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 FDADockets@oc.fda.gov. More information on these proposed changes is available on the SAMHSA web site at www.samhsa.gov.