Policy News Roundup: September 9, 2021

Key reads

Purdue bankruptcy plan approved

A federal bankruptcy judge approved Purdue’s settlement plan, under which Purdue will be dissolved and the Sacklers will pay more than $4 billion to address the opioid crisis. Judge Robert Drain called it a “bitter” end and said he wished claimants were getting more money. The settlement resolves all civil litigation against the Sacklers, Purdue, and other related parties and entities and awards them broad legal protection against future litigation, though Drain did narrow the scope of protections from what the Sacklers requested. The deal also requires the Sacklers to relinquish control of family foundations with over $175 million in assets to a National Opioid Abatement Trust, and Purdue’s operating assets will be transferred to a new public benefit company. However, the Justice Department’s Trustee and the several state attorneys general are expected to appeal.

Source: Judge conditionally approves plan to dissolve OxyContin maker Purdue Pharma (CNN); The Sackler Family Wins Immunity From Future Opioid Lawsuits (NPR)

A new approach is needed to address the overdose crisis

In a blog post, National Institute on Drug Abuse Director Nora Volkow explains the need for a new approach to the overdose crisis. Incarcerating people with addiction and underinvesting in prevention and medical care is not working. Effective prevention and treatment tools we have are not being used. The benefits of medications for opioid use disorder are well-known, but decades of prejudice have limited its reach. We must eliminate barriers to treatment, including by making it easier for clinicians to provide medications, expanding models of care that meet people where they are (e.g., digital health technologies, mobile clinics) and ensuring that payers cover effective treatments. Evidence-based harm reduction and addressing the social and economic stressors that increase risk of drug use, as well as both universal and targeted prevention efforts, are needed.

Source: Drug overdose deaths in 2020 were horrifying. Radical change is needed to address the drug crisis. (NIDA)

FDA denies some e-cigarette applications as it nears review deadline

The Food and Drug Administration (FDA) issued the first marketing denial orders for e-cigarettes after determining the applications for about 55,000 flavored products from three companies lacked enough evidence that they have a benefit to adult smokers sufficient to overcome the threat posed by youth use. The products may not be introduced for sale, and if already on the market, must be removed. The FDA has received applications from over 500 companies covering more than 6.5 million products. The FDA said it will likely miss the September 9 deadline for some applications and is prioritizing review based on applicants’ market share. The industry is bracing for changes that could favor big tobacco companies, as smaller companies don’t have the resources to thoroughly complete the FDA application. Large companies (e.g., Juul, NJoy) only sell a handful of types of e-cigarettes but have the resources to make their applications more likely to be cleared.

Source: FDA Denies Marketing Applications or About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health (U.S. Food and Drug Administration); FDA nears day of reckoning on e-cigarettes (Politico)

ONDCP releases fentanyl analogue scheduling recommendations

In preparation for the expiration of the temporary scheduling of fentanyl analogues coming October 22, the Office of National Drug Control Policy presented recommendations for a long-term, consensus approach to reduce the supply/availability of illicitly manufactured fentanyl-related substances (FRS), while protecting civil rights and reducing barriers to research for Schedule I substances. The proposal recommends permanently placing FRS into Schedule I of the Controlled Substances Act to provide law enforcement with the tools to respond to trafficking and manufacturing; excluding FRS that are scheduled by class from all quantity-based mandatory minimum penalties; creating a streamlined process to identify and remove or reschedule any FRS found not to have high abuse potential; ensuring that a federal court can vacate or reduce the sentence of an individual convicted of an offense involving an FRS that is subsequently removed or rescheduled; establishing a simplified process to align research registration for all Schedule I substances more closely with that for Schedule II substances; and directing the Government Accountability Office to analyze the implementation and impact of permanent class scheduling of FRS.

Source: Biden-Harris Administration Provides Recommendations to Congress on Reducing Illicit Fentanyl-Related Substances (ONDCP)

White House considers clemency to prevent people with nonviolent drug offenses from returning to prison post-pandemic

President Biden is considering using his clemency powers to commute the sentences of certain individuals with federal nonviolent drug offenses released to home confinement during the pandemic rather than forcing them back to prison after the pandemic emergency ends. Other ideas being considered include broader use of “compassionate release” of sick or elderly inmates and enactment of a law to allow some inmates to stay in home confinement after the pandemic. Under normal circumstances, the law permits home confinement only for inmates in the final six months or 10% of their sentence. As many as 2,000 inmates sent home during the pandemic may fall outside that limit. The Justice Department will soon begin requesting clemency petitions for individuals with nonviolent drug offenses with less than four years left on their sentence, which will be reviewed by the pardon office. It is unclear whether the Biden team is leaning toward commuting the sentences to home confinement, reducing the length of sentences to bring them within the normal window for home confinement, or a mix.

Source: White House Weighs Clemency to Keep Some Drug Offenders Confined at Home (New York Times)

Distributor and J&J settlement to move ahead

AmerisourceBergen, Cardinal Health, McKesson and Johnson & Johnson will proceed with a proposed $26 billion settlement after “enough” states joined in. The distributors said 42 states, five territories and Washington, D.C., signed on to their agreement. Alabama, Georgia, Nevada, New Mexico, Oklahoma, Washington and West Virginia are not participating in the settlement. New Hampshire agreed to settle only with the distributors, and Rhode Island joined only Johnson & Johnson’s deal. The companies will make their first annual payments in escrow by September 30. The final payment will depend on several factors, including the final participation rate of states and political subdivisions. The settlement’s formula envisioned at least 44 states participating, but ultimately the companies got to decide whether a “critical mass” had joined and whether to finalize the deal. Cities and counties within participating states have through January 2 to join as well.

Source: Drug companies say enough U.S. states join $26 bln opioid settlement to proceed (Reuters)

Hospitals create programs to provide addiction services in emergency departments

Some hospitals have implemented models to address the lack of addiction care in emergency departments (ED). CA Bridge provides navigators to patients in the ED to champion addiction treatment and connect patients to care in the community. The model is used by about 130 California hospitals, and the state allotted $40 million to expand it to over 100 others. Funds cover navigators’ salaries, training for ED staff on prescribing buprenorphine, and other technical assistance. New York MATTERS gives patients access to buprenorphine and quickly links them to addiction clinics to continue treatment. It provides pharmacy vouchers that cover 14 days of medication and Uber vouchers to cover transportation to the clinic. The Mountain Area Health Education Center in North Carolina has trained staff at Federally Qualified Health Centers and health departments to provide medications for opioid use disorder. The centers have become referral spots for doctors who start patients on medication in the ED. Governor’s Institute in North Carolina has helped to incorporate training into medical school curricula.

Source: Many ERs Fail People Who Struggle With Addiction. These New Approaches Might Help. (NPR)

Illinois enacts law to advance parity

Illinois Gov. Pritzker signed HB 2595, which advances access and equity in mental health care. It will require health plans to cover medically necessary mental health and addiction care, ending insurers’ practice of using flawed and discriminatory guidelines to avoid paying for such services. The law establishes clear definitions and standards for when services and treatment qualify as medically necessary, requires insurers to rely on transparent criteria published by nonprofit clinical societies for medical necessity determinations, requires insurers to cover all medically necessary mental health and substance use disorder care and explicitly prohibits limiting benefits to short-term acute treatment or refusing to cover levels of care. It also encourages compliance with the state parity law by making sure illegal practices are appropriately penalized.

Source: Governor Pritzker Cements Mental Health and Addiction Care with Gold-Standard Mental Health Bill (Health is Health)

Parity law loophole leaves gaps in mental health and addiction coverage

Exemptions in the Mental Health Parity and Addiction Equity Act for state or local government coverage (for employees like teachers and police officers) and potentially illegal workarounds put in place by employers and insurers, coupled with lax oversight, have resulted in unequal access to care for millions. The exemption afforded governments for their employees is widely in use, particularly in strained economic times, maintaining a loophole advocates have tried to close repeatedly. Dozens of plans across the country have requested an exemption for the current coverage year. Some members of Congress, including Senator Chris Murphy of Connecticut, are calling for a closing of the loophole, as are unions that represent these employees.

Source: Loopholes Leave Gaps in Mandated Coverage for Mental Health (New York Times)

Syringe services programs are proven to promote public health but are often undermined

Recent moves to shutter or undermine syringe services programs (SSPs) (e.g., in West Virginia, Atlantic City, New Jersey and Scott County, Indiana) promise to have devastating impacts on underserved communities. Evidence shows that SSPs are cost-effective and promote public health. Federal law prohibited federal funds to support SSPs for the better part of three decades. Although Congress temporarily lifted the ban in 2010, it was reinstated two years later. In 2018, Congress permitted the use of funds to support SSPs under certain circumstances but outlawed the use of funds to purchase sterile needles. The American Rescue Plan Act signed in March included an unprecedented allocation of $30 million to harm reduction services, including SSPs, and the funding is exempt from the restriction on the use of federal dollars to purchase syringes. State and local governments that have enacted laws and regulations that eliminate or restrict the operation of SSPs face potential legal challenges, ranging from Americans with Disabilities Act and Rehabilitation Act claims to state and federal Equal Protection and Due Process Clause violations.

Source: Defending Syringe Services Programs (Health Affairs)