HHS Final Rule to Solidify Access to OUD Medications via Telehealth

February 01, 2024 - The Department of Health and Human Services (HHS) will publish a final rule on February 2 that significantly expands access to medications for opioid use disorder (OUD), including allowing treatment initiation through telehealth.

This final rule updates certain provisions of regulations related to Opioid Treatment Program (OTP) accreditation, certification, and standards for treating OUD with medications. These are the first substantial changes to the rules governing OTPs in 20 years.

In March 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) released guidance on flexibilities that could be leveraged during the COVID-19 pandemic, including the provision of unsupervised methadone doses and the use of telehealth to initiate buprenorphine treatment. The final rule makes these flexibilities permanent.

The rule states that patients may be eligible for unsupervised, take-home doses of methadone based on the clinical judgment of the treating healthcare provider.

The rule further permits the initiation of buprenorphine at the OTP if authorized healthcare professionals under the supervision of a program physician determine that an adequate evaluation of the patient can be, or was, accomplished via audio-only or audio-visual telehealth technology.

The rule also permits the use of audio-visual telehealth for OTP patients receiving methadone treatment under the above stipulations.  

“This final rule represents a historic modernization of OTP regulations to help connect more Americans with effective treatment for opioid use disorders,” said Miriam E. Delphin-Rittmon, PhD, HHS assistant secretary for mental health and substance use, and leader of SAMHSA, in a press release. “While this rule change will help anyone needing treatment, it will be particularly impactful for those in rural areas or with low income for whom reliable transportation can be a challenge, if not impossible. In short, this update will help those most in need.”

But the flexibility for virtual methadone treatment does not include audio-only telehealth platforms “because methadone, in comparison to buprenorphine, holds a higher risk profile for sedation in patients presenting with mild somnolence which may be easier to identify through an audio-visual telehealth platform,” SAMHSA notes.

The agency also states that the final rule does not authorize the prescription of methadone after a telehealth visit but rather applies only to the ordering of methadone by appropriately licensed OTP practitioners and dispensed through OTPs. The final rule expands provider eligibility, allowing nurse practitioners and physician assistants to order medications in OTPs.

Additionally, the final rule updates OTP admission criteria, eliminating barriers to entry, such as the requirement that patients have a history of addiction for one year before being eligible for treatment.

The American Medication Association (AMA) applauded the final rule.

“Cementing these policies is a step in the right direction in the fight against the worsening overdose epidemic to increase equitable access to care, reduce the stigma of seeking treatment for OUD, and embrace technology in medicine,” said Bobby Mukkamala, MD, chair of the AMA Substance Use and Pain Care Task Force, in an emailed statement.

This final rule come two years after HHS announced its Overdose Prevention Strategy. In 2021, 106,699 drug overdose deaths occurred in the US, with the rate of overdose deaths increasing by 14 percent from 2020 to 2021, according to the Centers for Disease Control and Prevention (CDC).

Research shows that engaging in OUD care through telehealth was associated with a reduction in fatal drug overdoses. The study published in 2023 focused on data for 105,162 Medicare beneficiaries between September 1, 2018, and February 29, 2020, and 70,479 beneficiaries between September 1, 2019, and February 28, 2021. Researchers found that OUD care provided via telehealth was linked to a 33 percent lower risk of a fatal drug overdose.

Another 2023 study revealed that using telehealth to begin OUD treatment is linked to high retention in treatment among Medicaid beneficiaries. Researchers examined Medicaid claims and enrollment data from November 1, 2019, to December 31, 2020, for adults aged 18 to 64 in Kentucky and Ohio.

They found that the proportion of individuals who initiated buprenorphine treatment via telehealth in the second or third quarter of 2020 and continued for at least 90 days was 45 percent in Kentucky and 28.5 percent in Ohio.