Alignment for Progress: 
A National Strategy for Mental Health and Substance Use Disorders

Fatal drug overdoses have increased rapidly in recent years and now kill more than 110,000 individuals annually.[3] These increases have been driven by extremely dangerous fentanyl and FRS, which can be lethal in extraordinarily low amounts and have been difficult to interdict. Current federal laws, though, are not structured to keep up with new FRS variants. The federal Controlled Substances Act schedules drugs, substances, or chemicals based on their potential for misuse, with Schedule I for those with a high potential for misuse and no currently accepted medical value.[4] Schedule I substances are tightly regulated and controlled.

FRS are not automatically included on Schedule I. While Congress has temporarily allowed the Drug Enforcement Administration to place FRS onto Schedule I (which expires on December 31, 2024), a more permanent solution is needed.

The Biden Administration has previously put forward recommendations relating to FRS[5], and reiterated its position supporting the permanent scheduling of all FRS into Schedule I in a Statement of Administration Policy.[1] Several pieces of legislation would permanently schedule FRS as Schedule I, including the SAFE Act[6] and the HALT Fentanyl Act. The U.S. House of Representatives passed the HALT Fentanyl Act in May 2023.[2] To save lives, Congress should act to send legislation to the President that permanently places FRS into Schedule I without delay.

Congress should also take action to improve interdiction of fentanyl and FRS at our borders, including increasing the availability of mass spectrometers at points of entry to identify dangerous substances. U.S. Customs and Border Protection and the U.S. Postal Inspection Service should be provided additional resources to purchase technologies and drug-detection canines to intercept FRS and other dangerous synthetic opioids.[7]

A controlled substance is a medically prescribed drug or substance regulated by the government because of its propensity for misuse and addiction.[2] Since all potential side effects of a drug can't be identified during the pre-approval phase, the Food and Drug Administration (FDA) maintains a system of post-marketing surveillance or requiring drug companies to conduct additional studies once a drug has already been approved for marketing.[3] Information the agency obtains from this process is used to update the drug’s label or revisit the approval decision.[3]

Historically, phase three clinical studies of opioid analgesics have examined the drug over a 12-week treatment period, with long-term safety extensions of 6 to 12 months. Accordingly, there are limited controlled study data evaluating the effectiveness of opioids beyond 12 weeks. Due to the paucity of pertinent high-quality data and safety concerns there is a need for more clinical trial data to better inform the benefit-risk balance of long-term opioid use. In April 2023, the FDA held a meeting of its Anesthetic and Analgesic Drug Products Advisory Committee to examine how clinical trials could be designed and executed to fill the knowledge gaps about long-term usage of opioids.[4] The FDA should move forward expeditiously with this work and apply such frameworks to other controlled substances as well.

On paper, the Affordable Care Act’s requirement that individual and small group plans (Qualified Health Plans, or QHPs) cover MH/SUD services as one of ten EHB was game-changing, intended to rectify the longstanding history of discriminatory practices by insurers against individuals with MH/SUD. In practice, while the MH/SUD category for EHB has ensured basic coverage of many MH/SUD services, CMS’s benchmark approach to define the services in the EHB categories has failed to require sufficient coverage of MH/SUD services. Examples of key coverage gaps include the widespread failure to cover: MH/SUD emergency (“crisis”) services, complete levels of care described in nonprofit clinical specialty association criteria, and Coordinated Specialty Care to treat early psychosis.

CMS itself has expressed concerns that the EHB-benchmark approach creates a “patchwork” and “disparate coverage nationwide.”[2] Reviews of benefits in the benchmark plans have identified significant variation in the MH/SUD benefits offered across the states.[3] This level of variation is an unacceptable outcome for a federal law intended to improve health care access across the country. Additionally, many state benchmark plans are MHPAEA non-compliant. A 2017 review of benchmark plans by the Partnership to End Addiction discovered numerous facial and likely MHPAEA violations. Many of these parity non-compliant plans are still in effect today.[4]

CMS should address these unacceptable gaps by changing its implementation of the ACA’s EHB requirements in the following three ways. First, CMS should establish a federal definition in the MH/SUD benefit category that establishes the minimum level of benefit coverage required for EHB. This would eliminate ambiguity in how the benefit is currently defined and variation in the benefits covered across states, close coverage gaps, reduce discriminatory insurance coverage practices, and increase access to affordable, life-saving care for individuals with MH/SUD. This minimum federal definition should ensure that all levels of MH/SUD care are covered benefits and that key services – including for MH/SUD emergencies (“crisis”) – to treat MH/SUDs are covered.[1]

Second, CMS should also require states to demonstrate that their benchmark plans are fully compliant with MHPAEA. Many states’ benchmark plans were never parity compliant, which has had the effect of permitting MHPAEA non-compliance among QHPs and other state-regulated plans.[1]

Third, CMS should establish an enforcement structure and process for ensuring that the benchmark plans, and QHPs based on the benchmark plans, are compliant with all legal coverage requirements, including, but not limited to, parity, EHB, network adequacy, and provider directory accuracy. CMS currently lacks an effective enforcement structure for holding states and QHPs accountable for their compliance with federal law.[1]

Mental health and substance use disorders (MH/SUDs) are complex, and for some conditions there may never be a single medication that effectively treats an entire condition (e.g., major depressive disorder, bipolar disorder, or schizophrenia). However, researchers have successfully mapped many specific symptoms onto specific neuronal circuits.[1] For example, researchers have mapped the neuronal circuitry for anhedonia, the reduced ability to experience pleasure. Anhedonia is an important and overlooked aspect of opioid use disorder.[2] Where good supportive data exists, the FDA should give a formal indication for medications to treat specific symptoms such as anhedonia regardless of MH/SUD diagnosis.

FDA-approved indications for medicines to treat specific psychiatric symptoms would encourage on-label prescribing across diagnoses where an individual experiences that specific symptom. Such indications would also encourage medication development because medications to treat a specific symptom that has been mapped onto a specific neuronal circuit would have broader indications than one or more diagnoses.

The Emergency Medical Treatment & Labor Act (EMTALA) ensures that hospitals provide emergency services, including stabilizing treatment for emergency medical conditions, regardless of an individual’s ability to pay.[2] Conditions related to substance use disorders (SUDs) are responsible for about one out of eleven emergency department visits, making hospitals an important location to initiate treatment.[3] Unfortunately, many emergency departments fail to comply with EMTALA by not conducting SUD screening and diagnosis assessments, by not providing medication for opioid use disorder (OUD), and by not providing post-discharge treatment options and medication.[4] Currently, many emergency departments do not provide adequate SUD screening and treatment due inadequate provider training and bias against SUDs.[5] Social workers and case managers can support hospitals by providing support services for individuals with SUD.[3] To improve SUD screening and treatment in hospitals, updated EMTALA guidance is needed to increase compliance. Congress should also pass legislation to incentivize the initiation of SUD care in emergency departments similar to the Improving Mental Health Access from the Emergency Department Act.[1]

For years, the ONDCP Director was a Cabinet-level position, but unfortunately was downgraded in 2009. In early 2023, a bipartisan group of 55 members of Congress wrote to President Biden asking him to elevate the Director. They noted that, in 2001, then-Senator Biden supported the ONDCP Director as a cabinet-level position.[1] Without the status as a cabinet member, the ONDCP Director is left without access to the same resources and mechanisms as other higher-ranking leaders, and the drug crisis in our country is left without an advocate at cabinet-level meetings.[3]

For its part, Congress should amend 21 U.S.C. § 1702 to integrate mental health into the authorizing statute that creates ONDCP. Such integration is vital given the interconnectedness between mental health and substance use disorders, which are frequently co-occurring conditions.[2] Indeed, substance use disorders are a type of mental disorder within the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders. Mental health and addiction policy should not continue to be structurally segregated.