#25 Methadone in the Clinic with Dr Ruth Potee and Dr David Frank

July 18, 2024 | By Shawn Cohen

Audio

Video

Transcript available via YouTube

OTP yea you know me

Make methadone a part of your practice. Learn how the methadone system in the US works and how you can play an active role in improving care for people with opioid use disorder treated with methadone. We’re joined by Dr. Ruth Potee @DrRuthPotee (website) and Dr. David Frank @highway_dave 

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Production Partner: ACAAM

The Curbsiders Addiction Medicine are proud to partner with  The American College of Addiction Medicine (ACAAM) to bring you this mini-series.  ACAAM is the proud home for academic addiction medicine faculty and trainees and is dedicated to training and supporting the next generation of academic addiction medicine leaders. Visit their website at acaam.org to learn more about their organization.

Show Segments

• Intro, disclaimer, guest bio
• 5:00 Guest one-liner
• 10:25 Case from Kashlak; Definitions
• 11:19 Methadone pharmacology and evidence
• 17:08 What an OTP feels like
• 20:25 OTP intake
• 24:45 Talking through methadone with a patient
• 28:15 Personal impact of methadone
• 30:20 Requirements at an OTP
• 33:43 What your patient needs to access an OTP
• 37:25 The line
• 39:06 Dosing/Take homes
• 44:48 Loss of take homes
• 48:39 How to interact with an OTP as a PCP
• 52:50 Methadone at STRs
• 57:03 How to clinicians use their voice to improve things
• 1:00:45 Take home points
• 1:03:00 Plugs
• 1:04:24 Outro

Methadone in the Clinic Pearls

1. Methadone is strictly regulated in the outpatient setting and can only be accessed through Opioid Treatment Programs (OTPs).
2. State, insurance company, and OTP policies may be more restrictive than federal methadone regulations leading to more difficulty accessing and continuing care.
3. Federal methadone regulations were recently relaxed to ease admission requirements and decrease requirements surrounding take-home doses.
4. Primary care clinicians (and other clinicians) can facilitate OTP admission by completing a screening exam by diagnosing moderate-severe opioid use disorder and conducting a physical exam.
5. Clinicians can take an active role in their patient’s methadone treatment with open communication and advocacy with the OTP. 
6. Skilled Nursing Facilities (SNFs) declining admission because a person is in treatment with methadone is illegal. 
7. There are several ways to facilitate methadone provision at SNFs.

Methadone in the Outpatient Setting Notes 

It’s worth taking a brief step back to emphasize we are living in an overdose crisis driven by the presence of high-potency synthetic opioids, such as fentanyl and fentanyl analogs, in the drug supply. Over 100,000 people died of an overdose in the last year (CDC 2024). That may seem like an unfathomably large number, so to give it context – in the time it takes you to listen to this 1-hour podcast about methadone, 10 people will die of an overdose.

Dr. Potee and Dr. Frank both comment on how much high-potency synthetic opioids (fentanyl and fentanyl analogs) have drastically changed the landscape. They describe fentanyl as a “garbage drug” that’s everywhere and how its shorter “legs” (how long the effect of fentanyl lasts) may lead to more frequent and higher-risk use (Lambdin 2019, Geddes 2018, Kenny 2023). This in turn has been associated with increasing rates of serious infections, including endocarditis and osteomyelitis (Gomes 2022). This makes it even more critical that we effectively connect people with evidence-based, life-saving treatments like methadone.

Methadone – an amazingly effective medication for OUD

For an in-depth guide about methadone, its dosing, and amazing effectiveness, please check out the inaugural Curbsiders Addiction Medicine Episode #1 Methadone for OUD: Find your Rage which also featured Dr. Ruth Potee.

To briefly review, methadone is a long-acting, full- agonist opioid  FDA-approved for the treatment of opioid use disorder. 

Methadone has robust literature supporting its benefits in treating OUD beginning in the 1960s. (Dole, 1965). The current evidence repeatedly shows that treatment with methadone reduces mortality and overdoses by up to 50%, making it one of the most effective medications available in medicine (Pearce 2020, Wakeman 2020, Krawczyk 2020, Larochelle 2018, Santo Jr, 2021, National Academies of Medicine 2019). Methadone treatment is also associated with improved quality of life (Ponizovsky 2008), reduced physiological stress response (Bart, 2012), decreased HIV (MacArthur 2012, Bruce 2010) and HCV transmission (Alavian 2013).

It’s worth noting that the benefits of methadone are dependent on finding a dose that’s effective for the person you’re treating. In the pre-fentanyl era, studies showed that doses >60 or 80 mg were associated with higher retention in treatment (Caplehorn 1994, Bao 2009, Strain 1999). Now in the era of fentanyl, doses may need to be increased to meet a patient’s treatment goals. (Buresh 2022). 

Dr Potee likens methadone dosing to the use of thyroid hormone replacement in that there is no right dose for everyone. Finding the right dose takes time and requires partnering with your patient and understanding their goals.

How is methadone regulated?

Methadone for the treatment of opioid use disorder is regulated unlike any other medicine in the United States: it is not available through pharmacies and must be dispensed through federally licensed opioid treatment programs (OTPs).

 The regulations surrounding methadone were originally written in the 1970s and were influenced by the prevailing idea that people who used drugs were criminals and needed to be controlled (Adams, 2022, Adams 2021). It must be noted that these regulations were intentionally meant to police minoritized, and particularly Black, people with opioid use disorders (Hansen 2012). Despite improvements in the regulations in the past year, at its heart current methadone regulations remain controlling, leading to methadone to be described as “liquid handcuffs” (Frank 2021). The United States is a marked outlier in how restrictive our methadone regulations are; in other countries, office-based methadone is the standard (Pew 2023, Kleinman 2022).

Federal methadone regulations serve as only the baseline – methadone is further regulated and restricted at the state and individual clinic level (Stanley 2022) leading to variable accessibility and restrictions from state to state and clinic to clinic (Roy 2024, Pew 2022). As Dr Potee notes these restrictions are not always evidence-based. 

Dr Potee and Dr Frank both emphasized the variability in what OTPs are like. There are amazing clinics providing patient-centered care and doing everything they can to reduce barriers to accessing methadone.

On top of that close to 80% of US counties do not have any OTPs (Duff, 2019).

What methadone treatment at an OTP is actually like

It’s worth re-emphasizing what an amazing medication methadone can be. Dr Frank describes his personal experience with starting methadone, feeling like he was at the end of his rope and needing something to change. He really underlines the miraculousness of methadone, recounting that after his first dose, he had the overwhelming feeling that his life had changed and he may never have to be in withdrawal again.

Unfortunately, the bureaucratic side of starting methadone at an OTP can be long. Per Dr. Potee, someone starting methadone should expect the intake and paperwork to be variable, ranging from one to four hours. Long initial visits can be challenging for patients to tolerate while experiencing worsening opioid withdrawal throughout the process.

Fortunately, some of the restrictions around methadone have been eased with the updated SAMHSA regulations released this year, often referred to as the Final Rule (Federal Register 2024).

Federal requirements for methadone intake and treatment (states/clinics/insurance may require more):

• Screening examination to confirm moderate-severe OUD diagnosis and ensure no contraindications to methadone (This can be done by a non-OTP clinician including PCPs_
• A full physical exam from a licensed practitioner (including physicians and advanced practice providers) within 14 days of intake, dosing can start prior to the exam although many clinics require this prior to providing methadone
• Drug screens at least 8 times/year 
• Counseling must be available 
• The final rule states that counseling can be declined and declination cannot lead to the denial of methadone
• Laboratory evaluation 
• Specific labs are left up to the discretion of the clinic but the final rule states patients cannot be discharged or not treated if decline lab evals

Patient requirements to be able to access methadone

• Diagnosis of moderate-severe opioid use disorder
• If a minor (<18 years old), need parental/guardian consent, unless not required by state law
• A photo ID card
• A way to pay for methadone 
• Medicaid is required to cover methadone (CMS), yet 10 states still have not expanded Medicaid (KFF 2024) and not all clinics accept Medicaid 

Patients often have to have time (often a lot of it)

• Required to be able to get there and get your dose (Joudrey 2019) 
• Limited by clinic hours – often only open for a few hours per day

Dr. Frank describes the actual experience of accessing methadone as controlling. There can be a line out the door of people waiting to be dosed. The level of security at OTPs is high with guards and cameras, which is a regulatory requirement. 

Take-homes

At OTPs, methadone is generally dosed at a dosing window where it is administered and observed by a nurse. Observed dosing often occurs daily. “Take-homes”, doses patients are given to take at home unobserved, can be life-changing by allowing patients the time to live their lives (Frank 2021) and improve patient satisfaction (Panwala 2023).

Yet take homes are often hard to come by. Requirements to get them were relaxed throughout the COVID-19 pandemic, but their implementation varied across states (Roy 2024) and OTPs (Levander 2022). Fortunately, these more flexible requirements were part of the SAMHSA Final Rule (Federal Register 2024). Since these flexibilities are new, not all OTPs are aware of them, so this can be an area for advocacy to improve the care of people being treated with methadone.

For a great explainer on the difference between the new and old guidelines check out Vital Strategies overview (specifically pages 8 and 9 for take-homes). 

A few important things to note about take-homes:

• Requires absence of active substance use disorder (as Dr. Potee notes this is not dependent on urine drug screen results or even on current use but rather on clinician assessment)
• Take-homes need to be able to be stored safely (as Dr. Potee notes, this does not mean that unhoused people can’t have take-homes, as she finds that they often benefit most and can safely store them)
• Patients can get as many as a week of take-homes when starting methadone, but while methadone is being uptitrated (first weeks), more frequent check-ins are probably best
• There is no automatic process to get take homes; getting them often requires self-advocacy 

On the flip side, Dr Frank tells us that for people who have take-home methadone doses, losing them can be shattering. In his qualitative work and amongst friends, he’s seen it lead to a loss of confidence and sense of self. Worst of all, it can lead to an inability to continue accessing methadone which often leads to a recurrence of use of the toxic drug supply and overdoses.

How PCPs can interact with the methadone system

Discussing methadone with your patient 

As a PCP with an interest in addiction, you may be the first person to explain the benefits of methadone and how to access it to your patients.

Dr. Frank adds that this conversation is contextual based on your patient’s situation. He says it’s important to emphasize the positive aspects of methadone while being pragmatic about the system. The mortality benefit may be compelling to clinicians, but speaking about the impact on their life/function may mean more to someone with OUD – things like the idea that they won’t be dope sick again or will have the space/time to build a life. Given the variability of OTPs, it’s important to learn about your local OTPs to paint a realistic picture of what care will be like.

Become an active part of your patient’s methadone treatment

The first step is to find your local OTPs, a good national reference is the SAMHSA treatment locator which allows you to search by location and filter for OTPs (https://findtreatment.gov/locator). If none are nearby, Dr Potee encourages us to fill that gap and make one!

Once you’ve found the local OTP(s), call them and start a conversation. Speak with the medical director and find out their admission criteria/process, insurance accepted, what types of identification are accepted, and policies on take-homes. Use this opportunity to advocate for policies that follow the SAMHSA guidelines rather than more restrictive policies. You have the opportunity here to help facilitate care through the OTP.

• If there are transportation barriers – Are there insurance-covered transportation options or other avenues your clinic uses to help patients access care?
• If the patient doesn’t have an ID – Will the OTP accept an ID from the medical record (photo and information from the medical record face sheet) or are there other identification options your clinic can help with?

This is also the time to bring up the role you can play in completing the screening examination for OTP enrollment (the exam needed before methadone dosing can begin). As a reminder, licensed practitioners outside the OTP can conduct a screening exam to allow a person to begin treatment with methadone (must be completed no more than 7 days before OTP admission). The requirements for the screening exam are diagnosing moderate-severe OUD and a narrative of a physical exam including vitals (42 CFR 8.12(f)(2)(ii)). You can also send labs and a urine drug screen if you have them but not necessary). Check with your local methadone clinic director to see how this screening exam requirement is implemented at your local OTP.

Methadone at Skilled Nursing Facilities

For patients who require short- or long-term care at a skilled nursing facility (SNF), methadone can complicate admission. It is common for SNFs to decline admission to people on methadone (Kuye 2024, Kimmel 2022, Kimmel 2021), but this practice is illegal. (Cohen 2023). It is a violation of the Americans with Disabilities Act, the Department of Justice specifically cites it as example A in their guidance on ADA violations (Department of Justice).

There are several ways to help facilitate methadone at skilled nursing facilities. All require a close partnership between the OTP and SNF.

• First, the OTP can provide weeks of take-home methadone doses for a patient through a medical exemption, but transferring the methadone to the SNF requires chain of custody. 
• Second, the OTP can establish a satellite at the SNF to allow it to provide services directly there. 

In Dr Potee’s expert opinion, a third option is for the SNF to directly dispense methadone to patients with OUD based on current SAMHSA regulations (42 CFR 8.11(h)(3), 42 CFR 8.2 “Long-term care facilities”) It’s important to note that this would allow SNF to DISPENSE methadone  (similar to how medication are dispensed in a hospital);  not for methadone to be prescribed (like other outpatient medications). To our knowledge, this is not common practice and would still require connection with an OTP on discharge for continued methadone treatment.

In addition to trying to facilitate methadone at SNFs, legal advocacy to address this discrimination is warranted. Complaints can be filed with the Department of Justice at https://www.ada.gov/file-a-complaint/. This has led to several statewide investigations and settlements (Legal Action Center, 2024). People who directly interact with SNF admissions staff can also send letters informing them that declining patients because they’re treated with methadone is illegal (Legal Action Center, 2024).

How do we advocate to improve things?

The long-term goal of all people, particularly health professionals, who want to make methadone more accessible is larger systemic change. While the recent regulation changes are positive and welcome, much more work is needed to lower barriers to methadone treatment (Krawczyk 2023). Clinicians can advocate to allow office-based methadone treatment (McCarty 2021, Adams, 2022).

Dr. Frank and Dr. Potee both note they’ve never been more hopeful for improvement in the methadone system as there seems to be momentum to improve things. Clinicians have power in their voice and can use it – join the National Coalition to Liberate Methadone, advocate with your senator or representative for the Modernizing Opioid Treatment Access Act (legislation to allow office-based methadone treatment by addiction physicians – ASAM explainer), and educate your colleagues about methadone!!

Links

1. National Coalition to Liberate Methadone
2. MASAM (youtube channel on methadone dosing in fentanyl era, methadone dosing in pregnancy)
3. Final SAMHSA Methadone rule
4. Yale Addiction Medicine Grand Rounds on the SAMHSA Methadone updates moderated by Dr Kim Sue

Goal

Listeners will develop an understanding of the system of methadone regulation and administration in the United States and how they can interact with it to improve care for people with opioid use disorder 

Learning objectives

After listening to this episode listeners will…  

1. Describe the current system of methadone and recent changes to regulation 
2. Develop strategies to help patients access methadone and advocate for their care 
3. Explain how methadone regulations impact care in other medical settings (ie STRs)

Disclosures

Dr. Potee and Dr Frank report no relevant financial disclosures. The Curbsiders report no relevant financial disclosures. 

Citation

Cohen SM, Frank D, Potee R, Roy P, Chan, CA. “#25 Methadone in the Clinic with Dr Ruth Potee and Dr David Frank”. The Curbsiders Addiction Medicine Podcast.https://thecurbsiders.com/addiction  July 18, 2024.