Since H.R. 6 has been amended with the conference report for the bicameral, bipartisan opioid response package we've transferred the summary of the Senate's initial bill below.

What is it?

(Updated 9/14/18) This bill has been amended from its original form by the Senate, after the House passed it as the SUPPORT for Patients and Communities Act. In its current form, this bill — the Opioid Crisis Response Act — would implement more than 70 bipartisan proposals aimed at stopping illegal drugs at the border, such as synthetic opioids, reduce over-prescription of opioids, and develop alternatives to opioids. A breakdown of of its provisions, including the major individual bills that were included along with Justice Department & Food and Drug Administration reforms, can be found below.

Opioid Crisis Response Act

This section of the bill would reauthorize and extend funding for targeted opioid response grants to states that were created under the 21st Century Cures Act. It’d also provide funding for research into a new, non-addictive painkiller along with early warning signs or risk factors for substance use disorders. The Dept. of Health and Human Services (HHS) would be required to produce a report on the health effects of new psychoactive substances on adolescents and young adults.

Food and Drug Administration (FDA) regulations would be clarified to expedite approval non-addictive, non-opioid treatments for pain or addiction and provide manufacturers with assistance for designing clinical trials. The bill would also allow the FDA to require drug manufacturers to package certain opioids to allow for a small, set treatment — like a blister pack with a 3 or 7 day supply.

The FDA and Customs and Border Protection (CBP) would enter into formal coordination around detecting and seizing illegal drugs, like the synthetic opioid fentanyl. The current practice of FDA providing packages with illegal opioids to CBP for destruction would be codified into law.

A grant program under the Comprehensive Addiction and Recovery Act that provides training for first responders to administer overdose reversal drugs like naloxone, along with training on safety around dangerous illicit drugs.

HHS would be required to provide technical assistance to hospitals and other acute care settings on alternatives to opioids, along with issuing best practices for emergency treatment of a known or suspected drug overdose and the coordination of care after overdoses.

A new grant program would be established to help individuals in recovery from a substance use disorder with stable, temporary housing.

HHS would be required periodically update strategies related to prenatal opioid use, including neonatal abstinence syndrome, and a grant program that funds treatment for pregnant and post-partum women would be reauthorized.

HHS and the Dept. of Justice (DOJ) would be required to report on the impact of federal and state laws and regulations that limit the length, quantity, or dosage of opioid prescriptions.

HEAL Act of 2018

This section would require that the annual “Medicare & You” handbook for Medicare beneficiaries include references to educational resources on opioid use and pain management, a description of categories of alternative, non-opioid Medicare-covered pain management treatments, and a suggestion that beneficiaries talk to their physicians about the subject. It’d also make the following changes to Medicare:

• The Medicare Initial Preventive Physical Examination and annual wellness visits would include a review of the beneficiary’s current opioid prescriptions and screening for potential substance use disorder.
• Opioid prescriptions under Medicare Part D would be prescribed electronically to improve tracking of opioid use and prevent diversion.
• Beneficiaries with a history of opioid-related overdose would be monitored in the Medicare system to enable prescription drug plans to take steps that inform prescribers and dispensing pharmacies to improve care.

The following provisions of the bill would impact Medicaid:

• States’ ability to provide care under Medicaid for infants with neonatal abstinence syndrome in recovery centers would be clarified, as would those centers’ option to provide counseling or other services to mothers or caretakers.
• The Centers for Medicare and Medicaid Services (CMS) would issue a guidance to explain options for states to provide substance use disorder treatment via telehealth and managing beneficiaries’ pain through non-opioid treatment.

The following provisions of the bill would impact HHS:

• HHS would be required to develop and issue guidance to states identifying opportunities to support family-focused residential substance abuse treatment programs.
• HHS would replicate a “recovery coach” program for parents with children in foster care due to parental substance abuse with $15 million.

Other Provisions

A wide variety of anti-drug trafficking and substance abuse prevention programs within the Dept. of Justice (DOJ) would be reauthorized. DOJ would also be allowed to issue grants for drug disposal programs administered by collectors designated by the state for five years in at least five states, at least three of which would be chosen from states with low participation rates for drug take-back programs.

The Drug Enforcement Administration (DEA) would be required to make anonymized information available in the ARCOS database to help drug manufacturers and distributors identify, report, and stop suspicious orders of opioid to reduce drug diversion. Civil and criminal penalties for drug manufacturers would be increased.

Other provisions include:

• The Transportation Dept. would be directed to create regulations related to drug testing within the agency.
• The Federal Trade Commission would be authorized to investigate false or misleading representations related to opioid treatment programs and products, violations of which would be civil offenses.

Impact

People who would receive treatment or other services through Medicaid, Medicare, or other programs covered by the bill; state Medicaid programs; CMS; CDC; and HHS.

Cost

The CBO estimates that enacting this bill would increase direct spending by $29 million over the 2019-2028 period.

More Information

In-Depth: Senate Health Committee Chairman Lamar Alexander (R-TN) introduced this package of more than 70 bipartisan bills aimed at curbing the epidemic of opioid abuse and said:

“This legislation represents the work of over 70 senators, five committees, and countless staff who have worked together to help put an end to the opioid epidemic ravaging virtually every American community. THe proposed bill includes the STOP Act to help stop illegal drugs at the border, including the shipment of synthetic opioids. It allows the FDA to require prescription opioids to be packaged in set amounts like a 3 or 7 day supply of blister packs, and spurs the development of a new non-addictive painkiller.”

This legislation passed the Senate HELP Committee unanimously and has the support of 18 bipartisan cosponsors, evenly divided between the two parties.

Of Note: According to data from our partners at USAFacts, a non-profit civic data initiative, the opioid epidemic resulted in 52,745 deaths from overdoses in 2016 alone compared to 21,204 deaths from non-opioid overdoses. Deaths from overdoses on synthetic opioids such as fentanyl have spiked in recent years, accounting for 19,413 of the overdose deaths in 2016 when they had never 3,5000 deaths in a year prior to 2014.

Media:

• Senate Health, Education, Labor and Pensions Committee Press Release
• HELP Committee Section-by-Section
• CBO Cost Estimate (Standalone Bill Only)
• CBO Cost Estimate (Updated)
• The Hill
• Washington Post

Summary by Eric Revell

(Photo Credit: courtneyk / iStock)