28 February 2023 • 8 minute read
SAMHSA updates opioid treatment program standards, including telehealth, and proposes removing “x” waivers to prescribe buprenorphine
The HHS Substance Abuse and Mental Health Services Administration (SAMHSA) recently proposed to modify certain provisions of 42 C.F.R. Part 8 to update Opioid Treatment Program (OTP) accreditation, certification, and treatment standards for the provision of medications for opioid use disorder (OUD).
In addition to these proposals, issued in December 2022, SAMHSA also issued a supplemental proposal in February 2023 to eliminate the requirement for qualified practitioners to obtain an “X” waiver in order to prescribe certain schedule III-V medications for the treatment of OUDs, including buprenorphine.
December 2022 proposal
Pandemic flexibilities made permanent and updated standards
SAMHSA acknowledges that the recent COVID-19 Public Health Emergency (PHE) permitted flexibilities in the provision of unsupervised doses of methadone and the use of telehealth in initiating buprenorphine as the first substantial changes to OTP treatment and medication delivery in over 20 years. It further found that these flexibilities facilitated access to treatment and eliminated criteria that promoted stigma and discouraged people from accessing care from OTPs. The December 2022 proposed rule would make those flexibilities permanent and also update standards to reflect an accreditation and treatment environment that has evolved since 42 C.F.R. Part 8 went into effect in 2001.
Among these changes are updates to admission criteria to remove significant barriers to entry, such as the one-year requirement for OUD. This one-year requirement mandated that the person be currently addicted to an opioid drug and that the person became addicted at least one year before admission for treatment. SAMHSA also proposes new definitions to expand access to evidence-based practices and removes and replaces the term “detoxification” and corresponding definitions and standards for short- and long-term detoxification. This would be replaced with “withdrawal management.” This term is defined as the dispensing of medications for OUD in decreasing doses to an individual to alleviate physical effects incident to withdrawal from the continuous or sustained use of an opioid and as a method of bringing the individual to an opioid-free state within such period; long-term withdrawal management refers to the process of medication tapering that exceeds 30 days.
SAMHSA proposes additional changes that it views as consistent with modern treatment standards since these changes allow for greater flexibility in creating plans of care that promote recovery activities such as employment, while also eliminating the barrier of frequent visits for individuals without access to reliable transportation. These include the removal of consideration of the length of time an individual has been in treatment, as well as rigid reliance on toxicology testing results that demonstrate complete and sustained abstinence from all substances prone to misuse. Further, if permitted by the treating provider, patients may be eligible for unsupervised, take-home doses of methadone upon entry into treatment.
According to SAMHSA, accreditation and certification standards would be modified to codify the use of online/electronic forms, to eliminate types of certifications that are no longer in use, and to update existing types of certifications in a manner that reflects established practice.
Prescribing via telehealth
Recognizing that the pandemic spurred use of telemedicine for the treatment of OUD using buprenorphine, a schedule III partial opioid receptor agonist, SAMHSA implemented various OTP regulatory flexibilities designed to help address the impact of the COVID-19 pandemic on OTPs and their patients. These included exempting OTPs from the requirement to perform an in-person physical evaluation for any patient who will be treated by the OTP with buprenorphine if a program physician, primary care physician, or an authorized healthcare professional under the supervision of a program physician, determines that an adequate evaluation of the patient can be accomplished via telehealth.
Since SAMHSA views the escalating overdose crisis and an increasing need to reach remote and underserved communities to be of paramount importance, it is proposing to make the buprenorphine telehealth flexibility permanent. Note: This does not impact whether the Drug Enforcement Administration (DEA) will continue to permit prescribing of schedule II-V controlled substances to new patients without an in-person visit when the PHE expires on May 11, 2023; nor will it supersede any state restrictions on the prescribing of controlled substances via telehealth.
The proposal makes permanent buprenorphine initiation criteria by OTPs via audio-only or audio-visual telehealth technology if an OTP physician, primary care physician, or an authorized healthcare professional under the supervision of a program physician, determines that an adequate evaluation of the patient can be accomplished via telehealth. The proposal would also permit the use of audio-visual telehealth for any new patient who will be treated by the OTP with methadone if a program physician or an authorized healthcare professional under the supervision of a program physician determines that an adequate evaluation of the patient can be accomplished via audio-visual telehealth platform.
SAMHSA specifically declined to extend this change to the use of audio-only telehealth platforms in assessing new patients who will be treated with methadone because it found that in comparison to buprenorphine, methadone holds a higher risk profile for sedation in certain patients that would be easier to identify through an audio-visual telehealth platform. SAMHSA also declined to make the proposal applicable to the prescription of methadone available pursuant to a telehealth visit. Instead, SAMHSA would permit ordering of methadone by appropriately licensed OTP practitioners and dispensed to the individual patient by the OTP under existing OTP procedures (SAMHSA refers to this as “take home” use). In the proposed rule, SAMHSA also reminds health care providers who receive Federal financial assistance to remember obligations to ensure that audio-only and audio-visual telehealth platforms are accessible to individuals with disabilities and afford an opportunity for meaningful access for limited English proficient individuals.
February 2023 proposal
Elimination of “X” waivers
Since 2016, qualified practitioners who intended to prescribe buprenorphine and other medications for the treatment of OUDs had to obtain an “X” waiver from SAMHSA. The “X” waiver was previously required for qualified practitioners to prescribe buprenorphine to treat patients with OUD; further, there were limits on the number of patients a prescriber could treat for OUD with buprenorphine.
SAMHSA’s proposed changes related to the “X” waiver remove the regulatory requirements and references associated with the “X” waiver. Even though HHS has not finalized its proposal yet, SAMHSA has already operationalized the elimination of “X” waivers as its website states that effective immediately, SAMHSA will no longer be accepting notices of intent to file “X” waiver applications. However, DEA guidance notes that there will be training requirements for buprenorphine prescribers that will go into effect in June 2023. Comments to this February proposal are due on or before March 14, 2023.
Impacts
As noted above, whether the DEA would continue to permit schedule II-V controlled substances prescribing without an in-person visit once the PHE ends is separate and apart from the SAMHSA proposal. While stakeholders urge the DEA to release proposed rules for the Special Registration for Telemedicine that would exempt telemedicine providers from DEA in-person visit requirements as soon as possible, the DEA has not yet done so (at least as of the date of this publication/alert).
Healthcare providers should carefully review their online prescribing practices to ensure continued compliance with DEA requirements in effect when the PHE expires as well as applicable state laws addressing the prescribing of medications. The SAMHSA proposal is only applicable to an OTP’s initiation of buprenorphine (audio-only or audio-visual) and methadone (audio-visual) treatment for new patients if the program physician, primary care physician, or an authorized healthcare professional under the supervision of a program physician, determines that an adequate evaluation of the patient can be accomplished via telehealth.
SAMHSA notes in the December proposal that as of June 2022, there are over 1,920 OTPs in the US, providing care to over 650,000 patients; further, practitioners treating OUD and the OTPs in which they practice must continuously adapt to evolving patterns of drug misuse, which has been complicated over the past 40 years by rapid changes in prescribing practices, supply chains, and patterns of drug use. Pandemic-exacerbated substance misuse and overdose death brought on through isolation, anxiety, and reduced access to resources, along with the rise in fentanyl use/exposure and concurrent substance misuse are cited by SAMHSA as some of the key reasons for these changes.
While it appears that both proposals are meant to provide increased flexibility and update standards to reflect a changed OUD accreditation and treatment environment, OUD practitioners and OTPs should closely review these proposed changes and ensure their compliance programs are aligned appropriately. Practitioners and OTPs should also continue to monitor related federal and state laws regarding the prescribing of controlled substances via telehealth to ensure that their practices continue to comply with applicable law, particularly following the expiration of the PHE.
For more information about these recent proposals, please contact your DLA Piper relationship partner, the authors of this alert, or any member of our healthcare industry group.
In addition to these proposals, issued in December 2022, SAMHSA also issued a supplemental proposal in February 2023 to eliminate the requirement for qualified practitioners to obtain an “X” waiver in order to prescribe certain schedule III-V medications for the treatment of OUDs, including buprenorphine.
December 2022 proposal
Pandemic flexibilities made permanent and updated standards
SAMHSA acknowledges that the recent COVID-19 Public Health Emergency (PHE) permitted flexibilities in the provision of unsupervised doses of methadone and the use of telehealth in initiating buprenorphine as the first substantial changes to OTP treatment and medication delivery in over 20 years. It further found that these flexibilities facilitated access to treatment and eliminated criteria that promoted stigma and discouraged people from accessing care from OTPs. The December 2022 proposed rule would make those flexibilities permanent and also update standards to reflect an accreditation and treatment environment that has evolved since 42 C.F.R. Part 8 went into effect in 2001.
Among these changes are updates to admission criteria to remove significant barriers to entry, such as the one-year requirement for OUD. This one-year requirement mandated that the person be currently addicted to an opioid drug and that the person became addicted at least one year before admission for treatment. SAMHSA also proposes new definitions to expand access to evidence-based practices and removes and replaces the term “detoxification” and corresponding definitions and standards for short- and long-term detoxification. This would be replaced with “withdrawal management.” This term is defined as the dispensing of medications for OUD in decreasing doses to an individual to alleviate physical effects incident to withdrawal from the continuous or sustained use of an opioid and as a method of bringing the individual to an opioid-free state within such period; long-term withdrawal management refers to the process of medication tapering that exceeds 30 days.
SAMHSA proposes additional changes that it views as consistent with modern treatment standards since these changes allow for greater flexibility in creating plans of care that promote recovery activities such as employment, while also eliminating the barrier of frequent visits for individuals without access to reliable transportation. These include the removal of consideration of the length of time an individual has been in treatment, as well as rigid reliance on toxicology testing results that demonstrate complete and sustained abstinence from all substances prone to misuse. Further, if permitted by the treating provider, patients may be eligible for unsupervised, take-home doses of methadone upon entry into treatment.
According to SAMHSA, accreditation and certification standards would be modified to codify the use of online/electronic forms, to eliminate types of certifications that are no longer in use, and to update existing types of certifications in a manner that reflects established practice.
Prescribing via telehealth
Recognizing that the pandemic spurred use of telemedicine for the treatment of OUD using buprenorphine, a schedule III partial opioid receptor agonist, SAMHSA implemented various OTP regulatory flexibilities designed to help address the impact of the COVID-19 pandemic on OTPs and their patients. These included exempting OTPs from the requirement to perform an in-person physical evaluation for any patient who will be treated by the OTP with buprenorphine if a program physician, primary care physician, or an authorized healthcare professional under the supervision of a program physician, determines that an adequate evaluation of the patient can be accomplished via telehealth.
Since SAMHSA views the escalating overdose crisis and an increasing need to reach remote and underserved communities to be of paramount importance, it is proposing to make the buprenorphine telehealth flexibility permanent. Note: This does not impact whether the Drug Enforcement Administration (DEA) will continue to permit prescribing of schedule II-V controlled substances to new patients without an in-person visit when the PHE expires on May 11, 2023; nor will it supersede any state restrictions on the prescribing of controlled substances via telehealth.
The proposal makes permanent buprenorphine initiation criteria by OTPs via audio-only or audio-visual telehealth technology if an OTP physician, primary care physician, or an authorized healthcare professional under the supervision of a program physician, determines that an adequate evaluation of the patient can be accomplished via telehealth. The proposal would also permit the use of audio-visual telehealth for any new patient who will be treated by the OTP with methadone if a program physician or an authorized healthcare professional under the supervision of a program physician determines that an adequate evaluation of the patient can be accomplished via audio-visual telehealth platform.
SAMHSA specifically declined to extend this change to the use of audio-only telehealth platforms in assessing new patients who will be treated with methadone because it found that in comparison to buprenorphine, methadone holds a higher risk profile for sedation in certain patients that would be easier to identify through an audio-visual telehealth platform. SAMHSA also declined to make the proposal applicable to the prescription of methadone available pursuant to a telehealth visit. Instead, SAMHSA would permit ordering of methadone by appropriately licensed OTP practitioners and dispensed to the individual patient by the OTP under existing OTP procedures (SAMHSA refers to this as “take home” use). In the proposed rule, SAMHSA also reminds health care providers who receive Federal financial assistance to remember obligations to ensure that audio-only and audio-visual telehealth platforms are accessible to individuals with disabilities and afford an opportunity for meaningful access for limited English proficient individuals.
February 2023 proposal
Elimination of “X” waivers
Since 2016, qualified practitioners who intended to prescribe buprenorphine and other medications for the treatment of OUDs had to obtain an “X” waiver from SAMHSA. The “X” waiver was previously required for qualified practitioners to prescribe buprenorphine to treat patients with OUD; further, there were limits on the number of patients a prescriber could treat for OUD with buprenorphine.
SAMHSA’s proposed changes related to the “X” waiver remove the regulatory requirements and references associated with the “X” waiver. Even though HHS has not finalized its proposal yet, SAMHSA has already operationalized the elimination of “X” waivers as its website states that effective immediately, SAMHSA will no longer be accepting notices of intent to file “X” waiver applications. However, DEA guidance notes that there will be training requirements for buprenorphine prescribers that will go into effect in June 2023. Comments to this February proposal are due on or before March 14, 2023.
Impacts
As noted above, whether the DEA would continue to permit schedule II-V controlled substances prescribing without an in-person visit once the PHE ends is separate and apart from the SAMHSA proposal. While stakeholders urge the DEA to release proposed rules for the Special Registration for Telemedicine that would exempt telemedicine providers from DEA in-person visit requirements as soon as possible, the DEA has not yet done so (at least as of the date of this publication/alert).
Healthcare providers should carefully review their online prescribing practices to ensure continued compliance with DEA requirements in effect when the PHE expires as well as applicable state laws addressing the prescribing of medications. The SAMHSA proposal is only applicable to an OTP’s initiation of buprenorphine (audio-only or audio-visual) and methadone (audio-visual) treatment for new patients if the program physician, primary care physician, or an authorized healthcare professional under the supervision of a program physician, determines that an adequate evaluation of the patient can be accomplished via telehealth.
SAMHSA notes in the December proposal that as of June 2022, there are over 1,920 OTPs in the US, providing care to over 650,000 patients; further, practitioners treating OUD and the OTPs in which they practice must continuously adapt to evolving patterns of drug misuse, which has been complicated over the past 40 years by rapid changes in prescribing practices, supply chains, and patterns of drug use. Pandemic-exacerbated substance misuse and overdose death brought on through isolation, anxiety, and reduced access to resources, along with the rise in fentanyl use/exposure and concurrent substance misuse are cited by SAMHSA as some of the key reasons for these changes.
While it appears that both proposals are meant to provide increased flexibility and update standards to reflect a changed OUD accreditation and treatment environment, OUD practitioners and OTPs should closely review these proposed changes and ensure their compliance programs are aligned appropriately. Practitioners and OTPs should also continue to monitor related federal and state laws regarding the prescribing of controlled substances via telehealth to ensure that their practices continue to comply with applicable law, particularly following the expiration of the PHE.
For more information about these recent proposals, please contact your DLA Piper relationship partner, the authors of this alert, or any member of our healthcare industry group.
