Recent federal actions significantly enhance access to substance use disorder treatment

Several developments in federal policy are likely to have significant impacts on access to treatment for substance use disorder (SUD) in 2023. These include (1) new legislation to allow all providers that are registered by the Drug Enforcement Administration (DEA) to prescribe buprenorphine, a key drug for the treatment of opioid addiction, (2) proposed rules to offer new operational flexibilities for methadone clinics, including greater flexibility to dispense take-home doses to patients when clinically appropriate, and (3) proposed rules to better align SUD treatment data confidentiality requirements with regulations for protected health information (PHI) under the Health Insurance Portability and Accountability Act (HIPAA).

These new and proposed flexibilities are critically important, given the ongoing and worsening substance use disorder epidemic in the United States, which has been further exacerbated by the COVID-19 pandemic. The most recent available data analyses from the Centers for Disease Control and Prevention (CDC) show that an estimated 107,375 people in the United States died from a drug overdose in the 12-month period ending in January 2022. Many of these changes complement the strategies that articulated in the 2022 CMS Behavioral Health Strategy, as the Biden administration continues to seek ways to enhance access to high quality mental health and substance use disorder services.

Elimination of the X-Waiver

As part of the Consolidated Appropriations Act of 2023 (P.L. 117-328), Congress acted upon long-running requests to eliminate requirements for providers to obtain a special waiver to prescribe buprenorphine.

Historically, most patients with an opioid use disorder (OUD) were treated in Opioid Treatment Programs (OTPs, sometimes referred to as methadone clinics). In 2000, Congress passed the Drug Addiction and Treatment Act (DATA), which allowed providers that completed specialized trainings to obtain a waiver to prescribe buprenorphine to treat a certain number of patients with OUD outside of an OTP. This waiver was alternately known as a DATA-waiver or an X-waiver (since providers that obtained it had an X added to their DEA registration number). Although regulators offered increasing flexibility over time with regard to the types of providers that can obtain the X-waiver and the level of the limit on the number of patients they could treat, the requirement to obtain the X-waiver remained a barrier that prevented many providers from treating patients with OUD.

On Jan. 12, 2023, the Drug Enforcement Administration (DEA) confirmed in a letter to registrants that Congress has eliminated the DATA-Waiver Program. This change in law, effective immediately, means that any practitioner that is authorized by the DEA to prescribe Schedule III controlled substances may prescribe buprenorphine for OUD to the extent of their licensure, scope of practice, and state law. Elimination of the waiver requirement also means that there are no longer any specific limits on the number of patients that a practitioner may treat with buprenorphine. Guidance regarding training requirements will be for the delivery of these services will be forthcoming.

This new flexibility is significant because primary care and other office-based providers are accessible to a far broader range of Americans than the facility-based OTP providers that have traditionally comprised the backbone of the SUD treatment system. Many obstacles remain that may prevent a qualified provider from treating OUD — including lack of specific expertise or training, lack of access to or referral relationships with facility-based providers offering more intensive levels of care, and stigma — but the sheer quantity of additional providers that are now able to prescribe buprenorphine is a radical, overnight change.

Expanded flexibilities for Opioid Treatment Programs

On Dec. 13, 2022, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a proposed rule to enhance access to services in OTPs.

Although methadone is a safe and effective treatment for the treatment of OUD, patients have traditionally been required to show up at an OTP nearly every day to get it. Because many patients are unable to travel to a methadone clinic every day due to responsibilities to their employers and families, or due to a lack of transportation or motivation, a large majority of patients receiving medications for OUD are treated with buprenorphine.

In response to the COVID-19 public health emergency (PHE), SAMHSA issued guidance to permit OTPs to dispense up to 28 days’ worth of take-home methadone doses to patients that the OTP practitioner deems stable, or up to 14 days’ worth of doses to patients that the practitioner deems less-stable. The PHE guidance also expanded the definition of “practitioner” to include non-physician clinicians with prescribing powers, including nurse practitioners and physician assistants. Under the proposed rule, these PHE flexibilities would become permanent. The proposed rule would also eliminate rigid limits on access to take-home doses based on length of time in treatment and drug testing results, and would instead allow the treating practitioner to exercise more discretion to determine the clinical appropriateness of take-home doses. The proposed rule would also make permanent the current flexibility under the PHE guidance for OTPs to initiate buprenorphine via telemedicine without an in-person visit, among other changes.

Despite these significant expansions of flexibility for OTPs, the actual impact on patient access to treatment may be muted. First, there are currently only around 1,900 OTPs in the United States, and most of them are located in urban areas, so it is not possible for many patients to receive in-person services from an OTP. Second, some states may fail to amend relevant state laws, and some providers may choose not to exercise the new authority. Moreover, the requirement to show up on a daily basis will still apply in the early stages of methadone treatment for most patients.

The deadline for public comments on this proposed rule is Feb. 14, 2023.

Better alignment with HIPAA for privacy and confidentiality requirements for SUD treatment data

On Dec. 2, 2022, the Department of Health and Human Services (HHS) published a proposed rule to update confidentiality requirements for SUD patient records to better align with data privacy and confidentiality requirements under HIPAA.

The stated intent of the proposed rule is to improve access to health data, support care coordination, and improve the interoperability of electronic health records systems, and thereby to improve the ability of entities subject to these restrictions to use, disclose, and redisclose SUD treatment information. Differences between the more-stringent requirements for SUD treatment records and the relatively more familiar HIPAA requirements cause significant administrative burdens for plans, providers, and other entities that need access to these data. This proposed rule would significantly reduce the scope of those differences, generally as required by Congress under the CARES Act of 2020.

Unfortunately, the CARES Act did not amend the core requirement for providers to obtain patient consent to disclose their SUD treatment information to third parties. In addition, the current and proposed rules are more stringent than the underlying statute in a variety of ways, including by allowing patients to orally revoke their consent to share SUD information. Because HIPAA does not require the patient to consent to the sharing of protected health information for the purposes of treatment, payment, and health care operations but the SUD requirements do, and because minor but complex differences between the SUD confidentiality requirements and HIPAA would continue to persist, providers and other entities will continue to have to segregate SUD information from other health information despite the increased alignment. This regulatory complexity and administrative burden will unfortunately continue to inhibit many providers from offering SUD treatment services.

One more regulatory development to watch for in 2023

Beyond the recent legislation and proposed rules discussed above, health plans and providers should also watch for potential guidance from the DEA to create a special registration for qualified practitioners to prescribe buprenorphine via telemedicine without an in-person visit.

Related: How employers can help prevent drug misuse

Under the Ryan Haight Act and state law in many states, providers are required to conduct an in-person assessment of a patient before prescribing controlled substances via telemedicine. In 2018, Congress passed the SUPPORT Act, which included a requirement for the DEA to promulgate regulations to allow qualified telemedicine providers to obtain a special registration to forego this in-person visit requirement. However, the one-year deadline for the DEA to create these regulations passed in 2019 and no regulations have been published to date. Meanwhile, during the COVID-19 pandemic, the DEA and many states have waived this in-person visit requirement pursuant to their public health emergency authority. Congress has also introduced legislation to make the current waiver permanent, including the bipartisan bill S. 4103: Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act, but to date no statutory fix has been passed. As the end to the public health emergency likely approaches, patients and providers are left wondering whether the current waiver will elapse without a permanent solution to allow telemedicine access to SUD treatment for patients in remote and underserved areas.

David Shillcutt, Senior Counsel, Epstein Becker Green P.C.