On September 17, the United States Senate passed the Opioid Crisis Response Act of 2018 in a near-unanimous vote. The bill, which would disburse almost $8 billion, covers broad categories of action designed to address the national opioid crisis, including research, controlled substances safety, treatment and recovery, and prevention.

The lead sponsor, Senator Lamar Alexander, will now spearhead an effort to reconcile this legislation with a similar House bill passed in June. If successful, the reconciled legislation would be presented to the President for signature. Last year, the President declared the opioid epidemic to be a public health emergency.

The Senate bill establishes, expands or modifies programs across numerous federal agencies, including the National Institutes of Health, the Food and Drug Administration, the Substance Abuse and Mental Health Services Administration, the Centers for Disease Control, the Drug Enforcement Administration, and the Centers for Medicare and Medicaid Services.

Features of the legislation include the following:

• Calls upon the FDA to develop guidelines and create regulatory pathways for the development of non-addictive medical products designed to treat pain and addiction.
• Clarifies the FDA’s authority to require blister packs for opioids tied to set treatment durations (such as 3 and 7 days), to encourage responsible prescribing.
• Mandates that the FDA work with Customs Border Protection and the U.S. Postal Service to improve the identification and seizure of illegal drugs at the border and in the mail, through innovative detection technology and testing equipment.
• Requires the Secretary of the U.S. Department of Health & Human Services establish a program to award competitive grants to at least ten comprehensive opioid recovery centers nationally, giving priority to entities or integrated delivery networks in states with high overdose mortality rates. Similarly, the Secretary will develop a competitive grant program to support implementation of programs for care and treatment of individuals after an opioid overdose, and to strengthen recovery networks.
• Improves flexibility for medication-assisted treatment (MAT) of opioid use disorders, by allowing qualified practitioners to prescribe MAT for up to 275 patients.
• Requires the Secretary of Labor to implement a competitive grant program to address economic and workforce impacts associated with a high rate of substance use disorder.
• Calls upon the Secretary of HHS to implement various initiatives and grant programs to better support children, adolescents, infants and families impacted by opioid use. Also requires increased attention to reducing prenatal opioid use and addressing neonatal opioid abstinence syndrome (including enhanced funding for residential treatment programs).
• Requires the Attorney General, within one year after enactment, to promulgate final regulations specifying the circumstances in which the DEA will allow qualified providers to prescribe controlled substances via telemedicine.
• Modifies National Health Service Corps provisions to allow providers to furnish services in schools and community-based settings, and would provide loan repayment to substance use disorder treatment providers for practicing in underserved areas.
• Requires the CDC to collect, analyze and disseminate data, and to support states in these efforts, to improve responses to the opioid crisis. Also mandates that the CDC develop various educational programs to improve health outcomes and pain management.
• Streamlines federal requirements for state Prescription Drug Monitoring programs so that physicians and pharmacies can know if a patient has a history of substance use.
• Requires HHS to develop best practices for prominently displaying a history of opioid abuse in electronic health records, if requested by the patient.

For health care providers, residential treatment facilities, health care practitioners, pharmaceutical companies, and state and local governments, the Opioid Crisis Response Act merits close monitoring.  If enacted, it will offer grant funding opportunities, expanded resources, and greater flexibility in connection with the prevention and treatment of those impacted by the opioid epidemic.

For the latest news and updates, follow Hinckley Allen on Twitter and LinkedIn.