Senate Amendment to H.R. 6, The Opioid Crisis Response Act of 2018
Background: The HELP, Finance, Judiciary, and Commerce committees have advanced bipartisan legislation to combat the opioid crisis. The bill is an amendment in the form of a substitute to H.R. 6, which the House passed in June. Read RPC’s recent paper on the opioid problem here.
Floor Situation: The Senate may begin consideration of this legislation the week of September 10.
Executive Summary: The legislation reauthorizes and expands state targeted grants authorized in the 21st Century Cures Act, funding the program at $500 million annually through fiscal year 2021. It provides increased funding to NIH to expedite research related to substance abuse. The package includes proposals to reform Medicare, Medicaid, and family services programs, providing treatment and recovery support services for beneficiaries with substance abuse problems. It increases access to addiction treatment medications. The bill also improves detection of prohibited drugs being illegally imported through the mail.
OVERVIEW OF THE ISSUE
In October, President Trump declared opioid abuse a public health emergency. The administration released funds to assist states in their response efforts and directed federal agencies to take all appropriate steps possible to reduce the number of drug overdoses.
The bipartisan proposals advanced by the HELP, Finance, Judiciary, and Commerce committees aim to combat the crisis by advancing prevention, treatment, and recovery efforts. The legislation provides states with the flexibility and resources needed to address the crisis at the state and local level.
NOTABLE BILL PROVISIONS
Title I – OPIOID CRISIS RESPONSE
Reauthorization of CURES Funding
Reauthorizes $500 million for each of fiscal years 2019-2021 in opioid grant funding created by the 21st Century Cures Act. States can use the funds to make substance abuse treatment more accessible, train health care providers, and further research on prevention. The reauthorization allows for the expansion of the program to include Indian tribes and improves flexibility for states and tribes to use the funding to combat the opioid crisis.
Research and Innovation
Supports NIH research to respond to the opioid crisis and to research non-addictive pain treatments.
Encourages the Interagency Pain Research Coordinating Committee at NIH to support research efforts specifically targeting the early warning signs of substance use disorders and provide a summary of advances in pain care research.
Medical Products and Controlled Substances Safety
Aims to increase the development of non-addictive and non-opioid products by requiring the FDA to issue guidance on expediting its approval process for these products.
Discourages overprescribing by clarifying FDA’s authority to require packaging options for drugs such as opioids to allow a set treatment duration, such as blister packs for patients who may only need a three to seven day supply.
Gives the FDA facility upgrades and improved capacity to improve detection of illicit drug importation through international mail. Gives FDA innovative technology and equipment to facilitate near-real time information sharing between the FDA, DHS, and USPS.
Expands a grant program to train first responders administering naloxone, the drug that reverses opioid overdoses. The expansion allows for training on exposure to fentanyl, carfentanil, and other dangerous drugs. Provides $36 million annually from 2019 to 2021, an increase of $24 million annually from current law.
Allows certain trained professionals in hospice centers to safely dispose of unneeded controlled substances for the purpose of reducing misuse and diversion.
Treatment and Recovery
Expands treatment and recovery efforts by the Substance Abuse and Mental Health Services Administration, requiring it to award competitive grants to states to establish substance abuse rehabilitation facilities.
Authorizes HHS to issue competitive grants to states and Tribes to assist people living in areas impacted the hardest by the crisis and transitioning from substance abuse recovery to independent living.
Requires HHS, in consultation with the Department of Education, to provide to state educational agencies and Indian tribes three-year grants targeting youth substance abuse prevention and recovery. Authorizes funding for each of fiscal years 2019 through 2023.
Authorizes $60 million in annual funding for fiscal years 2019-2023 to states for collaboration between their health, welfare, and related state agencies to develop and oversee “plans of safe care” of substance-exposed infants. Plans of safe care assess and monitor the health and substance abuse treatment needs of infants and families.
Updates DEA regulations to improve substance abuse treatment access for patients in rural and underserved areas through telemedicine.
Directs HHS to enter into contracts to provide loan repayment to eligible health professionals providing substance abuse treatment services in regions where there is an insufficient number of mental health providers. Authorizes $25 million annually for 2019-2023. Reauthorizes SAMHSA’s Residential Treatment for Pregnant and Postpartum Women grant program at $29.9 million in funding each year for fiscal years 2019-2023. The program increases access to residential substance abuse health services for pregnant and postpartum women.
Authorizes $486 million for CDC data collection and analyses of overdoses related to controlled substances. The authorization would expand prescription-drug monitoring programs and provide grants to states to encourage and improve data sharing between states. States and authorized entities utilize PDMPs as a central database for monitoring and analyzing patient prescription drug use. The data collection assists states in reducing prescription drug abuse and diversion.
Reauthorizes the National All Schedules Prescription Electronic Reporting grant program at $10 million annually in years 2022 through 2026. The program promotes increased data sharing between states by allowing prescribers and pharmacies to better detect and prevent substance abuse.
Reauthorizes the National Child Traumatic Stress Initiative at $54 million and increases the authorization amount by $7 million annually for the SAMHSA grant program between fiscal years 2019 and 2023. This grant program aids the development of best practices and interventions for children and families who have experienced trauma. A new grant program at the Department of Education will connect schools with mental health systems to increase student access to services that help children cope with the effect of substance abuse on their families.
Title II – FINANCE
Adds educational resources to the annual Medicare beneficiary handbook to promote proper pain management and improve patient-provider dialogue on opioid use and pain management treatments.
Allows beneficiaries to receive Medicare-covered telehealth services for substance abuse disorders regardless of where the treatment occurs.
Requires that beneficiaries’ annual wellness screenings assess pain severity, provide information on pain treatment options, and evaluate for substance use disorders, with referral for treatment as appropriate.
Establishes a five-year demonstration project to test coverage and payment for opioid use disorder treatment services furnished by an opioid treatment program, a setting not currently recognized by Medicare.
Requires providers to electronically prescribe Part D controlled substances that are Schedule II, III, IV, or V to ensure proper tracking and impede diversion. This change would be effective January 1, 2021.
Requires CMS to establish and maintain a secure website to facilitate data sharing with Part D plans and other relevant agency contractors to better address fraud, waste, and abuse.
Requires the HHS secretary and CMS to identify beneficiaries who have been treated for an overdose and provide that information to Part D plans to facilitate proper treatment.
Requires CMS, in consultation with stakeholders, to establish a program to alert Part D opioid prescribers who excessively prescribe opioids and provide them with evidence-based educational resources to improve patient care.
Provides recovery care at hospitals or residential pediatric recovery centers for babies born suffering from opioid withdrawal, and ensures moms in institutions for mental disease receive prenatal and postpartum care outside the institution.
Requires CMS to issue guidance on state reimbursement opportunities for substance abuse services administered via telehealth, including patient monitoring.
Requires CMS to issue guidance to states on what non-opioid pain treatment and management services are covered by Medicaid.
Improves states’ ability to access and share data from prescription drug monitoring program databases for the purpose of providing the information with Medicaid providers and Medicaid managed care entities.
Requires the HHS secretary to publish the most recent data detailing, for each state, statistics on the prevalence and treatment of substance abuse disorder among Medicaid beneficiaries, including those receiving treatment under fee-for-service and managed care arrangements.
Directs HHS to provide guidance to states on how to help them identify opportunities to coordinate and use federal funds, such as Medicaid and child welfare, to support family-focused residential programs in providing substance abuse treatment.
Allocates $15 million to HHS to implement and evaluate a family recovery and reunification program, pairing a recovery coach with parents who have children in foster care as a result of parental substance abuse.
For fiscal years 2019-2023, authorizes $20 million for states to develop, enhance, or evaluate family-focused residential treatment programs. The goal is to increase the number of evidence-based programs that will qualify for funding under the Family First Prevention Services Act.
Synthetics Trafficking and Overdose Prevention
Imposes processing fees on items that are shipped to the U.S. through the international postal network by inbound express mail service. These fees would take effect in 2020.
Requires shipments from foreign countries through the U.S. postal system to provide electronic advance data that includes information on where the package is being shipped from, where it is going, and what it contains.
Instructs USPS and U. S. Customs and Border Protection to develop technology to better identify illegal narcotics, specifically fentanyl.
Title III – JUDICIARY
Access to Increased Drug Disposal
Requires the Justice Department to provide grants to five states for the purpose of increasing participation in programs to collect and dispose of unused prescription drugs. Grant applications must include details on how the state will increase participation in the drug disposal program and how eligible collectors will be chosen.
Limits the attorney general to awarding grants for the first five fiscal years following the implementation of the bill.
Using Data to Prevent Opioid Diversion
Increases Drug Enforcement Administration reporting requirements relating to the legal distribution of controlled substances, especially those drugs that are most likely to be abused.
Requires the DEA to provide drug distributors and manufacturers with anonymized data through the Automation of Reports and Consolidated Orders System to divert suspicious opioid orders.
Increases civil and criminal penalties for drug manufacturers and distributors that fail to review DEA provided information.
Substance Abuse Prevention
Reauthorizes drug prevention efforts and programs at the Office of National Drug Control Policy. The following programs are reauthorized through 2022:
Drug-Free Communities Program, provides grants to communities to decrease the demand for illegal narcotics and prevent substance abuse among adolescents.
National Community Anti-Drug Coalition Institute, provides grants to enhance community anti-drug coalitions.
High-Intensity Drug Trafficking Area Program, aids law enforcement serving in areas of high drug trafficking regions.
Drug Court Program, the bill authorizes $75 million in funding for drug courts from fiscal years 2018-2022.
The provision also authorizes grants to support state efforts in combatting drug abuse, with grants specifically targeted at supporting law enforcement agencies and assisting programs to keep intact families affected by substance abuse.
Authorizes SAMHSA to award grants to states to establish sobriety treatment and recovery teams to determine the effectiveness of pairing social workers and mentors with families that are struggling with a substance abuse disorder and child abuse or neglect. The law authorizes SAMHSA to award no more than $10 million each year for fiscal years 2018-2022.
Within 60 days of the law’s enactment, the attorney general and HHS secretary are required to provide a plan for educating and training medical professionals in best practices for prescribing controlled substances.
Synthetic Abuse and Labeling of Toxic Substances
Amends the Controlled Substances Act to allow DOJ to consider additional factors when establishing whether a controlled substance analogue was intended for human consumption, including the marketing, advertising and labeling of a substance, and its known use.
Provides that the lack of marketing, advertising, or labeling for human consumption will not prohibit the DOJ from establishing that the substance was intended for human consumption.
Opioid Quota Reform
Amends the Controlled Substances Act to authorize DEA to consider certain factors, such as diversion, substance abuse, overdose deaths, and public health impacts, when setting annual opioid quotas.
Preventing Drug Diversion
Amends the Controlled Substances Act to require DEA to establish a database, in compliance with all federal and state privacy laws, for the collection of suspicious orders of controlled substances as reported by all registrants and to share this information with all states.
Title IV – COMMERCE
Fighting Opioid Abuse in Transportation
Requires the Department of Transportation and HHS to issue and revise drug and alcohol testing regulations, including to expand requirements to certain safety-sensitive transportation railroad employees.
Requires DOT to create and maintain a publicly available database on its website that includes transportation industry employee drug and alcohol testing data.
Requires HHS to update its drug testing guidelines to include fentanyl on the testing panel, subject to certain findings. Should the department determine the inclusion necessary, the secretary would be required to revise HHS mandatory guidelines to include fentanyl on the panel, and the DOT would be required to update its regulations accordingly.
Sets a deadline for the secretary to revise HHS mandatory guidelines to allow for oral fluid testing, which would also be incorporated into DOT testing regulations.
Opioid Addiction Recovery Fraud Prevention Act
Prohibits the deceptive marketing of opioid treatment programs and products. Provides additional tools to the Federal Trade Commission and states to stop these practices.
Allows the FTC to impose civil penalties for making false or misleading claims about the cost, price, effectiveness, performance, benefit, risk, or safety of any opioid treatment program and product, such as supplements or medications marketed to treat or prevent substance abuse.
Authorizes states to pursue civil action on behalf of their residents to obtain restitution for any violation of the rule.
A Statement of Administration policy is not available at this time.
The Congressional Budget Office estimates the legislation will cost $29 million between 2019 and 2028.