Frequently Asked Questions About the Proposed New Methadone Regulations

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.

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