Today, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra marked the one-year anniversary of HHS’s Overdose Prevention Strategy (Strategy) by announcing the progress the nation has made since the release of the Strategy, showing expanded treatment capacity, lives saved from overdose, and commitment to long term recovery supports. The Overdose Prevention Strategy helps advance President Biden’s National Drug Control Strategy and his Unity Agenda to beat the overdose epidemic.

Prevention

• The 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain was recently released and updates and replaces the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. It includes new evidence and recommendations on acute, subacute, and chronic pain.
• For the first time, Medicare has finalized new payments for person-centered, comprehensive management and treatment of chronic pain effective January 1, 2023, aligned with HHS’ National Pain Strategy and the recommendations of its inter-agency Pain Management Task Force.
• U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA) issued joint warning letters to operators of websites illegally selling Schedule II stimulants.
• The Administration for Children and Families (ACF) awarded 18 grants totaling $8.8 million to increase well-being, improve permanency and enhance the safety of children who are in, or at risk of, an out-of-home placement as a result of a parent’s or caregiver’s opioid or other substance misuse.
• CDC awarded approximately $300 million to state, local, and territorial health departments through Year 4 of its Overdose Data to Action program.
• The Substance Abuse and Mental Health Services Administration (SAMHSA) released the Strategic Prevention Framework for Prescription Drugs (SPF Rx) Notice of Funding Opportunity. Six grants were awarded at up to $500,000 per year per award for up to five years, with $3,000,000 total available funding.
• The NIDA-supported Adolescent Brain and Cognitive Development (ABCD) study, which is the largest long-term study of brain development in the United States, has generated approximately 100 peer-reviewed reports this fiscal year with implications for the role of early experiences, including substance use, on health over the lifespan.
• The NIH HEAL Preventing Opioid Use Disorder research program released two funding opportunity announcements this fiscal year to develop and test interventions to prevent opioid misuse and OUD among patients at community health centers and by intervening on social determinants of health.

Harm Reduction

• CDC issued initial guidance to state, local, and territorial health departments to allow purchase of naloxone with Overdose Data to Action cooperative agreement funding.
• FDA issued the immediately-in-effect guidance, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency. This guidance clarifies the scope of the public health emergency (PHE) as it applies to the distribution of naloxone to harm reduction programs during the opioid PHE. FDA also published a blog discussing efforts to expand availability of and access to naloxone.
• FDA published the Federal Register Notice (FRN) announcing the preliminary assessment that certain naloxone products may be safe and effective for over-the-counter (OTC) use.
• FDA Announced Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use | FDA
• SAMHSA received saturation plans from all 50 States, the District of Columbia, Puerto Rico, and Guam, which outline how they aim to saturate their communities with naloxone.
• CDC launched the Stop Overdose Mini Campaigns to educate people who use drugs about the dangers of illicitly manufactured fentanyl, the risks and consequences of mixing drugs, the lifesaving properties of naloxone, and the importance of reducing stigma around recovery and treatment options. Since October 2021, there have been approximately 2 billion impressions of the campaigns.
• NIH Harm Reduction videos had more than 16,000 individual views.
• NIH has awarded 10 grants to establish a research network that will test harm-reduction strategies in communities across the United States, hit hard by overdose deaths.
• SAMHSA released the Harm Reduction Notice of Funding Opportunity at the end of 2021. Twenty-five grants were awarded on May 15, 2022 at up to $400,000 per year per award for up to three years, with $30,000,000 total available funding.

Treatment

• CMS released the 2022 Medicare Physician Fee Schedule (PFS) Final Rule, effective January 1, 2022. This rule modified Medicare telehealth services to permanently allow audio-only telehealth visits for mental health care, a key flexibility leveraged during the pandemic which has shown to be particularly helpful for Americans living in health provider shortage areas. Other key pieces of the PFS include:
  • Increased payment rates to Opioid Treatment Programs.
  • Clarified that, in line with requirements of the DEA, Opioid Treatment Programs may bill Medicare for services performed by mobile units.
  • Finalized payment changes that strengthen the Medicare behavioral health workforce, so practitioners can practice to the full extent of their license.
  • New payments for holistic chronic pain care (referenced above).
• As part of a section 1115 demonstration, California will pilot a contingency management program, in conjunction with a comprehensive outpatient treatment program for stimulant use disorders, in certain counties that elect and are approved by the state to participate.
• Within the NIH HEAL Initiative, the Novel Therapeutic Options for Opioid Use Disorder and Overdose program is developing medications and biologics to prevent and treat OUD and/or stimulant use disorder and overdose; longer-duration formulations to counteract opioid overdose and respiratory depression; and new medications to address withdrawal, craving, and return to use. In 2022, the program expanded to support the development of novel digital therapeutics to treat OUD or polysubstance use disorders.
• SAMHSA awarded nearly $1.6 billion throughout the country for the State Opioid Response and Tribal Opioid Response grant programs.
• HRSA awarded more than $104 million to expand treatment and prevention services for substance use, including medications for OUD, in rural communities nationwide as part of its Rural Communities Opioid Response Program.
• Collaborative HHS research generated key insights into the impacts of SUD treatment delivery; showing, for example, that telehealth for SUD during the pandemic was associated with increased treatment retention and lower overdose risk, and that OUD medication flexibilities during the pandemic did not increase methadone overdose deaths.
• NIH-funded research demonstrated that receiving medication for OUD while incarcerated reduces recidivism.
• NIDA’s Center for Clinical Trials Network (CTN) continues to investigate behavioral, pharmacological, and integrated therapies across diverse settings and populations, and to develop implementation strategies that help bring research results into practice.

Recovery

• Since October 2021, HHS has staffed up the first-ever Office of Recovery within SAMHSA. The Office of Recovery now serves as a national clearinghouse and resource for recovery services across the mental health, substance use, and co-occurring domains to promote recovery by working in partnership with recovery community leaders.
• SAMHSA announced the 10 winners of its behavioral health Recovery Innovation Challenge. Challenge participants were encouraged to share details about the practices they use to advance recovery, and to demonstrate how these practices either expand upon SAMHSA’s definition of recovery or help them overcome challenges in incorporating recovery into their behavioral health services or systems.
• SAMHSA held a two-day Recovery Summit that brought together over 100 individuals from across the substance use and mental health recovery fields, and during which, attendees reaffirmed SAMHSA’s nationally recognized definition of recovery.
• Through the NIH HEAL Initiative, NIDA is supporting several new research projects that will add to our knowledge of recovery residences, clinical continuing care, linkage to recovery community centers, and peer interventions to increase retention in treatment with medication for opioid use disorder (MOUD).