New Regulations Have Potential to Remove Barriers to Care

On December 10, 2021, the Biden-Harris administration released its fall 2021 regulatory agenda. Many proposed regulatory actions can make a positive impact on behavioral healthcare delivery.

On the same day, the Government Accountability Office (GAO) released a report titled “Behavioral Health and COVID-19: Higher-Risk Populations and Related Federal Relief Funding,” and stated that the federal government has awarded $8 billion in COVID-19 relief funding specifically to address behavioral health needs. Such funding has been used, in part, to promote mental health awareness and provide federal funding to states, local communities, and other providers to support community-based mental health and substance use treatment and prevention services. While such funding is an integral part of delivering behavioral healthcare moving forward, there are still many federal regulations in place that impede behavioral health providers from delivering optimal care. Several federal agencies have acknowledged these constraining regulations and have relaxed them during the COVID-19 pandemic. Nonetheless, these restrictive regulations may no longer be waived once the COVID-19 pandemic ends. That is why proposed regulations are needed sooner than later to be implemented to make regulatory flexibilities that improve behavioral healthcare delivery permanent.

Here are some of the federal regulations to be proposed or finalized in 2022 that will have the potential to remove barriers to initiating and continuing behavioral health treatment and to sharing necessary health information for whole-person healthcare.

January 2022 — Proposed Regulations for Special Registration for Telemedicine Prescribing

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) permits the prescription of controlled substances via telemedicine to patients in their homes only if an in-person medical evaluation has been completed or the prescriber is able to meet a narrow exception. One of these exceptions is the “special registration” exception where the Drug Enforcement Administration (DEA) would implement rules to permit providers to prescribe controlled substances through telemedicine to patients in their homes and other locations. Even though the Special Registration for Telemedicine Act of 2018 required the DEA to finally address telehealth prescribing of controlled substances by October 2019, the DEA has yet to release proposed rules. Due to the COVID-19 pandemic, many have relied on the DEA’s flexibility in permitting prescribing via telehealth without in-person examination. There are concerns, however, that there is no plan in place to address such prescribing once the COVID-19 public health emergency has expired.

The spring 2021 regulatory agenda provided that proposed rulemaking would be issued by the DEA in September 2021. Now the fall 2021 regulatory agenda states that the proposed rulemaking will be issued in January 2022. Given the continual pressure by stakeholders, including but not limited to members of Congress, countless stakeholders wait with bated breath for these proposed regulations to finally be released by the DEA.

January 2022 — Proposed Regulations for CARES Act Revisions to 42 CFR Part 2

On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (CARES Act) was enacted to address the COVID-19 pandemic. The CARES Act also brought significant changes to 42 CFR Part 2 (Part 2) to partially align with the Health Insurance Portability and Accountability Act (HIPAA). Substance use records that are subject to Part 2 are significantly restricted in how they are used and disclosed in comparison to medical records subject to HIPAA. Such restrictions can greatly prohibit care coordination and disclosures that optimize whole-person care delivery. The CARES Act, in part, requires Department of Health and Human Services (HHS), by regulation, to change Part 2 patient consent so once initial patient consent has been obtained, a record subject to Part 2 can be disclosed, similarly to how medical records are disclosed under HIPAA (e.g., for treatment, payment, and healthcare operations purposes). Such changes were to be effectuated by the HHS regulations in the near future to apply to uses and disclosures subject to Part 2 on or after March 27, 2021.

Many had hoped that since the Part 2 changes would be for disclosures and uses around March 27, 2021, the proposed Part 2 regulations would be quickly forthcoming. The fall 2020 regulatory agenda stated that forthcoming proposed rules would be released in December 2020. Then, the spring 2021 regulatory agenda provided that the proposed rules would be released in October 2021.

HHS has now stated, in the new fall 2021 regulatory agenda, that the proposed rules will be published in January 2022. For the first time in the regulatory agenda for the Part 2 proposed rules, HHS says that it initially considered whether the CARES Act Part 2 provisions could be implemented through guidance rather than regulations, but eventually decided that such guidance would be contrary to the CARES Act requirement that HHS implement regulations for the CARES Act Part 2 provisions. HHS also was evaluating whether to include additional changes to Part 2 that were not addressed by the CARES Act. Nonetheless, HHS determined that at this time, it will only propose Part 2 regulations that align with its obligations to propose Part 2 regulations under the CARES Act after it identified that any additional proposed changes to Part 2 would probably further delay the publication of the proposed rules.

Given this discussion by HHS, one can hope that the significant delays in the Part 2 proposed regulations are now in the past and that they will be released in January 2022.

September 2022 — Proposed Regulations for Treatment of Opioid Use Disorder with Extended Take-Home Doses of Methadone

For the first time in a regulatory agenda, the Substance Abuse and Mental Health Services Administration (SAMHSA) is proposing to finalize some of the flexibilities it gave for dispensing prescribed methadone for opioid use disorder (OUD) for SAMHSA-regulated opioid treatment programs (OTPs) due to the COVID-19 pandemic. SAMHSA issued an exemption to OTPs on March 16, 2020, whereby states could request blanket exceptions for all stable patients in an OTP to receive 28 days of take-home doses of methadone for OUD to avoid patients having to be physically present daily at an OTP to receive prescribed methadone. SAMHSA noted that states could also request up to 14 days of take-home doses of methadone for patients who are less stable, but an OTP determined could safely handle the drug at home.

On November 18, 2021, SAMHSA issued a press release stating that it would extend the methadone take-home flexibilities for 1 year on the eventual expiration of the HHS public health emergency declaration for the COVID-19 pandemic. The press release noted that initial studies determined that the ability to take home-prescribed methadone led to increased treatment and engagement and there were few occurrences of methadone misuse or medication diversion. The fall 2021 regulatory agenda provides that making this flexibility permanent would facilitate treatment engagement and allow patients to maintain employment and follow daily activities without the concern of seeking transportation to receive daily prescribed methadone. SAMHSA expects to release proposed regulations in September 2022.

September 2022 — Proposed Regulations for Treatment of Opioid Use Disorder with Buprenorphine Utilizing Telehealth

Similar to the forthcoming proposed regulations for methadone addressed above, SAMHSA is also proposing, for the first time, to make permanent the buprenorphine telehealth flexibility that resulted from the COVID-19 pandemic for OTPs. The flexibility permits patients to be prescribed buprenorphine by an OTP without completing an in-person medical examination as long as an adequate examination of the patient can occur via telehealth before prescribing. SAMHSA expects to release proposed regulations in September 2022.

October 2022 — Finalized Regulations for HIPAA Privacy Rule for Care Coordination and Case Management

On December 10, 2020, right before the change in administration, HHS released its notice of proposed rulemaking with significant proposed changes to HIPAA, seeking, in part, to improve care coordination and case management, and facilitate disclosures to address social determinants of health. HHS also sought to find ways for family members, friends, and caregivers to have access to necessary health information when involved in care for an individual with a substance use disorder (SUD) or serious mental illness (SMI) and when a provider determines that such disclosure is in the best interest of the individual. In the proposed rulemaking, HHS requested specific comments about whether such efforts to facilitate disclosures of information for individuals with SUD and/or SMI would deter such individuals from seeking mental health treatment. The comment period for the proposed rulemaking was extended until May 2021. HHS stated in the fall 2021 regulatory agenda that it expects to release the final regulations in October 2022. Due to the fact that HHS has received multiple comments on the challenges of implementing significant changes to HIPAA, as well as a change in administration after the release of the HIPAA proposed rules, it is unclear how the final regulations will align with the previous proposed regulations.

Jena Grady is an associate in Nixon Peabody’s Health Care practice group.

The views expressed in Perspectives are solely those of the author and do not necessarily reflect the views of Behavioral Healthcare Executive, the Psychiatry & Behavioral Health Learning Network, or other Network authors. Perspectives entries are not medical advice.