This month, the U.S. Division of Well being and Human Providers (HHS) and the Substance Abuse and Psychological Well being Providers Administration (SAMHSA) took steps to increase entry to opioid use dysfunction therapy via its new ultimate rule, which features a provision that completely permits for the initiation of therapy (methadone and buprenorphine) by way of telehealth. Nonetheless, the ultimate rule narrowly applies to solely practitioners working in Opioid Remedy Packages (OTPs) and doesn’t embrace different suppliers like major care physicians and dependancy drugs specialists.
Telehealth advocates applaud HHS’ ultimate rule however say additional motion must be taken by the Drug Enforcement Administration (DEA) to extra broadly increase entry to therapy by way of telehealth. Whereas HHS and SAMHSA have jurisdiction over OTPs, the prescribing of managed substances is beneath the DEA’s jurisdiction.
OTPs are clinics licensed by a state’s well being division and require federal accreditation to dispense medication-assisted therapy (MAT) providers. The telehealth capabilities for OTPs started in the course of the Covid-19 pandemic when it was harder to hunt therapy in particular person. Underneath the ultimate rule, practitioners in OTPs can begin sufferers on methadone by way of an audio-visual telehealth appointment and begin sufferers on buprenorphine by way of an audio-only telehealth appointment. The ultimate rule doesn’t permit for an audio-only appointment for methadone as a result of, in comparison with buprenorphine, it “holds a better danger of sedation, particularly if taken by somebody who already is experiencing some drowsiness,” in accordance with the SAMHSA.
Along with the telehealth modifications, the ultimate rule additionally permits sufferers to obtain take-home doses of methadone and expands supplier eligibility to permit nurse practitioners and doctor assistants to order medicines in OTPs. It additionally eliminated standards that required sufferers to have a historical past of dependancy for a full yr earlier than being eligible for therapy.
“The better we make it for folks to entry the therapies they want, the extra lives we are able to save,” mentioned HHS Deputy Secretary Andrea Palm in a press release. “With these bulletins, we’re dramatically increasing entry to life-saving medicines and persevering with our efforts to satisfy folks the place they’re of their restoration journeys.”
What the ultimate rule doesn’t embrace is the digital prescribing of a broader vary of managed substances along with buprenorphine, resembling Adderall, Percocet and Xanax. The rule additionally doesn’t apply to a broader vary of suppliers, resembling major care suppliers, psychiatrists and digital suppliers. The DEA launched a proposed rule final yr that might roll again Covid-19 flexibilities that allowed a spread of practitioners to prescribe managed substances nearly. Nonetheless, after receiving a file variety of feedback, the company has prolonged the flexibilities via December of this yr. And now with HHS issuing this ultimate rule on OTPs, some are hoping the DEA will increase who’s eligible to offer care via telehealth and make these flexibilities everlasting.
Whereas the ultimate rule is “actually essential,” one telehealth advocate is left wanting extra.
“We hope that this forward-looking entry to care that’s been achieved via this ultimate rule shall be one thing that’s taken up by the DEA, working along with SAMHSA on this broader overarching coverage that we nonetheless don’t have a everlasting basis for. … SAMHSA has utilized classes realized to make sure applicable ranges of entry for these sufferers who will go to therapy facilities,” mentioned Kyle Zebley, senior vp of public coverage on the American Telemedicine Affiliation, in an interview. He added that he hopes the DEA “exceeds” what SAMHSA has performed with regards to the digital prescribing of managed substances.
One supplier who shouldn’t be affected by HHS’ rule and is awaiting course from the DEA is Bicycle Well being. The Boston-based telehealth firm at present affords entry to buprenorphine and treats sufferers throughout 32 states.
Dr. Brian Clear, chief medical officer of the corporate, mentioned “it’s about time” that the HHS ultimate rule was handed, however famous that there are limitations. In March of 2021, there have been simply 1,816 OTPs within the U.S., in accordance with Pew Charitable Trusts. That simply barely scratches the floor of the necessity with regards to opioid use dysfunction.
Clear argued that HHS and SAMHSA’s rulemaking is predicated on proof from major care suppliers and applications like Bicycle Well being that reveals digital prescribing of buprenorphine is secure and efficient. Due to this fact, it might be “absurd” if the DEA decides suppliers like Bicycle Well being can’t additionally prescribe therapy nearly.
One other digital opioid use dysfunction supplier additionally cheered the ultimate rule whereas echoing Clear and Zebley on its limitations.
“There are important methods wherein this ultimate rule will help increase entry to OTP providers, however challenges additionally stay for sufferers who need or want low-barrier entry to medication-based therapy for SUD,” mentioned Ben Maclean, common counsel at Portland, Oregon-based Boulder Care.
What particularly ought to the DEA do to increase entry?
Zebley of the American Telemedicine Affiliation mentioned the company ought to create a particular registration course of that permits medical professionals to register with the company to be able to nearly prescribe managed substances. Congress mandated the DEA to create this course of again in 2008, however the company has but to take action.
Zebley mentioned it’s “harmful to make too many predictions” about whether or not the DEA will comply with HHS’ footsteps. Nonetheless, he famous that the digital prescribing of managed substances has now been allowed for 4 years. By the point the extension ends in December, it’ll be simply shy of 5 years.
“Why would we throw the door again up, gates again up, construct that wall again up and depart loads of weak sufferers out within the chilly? I do assume it’s a life or demise circumstance for some,” he mentioned. “Some People receiving care now may have their continuity of care severed and a few People sooner or later won’t ever have this chance to have that degree of entry to care that they want when and the place they want it.”
Picture: sorbetto, Getty Photographs
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