PURPOSE: This amendment is necessary to implement the
provision of Senate Bill 718 (2018) passed by the 99th General Assembly. The
proposed amendment change permits an advanced practice registered nurse (APRN)
to prescribe buprenorphine, a Schedule III drug, for thirty (30) days without
refill for patients receiving medication-assisted treatment for substance use
disorders under the direction of the collaborating physician. It also prohibits
the collaborating physician or supervising physician from entering into a
collaborative practice arrangement or supervision agreement with more than six
(6) full-time equivalent advanced practice registered nurses, full-time
equivalent licensed physician assistants, or full-time equivalent assistant
physicians, or any combination thereof.
PURPOSE: In accordance with section
334.104,
RSMo, this rule defines collaborative practice arrangement terms and delimits
geographic areas; methods of treatment; review of services; and drug/device
dispensing or distribution pursuant to prescription and implements the
Utilization of Telehealth by Nurses as required by section
335.175,
RSMo and APRN involvement in the "Improved Access to Treatment for Opioid
Addictions Act" (IATOA) pursuant to sections
334.104
and 630.875, RSMo.
(1) For the purpose of these rules, the
following definitions shall apply:
(A)
Advanced practice nurse-A registered professional nurse (RN) who is also an
advanced practice registered nurse (APRN) as defined in section
335.016(2),
RSMo;
(B) Controlled substance
prescriptive authority-the eligibility and certificate granted by the Missouri
State Board of Nursing (MSBN) to an APRN who has been delegated the authority
to prescribe controlled substances from Schedules III, IV, and/or V in a
written collaborative practice arrangement by the collaborating physician as
defined in section
335.019,
RSMo;
(C) Collaborative practice
arrangements- Refers to written agreements, jointly agreed upon protocols, or
standing orders, all of which shall be in writing, for the delivery of health
care services;
(D) Population-based
public health services-Health services provided to well patients or to those
with narrowly circumscribed conditions in public health clinics or community
health settings that are limited to immunizations, well child care, human
immunodeficiency virus (HIV) and sexually transmitted disease care, family
planning, tuberculosis control, cancer and other chronic disease, wellness
screenings, services related to epidemiologic investigations, and prenatal
care; and
(E) Registered
professional nurse-An RN as defined in section
335.016(16),
RSMo, who is not an APRN.
(2) Geographic Areas.
(A) The collaborating physician in a
collaborative practice arrangement shall not be so geographically distanced
from the collaborating RN or APRN as to create an impediment to effective
collaboration in the delivery of health care services or the adequate review of
those services.
(B) The following
shall apply in the use of a collaborative practice arrangement by an APRN who
provides health care services that include the diagnosis and initiation of
treatment for acutely or chronically ill or injured persons:
1. If the APRN is providing services pursuant
to section
335.175,
RSMo, no mileage limitation shall apply;
2. If the APRN is not providing services
pursuant to section
335.175,
RSMo, the collaborating physician and collaborating APRN shall practice within
seventy-five (75) miles by road of one another; and
3. Pursuant to section
630.875, RSMo, an APRN
collaborating with a physician who is waiver-certified for the use of
buprenorphine, may participate in the "Improved Access to Treatment for Opioid
Addictions Program" (IATOAP) in any area of the state and provide all services
and functions of an APRN. A remote collaborating physician working with an
on-site APRN shall be considered to be on-site for the purposes of
IATOAP.
(C) An APRN who
desires to enter into a collaborative practice arrangement at a location where
the collaborating physician is not continuously present shall practice together
at the same location with the collaborating physician continuously present for
a period of at least one (1) month before the collaborating APRN practices at a
location where the collaborating physician is not present. It is the
responsibility of the collaborating physician to determine and document the
completion of the same location practice described in the previous
sentence.
(D) A collaborating
physician shall not enter into a collaborative practice arrangement with more
than six (6) full-time equivalent APRNs, full-time equivalent physician
assistants, fulltime equivalent assistant physicians, or any combination
thereof. This limitation shall not apply to collaborative arrangements of
hospital employees providing inpatient care service in hospitals as defined in
Chapter 197, RSMo, or population-based public health services as defined in
this rule or to a certified registered nurse anesthetist providing anesthesia
services under the supervision of an anesthesiologist or other physician,
dentist, or podiatrist who is immediately available if needed as set out in
section
334.104(7),
RSMo.
(3) Methods of
Treatment.
(A) The methods of treatment and
the authority to administer, dispense, or prescribe drugs delegated in a
collaborative practice arrangement between a collaborating physician and
collaborating APRN shall be within the scope of practice of each professional
and shall be consistent with each professional's skill, training, education,
competence, licensure, and/or certification and shall not be further delegated
to any person except that the individuals identified in sections
338.095
and
338.198,
RSMo, may communicate prescription drug orders to a pharmacist.
(B) The methods of treatment and authority to
administer and dispense drugs delegated in a collaborative practice arrangement
between a collaborating physician and a collaborating RN shall be within the
scope of practice of each professional and shall be consistent with each
professional's skill, training, education, and competence and shall not be
delegated to any other person except the individuals identified in sections
338.095
and
338.198,
RSMo, may communicate prescription drug orders to a pharmacist.
(C) The collaborating physician shall
consider the level of skill, education, training, and competence of the
collaborating RN or APRN and ensure that the delegated responsibilities
contained in the collaborative practice arrangement are consistent with that
level of skill, education, training, and competence.
(D) Guidelines for consultation and referral
to the collaborating physician or designated health care facility for services
or emergency care that is beyond the education, training, competence, or scope
of practice of the collaborating RN or APRN shall be established in the
collaborative practice arrangement.
(E) The methods of treatment, including any
authority to administer or dispense drugs, delegated in a collaborative
practice arrangement between a collaborating physician and a collaborating RN
shall be delivered only pursuant to a written agreement, jointly agreed-upon
protocols, or standing orders that shall describe a specific sequence of
orders, steps, or procedures to be followed in providing patient care in
specified clinical situations.
(F)
The methods of treatment, including any authority to administer, dispense, or
prescribe drugs, delegated in a collaborative practice arrangement between a
collaborating physician and a collaborating APRN shall be delivered only
pursuant to a written agreement, jointly agreed-upon protocols, or standing
orders that are specific to the clinical conditions treated by the
collaborating physician and collaborating APRN.
(G) Methods of treatment delegated and
authority to administer, dispense, or prescribe drugs shall be subject to the
following:
1. The physician retains the
responsibility for ensuring the appropriate administering, dispensing,
prescribing, and control of drugs utilized pursuant to a collaborative practice
arrangement in accordance with all state and federal statutes, rules, or
regulations;
2. All labeling
requirements outlined in section
338.059,
RSMo, shall be followed;
3.
Consumer product safety laws and Class B container standards shall be followed
when packaging drugs for distribution;
4. All drugs shall be stored according to the
United States Pharmacopeia (USP), (2010), published by the United States
Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland
20852-1790, 800-227-8772;
http://www.usp.org/ recommended conditions,
which is incorporated by reference. This does not include any later amendments
or additions;
5. Outdated drugs
shall be separated from the active inventory;
6. Retrievable dispensing logs shall be
maintained for all prescription drugs dispensed and shall include all
information required by state and federal statutes, rules, or
regulations;
7. All prescriptions
shall conform to all applicable state and federal statutes, rules, or
regulations and shall include the name, address, and telephone number of the
collaborating physician and collaborating APRN;
8. An RN shall not, under any circumstances,
prescribe drugs. The administering or dispensing of a controlled substance by
an RN or APRN who has not been delegated authority to prescribe in a
collaborative practice arrangement, pursuant to
19 CSR
30-1.066, shall be accomplished only under the
direction and supervision of the collaborating physician, or other physician
designated in the collaborative practice arrangement, and shall only occur on a
case-by-case determination of the patient's needs following verbal consultation
between the collaborating physician and collaborating RN or APRN. The required
consultation and the physician's directions for the administering or dispensing
of controlled substances shall be recorded in the patient's chart and in the
appropriate dispensing log. These recordings shall be made by the collaborating
RN or APRN and shall be cosigned by the collaborating physician following a
review of the records;
9. In
addition to administering and dispensing controlled substances, an APRN, as
defined in section
335.016, RSMo, may be
delegated the authority to prescribe controlled substances listed in Schedule
II-hydrocodone and Schedules III, I V, and V of section
195.017,
RSMo, in a written collaborative practice arrangement, except that, the
collaborative practice arrangement shall not delegate the authority to
administer any controlled substances listed in Schedule II-hydrocodone and
Schedules III, I V, and V of section
195.017,
RSMo, for the purpose of inducing sedation or general anesthesia for
therapeutic, diagnostic, or surgical procedures. When issuing the initial
prescription for an opioid controlled substance in treating a patient for acute
pain, the APRN shall comply with requirements set forth in section
195.080,
RSMo. Schedule II-hydrocodone and Schedule III narcotic controlled substance
prescriptions shall be limited to a one hundred twenty- (120-) hour supply
without refill. An APRN may prescribe buprenorphine, a Schedule III controlled
substance, for up to a thirty- (30-) day supply without refill for patients
receiving medication-assisted treatment for substance abuse disorders under the
direction of the collaborating physician as described in sections
334.104
and 630.875, RSMo;
10. An APRN may not prescribe controlled
substances for his or her own self or family. Family is defined as spouse,
parents, grandparents, great-grandparents, children, grandchildren,
great-grandchildren, brothers and sisters, aunts and uncles, nephews and
nieces, mother-in-law, father-in-law, brothers-in-law, sisters-in-law,
daughters-in-law, and sons-in-law. Adopted and step members are also included
in family;
11. An APRN or RN in a
collaborative practice arrangement may only dispense starter doses of
medication to cover a period of time for seventy-two (72) hours or less with
the exception of Title X family planning providers or publicly funded clinics
in community health settings that dispense medications free of charge. The
dispensing of drug samples, as defined in
21
U.S.C. section
353(c)(1), is
permitted as appropriate to complete drug therapy;
12. The collaborative practice arrangement
shall clearly identify the controlled substances the collaborating physician
authorizes the collaborating APRN to prescribe and document that it is
consistent with each professional's education, knowledge, skill, and
competence; and
13. The medications
to be administered, dispensed, or prescribed by a collaborating RN or APRN in a
collaborative practice arrangement shall be consistent with the education,
training, competence, and scopes of practice of the collaborating physician and
collaborating RN or APRN.
(H) When a collaborative practice arrangement
is utilized to provide health care services for conditions other than acute
self-limited or well-defined problems, the collaborating physician, or other
physician designated in the collaborative practice arrangement, shall examine
and evaluate the patient and approve or formulate the plan of treatment for new
or significantly changed conditions as soon as is practical, but in no case
more than two (2) weeks after the patient has been seen by the collaborating
APRN or RN. If the APRN is providing services pursuant to section
335.175,
RSMo, the collaborating physician, or other physician designated in the
collaborative practice arrangement, may conduct the examination and evaluation
required by this section via live interactive video or in person. Telehealth
providers shall obtain the patient's or the patient's guardian's consent before
telehealth services are initiated and shall document the patient's or the
patient's guardian's consent in the patient's file or chart. All telehealth
activities must comply with the requirements of the Health Insurance
Portability and Accountability Act of 1996, and all other applicable state and
federal laws and regulations.
(I)
Nothing in these rules shall be construed to permit medical diagnosis of any
condition by an RN pursuant to a collaborative practice arrangement.
(4) Review of Services.
(A) In order to assure true collaborative
practice and to foster effective communication and review of services, the
collaborating physician, or other physician designated in the collaborative
practice arrangement, shall be immediately available for consultation to the
collaborating RN or APRN at all times, either personally or via
telecommunications.
(B) The
collaborative practice arrangement between a collaborating physician and a
collaborating RN or APRN shall be signed and dated by the collaborating
physician and collaborating RN or APRN before it is implemented, signifying
that both are aware of its content and agree to follow the terms of the
collaborative practice arrangement. The collaborative practice arrangement and
any subsequent notice of termination of the collaborative practice arrangement
shall be in writing and shall be maintained by the collaborating professionals
for a minimum of eight (8) years after termination of the collaborative
practice arrangement. The collaborative practice arrangement shall be reviewed
at least annually and revised as needed by the collaborating physician and
collaborating RN or APRN. Documentation of the annual review shall be
maintained as part of the collaborative practice arrangement.
(C) Within thirty (30) days of any change and
with each physician's license renewal, the collaborating physician shall advise
the Missouri State Board of Registration for the Healing Arts whether he/she is
engaged in any collaborative practice agreement, including collaborative
practice agreements delegating the authority to prescribe controlled substances
and also report to the board the name of each licensed RN or APRN with whom
he/she has entered into such agreement. A change shall include, but not be
limited to, resignation or termination of the RN or APRN; change in practice
locations; and addition of new collaborating professionals.
(D) An RN or an APRN practicing pursuant to a
collaborative practice arrangement shall maintain adequate and complete patient
records in compliance with section
334.097,
RSMo.
(E) The collaborating
physician shall complete a review of a minimum of ten percent (10%) of the
total health care services delivered by the collaborating APRN. If the APRN's
practice includes the prescribing of controlled substances, the physician shall
review a minimum of twenty percent (20%) of the cases in which the APRN wrote a
prescription for a controlled substance. If the controlled substance chart
review meets the minimum total ten percent (10%) as described above, then the
minimum review requirements have been met. The collaborating APRN's
documentation shall be submitted for review to the collaborating physician at
least every fourteen (14) days. This documentation submission may be
accomplished in person or by other electronic means and reviewed by the
collaborating physician. The collaborating physician must produce evidence of
the chart review upon request of the Missouri State Board of Registration for
the Healing Arts. This subsection shall not apply during the time the
collaborating physician and collaborating APRN are practicing together as
required in subsection (2)(C) above.
(F) If a collaborative practice arrangement
is used in clinical situations where a collaborating APRN provides health care
services that include the diagnosis and initiation of treatment for acutely or
chronically ill or injured persons, then the collaborating physician shall be
present for sufficient periods of time, at least once every two (2) weeks,
except in extraordinary circumstances that shall be documented, to participate
in such review and to provide necessary medical direction, medical services,
consultations, and supervision of the health care staff. In such settings, the
use of a collaborative practice arrangement shall be limited to only an APRN.
If the APRN is providing services pursuant to section
335.175,
RSMo, the collaborating physician may be present in person or the collaboration
may occur via telehealth in order to meet the requirements of this section.
Telehealth providers shall obtain the patient's or the patient's guardian's
consent before telehealth services are initiated and shall document the
patient's or the patient's guardian's consent in the patient's file or chart.
All telehealth activities must comply with the requirements of the Health
Insurance Portability and Accountability Act of 1996, and all other applicable
state and federal laws and regulations.
(G) The collaborating physician and
collaborating RN or APRN shall determine an appropriate process of review and
management of abnormal test results which shall be documented in the
collaborative practice arrangement.
(H) The Missouri State Board of Registration
for the Healing Arts and the Missouri State Board of Nursing separately retain
the right and duty to discipline their respective licensees for violations of
any state or federal statutes, rules, or regulations regardless of the
licensee's participation in a collaborative practice arrangement.
(5) Population-Based Public Health
Services.
(A) In the case of the
collaborating physicians and collaborating registered professional nurses or
APRN practicing in association with public health clinics that provide
population-based health services as defined in section (1) of this rule, the
geographic areas, methods of treatment, and review of services shall occur as
set forth in the collaborative practice arrangement. If the services provided
in such settings include diagnosis and initiation of treatment of disease or
injury not related to population-based health services, then the provisions of
sections (2), (3), and (4) above shall apply.