In a continuation of our series examining the end of the COVID-19 federal Public Health Emergency (PHE), we do a deeper dive into federal telehealth flexibilities and policies that will expire. Among those flexibilities is a waiver of the requirement to conduct an in-person examination prior to prescribing controlled substances via telehealth, including via telephone, without first conducting an in-person visit. This flexibility has allowed providers to begin buprenorphine induction for patients with opioid use disorder (OUD) without first examining them in-person.
With this flexibility set to expire on May 11th, two recently proposed federal rules will affect how providers may prescribe controlled substances via telehealth after the end of the PHE.
- In December 2022, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a proposed rule that, if promulgated, would permanently permit Opioid Treatment Program (OTP) providers to prescribe treatment via telehealth in certain circumstances and extends methadone take-home dose flexibility, among other changes.
- Earlier this month, the Drug Enforcement Agency (DEA) also published a proposed rule, that, if promulgated, would implement more stringent parameters around providers beginning buprenorphine treatment via telehealth.
The major provisions of both rules, and their implications, are summarized below.
SAMHSA’s Proposed Rule
Buprenorphine and Methadone Induction Via Telehealth
- Under the proposed rule, an OTP physician, primary care physician, or authorized and supervised healthcare professional would be required to conduct an in-person examination within 14 days of a patient’s admission to the OTP. For patients admitted to the OTP for buprenorphine treatment, the proposed rule would allow the examination to be performed via audio-visual or audio-only telehealth if a qualified practitioner or primary care provider determines that the patient can be appropriately evaluated virtually.
- For patients admitted to an OTP for methadone treatment, the proposed rule would allow the examination to be performed via audio-visual telehealth if a qualified practitioner or primary care provider determines that the patient can be appropriately evaluated virtually. SAMHSA chose not to extend the audio-only telehealth option to methadone induction, due to the concern that methadone “holds a higher risk profile for sedation which may be easier to identify through an audio-visual telehealth platform.”
Methadone Take Home Dose
- In March 2020, SAMHSA released OTP guidance allowing states to request blanket exceptions for stable OTP patients to receive 28 days of take-home doses of their prescribed medication for OUD, with less stable patients to receive 14 days of take-home doses. In November 2021, SAMHSA extended the methadone take-home flexibility to one year past the end of COVID-19 PHE. This flexibility has been well received by provider and patient communities and has facilitated better access to and engagement in treatment without an associated increase in medication misuse and diversion. SAMHSA’s proposed rule suggests a permanently flexible take-home schedule as follows:
- Up to 7-day take home supply during the first 14 days of treatment;
- Up to 14-day take home supply between day 15 and 30 of treatment;
- Up to 28-day take home supply starting on day 31 of treatment.
Additional Provisions Unrelated to Telehealth
- Harm reduction has received renewed attention and funding in recent years, including $30 million to support harm reduction services under the American Rescue Plan Act (ARPA). The proposed rule offers a new, broad definition of harm reduction, which includes testing for infectious disease and distribution of opioid overdose reversal medications and requires OTPs to connect clients to such services.
- The proposed rule includes several significant changes that would remove stigmatizing language from federal regulations, including replacing “medication assisted treatment” (MAT) with “medication for opioid use disorder” (MOUD) and “detoxification treatment” with “withdrawal management.”
Should SAMHSA’s proposed rule go into effect, it would preserve the increased access to both of these life-saving medications that COVID-era flexibilities allowed. Increasing access to and use of buprenorphine as treatment for OUD during the pandemic did not cause a corresponding increase in buprenorphine-related overdose deaths, while early data has shown that “despite a near doubling of take-home methadone does during the COVID-19 exemption period, the increase in take-home doses was not associated with negative treatment outcomes in methadone-adherent clients.” Turning these PHE flexibilities into permanent policies will enable states to provide evidence-based treatment to a greater number of people and save countless lives.
DEA’s Proposed Rule
Requirements for Individual Practitioners Starting Patients on Buprenorphine via Telehealth
Under the proposed rule, in order to prescribe buprenorphine via telehealth, providers would be required to:
- Obtain a DEA dispensing registration in the state where the provider will be issuing prescriptions
- Be authorized by state law to provide telehealth services in their own state and in the state where the patient is located
- Be technically able to provide telehealth services using audio and video equipment
The proposed rule is deferential to state laws prohibiting prescribing controlled substances based on audio-only evaluations, so providers will be able to prescribe buprenorphine based on audio-only evaluations in states that permit such evaluations but will be unable to do so in states that prohibit such evaluations.
Prescription Drug Monitoring Program (PDMP) Review
- The proposed rule would require providers to review PDMP data, including any controlled substance prescriptions given to the patient within the past year, prior to prescribing buprenorphine. Providers that are unable to access PDMP data may prescribe a 7-day supply of buprenorphine. Providers are also required to review PDMP data within 7 days of providing the telehealth service and further document their attempts to access PDMP data. The DEA argues that reviewing PDMP data will allow providers to practice prudent clinical decision-making, advise patients on the risks of mixing multiple medications, and prevent patients from being prescribed multiple buprenorphine prescriptions.
Medical Evaluation Within 30 Days
- Under the proposed rule, the prescribing provider would be required to conduct an in-person evaluation of the patient who has been inducted via telehealth within 30 days of starting treatment in order to prescribe additional medication. Alternatively, the prescribing provider may virtually examine the patient using an audio-visual platform “while the patient is in the physical presence of another DEA-registered practitioner.” The DEA reasons that requiring in-person medical evaluations within 30 days of virtual buprenorphine induction will better allow providers to confirm the prescribed medication is the best form of treatment for the patient.
Recordkeeping Requirements
- DEA proposes to require practitioners to keep comprehensive records establishing the nature of the encounter, the patient’s proffered reason for the audio-only encounter, and all efforts to comply with PDMP checks.
Of concern, patients who experience barriers to accessing treatment, including those without transportation, those who are experiencing homelessness, and those who live in rural areas, will be particularly affected by the proposed DEA requirements. Similarly, audio-only telehealth services have proven significantly impactful for individuals without reliable broadband access, and this population will likely be disproportionately affected should the DEA rule go into effect. It is also important to note that buprenorphine and methadone comprise only 15% of diversion reports, compared to oxycodone and hydrocodone, which account for 67% of diversion reports. People with OUD have self-reported that they use buprenorphine without a prescription to control withdrawal symptoms and desire to use other drugs. Furthermore, increasing access to buprenorphine treatment has been shown to reduce use of the drug without a prescription.
The comment period for SAMHSA’s proposed rule closed on February 14th, 2023, and the comment period for DEA’s proposed rule will close on March 31st, 2023.
