Policy News Roundup: July 14, 2022

Key reads

988 launch downplayed amid capacity concerns

State health officials are tempering expectations days ahead of the 988 mental health hotline launch, unsure they have the money or staff to respond to an expected flood of calls. Senior federal officials are downplaying Saturday’s launch as more of a “transition.” The Department of Health and Human Services has dispatched new funds to help states expand their crisis networks in recent months, but federal officials say few states have kept up their end of the bargain and implemented long-term funding. Some states have 24/7 crisis call centers, while others are only now expanding to 24/7 operations. The number of call centers varies greatly by state. Some have long paid their staff, while others have relied on volunteers. Some states answer virtually every contact, but others route more than half of calls out-of-state to 15 backup centers. Many states are having trouble persuading their legislatures to pass a fee to fund the program.

Source: 988 set for quiet launch in light of state, federal concerns about crisis call spike (Politico)

FDA takes first action against synthetic nicotine product manufacturers

The Food and Drug Administration (FDA) issued its first two warning letters to manufacturers for unlawfully marketing non-tobacco nicotine e-liquid products without the required authorization, after a law that went into effect in April gave the FDA authority to regulate such synthetic nicotine products. The two companies have listed a total of approximately 10,000 products with the FDA. Neither company submitted a premarket application for its products by the May 14 deadline as required by law. The FDA has also issued 107 warning letters to retailers in the past two weeks for illegally selling synthetic nicotine products to underage purchasers. After July 13, any new non-tobacco nicotine product that has not received premarket authorization from the FDA cannot be legally marketed. The FDA is currently processing applications for approximately one million products submitted by more than 200 manufacturers by the May 14 deadline.

Source: FDA Continues to Implement Law, Regulate Non-Tobacco Nicotine Products, Warns Retailers and Manufacturers Against Illegal Sales (Food and Drug Administration)

ONDCP announces funding for Drug-Free Communities coalitions

The Office of National Drug Control Policy announced approximately $81 million for 645 local coalitions across the country as part of the Drug-Free Communities Support Program Continuation Grant Awards. The grants will provide funding to community coalitions working to prevent youth substance use by supporting individuals and communities in their work.

Source: The White House Announces Funding for 645 Community Coalitions Working to Prevent Youth Substance Use (Office of National Drug Control Policy)

FDA and Juul suspend court case as FDA reviews application

The Food and Drug Administration (FDA) and Juul agreed to put their court fight on hold while the government reopens its review of the company’s e-cigarettes. The agreement comes after the FDA placed a hold on its initial order banning Juul’s products from the market, saying Juul’s application for market authorization warranted additional review. Juul can continue to sell in the meantime. If the FDA decides to reimpose its ban, Juul will have 30 days to seek another stay.

Source: Juul, FDA suspend court case while e-cigarette ban on hold (Associated Press)

CMS proposed rule outlines behavioral health policy changes

The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule on policy changes for Medicare payments under the Physician Fee Schedule. It includes several proposals to address behavioral health. CMS is proposing to create an exception to supervision requirements. This would allow marriage and family therapists, licensed professional counselors, addiction counselors, certified peer recovery specialists and others to provide services under “general” rather than “direct” supervision. This means they can provide care without a doctor physically on site. CMS is proposing to pay psychologists and social workers to help manage behavioral health needs as part of a primary care team. CMS is also proposing new payments for team-based, comprehensive chronic pain management, as well as policies to strengthen the Medicare Shared Savings Program, which has shown success in providing high-quality behavioral health care. CMS is clarifying that opioid treatment programs (OTPs) may bill Medicare for services performed by mobile units without obtaining separate registration. CMS is also proposing to increase payment rates to OTPs and to pay for the initiation of buprenorphine over telehealth.

Source: Strengthening Behavioral Health Care for People with Medicare (Centers for Medicare and Medicaid Services)

Teva and Allergan settle San Francisco opioid lawsuit

Teva and Allergan reached a $58 million settlement with San Francisco just before completion of a trial over claims that they fueled an opioid crisis in the city. Teva will pay $25 million in cash and contribute a $20 million supply of Narcan, and Allergan will pay $13 million. San Francisco will receive $54 million, and $4 million will go toward attorneys’ fees. San Francisco proceeded with closing arguments against Walgreens, the last remaining defendant in the case. San Francisco had accused Walgreens, Teva, Allergan and Anda (subsidiary of Teva) of creating a public nuisance by flooding the city with opioids and failing to prevent them from being diverted for illegal use.

Source: San Francisco reaches $58 mln opioid settlement with Teva, Allergan (Reuters)

New York AG finds that Teva lied to avoid accountability for the opioid crisis

New York Attorney General Letitia James filed a motion by order to show cause that outlines how Teva made misrepresentations to the Office of the Attorney General (OAG) and the court about its role in the opioids industry in the U.S. in order to evade legal action and accountability. New evidence shows that, despite sworn testimony that Teva Pharmaceutical Industries, Ltd. (parent company of Teva Pharmaceuticals USA) transacted no business in the U.S., held no property in the U.S. and had no role in the U.S. opioids business, it was a primary decision maker for its American subsidiary, maintained property and employees in the country and exerted control over its finances. James argues that the court should vacate its previous dismissal of the parent company from opioid litigation to allow OAG to examine the company’s role in the opioid crisis and whether it compromises Teva USA’s ability to pay New York by improperly transferring billions of dollars out of the company.

Source: Attorney General James Uncovers Evidence That Teva Pharmaceuticals Lied to Evade Accountability for Opioid Crisis in New York (New York State Office of the Attorney General)

Minnesota legalizes low-potency hemp-derived THC products

A law that took effect in Minnesota last week allows anyone 21 or older to purchase edibles or beverages with up to 5 milligrams of hemp-derived THC per serving, or 50 milligrams per package. Those relatively low-potency products are still enough to create a high. The provision was adopted during a marathon conference committee meeting in May without debate or objection, and some key lawmakers are seemingly confused about the ramifications. In recent years, the Democratic-controlled House has twice passed legislation to legalize marijuana, but the Republican-controlled Senate has remained opposed. Democrats say they were fully aware of what the legislation would do, noting that the bill received three committee hearings in the House, but Senate Republicans are less willing to discuss the bill and whether they realized it would permit intoxicating cannabis products.

Source: Did Minnesota accidentally legalize weed? It’s complicated. (Politico)

New York funds crisis stabilization centers

New York Governor Kathy Hochul announced $71 million for the development of 12 new Supportive Crisis Stabilization Centers, which will provide support and assistance to individuals with mental health or substance use crisis symptoms who are experiencing potentially harmful situations. The Centers will provide all services on-site, 24/7. All services are voluntary, person-centered and trauma-informed, with an emphasis on peer support.

Source: Governor Hochul Announces $71 Million Available for Development of 12 Supportive Crisis Stabilization Centers (Governor Kathy Hochul)

More behavioral health integration is needed

Despite strong evidence and recent changes to encourage behavioral health integration (BHI), adoption by primary care practices remains the exception. Obstacles include high start-up costs, low reimbursement, complicated and burdensome billing requirements, siloed data and limited workforce. Payers should expand coverage and fair payment for BHI models; evaluate cost sharing for collaborative care models and integrated behavioral health services; offer technical support, provider training and regional sharing of resources; minimize/eliminate prior authorization and other use management practices for BHI services; and design, pilot and launch whole-person, employer-based behavioral health programs. Federal and state policymakers should provide long-term sustainable funding opportunities for primary care practices to support training and education on BHI implementation; raise payment levels for BHI services in federal and state coverage programs; work with health plans to limit use of management review practices, enforce parity and strengthen network adequacy regulations; and increase federal funding to grow the workforce.

Source: Combating A Crisis By Integrating Mental Health Services And Primary Care (Health Affairs)