Form Sma162 PDF Details

At the heart of the United States' efforts to regulate and oversee opioid treatment programs is the Form SMA-162, a crucial document that serves as an Application for Certification to Use Opioid Drugs in a Treatment Program. Administered by the Substance Abuse and Mental Health Services Administration (SAMHSA), a branch of the Department of Health and Human Services, this form embodies the regulatory framework under 42 CFR § 8.11 and is tied to key legislation including the Controlled Substances Act and the Drug Abuse Prevention and Control Act of 1970. The form seeks comprehensive details about the treatment program, from the basic identification such as the program's name and its primary dispensing location, to the intricate operational elements like DEA registration numbers and the accreditation status. Moreover, it demands transparency about the program's medical director, funding sources, and patient counts, establishing a rigorous screening process for those looking to offer opioid treatment. Within its pages, program sponsors affirm their commitment to adhere to federal opioid treatment standards, consent to oversight by relevant authorities, and ensure the maintenance of a patient records system that respects the confidentiality required by federal law. Failure to comply with the stipulations of the SMA-162 can lead to recommendations for suspension or revocation of the opioid treatment program registration, underscoring the form's role in maintaining the integrity and efficacy of opioid addiction treatment across the nation.

QuestionAnswer
Form NameForm Sma162
Form Length2 pages
Fillable?No
Fillable fields0
Avg. time to fill out30 sec
Other names2010, sma 162 form to print, sma 162 form, OMB

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION

CENTER FOR SUBSTANCE ABUSE TREATMENT

Application for Certification to Use Opioid Drugs in a Treatment Program Under 42 CFR § 8.11

Form Approved: OMB Number 0930-0206

Expiration Date: 06/30/2016 See OMB Statement on Reverse

DATE OF SUBMISSION

Note: This form is required by 42 CFR 8.11 pursuant to Sec. 303, Controlled Substances Act (21 USC § 823) and the Drug Abuse Prevention and Control Act of 1970 (42 USC § 275(a)). Failure to report may result in a recommendation for the suspension or revocation of the opioid treatment program registration.

 

1a. Name of Program: (Name of primary dispensing location)

d. DEA Registration Number:

 

b. Doing business as:

 

e. ISATS-ID: (e.g., AL100002)

 

c. Opioid Treatment Program Number: (e.g., AL-10001-M)

f. National Provider Identification Number: (e.g., 1234567890)

 

 

 

 

 

2. Address of Primary Dispensing Location: (Include ZIP Code)

3.

Telephone Number: (Include Area Code)

 

 

 

4.

Fax Number: (Include Area Code)

 

 

 

5.

E-Mail Address:

 

 

 

 

 

6. Name and Address of Program Sponsor: (Include ZIP Code)

7.

Telephone Number: (Include Area Code)

 

 

 

8.

Fax Number: (Include Area Code)

 

 

 

9.

E-Mail Address:

 

 

 

 

 

10. Name of Medical Director: (and Address—if different than Dispensing

11.

DEA Registration Number:

 

Location, above)

 

 

 

 

 

 

 

12.

Telephone Number: (Include Area Code)

 

 

 

13.

Fax Number: (Include Area Code)

 

 

 

14.

E-Mail Address:

 

 

 

 

 

 

15. Purpose of Application:

 

 

□ New Medical Director □ Relocation □ Medication Unit

 

□ Provisional Certification □ Renewal/Re-certification □ New Sponsor

 

16. Number of Patients in Treatment on Date of Submission:

 

 

 

 

 

 

 

 

_____Methadone

_____Buprenorphine

 

 

 

_____Other (Specify) _____________________________________________________________________________________________________

17a. Program Status: □ For-profit □ Nonprofit □ Public/Government □ VA

□ Other (Specify) _____________________________

b. Program Funding Sources: (Check each appropriate agency and attach the address of each, if applicable.)

□ SAMHSA (Block Grant)

□ Private Charities

□ Department of Veterans Affairs

□ Patient Payment

□ State Government

□ County Government

□ Indian Health Service

□ Private Health Insurance

□ Other (Specify) _____________________________

 

 

 

 

18. Application

Center for Substance Abuse Treatment Division of Pharmacologic Therapies

Substance Abuse and Mental Health Services Administration Attention: OTP Certification Program

1 Choke Cherry Road, Suite 2–1086 Rockville, MD 20857

Overnight:

1 Choke Cherry Road, Suite 2–1086

Rockville, MD 20850

Dear Sir/Madam:

As the person responsible for the program (OTP), I submit this application in triplicate for approval to use approved opioid drugs in a program for detoxification and/or maintenance treatment for narcotic addicts in accordance with 42 CFR Part 8, Certification of Opioid Treatment Programs. A copy of this application has been sent to the State Authority within which State the program is located. I understand that SAMHSA and State approvals are necessary to obtain a registration from the Drug Enforcement Administration (DEA).

A. I have a copy of, or access to 42 CFR Part 8, Certification of Opioid Treatment Programs, including 42 CFR § 8.12, the Federal Opioid Treatment Standards. I have read, understand and will comply with these standards which govern the treatment of narcotic addiction with approved opioid drugs.

B. Attached is a description of the current accreditation status of the OTP. This description includes the name and address of the accreditation body and the date of the last accreditation action.

C. Attached is a description of the organizational structure of the OTP which includes the name and complete address of any central administration or larger organizational structure to which this program is responsible. The description shall specify how the program will provide adequate medical, counseling, vocational, educational, and assessment services, at the primary facility, unless the program sponsor has entered into a formal documented agreement with another entity to provide these services to patients enrolled in the OTP. In addition, the attachment includes the names of the persons responsible for the OTP.

FORM SMA-162 (revised 2010) (FRONT) (Submit in triplicate)

D. Attached are the names, addresses, and a description of each hospital,

I. I shall comply with the security standards for the distribution of

institution, clinical laboratory, or other facility used by this program to

controlled substances, as required by 21 CFR § 1301, Registration of

provide the necessary medical and rehabilitative services.

Manufacturers, Distributors, and Dispensers of Controlled Substances.

E. A medical director will be designated to assume responsibility for

J. I agree to comply with the conditions of certification set forth under

administering all medical services performed by the program. If a medical

42 CFR § 8.11(f). In addition, I shall allow, in accordance with Federal

director is responsible for more than one program, the feasibility of such

controlled substance laws and Federal confidentiality laws, inspections

an arrangement will be documented and submitted to SAMHSA. Within

and surveys by duly authorized employees of SAMHSA, by

three weeks of any replacement of the medical director, I shall notify

accreditation bodies, the DEA, and by authorized employees of any

SAMHSA.

relevant State or Federal governmental authority. I agree that OTPs

 

must operate in accordance with Federal opioid treatment standards

F. Attached is the address of each medication unit or other facility under

and accreditation elements.

control of the OTP. Any new dispensing site for this program, including

 

 

medication units shall be approved by SAMHSA and the State authority

K. I agree to adhere to all rules, directives, and procedures set forth in

prior to its use. SAMHSA and the State authority shall be notified within

42 CFR Part 8, and any regulation regarding the use of an opioid drug

three weeks of the deletion of any facility used to dispense opioid

for the treatment of narcotic addiction which may be promulgated in

treatment drugs.

the future. I shall inform other individuals who work in this treatment

 

program of the provisions of this regulation, and monitor their

G. A patient records system will be established and maintained to

activities to assure compliance with the provisions.

document and monitor patient care in this program. It shall be maintained

 

 

so as to comply with the Federal and State reporting requirements

L. I understand that failure to abide by the rules directives, and procedures

relevant to narcotic treatment. A drug dispensing record will be maintained

described above may cause a suspension or revocation of approval of my

to show dates, quantity, and batch or code marks of the drug administered

registration by the Drug Enforcement Administration.

or dispensed, traceable to specific patients. This drug dispensing record

 

 

must be retained for a period of three years from the date of dispensing.

M. As program sponsor, I certify that the information submitted in

 

this application is truthful and accurate.

H. I have a copy of, or access to 42 CFR Part 2, Confidentiality of Alcohol

 

 

and Drug Abuse Patient Records. I have read and understand the

 

 

requirements to maintain the confidentiality of alcohol and drug abuse

 

 

treatment patient records. I agree to protect the identity of all patients in

 

 

accordance with the regulations.

 

 

 

 

 

Program Sponsor: (Signature)

Date:

 

 

 

Please send three copies of this form and all attachments to:

Center for Substance Abuse Treatment

Division of Pharmacologic Therapies

Substance Abuse and Mental Health Services Administration

Attention: OTP Certification Program

1 Choke Cherry Road, Suite 2–1086

Rockville, MD 20857

 

 

Overnight:

 

 

1 Choke Cherry Road, Suite 2–1086

Rockville, MD 20850

 

 

and two copies to the appropriate State authority.

The preferred method for submitting this form to CSAT/DPT is online at the DPT Web site, http://dpt.samhsa.gov. The Web site contains

complete instructions for preparing and submitting your request. If you are unable to submit online, the form may be e-mailed as an

attachment to otp@samhsa.hhs.gov or sent by traditional mail (include three copies of all attachments) to the mailing address above.

 

 

Paperwork Reduction Act Statement

Public reporting burden for this collection of information is estimated to average between 6 minutes and 1 hour per response, including the time for

reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of

information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this

burden to SAMHSA Reports Clearance Officer; Paperwork Reduction Project (0930-0206); Suite 7-1043, 1 Choke Cherry Road, Rockville, MD 20857.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB

control number. The OMB control number for this project is 0930-0206.

 

 

 

 

 

FORM SMA-162 (revised 2010) (BACK)

 

 

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