Unintended consequences of methadone regulation for opioid use disorder treatment among hospitalized patients

Abstract

Background:

In the United States, there are no federal restrictions on the use of methadone to manage opioid withdrawal symptoms when patients are hospitalized with a medical or surgical condition other than addiction. In contrast, in an outpatient setting, methadone for opioid use disorder (OUD) is highly regulated by federal and state governments and can only be dispensed from an opioid treatment program (OTP). Discrepancies in regulatory requirements across these settings may lead to barriers in care for patients with OUD.

Objective:

Identify how methadone regulation impacts the care of patients with OUD during hospitalization, care transitions, and in the OTP setting.

Methods:

We completed 26 interviews with clinicians and social workers working on hospital-based addiction consultation services across the United States. Study findings are the result of a secondary content analysis of interviews to identifying the word “methadone” and construct themes resulting from the data.

Results:

We identified three major themes related to “methadone” for OUD treatment, all of which impacted patient care: (1) limited OTP hours leads to tenuous or delayed hospital discharges; (2) inadequate information-sharing between hospitals and OTPs leads to delays in care; and (3) methadone regulations create treatment barriers for the most vulnerable patients.

Conclusion:

Strict methadone regulations have resulted in unintended consequences for patients with OUD in the hospital setting, during care transitions, and in the OTP setting. Recent and ongoing federal efforts to reform methadone provision may improve some of the reported challenges, but significant hurdles remain in providing safe, equitable care to hospitalized patients with OUD.

INTRODUCTION

In an era of lethal, high potency synthetic opioids, hospitals are an essential site of care for people with opioid use disorder (OUD).^1,2 From 2000 to 2016 in the United States, hospitalizations related to OUD increased 219%, a threefold increase.³ Hospitalization is a critical time to engage out-of-treatment adults in OUD treatment and national hospital-based guidelines recommend initiating buprenorphine or methadone to treat opioid withdrawal among hospitalized adults with OUD.^2,4,5

Methadone is a first-line medication used to treat opioid withdrawal and OUD.² In the United States, there are no federal restrictions on the use of methadone to manage opioid withdrawal symptoms when patients are hospitalized with medical conditions other than addiction.⁶ In contrast to the hospital setting, in the outpatient setting, methadone for OUD is highly regulated by federal and state governments.⁷ Patients initiated on methadone during hospitalization must follow-up at a federally certified opioid treatment program (OTP) after hospital discharge for methadone treatment continuation.⁷ To meet legal requirements for OTP enrollment, patients must complete an examination by an “appropriately licensed practitioner” who is OTP-affiliated or, if the practitioner is not OTP-affiliated, hospital to OTP linkage must occur within 7 days of the examination.^6,7 These regulations create challenges for patient engagement in methadone treatment following hospital discharge.^8–10 Once enrolled, patients present daily to the OTP for methadone dosing, though recent federal rules have loosened restrictions to allow for more frequent take-home methadone doses.^11,12 These requirements are unique to the United States and disproportionally affect vulnerable and medically ill patients.⁹

Previous qualitative work described patient- and clinician-reported benefits of initiating methadone and buprenorphine during hospitalization. Patients report that opioid withdrawal contributes to a self-directed discharge¹³; however, receipt of buprenorphine or methadone reduces opioid withdrawal symptoms and supports patients to remain in the hospital to receive necessary medical treatment.^10,14 Clinicians report that the use of methadone and buprenorphine reduces opioid withdrawal symptoms and facilitates meaningful interactions with patients, leading to greater job satisfaction.^10,15,16 When patients request methadone continuation after hospital discharge, navigating the hospital to OTP linkage can be challenging for patients and for clinicians who are responsible for ensuring safe care transitions. Hospital to OTP linkage barriers include uncontrolled opioid withdrawal and pain, lack of transportation, identification, or housing, and unstable medical or mental illness.^10,17 Methadone access varies by geography,^18–20 insurance,^21,22 treatment location,^23–25 and race/ethnicity.^21,26,27 People living in rural areas are often unable to access methadone due to travel burden and cost.^9,19,28,29 Income inequality, housing and transportation instability, insurance status, mistrust in healthcare, and stigma contribute to OUD treatment barriers.^17,30–32

Methadone is a highly effective treatment for OUD³³; however, there are unique federal and state regulations surrounding its use in the United States. We aimed to describe hospital-based clinician perspectives of methadone use for OUD treatment among hospitalized patients, their perspectives on hospital to OTP treatment linkage, and their perspectives on the current OTP system for methadone treatment.

METHODS

Study design

The study findings are the result of secondary data analysis of 26 in-depth, semistructured key informant interviews with clinicians and social workers who work on hospital-based addiction consultation services. The original study aimed to explore factors that contribute to burnout and resilience among this workforce, recognizing that addiction treatment providers may be at heightened risk for burnout because people who use drugs often have complicated social and behavioral needs and many have experienced significant trauma.^8,34,35 Given previously reported challenges with methadone access in the United States,^{9,19,29,36,37} we sought to identify if methadone provision contributed to burnout or resilience among this workforce.³⁸ Full details of the study design, data collection, data analysis, participant demographics, and Institutional Review Board approval are reported separately.⁸

Data collection and participants

To capture a range of perspectives and experiences, we interviewed physicians, social workers, and advanced practice providers (APPs) working on addiction consultation services across 12 US hospitals. Participants were recruited via email solicitation to addiction consultation service directors and then snowball sampling. Providers working part- or full-time on an addiction consultation service were eligible for inclusion. Four authors (E. B., S. L. C., C. T., L. T.) conducted in-person, telephone, or video interviews, which lasted between 30 and 60 min. Interviews followed a semistructured interview guide developed by an interdisciplinary team including addiction consultation service clinicians (E. B., S. L. C., L. T.) and an experienced qualitative researcher (C. T.). Given that three authors (E. B., S. L. C., L. T.) were addiction consultation service providers at the same institution, a nonclinician author (C. T.) conducted interviews with participants working at the authors’ institution to minimize bias. All interviews were recorded and transcribed. All participants provided informed consent. Interviewees received a $25 gift card for participation.

Analysis

For this secondary analysis, we conducted a summative and generalized content analysis of 26 key informant interviews and associated memos by identifying the word “methadone” in the interview transcripts, and then by studying the context in which key informants discussed “methadone” as it related to the larger conversation of burnout and resilience when caring for hospitalized patients with OUD.^39–41 The interviewers did not explicitly inquire about methadone; thus, any discussion involving methadone as it related to burnout and resilience was unprompted. All the study authors (three addiction consultation service physicians, two of whom are also health services researchers [S. L. C., E. B., L. T.]; an expert in qualitative methods [C. T.]; and a qualitative research service professional [A. D.]) participated in the summative content analysis. First, S. L. C. identified the word “methadone” and counted its frequency across the 26 transcripts.⁴⁰ Next, S. L. C. identified the word “methadone” in the original study’s analytic memos, which summarized key factors that contributed to burnout or resilience.⁸ After identifying quotations and memos involving “methadone,” S. L. C. compiled the data for all study authors. The study authors independently examined the study data with the aim to gather insight into how “methadone” was used in the context of burnout and resilience. Through iterative data review between study authors, the team constructed themes reflective of the physician and social worker’s experience with methadone in the hospital. The team considered the emergent themes, reviewed the data, and refined themes before coming to a consensus. The study authors used investigator triangulation, informed by their clinical expertise practicing addiction medicine, their understanding of the current body of literature describing methadone access and treatment in the United States, and their personal expertise in qualitative research methods. This allowed for different investigators to interpret the same data and provide their independent analysis for further comparison, discussion, and refinement and to increase the trustworthiness of the findings.^42,43

RESULTS

Across 26 key informant interview transcripts, the word “methadone” was mentioned 106 times by 19 unique key informants (Table 1). The results include demonstrative quotations from eight physicians and two social workers obtained from the original 26 interviews. We constructed three major themes related to federal and state regulations governing methadone treatment for OUD, which impacted patient care in the hospital, during care transitions, and in the OTP setting and contributed to burnout ore resilience (Table 2). Figure 1 depicts a conceptual framework highlighting unintended consequences of methadone regulation across the hospital to community settings.

TABLE 1.

Participant characteristics.

Addiction provider characteristics (n = 25)a,b
Gender
Male	9 (36%)
Female	16 (64%)
Provider type
Physician	14 (56%)
Social worker	8 (32%)
Advanced practice provider	3 (12%)
Years practicing in addiction medicine
2 or less	7 (28%)
3–5	11 (44%)
6–10	4 (16%)
11+	3 (12%)
Characteristics of physician providers (n = 14)
Boarded in addiction medicine
Yes	11 (79%)
No	3 (21%)
Training background
Internal medicine	10 (71%)
Family medicine	2 (14%)
Psychiatry	2 (14%)

^aOne provider did not complete the demographic questionnaire.

^bNineteen of the 26 key informants mentioned the word “methadone.” Key informant characteristics data were deidentified at the time of data collection and disaggregation of key informant characteristics at the individual level for the 19 key informants who mentioned “methadone” is not possible.

TABLE 2.

Constructed themes with supportive quotations.

Limited OTP hours lead to delayed or tenuous hospital discharges	“The methadone clinic was only open until 11:00 AM on a Friday and then was closed during the weekend. So, I’m trying to figure out the logistics of how my patient was going to get methadone through the weekend when they’re clinically stable enough for hospital discharge. We can’t discharge this person without their methadone through the weekend. And that just felt like so soul crushing that, you know, the logistics didn’t align that we could have a successful hospital discharge.” (Physician #2)
	“If somebody is on methadone, well, you can’t discharge them on a Friday or Saturday because they can’t go to methadone clinics.” (Physician #6)
	“Some of the worst days were when we put a lot of time and effort in coming up with treatment plans. And then, for some reason, if it were barriers imposed by community referrals, or like logistical reasons, in terms of methadone clinic being closed at 1:00 PM on a Friday, that the plan would then just kind of crumble and you kind of re-enter crisis mode.” (Physician #7)
	“I feel that sometimes, they’re just trying to get people out, and I get really frustrated. I say, “Can we keep’em? I’m trying to get them into a clinic and that clinic doesn’t take a direct admission over the weekend.” (Social Worker #2)
Challenges with information-sharing between medical facilities and OTPs lead to delays in care	“We were only able to verify their methadone, Monday through Friday when the service was available versus 24/7 when the patients were coming in. So, someone came in at 6:00 PM on a Friday, there was no way of being able to verify their methadone dose over the weekend.” (Physician #7)
	“I’ve referred a patient, and they’ve been connected to one methadone clinic for weeks, and then at the 11th hour at time of discharge, they decided that they’re gonna stay somewhere else, and I have to change the methadone clinic and I can’t get a hold of anyone.” (Social Worker #2)
Burdensome methadone regulations create barriers in accessing medical care in the OTP system and the postacute care setting	“I encounter systemic issues that preclude patients from getting a new heart valve or um, going to a skilled nursing facility because they’re on methadone. These types of things that we see over and over, it never happen to patients who don’t have addictions. The medical team has to tell the patient, “Sorry, you can’t go to a skilled nursing facility because there’s no place that’s gonna accept you so you’re either discharged to the street or discharged to a shelter.” It is exhausting to fight that fight over and over again with case managers and facilities and often lose.” (Physician #1)
	“I think, housing first, then lower threshold treatment, and the methadone regulatory issues, like, making methadone more accessible, but above, like across the substance use disorders, I think, um, accessible housing is probably the biggest thing, housing and transportation.” (Physician #3)
	“We have limited access to community or resources specifically when it comes to addiction medicine. We have just a significant homeless crisis, um, and that some of the restrictions around medication for opioid use specifically that limit people to accessing those already limited resources.” (Physician #8)

Abbreviation: OTP, opioid treatment program.

FIGURE 1.

Conceptual framework highlighting unintended consequences of US Methadone Regulations from the hospital to the community setting. OTP, opioid treatment program.

Theme 1: Limited OTP hours lead to tenuous or delayed hospital discharges

Participants described how the misalignment of methadone regulations, community OTP access, and the realities of inpatient processes make it difficult—or at times, impossible—for patients to safely link from the hospital to the OTP in a timely manner without experiencing opioid withdrawal. One physician explained:

Methadone clinics here aren’t open on Sundays, and they don’t do posthospital follow-up on the weekend. If someone stays in the hospital on Friday, then the next time they can discharge is Sunday. There are many times where the team says, “we will keep them in the hospital.” And then I look back and they discharged them on a Saturday, so that person didn’t have methadone for a day. Who knows what’s happening to them now.

(Physician #1)

Other times medical teams may elect to keep the patient in the hospital over the weekend to administer methadone and to facilitate a direct OTP linkage during usual business hours. Participants described this as “frustrating” because it prolonged hospitalization for otherwise medically stable patients ready for hospital discharge. One social worker noted:

It is frustrating when there is a methadone referral coming in at noontime, and the medical team’s saying, “We’re ready to discharge them,” and I say, “You’re gonna have to keep them another night because the clinic’s about to close.”

(Social Worker #1)

One scenario increases the risk that the patient will return to illicit opioid use; the other increases healthcare costs by housing a patient in the hospital when they are medically stable for discharge.

Theme 2. Inadequate information-sharing between medical facilities and OTPs lead to delays in care

Hospital admissions occur at all times of the day and night. In contrast, OTPs have more limited hours, making information sharing between the two entities difficult. One physician described a challenge with verifying a patient’s methadone dose who was in active labor:

It’s 5:00 or 6:00 PM, and you get a call. “I got a lady in labor who tells me that she was on methadone, but we can’t figure out her methadone dose, and she looks horrible, and she’s in withdrawal.” “I’m like, oh, God.”

(Physician #2)

Additionally, participants reported that patient information could still be difficult to access in a timely manner even when OTP and hospital hours overlapped. Some OTPs require that patients sign a release of information before providing a patient’s methadone dosing information to outside clinicians which delays medical care. One physician explained:

I had to call the methadone clinic to verify their dose. I had to fax over the release of information, I had to get them to sign to even communicate with the methadone clinic.

(Physician #1)

These delays in information-sharing can directly impact patients’ health. For example, participants noted that patients develop opioid withdrawal when they are not receiving their prescribed methadone dose and “making sure, in particular, that patients get back on methadone or get that reinitiated, that is really helpful” (Physician #3). Barriers limiting the resumption of a stable, daily methadone dose may negatively impact a patient’s hospitalization, leading to a patient-directed discharge⁴⁴ which has been associated with an increased risk for rehospitalization⁴⁵ and death.⁴⁶

Theme 3: Methadone regulations create treatment barriers for the most vulnerable patients

Respondents reported that methadone regulation creates barriers for patients to access OUD treatment across the inpatient, postacute care, and outpatient settings. One physician explained:

The walls that you run up against over and over and over again, clinically, are institutional, cultural and policy walls. Like, you know, your sickest patients are always the patients who can’t get into a methadone treatment program. I mean, that makes no sense, why we have high bar access to a lifesaving medication.

(Physician #4)

Participants felt that the high bar for accessing outpatient methadone treatment was reinforced by discrimination among gatekeepers of these facilities. Some respondents noted a pattern of rejection by skilled nursing facilities (SNF) when they refer patients who are enrolled in methadone programs to postacute care for physical rehabilitation after hospitalization. One physician stated:

Regs around methadone are probably the biggest thing, more discharge planning …. We have a lot of issues despite partnerships with the SNF, it’s based on discrimination. It’s cited in different ways, but refusing patients who otherwise would benefit … and so you do the appeals, but then the patient ultimately gets rejected. It feels like they’re getting substandard care.

(Physician #3)

Another physician noted that to provide methadone for OUD, “you have to be really knowledgeable about the treatments you’re offering, and the treatment system”… and have a “nuanced understanding of what it means to get methadone” (Physician #5). This resulted in a paucity of clinicians who were willing or understood how to prescribe methadone, limiting treatment for patients with OUD. One physician explained this concern:

I would argue that it should be within the scope of practice for a hospitalist to be able to do the basics of methadone. The opioid crisis was caused, in part, by our own behavior, right? The healthcare system really needs to take ownership and responsibility. But sometimes, despite all the effort that we’ve put into it, me and so many of my colleagues and others, it feels like the demand for treatment constantly far outweighs the supply.

(Physician #6)

Participants perceived that methadone regulations shielded SNFs from accepting patients with OUD, created hurdles for patients to engage in OUD treatment, and deterred clinicians from treating OUD at a time when the United States is experiencing a crisis in overdose deaths.

DISCUSSION

In this study, hospital-based addiction physicians and social workers identified challenges resulting from unintended consequences of federal and state methadone regulations that impacted patient care during hospitalization, care transitions, and in the OTP system.

Respondents expressed concern when patients were discharged from the hospital without a safe plan to continue methadone after discharge. Due to the lethality of the unregulated drug supply, transitional periods, including hospital to community, are associated with increased overdose⁴⁷ and death.⁴⁸ However, keeping patients in the hospital to receive daily methadone doses until OTP enrollment during usual business hours is an inefficient use of healthcare resources, where an average day in a US hospital costs $2800.⁴⁹ Notably, in August 2023, the DEA amended its regulation to allow practitioners to dispense, but not prescribe, up to a 3-day supply of methadone for OUD.⁵⁰ In response, some addiction consultation services developed protocols to dispense methadone from the inpatient setting which allows patients to receive a bridge supply of take-home methadone to prevent opioid withdrawal and facilitates OTP linkage during routine business hours.⁵¹ Data on average number of doses dispensed per patient, usual day of discharge, and cost savings are not currently available, but this strategy has the potential to improve the patient experience and reduce hospitalization costs.

Respondents noted that information sharing between hospital-based clinicians and OTP staff can be cumbersome and delay medical care. Methadone for OUD treatment is not routinely reported in the state prescription drug monitoring program (PDMP) because it is dispensed from an OTP, not a pharmacy. Methadone dose verification requires that a hospitalized patient first disclose their OTP enrollment to the medical team. Next, a medical team member must verify the OTP’s location, telephone number, and then call to confirm the patient’s last methadone dose and take-home doses dispensed. Obtaining this information is challenging when the patient is altered or incapacitated. Care may also be delayed if the OTP is not open outside of routine business hours or if the OTP does not have an on-call, after-hours number, resulting in a risk of under- or overtreatment with methadone in a medically ill patient. If methadone for OUD treatment were reported in the PDMP, then that may reduce some of these barriers. However, most PDMP reporting systems are not designed to report daily, updated methadone dosing information, which clinicians use to inform methadone dosing decisions. Furthermore, reporting methadone information in the PDMP for OUD treatment may be a violation of the Code of Federal Regulations Part 2, which requires patient consent for release of substance use disorder treatment information.⁵²

Respondents described that methadone regulations impacted OUD treatment across care transitions and into the outpatient setting. Previous work identified systematic rejection of hospitalized patients stabilized on methadone or buprenorphine by postacute care facilities, a known violation of the American with Disabilities Act.³⁶ To address this discriminatory behavior, the Civil Rights Unit of the US Attorney’s Office in Massachusetts entered into more than 10 settlement agreements with entities owning SNF’s for refusing to accept people maintained on medication for OUD.⁵³ Federal and state OTP regulations also impact patient’s engagement in methadone treatment due to strict OTP clinic policies requiring daily, in-person methadone dosing prompting the phrase “liquid handcuffs” to describe methadone in the OTP system.⁵⁴ In 2024, federal regulatory changes allowed for greater flexibility to dispense “take-home” methadone doses that may improve OTP treatment engagement and retention.⁶ While many hurdles remain, efforts are underway to increase methadone treatment access to people with OUD.

LIMITATIONS

Because these results are from a secondary analysis of a study examining factors associated with burnout and resilience, key informants were not explicitly asked about their experiences with methadone. Thus, we may have missed significant concepts or ideas that were not fully explored in the original interviews. It is also possible that the discussion of burnout and resilience inadvertently primed key informants to mention their experiences with methadone. It is notable, however, that almost 75% of key informants mentioned methadone, indicating its impact on the clinicians interviewed and their clinical practice. Next, we did not conduct member checking with key informants that would have increased the credibility of the constructed themes. However, three of the study authors (S. L. C., E. B., L. T.) practice addiction medicine and hospital medicine and, while their clinical experience likely informed the interpretation of the data and the thematic construction, the quotations and experiences described by the key informants resonated with their clinical experience. Third, while the federal government oversees OTP regulations, accreditation, and certification, some individual State Opioid Treatment Authorities include additional regulation over their state’s OTPs.^6,55 Greater state regulation may lead to variation in key informant experiences with OTPs in their respective states, and is not necessarily generalizable to the experiences of all clinicians, patients, and OTPs. Lastly, we did not include the voices of hospitalized patients whose experiences with methadone would greatly enrich the content of this study. Previous qualitative work has demonstrated that receipt of medications for OUD, including methadone, improves patient satisfaction.^10,14 Future work should study the impact of methadone policy on hospital to OTP transitions from the perspectives of patients and their families.

CONCLUSION

Methadone regulations for OUD treatment have resulted in unintended consequences that impact patient care during hospitalization, care transitions, and in the OTP setting. Increasing access to methadone is essential to reduce rates of preventable mortality among people with OUD.^48,56 Recent federal efforts to reform methadone provision for OUD may improve some of the reported challenges, but significant hurdles must be overcome to ensure patients with OUD receive safe, equitable care during hospitalization and care transitions.