NOI Qualifying Other Practitioner NP and PA 30 and 100_30E_Revised OIRA Questions and Edits_CLEAN_5-26-2021

NOI Qualifying Other Practitioner NP and PA 30 and 100_30E_Revised OIRA Questions and Edits_CLEAN.docx

Notification of Intent to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction

NOI Qualifying Other Practitioner NP and PA 30 and 100_30E_Revised OIRA Questions and Edits_CLEAN_5-26-2021

OMB: 0930-0234

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Notification of Intent to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment
of Opiate Addiction by a “Qualifying Other Practitioner” under 21 USC  § 823(g)(2
)(G)(iv)


Form Approved: 0930-0234
Expiration Date: 01/31/2023

See OMB Statement Below

DATE OF SUBMISSION

Note:  Notification is required by § 303(g)(2), Controlled Substances Act (21 USC § 823(g)(2)). See instructions on reverse. PLEASE DON’T FORGET TO SIGN AND DATE THIS FORM (ITEM 12)

1A. NAME OF PRACTITIONER (See instruction below)



1B. State Health Professional License Number 1C. Professional Discipline 1D. DEA Registration Number



2. ADDRESS OF PRIMARY PRACTICE LOCATION (Include Zip Code) (See instruction below)



2A. Is this practice location a Federally Qualified Health Center (FQHC) as defined under Section 1861(aa)(4)(B) of the Social Security Act (42 U.S.C. 1395x)?


Yes No


3. TELEPHONE NUMBER (Include Area Code)
4. FAX NUMBER (Include Area Code)

5. EMAIL ADDRESS (Required)

6. PURPOSE OF NOTIFICATION (See instruction below)

New Notification to treat up to 30 patients

New Notification, with the intent to immediately facilitate treatment of an individual (one) patient

Second notification of need and intent to treat up to 100 patients

New notification to treat up to 100 patients*

*NOTE: In order to treat up to 100 patients in the first year, practitioners must provide medication-assisted treatment with covered medications (as such terms are defined under 42 C.F.R. § 8.2) in a qualified practice setting as described under 42 C.F.R. § 8.615.


7. CERTIFICATION OF USE OF NARCOTIC DRUGS UNDER THIS NOTIFICATION

When providing maintenance or detoxification treatment, I certify that I will only use Schedule III, IV, or V drugs or combinations of drugs that have been approved by the Food and Drug Administration (FDA) for use in maintenance or detoxification treatment and that have not been the subject of an adverse determination.

8. CERTIFICATION OF QUALIFYING CRITERIA (See instructions below)


SAMHSA/HHS Buprenorphine practice guideline exemption (April 2021). These practice guidelines exempt covered practitioners licensed under state law, and who possess a valid DEA registration, from certification requirements related to training, counseling, and other ancillary services (i.e., direct provision of or referral to psychosocial services).


This exemption only applies to those treating up to 30 patients. Time spent practicing under this exemption will not qualify the practitioner for a higher patient limit.


NEW NOTIFICATION- I certify that I am either a nurse practitioner or physician assistant who satisfies the definition of a “qualifying other practitioner” under 21 U.S.C. § 823(g)(2)(G)(iv), as amended by the Comprehensive Addiction and Recovery Act of 2016.


NEW NOTIFICATION- I certify that I am either a clinical nurse specialist, certified registered nurse anesthetist or certified nurse midwife who satisfies the definition of a “qualifying other practitioner” under 21 U.S.C. § 823(g)(2)(G)(iv), as amended by the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018, and I am aware that clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives, will be included in the definition of a “qualifying other practitioner” under 21 U.S.C. § 823(g)(2)(G)(iv) until October 1, 2023.


I certify that I am licensed to prescribe Schedule III, IV, or V medications for the treatment of pain under State law.


I certify that I am NOT required by State law to be supervised by OR work in collaboration with a qualifying physician to prescribe Schedule III, IV, or V medications.

OR

I certify that I am required by State law to be supervised by OR work in collaboration with a qualifying physician to prescribe III, IV, or V medications.

Supervisory/Collaborating Physician Name: _______________________________________

Supervisory/Collaborating Physician DEA Registration Number: ________________________

Supervisory/Collaborating Physician Phone Number: ________________________________


I certify that I have completed the required 24 hours of training for the treatment and management of opioid-dependent patients described under 21 U.S.C. § 823(g)(2)(G)(iv)(II)(aa), which covered the following topics: opioid maintenance and detoxification; appropriate clinical use of all drugs approved by the FDA for the treatment of opioid use disorder; initial and periodic patient assessments (including substance use monitoring); individualized treatment planning, overdose reversal, and relapse prevention; counseling and recovery support services; staffing roles and considerations; and diversion control. I am therefore a qualifying other practitioner. Check and provide copies of documentation (e.g., certificates of completion for the 8- and 16-hour MAT training courses) for all that apply.


Completion of:


American Society of Addiction Medicine (ASAM)

American Osteopathic Association (AOA)/American Osteopathic Academy of Addiction Medicine (AOAAM)

American Academy of Addiction Psychiatry (AAAP)

American Medical Association (AMA)

American Psychiatric Association (APA)

The American Association of Nurse Practitioners (AANP)

The American Academy of Physician Assistants (AAPA)

SAMHSA’s Providers’ Clinical Support System (PCSS)

American Nurses Credentialing Center (ANCC)


Please Provide Date(s) of Completion: ____________________________________________________________________________

Upload Training Documentation Here: ____________________________________________________________________________


SECOND NOTIFICATION FOR 100 PATIENTS - I certify that my qualifications from my initial notification request have not changed.


Upload Board Certification or Training Documentation

File to Upload

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NEW NOTIFICATION TO TREAT 100 PATIENTS - I certify that I provide medication-assisted treatment with covered medications (as such terms are defined under 42 C.F.R. § 8.2) in a qualified practice setting as described under 42 C.F.R. § 8.615.



9. CERTIFICATION OF CAPACITY


I certify that I have the capacity to provide patients with appropriate counseling and other appropriate ancillary services, either directly or by referral.


I certify that I have the capacity to provide, directly or through referral, all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, including for maintenance, detoxification, overdose reversal, and relapse prevention.


10. CERTIFICATION OF MAXIMUM PATIENT LOAD (select one)


I certify that I will not exceed 30 patients for maintenance or detoxification treatment at one time.


Second Notification – I have provided treatment at the 30-patient limit for one year and need to treat up to 100 patients and I certify that I will not exceed 100 patients for maintenance or detoxification treatment at one time.


New Notification for 100 Patients – I will not exceed 100 patients for maintenance or detoxification treatment at one time.


11A. CONSENT (Read instruction 11 below before answering)

I consent to the release of my name, primary practice address, and phone number to the SAMHSA Treatment Locators.

I do not consent to the release of my name, primary practice address, and phone number to the SAMHSA Treatment Locators.


11B. Do you also want to be identified on the SAMHSA Treatment Locators as providing treatment with:

  1. Long-acting injectable naltrexone Yes No


  1. Long-acting injectable buprenorphine Yes No


  1. Long-acting implantable buprenorphine Yes No

12. I certify that the information presented above is true and correct to the best of my knowledge. I certify that I will notify SAMHSA at the address below if any of the information contained on this form changes. Note: Any false, fictitious, or fraudulent statements or information presented above or misrepresentations relative thereto may violate Federal laws and could subject you to prosecution, and/or monetary penalties, and or denial, revocation, or suspension of DEA registration. (See 18 USC § 1001; 31 USC §§ 3801–3812; 21 USC § 824.) 


X__________________________________  X ________________________

Signature Date


Substance Abuse and Mental Health Services Administration,
Please complete online at: http://buprenorphine.samhsa.gov/pls/bwns/waiver

For questions, please contact the Buprenorphine Help Desk at
1-866-287-2728 (1-866-BUP-CSAT) or [email protected]

This form is intended to facilitate the implementation of the provisions of 21 USC § 823(g)(2). The Secretary of DHHS will use the information provided to determine whether practitioners meet the qualifications for waivers from the separate registration requirements under the Controlled Substances Act (21 USC § 823(g)(1)). If such qualifications are met, the Drug Enforcement Administration will assign an identification number to qualifying practitioners and the number will be included in the practitioner’s registration under 21 USC § 823(f).

1. The practitioner must identify the DEA registration number issued under 21 USC § 823(f) to prescribe substances controlled in Schedules III, IV, or V.  

2. Although practitioners may practice in multiple sites, only the primary practice address should be specified. For the practitioner to dispense the narcotic drugs or combinations to be used under this notification, the primary practice address listed here must be the same primary address listed in the practitioner’s DEA registration under § 823(f). Practitioners may provide any additional practice locations by Using the Update Practitioner Contact Information form on SAMHSA’s Buprenorphine website, http://buprenorphine.samhsa.gov/forms/update-contact-info-login.php.

6. Purpose of notification:
New Notification - an initial notification for a waiver submitted for the purpose of obtaining an identification number from DEA for inclusion in the registration under 21 USC § 823(f). New Notification, with the intent to immediately facilitate treatment of an individual (one) patient - an initial notification submitted for the purpose described above, with the additional purpose of notifying the Secretary and the Attorney General of the intent to provide immediate opiate addiction treatment for an individual (one) patient pending processing of this waiver notification.

Increase to 100 Notification - For practitioners who submitted a new notification not less than one year ago and intend and need to treat up to 100 patients.

8. The term “qualifying physician” is used in the NOI as the Controlled Substance Act (CSA) requires that NPs and PAs be supervised (or collaborate with) a “qualifying physician” when required by state law to work with a supervising physician (see 21 USC 823(g)(2)(G)(iv)(III)). The term “qualifying physician” is specifically defined under 21 USC 823(g)(2)(G)(ii). 

11. The SAMHSA Treatment Locators are accessible at http://buprenorphine.samhsa.gov/bwns_locator/ and https://findtreatment.samhsa.gov/ . The Websites list the name, primary practice address, types of long-acting medication-assisted treatment offered, and contact information of practitioners with DATA waivers who consent to be listed on these sites. The Treatment Locators provide links to many other sources of information on substance abuse. No practitioner listings on the SAMHSA Treatment Locator will be made without the express consent of the practitioner.


Privacy Act Information

Authority: Section 303 of the Controlled Substances Act of 1970 (21 USC § 823(g)(2)). Purpose: To obtain information required to determine whether a practitioner meets the requirements of 21 USC § 823(g)(2).Routine Uses: Disclosures of information from this system are made to the following categories of users for the purposes stated:
A. Relevant Licensing Boards to verify practitioners’ qualifications.
B. Other federal law enforcement and regulatory agencies for law enforcement and regulatory purposes.
C. State and local law enforcement and regulatory agencies for law enforcement and regulatory purposes.
D. Persons registered under the Controlled Substance Act (PL 91-513) for the purpose of verifying the registration of customers and practitioners.

Effect: This form was created to facilitate the submission and review of waivers under 21 USC § 823(g)(2). This does not preclude other forms of notification.

Paperwork Reduction Act Statement

Public reporting burden for completing this form is estimated to average 4 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the completed form. 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 0930-0234. 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 (0930-0234); 5600 Fishers Lane, 13E21C, Rockville, MD 20857



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