Relaxed take-home rules for methadone patients were announced in March 2020 as a result of COVID-19, to limit the requirements for on-site dosing for many patients and the unavoidable exposure to virus transmission this entailed (see https://atforum.com/2020/03/otp-regulations-loosened-due-to-pandemic/). The relaxed rules allowed opioid treatment programs (OTPs) to give two weeks of take-homes to “less than stable” patients. Amid calls to extend the relaxed rules as opioid overdoses soared above 100,000, the federal government is doing so.
November 18, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that it was extending the relaxed take-home rules for methadone for one year while it considers a permanent solution. The relaxations will continue even when the COVID-19 Public Health Emergency expires, which it eventually will (at least that’s what SAMHSA says).
SAMHSA is also considering ways to make these relaxations permanent.
The exemption from the rules “was issued to protect public health by reducing the risk of COVID-19 infections among patients and health care providers,” according to SAMHSA. “While the take-home flexibility achieved that goal, it also proved to have other benefits for patients,” the agency noted.
Specifically, SAMHSA allowed OTPs
- to dispense 28 days of take-home methadone doses to stable patients for the treatment of opioid use disorder, and
- up to 14 doses of take-home methadone for less stable patients, “who the OTP determines can safely handle this level of take-home medication.”
That meant a lot of attention needed to be paid to which patients could and couldn’t handle this level, but in fact, the attention paid off, and diversion was limited, as evidenced by patients not returning early for more pills, for example. And patients loved it.
“The methadone take-home flexibility has received widespread support among patients, service providers, and state authorities,” said HHS Assistant Secretary for Mental Health and Substance Use Miriam Delphin-Rittmon, Ph.D., the leader of SAMHSA. “Innovative treatment solutions like this are in line with the Biden-Harris Administration’s efforts to make it easier to connect Americans to effective recovery solutions and support.”
The relaxation showed that almost two years after the exemption was first granted, there was increased engagement with treatment, improved patient satisfaction, and very little diversion or medication misuse, according to SAMHSA, citing preliminary studies.
“The flexibility promotes individualized, recovery-oriented care by allowing greater access for people who reside farther away from an OTP location or who lack reliable transportation,” according to SAMHSA. “Fewer visits also means people generally have more time to work, care for loved ones, and conduct other routine activities in their daily life.”
In terms of stigma, the expanded take-homes have probably had a strong beneficial effect, making the treatment with methadone more in line with treatment with other medications. The relaxed rules “may also reduce stigma for those seeking treatment, while providing more equitable access to care as telehealth in OTPs is expanded,” added Dr. Delphin-Rittmon.
For specifics, go to this guidance which includes frequently asked questions.
Patients and OTPs
Zachary C. Talbott, president of NAMA Recovery, as well as Mark W. Parrino, M.P.A., president of the American Association for the Treatment of Opioid Dependence, strongly supported SAMHSA’s change. NAMA Recovery is the organization that represents methadone and buprenorphine patients, and whose Board is mandated to be comprised of a majority of patients. NAMA Recovery “balances the realities of methadone pharmacology that can harm and even kill patients if we remove all guardrails or go too far,” Mr. Talbott told AT Forum.
“NAMA Recovery applauds the Administration’s move to ensure the increased clinical decision making on the part of OTP physicians regarding unsupervised use of methadone remains in place beyond the public health emergency,” said Mr. Talbott, who was not as sanguine as SAMHSA about the public health emergency ending soon. “Chaining patients to OTPs due to arbitrary time in treatment requirements has no basis in objective research or best practices, and it’s long past time we move beyond such draconian regulatory barriers to recovery,” Mr. Talbott told AT Forum. “We applaud Assistant Secretary Dr. Miriam Delphin-Rittmon and Acting CSAT Director Dr. Yngvlid Olsen on their recovery-focused move that pushes our federal regulatory structure to recognize the majority of methadone patients have the agency to take our medication without a nurse watching us, just like patients of any other chronic disorder. We look forward to continuing our work on behalf of patients with SAMHSA and the ONDCP over the coming years.”
“In my judgement, SAMHSA issued a balanced statement with reasonable guidance,” Mr. Parrino told AT Forum. “I understand how they are redefining stability and it is clear that they are giving OTP clinicians the discretion on how to provide take home medication.”
Mr. Parrino lauded SAMHSA for providing “more balanced guidance with regard to getting take-home medication to less stable patients,” noting that OTPs are “not required to provide such take-home medication, but that they should consider the federal guidance in monitoring how well the patient is progressing in treatment.”
The real challenge, Mr. Parrino noted, is working with third-party reimbursement. For a less-than-stable patient to be given two weeks of take-homes and monitored on a regular basis via telehealth, with all the clinical decision-making and risks involved, clearly must be reimbursed more than the one visit to pick up the medication, for example. Mr. Parrino expects that SAMHSA is currently working out these reimbursement challenges.
“I believe that SAMHSA is are working to find a middle ground between more extreme ideas and approaches that will bring greater flexibility in treating our patients with what we learned during COVID-19,” said Mr. Parrino. “I believe that these recommendations will increase retention in treatment, which is critically important to successful patient outcome.”
There is some concern that OTP take-home extensions will not provide relief to new patients, who do not yet have the combination of at least 30 days in treatment, plus 30 days of negative toxicology tests, and would be required to attend 6 days a week until they do, said Joseph Adams MD, Medical Director, of A Helping Hand, Genesis Treatment Services, and Veni Vidi Vici Treatment Services, all in Maryland.
“Per OTP regulations even before and after the public health emergency, all patients have the ability to receive up to two total take home doses in the first 90 day days, and up to three in the next 90 days, without the need for an exception request, including the many patients that will not meet the partial post-pandemic extension of take home flexibilities,” said Dr. Adams.
“Unfortunately, State Opioid Treatment Authorities (SOTAs) typically act as if OTP medical directors are able to grant only one total take home dose in the first 90 days, not two, despite clear language that up to two are permitted in federal regulations.”
And Steven Rabinowitz, co-chair of the public policy department of Stop Stigma Now, stressed that “the take-home flexibility provisions need to be made permanent, and that the SOTAs need to promulgate regulations that require OTPs to provide that flexibility, not just at their discretion, and to provide telehealth opportunities for patients with extended take-home schedules.”
Providers don’t always do as much as they are allowed to do, even in states like New York which themselves had liberal take-home policies even before the emergency. “During the height of the pandemic in New York we saw several large providers who refused to allow for extended take-homes, primarily for ideological reasons, and I expect this was true in other states as well,” said Rabinowitz. “OTP patients have a right to the same kind of respectful treatment as anyone else in the health care system.”
Dr. Adams agreed, noting that clarification from SAMHSA would “go a long way” to fixing the problem of misinterpretation of the federal regulations by the SOTAs.
The new ASAM policy on Regulation of the Treatment of Opioid Use Disorder with Methadone recommended, among other things:
SAMHSA should issue guidance clarifying that absence of substance use, or a substance use disorder, is not a strict requirement for unsupervised dosing, but is a factor to be considered.
SAMHSA should specify time in treatment requirements for unsupervised dosing in practice guidelines rather than in federal regulations. . .”
From the trenches
Meanwhile, a medical director for an OTP who requested anonymity said that the relaxed take-home rules are a good idea,but create a “logistical nightmare.”
Doling out 28 separate take-home bottles with individual labels is very labor- and time-consuming, he said adding that there were lines stretching out the door for hours while patients waited for these take-homes. If a program has only two dosing windows, even trying to stagger take-home days isn’t a solution. And methadone dosing is among the most highly regulated of all medications.
Still that medical director is in favor of more liberal take homes.
Some OTPs refuse to allow more than six take-homes to any patient.
“It needs to be permanent,” said patient advocate Joycelyn Woods. New York City had few providers who refused to give take-homes, she told AT Forum. “But outside of New York City the state is like the rest of the United States.” And in states that did – or do – not see COVID as a problem, take-homes, if any were given in the first place, were quickly rescinded, she said.
There’s still a lot of work to be done, but progress is taking place.