1. Q—How does an OTP inform SAMHSA of program changes?
A—You may access this form on the Internet at www.dpt.samhsa.gov. Submit an SMA-162 form. In Item 14 of the form, check the box that indicates why you are submitting the application. Choices that appear on the form are Provisional Certification, New Sponsor, New Medical Director, Relocation, Medication Unit, and Renewal.
2. Q—What do you check on the form for a generic program update? For example, if a new program director comes on board in my program, how do I inform SAMHSA of the change? How do I notify SAMHSA of other relevant changes to my organization?
A-Substance Abuse and Mental Health Services Administration Office of Pharmacologic and Alternative Therapies Attention: OTP Certification Program Room 2-1086 1 Choke Cherry Road Rockville, MD 20857 You do not need to check a box on the form to submit a generic program update. However, SAMHSA prefers that you fill out an SMA-162 and attach an explanation of the change. You may also inform SAMHSA of the organizational change with a letter. Please fax the form (or letter) to 1–240–276–1630. You may also mail the form to the address listed below.
3. Q—What do you do if you start a new program and do not have an FDA number?
A—Now that SAMHSA provides oversight for opioid addiction treatment under 42 CFR Part 8, the "FDA number" is now called a "SAMHSA number." To request a SAMHSA number, please submit a completed SMA-162, and in Item 14 on the form, check the "Provisional Certification" box. SAMHSA will review your application for completeness using the checklist, included in your application packet, and will notify you of the need for additional information. After your State and the DEA have completed their OTP approval process and have notified SAMHSA, SAMHSA will complete the approval review. Once your program is approved, SAMHSA will assign a number to you.
4. Q—What do you do if you are an existing program and do not know your SAMHSA number?
A—To find out your SAMHSA number, please e-mail firstname.lastname@example.org or call 1–240–276–2700.
5. Q—Does an existing medication unit have to submit an SMA-162 separately from the original OTP?
A—No, we require only a single submission. Medication units are defined under Federal regulations as facilities, including community pharmacies that dispense treatment medications. The SAMHSA-certified OTP assumes all responsibilities for medication units. If the OTP already has an existing medication unit and the OTP is filing an SMA-162 with a program update, then the program needs to submit only one SMA-162 and the appropriate attachments. One of the attachments always will be a description of the medication unit along with the DEA registration number assigned to that medication unit. The medication unit’s DEA number will be different from the DEA number for the original OTP. For instructions on how to open a new medication unit, see the next question.
6. Q—How does an OTP apply to open a new medication unit?
A—Please submit an SMA-162 with all requested attachments and signed documents to SAMHSA. In Item 14 of the application, "Purpose of Application," check off "Medication Unit." After SAMHSA processes the form, it will forward its approval to the DEA, which will arrange an inspection. The program should also submit any required materials to the State Methadone Authority (SMA) to seek State approval, as appropriate. Once the DEA approves the medication unit, it will assign a new registration number for that medication unit. The SAMHSA-assigned number usually will stay the same for both the original site and the medication unit.
7. Q—Does "Program Sponsor" on the SMA-162 refer to a program or a person?
A—A Program Sponsor (Item 6) should always be a person’s name, not the name of a program. The sponsor is the person who is legally responsible for the OTP and who serves as the formal contact between SAMHSA and the OTP.
8. Q—How much notice does an OTP have to give when informing SAMHSA of a program change?
A—OTPs should notify SAMHSA within 3 weeks of any change indicated in Items 6 and 10 (14?) of the SMA-162 (e.g., medical director or program sponsor).
9. Q—What are the differences between provisional certification, certification, and accreditation? Certification is the process by which SAMHSA determines that an OTP is qualified to provide opioid treatment under the Federal Opioid Treatment Standards. To become certified by SAMHSA, OTPs must successfully complete the accreditation process and meet other requirements enumerated in regulation 42 CFR Part 8. Once certified, programs must renew certification at least every 3 years.
Provisional Certification is a temporary certification granted for up to 1 year for a new OTP until it becomes accredited. SAMHSA may grant provisional certification to an OTP that has applied for accreditation. Provisional certification is granted to OTPs that have submitted form SMA-162, along with a statement identifying the accreditation body to which the OTP has applied, 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. Provisional certification may be granted for 1 year, unless SAMHSA determines that the patient’s health would be adversely affected by the granting of provisional certification. Accreditation is defined by 42 CFR § 8.2 as the process of review and acceptance by an accreditation body. An accreditation body is an independent, not-for-profit organization or State governmental entity that has been approved by SAMHSA under § 8.3 to accredit OTPs that use opioid agonist treatment medications. An OTP must receive accreditation before it may be certified by SAMHSA.
10. Q—When a new OTP is just getting started, how much time does it have to get accreditation?
A—Up to 1 year. New OTPs must apply for accreditation with a SAMHSA-approved accreditation body and then apply to SAMHSA requesting provisional certification. With the application (SMA-162), the OTP should include a statement identifying the accreditation body to which the OTP has applied, 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 will be granted for up to 1 year, unless SAMHSA determines that patient health would be adversely affected by the granting of provisional certification. The program must achieve accreditation within that same year.
1. Q—Is a detoxification program considered to be an OTP?
A—Yes. CFR defines an OTP as a "program or practitioner engaged in opioid treatment of individuals with an opioid agonist treatment medication." The regulations—42 CFR § 8.11 (a) (1)—state that an OTP must have a current, valid certification from SAMHSA to be considered qualified by the Secretary of DHHS to dispense methadone, LAAM, or buprenorphine for the treatment of addiction. A unit of a hospital that intends to offer new detoxification services using methadone should apply to SAMHSA for provisional certification.
2. Q—Will SAMHSA require inpatient detoxification programs that use methadone to be accredited and certified? As a freestanding detoxification/rehabilitation facility dispensing methadone for detoxification only, will we be held to these accreditation/certification standards?
A—Yes. Title 42 of the CFR Part 8 addresses all forms of opioid treatment, including maintenance and detoxification treatment.
3. Q—If so, will the process differ in any way from what is being required of maintenance programs?
A—No. Detoxification programs are subject to the same standards as maintenance programs. Standards are detailed in the Final Rule (42 CFR § 8). OTPs providing inpatient detoxification services must be accredited and certified. Accreditation bodies may develop specific detoxification treatment accreditation standards and processes for surveying OTPs providing such services.
4. Q—Please comment on the guidelines for physicians and clinics who administer detoxification without SAMHSA accreditation.
A— The intent of 21 CFR 1306.07 (b) is to provide practitioner flexibility in emergencies in which a patient undergoing withdrawal needs treatment. In such emergencies, it is impractical to require practitioners to obtain a separate registration. The 72-hour exception offers an opioid-dependent individual relief from experiencing acute withdrawal symptoms while the physician arranges placement in a maintenance/detoxification treatment program. This provision was established to augment, not to circumvent, the separate registration requirement. This information is available at http://www.deadiversion.usdoj.gov/drugreg/faq.htm
In addition, there are other situations in which registration and certification may not be required. The Final Rule, 42 CFR § 8.11 (1) (2), contains the following language:
Certification as an Opiate Treatment Program will not be required for the maintenance or detoxification treatment of a patient who is admitted to a hospital or long-term care facility for the treatment of medical conditions other than opiate addiction and who requires maintenance or detoxification treatment during the period of his or her stay in that hospital or long-term care facility. Under the Narcotic Addiction Treatment Act of 1974, all practitioners who use narcotic drugs for treating opiate addiction must obtain a separate registration.
However, according to the DEA, an exception to the registration requirement, known as the "3-day emergency exception"—21 CFR 1306.07(b)—allows a practitioner who is not separately registered as a narcotic treatment program to administer (but not prescribe) narcotic drugs to a patient for the purpose of relieving acute withdrawal symptoms while arranging for the patient’s referral for treatment, under the following conditions: (1) not more than 1 day’s medication may be administered or given to a patient at one time; (2) this treatment may not be carried out for more than 72 hours; (3) this 72-hour period cannot be renewed or extended.
5. Q—Are there restrictions on how many times a patient can be detoxified this way?
A—The 3-day emergency exception cannot be renewed or extended. Because this is a DEA rule, please consult with DEA for further details.
6. Q—The regulations state that, in order to have take-home medications, a person has to be in a comprehensive maintenance program, but long -term detoxification is not ad-dressed. Old regulations did not allow take-homes for those on long-term detoxification. Is it the same with the new regulations?
A—No. Both maintenance patients and long-term detoxification patients are eligible for take-home medications, while short-term detoxification patients are not.
1. Q—The regulations regarding take-home privileges indicate that a patient may have an extra take-home dose for the day that the clinic is closed. Can you make weekly take-homes adjacent to one-another, so that patients may receive take-homes for a longer period around the weekend?
A—Sometimes. You may not give this privilege to all patients in a clinic. This practice may be justified for an individual patient on occasion. By granting take-home privileges, you are acknowledging that the patient meets the eight criteria in the regulations for take-home medications. The take-home schedule must be tailored to each patient. It also would not be appropriate to give a relatively new patient take-home medications in such a manner because it may place the patient at risk for relapse or tempt the patient to divert medication for illegal use.
2. Q—Our program is considering dispensing tablets for patients who have take-home privileges. Is this a diversion risk?
A—All opioid treatment medications pose a risk of diversion. The physician must determine that a patient is responsible enough to receive solid take-home medication. Diskettes formulated to reduce the potential for intravenous administration pose less diversion risk than tablets.
3. Q—The regulations state that a person on short-term detoxification cannot have take-home medications. How does this apply to the programs that want to close on a holiday or on a Sunday?
A—The previous regulation prohibited take-home medication for both short- and long-term detoxification patients. Under the previous regulation, FDA approved program-wide exemptions to permit holiday take-home medications. SAMHSA will review annual program-wide exemption requests to permit take-home dosages for holidays for patients in short-term detoxification treatment.
4. Q—The regulations state that in order to have take-home medications, a person has to be in a comprehensive maintenance program. Old regulations did not allow take-homes for those on long-term detoxification. Is it the same with the new regulations?
A—No. Both maintenance patients and long-term detoxification patients are eligible for take-home medications, while short-term detoxification patients are not.
5. Q—Assume that a patient is in a comprehensive maintenance program, is on take-home status, and requests a medically supervised withdrawal. Can she or he remain on take-homes during the withdrawal period?
A—Yes. The patient was admitted to maintenance treatment. Take-homes would be permitted.
1. Q— The regulation regarding Medical Examination Services (§ 8.12 (f) (2), Initial Medical Examination Services) states that the initial exam should take place before admission or within the first 14 days. Can the patient begin treatment immediately on admission and see the physician any time within that 14-day period, or must she or he see the physician before treatment commences?
A—The statement preceding the question does not reflect the meaning of the language in the regulation. 42 CFR § 8.12 (f) (2) addresses this question as follows: OTPs shall require each patient to undergo a complete, fully documented physical examination by a program physician or a primary care physician or an authorized health care professional under the supervision of a program physician, before admission to the OTP. The full medical examination, including the results of serology and other tests, must be completed within 14 days following admission.
2. Q—When a person in treatment for opiate addiction tests negative for opiates, but tests positive for another drug, can we keep him or her in treatment?
A—Yes. SAMHSA encourages OTPs to ensure that the abuse of drugs other than opiates is addressed in treatment. The OTP should provide appropriate counseling and other treatment if it identifies abuse of other drugs or alcohol as a problem. When necessary, the OTP may refer the patient to another program for additional treatment services. For further information, please refer to the Treatment Improvement Protocols at http://www.treatment.org/Externals/tips.html
3. Q—The SAMHSA regulations do not state the drugs for which patients should be tested. How do we determine the drugs for which to test?
A—The regulations require that OTPs perform adequate testing services at minimum intervals. SAMHSA guidelines recommend that drug-screening tests should include tests for opiates, methadone, amphetamines, cocaine, and barbiturates. Testing for other drug use should be determined by community drug use patterns or individual medical indications. Accreditation bodies may adopt a more flexible standard, which would allow the OTP not to test for drugs that are not commonly used in that particular community or population. The accreditation bodies may offer additional guidance on this subject.
4. Q—What happens when drug testing reveals use of specific drugs, such as amphetamines and barbiturates?
A—The OTP should provide appropriate counseling and other treatment if abuse of other drugs is identified as a problem. When necessary, the OTP may refer patients to other programs for additional treatment services.
5. Q—Until May 2001 (when the regulations changed), the FDA required that all clinics use an FDA Consent to Methadone Treatment form. On that form, it stated that breast-feeding was not recommended for female patients. As clinics, we were required by law to have patients sign this form. How should we advise pregnant or lactating patients?
A—Regulations require that OTPs obtain every patient’s informed consent to treatment; however, there is no longer a standard, required form. OTPs should develop their own form for consent to treatment. The Accreditation Guidelines state, "The program encourages breastfeeding during methadone/LAAM therapy unless medically contraindicated, e.g., by the presence of HIV/AIDS infection in the mother." However, this decision is a medical decision that the physician and the mother should make.
Compiled And Edited: Deborah Shrira Date: March 31, 2008