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

Current regulations require the Centers for Medicare and Medicaid Services (CMS) to develop a Medicaid Managed Care Quality Rating System in consultation with states and other stakeholders.[2][3] Under these regulations, CMS is responsible for identifying key performance indicators, including a subset of mandatory performance indicators, and providing guidance to states regarding these or their own proprietary quality measurement programs.[1] Beginning in 2024, federal law mandates that states report on two core sets of quality measures: a pediatric set and an adult set.[4][5] Each of these includes behavioral health measures. As these core sets cover a spectrum of specialty and primary care services, core behavioral health measures should include benchmarks for behavioral health integration.[1]

To provide whole-person care, clinical care teams need patient information related to mental health, substance use, and physical health. However, 42 CFR Part 2, a discriminatory provision of federal law, places severe restrictions on the sharing of SUD patient information that go far beyond HIPAA’s requirements. This restriction further stigmatizes SUDs and hinders the integration of SUD care with mental and physical health care. These separate rules have put patient safety at risk by inhibiting sharing of patient information among teams of clinicians (e.g., a physical health care provider might unknowingly prescribe an opioid to an individual with opioid use disorder). These restrictions have also decreased the overall quality of SUD care by making it harder to address patients co-occurring SUD, mental health, and physical health needs, and hindering clinical research that has been made more difficult by keeping SUD data segregated from mental and physical health data.[1]

To address these problems, Congress passed the Protecting Jessica Grubb’s Legacy Act as part of the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act.[2][3] The law takes steps to align 42 CFR Part 2 with HIPAA by facilitating the sharing of clinical information with care teams that are essential to accurately diagnose, treat, and provide whole-person care. While HHS has proposed rules that effectively implement many of the CARES Act regulations, the proposed rules do not go far enough. The Congressional sponsors – as well as advocates – have urged HHS to ensure the final rule has patient consent requirements that allow the sharing of SUD information simple and straightforward.[4][5] For example, it is essential that the consent process be folded into the existing HIPAA consent process. HHS should also ensure that SUD patient data does not need to be segregated from other HIPAA-protected data once data has been transmitted between providers. In short, HHS must ensure that the intent of the CARES Act provisions is implemented and that it does not leave barriers that effectively result in a patient’s SUD information, after consent has been given, not being integrated with other patient health information.[1]

If HHS does not effectively address these longstanding barriers in its final regulations, Congress should simply eliminate any discriminatory distinctions between SUD and other patient health information, which are all currently subject to HIPAA’s requirements.

In 2017, the Centers for Medicare and Medicaid Services (CMS) began paying physicians and non-physician practitioners separately for supplying patients with Behavioral Health Integrated Services (BHI).[4] These services involve a closer partnership between treating physicians and mental health and substance use disorder (MH/SUD) professionals, which has proven beneficial to patients and has evolved into the Collaborative Care Model (CoCM). This model has been demonstrated effective by more than 90 randomized-controlled trials and can help to more effectively utilize limited MH/SUD provider capacity.[5]

Critical infrastructure is required to effectively implement BHI/CoCM services.[4] When properly incentivized, BHI/CoCM approaches to care have a demonstrated potential to improve care for individuals with MH/SUD. CMS uses G-codes to assess and address functional limitations in patients, including difficulty seeing, hearing, mobility, communication, cognition, and self-care.[6][7] These billing codes include approvals for reimbursement of services using CoCM approaches, but reimbursement levels have been insufficient to scale adoption more broadly.[3] Insufficient compensation for training and technical support has effectively contributed to continued payment silos between MH/SUD care and primary care.[1]

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]