On December 13, the U.S. Department of Health and Human Services (HHS), through its Substance Abuse and Mental Health Services Administration (SAMHSA), proposed to expand access to treatment for opioid use disorder (OUD).
This is very good news for patients, providers, and other stakeholders. Here is the informational statement from SAMHSA. At the end of the article, find more comments from stakeholders.
Key to the proposal: OTPs stay in charge of treatment.
The proposal would update the federal regulations that oversee OUD treatment standards as part of HHS’ Overdose Prevention Strategy that supports President Biden’s National Drug Control Strategy – a whole-of-government approach to beat the overdose epidemic. Specifically, the proposed rule change would allow Americans to access the treatment by allowing take home doses of methadone and the use of telehealth in initiating buprenorphine at opioid treatment programs (OTPs).
In its Notice of Proposed Rulemaking (NPRM) to update 42 CFR Part 8, SAMHSA is proposing to improve Americans’ access to and experiences with OUD treatment, in particular through OTPs. The proposed changes reflect the widespread desire by many stakeholders for SAMHSA to provide greater autonomy to OTP practitioners, positively support recovery, and continue flexibilities that were extended at the start of the nation’s COVID-19 public health emergency.
“These proposed updates would address longstanding barriers treatment in regulations – most of which have not been revised in more than 20 years,” said Miriam E. Delphin-Rittmon, the HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA. “I am committed to moving these forward as quickly as possible because we have heard from both providers and patients how urgent the need is for treatment.”
According to Centers for Disease Control and Prevention (CDC) data, more than 107,000 Americans died from drug overdoses in 2021, an increase of more than 15 percent from 2020. These updates could help reduce overdose deaths.
SAMHSA proposes to update Part 8 by removing stigmatizing or outdated language; supporting a more patient-centered approach; and reducing barriers to receiving care. For example, in March and April 2020, SAMHSA published flexibilities for the provision of take-home doses of methadone and for the use of telehealth in initiating buprenorphine in OTPs. Patients deemed stable by physicians have been able to take home up to 28 days’ worth of methadone doses; other patients – again, so determined by their physicians – received up to a 14-day supply. A recent study showed that patients who received increased take-home doses after federal flexibilities were enacted during COVID-19 saw positive impacts on their recovery, including being more likely to remain in treatment and less likely to use illicit opioids.1
These flexibilities represented the first substantial change to OTP treatment standards in more than 20 years. Under the NPRM for Part 8, SAMHSA proposes to make these flexibilities permanent.
SAMHSA’s proposed changes also would update standards to reflect an OTP accreditation and treatment environment that has evolved since Part 8 went into effect in 2001. Accordingly, SAMHSA proposes updates that reflect evidence-based practice, language that aligns with current medical terminology, effective patient engagement approaches, and the workforce providing services in OTPs, including:
• expanding the definition of an OTP treatment practitioner to include any provider who is appropriately licensed to dispense and/or prescribe approved medications. The current Part 8 rule defines a practitioner as being: “a physician who is appropriately licensed by the State to dispense covered medications and who possesses a waiver under 21 U.S.C.823(g)(2).” During the COVID-19 public health emergency, this has been formally expanded to align with broader definitions of a practitioner (nurse practitioners, physician assistants, etc.), and OTPs reported that this change was essential in supporting workflow and access;
- adding evidence-based delivery models of care such as split dosing, telehealth and harm reduction activities
- removing such outdated terms as “detoxification”;
- updating criteria for provision of take-home doses of methadone;
- strengthening the patient-practitioner relationship through promotion of shared and evidence-based decision-making;
- allowing for early access to take-home doses of methadone for all patients, to promote flexibility in creation of plans of care that facilitate such everyday needs as employment, while also affording people with unstable access to reliable transportation the opportunity to also receive treatment; likewise, promoting mobile medication units to expand an OTP’s geographic reach; and
- reviewing OTP accreditation standards.
To facilitate expansion of access to care, SAMHSA proposes to update OTP admission criteria in Part 8. This includes removal of the one-year requirement for opioid addiction before admission to an OTP, in favor of considering a person’s problematic patterns of opioid use. In conjunction with updated standards that include extended take-home doses of methadone and access to telehealth, these changes are likely to expand access while also improving retention in treatment. The NPRM also proposes to eliminate the requirement that practitioners who have a waiver to prescribe buprenorphine for up to 275 patients provide reports to SAMHSA on an annual basis.
The NPRM also promotes the chronic disease model of management, while removing barriers to providing individualized care. “Removing these barriers promotes patient trust and reduces the need for individuals to attend an OTP each day to receive treatment services,” said Assistant Secretary Delphin-Rittmon. “In this way, the proposed changes to Part 8 are focused on the individual and their treatment environment.”
Under the guidance of president Mark Parrino, AATOD has long fought for such changes. The continued involvement of OTPs making clinical decisions in opening up more methadone treatment is crucial. AATOD and OTPs have opposed the Opioid Treatment Access Act (OTAA), a bill which, if passed, would allow office-based physicians to prescribe methadone for OUD without any involvement of OTPs (see https://atforum.com/2022/11/otp-pressure-oota/).
“AATOD is extremely grateful to SAMHSA’s leadership in responding to our request to provide greater clinical flexibility in making patient centered decisions in the OTPs,” Parrino told AT Forum. “We have advocated for these changes in our public policy statements and in numerous discussions with SAMHSA representatives,” he said. “Providing these flexibilities comes at an extremely important time for OTPs as we treat a greater number of patients using fentanyl as they are admitted to treatment. I know that OTP clinicians are accelerating dosage induction schedules to the extent that they can do so safely. In our judgement, these flexibilities will provide greater opportunity for patients to enter and remain in treatment. SAMHSA has been extremely thoughtful in creating these changes and we believe that this will advance the work of our field. We enthusiastically support the balance of these new proposals and encourage the states to follow suit. We certainly hope that state regulatory policies will evolve to be in greater alignment with SAMHSA’s regulatory provisions as a method of moving our field forward.”
The National Association for Behavioral Health (NABH), which, like AATOD, includes OTPs among its membership, also expressed unconditional support for the NPRM. “We are very pleased with this tremendous effort by SAMHSA to expand access to opioid treatment services,” said Sarah A. Wattenberg, director of quality and addiction services at NABH. “We are especially gratified to see the revisions related to permitting the use of audio-visual telehealth for new patients treated with methadone. NABH has long advocated for this change, as well as many of the other revisions that were included in the proposed rule. OTPs want to expand access to care but want broadened access to take place in a thoughtful and measured manner; we think this is achieved with the new revisions.”
Initial doses would still be low. “The regulation of an initial dose of methadone remains at 30 mg, not to exceed 40 mg on the first day, with the incorporation of a provision for higher doses if clinically indicated and documented in the patient’s record,” according to the NPRM.
One thing hasn’t changed: OTPs still bear the full liability for any decisions they make.
Not far enough
The American Society of Addiction Medicine (ASAM) supports the NPRM, but wants regulations to go farther, allowing office-based physicians to prescribe methadone for OUD by passage of the OTAA.
“The American Society of Addiction Medicine applauds today’s proposal by the U.S. Department of Health and Human Services, through its Substance Abuse and Mental Health Services Administration, to expand access to treatment for opioid use disorder, in particular with methadone through opioid treatment programs,” said Brian Hurley, M.D., president-elect of ASAM, on Dec. 13. “The proposed changes will provide greater autonomy to OTP practitioners, as well as expand on telehealth and take-home flexibilities initially granted in connection with the nation’s COVID-19 public health emergency. Several proposals are aligned with recommendations in ASAM’s 2021 Public Policy Statement on Regulation of the Treatment of Opioid Use Disorder with Methadone. In the spirit of these proposed rules, now is the time for Congress to build on these regulatory efforts by creating a new statutory pathway that would allow addiction specialist physicians to prescribe methadone for OUD treatment that can be picked up from pharmacies, subject to take-home rules or guidance to be set by SAMHSA.”
Some of the main reservations from ASAM and other supporters of the OTAA about the NPRM are that it didn’t go far enough. For example, NAMA Recovery does support office-based prescribing by addiction physicians, saying this would be an added benefit to patients. “NAMA Recovery is still processing the nuance and full implications of the NPRM,” Zachary Talbott, president of NAMA Recovery, told ATForum last week, adding “but we applaud the significant progress and move toward patient-centered care that has become evident in our first readings of the proposed draft rules.”
The NPRM, on display with the Federal Register, is viewable at https://public-inspection.federalregister.gov/2022-27193.pdf (PDF | 626 KB). Public comment on the proposed regulatory changes may be made until February 14, 2023.