Q&A: Federal regulations for opioid use disorder treatment may change
In an effort to create a safer, more patient-friendly treatment system for opioid use disorder, providers and policymakers are analyzing shifting federal regulations and their potential impacts.
The Coalition of Medication-Assisted Treatment Providers and Advocates of New York State (COMPA), a nonprofit membership organization, recently held a symposium to discuss changing federal regulations for opioid use disorder (OUD) treatment, which included a roundtable discussion with Chinazo O. Cunningham, MD, MS, the commissioner of the New York State Office of Addiction Services and Supports, Allegra Schorr, MS, president of COMPA, and Mark Parrino, MPA, president of the American Association for the Treatment of Opioid Dependence.
In just 1 year, from April 2020 to April 2021, more than 100,000 Americans died of drug overdoses, according to Parrino. Opioids caused 75,000 of these deaths, and fentanyl was responsible for more than 64,000. However, stigma toward treatment options like methadone as well as federal regulations can limit access and complicate treatment for OUD.
Schorr and Parrino spoke with Healio about some of the discussion’s key takeaways and the paradigm shift in treatment for OUD.
Healio: Could you provide some background information about the symposium? What were some of the key takeaways?
Schorr: We had attended ... [the National Academies for Engineering, Science and Medicine virtual workshop sponsored by the White House Office of National Drug Control Policy] that happened in March ... and we were struck by the fact that a lot of that was sort of very research based [and] academic. [It was] very interesting, but they didn't necessarily have a lot of participation from people who were providing care directly, and that's what our members are: the actual providers.
I think the takeaways were how these regulations are really going to impact the delivery of care and service delivery, and the importance of clinical care and how that affects policy and regulatory policymaking.
You can't just have research in a vacuum, and I think that this was ... more informed by people who do this every day.
Parrino: I think the focus really was more of the clinical care side. Right now, there's a split between policy-related issues and, as Allegra indicated, more of a nuanced clinical treatment approach. And then while there are broad policy agendas at stake, certainly in Congress and in regulatory agencies, how it translates into patient care generally gets neglected. So, this forum provided that sort of exchange opportunity.
Healio: Can you briefly explain the current regulations for OUD treatment and how they might change?
Schorr: [Opioid treatment programs (OTPs)] are subject to regulations by several authorities. In New York, as in most states, there are both federal and state regulations. Federally, [the Substance Abuse and Mental Health Services Administration (SAMHSA)] has oversight and regulates OTPs. The discussion in the COMPA symposium was focused on the SAMHSA federal regulations. SAMHSA provides oversight through national accreditation organizations. So aside from the federal regulations, accreditation standards are another level of compliance that OTPs must meet — and there can be well over 2,000 accreditation standards. Finally, the Drug Enforcement Agency (DEA) has additional regulations regarding OTPs.
Changes to increase flexibility and access to treatment could include eliminating the need for specific time in treatment before allowing take-home doses, as an example.
Parrino: SAMHSA has not approved telehealth induction with methadone. We anticipate that this may change. People under 18 cannot be admitted to an OTP unless they have tried and failed at other treatment interventions. We also hope that this will change. Time in treatment is also a required element of determining stability in treatment with regard to providing take-home medication. Given what we have learned in treating patients throughout COVID-19, we also believe that this will change as well.
Healio: What, if any, changes should be made to admission criteria for OTPs (age, period of time with OUD, failure on other treatments, etc.)?
Schorr: There should be no restrictions on admission other than medical necessity. No reason to wait a year. No reason for someone under 18 to undergo two failed attempts at short-term detox or “drug-free” treatment — which only increases their risk of overdose and death. And the limitation on only admitting people with a diagnosis of OUD prevents OTPs from treating family members and significant others who may need their own services.
Healio: Should there be greater flexibility regarding access to take-home doses for stable patients and how is that done safely?
Schorr: Decisions regarding take-home doses are clinical decisions. Regulations should allow clinicians to determine the best treatment with their patients, weighing the risks and benefits.
Parrino: SAMHSA is working on new regulations/guidance that will provide more flexibility regarding take-home medication for patients.
The point here is that clinicians in the OTPs should have the ability to execute their clinical judgment. It is important to keep in mind that OTPs are composed of professional teams, and they collectively evaluate which patients should receive take-home medications. It is also important to keep in mind that its OTPs and its personnel are ultimately accountable when providing take-home medication. If they make an incorrect clinical decision, then the consequences are dire. This is why you need a team of trained professionals to respond to the needs of the patient and determine if it is safe to provide take-home medications.
Healio: What are some of the most critical elements to consider when discussing changing federal regulations?
Schorr: I think for us, it's really making sure that we're striking the balance. It's critically important that we gain flexibility, that there's a liberalization of the regulations wherever possible, so that there is an emphasis on the clinical and not an over-emphasis on ... regulatory type of thinking. There's clearly a need for that, and we saw that during COVID. It's really a matter of getting that right. And the concern that you were hearing, I think, from the providers was, “How do we make sure that we get those changes and that those are done in a way that's effective, and we don't make any mistakes along the way?”
Parrino: The issue here is anticipating the results of what you're talking about. Trying to anticipate how new policies actually translate into care and to ensure that the patients are getting the treatment that they need. A medication-only approach is not seen as the most viable method of providing care to the majority of our patients, and so we need to be careful in the recommendations that we're providing to ensure that people are going to receive better care.
Healio: Commissioner Cunningham said that a paradigm shift is needed from drug control to patient priorities. Does that ring true for you? Why or why not?
Schorr: I think that is true. If you look at the current language, it's very focused on diversion and maybe that was appropriate at the time it was written, but it's not focused on patient care at all, and that's just no longer best practice. That is a huge paradigm shift and isn't the way people treat patients. It's just simply not good care. And the regulations need to reflect what's happening currently.
Parrino: We agree with Commissioner Cunningham that, yes, the approach isn't about control, it's about changing patient's lives for the better. The only way you do that is by focusing their care on the needs that they present, but you need a systemic response. We also talked about integration of care, so that there are other professionals who understand what’s being offered to the patients in the OTPs in the country. There are 1,900 of these programs and we’re treating about 600,000 patients on any given day. So, the policies have to translate, again, into being sure that the patient is getting what they need.
Healio: Why is this so controversial? Will you describe some of the stigma surrounding OUD medication treatment, current federal regulations, and how those areas might intersect?
Schorr: Well, my personal feeling is that a lot of this really is stigma. There's no question buprenorphine has stigma around it, but methadone — if there's a caste system of addiction treatment, methadone has unfortunately, traditionally sort of occupied the lowest rung, and for no good reason. I think that it's really critically important that we really look at the regulations with a fresh eye. Use them appropriately so that they're doing the right thing. And certainly, providers should be held accountable to provide good care, but there's no reason that they should be stigmatized. In fact, these programs, I think, are really underutilized, and that has to change. As Mark pointed out, there's need for integration, and the potential for fully integrating comprehensive care isn't realized. There's an enormous amount of good that can be done that hasn't happened yet.
Healio: Mr. Parrino, you mentioned how the COVID-19 pandemic impacted federal regulations, calling it a “complete reversal.” Can you go into some more detail about that? Did the pandemic and its effects change your mind about anything related to OUD?
Parrino: Well, what happened with the federal regulations in March 2020, when our system was at the beginning of a major impact — the federal authorities have traditionally been very conservative about how take-home medication doses were prepared in OTPs. So, you went from having patients coming in 5 to 6 days a week to get potentially a week’s worth of medication, or even more, even though they were not fully stabilized after admission, and then you had more stable patients who might be coming to the program once a week now coming to the program once a month. It was an incredible shift.
Remember, this was going back March of 2020, to an absolutely frightening time in our nation’s history. We had never experienced a pandemic in modern times, and it had a universal effect on everything from transportation to work environments to taking flights and going on vacation. Whatever it was, it was transformative. Well, that happened with the methadone-specific regulations too, and there wasn't much time for the system to absorb the impact. It was a sudden impact and programs had to adapt quickly. It was fortunate that we were able to do this, learn lessons, and the patients did not misuse their medication by large measure.
I think I would say COVID-19 has made me realize the value of adapting the system to change ... It didn't change my concept of how opioid use disorder should be treated because our view has been consistent over the course of time ... but we've certainly learned to be far more flexible.
Healio: Should all physicians be able to prescribe methadone through pharmacies outside an OTP setting? What are the surrounding concerns?
Schorr: It’s important to allow methadone prescriptions for OUD to be filled by pharmacies in certain circumstances. However, prescribing methadone for OUD should not be open to all physicians. Physicians working in OTPs should be able to add prescribing methadone through pharmacies to increase access and improve flexibility for patients who are stable in treatment.
There is a significant concern that allowing all physicians to prescribe methadone for OUD would destabilize the existing OTP infrastructure. Notably, a large proportion of physicians who are waivered to prescribe buprenorphine do not prescribe to their full capacity.
In considering the issue of allowing all physicians to prescribe methadone, if the regulatory framework between OTPs and physicians is identical, then how have barriers been reduced? Alternatively, if regulations are lessened for physicians/pharmacies (as with buprenorphine prescribing) but not for OTPs, then why would patients seek treatment from programs where more restrictions are imposed?
Parrino: The conclusion of five reports [published between 2003 and 2010] was that methadone prescribing by practitioners to treat pain resulted in increased methadone related mortality.
These medications were distributed through pharmacy channels. As a knowledgeable pain management advocate acknowledged many years ago, “methadone is an extremely effective medication when used properly but it is unforgiving when not used properly.”
Healio: Should OTPs be able to admit patients to medication-assisted treatment (buprenorphine and methadone) using telehealth?
Schorr: Yes, telehealth should be used for both medications.
Parrino: The answer is yes.
Healio: What are some of your concerns moving forward and what do you see as the best path ahead?
Parrino: From my point of view, it's that we continue to address the needs of the patient [and] that we prevent policymaking that has negative consequences. As an example, if practitioners are not trained in treating opioid use disorder, we can't assume that they know exactly what they're doing — and if anybody thinks that, what's the basis for that? Going forward, I think it's also important to consider that whatever the regulatory changes are, there's funding that comes along with this. We're not going to be able to expand access to care unless funding levels and third-party reimbursement for Medicare and Medicaid change as well. And there has to be also an education to the country about what we've gone through with opioid use disorder and how people get into trouble using opioids. And then what really is the message about how methadone works? It's a highly stigmatized medication, but until the American public is exposed to a far better understanding about what it is, then how are they necessarily going to support it? I think with all of the opportunities for change and policy, you need to provide the American public with a real understanding of what treatment is and how medications work, in particular.
Schorr: I think it's very important that, as a field, we listen to the criticism that's been placed on OTPs because there certainly is ... criticism that the system is too regulated, not patient friendly and not patient centered. I think that this is an opportunity to really make sure that is heard and that we respond to it. It's essential that those regulations change so that the system can really respond to those criticisms and change and respond in a way that makes the care much more flexible for patients and work for them in a way that's better. Destabilizing the system ... is really where the danger lies. In seeking to expand treatment, we don't want to put ourselves in a position where we end up destabilizing treatment.
Healio: Is there anything else you’d like to add?
Schorr: I think that New York is doing a really great job in terms of expanding care and expanding access. I think that it's really critical that we make sure that we really loop in all the different pieces of the addiction treatment system. It has been a very siloed system too long. That requires state leadership, and we've got terrific leadership now, so that's encouraging. At the end of the day, this is always about changing hearts and minds. With the continuing overdoses, it's that we have that buy-in from providers from all over the state and from all over different types of modalities, and they start to recognize the need to really integrate care across the board.
Parrino: I'm very encouraged by the expansion of mobile vans, which have been approved only for the last year by the DEA.
And then the second game changer, which is happening in New York by the end of this year, is the increased access to treatment behind the walls in correctional facilities. From our point of view, and Commissioner Cunningham agreed, it's a game changer. It means people who have need of care can access that care during that period of confinement, and then be referred to continued care in OTPs upon release. We've seen this replicated in other states to great effect, with a major reduction in recidivism by over 50% and post-release mortality, also by over 50%. So, we think New York State is on the precipice of major and really incredible change, which is going to help the people that need access to care.