The Drug Enforcement Agency (DEA) is proposing to roll back flexibilities implemented during the public health emergency (PHE) in tele-prescribing buprenorphine. The proposed new regulation would mandate an initial in-person visit with a prescriber in order for a patient to receive more than a 30-day buprenorphine prescription. Since 2020, those with opioid use disorder have been able to receive prescriptions for buprenorphine, including the initial prescription, following a tele-appointment.
Patients who began buprenorphine treatment during the PHE under the expanded flexibilities would have a 180-day grace period but would then need to see a prescriber in person before continuing treatment under the DEA’s proposed rule.
The proposed rule and instructions for providing comments are available online. The public comment period closes March 31, 2023.
Resources for Integrated Care (RIC) recently released a brief on telehealth and its impact on dually eligible people with intellectual and developmental disabilities (I/DD). As noted by RIC, people dually eligible for Medicare and Medicaid, as well as people with I/DD, are diagnosed with multiple chronic conditions at higher rates than the general population and often face barriers with access to healthcare.
Telehealth services have been increasing in popularity and usage and have the potential to positively impact people with I/DD. Health plans can utilize this information to further their understanding of how telehealth modalities can improve access to person-centered care for people with I/DD.
On January 30, the Biden Administration announced that the COVID-19 national emergency and public health emergency (PHE) will both expire on Thursday, May 11, 2023. Under Act 30 of 2022, the Department of Drug and Alcohol Programs’ (DDAP) regulatory suspensions that are “related to federal exemptions granted under the federal public health emergency declaration” were extended until “the last day federal exemptions granted under the federal public health emergency declaration are authorized.” In other words, Act 30 aligned the timing for DDAP’s regulatory suspensions with the deadline for flexibilities granted by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Drug Enforcement Administration (DEA) — not with the deadline of the PHE itself.
Below is a description of each currently suspended regulation and what DDAP knows about efforts to make these changes permanent at the federal level.
Methadone Take-Home Supply
Current regulatory suspension: Under the federal PHE, SAMHSA is currently allowing up to 28 days of take-home medications for patients on stable dosages, as deemed appropriate by their physician. DDAP’s regulation 28 Pa. Code § 715.16(e) (prohibiting narcotic treatment programs [NTPs] from permitting a patient to receive more than a two-week take-home supply) is currently suspended under Act 30.
Expiration of the PHE: In November 2021, SAMHSA announced that the methadone take-home flexibilities will be extended for one year after the end of the PHE (now May 11, 2024). DDAP submitted its written concurrence with this exemption in February 2022. Furthermore, SAMHSA issued a notice of proposed rulemaking in December 2022 that proposes modifying regulations related to methadone take-home supply up to 28 days, among other changes.
Current regulatory suspension: Under the federal PHE, SAMHSA and the DEA are currently allowing initial evaluations for a patient who will be treated with buprenorphine to be completed via telehealth. DDAP has two related regulations that are currently suspended under Act 30:
Expiration of the PHE: In March 2022, the DEA announced that it is currently working to make its teleprescribing regulations permanent. In June 2022, SAMHSA announced to State Opioid Treatment Authorities that flexibilities around telehealth evaluations before buprenorphine treatment at NTPs, specifically, will be extended for one year after the end of the PHE (now May 11, 2024).
SAMHSA and DEA have made clear that support for these flexibilities has been overwhelmingly positive, decreased stigma associated with OUD, and enhanced care for patients. Given the information above, DDAP does not anticipate any lapses in these flexibilities at either the federal or state level but will continue to provide updates and guidance as available.
If you have any further questions, please contact the Bureau of Program Licensure at (717) 783-8675 or via email.
OMHSAS Approves RCPA Telehealth Extension Request
Deadline for Consent/Service Verification Compliance Now March 31, 2023
In an effort to assist provider members in their efforts toward consent and service verification compliance, RCPA requested an extension of the December 31, 2022, deadline. RCPA outlined ongoing challenges towards meeting these standards that included integrating new platforms into existing infrastructure, funding, training, and internal process changes.
Yesterday, we met with the Office of Mental Health and Substance Abuse Services (OMHSAS) to outline these concerns and review provider progress towards compliance. In response, OMHSAS has agreed to extend the date for meeting the consent and service verification standards to March 31, 2023. Funding concerns, especially in the middle of a budget year, were also discussed, and OMHSAS will make available funds to aid providers in implementing these practices.
As part of the RCPA Telehealth Work Group meeting at 10:00 am on Tuesday, December 20, 2022, we will be covering this and other telehealth topics on the agenda. These include our hope to conduct online polling on specific telehealth issues. You can register for the meeting here. Additionally, the second half of the meeting will feature OMHSAS Policy Director Jenna Mehnert Baker, who will provide updates, guidance, and a Q&A. We hope you are able to join us for this call, as your participation in the meeting will provide up-to-date information on your efforts and information that will assist RCPA in our collective endeavors.
We are grateful for the collaboration with OMHSAS and their willingness to extend the compliance timeframe. RCPA is committed to working with providers to ensure telehealth services remain a viable part of the service delivery continuum.
Please forward all questions you may have for OMHSAS to RCPA Policy Director Jim Sharp.
Read the OMHSAS response from Dr. Dale Adair below:
The purpose of this communication is to address concerns expressed by RCPA specific to the impact of ending OMHSAS’ bulletin suspensions on 12/31/22. There appears to be a significant amount of concern about providers’ ability to have telehealth platforms in place by 01/01/2023. Just to clarify, at no point has OMHSAS stated that providers must have HIPAA-compliant platforms in place by January 2023? It is important to note that the Pennsylvania General Assembly has defined telebehavioral health to specifically include platforms. Act 76 of 2022 defined: “Telebehavioral health technology. (i) Any of the following:(i) Real-time interactive audio and video communication using technology that conforms to industry-wide standards and is in compliance with Federal and State privacy and security laws.(ii) Real-time interactive audio-only telecommunication, provided that the use of audio-only telecommunication technology is consistent with Federal and State laws, guidance and requirements.(2) The term does not include technology solely using voicemail, electronic mail messages, facsimile transmissions or instant messaging, or a combination thereof.”
OMHSAS Memorandum dated February 18, 2021, that temporarily suspended portions of bulletins and other guidance documents, stated that “verbal consent must be documented at the time of service, and providers are strongly encouraged to obtain electronic signatures when possible.” This language allowed verbal consent without a second witness during the public health emergency. At that time, OMHSAS also stressed the need for providers to acquire platforms capable of securing electronic signatures. Given OMHSAS’ previous recommendation, providers have had nearly two years to secure a platform capable of securing electronic signatures for consent and service verification. DHS is intending to provide a funding opportunity for providers per the approved HCBS spending plan. OMHSAS continues to look for additional ways to support compliance with the expectations of the Pennsylvania Act 69 of 1999 (Electronic Transactions Act).
It remains imperative for all entities delivering MA funded behavioral health services to have policies in place to capture consent in a way that creates an auditable trail. There are multiple ways that providers of telebehavioral health can meet this requirement including messages typed into the chat box of an audiovisual platform, email, text messaging, USPS mail and two-person verification of a verbal consent secured over the phone. Given the options available to providers and the fact that since 02/2021 OMHSAS has stressed the importance of developing appropriate systems to capture electronic signatures, OMHSAS asks that providers meet federal and state expectations. Understanding the challenges providers are experiencing, OMHSAS will extend the bulletin suspension specific to consent to treat, service verifications and treatment plans only that is scheduled to end on 12/31/2022 until 3/31/23. Effective on April 1, 2023, providers are expected to capture consent to treat, service verifications and approval of treatment plans in a manner that creates an auditable file and in accordance with the timelines expected within regulation. While we understand the operational challenges, waiving the requirement that consent and service verification are secured in a manner that would withstand an audit any longer than three additional months is simply not possible. We believe the definition created in Act 76 serves to govern the delivery of telebehavioral health in the Commonwealth moving forward.