Policy News Roundup: December 16, 2021

Key reads

Naloxone's prescription-only status limits access

Naloxone’s prescription-only status creates barriers to increasing access. All states allow individuals to buy naloxone at pharmacies without a prescription, but they do not have authority to designate it as over-the-counter (OTC). They have created workarounds such as a state health official writing one prescription that can be used by every resident. However, when organizations purchase naloxone from pharmaceutical companies, the companies are required to treat naloxone as a prescription drug and impose requirements. For example, a doctor must sign for the order, and that doctor must be someone who has not signed for another group. The organization must have a medical or pharmacy license and the ability to comply with regulations for storage and dispensing. Groups are calling on the Food and Drug Administration (FDA) to allow naloxone to be sold OTC so they can order it more easily and distribute it to people at greatest overdose risk, who are unlikely to turn to a pharmacy. The FDA says it has encouraged manufacturers to apply for OTC designation.

Source: To save lives, overdose antidote should be sold over-the-counter, advocates argue (NPR)

Monitoring the Future survey largely shows declines in adolescent substance use in 2021

The 2021 Monitoring the Future survey of 8th, 10th and 12th graders found that the percentage of adolescents reporting substance use decreased significantly in 2021. In line with continued long-term declines in the use of many illicit substances among adolescents previously reported, these findings represent the largest one-year decrease in overall illicit substance use reported since the survey began in 1975. There were decreases in use of alcohol, marijuana and vaped nicotine, the most common substances used in adolescence. The 2021 decrease in vaping for both marijuana and tobacco follows sharp increases in 2017-2019. Students reported moderate increases in feelings of boredom, anxiety, depression, loneliness, worry, difficulty sleeping and other negative mental health indicators since the beginning of the pandemic. While the 2021 survey represents about 75% of the sample size of a typical year, the results were statistically weighted to provide national numbers.

Source: Percentage of adolescents reporting drug use decreased significantly in 2021 as the COVID-19 pandemic endured (National Institute on Drug Abuse)

Rep. Trone's personal experience fuels leadership on the addiction crisis

As a result of his nephew’s struggle with addiction and overdose death in 2016, Rep. David Trone of Maryland has largely focused his efforts in Congress on addressing addiction and has become a leading lawmaker on the issue. Trone has led efforts in Congress as well as in his district. He has done this not just by introducing legislation, but also by regularly speaking about the issue, hiring people in recovery and supporting efforts to address the crisis in his district. The Bipartisan Addiction and Mental Health Task Force, of which he is a chair, has put forth roughly 70 bills. These include the Family Support Services for Addiction Act, which would devote resources to helping families navigate treatment options for loved ones with addiction – something Trone said he struggled with when he and his wife were trying to vet effective programs for his nephew.

Source: In Congress, David Trone keeps it personal: Combating the opioid epidemic that killed his nephew (Washington Post)

FDA commissioner nominee discusses opioid and tobacco regulations in confirmation hearing

In his nomination hearing before the Senate Health, Education, Labor and Pensions Committee, Food and Drug Administration (FDA) Commissioner nominee Robert Califf frustrated lawmakers with his responses on the FDA’s approach toward approving opioids, including its reluctance to crack down on long-term prescribing and recent decisions to approve new high-dose opioids. Califf insisted he had taken the issue seriously when he previously led the FDA, but that the FDA needed clear evidence to limit marketing and prescribing of opioids for long-term use. Sen. Maggie Hassan of New Hampshire pointed to mounting opioid overdose deaths as evidence. Califf promised a “very aggressive approach” toward opioids, including a “comprehensive review of the status of opioids” in the first month of his tenure. Sen. Joe Manchin of West Virginia opposes Califf’s nomination due to concerns about the opioid crisis. Califf also faced questions on tobacco regulation. He pledged to crack down on synthetic nicotine products and work to protect children from tobacco use.

Source: Califf sails through confirmation hearing for FDA job, despite tensions over opioids (STAT)

Agencies outline regulatory priorities

Agencies announced their regulatory priorities in the Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions. The Department of Health and Human Services’ plan includes rules that would: make permanent regulatory flexibilities that allow extended methadone take-home doses and providing buprenorphine via telehealth; clarify group health plans and health insurance issuers’ obligations under parity and promote compliance; reform the 42 CFR Part 2 confidentiality standards; and ban menthol as a characterizing flavor in cigarettes and ban characterizing flavors in all cigars. The Drug Enforcement Administration intends to propose regulations that allow practitioners to supply up to a three-day supply of buprenorphine or other medications for the maintenance and detoxification treatment of opioid use disorder and that clarify procedures for suspicious orders of controlled substances. The Department of Labor’s priorities include rulemaking to strengthen parity enforcement and promote compliance.

Source: Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions (Office of Information and Regulatory Affairs)

GAO reports on COVID relief funding for behavioral health

As required by the CARES Act, the Government Accountability Office issued a report on its monitoring and oversight related to COVID-19. It describes populations at higher risk of behavioral health effects, the amount and type of funding the federal government provided in COVID-19 relief to address behavioral health, and whether relief funds for behavioral health could serve higher-risk populations and how selected funding recipients plan to use the funds. As of November 2021, the federal government awarded over $8 billion in COVID-19 relief for behavioral health, with over 97% provided through six programs – one Federal Emergency Management Agency program (Crisis Counseling Assistance and Training Program) and five Substance Abuse and Mental Health Services Administration programs (Community Mental Health Services Block Grant; Substance Abuse Prevention and Treatment Block Grant; Certified Community Behavioral Health Clinic Expansion Grants program; Community Mental Health Centers Grant Program; and Emergency Grants to Address Mental and Substance Use Disorders During COVID-19).

Source: Behavioral Health and COVID-19: Higher-Risk Populations and Related Federal Relief Funding (Government Accountability Office)

Toolkit can help communities and states expand community responder programs

The Council of State Governments Justice Center released a toolkit for local communities and states looking to establish or strengthen community responder programs. It draws on the experience of emerging models across the country and presents key issues that are crucial to the success of any program. It covers issues including community engagement and collaboration, needs assessment, program staffing, call triaging, use of data to inform decision making, safety and wellness, financial sustainability and legislative strategies.

Source: Expanding First Response: A Toolkit for Community Responder Programs (Council of State Governments Justice Center)

State Medicaid and legislative changes could increase access to telehealth for addiction treatment

Pew released an issue brief with recommendations for state Medicaid agencies and lawmakers to ensure patients can continue to benefit from telehealth treatment for opioid use disorder (OUD) after the pandemic. The brief proposes requiring public and private insurers to reimburse OUD treatment providers for all services delivered via telehealth; reimbursing telehealth OUD services at in-person rates; expanding locations where patients can receive OUD treatment via telehealth, including their homes; allowing audio-only OUD treatment services for patients with Medicaid; and enabling correctional institutions to use telehealth for OUD treatment. It also includes recommendations for overcoming barriers including issues surrounding infrastructure, broadband access and monitoring and evaluation.

Source: State Policy Changes Could Increase Access to Opioid Treatment via Telehealth (Pew Charitable Trusts)

New York secures $3.1 million from parity compliance reviews

The New York Department of Financial Services (DFS) secured $3.1 million for New Yorkers, following a review of insurers’ compliance with state and federal cost-sharing requirements and parity. DFS reviewed parity reports that insurers are required to submit every two years and found that Aetna, Oscar and Wellfleet sold policies that required consumers to pay a copayment or coinsurance for mental health and addiction benefits that was not permitted under the law. Nearly $2.3 million will go to the Behavioral Health Parity Compliance Fund, which provides funding for initiatives supporting parity implementation and enforcement on behalf of consumers, including the Behavioral Health Ombudsman Program.

Source: Acting Superintendent Adrienne A. Harris Secures $3.1 Million For New Yorkers Following Mental Health And Substance Use Disorder Parity Compliance Review (New York State Department of Financial Services)

Sex traffickers use addiction to exploit young men