Policy News Roundup: October 19, 2023

Key reads

Insurers pan proposed parity rules

The proposed parity regulations aimed at bolstering coverage of mental and behavioral care received more than 9,000 responses during the comment period. Health care payers are urging the Biden administration to drop major features of the proposed rules, including a new formula to determine whether insurers are improperly limiting patients’ access to mental health care. The ERISA Industry Committee, which advocates for employers on health benefits issues, said the proposed rules are so burdensome that employers would have to re-think the type and level of their plans’ coverage of mental health. The organization also argued the rules go beyond the administration’s authority to discourage limits on mental health and addiction treatment, hinting it may sue if officials finalize the policy. AHIP, an insurance lobbying group, said officials should withdraw the entire proposal and restart the process to address what it says are significant legal and operational flaws in the plan. Mental health professionals and advocates voiced support for the formula for determining whether limits on treatment are too restrictive and suggested officials nix some of the proposed exceptions for insurers written into the policy.

Source: Insurers bash Biden’s mental health parity proposal (Axios)

FDA sends rules banning menthol cigarettes and flavored cigars for final OMB approval

The Food and Drug Administration took a momentous step toward banning menthol in cigarettes and banning flavored cigars, sending the proposed rule to the White House Office of Management and Budget (OMB) for final review. This is the last regulatory step before the rule becomes final. The American Lung Association said it may be the most significant action the agency has taken in the 14 years since it was given the authority to regulate tobacco. The association and several other groups are urging OMB to act quickly and expedite the review so the final regulations could be issued by the end of the year. Once the federal government makes its final rules, tobacco companies are expected to sue, as they have with nearly every other tobacco restriction.

Source: FDA takes ‘momentous’ step toward banning menthol cigarettes and flavored cigars (CNN)

Senators create bipartisan Mental Health Caucus

Sens. Padilla, Tillis, Smith and Ernst launched the Senate Mental Health Caucus, bonded over their experiences with mental health crises. Padilla’s wife took care of her mother, who has manic-depressive and schizoaffective disorders, and dedicated her career to mental health advocacy. Tillis cared for his grandmother, who developed Alzheimer’s at an early age, and later experienced his own crisis when a medication caused him to experience manic behavior and depression for several months. Smith struggled with depression in college and as a young mom, and Ernst experienced trauma from years of mental and physical abuse by her ex-husband. Seeing politicians discuss their own mental health experiences can help erode stigma. The House has had a mental health caucus since 2020, and it currently has 105 members from both sides of the aisle. As part of its initial actions, the caucus will work to use funds already appropriated as part of the Bipartisan Safer Communities Act and to ensure that states and local governments fully understand the scope of the resources at their disposal.

Source: ‘It’s not a red state, blue state thing’: Senators form bipartisan Mental Health Caucus (NBC)

FDA issues marketing denial orders for flavored Vuse Alto e-cigarettes

The Food and Drug Administration issued marketing denial orders to R.J. Reynolds Vapor Company for six flavored e-cigarette products under its Vuse Alto brand, including three menthol-flavored and three mixed berry-flavored products (each flavor offered in three nicotine strengths). Vuse is the most commonly sold e-cigarette brand in the U.S., with Vuse Alto being its most popular sub-brand. The National Youth Tobacco Survey found that Vuse e-cigarettes, which are cartridge-based, have been the second most commonly reported e-cigarette brand used by youth in the U.S. since 2021.

Source: FDA Denies Marketing of Six Flavored Vuse Alto E-Cigarette Products Following Determination They Do Not Meet Public Health Standard (Food and Drug Administration)

Volkow explains how employers can promote whole-person health

National Institute on Drug Abuse (NIDA) Director Nora Volkow explains the ways employers can promote mental health and prevent substance use and intentional misuse. She explains whole-person health and how negative factors such as a stressful environment at work can create a higher risk for substance use and substance use disorder (SUD). Positive aspects of a person’s environment (such as fair and equitable workplace policies on health insurance, paid sick leave, family leave, flexible work schedules and other benefits/assistance) can protect against SUD. Employers have an interest in preventing on-the-job impairment related to substance use, which could affect safety, increase health care costs, increase absenteeism and decrease job performance. Employers can learn how best to integrate comprehensive coverage of mental health and SUD treatment into their insurance and reimbursement processes. Employee wellness programs can deliver evidence-based prevention interventions. Employers can also provide naloxone on worksites and train employees how to use it. Employers should approach SUD as a medical condition to reduce stigma. Employers can start developing a culture of openness and acceptance by learning and sharing NIDA’s Words Matter guide.

Source: The power of protective layers: Employers advancing whole-person health (National Institute on Drug Abuse)

One-third of Medicaid enrollees with OUD did not receive medication

Department of Health and Human Services Office of the Inspector General (OIG) released a report examining the extent to which Medicaid enrollees with opioid use disorder (OUD) received medications for opioid use disorder (MOUD) in 2021. One-third of the 1.5 million Medicaid enrollees with OUD did not receive MOUD in 2021. Certain demographic groups, including Black or African American enrollees, enrollees 18 years of age and younger and enrollees with a disability and/or blindness, were less likely to receive MOUD. In 10 states, less than half of enrollees with OUD received MOUD. Findings underscore the need for continued efforts to increase use of MOUD in Medicaid. OIG recommends that the Centers for Medicare and Medicaid Services encourage and support states’ efforts to reduce barriers to MOUD, especially among groups who may be underserved, and encourage states and work with federal partners to educate Medicaid and CHIP enrollees about access to MOUD.

Source: Many Medicaid Enrollees with Opioid Use Disorder Were Treated with Medication; However, Disparities Present Concerns (Department of Health and Human Services Office of the Inspector General)

Many states addressed addiction in this year's legislative sessions

The Georgetown University O’Neill Institute released a report on trends in addiction-related state legislation in 2023. Multiple states and DC passed legislation on dissemination of opioid litigation funds. Legislation established separate opioid litigation funds in several states and clarified allowable uses, and a few states established settlement advisory committees and/or board appointment criteria. Multiple states passed legislation expanding access to medications for opioid use disorder (MOUD) and laws relating to opioid treatment programs. Some states authorized pharmacists to prescribe and dispense MOUD and authorized narcotic treatment programs. Other new laws prevent insurers from reviewing or denying coverage for MOUD. Several states passed legislation expanding access and distribution of naloxone, specifically in emergency departments and education facilities. Some authorized bystander possession and administration of naloxone, and many required law enforcement and emergency responders to carry naloxone and facilities such as hospitals and schools to have naloxone available. Many states prioritized community outreach and increased distribution efforts and accessibility. A handful of states passed legislation regarding syringe services programs, and many states passed legislation authorizing possession and use of fentanyl test strips. Several states passed legislation to enhance criminal penalties relating to fentanyl, including establishing mandatory minimums for fentanyl-related offenses. Two states passed substance-induced homicide legislation. A handful of states passed legislation expanding access to, requiring or permitting MOUD in jails/prisons. No legislation was introduced specifically addressing incarcerated people experiencing withdrawal in custody.

Source: 2023 State Legislation Addiction Policy Update (Georgetown University O’Neill Institute)

California reaches settlement with Kaiser Permanente over deficiencies in behavioral health services

The California Department of Managed Health Care announced a settlement agreement with Kaiser Permanente to make significant changes to the plan’s delivery of behavioral health services. The settlement agreement includes a $50 million fine and requires Kaiser Permanente to address deficiencies. Kaiser Permanente pledged to make $150 million in additional investments to improve the delivery of behavioral health services. Violations/deficiencies found included issues in providing timely access to care, oversight of providers and medical groups, network adequacy, parity compliance and grievances/appeals. Kaiser Permanente must enhance oversight to ensure timely access, network adequacy, continuity of care, level of care and quality of care; improve procedures to ensure enrollees can access behavioral health appointments consistent with timely access standards; provide a clearly defined and implemented policy/process to ensure enrollees are provided with timely behavioral health services based on individualized determinations of medical necessity; improve the ability of enrollees to access the network of providers for behavioral health services and out-of-network providers when the plan’s network cannot offer timely care; and develop processes to ensure parity compliance, including ensuring enrollees receive appropriate treatment based on individualized determinations of clinical appropriateness.

Source: DMHC, Kaiser Permanente Reach Settlement Agreement to Transform Plan’s Behavioral Health Care Delivery System and Improve Behavioral Health Statewide (California Department of Managed Health Care)

Rite Aid files for bankruptcy amid opioid lawsuits

Rite Aid filed for bankruptcy, weighed down by billions of dollars in debt, declining sales, and more than a thousand lawsuits claiming it filled thousands of illegal prescriptions for opioids. The company filed for Chapter 11 bankruptcy protection in New Jersey. The pharmacy raised $3.45 billion to fund operations while it is in bankruptcy. In March, the Department of Justice filed a complaint against Rite Aid and its subsidiaries asserting the company filled prescriptions for excessive quantities of opioids that had “obvious, and often multiple, red flags indicating misuse.” It is also one of many drugstore chains dealing with state and local lawsuits. The company’s new head said his focus would be to steer the company through the bankruptcy process, when it will be able to trim debt, close some stores and deal with the opioid litigation.

Source: Rite Aid, Facing Slumping Sales and Opioid Suits, Files for Bankruptcy (The New York Times)

Indivior makes push for Opvee over naloxone

Indivior has started shipping Opvee overdose reversal medication to first responders and pharmacies. Opvee is a nasal spray version of nalmefene. It is approved for people 12+ and requires a prescription. It arrives in a crowded market of overdose reversal drugs. Indivior aims to convince public health agencies and consumers that Opvee can better combat illicit fentanyl because it lasts longer than naloxone. Indivior is attempting to generate interest among government purchasers by offering free doses to state and local agencies that employ emergency medical personnel. The company also wants to add retail offerings through pharmacies and build public awareness. It will also advocate for policy changes such as standing orders. Opvee will cost $75 per kit for government or public interest purchasers and $98 for others with no insurance coverage. Private health insurers do not yet cover the drug. Critics say Opvee may trigger longer-lasting withdrawal symptoms than naloxone.

Source: A new ‘fentanyl fighter’ hits a market crowded with overdose reversal drugs (USA Today)