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About the New SAMHSA Regulations for Methadone TreatmentOn May 18, 2001, the Federal Government issued new regulations, repealing the Food and Drug Administration’s (FDA) Regulations 21 CFR Part 291, and enacting the Substance Abuse and Mental Health Services Administration’s (SAMHSA) Regulations 42 CFR Part 8 entitled "Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Final Rule. Under the New Rule, the responsibility for the regulation and oversight of Opioid Treatment Programs (OTP) was assigned to the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Administrator of SAMHSA has delegated certain responsibilities to the Center For Substance Abuse Treatment (CSAT), and within CSAT, to the Division of Pharmacologic Therapies (DPT) to carry out those responsibilities. The following Frequently Asked Questions were developed as a result of responding to the questions presented by patients in treatment, their family members and Medication Assisted Treatment supporters throughout the country.
1. Have the Federal Regulations governing Opioid Agonist Treatment (OAT) utilizing methadone and LAAM changed. Yes. On May 18, 2001 the administrative responsibility and oversight for Opioid Drugs in maintenance and detoxification treatment of opiate addiction shifted from the Food and Drug Administration (FDA) to the Substance Abuse and Mental Health Services Administration (SAMHSA). The Center for Substance Abuse Treatment (CSAT), an agency within SAMHSA will administer the day to day responsibilities of the new regulations. The old Code of Federal Regulations (21 CFR Part 291) has been repealed and in its place, new Federal rules have been issued (42 CFR Part 8). The new rule includes the creation of a regulatory system based on an accreditation model that allows for greater administrative flexibility, fewer constraints on clinical judgment, and increased focus on the needs of patients. Since most hospital and many ambulatory and behavioral health care medical services in this country are subject to accreditation, it is anticipated that this new system will increase significantly the direct participation of the medical and behavioral health care communities in the delivery and oversight of opioid agonist treatment. 2. Do the new regulations change unsupervised or take-home medication standards? Yes. The new regulations allow for increased medical and clinical judgment and contain updated requirements to receive unsupervised or take-home medication. The following eight conditions remain unchanged from the previous rule: (1) no recent drug use, (2) attends clinic regularly, (3) no serious behavioral problems, (4) no criminal activity, (5) stable home environment and good social relationships, (6) length of time in treatment (see below), (7) assurance that take-home medication will be safely stored, and (8) judgment that the rehabilitative benefit to the patient will outweigh the risk of diversion (42 CFR Part 8.12.i (2) (i-viii)). Patients that meet the 8 conditions are eligible for the following take home schedule. NOTE: The following schedule is the minimum standard; states and programs can choose to raise the standards, i.e., require longer time periods of stability, provide fewer total take-home doses, etc. For purposes of these FAQs, take-home medication will consist of Automatic take-homes (when the program is closed on Sundays, State and Federal holidays) and Scheduled take-homes (when the physician and program staff recognize the patient’s progress in treatment, or hardship satisfies the criteria to receive take-home medication).
Patients taking LAAM may now earn the same take-home schedule as those taking methadone. However, it should be emphasized again that just because a patient is eligible does not mean that he/she automatically would receive take-home medication. As with the previous FDA regulations, this is a decision that is made by the medical director (physician) of the program. The physician must assess each patient’s progress and determine whether the rehabilitative benefit derived from decreasing the frequency of attendance outweighs any potential risks. While programs are being encouraged to utilize the SAMHSA take-home schedule, this does not mean that they are required to do so. 3.Do the new regulations allow programs to dispense tablets or diskettes? Under the new regulations (42 CFR Part 8.12.h (3) (I)), programs must continue to dispense or administer methadone in oral form only, and it must be formulated in a way as to reduce the possibility of parenteral (IV) abuse. This means that the programs may continue to use liquid medication at the window and for general take-home purposes. However, in cases of stable patients permitted to receive extended take-home doses (14 to 31 doses), 40mg. diskettes may be used to prevent spoilage, and reduce the bulk of take-home bottles. Tablets may be used in cases where increments of 5mgs are necessary and the program does not feel comfortable trimming 5ml. from a 40mg. diskette. Tablets may be used but are not recommended as the total dose either at the window or as the take-home medication. 4. What if my program does not choose to implement these new take-home schedules as outlined in the SAMHSA Regulations? Although these are Federal Regulations, nothing in these new SAMHSA regulations is intended to usurp or limit the authority of the State and local governmental entities to regulate the use of opioid drugs in the treatment of opioid addiction. As stated in FAQ #2, the SAMHSA regulations are minimum treatment standards, and the State can elect to be more stringent. However, the regulations have been modified to permit greater clinical judgement and more individualized treatment. If the state regulations permit take-home medication in accordance with the new Federal Schedule, and many have already changed their regulations to conform, then OTPs should evaluate each patient as part of the individualization of treatment concept. The Accreditation bodies will then assess the program’s performance during the survey. 5.> Does CSAT have to be notified if patients on doses higher than 100mgs receive take-homes? No. This reporting requirement has been eliminated. Any patient with a dose over 100mgs can receive take-home medication providing the appropriate criteria is satisfied. The medical director of the program makes this decision based on the overall progress of the patient. In the new regulations there is no mention of dose levels limiting take-home medication (FR/Vol. 66, pg 4085 (15), January 17, 2001). If your dose has been restricted to under 100mgs in order to keep your take-homes, this is no longer necessary or appropriate. Schedule an appointment to see the doctor at your program and discuss the possibility of having your dose adjusted, if medically necessary. 6.> Are there any changes in the drug testing requirements? Yes. At least eight random drug abuse tests per year, per patient in maintenance treatment are required (regardless of the patient’s length of time in maintenance treatment), in accordance with generally accepted clinical practices (42 CFR Part 8.12.(f)(6)). For patients in short-term detoxification treatment (30 days or less), at least one initial drug abuse test per patient must be performed, and for patients receiving long-term detoxification treatment (31 days to 180 days), the program must perform initial and monthly random tests on each patient (42 CFR Part 8.12.(f)(6)). NOTE: SAMHSA regulations regarding drug testing permit adequately tested and Federally approved toxicological testing procedures, such as oral swab, hair, etc. Furthermore, the SAMHSA/CSAT Guidelines for the Accreditation of Opioid Treatment Programs states that "...urine and other toxicological specimens are to be collected in a therapeutic context that suggests trust, respect and minimizes falsification. Reliance on direct observation, video camera monitoring, or one-way mirrors, although necessary for some patients, is neither necessary nor appropriate for all patients. Temperature testing is minimally intrusive and highly effective in identifying counterfeit or altered specimens." Therefore, clinical requirements, such as drug testing, should be individually based, and observation utilized when clinically necessary. 7.> Do the regulations make any provisions for patient grievances? Yes. The Federal regulations include provisions for receiving and acting upon patient grievances (42 CFR Part 8.4.(e)). The SAMHSA/CSAT approved accreditation bodies are required to have policies and procedures to respond to complaints from SAMHSA/CSAT, patients, facility staff, and others, within a reasonable period of time but not more than 5 days from the receipt of the complaint. Some accreditation bodies permit complaints to be submitted online. Additionally, in the SAMHSA/CSAT Guidelines for the Accreditation of Opioid Treatment Programs, under Consumer Bill of Rights and Responsibilities (XVI.B.14.g) Complaints and Appeals: All consumers have the right to a fair and efficient process for resolving differences with their health plans, health care providers, and the institutions that serve them, including a rigorous system of internal review and an independent system of external review. This is an area that the surveying accreditation organization will review. 8. Will the Accreditation Bodies selected by SAMHSA/CSAT have direction or guidance in how and what to review when surveying an Opioid Agonist Treatment Program? Yes. Beginning in 1996, CSAT’s Division of Pharmacologic Therapies (DPT), co>nvened a special field-based Guideline Development Panel of Methadone and LAAM treatment experts and consumer advocates to provide content input to SAMHSA/CSAT as it began the process of developing guidelines for the accreditation organizations. J. Thomas Payte, M.D., Medical Director of Drug Dependence Associates and Co-Chair of the American Society of Addiction Medicine’s Committee on Methadone Treatment, chaired the Panel. The Panel met numerous times reviewing and refining the document prior to its release in April, 1999 as the "Guidelines for the Accreditation of Opioid Treatment Programs." All SAMHSA/CSAT approved accrediting bodies are required to base their standards on the SAMHSA regulations. Additionally, the CSAT Guidelines for the Accreditation of Opioid Treatment Programs have been provided to the accreditation bodies to help implement the SAMHSA regulations and guide their development and adaptation of standards when conducting a survey of an Opioid Agonist Treatment Program. 9. Do all Programs have to comply with the Accreditation Guidelines in addition to the Federal Regulations? While it's true that States and programs can make their regulations more restrictive than the Federal rules, all Opioid Agonist Treatment Programs will be surveyed by a SAMHSA/CSAT approved accreditation organization with standards based on the SAMHSA regulations and the CSAT Guidelines for the Accreditation of Opioid Treatment Programs. 10. Do the new regulations allow any doctor to prescribe methadone to treat opiate addiction? No. Although appropriately licensed and certified physicians can prescribe methadone as well as other scheduled drugs for the treatment of pain, the new Federal regulations do not permit physicians to prescribe narcotic drugs, including methadone and LAAM, for the treatment of opiate addiction. Only an Opioid Agonist Treatment Program possessing a current, valid certification from SAMHSA can be considered qualified by the Secretary under section 303(g)(1) of the Controlled Substances Act (21 U.S.C. 823(g)(1) to be registered to dispense opioid drugs in the treatment of opioid addiction. 11. Do the new regulations allow for exceptional circumstances or hardships by granting exceptions to the regulations? Yes. The new Federal regulations permit SAMHSA to consider requests for exemption from the requirements set forth under 42 CFR § 8.11 and § 8.12 (42 CFR § 8.11(h)). For example, a private practitioner (physician) who wishes to treat a limited number of patients in a rural area with no accessible Opioid Treatment Program (OTP), may seek to provide medical maintenance treatment with methadone and LAAM in his/her private office practice. For more information, refer to the CSAT "Dear Colleague Letter on Medical Maintenance" March 30, 2000, which is available on the SAMHSA Website (http://dpt.samhsa.gov). Examples of patient exceptions include hardship exceptions based on physical disabilities, unusual transportation/distance factors, employment issues, etc. These are requested by the program physician in writing and sent to the state methadone authority (SMA) and CSAT for review and possible approval. 12. Do privately owned clinics have to comply with the new Federal regulations? Yes. All clinics in the U.S. not only have to comply with the Federal regulations, they must also apply to one of the SAMHSA/CSAT approved accreditation bodies for accreditation. During the application phase, the applying program is granted provisional certification by SAMHSA pending the outcome of the accreditation survey. If a program is unable to receive or retain accreditation, it cannot become or remain SAMHSA certified and consequently, will need to surrender the SAMHSA Certification.
13. What will happen if a program is not accredited? If an OTP fails to receive accreditation from the SAMHSA/CSAT approved accreditation organization or loses it’s accreditation, the OTP may lose SAMHSA Certification and consequently will no longer be permitted to provide Opioid Agonist Treatment. OTPs have contingency plans for patient services when programs close for emergencies or other situations (weather, etc.). Accreditation bodies will review these plans during the accreditation survey. In the case of an operating program that loses or forfeits its SAMHSA Certification, the program has the responsibility of transferring all willing, active patients to an appropriately SAMHSA Certified Opioid Agonist Treatment Program. The State Methadone Authority’s Office may assist in this process. With the proper release of confidentiality signed by the patient, the patient record may be transferred to the patient’s receiving treatment program (42 CFR Part 2.19(1). It is advised, (may be mandated by some state regulations) that all inactive records be stored in a secure manner by the closing program in accordance with 42 CFR Part 2.19(a)(1)(b)(1)(2). The OTP should identify an individual to whom all inquires would be directed, such as requests for documentation of previous treatment or patient histories, which may be necessary for the patient to confirm the necessary addiction history to satisfy the admission criteria (42 CFR Part 8.12(e) Patient admission criteria). 14. Are the regulations that protect a patient’s confidentiality still in effect? Yes. The confidentiality regulations (42 CFR Part 2) have not been changed and remain in effect. 15. Are programs that have a policy of arbitrarily limiting the daily amount of medication a patient may receive or a dose cap as it is often called, violating treatment guidelines? Yes. Treatment programs that have policies that restrict the physician from ordering, or the program from dispensing the medically appropriate dosage that the patient legitimately requires, are operating outside of what has been determined by treatment experts as best practices. Additionally, the SAMHSA/CSAT Guidelines for the Accreditation of Opioid Treatment Programs endorse clinical practices that take into consideration the individual treatment of the patient. Programs that utilize blanket or boiler plate policies and treatment protocols that all patients must participate in regardless of their progress in treatment are not providing the individualized care that the 1995 Institute of Medicine Report found to produce the most positive outcome.² 16. >Under the new Federal Regulations, can programs continue to seek hardship exceptions when it is in the best interest of the patient’s treatment? Yes. The new Federal regulations continue to provide a program the opportunity to request from SAMHSA an exception from the regulatory requirements when the rehabilitative benefit outweighs the potential for diversion or other problems. Exceptions are often in line with the focus on individualized treatment, and are requested largely due to some hardship encountered by the patient. As stated above in FAQ 11, examples would be: living long distances from the OTP, transportation difficulties, medication hours conflict with patient’s employment, weather related travel advisories. These issues will be considered as long as the patient meets all other requirements. It should be noted that in most states, the State Methadone Authority may also need to approve exception requests. CARF : Commission for the Accreditation of Rehabilitation Facilities (pronounced Carf) CFR : Code of Federal Regulations (or Federal Code) CSAT : Center for Substance Abuse Treatment (pronounced Cee-Sat) FDA : Food and Drug Administration FR : Federal Register (a weekly government publication containing new Federal Code, grant announcements, etc.) JCAHO : Joint Commission for the Accreditation of Healthcare Organizations (pronounced Jay-Ko or called Joint Commission) OBOT : Office Based Opioid Treatment (pronounced O-Bot) SAMHSA : Substance Abuse and Mental Health Services Administration (pronounced Sam-Sa) TAPs : Treatment Assessment Protocols (pronounced Taps) TIPs : Treatment Improvement Protocols (pronounced Tips) Notes: 1. This time is dependent on how the Medical Maintenance Program or Office Based Opioid Treatment (OBOT) is set up and the criteria for admission. Essentially at 2 years a patient could be eligible, however, some States or programs may require more time in treatment. 2. TIPS (Treatment Improvement Protocols) and TAPS (Treatment Assistance Protocols) are a series of published treatment guidelines. The new Federal regulations are primarily based on the Institute of Medicine Report (1995, National Academy Press), State Methadone Treatment Guidelines (TIP1) and LAAM in the Treatment of Opiate Addiction (TIP 22). They can be obtained from the National Clearinghouse on Drug and Alcohol Information (NCADI) (http://www.health.org) by calling 1-800-SAY-NO TO (DRUGS). A revision of TIP#1, to include the Federal Regulatory changes, as well as other new information, is under development. Bibliography
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