UPDATED 2-24-17 UPDATE ON COMPREHENSIVE ADDICTION AND RECOVERY ACT (CARA)
For more information, to learn how nurse practitioners
(NPs) and physician assistants (PAs) can train and apply to become DATA-waiver
practitioners, please check the SAMHSA website: https://www.samhsa.gov/medication-assisted-treatment/qualify-nps-pas-waivers
APRNs Seeking DATA 2000 Waiver Notification of Intent
NPs and PAs who have completed the 24 hours of required
training may seek to obtain a DATA 2000-waiver for up to 30 patients may apply
by completing a hardcopy of the Notification
of Intent (NOI) (DOC | 64 KB) and sending to email@example.com,
along with copies of their training certificate(s).
Starting February 27, 2017 SAMHSA will only accept
electronic submissions of the NOI .
These waiver applications are forwarded to the DEA, which will assign the
NP or PA a special identification number. DEA regulations require this number
to be included on all buprenorphine prescriptions for opioid dependency
treatment, along with the NP’s or PA’s regular DEA registration number.
SAMHSA shall review waiver applications within 45 days of
receipt. If approved, NPs and PAs will receive a letter via email that confirms
their waiver and includes their prescribing identification number.
On July 22, 2016, President Obama signed the Comprehensive
Addiction and Recovery Act (CARA) into law as Public Law 114-198. One of CARA’s
important provisions expands access to substance use treatment services and
overdose reversal medications—including the full spectrum of services from
prevention to medication-assisted treatment (MAT) and recovery support—by
extending the privilege of prescribing buprenorphine in office-based settings
to qualifying nurse practitioners (NPs) and physician assistants (PAs) until
Oct. 1, 2021.
CARA requires that NPs and PAs complete 24 hours of training
to be eligible for a prescribing waiver. SAMHSA has created a list of
recommended learning objectives for the trainings. While we cannot require that
the organizations listed in the CARA Act use these learning objectives, we are
sharing them with the stakeholders. Access the Proposed
Learning Objectives for the NP and PA Waiver Training – 2017 (PDF | 196
For additional information, please contact the Drug Enforcement Agency (DEA) at 1-800-882-9539 (8:30 am-5:50 pm ET) or DEA.Registration.Help@usdoj.gov
REVISED ANNOUNCEMENT FOR APRNS REGARDING DEA RENEWAL APPLICATIONS
Starting January 2017, DEA will no longer send its second renewal notification by mail. Instead, an electronic reminder to renew will be sent to the email address associated with the DEA registration.
At this time, DEA will otherwise retain its current policy and procedures with respect to renewal and reinstatement of registration. This policy is as follows:
- If a renewal application is submitted in a timely manner prior to expiration, the registrant may continue operations, authorized by the registration, beyond the expiration date until final action is taken on the application.
- DEA allows the reinstatement of an expired registration for one calendar month after the expiration date. If the registration is not renewed within that calendar month, an application for a new DEA registration will be required.
- Regardless of whether a registration is reinstated within the calendar month after expiration, federal law prohibits the handling of controlled substances or List 1 chemicals for any period of time under an expired registration.
DEA Form 224a – Retail Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-Level Practitioner
New Applications Online
DEA Form 224 – Retail Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-Level Practitioner
KRS 314.011(8) defines "advanced practice registered nursing practice"
KRS 314.195 states the advanced practice registered nurse shall be considered a practitioner for prescriptive authority purposes for non-scheduled legend drugs and controlled substances.
For practice issues not addressed in KRS 314.011(8), please utilize the APRN Scope of Practice Decision-Making Model or contact the APRN Education & Practice Consultant.
APRN Scope of Practice Decision Making Model [PDF Format - 232KB]
Inquiries have been received in the KBN office regarding a variety of issues surrounding advanced practice registered nurse (APRN) practice. These questions have been addressed in the information and links provided.
APRN FORMS FOR PRESCRIPTIVE AUTHORITY
KRS 314.196(2) states that if the Kentucky Board of Nursing and the Kentucky Board of Medical Licensure agree on a common CAPA-NS form, KBN shall require its use. Both Boards agreed on the form in 2015. The common CAPA-NS form is available below and shall be used by all APRNs who wish to enter into a CAPA-NS. The law does not mandate a common CAPA-CS form. An APRN and the collaborating physician may use any form as long as it meets the requirements of KRS 314.042(10). A sample of a form that meets these requirements can be found on the website of the Kentucky Coalition of Nurse Practitioners and Nurse Midwives (www.kcnpnm.org)
Prescribing Non-Scheduled Legend Drugs (CAPA-NS)
KRS 314.042(8)(a-g) provides information about requirements to prescribe nonscheduled legend drugs.
KRS 314.042 (9)(a-e) states that the APRN who has maintained a CAPA-NS for four (4) years or more will no longer be required to maintain a CAPA-NS and shall not be compelled to maintain a CAPA-NS as a condition to prescribe after the four (4) years have expired, but an advanced practice registered nurse may choose to maintain a CAPA-NS indefinitely after the four (4) years. The KBN must be notified that an APRN is discontinuing a CAPA-NS.
Prescribing Controlled Substances (CAPA-CS)
KRS 314.042(10)(a) provides detail about prescribing controlled substances.
Collaborative Agreement CAPA-CS Form
The law does not mandate a common CAPA-CS form. An APRN and the collaborating physician may use any form as long as it meets the requirements of KRS 314.042(10). A sample of a form that meets these requirements can be found on the website of the Kentucky Coalition of Nurse Practitioners and Nurse Midwives
NOTE: When submitting the Notification of CAPA-CS form to KBN you must provide a copy of your DEA registration.
KASPER Registration KRS 218A.202, 201 KAR 20:057
ALL BUTALBITAL CONTAINING PRODUCTS (Fioricet, Bupap, Esgic, etc.) are SCHEDULE III CONTROLLED SUBSTANCES in the Commonwealth of Kentucky and are NOT exempt from the licensing, distribution, and recordkeeping provisions of KRS 218A.150-218A.172, 218A.180, and 218A.200. Prescriptions for butalbital containing products must be reported to KASPER.
Effective September 17, 2014, a prescriber without a DEA license cannot write or issue a prescription for a butalbital containing product (Fioricet, Bupap, Esgic, etc.) . In addition, any remaining refills on a butalbital containing product prescription issued by a prescriber without a valid DEA license may NOT be dispensed. If a DEA licensed prescriber issued a prescription for a butalbital containing product with refills AND it has not been more than 6 months from the date written, it MAY be refilled. Exception: APRNs who have a valid DEA Number are not permitted to write refills for butalbital containing products as APRNs are not permitted to write refills on Schedule III medications.
For questions regarding the changes made to 902 KAR 55:045 and 902 KAR 55:090, please call the Drug Enforcement and Professional Practices Branch at 502-564-7985.
House Bill 1 Materials
In 2012, HB1 established new procedures for the Board of Medical Licensure, established new requirements for physicians, required specific sanctions for certain conduct, required the Board to set out prescribing/dispensing standards in regulations, and established ownership and other requirements for pain management facilities.
Please view this page for a free training opportunity regarding House Bill 1 provided by CECentral.
APRNs & Medication Samples
The 2000 Regular Session of the General Assembly amended KRS Chapter 314 to allow advanced practice registered nurses to receive and dispense sample drugs. The applicable statutes are as follows:
KRS 314.011(8) states, in part: "‘Advanced practice registered nursing’ means the performance of additional acts . . . Advanced practice registered nurses who engage in these additional acts shall be authorized to issue prescriptions for and dispense nonscheduled legend drugs as defined in KRS 217.905, ...under the conditions set forth in KRS 314.042."
KRS 314.011(17) states: " ‘Dispense’ means to receive and distribute noncontrolled legend drug samples from pharmaceutical manufacturers to patients at no charge to the patient or any other party."
KRS 314.042(8) states: "Before an advanced practice registered nurse engages in the prescribing or dispensing of nonscheduled legend drugs as authorized by KRS 314.011(8), the advanced practice registered nurse shall enter into a written collaborative agreement for the APRN's prescriptive authority for nonscheduled legend drugs (CAPA-NS) with a physician that defines the scope of the prescriptive authority for nonscheduled legend drugs."
The 2006 Regular Session of the General Assembly amended KRS Chapter 314 to give APRNs limited authority to write prescriptions for controlled substances, but did not permit an APRN to receive and distribute, nor dispense, controlled substance samples.