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 last rule updating the laws relating to Opioid Remedy Applications (OTPs) as a part of the Biden Administration’s Overdose Prevention Technique. These introduced modifications are the primary replace to the OTP laws in over 20 years and considerably enhance entry to medicines 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 residence.

What are OTPs?

OTPs present medicine assisted therapy (MAT) for individuals identified with opioid use dysfunction (OUD). MAT makes use of medicines (usually methadone or buprenorphine) with psychosocial counseling and different behavioral well being companies to deal with sufferers. OTPs are generally referred to as methadone clinics as a result of these clinics are the one manner individuals can entry methadone therapy for opioid use dysfunction. OTPs could exist in quite a lot of settings together with intensive outpatient packages, residential packages, 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 potential 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 Last Rule change?

The ultimate rule updates OTP certificates and accreditation requirements, therapy requirements associated to medicines 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 modifications together with the rationale for these modifications.

Flexibility of Methadone Medicine 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 modifications. These flexibilities have been scheduled to sundown one yr previous the top of the COVID-19 Public Well being Emergency (PHE) (Could 11, 2024) or till a last rule was revealed.

This last rule created a everlasting possibility 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 could use their discretion to dispense medicines 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 could have a take-home provide as much as 28 days.

Flexibility to Prescribe Medicine for OUD by way of Telehealth with out an Preliminary In-person Bodily Analysis

In April 2020, SAMHSA applied regulatory flexibilities to handle the affect 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 Could 9, 2023, SAMHSA prolonged this telehealth flexibility till one yr previous the top of the COVID-19 PHE, or till such time that SAMHSA revealed a last rule.

This last rule permits an OTP practitioner to provoke therapy of methadone or buprenorphine by way of telehealth with out an preliminary in-person examination. The ultimate rule states that if sure practitioners, together with the OTP doctor, major care doctor, or different licensed well being care skilled beneath the supervision of program doctor determines that an analysis of the affected person may be completed by way of audio visible know-how, then a licensed OTP practitioner could prescribe and dispense methadone or buprenorphine to the affected person. Importantly, within the rule commentary, SAMHSA notes it’s not extending the usage of audio-only telehealth know-how to methadone as a result of methadone holds the next threat profile for sedation. If audio-visual know-how will not be 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 medicines. These further necessities considerably restrict the usefulness of audio-only know-how for the prescription of methadone.

SAMHSA notes that this last rule doesn’t authorize the prescription of methadone by way of 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 beneath current 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 yr historical past of OUD earlier than having the ability to entry therapy at an OTP. Second, this last rule removes the requirement that sufferers beneath the age of 18 have two unsuccessful makes an attempt at therapy earlier than getting into therapy at an OTP.

Scope of Observe Enlargement

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 medicines for opioid use dysfunction.” This implies, topic to state legal guidelines, many extra forms of non-physician practitioners similar to nurse practitioners or doctor assistant could prescribe or order medicine. Nevertheless, some states could not enable non-physician practitioners similar to licensed nurse-midwives, nurse practitioner, doctor assistants, or pharmacists to prescribe these medicines.

Influence of the Last Rule

These elevated flexibilities will vastly enhance affected person’s entry to life-saving OTP companies. Particularly, the modifications relating to methadone prescribing are an important step ahead in permitting sufferers entry to this necessary medicine. Whereas these modifications solely apply to the OTP regulatory scheme, the introduction of take-home medicines, the power to prescribe medicine by means of telehealth, modifications to admission standards, and increasing the scope of practitioners will enable OTPs to entry extra sufferers in a discipline that desperately wants extra suppliers.

Foley is right here that will help you deal with the short- and long-term impacts within the wake of regulatory modifications. We now have the sources that will help you navigate these and different necessary authorized issues associated to enterprise operations and industry-specific points. Please attain out to the authors, your Foley relationship accomplice, or to our Well being Care Observe Group with any questions.