On February 1, 2024, the Substance Abuse and Psychological Well being Companies Administration (SAMHSA), U.S. Division of Well being and Human Companies, introduced a closing rule updating the rules relating to Opioid Therapy Applications (OTPs) as a part of the Biden Administration’s Overdose Prevention Technique. These introduced adjustments are the primary replace to the OTP rules in over 20 years and considerably enhance entry to drugs like methadone and buprenorphine that deal with opioid use dysfunction by, amongst different issues, making everlasting prescribing of “take-home” doses and enabling use of telemedicine to increase OTPs to a affected person’s dwelling.
What are OTPs?
OTPs present medicine assisted therapy (MAT) for folks recognized with opioid use dysfunction (OUD). MAT makes use of drugs (sometimes methadone or buprenorphine) with psychosocial counseling and different behavioral well being companies to deal with sufferers. OTPs are typically known as methadone clinics as a result of these clinics are the one means folks can entry methadone therapy for opioid use dysfunction. OTPs might exist in a wide range of settings together with intensive outpatient applications, residential applications, and hospitals, however all OTPs require a selected license certification by SAMHSA, and accreditation by an unbiased, SAMHSA-approved accrediting physique. The OTP mannequin has been criticized as too burdensome in limiting a affected person’s means to simply entry life-saving medicine and coverings for OUD. The prior requirement that methadone solely be prescribed at these clinics and the prior restriction on unsupervised or take-home doses of medicines used to deal with OUD have traditionally required sufferers to make each day visits to an OTP, even within the outpatient setting.
What did the Ultimate Rule change?
The ultimate rule updates OTP certificates and accreditation requirements, therapy requirements associated to drugs disbursed by an OTP and eliminated language relating to the DATA Waiver. The DATA Waiver requirement was eliminated in January 2023. SAMHSA additionally launched a desk summarizing key adjustments together with the rationale for these adjustments.
Flexibility of Methadone Remedy Take-Dwelling Doses in OTPs
In March 2020, because of the COVID-19 Pandemic, SAMHSA issued exemptions permitting OTPs to dispense as much as 28 days of “take-home methadone doses for secure sufferers being handled for OUD and as much as 14 doses of “take-home” methadone for “much less secure” sufferers. Initially meant to cut back the chance of spreading COVID-19, OTPs and sufferers extensively supported these adjustments. These flexibilities had been scheduled to sundown one 12 months previous the top of the COVID-19 Public Well being Emergency (PHE) (Might 11, 2024) or till a closing rule was printed.
This closing rule created a everlasting choice permitting take-home medicine together with methadone, buprenorphine, buprenorphine mixture productions, and Naltrexone. First, the rule permits sufferers to have the ability to entry take-home medicine doses for days when the clinic is closed. Past these doses, the OTP practitioner might use their discretion to dispense drugs to sufferers for OUD topic to sure maximums. Throughout the first 14 days of therapy, the take-home provide is proscribed to most provide of seven days’ value of take-home medicine. Between 15-30 days of therapy, the take-home provide most is elevated to 14 days. Lastly, after 31 days, the affected person might have a take-home provide as much as 28 days.
Flexibility to Prescribe Remedy for OUD through Telehealth with out an Preliminary In-person Bodily Analysis
In April 2020, SAMHSA applied regulatory flexibilities to handle the impression of the COVID-19 pandemic together with exempting OTPs from the requirement to carry out an in-person bodily analysis for sufferers being handled with buprenorphine in an OTP. Notably, this flexibility didn’t apply to methadone. On Might 9, 2023, SAMHSA prolonged this telehealth flexibility till one 12 months previous the top of the COVID-19 PHE, or till such time that SAMHSA printed a closing rule.
This closing rule permits an OTP practitioner to provoke therapy of methadone or buprenorphine through telehealth with out an preliminary in-person examination. The ultimate rule states that if sure practitioners, together with the OTP doctor, main care doctor, or different approved well being care skilled below the supervision of program doctor determines that an analysis of the affected person could be completed through audio visible expertise, then a licensed OTP practitioner might prescribe and dispense methadone or buprenorphine to the affected person. Importantly, within the rule commentary, SAMHSA notes it isn’t extending using audio-only telehealth expertise to methadone as a result of methadone holds a better threat profile for sedation. If audio-visual expertise isn’t out there, an audio-only machine could also be used to prescribe methadone however solely when affected person is within the presence of a licensed practitioner who’s registered to prescribe and dispense managed drugs. These further necessities considerably restrict the usefulness of audio-only expertise for the prescription of methadone.
SAMHSA notes that this closing rule doesn’t authorize the prescription of methadone through telehealth exterior the OTP context Methadone should nonetheless be prescribed and disbursed by appropriately licensed OTP practitioners. Moreover, any medicine should nonetheless be disbursed to the affected person below present OTP procedures.
Admission Standards Modifications
Moreover, the ultimate rule eliminated stringent admission standards that prevented sufferers from initially accessing therapy. First, the ultimate rule eliminated the requirement that sufferers have a full 12 months historical past of OUD earlier than having the ability to entry therapy at an OTP. Second, this closing rule removes the requirement that sufferers below the age of 18 have two unsuccessful makes an attempt at therapy earlier than getting into therapy at an OTP.
Scope of Apply Growth
On the federal stage, the definition of practitioner was modified to incorporate any “well being care skilled who’s appropriately licensed by the state to prescribe and/or dispense drugs for opioid use dysfunction.” This implies, topic to state legal guidelines, many extra varieties of non-physician practitioners equivalent to nurse practitioners or doctor assistant might prescribe or order medicine. Nonetheless, some states might not enable non-physician practitioners equivalent to licensed nurse-midwives, nurse practitioner, doctor assistants, or pharmacists to prescribe these drugs.
Impression of the Ultimate Rule
These elevated flexibilities will vastly enhance affected person’s entry to life-saving OTP companies. Particularly, the adjustments relating to methadone prescribing are an important step ahead in permitting sufferers entry to this vital medicine. Whereas these adjustments solely apply to the OTP regulatory scheme, the introduction of take-home drugs, the flexibility to prescribe medicine by way of telehealth, adjustments to admission standards, and increasing the scope of practitioners will enable OTPs to entry extra sufferers in a subject that desperately wants extra suppliers.
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