SAMHSA Proposes Update to Federal Rules to Expand Access to Opioid Use Disorder Treatment and Help Close Gap in Care

SAMHSA Proposes Update to Federal Rules to Expand Access to Opioid Use Disorder Treatment and Help Close Gap in Care

Changes Would Make Permanent
COVID-Timed Medication Flexibilities,
and Update Decades-Old Definitions and
Standards for Opioid Treatment Programs
at a time when fewer than 1 out 10A mericans
can access treatment for substance use
disorder.

The U.S. Department of Health and Human
Services (HHS), through its Substance
Abuse and Mental Health Services Administration
(SAMHSA), is proposing to expand
access to treatment for opioid use disorder
(OUD) at a time when more than 107,000
Americans lost their lives to an overdose
last year. The proposal would update the
federal regulations that oversee OUD treatment
standards as part of HHS’ Overdose
Prevention Strategy that supports President
Biden’s National Drug Control Strategy – a
whole-of-government approach to beat the
overdose epidemic. Specifically, the proposed
rule change would allow Americans to access
the treatment by allowing take home doses
of methadone and the use of telehealth in
initiating buprenorphine at opioid treatment
programs (OTPs).

In its Notice of Proposed Rulemaking
(NPRM) to update 42 CFR Part 8, SAMHSA
is proposing to improve Americans’ access to
and experiences with OUD treatment, in particular
through OTPs. The proposed changes
reflect the widespread desire by many
stakeholders for SAMHSA to provide greater
autonomy to OTP practitioners, positively
support recovery, and continue flexibilities
that were extended at the start of the nation’s
COVID-19 public health emergency.

“These proposed updates would address
longstanding barriers treatment in regulations
– most of which have not been revised in
more than 20 years,” said Miriam E. Delphin-
Rittmon, the HHS Assistant Secretary
for Mental Health and Substance Use and
the leader of SAMHSA. “I am committed to
moving these forward as quickly as possible
because we have heard from both providers
and patients how urgent the need is for
treatment.”

According to Centers for Disease Control
and Prevention (CDC) data, more than
107,000 Americans died from drug overdoses
in 2021, an increase of more than 15 percent
from 2020. These updates could help reduce
overdose deaths.

SAMHSA proposes to update Part 8 by
removing stigmatizing or outdated language;
supporting a more patient-centered approach;
and reducing barriers to receiving care. For
example, in March and April 2020, SAMHSA
published flexibilities for the provision
of take-home doses of methadone and for
the use of telehealth in initiating buprenorphine
in OTPs. Patients deemed stable by
physicians have been able to take home up
to 28 days’ worth of methadone doses; other
patients – again, so determined by their physicians
– received up to a 14-day supply. A recent
study showed that patients who received
increased take-home doses after federal flexibilities
were enacted during COVID-19 saw
positive impacts on their recovery, including
being more likely to remain in treatment and
less likely to use illicit opioids.

These flexibilities represented the
first substantial change to OTP treatment
standards in more than 20 years. Under the
NPRM for Part 8, SAMHSA proposes to
make these flexibilities permanent. SAMHSA’s
proposed changes also would update
standards to reflect an OTP accreditation and
treatment environment that has evolved since
Part 8 went into effect in 2001. Accordingly,
SAMHSA proposes updates that reflect
evidence-based practice, language that aligns
with current medical terminology, effective
patient engagement approaches, and
the workforce providing services in OTPs,
including:

Expanding the definition of an OTP
treatment practitioner to include any provider
who is appropriately licensed to dispense
and/or prescribe approved medications. The
current Part 8 rule defines a practitioner as
being: “a physician who is appropriately
licensed by the State to dispense covered
medications and who possesses a waiver
under 21 U.S.C.823(g)(2).” During the
COVID-19 public health emergency, this
has been formally expanded to align with
broader definitions of a practitioner (nurse
practitioners, physician assistants, etc.), and
OTPs reported that this change was essential
in supporting workflow and access;

Adding evidence-based delivery models
of care such as split dosing, telehealth and
harm reduction activities;
Removing such outdated terms as
“detoxification”;
Updating criteria for provision of takehome
doses of methadone;
Strengthening the patient-practitioner
relationship through promotion of shared and
evidence-based decision-making;

Allowing for early access to takehome
doses of methadone for all patients,
to promote flexibility in creation of plans of
care that facilitate such everyday needs as
employment, while also affording people
with unstable access to reliable transportation
the opportunity to also receive treatment;
likewise, promoting mobile medication units
to expand an OTP’s geographic reach; and

Reviewing OTP accreditation standards.
To facilitate expansion of access to
care, SAMHSA proposes to update OTP
admission criteria in Part 8. This includes
removal of the one-year requirement for
opioid addiction before admission to an OTP,
in favor of considering a person’s problematic
patterns of opioid use. In conjunction
with updated standards that include extended
take-home doses of methadone and access
to telehealth, these changes are likely
to expand access while also improving
retention in treatment. The NPRM also
proposes to eliminate the requirement
that practitioners who have a waiver to
prescribe buprenorphine for up to 275
patients provide reports to SAMHSA on
an annual basis.

The NPRM also promotes the
chronic disease model of management,
while removing barriers to providing
individualized care. “Removing these
barriers promotes patient trust and reduces
the need for individuals to attend an OTP
each day to receive treatment services,”
said Assistant Secretary Delphin-Rittmon.
“In this way, the proposed changes to Part
8 are focused on the individual and their
treatment environment.”

The proposal, on display with the
Federal Register, is viewable at https://
public-inspection.federalregister.
gov/2022-27193.pdf. Public comment on
the proposed regulatory changes may be
made until February 14, 2023.

Anyone in the United States seeking
treatment for mental health or substance
use issues should call SAMHSA’s National
Helpline at 800-662-HELP (4357) or
visit findtreatment.samhsa.gov.

If you or someone you know is struggling
or in crisis, help is available. Call or
text 988 or chat 988lifeline.org.

Reporters with questions should send
inquiries to media@samhsa.hhs.gov.

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