Policy News Roundup: September 21, 2023

Key reads

Biden administration working to enforce parity

The Biden administration proposed new rules it says will make insurers comply with parity laws, and it is threatening fines if they do not. Insurers are pleading innocent and claiming the rules could make the problem worse. Insurers can be fined $100 per policyholder per day if they do not close loopholes the administration says they are using to limit what they pay for mental health care, such as prior authorization requirements, lower reimbursement rates for mental health providers and deliberate efforts to limit the number of in-network physicians available. If finalized, the new regulations would mandate that insurers analyze their coverage to ensure equivalent access to mental health care based on outcomes. The companies would have to look at how they respond to prior authorization requests for behavioral health compared with physical health and audit their networks and out-of-network reimbursement. Enforcement could be a challenge, and it is unclear how aggressive the administration would be. Previous enforcement has largely been collaborative, not punitive. Public comment is open on the regulations (Note: You can submit template comments and share your story here.).

Source: ‘The rule has sticks as well’: Biden’s getting tough with health insurers (Politico)

Emergent long resisted making naloxone available OTC

Emergent BioSolutions, Narcan’s manufacturer, for years refused to allow its drug to be sold over the counter (OTC), citing concerns about Narcan awareness and insurance coverage. The Food and Drug Administration blamed Emergent’s pursuit of profits. Emergent’s reluctance ended in late 2022 after a competitor prepared its own bid for OTC naloxone approval. Emergent spent years appealing to courts and regulators to stop other naloxone products from reaching the market and moved aggressively to lock up state contracts to supply the nation’s biggest customers, hindering distribution while the opioid crisis worsened. Emergent’s lobbying blurred the line between advocacy and sales. No company has profited from naloxone like Emergent, despite the medication’s patent having expired three decades ago. Emergent claims its lobbying and government involvement are aimed at raising awareness and expanding access. The company has not charged eye-popping prices, and list price has not gone up since it debuted in 2016. Public health agencies got discounts. However, Narcan has long cost 10 times more than other versions of naloxone, fueling shortages as public interest organizations and local governments have struggled to pay for it.

Source: How one company profited while delaying Narcan’s drugstore debut (The Washington Post)

Overdose deaths reach more than 111,000 in 12-month period

Centers for Disease Control and Prevention provisional data estimates that there were 111,355 overdose deaths in the year ending April 2023, a 1.7% increase over the year before. Overdose deaths reached another record level with more than 111,000 people dying in the 12-month period. The pace of increase is much slower than it has been in recent years, however. Still, about 1,000 more lives were lost in the 12 months ending in April than in the 12 months before that. While the national trends show relatively small increases, parts of the country, especially the West, continue to see major surges in overdose deaths. Fentanyl and other synthetic opioids were involved in nearly 70% of the deaths. Increases in overdoses involving these drugs accounted for the vast majority of the overall increase in deaths. Psychostimulants were involved in about a third of deaths, and cocaine about a quarter.

Source: Provisional Drug Overdose Death Counts (Centers for Disease Control and Prevention); Overdose deaths continue to rise in the US, reaching another record level, provisional data shows (CNN)

Cancer Moonshot includes several smoking cessation efforts

The Biden administration is taking action to advance the White House Cancer Moonshot. The Centers for Disease Control and Prevention announced a five-year, $15 million program to help increase adoption, implementation and enforcement of policies prohibiting the sale of menthol and other flavored tobacco products and increase awareness of cessation services and coverage options among populations experiencing tobacco-related disparities. The Department of Health and Human Services (HHS) will finalize its Framework to Support and Accelerate Smoking Cessation to enhance collaboration to equitably accelerate smoking cessation, focusing on communities disproportionately impacted by tobacco use. The National Cancer Institute is partnering with the Indian Health Service to launch SmokeFreeNative, a text messaging program to help American Indian/Alaska Native adolescents and adults quit smoking, while honoring the significance of traditional tobacco. NCI is also launching digital resources to help people who smoke menthol cigarettes quit, addressing barriers particularly in Black communities. The Department of Veterans Affairs and NCI will conduct a clinical demonstration project to assess how to more effectively engage veterans in tobacco use treatment programs. The African American Tobacco Control Leadership Council is making Emotional Brain Training services available for stress management and smoking cessation through a free app. CVS Health will launch an expanded smoking cessation program in a dozen states. The National LGBT Cancer Network is making tailored tobacco cessation materials more readily available.

Source: FACT SHEET: As Part of President Biden’s Unity Agenda, White House Cancer Moonshot Announces New Actions and Commitments to End Cancer as We Know It (White House)

FDA issues warnings to e-cigarette companies

The Food and Drug Administration (FDA) issued warning letters to 15 online retailers and three manufacturers and/or distributors for selling or distributing unauthorized e-cigarette products. In one case, the retailer illegally sold a product to an underage purchaser. The warning letters cite a range of popular and youth-appealing e-cigarette products, including disposable products, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang and Kangertech. The products were identified through rapid surveillance and a data-driven approach to investigations. Retail sales data, emerging internal data from surveys of youth and other data sources helped the FDA identify the rising popularity of these youth-appealing products, which were subsequently prioritized for investigation across the supply chain.

Source: FDA Roundup: September 15, 2023 (Food and Drug Administration)

Secretary of State announces synthetic drug response efforts at UN General Assembly

Secretary of State Antony Blinken announced during the United Nations General Assembly meeting that the U.S. is taking three additional steps to address the issue of synthetic drugs. First, the U.S. will name an envoy to elevate diplomacy on the issue, working with countries around the world to confront the threat. Second, the U.S. will introduce a resolution at the U.N. General Assembly in December highlighting the global health and security threat of synthetic drugs and urging international action to address them. Third, the U.S., alongside the U.N. Office on Drugs and Crime, will partner with tech companies in the fight against illicit drugs, including a focus on ways to deny criminals access to online platforms to market dangerous drugs and develop tools to help those seeking treatment for addiction.

Source: Secretary Antony J. Blinken at the Addressing the Public Health and Security Threat of Synthetic Drugs through Global Cooperation Event (U.S. Department of State)

Mobile crisis teams still limited in many places

Mobile crisis teams have been around for decades in places like Oregon, Arizona and Georgia. Federal agencies have praised the teams as essential to address mental health and substance use crises. In March 2022, the White House included them as a key pillar of its Unity Agenda, investing almost $1 billion into community-based services that include mobile crisis response. Since its launch in July 2022, demand for 988 has surged. It has rolled out subnetworks for Veterans, LGBTQ+ individuals, Spanish-speakers and users of ASL. However, some mobile crisis teams say they are still on the sidelines. Some say they are strapped for resources, leading them to operate at reduced hours and only limited geographies. As a result, police are often still responding to mental health crises. According to data from the past year, in Wyoming and Vermont, 100% of calls to 988 that required an in-person intervention received a police response. In New Mexico, 98% did, in Kansas, 87% and in Michigan, 79%. Alabama, Virginia and Washington do not even track the number of police versus mobile crisis team responses.

Source: Mobile crisis teams still sidelined despite growing need for mental health services in US, advocates warn (ABC)

Xylazine use varies geographically in U.S.

A report from drug testing lab Millennium Health found regional differences in the use of xylazine. While virtually all positive urine tests for xylazine also contained fentanyl, 16% of fentanyl-positive tests contained xylazine between April and July. The rates are much higher in some states, including Pennsylvania (42.8%), North Carolina (40%) and Ohio (36.1%). Millennium detected xylazine in 34 states since April. In Mid-Atlantic states, 40% of fentanyl-positive tests contained xylazine, compared to 33% in East North Central states, 22% in South Atlantic, 19% in East South Central, 16% in New England, 13% in West North Central, 5% in West South Central, 4% in Pacific and 2% in Mountain states. Use of multiple drugs was significantly higher among those using fentanyl with xylazine, compared to those using just fentanyl. They were about twice as likely to also use prescription opioids and three times as likely to use fentanyl analogues. They also used higher rates of gabapentin, benzodiazepines, cocaine and methamphetamine. The only exceptions were alcohol and marijuana.

Source: The stark U.S. divide in xylazine use (Axios)

Philadelphia city council votes to largely ban overdose prevention centers

Philadelphia’s city council voted to largely ban overdose prevention centers. The decision may stymie Safehouse’s plan to establish a site in the city. The Department of Justice (DOJ) sued Safehouse in 2019 over plans to establish a site. A federal judge ruled in Safehouse’s favor, but an appeals court overturned the decision in January 2021, and Safehouse then sued. DOJ under President Biden engaged in unsuccessful settlement talks with Safehouse, and DOJ is now asking a federal judge to dismiss the lawsuit. Safehouse said despite the city council decision, it will keep pressing its case in court and still hopes to open a facility in Philadelphia. The measure prohibits supervised injection facilities in 10 of the council’s 11 districts. The council member in the district where it would not apply opposed the ban and did not attend the meeting. An operator wanting to open such a site can seek a zoning variance, but only with support from residents and the district’s council member. The measure now goes to the mayor, who did not indicate whether he would approve it but stressed his support for overdose prevention centers. The council has the votes to override a veto.

Source: Philadelphia council bans safe-injection sites in most of the city (The Washington Post)

Vivitrol is preferred in criminal legal system but may be less safe and effective than originally suggested

Vivitrol is the opioid treatment preferred (over methadone or buprenorphine) by the criminal legal system, partly because it is not a controlled substance and because maker Alkermes heavily promoted it to those markets by claiming it is as safe as the other medications and easier to administer because it does not have to be taken daily. However, a new analysis of data from a 2018 trial comparing Vivitrol and Suboxone shows that researchers miscoded several overdoses in people taking Vivitrol, leading them to conclude that both drugs were equally safe and effective, while in fact, people on Vivitrol were more than twice as likely to overdose as those on Suboxone. Agonists preserve tolerance, meaning that if people use street opioids while taking methadone or buprenorphine, they are at lower risk of overdosing and dying. Vivitrol, however, stops tolerance. It protects from overdose by blocking the biochemistry that opioid receptors initiate, but this protection may decline during the last week before the next shot. Vivitrol may sensitize opioid receptors, making relapse more dangerous. Alkermes capitalized on the stigma surrounding methadone and buprenorphine and intensely marketed and lobbied Vivitrol as a result. In 2019, it was called out by the Food and Drug Administration for minimizing the risk of overdose, but Vivitrol’s use continues.

Source: Vivitrol, Used to Fight Opioid Misuse, Has a Major Overdose Problem (Scientific American)

Americans blame cartels and see opioid crisis as a security issue

A Morning Consult poll found that Americans most often blame Mexican drug cartels for the country’s opioid crisis, followed by people who use drugs themselves. Voters see the crisis as more of a security than a health issue, giving Republicans an edge heading into the 2024 elections. Respondents said they trust congressional Republicans more on national security and immigration issues, and Democrats more on health care. Voters in border states blame the U.S. government for the opioid crisis more than other voters do by an 11 percentage point margin. They are also more likely to say that punishing people who use drugs would be a “very effective” way to limit the supply of illegal drugs. Drug trafficking is among voters’ top foreign policy issues, behind only terrorism in the percentage of voters who cite it as among the top five most important foreign policy issues facing the U.S. (45% vs. 46%). Republicans are generally much more likely to think that enforcement measures like additional border security, sending U.S. military forces into Mexico to battle cartels and punishing drug violators will be effective ways to combat the crisis, while Democrats are 16 percentage points more likely to think that treating people with addiction would help. Adults on both sides of the aisle tend to say that tighter legal controls on opioids are an effective remedy.

Source: Security concerns give GOP edge on the opioid crisis: Poll (Axios)