Dr. James Madara, CEO and executive vice president of the American Medical Association (AMA), wrote lawmakers to promote federal payment and delivery system reforms to better combat the opioid epidemic. The goal is to “better support and incentivize clinicians who enhance their education on pain management and safe prescribing, become certified to prescribe buprenorphine, co-prescribe naloxone, utilize Prescription Drug Monitoring Program (PDMP) data in clinical practice and coordinate treatment and support services for patients experiencing pain and/or addiction.”
The AMA also suggested the federal government create a seventh protected class of drugs under Medicare Part D for medication-assisted treatment (MAT).
Over the weekend, HHS Secretary Alex Azar said the FDA would soon be issuing two guidance documents related to MAT.
In a letter to Sen. Orrin Hatch, R-UT, chairman of the Senate Finance Committee, and Sen. Ron Wyden, D-ORE, ranking member on the Senate Finance Committee, Madara touted ways physicians are already working to reduce the epidemic.
For instance, opioid prescriptions dropped by 17% nationally between 2013 and 2016 and there was a 121% increase in the number of queries by health professionals to state PDMPs.
However, opioid deaths and overdoses are still in crisis territory.
The AMA offered several policy ideas. On MAT, the AMA said the CMS’ overutilization monitoring system (OMS) has helped reduce the number of Medicare beneficiaries at risk of opioid misuse. However, the federal government can do more to ensure access to evidence-based MAT for patients with opioid use disorder. That includes eliminating the requirement of a special federal waiver to prescribe buprenorphine, which helps prevent relapse in people with opioid dependence.
Azar spoke Saturday to the National Governors Association, previewing two new guidance documents to improve quality and access to MAT.
The first relates to drugmakers working on new formulations of buprenorphine, which may be more effective for certain populations, for example in rural areas.
"FDA’s guidance will help clarify what kind of evidence is needed to gain approval for new depot forms of buprenorphine, such as data regarding how quickly the drug is distributed in the bloodstream," Azar said.
The second guidance seeks to encourage more flexible and creative designs of MAT studies.
The AMA's other suggestions included:
- Improve coverage and eliminate payment barriers for Medicare Advantage and Part D plans
- Allow Medicare coverage of methadone
- Ensure quality measurement does not lead to inappropriately treating pain
- Support alternative payment models for opioid therapy
- Enhance education of physicians and other providers
- Improve access to naloxone, which can reverse an opioid overdose
President Donald Trump declared the crisis a public health emergency in October, but his budget also looked to cut $5 billion over five years in resources to fight the epidemic. Also, the FDA is planning to expand MAT for people dependent on opioids and House and Senate committees are planning hearings on opioids this week with a hope of getting enforcement and patient safety legislation to the floor before Memorial Day.
Meanwhile, payers have stepped up efforts to battle opioid addiction. Aetna is now waiving copays for Narcan for its fully-insured commercial members. The insurer also has five-year goals to reduce opioid usage and abuse by 2022.
Also, America’s Health Insurance Plans launched a program last year called the Safe, Transparent Opioid Prescribing (STOP) Initiative. The project looks to collaborate with state and federal leaders, physicians and other providers on ways to address the crisis and supports adoption of clinical guidelines for pain care and opioid prescribing.
A shortage of primary care doctors is also a challenge in halting the crisis.
A recent Avalere report said 11 states, including Iowa, Illinois, Maryland, Michigan, Missouri, North Carolina, New Hampshire, Ohio, Virginia, Wisconsin and West Virginia, plus the District of Columbia, have lower than average rates of providers who can prescribe buprenorphine, which helps prevent relapse patients in people with opioid dependence.
Also, nine other states, including Arizona, Kentucky, Minnesota, Nevada, Oklahoma, South Carolina, South Dakota, Tennessee and Utah, have lower rates of providers per overdose than the national average.