The Senate has reached an agreement and will vote on their opioid bill next week. Below is a short summary in a press release, as well as an article about what is included in the bill. Attached is also a section-by-section. After passage the House and Senate will have to conference their bills and are not expected to vote on a conference report until after the elections during a lame duck session of Congress.
I want to draw your attention to following provisions from the section-by-section:
Subtitle B: Research and Innovation
Sec. 1201. Advancing CuttingEdge Research.
- Allows the National Institutes of Health (NIH) to use its “other transactions authority” for high impact cutting-edge research projects that respond to public health threats, including the opioid crisis and finding a new, non-addictive painkiller. NIH was given this authority for the Precision Medicine Initiative and fifty percent of the Common Fund in the 21st Century Cures Act.
Sec. 1202. Pain Research
- Updates the scope of the Interagency Pain Research Coordinating Committee to identify risk factors for, and early warning signs of, substance use disorders, and summarize advances in pain care research supported or conducted by the federal government, including information on best practices for the utilization of non-pharmacologic treatments, non-addictive medical products, and other drugs approved, or devices approved or cleared, by the Food and Drug Administration.
Sec. 1203. Report on Synthetic Drug Use
- Requires the Secretary of HHS to submit to Congress a report on the health effects of new psychoactive substances, including synthetic drugs, by adolescents and young adults.
Sec. 1306. First Responder Training.
- Expands a grant program authorized by the Comprehensive Addiction and Recovery Act, which was designed to allow first responders to administer a drug or device, like naloxone, to treat an opioid overdose, and to include training on safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs.
Package includes over 70 proposals from five Senate committees
Posted on September 6, 2018
WASHINGTON, September 6, 2018 — The Senate agreed today to vote next week on the Opioid Crisis Response Act of 2018—a bipartisan package of over 70 proposals recommended to the full Senate by five committees: Health, Finance, Judiciary, Commerce and Banking.
Senate health committee Chairman Lamar Alexander (R-Tenn.) 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 stopping 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. The House has already passed its version of the act, and there is a bipartisan urgency to work with our House colleagues to get the legislation to the President’s desk.”
The Opioid Crisis Response Act of 2018 will:
Reduce Use and Supply.
The legislation includes the STOP Act which will help stop illegal drugs at the border, as well as provisions that provide flexible grants for states to better share Prescription Drug Monitoring Programs data, clarify FDA authority to require set packaging for prescription opioids, such as a 3 or 7 day supply in a blister pack, and fight opioid diversion.
The legislation includes provisions to support states and Indian tribes in addressing substance use disorders, establish comprehensive opioid recovery centers, expand access to medication-assisted treatment, and improve community support, access to health professionals, tele-health services and long-distance care, and recovery housing services.
Support Caregivers and Families.
The legislation includes provisions to improve plans of safe care and support for substance-exposed babies and their mothers, promote family-focused treatment and recovery, help youth with substance use disorders recover, and strengthen trauma-informed care and support in schools and early childhood education programs.
Drive Innovation and Long-Term Solutions.
The legislation includes provisions to advance cutting-edge research to spur discovery and development of new non-addictive painkillers, address economic and workforce impacts of the opioid crisis, ensure parity in mental health and substance use disorder benefits, and improve pain management.
The Omnibus Appropriations bill enacted in March provided $4.7 billion directed towards the opioid crisis, including $1 billion for grants to states.
A section by section of The Opioid Crisis Response Act of 2018 is here.
Senate set to vote on opioid response package next week
By Brianna Ehley and Darius Tahir
09/06/2018 06:31 PM EDT
Senators have reached a deal on a bipartisan package to address the opioid crisis, paving the way for a vote next week, Senate Majority Leader Mitch McConnell announced Thursday.
The agreement comes after weeks of slowed negotiations between lawmakers over hot-button provisions like requiring Medicaid to cover treatment at more inpatient facilities and loosening privacy restrictions for substance abuse patients' medical records. Neither provision made it into the final deal, but they are part of an opioid response package passed by the House earlier this year.
The sweeping measure otherwise largely matches what the House produced, H.R. 6 (115). Senate HELP Chairman Lamar Alexander (R-Tenn.) led negotiations on the deal, which includes legislation reported out of his committee as well as the Judiciary, Finance and Commerce committees.
It would authorize new funding for states to fight drug addiction, expand access to medication-assisted treatment, grant the NIH more authority to research and develop non-opioid pain therapies and require the U.S. Postal Service to crack down on shipments of illicit fentanyl. It would also reauthorize the Office of National Drug Control Policy.
States would get a total of $500 million a year through 2021 for grants created under the 21st Century Cures Act to combat drug addiction. The bill would also create new comprehensive opioid recovery centers offering an array of treatment services, and it would require HHS to develop guidelines for recovery housing, which is currently unregulated.
In surprisingly direct language, the bill would require HHS and DOJ to conduct a study on the effect that federal and state opioid prescribing limits have had on patients — and specifically whether such limits are associated with higher rates of suicide.
The legislation would affect the health technology sector in several ways. It would promote sharing of behavioral health data, for example, by encouraging education and best-practice development initiatives. But it would not specifically target 42 CFR Part 2, a long-standing federal regulation that requires a patient's direct consent to share behavioral health records. Provider groups and others believe that privacy rule inhibits care coordination by making it harder to access relevant information. The House-passed legislation would alter it.
The Senate package would also promote the use of telemedicine for substance use disorder by waiving the restrictions that typically prevent reimbursement beyond rural and disadvantaged areas. Other technologies receiving a boost from the deal: e-prescriptions for controlled substances; electronic prior authorization; and incentive payments to speed adoption of electronic health records in behavioral health.
Senate leaders are planning to bring the measure up for a vote next week, setting the stage for a conference with the House. An open amendment process is not anticipated, likely killing an attempt to add a controversial transparency provision requiring drugmakers to publicly disclose every grant made to professional, educational and patient advocacy groups that could be seen as part of a stealth marketing campaign.
Congressional aides said a number of issues need to be reconciled in conference, such as the House-passed easing of privacy protections and the costly provision to require Medicaid coverage for substance abuse treatment in larger inpatient centers.
"This is a bipartisan compromise," a Senate Democratic aide told POLITICO. "It's not going to be exactly what all Democrats want and it's not going to be what all Republicans want."
President Donald Trump declared the opioid epidemic a national public health emergency last October and has renewed that declaration three times since. Congress earlier this year appropriated nearly $4 billion to combat the crisis, including money for law enforcement activities, treatment and prevention.
Meanwhile, overdose deaths continue to climb. The latest CDC provisional data shows total drug-related deaths approaching 72,000 for the 12 months that ended in January, up nearly 7 percent from the same period a year earlier.
The congressional response to the epidemic could factor in the midterm elections — especially for Democrats, like Sen. Joe Manchin of West Virginia, who represent states that Trump won handily in 2016. A Politico/Morning Consult Pol from July found 69 percent of respondents believed opioids were a serious problem in their state. The conservative American Action Network has poured some $5 million into ads in states with competitive House and Senate races, touting Republicans' efforts to address the crisis.
|Katie Weyforth Vanlandingham
Van Scoyoc Associates
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Washington, DC 20024