Policy News Roundup: February 2, 2023

Key reads

CMS approves first waiver to allow Medicaid services prior to release from incarceration

The Centers for Medicare and Medicaid Services approved a first-of-its-kind 1115 demonstration in California that will provide a set of pre-release services and improve access to care for people returning home from jails/prisons. Medi-Cal will be able to cover addiction treatment before a Medicaid beneficiary is released from a correctional facility. The state will be able to connect the person to community-based Medicaid providers 90 days prior to release. This is the first time Medicaid will be providing coverage to justice-involved individuals before release. A new Department of Health and Human Services report informs design of an 1115 demonstration opportunity to improve care transitions for individuals soon to be released from public institutions and otherwise eligible for Medicaid. It highlights challenges returning community members face in obtaining health coverage and transitioning health care, promising practices to support access to coverage and care during reentry and how states can use 1115 waivers to support justice-involved individuals.

Source: HHS Approves California’s Medicaid and Children’s Health Insurance Plan (CHIP) Demonstration Authority to Support Care for Justice-Involved People (Centers for Medicare and Medicaid Services); Health Care Transitions for Individuals Returning to the Community from a Public Institution: Promising Practices Identified by the Medicaid Reentry Stakeholder Group (Office of the Assistance for Planning and Evaluation)

Biden announces end of COVID emergency declarations

President Biden informed Congress that he will end the COVID-19 national emergency and public health emergency on May 11. The announcement came in a statement opposing House Republicans’ legislation to end them immediately. As a result of the end of the emergency, employers will no longer be able to offer telehealth access as a premium, tax-free benefit separate from other health plans. Eased rules for prescribing controlled substances, including for mental health and addiction treatment, without an in-person visit could end unless the Drug Enforcement Administration extends them. Work requirements for federal food assistance programs will return in many states. The end of the emergency will also end Title 42, a policy used to shut down the southern border. Medicare patients and people in high-deductible health plans will continue to have eased telehealth access through 2024 because of an extension included in the omnibus, which also set the Medicaid continuous enrollment requirement to end in April.

Source: President Biden to end COVID-19 emergencies on May 11 (Associated Press); Covid emergency’s end will mean new costs, hassles (Politico)

House Energy and Commerce Committee holds first hearing, on fentanyl and crisis lifelines

The House Energy and Commerce Committee held its first legislative hearing in the health subcommittee of the 118th Congress. It focused on the illicit fentanyl poisoning crisis, the cybersecurity breach of suicide lifelines, and Quality Adjusted Life Year measures. Legislation under discussion will include the HALT Fentanyl Act; the 988 Lifeline Cybersecurity Responsibility Act; the Block, Report, and Suspend Suspicious Shipments Act; and the Protecting Health Care for All Patients Act.

Source: Chairs Rodgers and Guthrie Announce First Health Subcommittee Legislative Hearing (House Energy & Commerce Committee)

FDA won't finish e-cigarette reviews until end of year

In a court-ordered update, the Food and Drug Administration (FDA) said it expects to complete its review of all marketing applications for vapes from major market players by the end of December, six months after it had previously estimated it would be done. The FDA cited multiple lawsuits companies with denied products have launched against it, saying defending those lawsuits and undertaking multiple related application re-reviews requires substantial agency resources.

Source: FDA pushes back estimate for vape review completion (Politico)

FDA reviews tobacco regulation progress

The Food and Drug Administration (FDA) Center for Tobacco Products released a summary of its action in 2022. The FDA proposed product standards to prohibit menthol cigarettes and flavored cigars and is drafting final rules. The FDA has made determinations on more than 99% of new tobacco product applications submitted. It has authorized 23 tobacco-flavored e-cigarette products and issued the first marketing denial orders for menthol e-cigarettes. The FDA reviewed more than 99% of the non-tobacco nicotine applications, accepting over 8,600 for further review and issuing refuse-to-accept letters to more than 925,000. The FDA has issued warning letters to manufacturers of non-tobacco nicotine products, retailers for sale of non-tobacco nicotine products to underage purchasers, companies marketing illegal flavored nicotine gummies and firms marketing e-cigarette products packaged to look like toys, food or cartoon characters. The agency launched education campaigns and resources for youth and adult cessation education materials.

Source: Looking Back, Looking Ahead: FDA’s Progress on Tobacco Product Regulation in 2022 (Food and Drug Administration)

FDA concludes new regulatory pathway for CBD is needed

The Food and Drug Administration (FDA) concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The FDA is prepared to work with Congress on this. The FDA also denied three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements. The use of CBD raises safety concerns, especially with long-term use. A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks, including through clear labels, prevention of contaminants, CBD content limits and measures such as minimum purchase age to mitigate risk of ingestion by children. Given available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements, food additives or substances in animal food. The FDA will therefore not pursue rulemaking allowing use of CBD in such products.

Source: FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward (Food and Drug Administration)

Flavored vapes remain easily accessible in California

California cities are supposed to be cracking down on sales of flavored vapes, which are now illegal in the state, but even cities that have banned such vapes for years are unwilling or unable to police the sellers. STAT visited 24 vape shops in six cities that have had bans for at least a year. Seventy percent were selling the products anyway, often openly with impunity, which portends badly for the state’s new ban. Enforcement will primarily be handled by the same local jurisdictions that have failed to enforce their own policies, not the state. The law is also weak – retailers can be fined $250 for each violation, but the law does not include increased penalties for repeat offenses. It is unclear how long it will take municipalities without flavor bans to set up enforcement programs. The state law does not specify which local agencies should be tasked with enforcement, set timelines for establishing enforcement programs or provide funding for enforcement.

Source: It’s easy to buy flavored vapes in California, even in cities with longtime bans (STAT)

NY awards $5.25 million for substance use prevention coalitions

New York Governor Kathy Hochul announced $5.25 million in awards to establish six substance use prevention coalitions across the state. The funding will enable recipients to focus prevention efforts on priority populations, including Black, Indigenous and people of color, veterans, older adults, individuals with disabilities and youth with a history of incarceration and other contact with the criminal-legal system. Prevention coalitions are designed to better engage vulnerable and isolated communities and populations in developing and implementing environmental change prevention strategies. The funding will help six new coalitions to develop culturally appropriate and tailored prevention initiatives.

Source: Governor Hochul Announces $5.25 Million to Support Addiction Prevention Services in High-Need Communities (Governor Kathy Hochul)

Wisconsin seeks public input for spending opioid settlement funds

A Wisconsin Department of Health Services (DHS) survey is asking the public to share thoughts on how to use a second round of opioid settlement funds ($8 million). DHS is required to submit a plan for anticipated settlement funds to the Joint Committee on Finance every year. The plan approved by the Committee in 2022 included funds for supporting school-based and community-based prevention programs, expanding the Narcan Direct Program, establishing and funding a program to distribute fentanyl test strips, supporting medications for addiction treatment and expanding the hub-and-spoke health home pilot program. It also included funds for supporting room and board costs for Medicaid members in residential treatment, supporting renovations or construction of care and treatment facilities, creating an overdose alert system, supporting tribal nations and supporting law enforcement agencies.

Source: DHS Seeks Ideas for $8 Million in Opioid Settlement Funds (Wisconsin Department of Health Services)

Appeals court rules against plaintiffs in Wit case