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5 Improving Access to Quality Treatment in Opioid Treatment Programs through Regulatory Innovation
Pages 45-58

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From page 45...
... . • Layer upon layer of regulations and accreditation standards have resulted in opioid treatment programs (OTPs)
From page 46...
... During the online open discussion period, Susan Staats Combs agreed, noting that many OTPs work earnestly to reduce stigma and help patients with an array of issues that led them to the clinic in the first place. "We help patients in every facet of their life," she added.
From page 47...
... Among these innovations, pharmacy-based dispensing, mobile units, and expanding the reach of the OTP as a hub site are discussed in this chapter. FEDERAL STATUTES AND REGULATIONS THAT GOVERN OPIOID TREATMENT PROGRAMS The regulatory structures that surround policy issues presented by OUD and other pressing social problems start with the statutes produced by Congress, said Bridget Dooling, research professor with the George Washington University Regulatory Studies Center.
From page 48...
... As Yngvild Olsen described in Chapter 4, at the beginning of the pandemic, SAMHSA issued a modification to the rule that allowed states to request exceptions allowing stable patients to receive 28 days of take-home doses and less stable patients to receive 14 days of take-home doses if the OTP believed the patient could handle these take-homes safely. The definition of "stable" and "less stable" were left open to interpretation, said Dooling.
From page 49...
... Robert Schwartz, a senior research scientist at Friends Research Institute, said an underused and often overlooked aspect of current OTP regulations is the possibility for an OTP to act as a hub, with pharmacies, physician offices, mobile units, or other "medication units" to serve as spokes. Moreover, as Schwartz noted, dispensing and administering medication is explicitly what pharmacies do extremely well, adding that they are experienced in maintaining, storing, and accounting for doses of controlled substances.
From page 50...
... NOTE: OA-MAT = opioid agonist medication-assisted treatment; OTP = opioid treatment program. SOURCES: Presented by Li-Tzy Wu, March 4, 2022; adapted from Jones et al., 2015.
From page 51...
... Brooner added that it will be important to work with Medicaid, Medicare, and commercial insurers to recognize prescribed methadone for OUD as an accepted benefit in pharmacy coverage plans. Wu discussed another pilot study in which the prescribing OTP physician provides remote supervision of the patient's care, plus electronic prescribing, through a collaborative practice agreement.
From page 52...
... The pilot study had three components: a collaborative practice agreement between the pharmacists and OTP physicians, electronic prescribing of methadone from the OTP physician to the pharmacy, and a methadone visit checklist to document pharmacist-provided intervention and check fidelity. After receiving exemption approval from DEA, SAMHSA, and the North Carolina State Opioid Treatment Authority to allow prescribing of methadone, and from the Duke Health IRB to undertake the study, 20 patients were enrolled in the 3-month study.
From page 53...
... To receive services at the mobile vans, individuals must meet MATI eligibility requirements, including low income and a history of injectable drug use, opioid dependence within the past year, or a positive test for opioids, said Mielke. They also cannot be enrolled concurrently in another opioid medication treatment program or be under the care of a prescriber of suboxone, she added.
From page 54...
... About 1,400 of these individuals have been released from the correctional facility on MOUD and 82 percent of those individuals continued treatment at a brick-and-mortar clinic site after release, she said. New Jersey's experience with mobile vans suggests that other states can consider initiating low-threshold, low-demand access programs such as in areas where individuals who are homeless gather or where individuals have difficulty accessing treatment, or in rural settings, said Mielke.
From page 55...
... He added that one of these spokes could provide access to treatment in correctional facilities if the facility wishes to engage in that opportunity, similar to the Project Kickstart program in New Jersey that Mielke mentioned. To enable any of these innovations, SAMHSA and the state opioid treatment authorities will need to work collaboratively, said Parrino, because some of the challenges lie within the states.
From page 56...
... But hospitals, skilled nursing facilities, rehabilitation centers, and other entities cannot initiate MOUD unless they have specific authority to do so, said Parrino. Changing this would require DEA to work in conjunction with SAMHSA to modify the regulations on how they provide oversight, he said.
From page 57...
... AATOD has also recommended the use of telehealth induction of methadone through OTPs. Mielke agreed, noting that the expanded use of telehealth during the pandemic as well as relaxation of the frequency of urine drug screens resulted in more patients accessing OTP services and staying in treatment.


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