Substance Abuse Mental Health Services Administration FAQ
July 22, 1999
1. Why is the Department of Health and Human
Services (HHS) moving away from direct federal
inspection by the FDA to surveys by accreditation
organizations?
HHS is proposing to move to an accreditation
system to improve the quality of treatment for
patients. While FDA regulation is geared toward
documentation of medication doses and other
procedures, accreditation focuses more on clinical
care, treatment services and patient outcomes.
This will lead to a higher standard of care for
patients. The impetus for reform of the methadone
regulatory system has come from several sources,
including recommendations from blue-ribbon
committees and other field studies of methadone
treatment programs. The Institute of Medicine
Report on Federal Regulation of Methadone Treat-
ment, 1995, and the 1997 NIH Consensus Develop-
ment Panel on Effective Medical Treatment of Heroin
Addiction both recommended that opiate addiction
be treated more like other medical conditions. The
IOM Report concluded that the federal regulations
pose an undue administrative burden, infringe on
clinical authority, and either do not affect-or have
an adverse impact on-patient outcomes and the
quality of services. The NIH Consensus Panel
argued that federal regulations that “prescribe
methadone treatment procedures in minute detail”
should be eliminated altogether.
2. Is this reform good for patients?
Absolutely. These reforms will improve and set
higher standards of care for patients. The
proposed regulations allow for the first time
clinical discretion and medical judgment in
determining appropriate individualized treatment,
particularly in managing methadone/LAAM doses
and communicating closely with patients to
determine whether, when, and how medically
supervised withdrawals from medication might
be undertaken. It is expected that all treatment
programs will have services available, on-site or
by referral, for medical care, treatment for
multiple addictive substances, prenatal care, and
HIV prevention, as well as for patients who
request assistance with vocational rehabilitation
and employment. The regulations spell out both
patients’ rights and responsibilities. Reliance on
science-based clinical practice guidelines will
allow treatment providers to alter treatment
based on the clients needs and treatment
procedures will be update as medical practices
evolve.
3. What are these proposed regulations supposed
to accomplish?
The proposed accreditation system will accomplish
two major goals. First, it will set a higher standard
of care for people receiving treatment for heroin
and similar addictions. And second it will improve
federal oversight of opioid treatment programs that
use methadone and other medications to treat
addiction. The quality of treatment programs will
be improved by shifting responsibility for treatment
decisions from regulators to clinicians. This shift will
ensure that patients are appropriately assessed and
matched to the right treatment, that treatment is
individualized and that the need for ongoing care is
professionally assessed and monitored for quality.
Current regulations make this approach difficult if not
impossible. Accreditation will for the first time allow
health care professionals the opportunity to provide
their patients services based on their needs-just like
it works in every other health care setting. Oversight
will be improved by the development of accreditation
standards for treatment programs. These standards
will be used to hold treatment providers more accoun-
table to the federal government, states and patients
for providing state of the art treatment services and
emphasizing outcome measures, especially those
pertaining to reductions in drug use and crime and
engagement in productive employment.
4. What are the new standards that methadone
programs will have to meet?
The proposed new federal opioid treatment
standards focus on required services, medication
dispensing practices, and quality assurance.
Treatment programs will be required to meet
these standards and the requirements of a
nationally recognized accrediting entity or a
state.
This approach includes continuous quality im-
provement in which programs define their own
practical, obtainable, and evolving clinical goals.
By adhering to such standards, which are
blueprints for efficient and effective operations,
opioid treatment programs will become more
accountable and credible to the public, to
patients, to purchasers of care, and to public
officials.
5. How were the accreditation standards
developed?
Standards have been developed in a two-step
process. First, accreditation guidelines were
drafted by two expert panels convened in
December 1996, and January 1998. The panels
prepared a document that was circulated to
substance abuse treatment professionals for
review and comment before incorporating
suggested revisions into the final guidelines.
In the second step, the Commission on
Accreditation of Rehabilitation Facilities
(CARF) and the Joint Commission on
Accreditation of Healthcare Organizations
(JCAHO) have developed methadone-specific
accreditation standards based on available
information. The guidelines and accreditation
standards provide a quality improvement
template for opioid treatment facilities. These
standards will continue to evolve as new infor-
mation and technology becomes available.
6. Why does HHS have to regulate methadone
treatment at all?
The Secretary is required by law to regulate
methadone treatment. The Comprehensive Drug
Abuse Prevention and Control Act of 1970, and
the Narcotic Addict Treatment Act of 1974, are
the most recent statutes spelling out this
requirement. The Secretary is required to establish
standards to determine that practitioners are
qualified. The HHS proposal would shift federal
oversight of narcotic treatment programs from
direct inspection by the Food and Drug Adminis-
tration (FDA) to a system administered by the
Substance Abuse and Mental Health Services
Administration (SAMHSA) that relies on
accreditation by independent organizations and
states. Accreditation has been proven over the
years to produce effective outcomes and is a
widely adopted external quality assessment
system used by the federal government, states,
managed care firms, insurers, and others to
ensure accountability for quality treatment.
7. When will these regulations become final?
There is a 120-day comment period. SAMHSA and
FDA will then analyze the comments and produce
a final rule.
8. Will FDA relinquish its day-to-day regulatory
responsibilities while the program is in transition?
A. No. Until the final rule goes into effect and the program is transferred to SAMHSA, FDA will continue its day-to-day regulatory responsibilities, which include approving or disapproving applications for new treatment programs, monitoring programs through periodic inspections, and obtaining compliance, including enforcement actions and proposals to revoke program approval. Eventually, FDA will refocus its efforts on assuring the safety and effectiveness of new treatment modalities and relinquish day-to-day oversight of the treatment programs.
9. When will there be a public hearing?
A separate notice will be published in the Federal Register announcing the date.
10. How do I comment on these proposed regulations?
You may submit your comments on the proposal in the Federal Register by writing to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland 20857. You may fax comments to 301-827-6870, but no one will monitor to ensure completeness. Comments, with an identifying title, may also be e-mailed to [email protected]. More information on these proposed changes is available on the SAMHSA web site at www.samhsa.gov.