Below is an eloquent comment on the most recent proposal to “modernize” methadone
treatment, obtained by AT FORUM. Dated May 26, it is by Arlin Silberman, D.O., F.A.O.A.A.M. (a
fellow of the American Osteopathic Academy of Addiction Medicine) and reviews “The
Modernizing Opioid Treatment Access Act (M-OTAA), H.R.1359/S. 644.”
In summary, the Modernizing Opioid Treatment Access Act (M-OTAA), H.R.1359/S. 644,
introduced by Representative Norcross and Senator Markey respectively, would allow for:
-Patients to be treated with methadone for opioid use disorder (OUD) outside of an
Opioid Treatment Program (OTP);
-Methadone for OUD to be dispensed by pharmacists outside of an OTP;
-Care completely through telehealth without any required in-person evaluation or
-Care to be provided by employees or contractors of an opioid treatment program, not
necessarily led by a physician or involving a physician who has expertise in addiction
medicine or addiction psychiatry.
Among shortcomings of this legislative proposal, M-OTAA fails to recognize:
- Substantial changes have recently been proposed to 42 C.F.R. Part 8, the regulations for OTP
operations, that would increase flexibility and access to care with methadone for OUD;
- Methadone has a risk of life-threatening cardiac rhythm abnormalities;
- OTPs provide services important to recovery beyond medication and counseling;
- In-person evaluation and treatment have important roles in the care of patients who have
- Patient care should be physician-led.
The Substance Abuse and Mental Health Services Administration (SAMHSA) has proposed
substantial changes to 42 C.F.R. Part 8 (“Part 8”) that would increase flexibility and access to
care with methadone for OUD. M-OTAA fails to acknowledge that regulatory amendments to
Part 8 have not yet been finalized and there is no track record that would serve as a meaningful
premise for the legislation. It is premature to consider the legislative proposal before the
effects of regulatory changes to Part 8 have been assessed.
In a comment letter, the American Medical Association (AMA) notes, “OTPs play a critical role in
our nation’s effective response to the drug-related overdose and death epidemic….” The letter
expresses support for the proposed new regulations.
The take-home dose (THD) issue
In a letter by the American Academy of Addiction Psychiatry (AAAP), comments were mixed.
Concerns regarded scope of practice and the potential to start take-home doses during
initiation of methadone treatment. AAAP writes, “…before eliminating the requirement that the
team is led by a qualified physician, we strongly urge HHS to continue to fund research to
determine whether and under what guidelines independent management of MMT by
nonphysicians would be safe and effective.
AAAP agrees that the schedule for allowing THD [take-home doses] can likely be safely
accelerated, but we are concerned that the proposed schedule for THD escalation starting
during initiation of MMT is not supported by the medical evidence to date…take home doses
should be gradually increased…and based on the patient’s clinical stability in recovery from
OUD and co-occurring disorders.” AAAP encourages research on safe and effective accelerated
scheduling of THD.
Methadone has a risk of life-threatening cardiac rhythm abnormalities. M-OTAA fails to
acknowledge that patient safety measures implemented by OTPs decrease the risk of a lethal
cardiac dysrhythmia due to methadone. The proposed legislation disregards the complexity of
patients who require treatment for OUD and the vital need to ensure patient safety.
Methadone prolongs conduction of electrical signals in the heart which can lead to fatal cardiac
dysrhythmias even at therapeutic doses. It is generally accepted that significant risk of torsades
de pointes occurs at QT interval measurements over 500 milliseconds. Ehret et al. found that
the lowest methadone dosage found to increase the QT interval above 500 milliseconds was 30
mg per day. The Substance Abuse and Mental Health Services Administration (SAMHSA) multi-
disciplinary Expert Panel on the Cardiac Effects of Methadone emphasized the importance of
patient safety and closely monitoring the initiation and dose changes of methadone.
Risks during induction
Wakeman and Beletsky acknowledge the increased risk of overdose during the induction
period. The dose of methadone used for opioid use disorder is much greater than those for pain
management, particularly when treating patients who have used fentanyl when often over 100
mg. methadone is required. Ehret et al. found that a higher daily methadone dose was
associated with significantly greater QT interval prolongation. Since the risk of cardiac
dysrhythmia is higher at higher doses of methadone, monitoring at times of dose initiation and
escalation is warranted. Methadone has a complex pharmacology.
Close monitoring during dose initiation and adjustment is indicated. Methadone has a slow
onset of action that peaks hours after a dose is taken and a long elimination half-life which
means that the full effect of any dose change is not realized for five to seven days later.
Methadone has a narrow therapeutic index with multiple drug interactions. Because
methadone is a pure mu opioid agonist, it can cause fatal overdoses when taken alone or in
combination with other sedating substances, including alcohol. When combined with other
medications and substances such as stimulants or cannabinoids that cause cardiac
dysrhythmias, the risk is increased.
One should recognize that regulatory flexibilities provided during the pandemic had limitations
in their success. Kleinman and Sanchesa found that successful outcomes were limited to highly
stable patients within the treatment structure of OTPs. They noted racial and ethnic disparitie=s
where deaths increased by 48% for Hispanic individuals, 31% among non-Hispanic Black
individuals, and 16% among non-Hispanic White individuals. Cautionary lessons can be learned
from the French experience with pharmacy administration of methadone. Frauger et al. report
data from 2008 to 2017 that show methadone was increasingly involved in drug overdoses and
deaths. Lapeyre-Mestre et al. report data obtained through the French Addictovigilance
Network that during the COVID-19 pandemic lockdown methadone was the most common
substance involved in drug overdoses.
Potential scenario under M-OTAA: “Queenie” is a 28 year old female who seeks treatment for
her history of OUD. She denies history of medical illness and is prescribed no medications. Her
physical examination and laboratory studies were unremarkable. Since she is being treated
outside of an OTP she had no EKG obtained prior to starting methadone. A long Q-T segment
was therefore not detected. She started taking methadone, had a fatal cardiac rhythm and had
OTPs provide services important to recovery beyond medication and counseling. The
Modernizing Opioid Treatment Access Act fails to acknowledge that OTPs provide services that
help to promote and sustain recovery, beyond medication and counseling. Comprehensive
assessment of patients who have OUD is essential to quality care for these complex patients.
For a patient in an OTP, this includes a complete history and physical examination to confirm
the diagnosis of opioid use disorder; check laboratory studies for comorbidities including
infectious diseases such as HIV and syphilis; and identify co-occurring medical and psychiatric
conditions that may make medication-assisted treatment unsafe, limit its effectiveness,
influence the selection of pharmacotherapy, or require prompt medical attention. When a new
patient is enrolled in an OTP for methadone, the patient is to be evaluated to determine if this
initial day’s dose suppresses opioid abstinence symptoms or if a higher dose is necessary.
This level of monitoring the dose’s effect and adjusting accordingly is not feasible in the model
provided in the proposed legislation.
OTPs are required to provide adequate random testing for drugs to assure absence of illicit
substances and presence of parent methadone and its metabolite, with the frequency
dependent on the patient’s phase of treatment, in accordance with generally accepted clinical
practice. Observed urine collection and/or temperature assessment to assure the urine
submitted is body temperature help to ensure the sample is valid. Testing is important to assess
adherence and successful treatment and to identify those who are at increased risk for opioid
overdose who should be considered for possible opioid antagonist therapy and/or inpatient
OTPs are required to provide adequate medical, counseling, vocational, educational, and other
assessment and treatment services. This valuable resource helps patients gain new skills and
promotes sustained recovery. For pregnant persons, an OTP must maintain current policies and
procedures that reflect the special needs of patients who are pregnant. Prenatal care and other
gender specific services or pregnant patients must be provided either by the OTP or by referral
to appropriate healthcare providers. OTPs are advised to facilitate prenatal care and at least
offer basic prenatal instruction on maternal, physical, and dietary care as part of its counseling
Potential scenario under M-OTAA: “Victoria” is a 53 year old female with a history of opioid use
disorder (OUD). Her residential environment was a factor in her OUD. She was prescribed
methadone outside of an OTP and therefore received no vocational and other support services.
She did not have the job training skills and without this support she was unable to leave her
environment and relapsed.
In-person evaluation and treatment have important roles in the care of patients who have OUD.
M-OTAA fails to acknowledge the importance of an in-person evaluation and treatment of
patients who have OUD. For high quality OUD care, a physical examination should be
performed to check for stigmata of opioid use disorder (e.g., old and fresh needle marks,
eroded or perforated nasal septum), to assure that the request for methadone is legitimate.
The level of opioid withdrawal should be measured with accurate vital signs. The patient should
be assessed for co-existing medical conditions such as congestive heart failure that may
necessitate inpatient induction. These are findings that are difficult to determine via telehealth.
It is questionable how the standard of care can be met without an in-person evaluation.
Relying on telehealth requires entire trust in the patient yet the patient relays subjective
reports. Without prior in-person contact with the patient to ascertain that the patient’s request
for methadone is legitimate, this increases the risk of diversion. Safeguards are necessary to mitigate the risk of diversion.
As limited as audio-visual telehealth is for this assessment, audio-
only fails to permit the necessary evaluation of the patient. As the Centers for Medicare and
Medicaid Services has acknowledged, “[T]here may be particular instances where visual cues
may help a practitioner’s ability to assess and treat patients with mental health disorders,
especially where opioids or mental health medications are involved….” Telehealth-only does
not allow for adequate random testing for drugs to assure absence of illicit substances and
presence of parent methadone and its metabolite, to determine if an alternate approach to
care is required such as an opioid antagonist or inpatient treatment.
Potential scenarios under M-OTAA:
“Sheila” is a 35 year old female and mother of 3. She has a history of IV drug use, a condition
associated with increased risk of heart valve damage due to infection. The patient was started
on methadone via telehealth and did not have an appropriate physical examination prior to
treatment. A heart murmur due to heart valve damage was missed leading to disseminated
infection, worsening heart function, and emergency cardiac surgery.
“Larry” is a 56 year old male who denies current history of alcohol use. The patient is evaluated
in a seated position via telehealth and appears fine from chest up. Liver chemistries are normal.
However, if he would have been examined in person you would have seen his abdomen was
significantly distended due to ascites due to chronic liver disease and that he would likely have
altered metabolism of methadone. Larry was prescribed a relatively low dose of methadone,
but overdosed due to his decreased metabolism of the drug.
“Sammy” is a 29 year old male who reports via telehealth that he has a history of intravenous
OUD. The telehealth examination did not include vital signs or examination of skin or other
organs. A full assessment would have revealed normal vital signs, no signs of needle track
marks or other physical evidence of intravenous OUD, no urine presence of opioids or
metabolites. He was prescribed methadone that he diverted for sale.
“Ulysses” is a 39 year old male with a history of OUD. He was prescribed methadone outside of
an OTP. His physical examination and laboratory tests including a scheduled urine screen
revealed no abnormalities. He did not have a random, observed urine test; hence it was missed
that his urine was not warm as body temperature and likely a false sample. His use of illicit
substances was missed. His lack of adherence with treatment was missed.
The role of physicians
Patient care should be physician-led. M-OTAA fails to acknowledge the importance of care led
by a physician and does not require expertise in addiction medicine or addiction psychiatry.
Care could be provided by “employees or contractors of an opioid treatment program;” while
the medical director of the OTP would be responsible for operations, the specific qualifications of the employee or contractor are unspecified.
With an interest in patient safety, AMA policy
promotes physician-led care. AMA policy recognizes expertise of those who practice addiction
medicine. The proposed legislation is unclear on this point. The complexity and acuity of
patients who have OUD necessitates having care led by a physician who has expertise in
addiction medicine or addiction psychiatry.
Privacy and other problems
Past experience: There is no assurance that the legislative proposal will expand access to safe
care with methadone for OUD. Prior to the removal of the X-waiver requirement for
buprenorphine, most waivered clinicians rarely reached their patient limit. With removal of the
X-waiver requirement, the change in availability of OUD care is yet to be seen.
Challenges with pharmacies: Pharmacies present barriers to access for buprenorphine and a
source of diversion; this could be an issue for pharmacy-dispensed methadone for OUD.
Winstanley et al. reported that 34% of subjects in treatment had problems filling their
buprenorphine prescription. The Department of Justice has filed or settled cases for violations
of the Controlled Substances Act. Examples include cases against Rite Aid and Walmart among
others, and settled with CVS. In view of security concerns it is questionable how many
pharmacies would be willing to stock the high levels of methadone that are required by OUD
patients being treated with this medication.
Privacy risk: Methadone dispensed at a pharmacy would be entered into PDMPs. Reports show
that PDMP reports are not secure from law enforcement. The patient records under the
proposed legislation would not have the higher level of privacy afforded to 45 C.F.R. Part 2
facilities. This exacerbates concerns with compromised confidentiality. Privacy is foundational
to care for OUD as fears of stigma, losing employment, housing, custody, and insurance, deter
patients from treatment. These concerns are well documented in National Surveys on Drug Use
Other ways to expand access
There are other ways to expand access. It is anticipated that access will expand once the 42
C.F.R. Part 8 changes are finalized. The number of OTPs could increase. Mobile units have been
utilized and should be promoted. AMA policy encourages the expansion of OTPs, including
mobile units as well as ensuring availability of all forms of MOUD. Education, training, and
board certification: If M-OTAA is enacted, it will be imperative for addiction medicine physicians
and addiction psychiatrists to have the requisite education, training, and board certification
testing that ensures the safe and effective management of the complex patients who are
treated with methadone for OUD. Since currently this clinical experience is limited mainly to
those who practice in OTPs, substantial attention will be necessary if the M-OTAA model is to
Additional organizations’ comments in reference to the Modernizing Opioid Treatment Access
National Association for Behavioral Healthcare wrote: “The potential for significant harm to
patients, particularly in populations that already suffer from health inequities: Recently
published studies of methadone take-home flexibilities showed that the regulatory changes
were not universally successful, with successful outcomes being limited only in highly stable
patients; and, equally important, within the treatment structure of OTPs.”
National Alliance for Medication Assisted Recovery said: “It is also important to remember that
the core evidence base which unequivocally demonstrates methadone’s efficacy was largely
conducted within or adjacent to the OTP system.”
The American Association for the Treatment of Opioid Dependence said: “…methadone
mortality reports from 2003 to 2010 [were reviewed]. The conclusion of all five reports was
remarkably consistent. Methadone mortality increased during that period of time when doctors
were prescribing methadone to treat pain and methadone was distributed through pharmacy