Press Release
July 22, 1999
National Alliance of Methadone Advocates NAMA
435 Second Avenue
New York, NY 10010
Email: [email protected]
NAMA applauds the hard work of SAMHSA, the ONDCP, NIDA and CSAT
for the release of the New Accreditation Guidelines for Methadone
and LAAM Treatment. We are aware that these agencies have made
tremendous efforts to improve treatment for patients.
NAMA is certainly proud to have been a part of this process and in
attending meetings regarding the changes on behalf of patients.
Carmen Pearman of The MAG of Indiana is the patient representative
for the Clinic Accreditation Committee. Alice Diorio is the patient
representative for the Office Based Treatment Committee. Our own
Lisa Torres spoke at the announcement today in Philadelphia with
General McCaffrey and Dr. Wesley Clark.
It will take some time for NAMA to look over the New Guidelines and
make comments on behalf of patients. We encourage all patients to
do the same and to contact NAMA about issues that they may have
questions about. This is our chance to have a say!
There will be a 120 day period of comment on the New Guidelines.
Comments can be sent to:
Documents Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane. Room 1061
Rockville, MD 20857
FOR IMMEDIATE RELEASE
July 22, 1999
Center for Substance Abuse Treatment
Contact:
Jim Michie Phone: 1-800-487-4890
Leah Young Phone: 301-443-3740
NEW FEDERAL RULES PROPOSED TO IMPROVE QUALITY
AND OVERSIGHT OF METHADONE TREATMENT
Methadone programs will have to be accredited under a
new proposal announced today by the U.S. Department
of Health and Human Services. The new accreditation
program will be managed by the Substance Abuse and
Mental Health Services Administration (SAMHSA) and
replaces a 30-year-old inspection program conducted
by the Food and Drug Administration (FDA). The new
program mirrors the recommendations that have been
made over the last decade by several independent
groups, such as the Institute of Medicine, the
Congressional General Accounting Office, and a
consensus conference of the National Institutes of
Health.
Under the proposed rule, published in the Federal
Register, narcotic treatment programs would be
accredited by independent agencies in accordance
with standards established by SAMHSA’s Center
for Substance Abuse Treatment (CSAT). These
proposed standards emphasize improving the
quality of care, such as individualized treatment
planning, increased medical supervision, and
assessment of patient outcomes. This new
program relies on “best practice guidelines”
developed by CSAT over the past 10 years.
“Treatment, along with research and prevention,
is an essential part of the national strategy to
reduce drug addiction and its consequences,”
HHS Secretary Donna E. Shalala said. “The
regulatory changes we are proposing today
will help improve federal oversight of narcotic
treatment programs that use methadone by
bringing the full force of our medical and
clinical knowledge to bear on treating heroin
addiction. These reforms will help ensure a
treatment system that is good for patients,
practitioners, providers and our communities.”
While the White House Office of National Drug
Control Policy (ONDCP) estimates that there are
810,000 heroin addicts in the United States,
only 138,000 to 170,000 people currently receive
methadone or Levo-Alpha-Acetyl-Methadol
(LAAM), as part of an addiction treatment
program. There are approximately 900
methadone treatment programs in the U.S.,
including programs approved for LAAM
treatment. “These regulations will improve
access to methadone treatment programs
and give doctors more flexibility in designing
treatment plans for their patients,” said
ONDCP Director Barry R. McCaffrey.
“Research provides strong evidence to
support methadone maintenance as the
most effective treatment for heroin
addiction. Methadone therapy helps keep
more than 100,000 addicts off heroin, off
welfare, and on the tax rolls as law-abiding,
productive citizens. Without methadone
programs, these individuals will be back on
the streets, back on drugs, and back on wel-
fare, at an enormous cost to society and to
the safety of all of us.” Accreditation has
been proven over the years to produce
effective outcomes and is a widely adopted
external quality assessment system used by
the federal government, states, managed
care firms, insurers, and others to ensure
accountability for quality treatment. The
reorganization toward accreditation follows
recommendations made by a recent National
Institutes of Health consensus panel. The
panel concluded that existing federal and
state regulations limit the ability of
physicians and other health care profes-
sionals to provide methadone maintenance
services to patients and recommended
accreditation in lieu of regulations to
improve the quality of care. The proposed
changes are also consistent with a 1995
report by the Institute of Medicine that
stressed the need to readjust the balance
among regulations, clinical practice
guidelines and quality assurance systems.
The HHS proposal details accreditation
standards and the requirements for
accrediting organizations. When the rule
is final, CSAT will enforce these
regulations. Until the program is trans-
ferred, FDA will continue to monitor
programs in accordance with existing
regulations.
The Drug Enforcement Administration is not
proposing any changes to its oversight and
monitoring activities and responsibilities as
a result of this proposal. The proposed rule
provides for a 120-day period for public
comment and a public hearing prior to
adoption of a final rule. The document
specifies a core of federal standards for
treatment that must be incorporated into
accreditation standards. CSAT is conducting
a study on a representative group of
treatment facilities that are implementing
accreditation standards developed by the
Commission on Accreditation of Rehabilitation
Facilities (CARF) and the Joint Commission on
Accreditation of Healthcare Organizations
(JCAHO). Accreditation standards will be
modified, if needed, to insure the best
quality of care for patients. The proposed
rule is available on the web at
http://www.access.gpo.gov/su_docs
by clicking on Federal Register. Written
comments on the rule may be submitted to
Documents Management Branch (HFA-305)
Food and Drug Administration, 5630 Fishers
Lane, Room 1061, Rockville, MD 20857. The
Center for Substance Abuse Treatment (CSAT)
is part of the Substance Abuse and Mental
Health Services Administration (SAMHSA).
SAMHSA, a public health agency in the U.S.
Department of Health and Human Services,
is the lead Federal agency for improving the
quality and availability of substance abuse
prevention, addiction treatment and mental
health services in the U.S. News media
requests for information on SAMHSA’s
programs should be directed to Media
Services at 1-800-487-4890. This release
may be obtained on the Internet at
www.samhsa.gov.
Comments on the Notice of Proposed Rule Making (NPRM)
On Behalf of Methadone Patients by the
National Alliance of Methadone Advocates (NAMA)
November 19, 1999
NAMA supports the NPRM because it will change the focus of methadone treatment from a paper counting oriented system to one of positive patient outcomes. In general the NPRM is more patient oriented and promotes quality treatment. Perhaps the best feature is that the NPRM will be more flexible and that professionals and policy makers knowledgeable about methadone maintenance will have the opportunity to change and modify guidelines that are not effective. Deregulation will also have an important effect on the perceptions about methadone treatment and hopefully this will be the start of the normalization of methadone treatment into mainstream medicine. As a specifically regulated medical procedure the inference is that it is not real medicine and that the clinicians who work in it are suspect or why else would their medical decisions be invalidated and replaced by regulations. These perceptions and attitudes are the core of the problem and in order for the medical profession to begin to recognize the treatment of opiate addiction as a medical procedure it will first be necessary for methadone to be treated as such. Therefore NAMA views the NPRM as the beginning of many changes that will occur for methadone treatment to fulfill the objectives that were once the aim of treatment.
NAMA will comment on the following issues that are important for quality treatment and better patient care.
The developing of accreditation standards for narcotic addiction treatment will improve the oversight and accountability of these programs. These standards will also serve to promote state-of-the-art treatment services, with emphasis on outcome. Measurements, especially those pertaining to the reduction of crime and drug use, and the engagement of patients in positive pursuits such as employment should be emphasized. These changes are expected to enhance the engagement of patients in their own treatment which will promote patient responsibility and hence advance patient rights as well. The National Institute of Health (NIH) and the Institute of Medicine (IOM) have said that methadone is over regulated, and that is been the main problem. From the day that a patient takes responsibility for their opiate addiction and enters methadone maintenance treatment they are treated with contempt and infantilized. With the emphasis on patient outcome the focus would begin to change from a system of negative reinforcement to one of positive reinforcement and the way that methadone treatment was intended to be.
The Drug Enforcement Administration (DEA) is not proposing any changes to its oversight and monitoring activities as a result of this proposal. NAMA believes that for Accreditation and deregulation to truly work that the DEA must be involved the process. Creative strategies to reduce the risk of diversion should be encouraged to replace the previous and often rigid regulation of unsupervised medication.
The NPRM specifically requests comment on how to modify the system to accommodate office based opioid treatment or if separate standards should be developed. NAMA believes that a variety of strategies should be explored and that treatment availability must reflect the region or area that is being served.
- Physicians could serve as satellite sites of a program.
- Pharmacies could provide daily dosing in rural areas.
- Clinicians with specialties other than addiction (i.e. liver or mental illness) could take on the care of stable patients or perhaps provide more structured treatment in the case of methadone patients with a mental illness.
- State agencies can assist in this process to create a program without Walls for patients in rural areas.
The Medical Maintenance Program has demonstrated the effectiveness of office based treatment for the long term stable patient. NAMA strongly urges that patient who are eligible for Medical Maintenance be moved from their clinics as soon as possible. These patients suffer daily in a clinic system that is suited for the dysfunctional patient and many have had to turn down opportunities.
However, little is known about the patient entering methadone treatment in an office based setting. NAMA would encourage further exploration in this area so that every individual needing and seeing treatment has access to the best treatment possible.
The NPRM proposes the following new definition for opiate addiction: 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 is vague and does not include any of the physical or biological aspects of opiate addiction. While this may appear overly demanding it is important that a government document contain a definition that is not confusing, reflects the recent research and works to reduce the stigma and prejudice that methadone patients experience.
NAMA proposes that the definition from the NIH Consensus Statement be used:
Opiate addiction is defined as a cluster of cognitive, behavioral, and physiological symptoms in which the individual continues use of opiates despite significant opiate-induced problems. Opiate dependence is characterized by repeated self-administration that usually results in opiate tolerance, withdrawal symptoms, and compulsive drug-taking.
The investigation of complaints required in the NPRM will be initially the most effective means to improve methadone treatment. NAMA strongly urges that patient advocates and advocacy organizations be involved is this process. Patients groups should be involved in the oversight of accreditation bodies and their methods for handling grievances.
The grievance report is one way to target those programs that are not providing quality treatment. NAMA recommends that reports be compiled and analyzed for trends. This information can be used in collaboration with patient advocacy groups and the information that they have compile to improve treatment and to recognize problem areas.
NAMA has prepared a Grievance/Compliment Report to collect complaints and other information about program policy that impacts patients negatively. NAMA also wants information on programs that have good policy in order to hold them up as the standard. The intention of the Grievance/Compliment Reporting Project is to make policy change so that methadone treatment becomes a caring and compassionate program providing quality treatment.
Team Membership
NAMA recommends not only that the accreditation body must include a licensed physician on staff but that physician must be trained in addiction medicine and in particular knowledgeable about methadone maintenance treatment.
NAMA strongly recommends that a patient or consumer advocate must be a part of the survey team. In addition accreditation bodies should be encouraged to have a patient advocate or advocacy organization as a consultant.
Evaluation of Accreditation Bodies
NAMA strongly recommends that professionals and patient advocates be involved in the performance evaluation of accreditation bodies. This creates a system with checks and balances that will maintain an equity of power between the ones being evaluated and the evaluators.
Take Home Medication
The NPRM asks for comments on one of four options for take home medication including oversight procedure to reduce the risk of diversion. NAMA supports option 2.
NAMA strongly urges that any reference to a dose level or limit be removed from the guidelines as this may be interpreted as a dose limit.
NAMA also encourages that LAAM be allowed to be given to patients for unsupervised use. This will be beneficial to many patients who have been forced to reject LAAM because they need to travel, etc. The decision to take a medication should be based solely on the medication that works best for the patient.
In order to end the use of take home medication as a behavioral tool by many programs NAMA strongly urges that the criteria and the methodology that a program uses to decide unsupervised medication policy should be included as an element in accreditation. Accreditation bodies should assess a programs criteria periodically and it should be included as part of the determination of whether to accredit the program.
Dose
A second element that accreditation bodies should use for evaluation is dosage. Underdosing is typical in many programs and limits are set despite considerable evidence demonstrating that this practice is not effective. Doses should reflect the needs of patients and their individual treatment plans. NAMA strongly urges that dosing levels should be part of the accreditation process and that programs with no dose over 100 mgs should be refused accreditation. Furthermore programs with doses under 100 mgs should initiate a set of responses to correct the problem including training, guidance from experienced clinicians and follow up review of the program.
Patient Surveys
Patient surveys that are part of the evaluation process should include a patient rating scale that can be used to evaluate the program. This scale should be standardized for all accreditation bodies to use and thus can be used to evaluate programs across the US. NAMA has developed a Patient Satisfaction Scale that can be easily modified. A copy of the scale is attached.
Standardization of Variable Criteria
NAMA would strongly encourage the development of a standard criteria for all accreditation bodies to use.
Under the present system the Federal Regulations are fairly liberal. The problems have been with the states and in particular program policy. NAMA believes that methadone treatment should be standardized and that all programs should have a standard basic policy. This should be an eventual goal for all licensing and policy making bodies.
Cost of accreditation should never increase the cost of treatment for patients.
Cost of Treatment
The cost of treatment has been a major barrier for many opiate dependent individuals seeking help. The majority of states do not include methadone treatment in state medicaid procedures. NAMA would encourage CSAT to use their influence when assessing a states need for treatment funding. Guidelines for a states funding should include some form of equal parity for methadone treatment. The two major barriers are cost and access. The NPRM addresses the problem of access with more liberal unsupervised medication guidelines and allowing physicians to prescribe methadone. However, access will remain limited until the cost of treatment is lowered to a level that is affordable to all.
Creation of Another Bureaucracy
NAMA is concerned that instead of a more acceptable system that the result may be another bureaucracy with an equal amount of paperwork and guidelines to address. Therefore for the first five years and perhaps then at designated intervals the system itself should be evaluated to ascertain that another bureaucracy with an equal amount of red tape and guidelines that no one knows why they do them is not re-created. This will be the most difficult challenge for CSAT to balance enough oversight in order to protect patients with enough leverage to insure quality treatment.
NAMA strongly urges the use of patient advocates in all levels of policy making and in particular in the oversight of treatment. Their omission risks the creation of a system that remains unresponsive to patients. By including patient advocates the process of accreditation promises to begin the creation of a caring and patient oriented system.
- From the date of my first contact, how long did it take to be admitted?
- How long does it take to be medicated?
- If you need a dose increase, how long does it usually take to get one?
- Do you have an assigned counselor?
- I am treated with respect and dignity by the staff?
- Is the facility usually clean?
- Are you involved in the development of your treatment plan?
- If you have a medical problem, is the doctor available to see you?
- Are the services you need available at this program?
- If you had a friend who had a problem with opiates, would you refer them to this clinic?
- When you come into the program do you feel good about being there?
Answer the following questions to the best of your ability.
Rate the following questions according to this scale.
| 0 | 1 | 2 | 3 | 4 | 5 |
|---|---|---|---|---|---|
| Uncertain | Never | Almost Never |
Usually (equal) |
Almost Always |
Always |
If not, what other services should be provided?
The goal would be for the program and patients to analyze the results, determine the level of satisfaction AND need for improvement.
For updates about the NRPM see Late Breaking News.