AN

Issue Brief

CHCF

 

APRIL 2022

by Leslie W. Suen, Oanh K. Nguyen, and Kelly R. Knight

Learning from COVID-19:

How Pandemic-Era Policies for Methadone
Prescribing Could Improve Opioid Treatment

was already seeing staggering numbers of drug

overdose deaths, with over 70,000 people dying
from an overdose in 2019. When the pandemic began
in early 2020, in-person health care visits presented
significant risk for COVID-19 infection and spread.
Federal agencies took swift action to create sweep-
ing, yet temporary, regulatory changes to opioid use
disorder (OUD) treatment policy so that patients could
maintain uninterrupted access to health care. Since the
onset of the pandemic, racial disparities in overdose
prevalence have widened in the state, with overdose
deaths among Black people outpacing other racial
groups in California.' Statewide, counties including
San Francisco, Los Angeles, and San Diego are facing
unprecedented increases in overdose-related mor-
bidity and mortality, in part due to the rise of illicitly
manufactured fentanyl.2 Because both the COVID-19
pandemic and the overdose crisis have evolved in the
past two years, re-examination of the role of addiction
treatment in reducing opioid-associated morbidity
and mortality and promoting health equity is needed.

B efore the COVID-19 pandemic, the United States

The History of Methadone Treatment
Policies and Regulations in the US Is
Highly Racialized

Methadone is a gold-standard medication effective
in reducing mortality for people with OUD. In the
US, patients can only access methadone treatment
through outpatient treatment programs, or OTPs (col-
loquially, "methadone clinics"). Before the COVID-19
pandemic, federal and state restrictions required
patients to visit clinics daily to receive their methadone

doses, ostensibly to guard against methadone over-
dose and misuse (defined as "the use of any drug ina
manner other than how it is indicated or prescribed"
including diverting prescriptions for nonmedical use
and altering the route of administration).? Only people
meeting strict criteria, including having stable housing
and sufficient length of time in treatment, had access
to methadone "take-home doses" or "take-homes."4

Methadone was first studied in the 1960s and
approved by the Food and Drug Administration in the
1970s for OUD treatment. The federal government
established OTPs as a national network of clinics oper-
ating separately from all other aspects of health care.°
OTPs offered methadone maintenance treatment
in parallel to services designed to enhance recovery
and social integration (e.g., in-person counseling, link-
ages to housing). OTPs were deliberately placed in
impoverished, inner-city locations, and the dominant
media narratives portrayed patients on methadone as
criminal, heroin-using Black and Latinx people. These
narratives allowed federal agencies, including the
Substance Abuse and Mental Health Services Agency
(SAMHSA) and the Drug Enforcement Agency, as the
alcohol and drug law enforcement agency of the US
Department of Justice, to create and regulate a meth-
adone treatment system centered on surveillance and
stigma.® This surveillance exists on the individual level
by requiring patients to attend clinic daily and be
directly observed taking their medication, and also at
the OTP level with OTPs having to comply with strict
reporting and regulatory requirements to state and
federal agencies. For example, before the COVID-19
pandemic, if a patient receiving methadone needed
to travel out of state for any reason, any requests for
additional take-home doses of methadone needed for
travel required pre-approval from SAMHSA through
State Opioid Treatment Authorities. No other con-
trolled substance or medication in the US requires this
level of regulation and restriction.

These treatment policies also have sociodemographic
implications, where more than 90% of OTPs are con-
centrated in urban areas, in part due to state and
federal regulations resulting in limited OTP expansion
into rural areas." Simultaneously, due to racial/ethnic
segregation and other forms of structural racism across
the US health system, Black and Latinx communities
lack access to other, less restrictive OUD treatments
like buprenorphine, which can be prescribed in any
primary care doctor's office licensed to prescribe it.®
These conditions make the highly surveilled system
of methadone the only medication option for many
communities of color. Experts have emphasized that
loosening restrictions to methadone is essential to
addressing these impacts of structural racism on both
overdose deaths and treatment access.'

Risks Posed by Burgeoning Fentanyl
Use Highlight Need for Expanded
Methadone Access

In recent years, illicitly manufactured fentanyl has come
to quickly dominate the US drug supply and is now the
most widely implicated opioid in overdose deaths."°
Unlike its predecessors (heroin and prescription opi-
oids), fentanyl has several unique pharmacologic
properties, including being easier to illicitly manu-
facture and transport with higher potency and slower
clearance from the body.'' These properties led to
both the proliferation of fentanyl in the US drug sup-
ply and a dramatically higher risk of overdose death
compared to heroin and other opioids. Early studies
demonstrate that among people using fentanyl, risk
of severe precipitated withdrawal symptoms when ini-
tiating buprenorphine is higher compared to people

using heroin, which may make buprenorphine a less
appealing medication treatment option in the era of
fentanyl for patients.'

Buprenorphine and methadone are the only two med-
ication treatments shown to reduce mortality from
OUD." For treatment of OUD from fentanyl, clinicians
and patient advocates speculate that methadone may
be the preferred medication for treatment initiation,
but regulatory barriers to accessing methadone will
be a significant challenge to effective long-term treat-
ment."* There is an urgent need for state and federal
governments to consider rapidly expanding metha-
done access as one way of reducing overdose deaths.

Prepandemic Restrictions on
Methadone Treatment Are
Unprecedented in Chronic Disease Care

Methadone for OUD treatment is restricted and regu-
lated in a manner singularly distinct from other chronic
medical illnesses, including treatments with simi-
lar risk for misuse and significant associated harms.
For example, many people with diabetes mellitus
- a relapsing-remitting chronic condition like OUD -
must take insulin to stay healthy. Insulin is an injectable
medication that requires the use of syringes and nee-
dles, a strict schedule, and careful attention to dosing
to avoid significant harms, including severe hypogly-
cemia, loss of consciousness, coma, and death. Even
with these considerations, millions of Americans are
routinely prescribed insulin and entrusted with self-
administration of this medication at home.

In another chronic illness, attention deficit hyperac-
tivity disorder (ADHD), standard first-line treatment
includes use of stimulant prescription medications
(i.e., amphetamines), which have similar potential for
diversion and misuse to methadone. Yet there are no
restrictions or regulations on prescribing or adminis-
tering stimulants for treatment of ADHD comparable
to those imposed on methadone.

 

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Both scenarios are starkly different from the restric-
tions and regulations placed on methadone treatment
for OUD, despite similar potential treatment harms
and risks. Methadone restrictions thereby unintention-
ally generate stigma and barriers to care that impede
OUD treatment engagement and stabilization.

When COVID-19 was declared a public health
emergency, over 400,000 Americans were receiv-
ing methadone for OUD treatment.'® In March 2020,
SAMHSA enacted temporary exemptions to metha-
done-prescribing policies. One of these exemptions
allowed OTPs individual discretion to initiate or extend
take-homes for anyone receiving methadone, effec-
tively removing the previous federal requirements for
take-home eligibility."* This report reexamines the state
of methadone dispensing in the US and evaluates the
impact of less restrictive methadone-prescribing poli-
cies implemented due to the COVID-19 pandemic.

COVID-19 Led to Sweeping National
Changes in Take-Home Methadone
Prescribing

Before the pandemic, for a patient receiving meth-
adone to be eligible for take-homes, SAMHSA
regulations required documentation that a patient
is "responsible in handling narcotic medications" as
demonstrated by meeting eight criteria (see sidebar).

In March 2020, SAMHSA issued emergency regula-
tions that vastly expanded eligibility for take-home
dosing, enabling OTPs to prescribe take-homes of:

> Up to 14 days for "less stable" patients

> Up to 28 days for "stable" patients

These emergency regulations gave OTP clinicians
discretion in determining who might be eligible for
take-homes, making it newly possible for patients
who may not have otherwise qualified for take-homes
to receive them. Additional federal exemptions
included waivers related to urine toxicology testing,
requirements for counseling, and allowances for bill-
able telehealth visits, methadone home delivery, and
surrogate methadone pickup. These changes were
implemented immediately across OTPs nationwide,
though implementation did vary.

SAMHSA Criteria for Take-Home Eligibility
Pre-Pandemic
1. Absence of recent abuse of drugs

(opioid or nonnarcotic), including alcohol

2. Regularity of clinic attendance

3. Absence of serious behavioral problems
at the clinic

4. Absence of known recent criminal activity
(e.g., drug dealing)

5. Stability of the patient's home environment
and social relationships

6. Length of time in comprehensive maintenance
treatment

7. Assurance that take-home medication can be
safely stored within the patient's home

8. Whether the rehabilitative benefit the patient
derived from decreasing the frequency of
clinic attendance outweighs the potential
risks of diversion

Source: Federal Guidelines for Opioid Treatment Programs,

Substance Abuse and Mental Health Services Administration,
March 2015, 82.

 

Learning from COVID-19: How Pandemic-Era Policies for Methadone Prescribing Could Improve Opioid Treatment 3
A Natural Experiment: Increased
Access to Methadone Take-Home
Doses During the Pandemic

Since March 2020, several early studies have been pub-
lished examining the impact of regulatory changes.
Findings include:

> OTP approaches to implementing these regu-
latory changes have varied nationwide, where
some OTPs reported quickly making adaptations
to their clinical practice to rapidly expand access
to take-home doses, while others have described
maintaining or reverting to prepandemic take-
home criteria.""

> Individual states have also made sweeping meth-
adone policy changes in response to COVID-19."®
For instance, New York, with special approval from
the Centers for Medicare & Medicaid Services,
began delivering Medicaid reimbursement for OTP
services in a weekly bundled rate. This was to help
OTPs avoid financial loss, since they were no longer
being reimbursed for daily in-person visits.'?

» Concerns about increased methadone diversion
or overdose with increased take-home access
have not borne out. Early observational stud-
ies from OTPs in Connecticut, New York, North
Carolina, Oregon, and Washington have not found
significant increases in either adverse outcome in
2020 compared to prior years."°

> Interviews with providers have highlighted
increased clinician satisfaction and positive
impacts on patient treatment experiences after
implementing increased take-home access, with
the majority expressing desire for these changes
to remain beyond the COVID-19 public health
emergency."

To explore these questions further, the authors'
research group conducted a mixed-method study
using qualitative and quantitative methods to assess
the impact of the less restrictive methadone-prescrib-
ing policies at an OTP in a public safety-net community
hospital in San Francisco.

In the qualitative component, stakeholder interviews
were conducted with 10 providers (including two phy-
sicians, five social worker associates, and three nurse
practitioners) and 20 patients receiving medication
treatment for OUD. All interviews were transcribed,
coded, and analyzed to identify emergent themes.
Qualitative findings" include:

> Providers were cautious when implementing
expanded take-home policies and reported mak-
ing individualized decisions, using patient factors to
decide if benefits outweighed risks of overdose and
misuse (e.g., patient drug use, overdose risk, hous-
ing status, and vulnerability to COVID-19).

"Instead of saying, everybody gets two weeks,
right, like pushing it to the max, we've said,
okay, everybody who has stimulant use
disorder can get two take-homes per week,
and if their attendance remains good, if they
show no evidence of relapse to heroin or
opioid [use], we can expand it from there and
step up to three, four, up to six take-homes

per week depending on their situation."
- OTP provider

 

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> New patient groups started receiving take-homes,
and providers noted few adverse events.

"We don't have any data from the urine
samples to look at whether there's been a
shift in what substances they're using. But
we also don't have tons of people, either
overdosing by mishandling them or even
coming back early and saying, 'Hey, | lost
my take-homes,' or, 'Something happened

with my take-homes.""
- OTP provider

> Patients who received take-homes appreciated
increased autonomy and flexibility with take-home
access, which in turn increased likelihood of treat-
ment stabilization and engagement.

"The whole thing was just a game changer
for me. Because there is no way | could have
done it [without take-homes]. | couldn't go
to school and carry a full load and be on

methadone. It would just not work."
- OTP patient

> Patients who remained ineligible for take-homes
(usually due to ongoing nonprescribed opioid or
benzodiazepine use) desired greater transpar-
ency in understanding why they were not getting
take-homes and shared decision-making with their
providers.

In the quantitative component, a retrospective analy-
sis was conducted using electronic health data from
both the OTP (Methasoft) and the health network
(Epic) from January 2019 to December 2020 for all
established patients in OTP care, defined as having
been in care for at least 90 days. Patients were cat-
egorized as having never received take-homes during
the study period, being new to receiving take-homes,

and having been on take-homes and having had them
increased. Clinic-level intake, retention, and take-
home prescribing; acute care utilization; and mortality
were assessed using pre-post analysis and chi-square
testing.

> Clinic volume, intake, and retention were largely
unchanged after implementation of the new
regulations, though the average monthly propor-
tion of patients receiving take-homes significantly
increased from 31% to 47% (p < .001).

>» Among 506 established patients at the OTP:

» There were no significant differences in 10-month
mortality: Among those who never received
take-homes, 10-month mortality was 2.7% com-
pared to 3.2% among those who newly started
take-homes (p = .79) and 0.8% among those with
increases in take-homes (p = .24).

» Ahigher number of patients who never received
take-homes had emergency department (ED)
visits (47.0%) compared to patients who newly
received take-homes (ED visits 29.2%, p < .001)
or who had increases in take-homes (ED visits
17.5%, p < .001) during the study period.

» Patients who never received take-homes also
had slightly higher hospitalizations (19.7%) than
those who newly received take-homes (14.3%,
p = .19) or who had increases in take-homes
(17.5%, p = .02), though only the latter compari-
son was Statistically significant.

Key Policy Considerations

> Increasing access to methadone treatment is a key
strategy to mediate the overdose crisis, especially
in the context of increased fentanyl availability and
use.

> Less restrictive methadone-prescribing regula-
tions issued due to the COVID-19 public health
emergency have increased access to methadone
take-homes.

 

Learning from COVID-19: How Pandemic-Era Policies for Methadone Prescribing Could Improve Opioid Treatment 5
» Early studies have not found substantial evidence of
increasing harms related to methadone overdose or
diversion despite increased access to take-homes,"?
and patients and clinicians have desired these regu-
lations to remain."

> Keeping methadone regulatory changes in place
after the COVID-19 public health emergency may
reduce barriers to methadone access and is a key
opportunity to improve equity in the care of people
with OUD.

Specifically, regulatory changes have potential to
improve the treatment experiences of patients
by increasing autonomy and quality of care, facil-
itating progression toward treatment stability.

> Any post-emergency regulatory changes that limit
already-established access to take-homes could
potentially amplify pre-pandemic inequities in
methadone treatment by undermining already-
fragile trust in health systems among communities
of color.

>» More extensive research is needed in evaluating the
long-term benefits and harms of expanding metha-
done access, in addition to exploring the impact of
methadone treatment structures and settings on
patient outcomes."

> Public and private insurers should make certain that
reimbursement practices for out-of-office OTP ser-
vices such as take-homes align with incentives that
facilitate treatment progression and stabilization.

Opportunities for Long-Term Reform

> The current temporary flexibilities regarding metha-
done take-homes and OTPs have been long sought
by advocates to minimize the burdens associated
with recovery from OUD.

> SAMHSA has several legal pathways to ensure
continuation of these regulatory changes indefi-
nitely without needing congressional approval.?é
Congress is also considering alternative routes of

expanding methadone access, including enacting
legislation that would expand dispensing of metha-
done to community pharmacies."

> By reducing the number and frequency of required
in-person interactions, policies such as telehealth
assessments, telehealth counseling, and take-home
dosing could help to increase enrollment in, and
adherence to, medication for addiction treatment
while reducing stigma.

Conclusion

SAMHSA issued emergency regulations that expanded
access to methadone take-homes to mitigate exposure
risks for COVID-19 infection. During the COVID-19
pandemic, the US, and especially California, has expe-
rienced unprecedented increases in opioid-associated
mortality due in part to increases in the availability of
illicit fentanyl. What opioid deaths might have been
without expanded methadone take-home access
is unknowable, though available data evaluating
SAMHSAs regulatory changes, including these study
findings, indicate high acceptability among patients
and providers, and few adverse events.

Policymakers could consider making the emergency
regulations permanent. Permanently expanding
increased access to take-homes could expand meth-
adone access for patients who use fentanyl and
increase autonomy, stabilization, and treatment satis-
faction among current patients receiving methadone.
Expanding methadone take-homes through perma-
nent regulatory changes could provide remediation
for the history of medical racism and treatment seg-
regation that historically contributed to stigma and
oversurveillance in methadone treatment, particularly
for Black and Latinx people with opioid use disorder
who face the highest risk for overdose mortality in
California.

 

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About the Authors

Leslie W. Suen, MD, MAS, is a National Clinician
Scholars Program fellow, at the Philip R. Lee Institute of
Health Policy Studies, School of Medicine, UCSF. Oanh
K. Nguyen, MD, MAS, is assistant professor, Division
of Hospital Medicine, at the School of Medicine,
UCSF. Kelly R. Knight, PhD, is professor and vice chair,
Department of Humanities and Social Sciences, at the
School of Medicine, UCSF. UCSF is one of the nation's
leading academic medical centers, connecting world-
class research, education, and patient care.

About the Foundation

The California Health Care Foundation is dedicated
to advancing meaningful, measurable improvements
in the way the health care delivery system provides
care to the people of California, particularly those
with low incomes and those whose needs are not
well served by the status quo. We work to ensure that
people have access to the care they need, when they
need it, at a price they can afford.

CHCF informs policymakers and industry leaders,
invests in ideas and innovations, and connects with
changemakers to create a more responsive, patient-
centered health care system.

Endnotes

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Modernize Opioid Use Disorder Treatment," Congressman
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Markey, press release, February 10, 2022.

 

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