Narcotic Drugs in Maintenance and Detoxification Treatment of Narcotic Dependence; Repeal of Current Regulations and Proposal to Adopt New Regulations

SUMMARY: The Secretary of the Department of Health and Human Services

(the Secretary) (DHHS) is proposing to revise the conditions for the

use of narcotic drugs in maintenance and detoxification treatment of

opioid addiction. The proposal includes the repeal of the existing

narcotic treatment regulations enforced by the Food and Drug

Administration (FDA), the creation of a new regulatory system based on

an accreditation model under new 42 CFR part 8, and a shift in

administrative responsibility and oversight from FDA to the Substance

Abuse and Mental Health Services Administration (SAMHSA). This proposal

follows a study by the Institute of Medicine (IOM) and reflects

recommendations by the IOM and several other entities to improve

narcotic addict treatment by allowing for increased clinical judgment

in treatment. The proposal is also part of DHHS's Reinvention of

Government review (Ref. 1).

DATES: Submit written comments on this proposal by November 19, 1999.

Submit written comments on the information collection provisions by

August 23, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20857. Submit comments on the information collection

requirements to the Office of Information and Regulatory Affairs, OMB,

New Executive Office Bldg., 725 17th St. NW., Washington, DC 20503,

Attn: Desk Officer for SAMHSA.

FOR FURTHER INFORMATION CONTACT:

Primary Contact: Nicholas Reuter, Center for Substance Abuse

Treatment (CSAT), SAMHSA, Rockwall II, 5515 Security Lane, Rockville,

MD 20857, 301-443-0457, or

Ellsworth Dory, Center for Drug Evaluation and Research (HFD-342),

Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,

301-827-7264.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction

II. Background

III. Summary of Proposed Rule

IV. Federal Opioid Treatment Standards

V. Legal Authority

VI. Proposed Implementation Plan

VII. Environmental Impact

VIII. Analysis of Impacts

IX. Paperwork Reduction Act of 1995

X. Request for Comments

XI. References

I. Introduction

The use of therapeutic narcotic drugs in the treatment of narcotic

addiction has been the subject of a unique system of Federal regulation

for nearly 30 years. As described as follows, one component of that

system has been the enforcement by FDA of ``process oriented

regulations'' governing the operation of ``narcotic treatment

programs.'' These regulations reflect the fact that narcotic addiction

is an illness with medical and societal origins, the treatment of which

must include careful professional oversight and the availability of

specialized support services. The regulatory system enforced by FDA

also reflects the risks of abuse and diversion that are endemic to

opioid agonist therapy (Ref. 2).

The current regulations and the system for enforcing those

regulations emerged at a time when narcotic maintenance treatment

experience was limited and abuses among practitioners providing

narcotic drug products, including methadone, to narcotic addicts were

not uncommon. In addition, there was considerable diversion of

methadone. Thus, the intent of the current system was to help ensure

quality treatment and reduce the risks of diversion while permitting

further study of the relatively unfamiliar methadone maintenance

treatment modality.

Additional study and experience has demonstrated the value of

narcotic maintenance therapy in reducing drug abuse, criminal behavior,

and infectious disease transmission. However, the narcotic addict

patient population, and the health-care system in general, have changed

dramatically since the inception of the current regulations. Despite

several retrospective reviews and prospective evaluations, the system

has remained essentially unchanged.

For example, compliance with the current system still depends upon

inspections conducted by either FDA or State inspectors, rather than by

expert accrediting teams (as is typical in many other areas of health

care). Second, the regulations themselves have been criticized for

imposing detailed requirements on program physicians and support

personnel in a manner that has been said to stifle clinical judgment,

to the detriment of the patient population. Several aspects of the

current regulations also appear to reflect scientific views on opioid

addiction that may be considered outdated. For example, the current

regulations do not address phases of treatment, with more intense and

focused treatment provided to patients at earlier stages. In addition,

the current regulations emphasize the suppression of abstinence

symptoms in determining appropriate dosing but do not integrate newer

concepts such as ``blockade'' in determining adequate dosing.

Third, the current regulations have been criticized as being overly

``process oriented'' in that they establish administrative requirements

for programs but ignore the need for ``effectiveness standards'' (Ref.

3). It has been said that under the current system, process takes

precedence over performance and that a reemphasis on clinical outcomes

and controls would greatly improve the effectiveness of treatment (Ref.

4).

This proposal would repeal the existing regulatory system and

substitute in its place an accreditation-based system that allows for

greater administrative flexibility, fewer constraints on clinical

judgment, and even more focus on the needs of patients. Among other

things, the new system would increase significantly the direct

participation of the medical community in the oversight of addiction

treatment. Moreover, individual programs will have increased

flexibility to design treatments for specific patients and communities.

This is expected to increase patient compliance and adherence to

therapeutic regimens which, in turn, will increase the likelihood of

successful outcomes.

Part and parcel with the proposed new regulatory approach will be a

shift in administrative and oversight responsibilities. FDA will

refocus its efforts on assuring the safety and effectiveness of new

treatment modalities and will relinquish day-to-

[[Page 39811]]

day oversight of the treatment programs. SAMHSA will take full

responsibility for carrying out the new system on behalf of the

Secretary. The transfer of authority to SAMHSA, whose mission includes

the goal of improving access to high quality programs for the treatment

of addictive and mental disorders, reflects in part the evolution of

methadone treatment from an emerging new drug therapy to a widely

accepted and well understood treatment modality.

II. Background

A. Statutory and Regulatory Developments

The current system by which FDA regulates and monitors the use of

narcotic drugs in the treatment of narcotic addiction began in 1970

with passage of the Comprehensive Drug Abuse Prevention and Control Act

of 1970 (the CDAPCA) (Pub. L. 91-513). Prior to the CDAPCA, FDA's

control over therapeutic narcotic drugs such as methadone, in the

treatment of addiction, was based on FDA's regulation of new drugs

under section 505 of the Federal Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 355).

Section 4 of Title I of the CDAPCA directed the Secretary to

determine, after consultation with the Attorney General and national

organizations, the appropriate methods of professional practice in the

medical treatment of narcotic addiction of various classes of narcotic

addicts (see 42 U.S.C. 257a). The primary intent of the legislation was

to reduce ``uncertainty as to the extent to which [physicians] may

prescribe narcotic drugs for addiction patients'' (Ref. 5). The

legislation also consolidated existing Federal drug control statutes

into the Controlled Substances Act (CSA) and the Controlled Substances

Import and Export Act.

In 1972, FDA issued its narcotic treatment regulations based in

part on the new drug provisions of the act and the CDAPCA. These

regulations provided for a closed distribution system for the treatment

of narcotic addiction, detailed procedures for approval of treatment

programs, medical treatment standards, and procedures for revoking

approval for failure to comply with the standards.

In 1974, Congress enacted the Narcotic Addict Treatment Act (the

NATA) (Pub. L. 93-281) to establish the basis for increased control of

narcotic addict treatment programs by the Attorney General and the

Secretary. The NATA ensured that only confirmed narcotic addicts would

be admitted to maintenance or detoxification treatment, that they would

receive quality care, and that illicit diversions would be limited.

Under the NATA, which amended the CSA (21 U.S.C. 801 et seq.),

practitioners who dispense narcotic drugs in the treatment of narcotic-

dependent persons must obtain an annual registration from the Attorney

General. This authority has been delegated to the Drug Enforcement

Administration (DEA). To be registered, practitioners must comply with

the requirements established by DEA for secure drug storage,

recordkeeping, and unsupervised use; practitioners must be qualified

under the treatment standards established by the Secretary; and

practitioners must comply with standards established by the Secretary

regarding quantities of narcotic drugs for unsupervised ``take-home''

use by persons undergoing treatment (21 U.S.C. 823(g)).

In 1980, FDA and the National Institute on Drug Abuse (NIDA)

jointly issued a final rule (45 FR 62694, September 19, 1980) amending

FDA's narcotic treatment regulations to make them consistent with the

requirements of the CSA, as amended by the NATA, and with implementing

regulations issued by DEA. The amended regulations, codified at

Sec. 291.505 (21 CFR 291.505), have provided the Secretary's regulatory

standards for the use of narcotic drugs in treating narcotic addiction.

The requirements of Sec. 291.505 have represented the minimum

standards for the appropriate methods of professional practice in the

medical treatment of narcotic addiction with narcotic drugs such as

methadone. Under the regulations, FDA approves new programs,

periodically inspects existing programs, and may revoke approval of a

program's application if the program fails to abide by all of the

requirements set forth in Sec. 291.505, or fails to monitor the

activities of those employed in the program.

New legislation enacted in 1992 restructured much of DHHS's drug

abuse services and research responsibilities. Under the Alcohol, Drug

Abuse and Mental Health Administration (ADAMHA) Reorganization Act

(Pub. L. 102-321), ADAMHA was restructured to transfer its substance

abuse and mental health research institutes, including NIDA, to the

National Institutes of Health (NIH), with SAMHSA established to support

and administer programs relating to substance abuse and mental health

prevention and treatment services. Part of SAMHSA's mission is to

improve the provision of substance abuse treatment and ``coordinate

Federal policy with respect to the provision of treatment services for

substance abuse utilizing anti-addiction medications, including

methadone'' (42 U.S.C. 290aa(d)(7)). Within SAMHSA, the Center for

Substance Abuse Treatment (CSAT) has developed and issued comprehensive

Treatment Improvement Protocols (TIPS) and Technical Assistance

Publications (TAPS), including the publication entitled ``Approval and

Monitoring of Narcotic Treatment Programs: A Guide on the Roles of

Federal and State Agencies and State Methadone Treatment Guidelines.''

CSAT has also developed guidelines on phases of treatment and

guidelines on the dosing of Levo-Alpha-Acetyl-Methadol (LAAM), another

approved opioid agonist treatment medication.

In 1993, FDA and SAMHSA revised the methadone regulations to set

forth conditions for authorizing ``interim methadone maintenance.'' The

change, which implemented provisions of the ADAMHA Reorganization Act,

authorizes public and nonprofit private narcotic treatment programs to

provide interim maintenance treatment to patients awaiting placement in

comprehensive maintenance treatment. In addition, the 1993 rule

required all narcotic treatment programs to provide counseling on

preventing exposure to, and preventing the transmission of, human

immunodeficiency virus (HIV) disease (58 FR 495, January 6, 1993).

Finally, the regulations were revised again in 1993 to establish

standards for the use of LAAM in the maintenance treatment of narcotic

addicts (58 FR 38704, July 20, 1993).

B. Current Oversight

FDA has enforced the existing narcotic treatment regulations (part

291 (21 CFR part 291)) by approving programs, monitoring programs

through periodic inspections, and pursuing various means of obtaining

compliance, including enforcement actions and proposals to revoke

program approval. Approximately 900 treatment programs are approved

under the regulations. The number of approved programs has not changed

significantly over the years.

Periodic compliance inspections are carried out by FDA personnel,

who generally have no specialized expertise in drug abuse treatment, or

by State officials under contract with FDA. These inspections are

primarily documentation audits, with an emphasis on appropriate

recordkeeping and control of take-home doses. FDA inspectors typically

focus their review on a sample of patient records to determine whether

the program has

[[Page 39812]]

complied with the regulations. If an inspection results in observations

of possible violations, FDA has several options for bringing the

program into compliance, ranging from informal meetings with the

program to warning letters to proposals to revoke the program's

operating approval.

The frequency with which FDA conducts routine inspections has been

steadily decreasing as FDA continues to focus on its other core

priorities.

C. Evaluations of the Current System

While both the patient population and the health risks associated

with illicit narcotic drug abuse have changed substantially over the

last 30 years, the Federal regulatory framework governing the treatment

of narcotic addiction has remained relatively unchanged. Coordination

among several Federal agencies through the Interagency Narcotic

Treatment Policy Review Board (Ref. 6) (INTPRB) has brought about

modest changes to the existing regulations. The INTPRB helped

coordinate the introduction of interim methadone maintenance and led

several changes that allowed increased flexibility with regard to

issues such as counselor-to-patient ratios and certain reporting

requirements (Ref. 7). Nevertheless, the system that remains in place

today largely remains unchanged from the original regulatory system.

The existing system, for example, has been roundly criticized for

its rigidity and for the constraints it imposes on clinical judgment.

As an expert agency-based panel noted:

Some regulations, although intended to foster quality care, are

based on the premise that a patient's behavior can be adequately

controlled through rules. This idea often conflicts with the

clinician's need to establish a therapeutic alliance and conflicts

with most treatment professionals' understanding that one person is

fundamentally powerless to control the drug use of another (Ref. 8).

Many in the field have also expressed concern about the future of

methadone maintenance treatment under managed care (Ref. 9). Since the

inception of the existing regulations, the health-care system has been

evolving to a managed care environment that relies on quality assurance

assessments and outcome measurements, with careful matching of patient

needs to particular treatment. In such an environment, the enforcement

of process oriented regulations has been criticized as having

``inhibited the development of patient-matching strategies [and]

diverted attention from more clinically focused approaches, such as

matching strategies and treatment guidelines'' (Ref. 10).

Others have criticized the current enforcement process to the

extent that ``[m]onitoring compliance by a regulatory agency is by

definition adversarial,'' and that inspectors are trained to find

violations and not to ``provide technical assistance'' (Ref. 11). Even

the very need for the current regulations has been questioned, with one

commentator noting:

The authorities provided to DEA by the NATA and the 1984 CSA

amendments [which provided DEA with ``public interest'' revocation

authority] themselves are sufficient to prevent the excesses, which

occurred during the late 1960's, of an unregulated narcotic

addiction treatment system. Thus, program registration by both the

FDA and the DEA is duplicative, costly, and unnecessary (Ref. 12).

These types of concerns prompted several noteworthy assessments of

the existing system, including reports by the General Accounting Office

(GAO) and the IOM, and a thorough assessment of these reports and other

relevant data by an interagency-work group.

1. The 1990 GAO Report

In 1990, the GAO issued a lengthy report, based on its review of 24

narcotic treatment programs, analyzing the effectiveness of the

existing narcotic treatment regulations. The report focused on: (1) The

extent of drug use by patients in methadone maintenance treatment

programs; (2) the goals, objectives, and approaches of the treatment

programs; and (3) the types of services available to patients in

treatment.

The report noted a wide disparity in the quality of treatment

provided among the 24 narcotic treatment programs reviewed. The GAO

found that:

* * * policies, goals, and practices varied greatly among the 24

methadone maintenance treatment programs. None of the 24 programs

evaluated the effectiveness of their treatment. There are no federal

treatment effectiveness standards for treatment programs. Instead,

federal regulations are process oriented in that they establish

administrative requirements for programs. Even with regard to these

requirements, federal oversight of methadone maintenance treatment

programs has been very limited since 1982 (Ref. 13).

Based on these findings, the GAO recommended that the Secretary

direct FDA or NIDA, as appropriate, to: (1) Develop result-oriented

performance standards for methadone maintenance treatment programs, (2)

provide guidance to treatment programs regarding the type of data that

must be collected to permit assessment of programs' performance, and

(3) assure increased program oversight oriented toward performance

standards.

In response to the GAO report, NIDA initiated the methadone

treatment quality assurance system (MTQAS). The goal of the MTQAS was

to develop outcome measures to compare the performance of methadone

maintenance treatment programs. In 1993, NIDA developed a survey form

with outcome variables adjusted for variations in case mix. For

example, NIDA used retention in treatment and patient drug abuse as

outcome variables for comparing the performance of individual treatment

programs. Initial results from pilot tests of this system showed that

performance measures, such as retention in treatment and decreased drug

abuse, could in fact differentiate the quality and effectiveness of

treatment.

The GAO report and the new information from MTQAS prompted the

Public Health Service (PHS) to fund a comprehensive study on the

Federal regulation of methadone treatment by the IOM.

2. The 1993 IOM Study

In 1993, NIDA, SAMHSA, and the Office of the Assistant Secretary

for Health funded a 2-year IOM study of the current regulations,

including enforcement issues, quality of treatment, and diversion.

In a report issued in 1995, the IOM concluded that the current

regulations have little effect on the quality of treatment provided in

clinics (Ref. 14). In particular, the report emphasized the need to

balance process oriented regulations with clinical practice guidelines

and quality assurance systems. The IOM found that ``enforceable federal

standards'' are needed, not for medical reasons, but to prevent

substandard or unethical practices, and to maintain community support.

It recommended, therefore, that the regulations be reduced in scope to

be less intrusive and to allow more clinical judgment in treatment.

Clinical practice guidelines, according to the IOM, would ensure that

clinical discretion is exercised in a ``sound manner.''

The IOM report also addressed the current system of enforcing the

regulations, noting costly overlap among multiple Federal, State, and

sometimes local inspections. As a result, the IOM recommended

``reducing the scope of administrative control by FDA and other DHHS

agencies'' (Ref. 15). This reduction in scope of administrative control

would follow the IOM's recommendation that:

FDA, with SAMHSA and NIDA, conduct an extensive review of

methadone enforcement policies, procedures, and practices by all

health agencies of

[[Page 39813]]

government - federal, state, and local - for the purpose of

designing a single inspection format, having multiple elements, that

would provide for (1) consolidated, comprehensive inspections

conducted by one agency (under a delegation of federal authority, if

necessary), which serves all agencies and (2) improve the efficiency

of the provision of methadone services by reducing the number of

inspections and consolidating their purposes (Ref. 16).

Moreover, the IOM recommended that ``DHHS conduct a review of its

priorities in substance abuse treatment, including methadone treatment,

in a way that integrates changes in regulations and the development of

practice guidelines with decisions about treatment financing.''

Finally, the IOM recommended that policy leadership on drug abuse

treatment should be elevated to the Office of the Assistant Secretary

for Health (Ref. 17).

3. The Interagency Narcotic Treatment Policy Review Board

In response to these recommendations, the Assistant Secretary for

Health requested that the Interagency Narcotic Treatment Policy Review

Board (INTPRB), which had been formed in the early 1970's to coordinate

Federal policy regarding the use of methadone, evaluate the IOM's

findings and recommendations. Membership on the INTPRB included

representatives from FDA, NIDA, SAMHSA (including CSAT), the Office of

the Secretary, the DEA, the Department of Veterans Affairs (VA), and

the Office of National Drug Control Policy (ONDCP). Representatives

from two other DHHS agencies, the Agency for Health Care Policy and

Research and the Health Care Financing Administration (HCFA), were also

included at various times.

After careful consideration of the IOM's work and all that

preceded, the INTPRB concluded that a regulatory system centered around

a core set of Federal treatment standards, in conjunction with

monitoring of treatment programs through private accreditation, would

be both feasible and preferable to the existing system.

First, the INTPRB reasoned that an accreditation-based system would

be more consistent with the oversight approach in most other health-

care fields. For example, HCFA relies on accreditation to certify

approximately 7,000 hospitals that provide services to Medicare

patients. In addition, under the Clinical Laboratory Improvement Act of

1988 (CLIA), private accreditation is now used as the primary basis for

certifying human clinical laboratories.

Moreover, a number of narcotic treatment programs are already

subject to accreditation standards and inspections. As noted in the IOM

report, approximately 5 percent of the methadone maintenance patients

in the United States are treated in facilities under the VA medical

system (Ref. 18), all of which are subject to outside accreditation.

In addition, the INTPRB found that interest in accreditation is

increasing steadily, due at least in part to its emphasis on self

assessment and improvement, and on the integration of quality assurance

and performance elements developed by expert accreditation

organizations. The expanded use of accreditation, particularly in the

substance abuse field, is reflected in the number of national

accreditation bodies with standards for substance abuse treatment. The

Joint Commission on the Accreditation of Healthcare Organizations

(JCAHO) and two other national accreditation bodies, the Commission on

Accreditation of Rehabilitation Facilities (CARF) and the Council on

Accreditation of Services for Families and Children, Inc. (COA), have

significant experience in accrediting substance abuse treatment

programs. CARF conducts approximately 1,000 surveys each year (Ref. 19)

and more than 100 entities, including the Federal government, have

accepted accreditation by CARF. COA accredits approximately 1,000

behavioral health-care programs and 3,000 social service programs

annually (Ref. 20). CARF, COA, and JCAHO all have developed or

expressed an interest in developing methadone treatment accreditation

standards.

The INTPRB also concluded that an accreditation-based system would

improve the quality of treatment by increasing the participation of the

treatment community in establishing measures for determining the

effectiveness and overall success of treatment programs. Some have

attributed problems in the methadone treatment area to the absence of

the medical profession's participation in determining the standards of

care in this area (Ref. 21). Professional accreditation bodies are

expected to be able to focus closely on those aspects of treatment

that, if maintained at appropriate levels, will show a measurable

improvement in treatment outcomes and a measurable improvement in the

overall quality of the medical care. Also, because of its widespread

use in health care, an accreditation-based regulatory system may also

help to mainstream the medical treatment of narcotic dependence.

The INTPRB also reasoned that accreditation could significantly

improve program performance, especially at poorly functioning programs,

by providing much-needed advisory services that generally have been

lacking under the existing system.

Importantly, the INTPRB noted that an accreditation-based system

provides an opportunity to reduce the layers of inspections from

Federal, State, and local regulatory entities. State authorities may

choose to apply to act as accreditation bodies for programs in their

jurisdiction and, if approved, would consolidate inspections and

minimize burdens. Alternatively, State authorities could adopt

accreditation body findings. At least one State, Ohio, accepts as

documentation of a program's compliance with State standards a

program's accreditation by any of the leading private accreditation

bodies (Ref. 22).

Overall, the INTPRB concluded that fewer resources would be

expended at the Federal level. While there would be costs to the

government in monitoring accreditation bodies, assuring that

accreditation body elements are appropriate, and reviewing and

approving guidelines, the overall cost should be less than that of the

present system. Treatment programs would be expected to absorb modest

accreditation fees, but treatment quality would be greatly improved by

being more closely matched to patient needs.

In addition, accreditation holds out the prospect for more

efficient treatment which, in time, would allow for more treatment at a

lower cost to payers. Indeed, with its similarity to HCFA's oversight

of Medicare and Medicaid programs, the accreditation-based regulatory

system provides the potential for a model system that unifies

``financing, treatment, and the regulation of services'' as envisioned

by the IOM and others:

Service providers have demanded that accrediting and regulatory

bodies conduct their reviews jointly and/or at least accept all or

part of each other's standards, reviews and reports as equivalent.

It is a hopeful sign that in at least 23 states, the surveys of the

JCAHO and of state health departments are being conducted jointly,

and 17 others are considering such arrangements. These

collaborations have been commended by the General Accounting Office

of the U.S. Congress, as cost-containing efforts that successfully

reduce some of the duplication of preparation and the overuse of

scarce resources, which could better be used toward the improvement

of quality of care (Ref. 70).

The INTPRB in April 1995 forwarded its recommendations to the

Assistant Secretary for Health who, thereafter, solicited views from

all Federal agencies with a substantial interest in therapeutic and

controlled substances. After

[[Page 39814]]

receiving and evaluating endorsements from other agencies, the

Assistant Secretary for Health concluded that DHHS should take all

necessary steps to phase out the existing regulatory approach and adopt

in its place an accreditation-based system centered around a limited

set of core Federal treatment standards.

In September 1995, the Assistant Secretary for Health assigned to

SAMHSA responsibility for developing the new regulatory approach.

Subsequently, an interagency workgroup of the INTPRB, with

representatives from DHHS (including SAMHSA, FDA, and NIDA), DEA, VA,

and ONDCP, was formed to develop the new system, including the

development of this proposed rule.

4. NIH Consensus Development Conference

On November 17 to 19, 1997, NIDA, the NIH Office of Medical

Applications Research, and the NIH Office of Research on Women's Health

sponsored a consensus development conference on the effective medical

treatment of heroin addiction. NIH convened this conference to present

the available data on opioid agonist treatment for heroin addiction in

order to address the most important and controversial issues

surrounding narcotic maintenance treatment. The independent panel

concluded that opioid addiction is a medical disorder and that

pharmacologic agents, such as methadone and LAAM, are effective in its

treatment. The panel also addressed barriers to such treatment,

including the existing regulations:

However well-intentioned the FDA's treatment regulations when

written in 1972, they are no longer necessary. We recommend that

these regulations be eliminated. Alternative means, such as

accreditation, for improving the quality of [opioid treatment]

should be instituted (Ref. 23).

5. State Licensure and Accreditation Activities

Many States have adopted requirements that are more rigorous than

the FDA standards alone. These requirements most often are imposed

through licensure or funding authorities. Licensure in these States

often involves a costly annual inspection program. However, the degree

of oversight varies enormously across and within States. For example,

many States require at least annual State licensure reviews. Of these,

only one State has regulations that do not include more stringent

compliance requirements than the FDA standards alone. Other States,

beyond initial opening requirements, rely almost exclusively on FDA and

DEA oversight of methadone programs for assuring continued compliance

with those standards and regulations.

FDA's model allows for more intense oversight by States, but does

not require it. Thus, many of the same problems that have been

identified at the Federal level have not necessarily been corrected at

the State level unless specifically addressed by a given State. To

raise the standard of care consistently throughout the country,

standards issued and/or required at the Federal level will have to

rise. Standards on which accreditation is based are generally viewed as

the highest standards of care.

At least one State, Michigan, has both a licensing and an

accreditation requirement. Michigan requires opioid treatment programs

(OTP's) to be accredited as a condition of receiving Medicaid and block

grant funds. DHHS understands that a number of private payers in

Michigan also require methadone programs to be accredited in order to

receive payment for services. Payers in Michigan appear to have decided

that opioid treatment should be held to the standards to which health-

care providers are held, and payers in Michigan generally require

hospitals and clinics to be accredited as a condition of participation.

In fact, a large number of private payers throughout the nation as a

whole require accreditation as a means to insure that the health care

meets standards of quality and appropriateness. Based on discussion

with officials in Michigan, the move to accreditation for substance

abuse programs has raised standards of care. Almost all OTP's in

Michigan have been accredited under this system, and it has been noted

that almost all of these OTP's increased the number of patients in

treatment after receiving accreditation.

6. Conclusion

This notice of proposed rulemaking (NPRM) addresses the problems

and potential of opioid agonist treatment which so far in the United

States has been limited to methadone and LAAM treatment. The NPRM is

consistent with national policy and direction regarding the role of

methadone and LAAM and other opioid agonist treatments in reducing

opiate addiction. Indeed, the Office of National Drug Control Policy

(ONDCP), in its ``Policy Paper--Opioid Agonist Treatment,'' highlights

this proposed accreditation-based regulatory system as a key element in

improving the quality of methadone treatment and expanding treatment

capacity (see appendix 1). The ONDCP Policy Paper notes that in

addition to a shortfall in treatment capacity, problems in the opioid

agonist treatment system have long existed at two levels: (1) OTP's

have not functioned with uniform high quality; and (2) Federal

oversight, grounded in process-focused regulations, has not served to

improve or maintain the quality of OTP's. To reduce the use of heroin

and illicit opioid drugs, both of these problems must be addressed.

Methadone, the most effective treatment for chronic opioid

addiction, has been used for the treatment of heroin addiction since

the 1960's. It is an effective, long-acting, synthetic opioid agonist

that is taken orally. Methadone blocks the craving and produces

tolerance to its own analgesic effects and psychoactive effects. When

used properly, at adequate doses, it also produces a physiological

cross-tolerance to other opioids, rendering the patient unable to

experience pharmacologic pleasure from the administration of practical

doses of other opioids. Treatment with methadone requires daily dosing;

LAAM blocks the effects of injected heroin for up to 3 days.

This NPRM introduces a model accreditation system for OTP's, with

transfer of regulatory oversight from FDA to SAMHSA. The current,

process-oriented regulatory approach, with routine inspections by HHS

(FDA) staff, will be replaced by a clinically-based accreditation

system, with additional oversight from SAMHSA.

D. Long Term Goals and Interim Steps

The long-term goals of this initiative are to make Federal

oversight more effective, reduce the variability in the quality of

opioid treatment services, and reform the treatment system to provide

for expanded treatment capacity. This requires a comprehensive set of

reforms including, but not limited to, the changes proposed in this

document.

By incorporating accreditation into the oversight model as

proposed, DHHS will be better able to identify and assist poorly

functioning programs. Accreditation reviews will be conducted every 3

years by experts in the field of substance abuse treatment. Oversight

will be more effective because medical experts, including addiction

treatment specialists, will be conducting the onsite reviews. In

addition, the onsite reviews will include a focus on treatment outcomes

rather than simply measuring adherence to process-oriented standards.

Importantly, the shift to an accreditation model will result in a

treatment system more responsive and accountable to the

[[Page 39815]]

public's desire to see improvement in outcomes of addiction care.

Elsewhere in this proposed rule, DHHS describes a transition plan

that sets forth a timetable for moving from the existing purely

regulatory system to the accreditation-based system. In addition, DHHS

has taken several key steps to ensure that the eventual implementation

of an accreditation-based system will be accomplished in the least

disruptive manner possible. CSAT has awarded a contract to CARF in 1997

and JCAHO in 1998 for development of accreditation guidelines and to

conduct accreditation surveys of a cohort of treatment programs.

Technical assistance will be provided to assist programs in preparing

for and working with these accreditation guidelines.

The impact of accreditation on these programs will be studied over

time and the findings used to help improve the accreditation approach.

SAMHSA's CSAT has developed a project to study the impacts of

accreditation using both existing standards and newly developed,

methadone/LAAM specific standards, in a cohort of OTP's. This

assessment will also help familiarize existing treatment programs with

the accreditation process as it becomes the new standard. Finally, the

study will allow for the phasing in of accreditation by providing

administrative feedback that can be used to adjust the implementation

of accreditation in such a manner as to minimize any potential

disruptive effects. The Secretary believes that this study will

demonstrate that programs will be able to achieve accreditation with

minimal disruption to treatment capacity.

III. Summary of Proposed Rule

The Secretary is proposing to add new part 8 under title 42 of the

Code of Federal Regulations to codify the new accreditation-based

system. The proposal also includes the repeal of the existing FDA-

enforced narcotic treatment regulations at 21 CFR part 291, which would

go into effect when the new regulations are finalized and effective.

The Secretary will delegate to SAMHSA the authority to oversee the new

program proposed under 42 CFR part 8.

The proposed regulations establish the procedures by which the

Secretary will determine whether a practitioner is qualified under

section 303(g) of the CSA (21 U.S.C. 823(g)(1)) to dispense certain

therapeutic narcotic drugs in the treatment of individuals suffering

from narcotic addiction. These regulations also establish the

Secretary's standards regarding the appropriate quantities of narcotic

drugs that may be provided for unsupervised use by individuals

undergoing such treatment (21 U.S.C. 823(g)(3)). (See also 42 U.S.C.

257a.)

Under the proposed regulations, a practitioner who intends to

dispense narcotic drugs in the treatment of addiction must first obtain

from the Secretary or her delegated authority, SAMHSA, a certification

that the practitioner is qualified under the Secretary's standards and

will comply with such standards. Eligibility for certification will

depend upon the practitioner obtaining accreditation from a private

nonprofit entity, or from a State agency, that has been approved by

SAMHSA to accredit narcotic treatment programs.

The proposed new regulations are divided into three parts, subpart

A, subpart B, and subpart C. Subpart A addresses accreditation that

includes, at proposed Sec. 8.3, the sequence of events that

accreditation bodies will follow to achieve approval to accredit OTP's

under the new system. It also establishes in proposed Sec. 8.4 the

accreditation bodies' responsibilities, including the use of

accreditation elements during accreditation surveys. Subpart B of part

8 sets forth the sequence and requirement for obtaining certification.

This section addresses how and when programs must apply for initial

certification and renewal of their certification. DHHS's opioid

treatment standards are included in this section and are segregated for

a separate detailed discussion because of their importance. Subpart C

of part 8 establishes the procedures for review of either withdrawal of

approval of the accreditation body or the suspension or proposed

revocation of an OTP certification. This section addresses procedural

and informational requirements in the event of a challenge to a SAMHSA

determination.

A. Subpart A--Accreditation

Subpart A of part 8 would establish the procedures whereby an

entity can apply to SAMHSA to become an approved accreditation body.

This part also establishes ``accreditation body responsibilities'' and

general standards for accreditation bodies to ensure that practitioners

are consistently evaluated for compliance with the Secretary's

standards for opioid treatment.

1. Definitions and Related Requirements

Section 8.2 in subpart A defines a number of key terms for purposes

of applying 42 CFR part 8. Most of these proposed definitions are

identical or similar to those set forth under the existing regulations

at Sec. 291.505(a). Several, however, are unique to the new

accreditation-based system and require brief mention.

For example, the Secretary is proposing to define the term

``accreditation body'' to mean a body that has been approved by SAMHSA

under proposed Sec. 8.3 to accredit OTP's. Under proposed Sec. 8.3(a),

private nonprofit organizations as well as State governmental entities,

including a political subdivision of a State (such as a county) may

apply to serve as an accreditation body. The Secretary believes that

allowing States to serve as accreditation bodies may also help expedite

the transition of previously approved programs to the new system.

It should be noted, however, that the Secretary is proposing in

Sec. 8.3 to limit eligibility to those applicants (including States and

political subdivisions of a State) who demonstrate that they will be

able to accredit at least 50 OTP's per year. The Secretary believes

that this requirement is needed to ensure the quality of the

accreditation services performed by accreditation bodies and to

minimize the variability in the standards used by accrediting

organizations. The Secretary is interested in comments on this

restriction and may revisit this requirement after the first 3 years.

Under the proposal, prospective accreditation bodies will be

required to develop and submit as part of an application for approval,

``accreditation elements''. These elements, which are defined in

proposed Sec. 8.2, are the elements that the accreditation body will

apply during ``accreditation surveys'' as the basis or benchmark for

determining whether a treatment program should receive accreditation.

The accreditation elements are expected at a minimum to incorporate the

``Federal opioid treatment standards'' issued by the Secretary in

proposed Sec. 8.12, albeit with much greater detail. One focus of

SAMHSA's oversight of the accreditation system will be the development

and publication of up-to-date treatment guidelines to assist

accreditation bodies in developing accreditation elements. It is also

expected that an essential part of the accreditation elements will be

clinical outcome and performance measures. Again, SAMHSA expects to

issue detailed guidance on the development of such measures.

As mentioned previously, accreditation bodies will base their

accreditation decisions on experience gained during onsite ``surveys,''

as defined in proposed Sec. 8.2. The accreditation body's policies and

procedures for conducting surveys will

[[Page 39816]]

be a major focus of the application process under proposed Sec. 8.3.

The Secretary expects these accreditation body surveys to, in large

measure, take the place of onsite inspections by DHHS investigators as

the primary means of monitoring the operations of OTP's. Nevertheless,

it is important to note that the Secretary has retained the right to

conduct inspections of programs, including ``for-cause inspections,''

as defined in proposed Sec. 8.2. A ``certified opioid treatment

program,'' as defined in proposed Sec. 8.2(i), is an organization that

administers or dispenses ``opioid agonist treatment medications'' (see

proposed Sec. 8.2(t)) for maintenance or detoxification treatment of

opioid addiction, and that is the subject of a current certification

issued by SAMHSA under proposed Sec. 8.11. As discussed below, to

obtain certification from SAMHSA, under proposed Sec. 8.11, a treatment

program must, at a minimum, ``be the subject of a current, valid

accreditation by an accreditation body approved by SAMHSA * * *.''

Certification will be granted for a period not to exceed 3 years and

will serve as the final determination by the Secretary that the program

is ``qualified,'' as that term is used under section 303(g) of the CSA

(21 U.S.C. 823(g)).

It is important to note that the proposed definition of a

``certified opioid treatment program'' includes individual

practitioners, such as private physicians. Although the term

``practitioners'' was used in the NATA, historically there have been

few individual practitioners who have applied to dispense methadone or

LAAM under the existing regulations. The Secretary is aware, however,

that there is considerable interest in the issue of physicians in

private or group practices providing opioid treatment outside the

traditional OTP setting.

The intent of this proposal is to develop a process for certifying

qualified providers to dispense opioid drugs in the treatment of opioid

addiction. Ideally, the proposed process would be sufficiently flexible

to allow individual practitioners themselves to provide such services.

Admittedly, the proposed Federal opioid treatment standards in some

instances may not be well suited to office-based treatment. The

Secretary therefore is specifically seeking comment on how the Federal

opioid treatment standards might be modified to accommodate office-

based treatment and on whether a separate set of Federal opioid

treatment standards should be included in this rule for office-based

treatment.

The proposal also retains the concept of ``medication units,'' as

defined in proposed Sec. 8.2(s). A ``medication unit'' is a facility

established as part of, but geographically dispersed from, the central

location of an OTP. Licensed private practitioners and community

pharmacists are permitted to administer and dispense opioid drugs from

medication units without seeking a separate accreditation or a separate

certification from SAMHSA. (Medication units, however, may require

separate registration from DEA under section 303(g) of the CSA and 21

CFR part 1300.) These units are also authorized to collect samples for

drug testing or analysis for narcotic drugs. Medication units can serve

to decrease the burden of patients who must travel considerable

distances to obtain medication. SAMHSA must be notified before a

medication unit can begin to provide opioid treatment medications to

patients.

Finally, the Secretary has proposed as a definition of the term

``opioid addiction,'' in proposed Sec. 8.2(u), a condition in which an

individual exhibits a compulsive craving for, or compulsively uses,

opioid drugs despite being harmed or causing harm as a result of such

craving or use. This definition reflects the idea that an individual

suffering from opioid addiction may not exhibit concurrent physical

dependence on opioids, as evidenced by the onset of signs of withdrawal

upon administration of an opioid antagonist or following the last dose

of an opioid drug.

2. Accreditation Body Approval and Related Requirements

Proposed Sec. 8.3 outlines the process for applying to SAMHSA to

become an approved accreditation body. The initial accreditation

application shall include the name, address, and telephone number of

the applicant and a responsible official for the application signed by

the responsible official. The application also requires evidence of the

nonprofit status of the applicant if the applicant is not a State

governmental entity or political subdivision. The application must also

include evidence that the applicant will be able to survey no less than

50 OTP's annually.

This section also requires that the application include a set of

accreditation elements and a detailed discussion showing how the

elements will ensure that each OTP surveyed by the applicant is

qualified to meet or is meeting each of the Federal opioid treatment

standards set forth in proposed Sec. 8.12. An accreditation body must

also include a detailed description of its decisionmaking process. The

process shall include procedures for initiating and performing onsite

accreditation surveys of OTP's and the procedures for assessing OTP

personnel qualifications.

The accreditation body must submit copies of the application used

for accreditation, along with guidelines, instructions, and other

materials to be sent to OTP's during the accreditation process. This

includes a request for a complete history of prior accreditation

activities and a statement that all information and data submitted in

the application for accreditation are true and accurate, and that no

material fact has been omitted. Applicant accreditation bodies must

also submit the policies and procedures for notifying OTP's and SAMHSA

of deficiencies and for monitoring corrections of deficiencies by OTP's

and policies and procedures for suspending or revoking an OTP's

accreditation. The application shall include the policies and

procedures that ensure processing of applications for accreditation and

applications for renewal of accreditation within a timeframe approved

by SAMHSA. Accreditation bodies must submit a description of the

applicant's appeals process to allow OTP's to contest adverse

accreditation decisions.

The application also must include a description of the policies

and procedures established by the accreditation body to avoid conflicts

of interest or the appearance of conflicts of interest by the

applicant's board members, commissioners, professional personnel,

consultants, administrative personnel, and other representatives. In

addition, the applicant must submit a description of the education,

experience, and training requirements of the applicant's professional

staff, accreditation survey team membership and the identification of

at least one licensed physician on the applicant's staff and a

description of the applicant's training policies. The application must

include fee schedules, with supporting cost data. Applicant

accreditation bodies must provide satisfactory assurances that the body

will comply with the requirements of proposed Sec. 8.4, including a

contingency plan for investigating complaints under proposed

Sec. 8.4(e). Finally the application must include policies and

procedures established to protect confidential information the

applicant will collect or receive in its role as an accreditation body

and any other information SAMHSA may require.

Proposed Sec. 8.4 sets forth accreditation body responsibilities.

Accreditation bodies will be responsible for conducting accreditation

surveys and to take actions based upon the results of

[[Page 39817]]

these surveys. In addition, the accreditation body will have to keep

certain records and submit periodic reports. Under proposed Sec. 8.5,

SAMHSA will periodically evaluate the performance of accreditation

bodies by inspecting a sample of OTP's that have been surveyed by the

accreditation body and determining whether there are deficiencies that

would warrant the withdrawal of the approval of the accreditation body

under proposed Sec. 8.6. Proposed Sec. 8.6 establishes the actions and

procedures that SAMSHA will take if it determines that an accreditation

body is not complying with the requirements in this rule. This section

describes contingencies for major and minor accreditation body

deficiencies, including probationary status and reinstatement. Finally,

proposed Sec. 8.6, provides an opportunity for accreditation bodies to

challenge an adverse finding by requesting a hearing. Proposed

Secs. 8.7 through 8.10 are reserved.

These provisions were developed after consulting other Federal

agencies, including the VA and the HCFA, and after reviewing existing

accreditation systems. DHHS has also carefully reviewed existing

certification-accreditation oversight systems, including FDA's

mammography regulatory system. As such, DHHS believes that these

provisions are reasonable and reflect what has become a standard

approach for ensuring the quality of health-care practices. Similarly,

it is customary for oversight agencies to validate the performance of

accreditation bodies through periodic direct inspections of

establishments that have or have not received full accreditation. DHHS

believes that validation inspections are a reasonable and efficient

mechanism for ensuring that approved accreditation bodies are carrying

out their responsibilities.

a. Patient confidentiality. The patient records maintained by OTP's

are subject to the confidentiality protections of State and Federal

laws. With respect to patient confidentiality, section 543 of the PHS

Act (42 U.S.C. 290dd-1) and its implementing regulations, 42 CFR part

2, are fully applicable to OTP's. OTP's are ``programs'' as defined by

42 CFR 2.11 and are ``federally-assisted'' as defined by 42 CFR

2.12(b)(2). Under these regulations, the treatment programs are

prohibited from disclosing patient identifying information except in

certain prescribed circumstances such as under patient consent, for

purposes of research, audit or evaluation, or under a court order

consistent with subpart E of 42 CFR part 2.

The regulations at 42 CFR part 2 would permit programs to disclose

patient records to accreditation bodies under the audit and evaluation

exception at 42 CFR 2.53. To the extent that the accreditation body

needs to copy records containing patient identifying information, it

must agree in writing to: (1) Maintain the patient identifying

information in accordance with the security requirements provided in 42

CFR 2.16 of the regulations, (2) destroy all patient identifying

information upon completion of the audit or evaluation, and (3) comply

with the limitations on redisclosure of 42 CFR 2.53(d).

b. Prevention of conflicts of interest. With respect to conflicts

of interest, the Secretary is proposing that accreditation bodies must

submit to SAMHSA, as part of an application for approval under proposed

Sec. 8.3(b)(6), the policies and procedures maintained by the

accreditation body to ensure that the body remains impartial and free

of commercial, financial, and other pressures that might present an

actual or apparent conflict. Although it is not possible to state

categorically all of the criteria for assessing whether an

accreditation body will be free of conflicts, the most common condition

that would indicate a potential conflict would be one in which any

member of the accreditation team (or an immediate family relative) has

a financial interest of any type, direct or indirect, in the treatment

program to which the team is assigned. Likewise, it may be appropriate

that anyone employed by the accreditation body who is involved in any

respect in the accreditation decision for a particular program must be

free of a financial interest in the program. DHHS seeks comments on the

types of financial conflicts that should be prohibited, or on the

amount of financial interest that may be considered de minimus such

that it would not rise to a conflict of interest. Fees charged to

programs must in no way be made contingent, in whole or in part, on a

particular accreditation decision or outcome.

B. Subpart B--Certification and Treatment Standards

Subpart B of part 8 proposes the process by which OTP's may obtain

certification from SAMHSA, the conditions necessary for remaining

certified, and the process by which SAMHSA may suspend or revoke

certification. In addition, subpart B of part 8 proposes the

Secretary's Federal opioid treatment standards.

1. OTP Certification

Under proposed Sec. 8.11, treatment programs must obtain

certification from SAMHSA for the program to be considered

``qualified'' by the Secretary under 21 U.S.C. 823(g). Certification

will be for a term not to exceed 3 years but may be extended as

necessary, with permission from SAMHSA, to accommodate accreditation

cycles.

A program must obtain a current, valid accreditation from a SAMHSA

approved accreditation body in order to be considered eligible for

certification. Although SAMHSA expects that most programs that obtain

accreditation will, as a matter of course, obtain certification, there

are circumstances in which SAMHSA could deny certification to an

accredited program. Under proposed Sec. 8.11(c)(2), SAMHSA may deny

certification if a program's application for certification (see

proposed Sec. 8.11(b)) is deficient in any respect; if SAMHSA

independently determines that the program will not be operated in

accordance with the Federal opioid treatment standards; if the program

has improperly denied access to the facilities or to its records; or if

it is determined that the program has in any respect made

misrepresentations or omitted material facts in the course of obtaining

accreditation or applying for certification. Although it is expected

that a denial of certification for a program that has obtained

accreditation would be a rare occurrence, the Secretary nevertheless

has retained the authority to deny certification. Likewise, the

Secretary has retained the authority to independently certify a program

that has not obtained accreditation. Again, this authority would be

used only in rare circumstances.

Proposed Sec. 8.11(d) provides for ``transitional certification''

during the period when the former regulations at part 291 will have

been repealed and the new accreditation based regulations, under 42 CFR

part 8, are just beginning to be implemented. The intent of these

provisions is to allow programs that were approved under the old

regulations to remain in operation for a reasonable period of time so

that there is sufficient time for: (1) SAMHSA to approve one or more

accreditation bodies, (2) programs to apply for and obtain

accreditation from one of the approved accreditation bodies, and (3)

SAMHSA to make certification decisions based on the outcome of the

accreditation process.

First, OTP's that have not obtained certification from SAMHSA, but

are the subject of a current approval by FDA

[[Page 39818]]

under part 291 as of the effective date of the regulation will be

granted ``transitional certification'' for a period of 90 days after

the effective date of the final rule. Under the proposal, programs that

are granted transitional certification must apply to SAMHSA during this

90-day period to extend their transitional certification for up to 2

years from the effective date of the regulation. To extend transitional

certification, an OTP must submit the information that would be

required in a new application for certification (proposed

Sec. 8.11(b)). In addition, the program must include a statement

certifying that the OTP will apply for accreditation from a SAMHSA

approved accrediting body within 90 days from the date SAMHSA approves

the first accreditation body under proposed Sec. 8.3. SAMHSA intends to

announce the approval of accreditation bodies in the Federal Register

and through other media. In addition, if a program has applied for

accreditation but the accreditation body is unable to complete its

survey prior to 2 years from the effective date of this regulation,

SAMHSA may extend a program's transitional certification for up to 1-

additional year.

It should be noted that the Secretary is proposing that treatment

programs will be subject to the requirements of these rules upon the

effective date. SAMHSA will be overseeing the regulations and will be

monitoring programs during the 90-day application period as well as

subsequently in accordance with the regulations. It is expected that 3

years will be sufficient time for all OTP's to become accredited,

although the Secretary would expect that most programs will be

accredited within 2 years.

Proposed Sec. 8.11 also provides a mechanism to allow for

``provisional certification'' when a program is diligently pursuing

accreditation. Under Sec. 8.11(e), OTP's that have not previously

obtained certification from SAMHSA, but have applied for accreditation

with an accreditation body, are eligible to receive a provisional

certification for up to 1 year. To receive a provisional certification

for up to 1 year, an OTP must submit the information set out in

Sec. 8.11(b) to SAMHSA along with a statement identifying the

accreditation body to which the OTP has applied for accreditation, the

date on which the OTP applied for accreditation, the dates of any

accreditation surveys that have taken place or are expected to take

place, and the expected schedule for completing the accreditation

process. A provisional certification for up to 1 year will be granted,

following receipt of the information described in this paragraph,

unless SAMHSA determines that patient health would be adversely

affected by the granting of provisional certification.

An extension of provisional certification may be granted in

extraordinary circumstances or otherwise to protect public health. To

apply for a 90-day extension of provisional certification, an OTP must

submit to SAMHSA a statement explaining the program's efforts to obtain

accreditation and a schedule for obtaining accreditation as

expeditiously as possible.

Proposed Sec. 8.11 also addresses the use of opioid treatment

medications in patients hospitalized or admitted to long-term care

facilities for treatment of a medical condition other than opioid

addiction. Under proposed Sec. 8.11(a)(4), the Secretary will not

require such facilities to seek certification in order to provide

maintenance or detoxification treatment to a patient who has been

admitted for medical conditions other than addiction or if the patient

is already enrolled in a certified OTP and such enrollment has been

verified. The terms ``hospital'' and ``long-term care facility'' are

determined according to the law of the State in which the facility is

located. This provision is not intended to relieve hospitals and long-

term care facilities from their obligations for registration under

section 303(g) of the CSA and under regulations issued by DEA (see 21

CFR 1306.07(c)).

Under DEA's regulations, DEA requires (and will continue to

require) registration of such facilities if approved controlled

substances are dispensed or administered from a location, such as a

long-term care facility, even though the controlled substances are not

stored overnight. Further, if an OTP patient is admitted to a hospital

for anything other than addiction, the hospital can administer or

dispense a narcotic drug to maintain or detoxify a person as an

incidental adjunct to medical or surgical treatment during the term of

the stay in the hospital. However, because long-term care facilities

are not considered hospitals by DEA, patients in long-term care

facilities cannot currently receive methadone as an adjunct to medical

or surgical treatment of conditions other than addiction unless the

facility is registered with the DEA. However, if the individual was

formerly a patient in an OTP, the OTP may transfer the opioid

medication (i.e., methadone or LAAM) to the long-term care facility

under a delivery protocol which complies with State and Federal

regulations.

Section 8.11(f) proposes the general conditions of certification.

First, under the proposal, OTP's must agree to comply with all

applicable State laws and regulations. The Secretary, however, will not

require State approval of a program as a condition precedent to

obtaining certification under proposed Sec. 8.11(c). DEA regulations

will continue to require State approval before issuing a DEA

registration.

As provided in the CSA, the Secretary's role in the oversight of

narcotic treatment is to set standards for the appropriate use of

narcotic drugs in the treatment of addiction, and then to ensure

compliance with those standards. The States, on the other hand, have a

broader set of responsibilities, including regional and local

considerations such as the number and distribution of treatment

facilities, the structural safety of each facility, and issues relating

to the types of treatment that should be available. For example, under

the ADAMHA Reorganization Act of 1992, the Chief Public Health Officer

within a State must certify that interim methadone maintenance will not

``reduce the capacity of comprehensive programs'' within the State. In

addition, some States consider the proximity of other treatment

programs in deciding whether to approve a treatment program, or the

number of treatment programs currently operating in the State (Refs. 25

and 26). And, at least one State limits methadone treatment to

nonprofit programs (Ref. 27).

Nothing in this part is intended to restrict State governments from

regulating the use of opioid drugs in the treatment of opioid

addiction. Importantly, there will still be extensive cooperation

between SAMHSA and relevant State authorities. However, in determining

whether an OTP that is applying for certification satisfies the

requirements of section 303(g) of the CSA (21 U.S.C. 823(g)), the

Secretary will not require that the program first obtain approval from

a relevant State authority.

Second, treatment programs must agree to allow SAMHSA, DEA

officials, relevant State officials, and authorized accreditation

bodies access to conduct surveys and inspections (including unannounced

inspections), and full access to patient records. Failure to allow such

access will be grounds for denial of certification or, in the case of a

certified facility, suspension or revocation of certification under

proposed Sec. 8.14(a)(4). Note also that SAMHSA will continue to

conduct inspections of OTP's to validate the performance of

accreditation bodies, in instances where accreditation is determined to

be inadequate and otherwise as needed to ensure that all treatment

programs are operating in a

[[Page 39819]]

manner consistent with the Federal opioid treatment standards.

Third, the proposal retains under Sec. 8.11(g) the provisions and

requirements for authorizing interim methadone maintenance program

approval. These provisions were mandated by the ADAMHA Reorganization

Act of 1992 and remain in effect. Under proposed Sec. 8.12(e), SAMHSA

will process requests for interim maintenance approval.

The proposal retains, under Sec. 8.11(h), a provision that allows

an OTP to request from SAMHSA an exemption from the regulatory

requirements set forth under proposed Secs. 8.11 and 8.12. An example

of a case in which an exemption might be granted would be for a private

practitioner seeking to treat a limited number of patients in an area

with few physicians and no geographically accessible rehabilitative

services. In such an instance, SAMHSA would consider a request for an

exemption from certain of the staff credential or required services

standards, as well as an exemption from the requirement to be

accredited. Another example would be an exemption that might be granted

to a State sponsored pilot program which uses innovative dose schedules

or dispensing practices for an already approved opioid agonist

treatment medication.

Finally, the proposal requires as a condition of continued

certification that programs must notify SAMHSA within 3 weeks regarding

any change in the status of the program sponsor, such as a corporate

reorganization, or a change in the status of the medical director, such

as the retirement or termination of the individual in that role.

2. Federal Opioid Treatment Standards

Proposed Sec. 8.12 proposes the Secretary's ``Federal opioid

treatment standards'' as enforceable regulatory requirements that

treatment programs must follow as a condition of certification. The

requirements, which are discussed in greater detail as follows, address

the opioid drug products approved for use in certified OTP's, dosage

form limitations, the requirements necessary to assure that medications

dispensed for unsupervised or ``take-home'' use do not present

inappropriate risks for diversion, the minimum program staffing

requirements and staff responsibilities, admission and enrollment

requirements, and required services. These standards will form the

outline for, and will inform the development of, each accreditation

body's approved accreditation elements.

Proposed Secs. 8.13 and 8.14 address the process that SAMHSA will

follow in suspending or revoking certification under these regulations.

The proposal includes timeframes for notifying DEA when a treatment

program's registration should be suspended or revoked. In addition,

these sections address the contingencies when an accreditation body

itself revokes a program's accreditation, or when an accreditation

body's approval to perform accreditations is revoked.

Proposed Sec. 8.14(b) provides the circumstances under which SAMHSA

will suspend a treatment program's certification. If SAMHSA finds

substantial evidence of an imminent hazard to health, SAMHSA will

suspend certification and notify DEA to suspend registration under 21

U.S.C. 824(d). Substantial evidence of imminent hazard could include

evidence that treatment program practices are leading to unacceptable

levels of diversion or other practices that create an unacceptable

level of risk to the safety of patients or the community.

The procedures set forth in this proposal for revoking or

suspending certification of treatment programs are similar to the

existing procedures for withdrawing approval under Sec. 291.505(h).

Notice and an opportunity for an informal review and hearing will be

provided prior to revocation, in accordance with proposed subpart C

(discussed as follows). An expedited process is also included for

seeking review of decisions to immediately suspend certification.

It should be noted that DEA also has a process for review when a

registration is revoked or suspended consistent with the requirements

of 21 U.S.C. 824(c). (See part 1301 (21 CFR part 1301).) Although the

procedures for review of a suspension or revocation set forth in this

notice are being proposed at this time, DHHS intends to work with DEA

to ensure that only a single hearing occurs when a program's

certification is suspended or revoked under the DHHS regulations, so as

not to duplicate effort. Specifically, it may be decided, as part of

the final rule, that DEA should have the lead in conducting the

hearing, in which case the regulations at part 1301 would apply rather

than the hearing process in subpart C of part 8 of the proposed rule.

Alternatively, it may be decided that the hearing process in subpart C

of part 8 will be retained in the final rule, but that SAMHSA would

request the DEA hearing official to defer to the decision of the

Secretary with respect to determinations made under 21 U.S.C. 823(g)(1)

and (g)(3). At this time, however, the Secretary is proposing a

separate hearing process and is seeking comment on the proposed

process.

The final provision in subpart B (proposed 42 CFR 8.15) proposes

two new application forms: SMA-162, Application for Certification for

Use of Opioid Drugs in a Treatment Program; and SMA-163, Application

for Becoming an Accreditation Body under proposed 42 CFR 8.3. SAMHSA is

in the process of obtaining OMB review for these new forms.

SMA-162, Application for Certification to Use Opioid Drugs in a

Treatment Program, will closely track the existing application form for

FDA approved treatment programs. The applicant will have to provide the

name of the program (or primary dispensing location), the address of

the primary dispensing location, the name and address of the program

sponsor, along with appropriate telephone numbers. In addition, the

form requires the submitter to provide estimates of the number of

patients to be treated and the program funding source, along with

descriptions of the organizational structure of the program. The new

form will retain the language on establishing a patient record system,

and maintaining patient records for at least 3 years. The proposed

SAMHSA form would require information on the program's accreditation

status as required by proposed Sec. 8.11(a)(2).

Under the existing regulation, a treatment program is required to

complete and submit a new form when there is a change in location of

the treatment program, or a change in program sponsor. SAMHSA is

retaining this reporting requirement. In addition, a treatment program

must submit a new form before establishing a medication unit.

Under the proposal, Form FDA-2635, Consent to Treatment with an

Approved Narcotic Drug, would be eliminated. Current regulations

require that the person responsible for the program must ensure that

the patient has voluntarily chosen to participate in treatment; that

all relevant facts concerning the use of the opioid drug are clearly

and adequately explained; and that the patient, with full knowledge and

understanding of its contents, signs the consent form. A specific

consent to treatment form was considered necessary when methadone

maintenance treatment was a relatively unfamiliar treatment modality in

the early 1970's. Indeed, Form FDA-2635 reflected the idea that

methadone is a drug that FDA had identified under 21 CFR 310.303 as one

for which

[[Page 39820]]

additional long-term studies were needed. FDA, however, has removed

that designation for methadone (61 FR 29476, June 11, 1996). While

patients should continue to be counseled on the risks of opioid agonist

maintenance therapy and provide written consent to treatment, and

accreditation bodies should include elements to assure such counseling,

the Secretary has tentatively concluded that a Federally mandated

consent-to-treatment form is no longer necessary.

Form FDA-2633, Medical Responsibility Statement for Use of Narcotic

Drugs in a Treatment Program, would also be discontinued. This form

predates the NATA, and was first announced in the initial 1972

regulation (Ref. 28). According to a Paperwork Reduction Act analysis

published in 1998 (Ref. 29), FDA estimated that 275 of these forms are

submitted annually, requiring a total of 70 hours to complete. The form

must be signed by all program physicians who, in turn, agree to assume

responsibility for dispensing and administering opioid substances and

agree to abide by the standards set forth in the regulations. In

addition, program physicians agree to adhere to the patient

confidentiality requirements of 42 CFR part 2. Finally, the form

requires that those program physicians who are also medical directors

will assume responsibility for administering medical services and for

ensuring compliance with all applicable Federal, State, and local laws.

While the Secretary is proposing to retain these requirements for

program physicians and medical directors, as part of the Federal opioid

treatment standards and as a condition for continued certification, the

requirement that a form be submitted is no longer considered necessary

in order to ensure compliance.

The Secretary is also proposing to eliminate the requirement for

separate forms for maintenance treatment and detoxification treatment

(see FDA-2636 Hospital Request for Methadone Detoxification Treatment).

Under the proposed rule, entities providing either maintenance or

detoxification treatment must conform to the same core Federal opioid

treatment standards. One qualification, however, is that a hospital-

based detoxification program would not be required to obtain a separate

accreditation if the hospital itself is accredited by a SAMHSA approved

accreditation body and certified by SAMHSA.

C. Subpart C--Procedures for Review of Denial, Suspension, or

Revocation of Certification

Subpart C of proposed part 8 sets forth procedures for programs to

seek review of denials, suspensions, or revocations of certification.

The subpart C procedures are also available to accreditation bodies who

are denied approval or whose approval has been revoked by SAMHSA.

The proposed procedures will ensure that programs will be given

adequate notice of adverse actions, ample opportunity to submit written

information, and an opportunity to request an oral hearing. The

procedural framework follows the procedures applied by SAMHSA's

Division of Workplace Programs under the ``Mandatory Guidelines for

Federal Workplace Drug Testing Programs'' (59 FR 29908, June 9, 1994).

IV. Federal Opioid Treatment Standards

A. General

Proposed Sec. 8.12 sets forth the Secretary's Federal opioid

treatment standards. These standards represent the Secretary's core

requirements for the medical treatment of opioid addiction with opioid

agonist treatment medications. Taken together, the Secretary's

standards outline the essential framework of a state-of-the-art

addiction treatment program, with additional details to be supplied

through Federal guidelines under development by SAMHSA and by

accreditation elements to be developed by expert accreditation bodies.

The Secretary's proposed standards also reflect the minimal

requirements necessary to reduce the risk of diversion of opioid

treatment drugs. Among other things, the Secretary has set forth

specific quantities of opioid drugs to be used for unsupervised ``take

home'' use and certain other constraints on take-home use.

On the whole, these standards carefully balance the need for

enforceable requirements, including clear standards to minimize the

risk of diversion, against the pressing need to increase the clinical

discretion and judgment in opioid addiction treatment. In addition,

these standards reflect many of the elements that the IOM identified as

necessary to prevent ``substandard treatment.''

B. Administrative and Organizational Structure

Section 8.12(b) proposes to require that an OTP's organizational

structure must be adequate to ensure patient care. At a minimum, there

must be a program sponsor who agrees to adhere to regulatory

requirements. In addition, the Secretary believes it is essential, as

with other medical treatments, that physicians oversee the medical

aspects of treatment. Therefore, all OTP's must have a designated

medical director.

C. Continuous Quality Improvement

Proposed Sec. 8.12(c) requires that OTP's have a quality assurance

plan and pursue continuous quality improvement activities. Importantly,

treatment programs must continuously assess patient outcomes.

Consistent with the findings from the GAO report, programs will be

required to assess and improve the quality of the treatment they

provide. In addition, as discussed elsewhere in this document,

considerable advancements have been made in the field of methadone

treatment outcome assessment. (See section II.C. of this document,

discussion of MTQAS.) Examples of possible outcomes include: Reducing

or eliminating illicit drug use, reducing or eliminating associated

criminal activities, reducing behaviors contributing to the spread of

infectious diseases, and improving quality of life by restoration of

physical and mental health status.

The Secretary also proposes, under Sec. 8.12(c)(2), that treatment

programs include a ``Diversion Control Plan'' as part of the quality

assurance plan. As noted elsewhere in this proposal, the IOM devoted an

entire chapter to the issue of the diversion of treatment medications,

an issue that remains a serious concern. While existing regulations

require programs to monitor patients with drug abuse tests, and to

include contingencies for positive results, the Secretary believes that

program specific diversion control plans will help to reduce the scope

and significance of diversion. Such plans would describe, among other

things, a comprehensive diversion monitoring program that assigns

specific responsibility to medical and administrative staff for

carrying out diversion control measures and functions.

D. Staff Credentials

Proposed Sec. 8.12(d) requires that physicians, nurses, addiction

counselors, and other licensed professionals have sufficient education,

training, and experience to enable them to perform assigned functions.

While the standard does not require that treatment programs retain on

staff individuals credentialed in the addiction treatment field, the

Secretary

[[Page 39821]]

notes the existence of such specialties and encourages treatment

programs to maintain or employ sufficient expertise in the field of

addiction treatment to ensure quality treatment. In addition, licensed

professional care providers, including addictions counselors, must

comply with the credentialing requirements of their respective

professions.

E. Patient Admission Criteria

The proposal retains most of the criteria from the existing

regulation for admitting patients to maintenance and detoxification

treatment. Under these criteria, patients eligible for admission to

detoxification treatment (the IOM used the term ``Medically Supervised

Withdrawal'') must be physiologically dependent upon opioids. In

addition, qualified personnel must use accepted medical criteria,

including those listed in the Diagnostic and Statistical Manual for

Mental Disorders (DSM-IV), to determine that patients eligible for

maintenance treatment are currently addicted to an opioid drug and

became addicted at least 1 year before admission to treatment. The

regulation retains exceptions for pregnant patients, patients released

from penal institutions, and previously treated patients.

The current criteria require a 7 day waiting period between each

detoxification treatment admission. The rationale for this requirement

seems to have been a concern that overlapping detoxification admissions

could lead to de facto maintenance treatment, albeit without the

comprehensive treatment requirements associated with maintenance

treatment. The Secretary has now tentatively concluded that 7 days is

more time than is needed for this purpose, and may unnecessarily expose

addicts to increased risks from HIV and other infectious diseases. The

Secretary seeks comments on a shorter period, perhaps 2 days, as a

waiting period between detoxification admissions.

F. Required Services

Under proposed Sec. 8.12(f), OTP's must provide adequate medical,

counseling, vocational, educational, and assessment services to

patients enrolled in the OTP. These services were identified in the IOM

report and elsewhere as essential standards of adequate treatment. The

proposal retains the provision that these services must be available at

the primary facility, unless the program sponsor has entered into a

formal agreement with another entity to provide these services.

Further, the proposal retains the requirement for the development and

periodic evaluation of a treatment plan for each patient that reflects

an assessment of the patient's current needs.

While the medication (methadone or LAAM) itself is an essential

element of this modality of treatment, most patients also require a

variety of other services to obtain the best and most expeditious

outcomes. Since their inception, the existing regulations have

reflected the need to provide services to patients in addition to the

treatment medications. Indeed, the IOM report recommended that certain

services should be retained as an enforceable requirement. This

proposal specifies such services in the opioid treatment standards. In

the past, DHHS has attempted to write all facets of these required

services into regulation. It is now accepted, however, that: (1)

Different patients, at different times, may need vastly different

services, and (2) the state of the clinical art has changed, to reflect

scientific developments and clinical experience, and is likely to

continue to change and evolve as treatment methods improve.

Through this rulemaking, DHHS is proposing a more flexible,

performance-based approach. With guidance from SAMHSA, the

accreditation bodies will develop the elements needed to determine

whether a given OTP is meeting patient needs for required services.

SAMHSA will review these elements as part of the accreditation body's

application to ensure that accreditation bodies have incorporated the

Federal opioid treatment standards into their accreditation elements.

SAMHSA will also review accreditation body elements to ensure that the

elements do not exceed Federal expectations.

G. Recordkeeping and Patient Confidentiality

Under proposed Sec. 8.12(g), OTP's must maintain a patient record

system that is adequate to document and monitor patient care and

outcomes, and comply with relevant Federal and State requirements. In

addition, OTP's are required to keep patient records confidential in

accordance with applicable Federal and State requirements.

Although difficult to quantify, there have been cases of patients

enrolling in more than one treatment program. The Secretary, therefore,

is retaining the requirement that treatment programs determine that

patients upon admission are not enrolled in any other OTP.

H. Medication Administration, Dispensing, and Use

The proposal retains requirements from the existing regulations

that treatment medications are dispensed by practitioners licensed

under all applicable Federal and State laws to dispense such

medications. In addition, the proposal retains initial and first day

dose requirements for methadone which are consistent with the IOM

recommendations.

Proposed Sec. 8.12(h)(2) includes the requirement that only

medications approved by FDA for the treatment of opioid dependence or

addiction shall be available for use by OTP's in treating these

conditions. Currently, methadone and LAAM are listed in this section.

If FDA approves a new opioid medication for the treatment of opioid

dependence, the Secretary would amend this regulation to address the

new medication. This section is not intended to preclude the use of

other types of medications in treating the patient for medical

conditions other than opioid addiction. Similarly, this section is not

intended to preclude the use of ancillary, approved nonnarcotic

medications for the treatment of the opioid addiction to improve the

effectiveness of the addiction treatment.

Moreover, approved medications must be used in accordance with

current, FDA-approved labeling. Deviations from the approved labeling

must be approved by the program physician and justified in the

patient's medical records.

The proposed regulations do not include the specific requirements

set forth in the existing regulations at Sec. 291.505(k)(1) for the use

of LAAM. These requirements include provisions on initial dosing with

LAAM, LAAM dosage form, distinguishing LAAM and methadone dosage forms,

and prohibiting the unsupervised (take-home) use of LAAM. In addition,

the regulations prohibit the use of LAAM in patients under 18 years of

age and require initial and periodic pregnancy testing for the drug to

be administered to patients of childbearing potential.

The Secretary is proposing to withdraw these LAAM specific

requirements from the Federal opioid treatment standards, to allow more

room for clinical judgment. Some of these changes reflect the

experience gained from over 4-years experience with the use of LAAM in

OTP's. Requirements relating to the unsupervised use of LAAM are

discussed as follows.

The Secretary notes that there are new medications under

development for the treatment of opioid addiction. While still under

investigation and review, it is conceivable that these new medications

will present safety and effectiveness profiles that differ from the

existing approved treatment

[[Page 39822]]

medications, methadone and LAAM. A new medication, for example, could

rely on weak or partial agonist properties or on mixed agonist-

antagonist properties, with pharmacokinetic and pharmacodynamic

properties that would minimize the risk of deliberate abuse through

injection and, in turn, would minimize the overall risk of diversion.

As such, it may be appropriate to tailor the Federal opioid treatment

standards to the specific characteristics of these future medications.

I. Unsupervised Use

The existing regulations establish a complex scheme to address the

unsupervised use of methadone, including extensive ``time in treatment

requirements.'' The program physician's rationale for prescribing take-

home doses must be documented in the patient's medical records and must

reflect eight subjective criteria (``take-home criteria'') specified in

the regulations (Sec. 291.505(d)(6)(iv)(B)(1) through

(d)(6)(iv)(B)(8)), to ensure that the patient will be responsible in

handling the opioid drugs.

Many have criticized the emphasis and extent of these requirements,

noting that methadone patients are already subject to extraordinary

degrees of monitoring (Ref. 30). The regulations governing the use of

take-home medications in OTP's are among the requirements that have

been in existence since 1972.

As noted in the 1995 IOM report, problems associated with diverted

methadone have been reduced substantially from the 1970's. The IOM, for

example, examined 1992 Drug Use Forecasting (DUF) data on arrests and

found that the recent use of methadone among those arrested is low

relative to other drugs included in the DUF database. The IOM noted

that ``while some street methadone is abused, it constitutes a

relatively small part of the drug abuse problem generally * * * [and]

instances of primary addiction are few'' (Ref. 31). The IOM concluded

that most of the diversion associated with methadone is from patients'

take-home supplies, however, ``the amount of methadone diverted to the

street, by whatever means, is relatively small.'' The IOM also found a

dearth of information on the degree to which methadone is implicated in

drug-related crimes and on the amount of police effort devoted to the

prevention of its diversion and, therefore, concluded that ``diverted

methadone plays a small part in the overall drug-crime problem and

receives a low priority in law enforcement efforts.''

The IOM also examined the extent to which diverted methadone

contributes to death and morbidity, and the extent to which proceeds

from the sale of diverted methadone are used to purchase other illicit

drugs. No strong evidence surfaced to demonstrate that methadone plays

a significant role in drug-related deaths or emergency hospital care,

or that proceeds from the sale of diverted methadone are used to any

notable extent in the purchase of illicit drugs.

DEA, on the other hand, published a ``Methadone Diversion'' (Ref.

32) report in April 1995 citing cases of armed robbery and clandestine

methadone laboratories and found that, indeed, methadone is diverted

and abused. In addressing some of the IOM recommendations, DEA stated

that ``[t]o relax controls in clearly identified areas which contribute

to the illicit trafficking would not enhance treatment, but instead

would further erode public confidence in treatment and expand traffic

and abuse of methadone.''

Having considered both sides of the issue, the Secretary is

proposing several options for determining whether OTP's comply with

standards respecting the quantities of opioid drugs which may be

provided to patients for unsupervised use. The Secretary is

specifically requesting comment on these approaches, as well as the

optimal combination of regulatory requirements, accreditation elements,

and oversight procedures to reduce the risks of diversion.

The options set forth as follows reflect two important factors.

First, the Secretary has tentatively concluded that certain of the

restrictions in the existing regulations are too restrictive,

especially when they are applied to those patients who have been in

treatment for extended periods and have demonstrated responsibility in

handling opioid drugs. Such a patient, for example, could greatly

benefit from having access to take-home supplies beyond 6 days, an

amount which under the current regulations would require the granting

of a special exemption by FDA. The options, then, reflect greater

flexibility for providing take-home supplies to certain long-term

patients.

Second, as noted previously, the current regulations prohibit the

dispensing of LAAM for unsupervised use. This prohibition reflected the

lack of experience with LAAM at the time of its approval in 1993,

coupled with concerns about LAAM's lengthy induction properties. LAAM

has now been available to treatment programs for several years, and the

number of programs authorized to use LAAM has grown considerably. In

addition, FDA and SAMHSA have received numerous inquiries expressing

concern about the prohibition on the unsupervised use of LAAM,

particularly with respect to those who need to travel and must abruptly

switch to methadone. Such switching can be disruptive to patients

stabilized on LAAM. Accordingly, the Secretary has tentatively decided

to remove the prohibition on the unsupervised use of LAAM.

Options 2, 3, and 4, would allow unsupervised use of any approved

opioid treatment medication. The Secretary, however, is specifically

requesting comments, including data from the treatment field, that bear

on the issue of whether to allow take-home use of LAAM.

1. Option 1--Retain Current System

Under the first option, the Secretary would retain the current

regulatory scheme prohibiting the unsupervised use of LAAM. For

methadone, the time-in-treatment requirements, maximum 6-day supply,

probation, exemptions, and criteria for determining responsibility all

remain as opioid treatment regulatory requirements. As in the current

regulations, the program physician would be required to consider the

following ``take-home criteria'' in determining whether a patient is

responsible in handling opioid drugs:

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; and

8. Whether the rehabilitative benefit to the patient derived from

decreasing the frequency of clinic attendance outweighs the potential

risks of diversion (Sec. 291.505(d)(6)(iv)(B)).

Accreditation bodies would have elements designed to ensure that

treatment program quality assurance plans include sentinel events and

followup actions to assure that patients are not misusing medications

provided for unsupervised use. SAMHSA would determine program-wide and

individual patient exemptions for take-home use beyond a 6-day supply.

[[Page 39823]]

2. Option 2--Follow the IOM's Recommendation

The second option tracks the IOM's recommendation. This option

would retain the regulatory requirement that the medical director shall

be responsible for determining whether a patient can responsibly handle

opioid treatment drugs for unsupervised use. In addition, all decisions

on take-home medications would be documented in the patient's medical

chart. The basis for the medical director's clinical judgment must be,

at a minimum, the eight criteria listed currently in

Sec. 291.505(d)(6)(iv)(B). These criteria would be a required part of

the accreditation elements that will be assessed periodically by

accreditation bodies and would be included in the determination of

whether to accredit the treatment program.

The Federal opioid treatment standards would include the following

restrictions on the use of controlled opioid medications for

unsupervised use:

1. For the first month of treatment, the maximum take-home supply

is limited to a single dose each week and the patient shall ingest all

other doses under appropriate supervision.

2. In the second month of treatment, the maximum take-home supply

is two doses after each supervised ingestion.

3. In the third month of treatment, the patient should have

ingestion observed at least twice a week, with take-home permitted for

other doses.

4. In the remaining months of the first year, the maximum take-home

supply of methadone is three doses after each supervised ingestion.

5. After 1 year, a selected patient would become eligible for less

intensive supervision of medical ingestion and may be given up to a 31-

day supply of take-home medication and monthly visits. Another

variation on this option would have patients receiving up to a 14 day

take-home supply after 1 year, and up to a 31-day supply after 2 years.

In addition, patients could be subject to monthly drug abuse

tests.Under this option, SAMHSA would still consider individual, but

not program-wide, exemptions for travel, medical, or other

``hardships.''

The Secretary has tentatively concluded that Option 2 contains the

optimal level of control and has therefore included this option in

Sec. 8.12 of the proposed rule. Option 2 is the alternative which

follows the IOM's recommendations and which involves the regulatory

requirement that the medical director shall be responsible for

determining whether a patient can responsibly handle unsupervised

medication. Documentation of the decision regarding take-home

medication would continue to be required in the patient record, and the

decision would be based on the eight criteria currently listed in

Sec. 291.505(d)(6)(iv)(B). Restrictions on controlled opioid

medications for unsupervised use would be: 1 take-home dose per week

for the first month of treatment; 2 doses per week after each

supervised ingestion in the second month of treatment; ingestion

observed at least twice weekly with take-homes permitted for other

doses during the third month of treatment and maximum take-home supply

of 3 doses per week after each supervised ingestion for the remainder

of the first year. After 1 year, a selected patient may become eligible

for less intensive supervision and may have take-home doses varying

from 14 to 31 days at a time. DHHS believes this take-home schedule

reflects patient responsibility timeframes and adequately balances the

need for clinical judgment in this treatment parameter with the risk of

medication diversion. The DEA supports proposed Option 2.

3. Option 3--Maximum Amount Approach

Under the third option, the regulations would set a maximum amount,

1.5 grams of methadone or 0.8 grams of LAAM, per 2-week period. In

addition, treatment programs would be required to maintain adequate

records on the dispensing of opioids for unsupervised use to

demonstrate compliance with conditions of accreditation. The existing

regulatory criteria would become accreditation elements.

4. Option 4--Retain Existing Requirements, Subject to Continuous Review

by Accreditation Bodies

The fourth and final option would retain the regulatory requirement

that the medical director, or a designated program physician, is

responsible for determining that a patient can responsibly handle

medication for unsupervised use. All decisions on take-home medications

would be documented in the patients' medical chart, using a

standardized format. The basis for the medical director's clinical

judgment must follow, at a minimum, the types of criteria listed in

Sec. 291.505(b)(3)(i)(D). The criteria and the methodology by which

they are applied must be included in the accreditation elements, must

be assessed periodically by accrediting bodies, and must be part of the

determination of whether to accredit the program. The methodology shall

include the OTP's quality assurance plan for regular review of all

take-home decisions (initial authorization, renewals, and revocations).

At least one existing accreditation body has accreditation

standards that address take-home privileges. COA's Methadone

Maintenance Service Standard requires that take-home privileges are

earned by the individual and are part of each individual's service

plan. A team consisting of the patients's counselor, medical and other

appropriate personnel, the patient, and whenever possible, his/her

family are involved in deciding whether the patient is ready to receive

take-home privileges. Factors that support initiation of take-home

privileges include: Length of time in treatment, attainment of clinical

stability, progress in rehabilitation, medical necessity, behavioral

factors, and emergency circumstances. In addition, the standard

includes protocols for deciding when take-home medication is

contraindicated, including: Signs or symptoms of withdrawal, continued

illicit drug use, the absence of laboratory evidence of methadone in

toxicology samples, potential complications from concurrent disorders,

ongoing criminal behavior, and an unstable home environment.

Moreover, under COA's standards, toxicology tests are to be

scheduled regularly to ensure that the patient is consuming the

methadone provided and remains free of illicit substance use, and other

such measures to help avoid diversion must be implemented. Importantly,

each patient's case or record is reviewed by a physician at least every

90 days, or more frequently if clinically indicated, and the team

periodically reviews the benefits and drawbacks of continuing take-home

privileges.

I. Interim Maintenance Treatment

The proposal retains standards for interim maintenance treatment.

Conceptually, interim maintenance treatment allows authorized programs

with documented treatment waiting lists to provide methadone treatment

to eligible patients without some of the services required under the

regulations. Interim maintenance treatment was mandated by the ADAMHA

Reorganization Act.

With respect to the issue of unsupervised use of opioid treatment

medications, the proposal retains the prohibition on unsupervised use

for patients in short-term detoxification treatment and interim

maintenance

[[Page 39824]]

treatment. Under the existing regulations, patients in long-term

detoxification treatment are permitted one unsupervised dose of

methadone per week. The Secretary is proposing to allow the

unsupervised use of treatment medications with responsible patients in

long-term detoxification treatment because long-term detoxification

patients who meet the time in treatment requirements set forth for

patients in maintenance treatment should be also eligible to be

considered for unsupervised use of treatment medications. This proposed

change is consistent with other changes in this notice (e.g.,

consolidated application forms) that will make the regulations less

complicated.

V. Legal Authority

The Secretary's legal authority under section 303(g) of the CSA to

issue treatment standards, including standards regarding the quantities

of opioid drugs that may be dispensed for unsupervised use, is well

established. (See generally section II.A of this document. See also 42

U.S.C. 257a.) In addition, the Secretary has specific authority,

through the Administrator of SAMHSA, to coordinate Federal policy with

respect to the provision of treatment services for substance abuse

using medications such as methadone (21 U.S.C. 290aa(d)(7)). The

Secretary is also authorized to establish conditions for allowing

interim treatment of opioid addiction. (See section 1976 of the PHS

Act, 42 U.S.C. 300y-11.)

Part and parcel with the Secretary's general authority to establish

treatment standards, and to ensure that those standards will be met, is

the authority to delegate to qualified third parties a role in helping

to ensure compliance with the Secretary's standards. The Secretary has

retained full responsibility for all final determinations, including

all standard setting determinations, as well as the authority to reject

the recommendations of an accreditation body, to independently inspect

treatment programs, and to perform her own independent certifications.

The proposal also includes ample measures to ensure the impartiality of

the accreditation body decision makers. Under these circumstances, the

Secretary believes that her reliance on accreditation bodies, as

outlined in the proposal, is fully consistent with the law as it

pertains to subdelegation of agency responsibilities to third parties.

See, e.g., Fleming v. Mohawk Wrecking and Lumber Co., 331 U.S. 111

(1947); Tabor v. Joint Board for Enrollment of Actuaries, 566 F.2d 705,

708 n.5 (D.C. Cir. 1977); National Association of Psychiatric Treatment

v. Mendez, 857 F. Supp. 85, 91 (D.D.C. 1994); Hall v. Marshall, 476 F.

Supp. 262, 272 (E.D. Pa. 1979), aff'd 622 F.2d 578 (3d Cir. 1980).

VI. Proposed Implementation Plan

There are approximately 900 OTP's (currently referred to as

narcotic treatment programs or ``NTPs'') approved under the existing

regulatory system. The Secretary intends to move entirely to the

accreditation-based system as soon as practicable, albeit with certain

accommodations to allow treatment programs sufficient time to obtain

accreditation and, thereafter, certification under new 42 CFR part 8.

The Secretary is proposing that the effective date of the rule,

once finalized, will be 60 days after publication of the final rule in

the Federal Register. However, as discussed in section III.B of this

document, the rule will allow for transitional certification for

programs that were approved under part 291 as of the effective date of

this regulation. In addition, SAMHSA will apply the provisional

certification provisions under proposed Sec. 8.11(e) to allow new

programs to begin to operate while completing accreditation.

These provisions will allow a sufficient amount of time for

accreditation bodies to apply for and obtain SAMHSA approval and, in

turn, to begin conducting accreditation surveys.

As part of the transition from the current regulatory approach to

the proposed accreditation/regulatory approach, SAMHSA's CSAT has

developed a study of an initial cohort of 180 randomly selected,

volunteer OTP's (Ref. 33). The study will be used by SAMHSA to develop

and continually update the agency's accreditation guidelines. The

study, which is not expected to be completed for several years, may

also provide useful information for refining the accreditation model

that is the subject of this proposed rulemaking.

The shift to an accreditation model is expected to have both

administrative and clinical consequences. The CSAT study is designed to

provide additional information on the processes, barriers,

administrative outcomes, and costs associated with an accreditation-

based system. The study will measure program accessibility, client

population served, program structure, operation and costs, clinical

practice, staff attitudes and behavior, methadone diversion, patient

satisfaction, and treatment outcomes at a sample of treatment providers

before and after they go through the accreditation process. No OTP

participating in the study will be prohibited by the FDA or the DEA

from operating because of failure to meet the standards for

accreditation.

The focus of the study is a pretest-posttest design with a

comparison or control group. This design assumes that a series of

variables will be influenced by the intervention, i.e., accreditation,

and that measurable information on these variables is available both

prior to and following the intervention. The effect of the intervention

is then measured by comparing the post-intervention values of the

outcomes with the pre-intervention values. The evaluation contractor

will collect pre-intervention data from participating OTP's at

approximately 6 months prior to accreditation to provide sufficient

lead time to measure the baseline status of these programs. It is

expected that the OTP's will make program changes to meet the

accreditation standards, apply for accreditation, undergo the

accreditation process, deliver services post-accreditation, and

collaborate in the evaluation. The evaluation contractor will collect

post-intervention data from each participating OTP at approximately 6

months following the accreditation survey to provide sufficient time to

measure the changes in OTP operations after the accreditation process.

The evaluation contractor will collect data from the control group at

approximately the same time that data will be collected from the study

group.

SAMHSA's CSAT Advisory Council will assist in the evaluation of the

study data. SAMHSA expects that the advisory council will establish a

subcommittee that will make recommendations to the full committee

which, after deliberation, will make recommendations to SAMHSA as

appropriate. SAMHSA expects to bring in consultants to the subcommittee

who ideally will include representation from stakeholders such as OTP's

(both large and small programs), medical and other substance abuse

professionals, consumers, and State officials. SAMHSA expects the first

meeting of the advisory committee and subcommittee on the issues will

convene within 6 months of the first group of accreditation surveys.

DHHS has determined that accreditation is a valid and reliable

system for providing external monitoring of the quality of health

care--including substance abuse treatment. This study, which will

proceed alongside the rulemaking proceeding, is expected to provide

important information to allow DHHS to keep its guidelines, and its

accreditation

[[Page 39825]]

program, as responsive and up-to-date as possible. Among other things,

the study will allow DHHS to continuously monitor the monetary costs of

accreditation, to ensure that successful OTP's are not precluded from

operating by the costs of accreditation, and that patients are not

denied treatment based on costs.

Finally, under the project, SAMHSA will fund the accreditation of a

large cohort of OTP's. As a result, a substantial subset of the

universe of approved programs will have experience with accreditation.

During the course of the study, CSAT will make technical assistance

available to OTP's to help them meet accreditation requirements.

VII. Environmental Impact

The Secretary has determined under 21 CFR 25.30(h) that this action

is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

VIII. Analysis of Impacts

A. Introduction

This section briefly describes the current estimates of

accreditation costs likely to accrue to OTP's as a result of this

proposed rule.

The Secretary has examined the impact of this proposed rule under

Executive Order 12866, under the Regulatory Flexibility Act (Pub. L.

96-354), under the Small Business Regulatory Enforcement Fairness Act

(Pub. L. 104-121), and under the Unfunded Mandates Reform Act (Pub. L.

104-4). Executive Order 12866 directs agencies to assess all costs and

benefits of available regulatory alternatives and, when regulation is

necessary, to select regulatory approaches that maximize net benefits

(including potential economic, environmental, public health and safety,

and other advantages, distributive impacts, and equity). The Regulatory

Flexibility Act requires agencies to analyze regulatory options that

would minimize any significant impact of a rule on a substantial number

of small entities. The Small Business Regulatory Enforcement Fairness

Act extends the Regulatory Flexibility Act by making such analyses

subject to more detailed reviews. The Unfunded Mandates Reform Act

requires that agencies prepare an assessment of anticipated costs and

benefits before proposing any expenditure by State, local, and tribal

governments, in the aggregate, or by the private sector, of $100

million (adjusted annually for inflation). A summary of the appropriate

analyses follows.

B. Purpose of the Proposed Regulation

Federal, State, local, and private sponsors spend billions of

dollars each year for substance abuse treatment programs (Ref. 34), of

which opioid maintenance has been an important option since the early

1970's. OTP's have been subjected to regulations administered by FDA

for more than 25 years. These regulations reflect the view that because

such treatment programs dispense treatment drugs with abuse potential

to drug abusers, they pose risks to communities from potential abuse

and/or diversion of the supplied therapeutic drug (Ref. 35). In

addition, DEA requires annual registration of OTP's, and enforces

regulations relating to security and control of the controlled drug

products (Ref. 36).

The motivation for providing opioid maintenance is rarely based on

economic criteria. One study indicated that treatment expenditures may

be offset by decreased direct costs of incarceration and legal

supervision (Ref. 37). Another study suggested that continued methadone

treatment for recovering opioid addiction resulted in significant

reductions in criminal activity (Ref. 38). Reduced health care costs

have also been identified as a benefit of continued treatment,

particularly as treatment procedures have been revised to reduce the

spread of HIV infection through needles (Ref. 39). Continued treatment

has also been shown to lead to increased earnings by allowing patients

to maintain regular employment (Ref. 40) and family and personal

relationships and to decrease mortality (Ref. 41). A recent study has

estimated that the value of avoiding morbidity associated with drug use

could be as high as $160,000 per case (Ref. 42). But studies show that

these benefits are obtainable only if patients continue to take active

roles in their treatments.

As discussed in section II.B of this document, compliance with

current regulations is assured through process oriented inspections

conducted by either FDA or State inspectors. As FDA has focused on

other core priorities, the annual number of OTP inspections by FDA has

declined. Meanwhile, as summarized in section II.C of this document,

several groups have questioned the emphasis of the current regulations.

This proposal is designed to improve the quality of care by shifting

oversight of OTP's from a system based on process compliance to an

accreditation-based system refocused on the needs of patients.

There has long been controversy centered around the appropriate

measures to use in assessing outcomes from drug abuse treatment

programs (Ref. 43), although substantial progress has been made in

outcome assessment over the last 20 years. One of the important areas

of progress from this research has been to shift the focus of treatment

outcome assessment from implicitly conceptualizing drug addiction as an

acute illness from which the patient either recovers (i.e., remains

abstinent) or does not (everything else) to one that is chronic and

relapsing. This shift in recognition has resulted in a change in

expectations for the outcomes of any one treatment episode where

reduced consumption, longer abstention periods, reduced psychiatric

symptoms, improved health, maintaining employment, fewer legal

problems, and improved family relations demonstrate treatment efficacy.

The strategy for measuring success is similar to that used with other

chronic disorders such as asthma, arthritis, diabetes, heart disease,

hypertension, and other psychiatric disorders. This strategy for

assessing outcomes has been adopted by the FDA for measuring

pharmaceutical efficacy (Ref. 44).

This change in the way drug addiction and abuse is viewed has led

to the development of improved outcome measures, such as those

contained in the Addiction Severity Index (Ref. 45), the Individual

Assessment Profile (Ref. 46), and the Client Assessment Profile (Ref.

46). These instruments all measure changes in the severity of the

problem areas that are commonly affected by addiction. These areas are:

Drug use, alcohol use, medical, legal, employment, family/social, and

psychiatric. Particularly notable have been studies demonstrating

reductions in criminal behavior associated with participation in

methadone treatment (Refs. 47, 48, and 49).

Improvements in outcomes after methadone treatment are almost

always equal to or greater than improvements seen in treatments for

other chronic relapsing disorders (Ref. 50). For example, studies of

methadone maintenance programs routinely show reductions of 80 percent

or more in heroin use after several months with even greater reductions

for patients who remain in treatment for more than 1 year (Refs. 51,

52, and 53). More recently, studies have consistently shown that the

risk for HIV infection is significantly reduced by opioid agonist

therapy, even

[[Page 39826]]

in the absence of total cessation of drug use (Refs. 54, 55, and 56).

These proposed regulations are designed to improve the therapeutic

impact of treatment programs by assuring adequate quality of care,

including adequate doses of medication to have optimal therapeutic

effects.

C. Baseline Description of the Industry

FDA has approved 869 methadone treatment programs as of early 1997,

including 209 programs also approved for LAAM treatment (Ref. 57). This

total encompasses only outpatient maintenance programs and does not

include almost 300 inpatient hospital detoxification units. This total

likely overstates the actual universe of OTP's because FDA considers

individual dispensing sites as separate treatment programs for

inspectional purposes, although sites may be affiliated with other

organizations. Another estimate of active programs includes 668 reports

of active methadone services from SAMHSA's 1996 Uniform Facility Data

Set (UFDS) (Ref. 58), although the definition of ``treatment unit'' was

left up to the discretion of the respective States (Ref. 59). This

estimate may understate the universe of approved treatment programs

because not all treatment programs responded to the annual survey. For

this assessment, the Secretary has assumed 900 active OTP's as the

universe of affected programs.

Data from SAMHSA's UFDS Data Set (Ref. 60) can be used to estimate

the number of patients in treatment. The 1996 Data Set includes a 1-day

census of patients in treatment, by type of care and jurisdiction.

According to the most recent report, there were 940,131 patients in

substance abuse treatment facilities (private and public funded) on

October 1, 1996. The 1996 report indicates that 13.2 percent or 124,098

of these patients were receiving narcotic substances (assumed to be

methadone or LAAM). For the purposes of this analysis, the Secretary

estimates the total census of patients in opioid treatment to be

approximately 125,000.

Data from SAMHSA indicate that some OTP's may be providing

treatment to over 2,085 patients, but most programs have very small

patient bases (Ref. 61). Approximately 20 percent of all programs treat

50 or fewer patients (Ref. 62), and 10 percent treat 10 or fewer

patients. The median OTP had a patient census of 125 patients, but the

mean program size was much larger. Two studies that included methadone

program cost parameters indicate a weighted average of 250 patients per

OTP (Refs. 63 and 64). For this assessment, the Secretary has assumed a

typical OTP can treat 140 patients, for a total industry census of

125,000 patients.

Current cost estimates of providing annual treatment have ranged

from approximately $2,500 (Ref. 65) to $4,000 (Ref. 66). The lower cost

estimate did not account for all fixed and variable costs associated

with operating a treatment facility (e.g., rent and equipment

maintenance and operating costs were not adequately accounted). For

this assessment, the Secretary has estimated that it costs

approximately $4,000 per year to treat one patient.

D. Costs of the Current Regulations

For purposes of this analysis, the Secretary estimates the costs of

enforcing the current regulations to average approximately $3.3 million

per year. These costs include inspections, support, review of

applications, and all overhead. In addition, OTP's found to be

violative must improve performance in order to continue operations.

Typically, many inspections result in observable violations based on a

failure to fully document or record activities. The Secretary has

estimated that a typical facility must improve patient recordkeeping as

a result of an inspection at a cost of $4.70 per patient per year (or

almost $660 per OTP per year ($4.70 x 140)). This cost is estimated by

assuming that 10 minutes of nurse/technician time will be required to

enter and check records for each patient per year. The total average

compensation for a nurse/technician in the health services sector

totaled $28.07 per hour in 1996 (Ref. 67). The estimated annual cost

for programs to meet requirements of current inspections and correct

violations equals $0.59 million. The Secretary seeks comments and

information to further assess or estimate the costs for programs to

meet the requirements of the current regulations. The total annual cost

of continuing the current regulations (in the absence of these proposed

regulations) is estimated to equal $3.9 million, most of which is

administrative costs of maintaining a regulatory system.

E. Costs of the Proposed Regulation

The proposed rule will generate regulatory costs to OTP's in two

general areas. These areas are: (1) The direct costs of becoming

accredited through a survey of practices and procedures, and (2) the

more indirect costs of improving procedures, if necessary, to meet the

quality level required to achieve and maintain accreditation, including

resurvey costs. The Secretary has developed preliminary estimates of

these cost elements in terms of costs per annual client. Thus, if an

OTP must initiate an activity to become accredited, the costs include

maintaining that activity at an acceptable level of quality.

In addition, SAMHSA will incur costs to provide oversight of

accreditation bodies, review and approve applications from prospective

programs, and conduct ``for-cause'' inspections. The Secretary has

assumed that DEA will not incur any change in enforcement costs due to

these proposed regulations.

Costs are estimated as average annual costs. A 7-percent discount

rate is used to estimate the present value of future expenditures and

to amortize one-time costs. A 3-year evaluation period (the length of

the expected accreditation cycle) is used to analyze any one-time costs

associated with compliance.

F. Accreditation of Opioid Treatment Programs

The process of professional accreditation includes external peer

review of practices in order to assure an acceptable level of quality.

Most accrediting organizations have criteria of what clinical

procedures assure a minimum level of quality of care. Usually, a team

consisting of various professional specialties will spend several days

at a candidate facility during an accrediting survey. The team will

examine records and observe practices that determine the facility's

level of quality. After receiving accreditation, a facility must show

that quality remains at an acceptable level by maintaining proper

procedures. Recently, the JCAHO announced that it would develop

specific performance outcome measures as accreditation criteria.

The costs of operating an accreditation program are estimated from

data provided by three national accreditation bodies: JCAHO, CARF, and

COA. Currently, most OTP's are not required to be routinely accredited

by any national accreditation body. However, all three bodies have some

experience accrediting OTP's. Approximately 36 hospital-affiliated

OTP's are currently accredited by the JCAHO, and CARF has accredited

some OTP's and is currently developing a specific accreditation manual.

COA has drafted standards for OTP services that incorporate many of the

requirements of the proposed regulation.

JCAHO would charge a mental health facility with size and operating

characteristics similar to an average OTP a base of $5,655 plus $0.23

per outpatient-visit (Ref. 68). JCAHO's definition of an outpatient

visit may not strictly apply to opioid treatment

[[Page 39827]]

because patients are typically treated as many as six times a week. For

the purposes of this analysis, the Secretary has applied the $0.23 per

outpatient-visit charge on a weekly basis. The estimated accreditation

survey charge for JCAHO accreditation is the base charge plus $1,674

(140 patients times $0.23 times 52 weeks), or approximately $7,300.

Discussions with CARF have indicated that a facility seeking

accreditation would pay an application fee of $300, purchase a survey

manual for $100, and pay $950 per surveyor per day to conduct an

accreditation survey. CARF expected a facility survey to require 2 days

onsite, and while they estimated two-person teams, three-person teams

may be likely. Thus, a CARF accreditation survey for an OTP seeking

accreditation is estimated to cost approximately $5,100, including

travel costs.

COA presented data that showed an average charge of about $5,500,

but added an additional $1,500 for travel expenses of the accreditation

survey team. In addition to the direct accreditation costs, the survey

team for COA incurs opportunity costs based on the time necessary to

complete a survey. Discussions with COA show that typically a survey

team consists of three unpaid persons from previously accredited

facilities. While JCAHO and CARF indicated that the labor costs for a

survey team were included in the charges, COA did not. For the purpose

of estimating the opportunity costs of these survey members, the

Secretary has estimated that a typical survey team will consist of an

administrator or program director, and a nurse or counselor or social

worker. A typical survey is expected to take 2 days to complete. The

Bureau of Labor Statistics collects average wage rates by occupation

(Ref. 69). In 1996 (the latest year for which these data are

published), the average hourly compensation of a nurse or technologist

was $28.07, while an administrator or clinic director had total hourly

compensation of approximately $33.29. Thus, the opportunity cost of the

survey team for conducting an accreditation survey adds almost $1,000

for a total estimated survey cost of $8,000.

For the purposes of this analysis, the Secretary estimates the

direct cost of conducting an accreditation survey as the average of

these three programs, or $6,800 per treatment program. Assuming a 3-

year accreditation cycle, and a 7-percent discount rate, the average

annual cost to a treatment facility of conducting accreditation surveys

will equal approximately $2,600. Overall, the total average annual

accreditation costs for all affected programs are likely to equal $2.3

million.

G. Compliance and Quality Assurance for Opioid Treatment Programs

According to COA, approximately 30 percent of the nonvoluntary

accreditation inspections result in some remedial action. CARF has

reported an approximately 25 percent less-than-full accreditation rate

for facilities that have been required to seek accreditation.

Regardless of what the less-than-full accreditation rate is for the

first accreditation cycle, subsequent accreditation cycles should have

significantly lower rates of less-than-full accreditation as programs

adjust to the accreditation process. In addition, CSAT will make

available technical assistance to help programs meet accreditation

requirements.

While it is possible that increased Federal inspection and

enforcement activity (in the absence of this rule) could result in

fewer violative programs, the Secretary believes the requirement of

accreditation will provide a greater impetus for program-by-program

improvements. Shorter accreditation cycles are believed to minimize the

opportunity for programs to become noncompliant. In addition, managed

health-care payers for psychiatric care often require program

accreditation for reimbursement (Ref. 70) and this trend is expected to

continue for opioid treatment.

The costs of remediation were estimated from variable program cost

data developed for SAMHSA from nine OTP's (Ref. 71). This study

presented annual operating costs per patient to maintain what is

presumed to be an acceptable level of quality. The consultants

collected accounting costs for 14 specific parameters that contribute

to overall program quality such as initial assessment, medical

examination, case management, etc. While the Secretary does not have

data to show that these 14 parameters are inclusive, a weighted average

of the costs for the variable cost parameters (for both methadone and

LAAM patients) resulted in an average cost per activity of

approximately $150 per parameter per patient.

Remedial action to achieve accreditation could require

implementation of a service that is currently not available, or it

could require only marginal improvements to the level of an ongoing

activity. For example, an OTP that did not offer acquired immune

deficiency syndrome (AIDS) counseling would be required to start doing

so, while a different OTP may be required to improve the quality of

such counseling.

At this time, the Secretary does not have data to indicate the

minimum level of compliance that would currently allow an OTP to remain

in operation. The Secretary has assumed that the complete absence of

any one quality enhancing activity would result in a loss of

accreditation. Assuming that 25 percent of facilities are expected to

require remediation from the initial cycle of accreditation surveys,

these facilities are likely to be distributed between two extremes.

The most costly compliance activities would be for OTP's that

currently do not offer one of the identified services. In order to

continue operations, these facilities would be required to offer these

services, and incur costs of $150 per patient or $21,000.

The other extreme would be OTP's that must increase resources to

one activity (e.g., improve recordkeeping). This may require increased

costs of only $0.67 per patient (based on dividing $150 by 25 percent

of the affected programs).

The average cost for a typical less-than-fully accredited OTP to

come into compliance during this initial inspection is estimated as the

average of these amounts, or approximately $75 per patient or $10,500

per noncompliant program. Having assumed that 25 percent of all OTP's

(or 225 programs) would require improvements in the first accreditation

cycle, the total costs to the industry are estimated to be $2.4

million.

These costs are estimated based on costs per patient per year, and

are thus annual operating costs of ongoing quality assurance activities

as well as implementation costs. As such, they also incorporate the

cost of maintaining acceptable quality levels between accreditation

cycles. These cost estimates take into account typical quality

assurance programs that include development of quality assurance

manuals and periodic meetings by a quality assurance staff through the

evaluation period. Each OTP is likely to invest in a quality assurance

program that will contain elements of authority, purpose, organization,

scope, responsibility, implementation, and evaluation (Ref. 72). Future

accreditation surveys may identify OTP's that do not receive full

accreditation, but the noncompliant rate is expected to be low. By

maintaining current expenditures and quality assurance programs as

estimated in this section, no additional costs are attributable to this

regulation.

[[Page 39828]]

A resurvey would be required for each OTP needing remedial action.

Direct costs for resurveying are part of the original survey, but

indirect costs must be accounted for, as measured by the opportunity

costs of the survey team. This would likely be travel costs ($1,500)

and opportunity costs for the survey team ($1,000) for a total of

approximately $2,500 for a resurvey. With an estimated 225 resurveys,

the total industry cost would equal $0.6 million. This one-time cost,

when amortized for 3 years at 7-percent discount rate to account for an

accreditation cycle, results in an average annual cost for the industry

of $0.2 million.

H. Annual Costs to Opioid Treatment Programs of the Proposed Regulation

Total costs of this proposed regulation include average annual

direct accreditation survey costs of approximately $2.3 million. The

average annual costs of both coming into compliance and ensuring an

acceptable level of quality is estimated to be $2.6 million. The total

average annual costs to OTP's for this proposed regulation is $4.9

million, which includes maintaining an improved quality level. These

annual costs equal approximately $5,400 per facility and $39 per

patient, an overall average increase of approximately 1.0 percent per

patient. Costs are expected to vary by facility and by patient

population.

I. Costs to SAMHSA of the Proposed Regulation

The average estimated annual cost of administering an accreditation

based system of regulation, based on SAMHSA estimates, is $3.4 million.

J. Total Net Costs of the Proposed Regulations

The total cost of these proposed regulations is the combination of

the industry and the government costs. The best estimate of the total

average annual cost is $8.3 million. The annual cost of FDA enforcement

of the current regulation of OTP's has been estimated to equal $3.9

million. The average annual net cost of this proposal equals the

difference, or $4.4 million.

K. Benefits of the Proposed Regulations

Methadone maintenance (and by extension LAAM maintenance) has been

identified as the most successful known treatment in avoiding relapses

in addiction. Depending on definitions, approximately 80 percent of

individuals seeking treatment for substance abuse (including alcohol),

from all such treatments (including all alternative treatments), have

been reported to have returned to substance use following treatment

(Ref. 73). While individual opioid maintenance programs vary in success

rates, a study of six clinics showed that the continued use of drugs

ranged from only 10 percent of patients in the most effective clinic to

56 percent in the least effective (Ref. 74). Among other factors, the

more effective clinics were characterized by treatment goals of ongoing

maintenance, better staff-patient relationships, and higher average

medication doses (Ref. 75).

A study of relapse rates reported that overall methadone

maintenance programs reported a 40-percent average relapse rate (Ref.

76), compared to an 80-percent relapse rate for all substance abuse

treatment. However, for patients still in treatment, the reported

relapse rate was 31.7 percent, while patients out of treatment reported

a 65-percent relapse rate. But, those patients who had completed a

course of treatment of at least 24 months reported relapse rates one-

third lower than those in treatment for fewer than 6 months (50 percent

to 71.8 percent) (Ref. 77). These findings imply that continuing

treatment and length of treatment decrease the probability of relapse.

The Secretary cannot with certainty predict the effect of these

regulations on the expected rate of relapse. However, the following

example illustrates the range of potential benefits that might be

achieved if the average patient remains in treatment for 6 months

longer than the current reported average duration of treatment (14.7

months to 20.7 months). In this instance, the expected average rate of

relapses would decrease from 40 percent to 32.3 percent. This implies

that the number of annual relapses from therapy would be reduced by

12,320 patients. In 1993, there were more than 13,000 drug related

mortalities (Ref. 78), not all of which could be attributable to drugs

treatable by opioid maintenance. However, it is likely that at least

some of these mortalities would be avoided if greater numbers of

patients avoided relapse by maintaining treatment.

In addition, other benefits such as reduced health expenditures,

better personal relationships, and reduced criminal activity would be

expected. Based on plausible values for such gains, even very minor

improvements in patient outcomes could easily offset the net annual

compliance cost of this proposed regulation.

L. Impact on Small Opioid Treatment Programs

1. Description of Impact

As discussed previously, the proposal is expected to provide more

frequent quality surveys of OTP's and allow for greater flexibility in

the delivery of opioid treatment.

Under definitions provided by the Small Business Administration

(SBA), virtually the entire industry would be composed of small

entities (Ref. 79). The SBA uses an estimate of $5.0 million in gross

revenues as a definition of small entity for industry SIC 8093

(Specialty Outpatient Facilities, NEC). An OTP would need to provide

treatment to 1,250 to reach that level. As stated earlier, 20 percent

of the OTP's serve 50 or fewer patients. This segment of the industry

may be assumed to be considered small relative to the typical OTP.

All small programs would be required to be accredited by an

accreditation body approved by SAMHSA. Each OTP, regardless of size

would be expected to maintain this accreditation in order to continue

to treat patients. There are several important changes in these

proposed regulations from current requirements, but no major changes in

current recordkeeping.

2. Analysis of Alternatives

Alternative regulatory schemes were considered. The continuation of

the current regulatory oversight was dismissed in light of the findings

and criticisms discussed in section II of this document. The idea of

providing greater levels of self-certification was deemed insufficient,

primarily because of concerns over the potential diversion of the

treatment medications.

SAMHSA has issued evaluation contracts to determine whether this

proposal will result in unforeseen impacts on small programs. In

particular, the feasibility of exempting small facilities from some

requirements will be examined. Some small OTP's may find it necessary

or desirable to forge arrangements with more financially secure

organizations so as to provide quality treatment services to

individuals in the community. SAMHSA will make every effort possible to

ensure that access to quality opioid addiction treatment services is

not diminished, especially in rural areas, as a consequence of this

regulatory reform.

3. Assuring Small Entity Participation

It is likely that this proposed rule may have a significant

economic effect on a substantial number of small entities.

[[Page 39829]]

Based on the cost parameters reported for the three smallest programs

included in a SAMHSA analysis (Ref. 80), the average cost to maintain

and service a patient for 1 year in a small, 50-patient facility was

estimated to be $3,200. An average accreditation survey for a program

of only 50 patients is expected to take only 1 day and cost

approximately $4,000, or approximately $1,500/year (at a 7-percent

discount rate). The average cost per patient of achieving and

maintaining a quality-enhancing activity at a small OTP at an

acceptable compliance level is assumed to be equal to the industry

average of $45. A 25 percent less-than-full accreditation rate (the

same as for the overall industry) was assumed and resurveys are

estimated to cost $500.

Overall, the cost per patient for a program servicing 50 patients

would increase by slightly more than the industry average ($50 compared

to $39) under the proposed regulations. This represents a greater

proportionate increase (1.6 percent as compared to 1.0 percent) than

the increase expected for the average sized facility. The Secretary is

in the process of collecting better data on this industry segment and

solicits comments in this area.

M. Conclusions

The average annual net cost of this regulation is estimated to be

$4.4 million. The costs represent a shift of costs to individual OTP's

to maintain accreditation and the accompanying assurance of quality.

Research has indicated that increased compliance with drug abuse

treatment is correlated with beneficial and therapeutic outcomes to

patients, and the Secretary believes that the use of private

accreditation would improve treatment outcomes. If patient

participation in therapy could be extended by an average of 6 months,

relapse rates could decrease by approximately 20 percent. Even modest

improvements, therefore, would bring substantial reductions in

mortality and significant improvements in physical health, decreased

criminal activity (including diversions), increased earnings and

employment, better family and personal relationships (Ref. 81). The

Secretary, including SAMHSA, continues to research this area and is

specifically soliciting comments on these issues.

This proposal constitutes a significant impact on a substantial

number of small entities. The Secretary solicits comments on how to

address this impact.

The estimated annual cost of $4.4 million is far below the

threshold defined by the Unfunded Mandates Act.

IX. Paperwork Reduction Act of 1995

This proposed rule contains information collections which are

subject to review by the Office of Management and Budget (OMB) under

the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3507(d)). The

title, description, and respondent description of the information

collections are shown in the following paragraphs with an estimate of

the annual reporting and recordkeeping burden. Included in the estimate

is the time for reviewing instructions, searching existing data

sources, gathering and maintaining the data needed, and completing and

reviewing the collection of information.

Title: Narcotic Drugs in Maintenance and Detoxification Treatment

of Narcotic Dependence; Repeal of Current Regulations and Proposal to

Adopt New Regulations.

Description. The Secretary is proposing to issue regulations to

establish an accreditation-based regulatory system to replace the

current system that relies solely upon direct Federal inspection of

treatment programs for compliance with process oriented regulations.

These proposed changes are intended to enhance the quality of

opioid treatment by allowing increased clinical judgment in treatment

and by the accreditation process itself with its emphasis on continuous

quality assessment. As set forth in this proposed rule, there will be

fewer reporting requirements and fewer required forms under the new

system. The total reporting requirements are estimated at 2,074 hours

for treatment programs, and 341 hours for accrediting organizations.

A recent FDA information collection analysis (Ref. 82) estimated

the annual paperwork burden for the existing regulations to be

approximately 1,500 hours. The proposed regulation requires a one-time

reporting requirement for transitioning from the old system to the new

system. The estimated reporting burden for ``transitional

certification'' is approximately 475 hours. The proposal also requires

ongoing certification on a 3-year cycle, with an estimated reporting

burden of approximately 300 hours. Deducting these two requirements

(total 775 hours) from the estimate for the proposed system (2,074

hours) leaves a reporting burden of approximately 1,300 hours, which is

less than the estimated burden under the existing system. This is

consistent with the streamlining of requirements under the proposal,

and the elimination of certain forms and reporting requirements

altogether.

Description of Respondents: Business or other for-profit; Not-for-

profit institutions; Federal government; State, local or tribal

government.

Table 1.--Annual Reporting Burden for Treatment Programs

------------------------------------------------------------------------

42 CFR

Citation No. of Responses per Minutes per

and Respondents Respondent Response Total Hours

Purpose

------------------------------------------------------------------------

8.11(b) 75 1 90 112.5

-New

program

approva

l SMA-

162

8.11(b) 300 1 60 300

-Renewa

l of

approva

l1 SMA-

162

8.11(b) 35 1 70 40.83

(3)--Re

locatio

n SMA-

162

8.11(d) 300 1 95 475

-Applic

ation

for

transit

ional

certifi

cation2

SMA-162

8.11(e) 75 1 30 37.5

(1)--Ap

plicati

on for

provisi

onal

certifi

cation

8.11(e) 30 1 15 7.5

(2)--Ap

plicati

on for

extensi

on of

provisi

onal

certifi

cation

8.11(f) 60 1 20 20

(5)--No

tificat

ion of

sponsor

or

medical

directo

r

change

8.11(g) 1 1 120 2

(2)--Do

cumenta

tion to

SAMHSA

for

interim

mainten

ance

8.11(h) 800 3 26.25 1050

-Reques

t to

SAMHSA

for

exempti

on from

8.11

and

8.12

8.11(i) 3 1 15 .75

(1)--No

tificat

ion to

SAMHSA

before

establi

shing

medicat

ion

units

8.12(j) 1 1 20 3.33

(2)--No

tificat

ion to

State

Health

Officer

when

patient

begins

interim

mainten

ance

8.24--C 2 1 15 .5

ontents

of

appella

nt

request

for

review

of

suspens

ion

8.25(a) 2 1 60 2

-Inform

al

review

request

8.26(a) 2 1 300 10

-Appell

ant's

review

file

and

written

stateme

nt

8.28(a) 2 1 60 2

-Appell

ant's's

request

for

expedit

ed

review

[[Page 39830]]

8.28(c) 2 1 300 10

-Appell

ant

review

file

and

written

stateme

nt

Totals 2,073.91

------------------------------------------------------------------------

\1\ Applications for renewal of certification are required every 3

years.

\2\ Transitional Certification is a one-time requirement and will be

included in the total annualized burden but averaged over the 3-year

period of the OMB collection activity approval.

The proposal does not increase the estimated annualized burden.

Certain reporting requirements have been proposed for elimination, such

as submissions for authorizations to use LAAM, the requirement to

submit a physician responsibility statement (FDA Form 2633), and

elimination of the requirement to obtain Federal approval for take-home

doses of methadone in excess of 100 mg that exceed a 6-day supply. The

proposal adds a one time requirement for existing programs to apply for

transitional certification, and a requirement to apply for

certification renewal every third year. The annualized burdens

associated with these new reporting requirements offset the burdens

proposed for elimination, resulting in no estimated net change.

Accreditation bodies will also require treatment programs to submit

information as part of the standard operating procedures for

accreditation. As mentioned earlier in this proposal, accreditation

bodies, under contract to SAMSHA, will be accrediting existing OTP's as

part of an initiative to gain more information on the accreditation of

OTP's. SAMHSA has prepared a separate OMB Paperwork Reduction notice

and analysis for that information collection activity (63 FR 10030,

February 27, 1998, OMB approval number 0930-0194).

Table 2.--Annual Reporting Burden for Accreditation Organizations1

------------------------------------------------------------------------

42 CFR

Citation No. of Responses per Hours per

and Respondents Respondents Response Total Hours

Purpose

------------------------------------------------------------------------

8.3(b)- 10 1 3 30

-Initia

l

approva

l SMA-

163

8.3(c)- 3 1 1 3

-Renewa

l of

approva

l SMA-

163

8.3(e)- 1 1 0.5 0.5

-Relinq

uishmen

t

notific

ation

8.3(f)- 1 90 0.1 9

-Nonren

ewal

notific

ation

to

accredi

ted

OTP's

8.4(b)( 2 2 1 4

1)(ii)-

-Notifi

cation

to

SAMHSA

for

serious

noncomp

liant

program

s

8.4(b)(1 2 2 1 4

)(iii)-

-Notifi

cation

to

noncomp

liant

program

s

8.4(d)( 10 2 0.5 10

1)--Gen

eral

documen

ts and

informa

tion to

SAMHSA

upon

request

8.4(d)( 10 6 0.2 12

2)--Acc

reditat

ion

survey

to

SAMHSA

upon

request

8.4(d)( 10 6 0.2 12

3)--Lis

t of

surveys

,

surveyo

rs to

SAMHSA

upon

request

8.4(d)( 10 7.5 0.5 37.5

4)--Les

s than

full

accredi

tation

report

to

SAMHSA

8.4(d)( 10 30 0.5 150

5)--Sum

maries

of

inspect

ions

8.4(e)- 10 1 0.5 5

-Notifi

cation

complai

nts

8.6(a)( 1 90 0.3 27

2) and

(b)(3)-

-Revoca

tion

Notific

ation

to

accredi

ted

OTP's

8.6(b)- 1 1 10 10

-Submis

sion of

90-day

correct

ive

plan to

SAMHSA

8.6(b)( 1 90 0.3 27

1)--Not

ificati

on to

accredi

ted

OTP's

of

probati

onary

status

Totals 341

------------------------------------------------------------------------

\1\ Because some of the numbers underlying these estimates have been

rounded, figures in this table are approximate. There are no

maintenance and operation costs nor start up and capital costs.

Recordkeeping--The recordkeeping requirements for OTP's set forth

in proposed Sec. 8.12 include maintenance of the following: A patient's

medical evaluation and other assessments when admitted to treatment,

and periodically throughout treatment Sec. 8.12(f)(4)); the provision

of needed services, including any prenatal support provided the patient

(Sec. 8.12(g)(1)and (g)(2)); justification of exceptional initial

doses; changes in a patient's dose and dosage schedule; justification

of exceptional daily doses (Sec. 8.12(h)(3)(iii)); justification for

variations from the approved product labeling for LAAM and future

medications (Sec. 8.12(h)(4)); and the rationale for decreasing a

patient's clinic attendance (Sec. 8.12(i)(3)).

In addition, proposed Sec. 8.4(c)(1) will require accreditation

bodies to keep and retain for 5 years certain records pertaining to

their respective accreditation activities. These recordkeeping

requirements for OTP's and accreditation bodies are customary and usual

practices within the medical and rehabilitative communities, and thus

impose no additional response burden hours or costs.

Disclosure--This proposal retains requirements that OTP's and

accreditation organizations disclose information. For example, proposed

Sec. 8.12(e)(1) requires that a physician explain the facts concerning

the use of opioid drug treatment to each patient. This type of

disclosure is considered to be consistent with the common medical

practice and is not considered an additional burden. Further, the

proposal requires under Sec. 8.4(i)(1) that each accreditation

organization shall make public its fee structure. The Secretary notes

that the preceding section of this notice contains publicly available

information on the fee structure for each of three accreditation

bodies. This type of disclosure is standard business practice and is

not considered a burden in this analysis.

As required by section 3507(d) of the PRA, the Secretary has

submitted a copy of this proposed rule to OMB for its review. Comments

on the information collection requirements are specifically solicited

in order to: (1) Evaluate

[[Page 39831]]

whether the proposed collection of information is necessary for the

proper performance of DHHS's functions, including whether the

information will have practical utility; (2) evaluate the accuracy of

DHHS's estimate of the burden of the proposed collection of

information, including the validity of the methodology and assumptions

used; (3) enhance the quality, utility, and clarity of the information

to be collected; and (4) minimize the burden of the collection of

information on those who are to respond, including through the use of

appropriate automated, electronic, mechanical, or other technological

collection techniques or other forms of information technology, e.g.,

permitting electronic submission of responses.

OMB is required to make a decision concerning the collection of

information contained in these proposed regulations between 30 and 60

days after publication of this document in the Federal Register.

Therefore, a comment to OMB is best assured of having its full effect

if OMB receives it within 30 days of publication. This does not affect

the deadline for the public to comment to DHHS on the proposed

regulations.

Organizations and individuals desiring to submit comments on the

information collection requirements should direct them to the Office of

Information and Regulatory Affairs, OMB, (address above).

X. Request for Comments

Interested persons may, on or before November 19, 1999, submit to

the Dockets Management Branch (address above) written comments

regarding this proposal. Two copies of any comments are to be

submitted, except that individuals may submit one copy. Comments are to

be identified with the docket number found in brackets in the heading

of this document. Received comments may be seen in the office above

between 9 a.m. and 4 p.m., Monday through Friday.

XI. References

The following references have been placed on display in the Dockets

Management Branch (address above) and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday through Friday.

1. Unified Agenda of Federal Regulatory and Deregulatory

Actions, 61 FR 62003 to 62502, November 29, 1996.

2. Glass, R. M., Methadone Maintenance New Research on

Controversial Treatment, Journal of the American Medical

Association, vol. 269, no. 15, p. 1995, 1993.

3. U.S. General Accounting Office, Methadone Maintenance: Some

Treatment Programs Are Not Effective, Greater Federal Oversight is

Needed, GAO/HRD-90-104, 1990.

4. U.S. Institutes of Medicine, Federal Regulation of Methadone

Treatment, National Academy Press, 1995.

5. U.S. Code Congressional and Administrative News, 91st Cong.,

2d sess., vol. 3, p. 4580, 1970.

6. METHADONE HEW/FDA Proposes Conditions for Use, 41 FR 17922,

April 29, 1976.

7. Nightingale, S. L., Methadone Treatment Programs, Quarterly

Bulletin of the Association of Food and Drug Officials of the United

States, vol. 38, no. 2, pp. 99-101, 1974.

8. Center for Substance Abuse Treatment, ``State Methadone

Treatment Guidelines: Treatment Improvement Protocol (TIP) Series

1,'' 1993.

9. Molinari, S. P., J. R. Cooper, D. J. Czechowicz, ``Federal

Regulation of Clinical Practice in Narcotic Addiction Treatment:

Purpose, Status, and Alternatives,'' The Journal of Law, Medicine

and Ethics, vol. 22, no. 3, 1994.

10. Center for Substance Abuse Treatment, ``Matching Treatment

to Patient Needs in Opioid Substitution Therapy: Treatment

Improvement Protocol (TIP), Series No. 20,'' p. 6, 1995.

11. Molinari, S. P., J. R. Cooper, D. J. Czechowicz, ``Federal

Regulation of Clinical Practice in Narcotic Addiction Treatment:

Purpose, Status, and Alternatives,'' The Journal of Law, Medicine

and Ethics, vol. 22, no. 3, 1994.

12. Molinari, S. P., J. R. Cooper, D. J. Czechowicz, ``Federal

Regulation of Clinical Practice in Narcotic Addiction Treatment:

Purpose, Status, and Alternatives,'' The Journal of Law, Medicine

and Ethics, vol. 22, no. 3, 1994.

13. United States General Accounting Office, ``Methadone

Maintenance: Some Treatment Programs Are Not Effective; Greater

Federal Oversight Needed,'' GAO HRD-90-104, 1990.

14. Institute of Medicine, Federal Regulation of Methadone

Treatment, National Academy Press, 1995.

15. IOM Report, p. 213.

16. IOM Report, p. 221.

17. IOM Report, p. 236.

18. IOM Report, p. 166.

19. The 1996 CARF Accreditation Sourcebook, Commission on

Accreditation of Rehabilitation Facilities, 1996.

20. A Voice for Quality: The Newsletter of the Council on

Accreditation of Services for Families and Children., COA, 1996.

21. Dole, V. P., ``Hazards of Process Regulations,'' Journal of

the American Medical Association, vol. 267, p. 2234, April 1992.

22. Annotated Code, State of Ohio, Ohio Annotated Code, p. 3793,

2-1-01, 1996.

23. ``Effective Medical Treatment of Heroin Addiction,'' NIH

Consensus Statement 1997, vol. 15, no. 6, p. 10, November 17 to 19,

1997.

24. ``Narcotic Analgesics,'' in The Pharmaceutical Basis of

Therapeutics, edited by Louis Goodman and Alfred Gilman, 14th ed.,

p. 237, 1971.

25. ``THIRD METHADONE CLINIC PROPOSED,'' Tammie Smith, The

Tennessean, January 18, 1997.

26. ``Marrero to Get Methadone Clinic,'' Copyright 1997 The

Times-Picayune Publishing Co., The Times-Picayune, February 28,

1997.

27. Annotated Code, State of Ohio, Ohio Annotated Code, p. 3793,

2-1-01, 1996.

28. METHADONE: Listing as New Drug With Special Requirements and

Opportunity for Hearing, 37 FR 26791, December 15, 1972.

29. Agency Information Collection Activities; Submission for OMB

Review; Request for Comments, Docket No. 97N-0456, Food and Drug

Administration, ``Conditions for the Use of Narcotic Drugs for

Treatment of Narcotic Addiction Reporting and Recordkeeping

Requirements,'' OMB Control Number 0910-0140--Reinstatement, 63 FR

14468, March 25, 1998.

30. New York Times, February 2, 1997, Sunday, Late Edition--

Final: Section 1; p. 12; Column 1; National Desk, ``Ex-Addicts Find

Methadone More Elusive Than Heroin,'' Christopher S. Wren.

31. IOM Report, pp. 92-118.

32. Methadone Diversion, DEA, April 1995.

33. Substance Abuse and Mental Health Services Administration,

``Request for Proposal (RFP) No. 270-97-7003: `Development and

Implementation of Opioid Treatment Program Accreditation','' April

15, 1997.

34. U.S. General Accounting Office, Billions Spent Annually for

Treatment and Prevention Activities, GAO/HEHS-97-12; October 8,

1996.

35. Glass, R. M., ``Methadone Maintenance: New Research on

Controversial Treatment,'' Journal of the American Medical

Association, vol. 269, no. 15, 1995.

36. U.S. Drug Enforcement Administration, Methadone Diversion:

1995, Office of Diversion Control, April 1995.

37. Rice, D., S. P. Kelman et al., The Economic Costs of Alcohol

and Drug Abuse and Mental Illness, 1985, San Francisco, University

of California, Institute for Health and Aging, 1990.

38. Anglin, M. D., G. Speckart et al., ``Consequences and Costs

of Shutting Off Methadone,'' Addictive Behaviors, vol. 14, pp. 307-

326, 1989.

39. Dennis, M., J. Fairbanks et al., ``Enhanced Counselor's

Manual,'' NIDA Grant No. 1-R18DA7262-01, Research Triangle

Institute, 1991.

40. Bradley, C. J., M. T. French et al., ``Financing and Cost of

Standard and Enhanced Methadone Tre

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