

"We conducted this analysis because it's essential that policymakers know what is working, and where additional progress can be made," said AMA President-elect Dr. Patrice A. Harris, who also chairs the AMA Opioid Task Force. "Colorado has implemented many important policies that are impacting patients' access to care. Using this momentum, we think Colorado can go even further to save lives of those affected by opioid use disorder."

Colorado is the second in a series of individual state studies. The AMA released a study on Pennsylvania last month.

Based on available data, review of policies and discussions with key policymakers, the analysis found four key areas where Colorado is succeeding:

"This analysis comes at an important time for Colorado," said Dr. Debra Parsons, Colorado Medical Society president. "Over the last six years, Colorado has developed policies, enacted laws and made important strides to have all stakeholders work together to reverse the opioid epidemic. While we continue these successful initiatives, we must closely evaluate how they are working so we can ensure we are putting our efforts in the right places."

The analysis also highlighted the work of the Colorado Consortium for Prescription Drug Abuse Prevention, which has brought together several hundred stakeholders and continues to develop a data-driven, county- and state-level data dashboard that can be used to help direct resources to areas of greatest need.

The analysis also found areas where additional progress could be made:

"Many of the recommendations in this report related to commercial insurance—such as strengthening our market conduct examinations to better enforce mental health parity and more comprehensive front-end reviews of the number of addiction professionals in insurers' networks—are fair and reasonable approaches that are within our authority to immediately tackle," said Michael Conway, Colorado Insurance Commissioner and head of the state's Division of Insurance. "We look forward to working with Colorado's health insurers and physicians to implement solutions that help ensure consumers receive the care that they need to help end our state's opioid epidemic."

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National Update

New moves by FDA could increase naloxone access

One of the most complicated steps in moving a drug from prescription to over-the-counter (OTC) availability is the creation of a medication label that can be easily understood by consumers so that they do not need the advice of a physician about whether, when and how to take the medication. The AMA praised a recent announcement by the Food and Drug Administration (FDA) that it has developed such a label for naloxone—the medication that can prevent opioid overdose deaths by reversing opioid-induced respiratory depression.

This new FDA action is likely to greatly facilitate the development of OTC proposals by manufacturers of the current naloxone products available by prescription. Although many states allow naloxone to be dispensed through a form of prescription known as "standing orders," OTC status would further increase access and save more lives that would otherwise be lost to opioid overdoses.

Federal legislation introduced to expand firearm background checks

On Jan. 8, Rep. Mike Thompson (D-CA), chairman of the House Democratic Gun Violence Prevention Task Force, introduced the Bipartisan Background Checks Act of 2019 (H.R. 8), with a group of nine colleagues from both sides of the aisle. Jan. 8 also marked the eighth anniversary of the shooting in Tucson, Arizona, that killed six and wounded 13, including Rep. Gabrielle Giffords. Former Rep. Giffords, who now heads the group Giffords: Courage to Fight Gun Violence, was present at the bill's introduction. AMA has expressed support for the bill.

Under current law, only federally licensed gun dealers must conduct background checks of firearms purchasers. Weapons sold at gun shows, on the internet or through other means are not subject to this requirement. H.R. 8 would close this loophole for almost all firearms transactions. 

The bill has quickly garnered 221 cosponsors, more than the number of votes needed to pass the House. It is expected that the House will take up the bill in the coming weeks. 

FDA releases updated software precertification model, plans testing for 2019

The FDA recently released an updated version of its Software Precertification Program working model, as well as a test plan for the model for 2019. The Software Precertification Program, or "Pre-Cert" program, represents FDA's work to develop a new system for regulation and oversight of software functioning as a medical device, as the current regulatory structure for medical devices is not a good fit for the rapidly changing software marketplace. According to FDA's current thinking, the software Pre-Cert program will function as a "pre-check" program for software manufacturers, where manufacturers that receive a satisfactory determination after a corporate "excellence appraisal" would be eligible for streamlined review of their software products. Continued safety and efficacy would be ensured through post-market surveillance of those products.

The FDA plans to test the current version of the model in 2019 with volunteer participants that will assist in evaluating all aspects of the Pre-Cert program. The FDA anticipates that over the course of the test period, changes will be made to the program based on lessons learned, so the current working model does not represent a final or permanent regulatory pathway. The AMA has been working closely with FDA on development of this program to ensure that the program addresses concerns from the physician community.

AMA comments on Medicaid and CHIP managed care

On Jan. 14, the AMA submitted comments on a proposed rule from the Centers for Medicare & Medicaid Services (CMS) on managed care in Medicaid and the Children's Health Insurance Program (CHIP). The proposed rule was published in the Federal Register on Nov. 14, 2018.

Substantial changes were made under the Obama Administration in 2016 to the regulation governing Medicaid managed care. CMS did not propose to replace the existing regulatory framework; rather the agency proposed revisions to the 2016 final rule, which included several provisions that went into effect for the plan year beginning July 1, 2018.

The AMA's comments focused on concerns that several significant provisions in the proposed rule could result in inadequate payments to physicians and other providers, weaken access protections for beneficiaries, especially through changes to network adequacy, and decrease information transparency. For more information on the AMA's comments, see the linked letter.

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State Update

We asked, you answered: See the top issues facing organized medicine this year

A new state legislative survey identified the top issues that medical societies will face in 2019 which include scope of practice, prior authorization, out-of-network billing and efforts to increase access to medication-assisted treatment. The survey, which represented the input of 75 national, state and specialty organizations, helps the AMA identify the top issues facing organized medicine and helps ensure the AMA focuses its resources on coordinating its advocacy efforts with its state and specialty partners. 

Contact the AMA Advocacy Resource Center with any questions.

Highlights from the State Advocacy Summit

As the 2019 AMA State Advocacy Summit wrapped up, hundreds of physicians and physician advocates left inspired to shape state health policy solutions by using strategies learned at the meeting. See what attendees had to say on social media, and access presentation slides from speakers and related resources. Stay tuned for additional coverage of the meeting in the weeks to come.

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Judicial Update

Doctors tell court: Medicare must seek comment before rule changes

If CMS leaders make decisions—even seemingly small ones—without input from stakeholders and the public, physicians and their Medicare patients may suffer substantial costs and other burdens, physicians told the U.S. Supreme Court.

In a friend-of-the-court brief that the Litigation Center of the American Medical Association and State Medical Societies filed on behalf of the AMA and the Medical Society of the District of Columbia in the U.S. Supreme Court, physicians told justices that "even 'seemingly minor' modifications in reimbursement determinations give rise to extreme financial consequences for providers and ultimately their patients."

The brief calls on the court to require that the Department of Health and Human Services (HHS), which oversees CMS, follow the Medicare statute that requires notice-and-comment rulemaking even if it seems burdensome.

"Notice-and-comment rulemaking facilitates public input into agency decision-making, as well as greater transparency and clarity on the part of the agency and in this way provides an important check against unbridled administrative power," the Litigation Center brief tells the court. "Because the administration of Medicare implicates the health of millions of Americans, fulsome opportunities for public input are essential."

The case before the U.S. Supreme Court, Azar v Allina Health Services et al., stems from a lawsuit that challenges whether CMS had the right to skip the notice-and-comment rulemaking process when it changed the method used to calculate payments to hospitals to cover their additional costs for serving low-income patients. 

Read more
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Other News

8 physician advocacy wins that set the stage for 2019

Given the turbulence in Washington, it's easy to overlook the many policy wins scored on behalf of patients and physicians at the national and state levels. In her opening address to the AMA State Advocacy Summit, AMA President Barbara L. McAneny, MD, detailed how physician advocacy has made a difference on gun violence, regulatory relief, physician payment and more, while offering a look ahead to the Association's ambitious 2019 policy goals. Read more.

AMA outlines policy proposals to combat prescription drug price increases

In an ongoing effort to increase drug price transparency and address the rising cost of prescription drugs, the AMA has released a two-page advocacy document "Improving Prescription Drug Price and Cost Transparency" which outlines specific policy proposals aimed at each of the key players involved in drug pricing: pharmaceutical companies, pharmacy benefit managers (PBMs) and health insurers. All these groups contribute to prescription drug cost increases that influence patient cost-sharing, prior authorization policies and patient adherence to treatment plans, which ultimately impact patient health status and outcomes.

To learn more about the AMA's grassroots campaign to expose the opaque process that pharmaceutical companies, PBMs and health insurers engage in when pricing prescription drugs, please visit TruthinRx.org.

Register by Feb. 8 for the AMPAC Candidate Workshop

Thinking about running for office? The 2019 AMPAC Candidate Workshop is designed to help physicians make the leap from the exam room to the campaign trail. The workshop will be taking place March 1-3 at the AMA office in Washington, DC.

The curriculum is targeted to AMA members, their spouses, residents, medical students and medical society staff who want to learn more about what it takes to be an effective candidate. You will learn:

  • How and when to make the decision to run
  • The importance of a disciplined campaign plan and message
  • The secrets of effective fundraising
  • What kinds of media advertising are right for your campaign
  • How to handle the inevitable crises that emerge for every campaign
  • The role of your spouse and your family
  • How to become a better public speaker

The registration fee is $250 for AMA members and $1,000 for non-members. Airfare and hotel accommodations are not included, but a discounted room block at the Washington Court Hotel on Capitol Hill is available.

Space is limited so register by Feb. 8.

Nominations for AMPAC award for political participation now open

The AMPAC Award for Political Participation recognizes an AMA or AMA Alliance member who has made significant personal contributions of time and talent in assisting friends of medicine in their quest for elective office at the federal and state levels. These can include volunteer activities in a political campaign or a significant health care-related election issue such as a ballot initiative or referendum.

The winning nominee will receive special recognition during the AMPAC Board Chair's speech before the House of Delegates or during the AMPAC luncheon at the AMA Annual Meeting in Chicago. Nominees must be a current member of the AMA or AMA Alliance as well as AMPAC with preference given to members with a demonstrated history of AMPAC involvement. The deadline to submit nominations is Jan. 31. The full criteria for the 2019 AMPAC Award for Political Participation, including how to submit a nomination, can be found here.

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Upcoming Events

Veterans Health Administration is offering two new webinars

Jan. 31 - VA Telemental Health Innovations 2019: Enhancing Veteran Access to Care will define what VA's "Anywhere to Anywhere" regulations for VA providers are and how they promote increased access to mental health care for veterans, and identify the purpose of the Telemental Health Hubs within the overall VA mental health care system.

Feb. 21- VHA Office of Community Care Overview will provide an overview of community care programs and policies with a focus on how to file clean claims, top rejection reasons and other provider issues. 

Register now for the AMA National Advocacy Conference

Held in Washington, DC, the AMA National Advocacy Conference, Feb. 11 – Feb. 13, is coming soon—register now to secure a spot. Hear the latest about key work on the Hill from industry experts, political insiders and members of Congress. Featured speakers include Margaret Brennan, moderator of CBS News' "Face the Nation" and CBS News senior foreign affairs correspondent, Indu Subaiya, co-founder, Health 2.0 & executive vice president, Healthcare Information and Management Systems Society (HIMSS), and Nicolle Wallace, political analyst and MSNBC anchor, New York Times Best-Selling Author, and former White House director of communications. Additional confirmed speakers include HHS Secretary Alex Azar, other high-ranking CMS staff and distinguished members of Congress who are making key decisions about our nation's health care system.

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