Pfizer offers naloxone at a discount to a national buyer’s club of harm prevention programs. However, after a manufacturing issue halted Pfizer’s production in April, the programs that rely on the buyer’s club have resorted to seeking donations to buy naloxone at market price or looking for supply from places where naloxone is sitting on shelves and expiring. The buyer’s club says the scarcity is expected to have deadly consequences, with one organizer estimating that the 250,000-dose backorder so far could result in at least 11,000 overdose deaths. Activists say those most likely to suffer are programs with limited funding or in communities without adequate laws and infrastructure to distribute naloxone. The FDA said the supply available through other producers is sufficient to meet demand, but Pfizer’s price is what made the distribution attainable, and other companies have not matched that offer. Naloxone through pharmacies or paramedics is helpful, but some people who use substances may be fearful to seek out naloxone through such sources, as opposed to harm reduction programs.
Source: Affordable naloxone is running out, creating a perfect storm for more overdose deaths, activists say (Washington Post)
Richard Frank, Keith Humphreys and Harold Pollack present practical legislative and executive actions required to address the addiction crisis, focusing on improving financing and delivery of substance use disorder (SUD) treatment and reducing population exposure to addictive and lethal substances. They discuss steps to integrate financing of SUD treatment within mainstream public and private insurance programs, reenergize parity enforcement, build more robust accountability systems in SUD care, expand medications for opioid use disorder (including in the criminal justice system), expand access to non-opioid alternatives for pain and increase harm reduction through naloxone and syringe support services. To reduce exposure, they suggest restoring the value of the federal alcohol tax, restoring international partnerships to reduce the flow of fentanyl and other substances, stepping up enforcement against misconduct by opioid distributors and curtailing industry promotion of controlled substances to prescribers.
Source: Policy Responses to the Addiction Crisis (Journal of Health Politics, Policy, and Law)
United Behavioral Health and United Healthcare Insurance Co. will pay $13.6 million to affected participants and beneficiaries, pay over $2 million in penalties and take other corrective actions following investigations and litigation by the Department of Labor and the New York Attorney General regarding parity violations. The investigation found that, going back to at least 2013, United reduced reimbursement rates for out-of-network mental health services and flagged participants undergoing mental health treatment for a utilization review, resulting in many denials. United’s action violated the federal parity law, and many beneficiaries did not receive the mental health or substance use disorder benefits to which they were entitled. United failed to disclose sufficient information about these practices to plans and their participants. In the settlement, United agrees to cease the violations, improve its disclosures to participants and commit to future compliance.
Source: United Behavioral Health, United Healthcare Insurance Co. Plans to Pay $15.6M, Take Corrective Actions After Federal, State Investigations (U.S. Department of Labor)
Certified Community Behavioral Health Clinics (CCBHCs) are being primed for a major expansion as the pandemic deepens mental health and substance use disorder struggles for many. Some see the Democrats’ reconciliation package as the best vehicle for a major expansion of CCBHCs. The estimated cost is close to $3 billion, which is not huge in the context of the $3.5 trillion budget target. However, with many competing priorities, nothing is guaranteed. Senators Debbie Stabenow (D-Mich.) and Roy Blunt (R-Mo.), the sponsors of the original legislation for the program, are pushing for a proposal that would give states the option of incorporating CCBHCs within their Medicaid programs, securing federal matching at an enhanced rate.
Source: Mental health clinics angle for a spot in Biden budget bill (Associated Press)
Senators Elizabeth Warren (D-Mass.) and Richard Blumenthal (D-Conn.) sent letters to the FDA and FTC raising concerns over recent revelations that Juul is mounting an all-out campaign against any FDA action that would impact their profits, including purchasing an entire issue of the American Journal of Health Behavior to publish industry-funded studies. The call for action comes as the FDA reviews Juul’s pre-market tobacco application and nears a decision on whether Juul’s e-cigarettes should remain on the market. In the letter to the FDA, they raise concerns about Juul’s deceptive behavior and the influence it could have on regulators’ decisions. They ask whether FDA will review conflicts of interest in the “Deeming Rule” process, how studies with a conflict of interest are evaluated and if the agency has had any communication with the companies regarding the industry-funded studies. In the letter to the FTC, they question whether the Juul-funded studies are a form of advertising, if the studies are a potential deceptive practice and if there is any precedent for the agency to take action.
Source: Warren, Blumenthal Blast Juul’s Deceptive Practices, Call for Close FDA and FTC Scrutiny (Senator Elizabeth Warren)
Violations discovered by parity examinations by the Delaware insurance department have resulted in $735,000 in fines and insurer corrections. Combined with two 2020 examinations, Delaware’s largest health insurers have been fined a total of $1,332,000 for parity violations. A high number of violations was expected, as these reports complete the first round of assessments by the department. Parity violations included greater limits on coverage of medicines for mental health and substance use disorder than for other illnesses, prior authorization requirements that were more stringent for these conditions than for surgical or other medical benefits, exclusion of mental health-related medication in cost-savings programs, and placement of mental health medications on formulary tiers with higher co-pays compared to medications offered in lower tiers.
Source: Mental Health Parity Examinations Find Inequities in Insurer Behavior (Delaware News)
Oasis, a needle-exchange program in Atlantic City that is the largest in New Jersey, was ordered to close after a majority of the city council voted last month to evict it, expressing frustration that it was the only needle exchange in the area. Oasis is expected to be gone from its location by early November, 17 years after the city unanimously endorsed it. Lawmakers and harm reduction advocates fear that the move could embolden some of the 6 other cities that offer exchanges to pull out. Governor Murphy tried to block the move, and city and state officials said discussions were ongoing that could result in an eleventh-hour deal to relocate Oasis outside of the tourist district. While only the needle exchange itself is required to leave, the council’s decision has the potential to gut the ancillary health care programing as well. New Jersey’s 2006 needle exchange law gives localities veto power over such sites, but a proposed bill would empower state health officials to establish programs in areas they deem high risk.
Source: As Overdoses Soar, This State’s Largest Needle Exchange Is Being Evicted (New York Times)
Purdue’s quest to settle thousands of lawsuits entered its final phase, the confirmation hearing on the bankruptcy plan, with the grudging support of many with claims against the company. The confirmation hearing could stretch out over two weeks. David Sackler, grandson of one of the Sackler brothers who bought Purdue nearly 70 years ago, testified. He said that unless the settlement is approved with protections included that get the Sacklers off the hook for all current and future lawsuits, the family will not contribute to the settlement and would instead litigate the claims. He stopped short of an apology for the family or company’s role in the opioid crisis, but said that because the company marketed an opioid, they bear a moral responsibility to help. However, when asked if the company has a legal responsibility for the toll of opioids, he said they do not believe any of their conduct was illegal. Richard Sackler, former president and board chair, also testified. He said that he, his family and the company are not responsible for the opioid crisis. His most common answer during the three hours of questioning was, “I don’t recall.” He said the family would not agree to the deal if states that oppose it were not bound by it and were allowed to move ahead with lawsuits against Purdue and the Sacklers.
Source: Purdue Pharma director grilled on proposed opioid settlement (Associated Press); Heir: Sacklers won’t settle unless freed from opioid suits (Associated Press); Ex-head of Purdue denies responsibility for opioid crisis (Associated Press)
Overdose deaths rates increased across all racial/ethnic groups 2018-2020, but increases were larger for American Indian/Alaska Native, Black, and Hispanic people compared to white individuals. White people continue to account for the largest share of overdose deaths, but people of color are accounting for a growing share over time. People of color are disproportionately experiencing substance use problems, with large shares of Hispanic and Black adults reporting that they started or increased alcohol and drug use during the pandemic. Fentanyl-related deaths may also be disproportionately affecting Black communities. Few people with substance use disorder receive treatment, and access to care issues and low utilization rates are more pronounced among people of color. Black and Hispanic people had more limited access to buprenorphine and were less likely to utilize specialty treatment and complete publicly funded treatment services. American Indian and Alaskan Native people also faced limited access to MAT. Access and utilization of substance use disorder services may have worsened during the pandemic, as funding decreased, treatment centers limited capacity or closed, fewer buprenorphine and naloxone prescriptions were filled, and many syringe service programs suspended operations. There have been some recent policy actions to address the crisis, including $4 billion in the American Rescue Plan Act, increased flexibilities around telehealth, new buprenorphine prescribing guidelines, insurance coverage expansion efforts and administration focus on increasing access to evidence-based treatment and recovery support, harm reduction and racial equity issues.
Source: Substance Use Issues Are Worsening Alongside Access to Care (Kaiser Family Foundation)
Sika Yeboah-Sampong (Legal Action Center) and Gail D’Onofrio (Yale University) explain the need for addiction care in emergency departments (EDs), highlighting the recent LAC report and American College of Emergency Physicians guidelines for treating opioid use disorder in the ED. Stigma and institutional inertia lead many EDs not to see the health care needs of patients coming to EDs for overdose or other addiction-related health crises. The authors argue that EDs are missing a key opportunity to improve health outcomes, save lives and reduce racial disparities. They may also be violating several federal laws, including the Emergency Medical Treatment and Active Labor Act, the Americans with Disabilities Act, and the Rehabilitation Act. In addition, they write, Black and Latinx individuals are more reliant than white individuals on EDs due to more limited access to primary care in their communities, so failure of EDs to provide care for substance use disorder can disproportionately hurt BIPOC communities.
Source: Medically, legally, and morally, emergency departments cannot ignore addiction care (STAT)