Biden-Harris Administration Marks Two Years of Advancements in HHS’ Overdose Prevention Strategy with New Actions to Treat Addiction and Save Lives

2023 OPS Fact Sheet
(link to 2022 fact sheet)

Today, the U.S. Department of Health and Human Services (HHS) marked two years of its Overdose Prevention Strategy (Strategy) by announcing bold new actions to combat overdoses. Actions announced today build on President Biden’s National Drug Control Strategy and his Unity Agenda call-to-action to address the overdose epidemic and save lives.

OVERDOSE PROGRESS

Overdose Deaths

• Unfortunately, in the United States we saw years of tragic and rapid increases in the overdose death rate from 2019 – 2021.
• Over the past three years, with historic investments and unprecedented action, we have been able to level off the devastating period of rapid, double-digit percent increases we saw in the overdose death rate from 2019 – 2021.
• When President Biden took office in January 2021, the overdose death rate was increasing 31.2% year-over-year. Today, the rate of increase is 2.8% year-over-year, which means the rate of increase since President Biden took office has decreased by more than 90%. Thanks to the historic actions and investments made under the President’s leadership, nearly every month in between has seen a decline in the overdose death rate.

Naloxone

• According to IQVIA National Sales Perspective data, total sales of naloxone products have increased substantially in the last year and since the implementation of the Overdose Prevention Strategy.
• A total of 12.9 million naloxone units were sold between October 2022 and September 2023. This is almost a 15% increase from the previous 12 months, and a 38% increase compared to the time between October 2020 and September 2021.

Treatment

• According to IQVIA Total Patient Tracker data, the total number of unique buprenorphine patients has increased in the last year, and since the implementation of the Overdose Prevention Strategy.
• In the last year, an average of 862,068 people received buprenorphine treatment each month. This is a 1% increase in unique patients from the previous year, and more than a 4.5% increase compared to the first year of the Overdose Prevention Strategy.

KEY HHS ACTIONS THAT CONTRIBUTED TO DATA IMPROVEMENTS IN YEAR TWO OF THE OVERDOSE PREVENTION STRATEGY

In Fiscal Year 2023, the Administration invested nearly $8 billion in programs supporting the Overdose Prevention Strategy across HHS and continues to expand efforts related to primary prevention, evidence-based treatment, harm reduction, and recovery support services across HHS programs; as well as funding to bolster the nation’s behavioral health infrastructure. This Administration remains committed to ensuring access to recovery support services.

Some key OPS activities from the last year include:

• Prevention
  • Chronic Pain Activities. CMS finalized new payment codes in Medicare for monthly chronic pain management and treatment services that support behavioral health, effective January 1, 2023. CMS finalized separate payment in the Ambulatory Surgical Center setting for five non-opioid pain management drugs starting in 2023. CMS issued guidance to states describing how states may increase coverage of non-opioid pain management treatments. CMS and NIH also partnered on a new web page for professionals for pain management assessment resources.
  • SAMHSA’s Youth Fentanyl Awareness Prize Challenge. In this Prize Challenge, SAMHSA sought the best ideas from U.S. youth, ages 14-18, on a community strategy to engage other youth on awareness, education and prevention strategies on fentanyl, especially the hidden dangers with fake pills and other contaminants that can lead to drug overdose deaths. It is important that the dangers of illicit fentanyl and fake pills be communicated with all youth to help prevent associated risks, and steps that can be taken to reduce risk (e.g., have naloxone and know how to use it). These messages will resonate with youth if they come from a trusted resource, like other youth. SAMHSA sought video submissions that pitched and demonstrated innovative ways to reach youth like social media posts, vlogs, podcasts, video journals, etc.
  • Blueprint for a National Prevention Infrastructure for Behavioral Health Disorders: a Study Supported by The National Institute on Drug Abuse (NIDA), SAMHSA and CDC. NIDA, SAMHSA and the CDC are supporting a National Academies of Science, Engineering, and Medicine consensus study to provide a roadmap of steps needed to develop and finance a sustainable prevention infrastructure at the national and/or state level for implementing evidence-based interventions for preventing psychiatric disorders like addiction.
  • NIDA’s Substance Use Prevention Services in Primary Care Challenge. In August 2023, NIDA selected three winners of a Primary Care Challenge to generate ideas for how primary care practices can more effectively identify people at risk for substance use or misuse and prevent substance use initiation and escalation of misuse to substance use disorders. Among winning submissions included proposed models of substance use screening and prevention services (or referral to those services) for adults who have been incarcerated, in pediatric clinics, and for youth via peer-led mental health care.
• Harm Reduction
  • New Overdose Reversal Agent Approvals. FDA approved the first-ever branded over-the-counter naloxone nasal spray and the first-ever generic over-the-counter naloxone nasal spray, as well as the second branded over-the-counter naloxone nasal spray.

    The FDA also approved Opvee, the first nalmefene hydrochloride nasal spray developed with funding from NIDA for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older.

  • Expanded Naloxone Availability. SAMHSA received plans from all 50 States, the District of Columbia, Puerto Rico, and Guam for how they aimed to saturate their communities with naloxone. SAMSHA worked closely with states to implement their Naloxone Saturation Plans. As a part of this work, SAMHSA, in collaboration with the National Association of State Alcohol and Drug Abuse Directors (NASADAD), held a 2-day virtual learning community with all 50 states in January 2023 to learn about naloxone saturation models and hear from their peers about innovative naloxone distribution efforts. In addition, SAMHSA, in coordination with CDC, NASADAD, and the Association of State and Territorial Health Officials, kicked off a policy academy with 10 states in July 2023 to discuss details of their saturation plans. State engagement and technical assistance continued over the fall of 2023 with a follow up all-state call in November in conjunction with NASADAD to highlight new federal policy changes related to naloxone and other opioid overdose reversal medications and share creative state activities.
  • NIDA Launched the Harm Reduction Research Network. With funding from the NIH HEAL initiative, the Harm Reduction Research Network was launched in late 2022 to address the U.S. overdose epidemic. The coordinated research network will build on existing research and test harm reduction strategies in different community settings that will inform efforts to help save lives. The network represents the largest pool of funding from NIH to date for research on harm reduction strategies to address overdose deaths.
• Treatment
  • Elimination of the X waiver. Section 1262 of the Consolidated Appropriations Act, 2023, eliminated the requirement for practitioners to submit a Notice of Intent (i.e., have a waiver) to prescribe buprenorphine for the treatment of opioid use disorder. SAMHSA and DEA coordinated workplans and communications to resolve outstanding issues related to the elimination of the X waiver.

    Of particular note:

    • SAMHSA and DEA hosted a webinar on the removal of the X waiver and SUD training requirements.
    • SAMHSA and DEA hosted more than 20 public presentations/stakeholder meetings on implementing sections 1262 and 1263 of the Consolidated Appropriations Act, 2023 (also referred to as the Mainstreaming Addiction Treatment Act (MAT)/Medication Access and Training Expansion Act (MATE).
    • SAMHSA participated in the American Academy of Addiction Psychiatrists podcast on MAT/MATE.
    • SAMHSA supported Provider Clinical Support System with $1.5 million dollars to provide training and TA.
  • Tele-prescribing. Since March 2020, HHS and DEA have allowed practitioners to prescribe schedule II-V controlled substances (“controlled medications”) pursuant to a telemedicine visit without conducting an initial in-person medical evaluation. Additionally, DEA waived the requirement for practitioners to obtain a DEA registration in the state where a patient is located, as long as the practitioner is authorized to prescribe controlled medications via telemedicine in both the state in which the practitioner is registered with DEA and the state in which the patient is located. Collectively, these are referred to as the “controlled medications telemedicine flexibilities.”

    DEA and SAMHSA extended these telemedicine flexibilities through December 31, 2024, thus ensuring continued access to patients receiving medications for opioid use disorder (MOUD).

  • CY 2023 Physician Fee Schedule. In the CY 2023 Medicare PFS, CMS finalized several policies aimed at expanding access to behavioral health services:
    • Increased Medicare payment rates to OTPs to better reflect costs of individual therapy and finalized changes to stabilize payments for treatment with methadone at OTPs. CMS also finalized that Medicare pay for buprenorphine initiation through telecommunications (rather than just in-person) to improve access to care.
    • Clarified that, in line with DEA requirements, OTPs may bill Medicare for services performed by mobile units, such as vans, without obtaining a separate registration. This can improve treatment access for hard-to-reach populations, such as individuals who are homeless or who live in rural areas.
    • Finalized changes that strengthen the Medicare behavioral health workforce, so practitioners can practice to the full extent of their license. The finalized policy allows clinicians such as marriage and family therapists, licensed professional counselors, and others to furnish behavioral health services under “general,” rather than “direct” supervision when furnished “incident to” a physician or non-physician practitioner.
  • IHS Emergency Department Pilot Projects. The Pain and Addiction Care in the Emergency Department (PACED) pilot project resulted in national American College of Emergency Physicians (ACEP) PACED accreditation for five IHS Emergency Departments. The accreditation program promotes access to naloxone and opioid overdose reversal and stabilization, enhanced care coordination activities, and supports evidence-based practices.
  • 1115 Waiver – Medicaid in Jails. In January 2023, CMS approved an 1115 demonstration amendment in California which allows Medicaid to cover a set of critical, pre-release SUD services to people returning home from jails and prisons. This is the first time in history Medicaid has provided coverage to justice-involved individuals before they’re released (CMS). It is a step forward in closing gaps in services this underserved community experiences, and HHS encourages other states to follow California’s lead. Most recently, Washington’s section 1115 Reentry demonstration was approved in June 2023 as part of a renewal of the state’s Medicaid Transformation Project.
  • OTPs in BOP Facilities. SAMHSA partnered with DEA and the Federal Bureau of Prisons on expanding treatment. The Federal Bureau of Prisons has worked to ensure that each of their facilities are equipped and trained to provide in-house medication-assisted treatment (MAT) (White House, SOTU). In addition to an original 7 full OTPs certified within the BOP at the beginning of 2023, DEA and SAMHSA worked to convert 87 of 89 BOP medication units to full, independent OTPs.
  • Strengthening Parity (Mental Health Parity and Addiction Equity Act NPRM). The departments of Labor, Health and Human Services, and the Treasury announced an important step in addressing the nation’s mental health crisis by proposing rules to better ensure that people seeking coverage for mental health and substance use disorder care can access treatment as easily as people seeking coverage for medical treatments. These proposed rules are designed to achieve Mental Health Parity and Addiction Equity Act’s purpose to ensure that participants, beneficiaries, and enrollees will not face greater restrictions on access to obtaining mental health and substance use disorder benefits than those for medical/surgical benefits.
  • Newly approved MOUD formulations. FDA approved new medication formulations for substance use disorder, including an extended-release buprenorphine injection to treat moderate to severe opioid use disorder and the first generic application for naltrexone extended-release injectable suspension to treat alcohol and opioid use disorder.
  • Culturally Responsive Peer Programs. IHS piloted new Educational Outreach that included tailored peer-to-peer interventions to support opioid stewardship activities, increase access to integrated treatment services, and promote high-quality care.  A new culturally responsive provider Opioid Stewardship educational campaign launched in November 2023.
  • Rural Communities Opioid Response Program. In late August 2023, HRSA, through the Rural Communities Opioid Response Program, provided more than $80 million in awards to rural communities in 39 states and two territories, to support key strategies to respond to the overdose risk from fentanyl and other opioids. The awards assist with expanding access to medications to treat opioid use disorder, supporting rural communities in preventing and responding to overdoses, meeting the behavioral health needs of young people, preventing and addressing neonatal exposure, and investing in and disseminating best practices. RCORP funding has supported prevention, treatment, and recovery services in more than 1,900 rural counties across 47 states and two territories.
  • SAMHSA’s Low Barrier Models of Care Advisory. This Advisory, released in December 2023, outlines the principles and components of low barrier care, a strategy and approach to overcoming substantial gaps in access to, and engagement in, substance use disorder treatment. The Advisory provides real world actionable examples to overcome stigma, expand access to the continuum of harm reduction, treatment, and recovery support services, and foster retention in care.
• Recovery
  • Building Communities of Recovery Program. HHS, through SAMHSA, awarded $5.54 million to recovery community organizations under the Building Communities of Recovery program to mobilize and connect a broad base of community-based resources to increase the prevalence and quality of long-term recovery support for people with substance use disorders and co-occurring substance use and mental health issues. These grants support the development, enhancement, expansion, and delivery of recovery support services as well as the promotion of and education about recovery. It is expected that these grant activities will be administered and implemented by individuals with lived experience who are in recovery from SUD and co-occurring SUD and mental health issues and reflect the needs and population of the community being served.
• Workplace Supported Recovery Program. CDC’s National Institute for Occupational Safety and Health (NIOSH) published a webpage with information for employers to consider when creating a Workplace Supported Recovery (WSR) Program. They will continue to build upon that webpage with additional content and resources.
• Recovery Support and Housing: Block Grant Guidance. SAMHSA published valuable guidance on what recovery support services may be covered via the Substance Use Block Grants. The guidance outlines several housing-related services and supports- including temporary housing assistance, deposits and costs of setting up power- which can be covered by grant funds to recovery housing organizations.

• Opportunities for Action
  • While provisional data from the Centers for Disease Control and Prevention suggests that the reported number of drug overdose deaths are slowly flattening, overdose deaths reached nearly 107,000 for the 12-month period ending in August 2023 (CDC, NCHS).
  • HHS is committed to reducing overdose deaths, now as much as ever.
  • Reducing overdose deaths will require continuing current efforts, as well as pursuing bold new actions. New actions around illicit stimulants, emerging potent synthetic opioids, provision of recovery supports, polysubstance use and early prevention are particularly needed, along with sustained and enhanced activity around comprehensive naloxone and MOUD provision to all populations.
  • That is why HHS is announcing bold new steps including the publication of updates to the rule governing opioid use disorder treatment as provided by Opioid Treatment Programs, or OTPs.
    • These rules have not been significantly revised in more than 20 years.
    • With the changes being released today, we are honoring the promise to make permanent flexibilities provided during the COVID-19 pandemic for take home doses of methadone and initiation of buprenorphine via telehealth in OTPs.
    • But the changes made extend far beyond this.
    • In finalizing the rule updates, SAMHSA is updating standards of care to reflect evidence-based practice in 2023, removing the requirement for a one-year period of opioid addiction prior to admission to an OTP, promoting the integration of harm reduction and recovery support services into OTPs, and further aligning the definition of treatment practitioner with the existing workforce of appropriately licensed practitioners.
    • Finally, in response to public comments, SAMHSA has expanded access to interim care with methadone and, in consultation with the DEA, clarified the status of carceral settings that are registered with the DEA as a hospital/clinic under the definition of long-term care facility, thus supporting opportunities for jails to provide methadone treatment to those who need it.
    • With the publication of this final rule, a key action item of the Biden-Harris Administration’s National Drug Control Strategy, one that improves access to life-saving medications for opioid use disorder, has been realized.