Advanced Practice Registered Nurses, 33155-33160 [2016-12338]
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Federal Register / Vol. 81, No. 101 / Wednesday, May 25, 2016 / Proposed Rules
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Dated: May 19, 2016.
Jacqueline C. Charlesworth,
General Counsel and Associate Register of
Copyrights.
[FR Doc. 2016–12227 Filed 5–24–16; 8:45 am]
BILLING CODE 1410–30–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
RIN 2900–AP44
Advanced Practice Registered Nurses
Department of Veterans Affairs.
Proposed rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) is proposing to amend its
medical regulations to permit full
practice authority of all VA advanced
practice registered nurses (APRNs)
when they are acting within the scope
of their VA employment. This
rulemaking would increase veterans’
access to VA health care by expanding
the pool of qualified health care
professionals who are authorized to
provide primary health care and other
related health care services to the full
extent of their education, training, and
certification, without the clinical
supervision of physicians. This rule
would permit VA to use its health care
resources more effectively and in a
manner that is consistent with the role
of APRNs in the non-VA health care
sector, while maintaining the patientcentered, safe, high-quality health care
that veterans receive from VA. The
proposed rulemaking would establish
additional professional qualifications an
individual must possess to be appointed
as an APRN within VA. The proposed
rulemaking would subdivide APRN’s
into four separate categories that
include certified nurse practitioner,
certified registered nurse anesthetist,
clinical nurse specialist, and certified
nurse-midwife. The proposed
rulemaking would also provide the
criteria under which VA may grant full
practice authority to an APRN, and
define the scope of full practice
authority for each category of APRN. VA
intends that the services to be provided
by an APRN in one of the four APRN
roles would be consistent with the
nursing profession’s standards of
practice for such roles.
DATES: Comments must be received by
VA on or before July 25, 2016.
ADDRESSES: Written comments may be
submitted: Through https://
www.Regulations.gov; by mail or hand-
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delivery to Director, Regulations
Management (02REG), Department of
Veterans Affairs, 810 Vermont Avenue
NW., Room 1068, Washington, DC
20420; by fax to (202) 273–9026.
Comments should indicate that they are
submitted in response to ‘‘RIN 2900–
AP44-Advanced Practice Registered
Nurses.’’ Copies of comments received
will be available for public inspection in
the Office of Regulation Policy and
Management, Room 1068, between the
hours of 8 a.m. and 4:30 p.m., Monday
through Friday (except holidays). Call
(202) 461–4902 for an appointment.
(This is not a toll-free number.) In
addition, during the comment period,
comments may be viewed online
through the Federal Docket Management
System (FDMS) at https://
www.Regulations.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Penny Kaye Jensen, Liaison for National
APRN Practice, 810 Vermont Ave. NW.,
Washington, DC 20420; (202) 461–6700.
(This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: Section
7301 of title 38 United States Code
(U.S.C.) establishes the Veterans Health
Administration (VHA) within VA, and
establishes that its primary function is
to ‘‘provide a complete medical and
hospital service for the medical care and
treatment of veterans, as provided in
this title and in regulations prescribed
by the Secretary pursuant to this title.’’
38 U.S.C. 7301(b). In carrying out this
function, VHA has an obligation to
ensure that patient care is appropriate
and safe and its health care practitioners
meet or exceed generally-accepted
professional standards for patient care.
The Secretary is responsible for the
proper execution and administration of
all laws administered by the Department
and for the control, direction, and
management of the Department, to
include agency personnel and
management matters. See 38 U.S.C. 303.
To enable the Secretary to direct,
control and manage VA, Congress
authorized the Secretary ‘‘to prescribe
all rules and regulations which are
necessary or appropriate to carry out the
laws administered by the Department
and are consistent with those laws.’’ 38
U.S.C. 501(a). The Under Secretary for
Health is directly responsible to the
Secretary for the operation of VHA (38
U.S.C. 305(b)). Unless specifically
otherwise provided, the Under Secretary
for Health, as the head of VHA, is
authorized to ‘‘prescribe all regulations
necessary to the administration of the
Veterans Health Administration,’’
subject to the approval of the Secretary.
38 U.S.C. 7304. To allow VA to carry
out its medical care mission, Congress
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33155
also established a comprehensive
personnel system for certain medical
employees in VHA, independent of the
civil service rules. See Chapters 73 and
74 of title 38, U.S.C. The Secretary was
granted express statutory authority to
establish the qualifications for VA’s
healthcare practitioners, determine the
hours and conditions of employment,
take disciplinary action against
employees, and otherwise regulate the
professional activities of those
individuals. 38 U.S.C. 7401–7464. As an
integrated Federal health care system
with the responsibility to provide
comprehensive care under 38 U.S.C.
7301, it is essential that VHA wisely
manage its resources and fully utilize
the skills of its health care providers to
the full extent of their education,
training, and certification. By permitting
APRNs throughout the VHA system a
way to achieve full practice authority in
order to provide advanced nursing
services to the full extent of their
professional competence, VHA would
further its statutory mandate to provide
quality health care to our nation’s
veterans. This proposed regulatory
change to nursing policy would permit
APRNs to practice to the full extent of
their education, training and
certification, without the clinical
supervision or mandatory collaboration
of physicians. Standardization of APRN
full practice authority, without regard
for individual State practice regulations,
would help to ensure a consistent
continuum of health care across VHA by
decreasing the variability in APRN
practice that currently exists across
VHA as a result of disparate State
practice regulations. As of March 7,
2016 CRNAs have full practice authority
in 17 states, while CNPs have full
practice authority in almost 50% of the
nation, which includes 21 states and the
District of Columbia.
It would also aid in fully maximizing
VHA APRN staff capabilities, which
would increase VA’s capacity to provide
timely, efficient, and effective primary
care services, as well as other services.
This would increase veteran access to
needed VA health care, particularly in
medically-underserved areas, as well as
decrease the amount of time veterans
spend waiting for patient appointments.
In addition, standardizing APRN
practice authority would enable
veterans, their families, and caregivers
to understand more readily the health
care services that VA APRNs are
authorized to provide. This preemptive
rule would increase access to care and
reduce the wait times for VA
appointments utilizing the current
workforce already in place.
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To ensure that VA would have
available highly qualified medical
personnel, Congress mandated the basic
qualifications for certain health care
positions, including registered nurses.
Sections 7401 through 7464 of title 38,
U.S.C., grant VA authority to regulate
the professional activities of such
personnel. To be eligible for
appointment as a VA employee in a
health care position covered by section
7402(b) (other than Director), of title 38,
U.S.C., a person must, among other
requirements, be licensed, registered or
certified to practice their profession in
a State. The standards prescribed in
section 7402(b) establish only the basic
qualifications necessary ‘‘[t]o be eligible
for appointment’’ and do not limit the
Secretary or Under Secretary for Health
from establishing other qualifications
for appointment, or additional rules
governing such personnel. In particular,
38 U.S.C. 7403(a)(1) provides that
appointments under Chapter 74 ‘‘may
be made only after qualifications have
been established in accordance with
regulations prescribed by the Secretary,
without regard to civil-service
requirements.’’ In addition, 38 U.S.C.
7421(a) directs that, ‘‘[n]otwithstanding
any law, Executive order, or regulation,
the Secretary shall prescribe by
regulation the hours and conditions of
employment and leaves of absence of
employees appointed under any
provision of [chapter 74] [in the
specifically numerated positions] in the
Veterans Health Administration’’
(including registered nurses). As the
head of VHA, the Under Secretary for
Health has the duty to ‘‘prescribe all
regulations necessary to the
administration of the Veterans Health
Administration,’’ subject to approval by
the Secretary. 38 U.S.C. 7304; see also
38 U.S.C. 501. Pursuant to this
authority, the Under Secretary for
Health is authorized to establish the
qualifications and clinical practice
standards of VHA’s nursing personnel
and to otherwise regulate their
professional conduct.
To continue to provide high quality
health care to veterans, VA is proposing
to amend its regulations to allow APRNs
to practice to the full extent of their
education, training, and certification,
regardless of individual State
restrictions that limit such full practice
authority, except for applicable State
restrictions on the authority to prescribe
and administer controlled substances,
when such APRNs are acting within the
scope of their VA employment. The
proposed rule would use the term ‘‘full
practice authority’’ to refer to the
APRN’s authority to provide advanced
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nursing services without the clinical
oversight of a physician when that
APRN is working within the scope of
their VA employment. Such full
practice authority would be granted by
VA upon demonstrating that the
established regulatory criteria are met.
In addition, full practice authority
would be granted appropriate to the
clinical service setting.
This proposed rule is consistent with
the recommendation of the Institute of
Medicine (IOM) of the National
Academy of Sciences to remove scopeof-practice barriers. Specifically, the
2010 IOM report, ‘‘The Future of
Nursing: Leading Change Advancing
Health,’’ (IOM Report) available at
https://iom.nationalacademies.org/
Reports/2010/The-Future-of-NursingLeading-Change-AdvancingHealth.aspx, recommended that
‘‘[a]dvanced practice registered nurses
(APRNs) should be able to practice to
the full extent of their education and
training.’’ Id. at 9. More generally, the
report stated that ‘‘[r]estrictions on
scope of practice and professional
tensions have undermined the nursing
profession’s ability to provide and
improve both general and advanced
care’’ and asserted that ‘‘[p]roducing a
health care system that delivers the right
care—quality care that is patient
centered, accessible, evidence based,
and sustainable—at the right time will
require transforming the work
environment, scope of practice,
education, and numbers and
composition of America’s nurses.’’ Id. at
26. In addition, the proposed rule is
consistent with the National Council of
State Boards of Nursing (NCSBN)
Consensus Model, as discussed in more
detail later in this rulemaking.
Significantly, many States already
permit full practice authority of APRNs
or are in the process of doing so. Under
the proposed rulemaking, APRNs would
not be authorized to replace or act as
physicians or to provide any health care
services that are beyond their clinical
education, training, and national
certification. The proposed rule would
limit an APRN’s full practice authority
to practice within the scope of their VA
employment, and any APRN practice
outside of VA employment would
remain subject to applicable State laws,
in the same manner as any other
licensed VA practitioner in their private
practice.
In this rulemaking, VA is proposing to
exercise Federal preemption of State
nursing licensure laws to the extent
such State laws conflict with the full
practice authority granted to VA APRNs
while acting within the scope of their
VA employment. Preemption would be
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the minimum necessary action for VA to
allow APRNs full practice authority. It
would be impractical for VA to lobby to
each State that does not allow full
practice authority to APRNs to change
their laws regarding full practice
authority. This process would be costly
and time consuming for VA and would
not guarantee the desired result of full
practice authority to all APRNs.
Section-by-Section Analysis of the
Proposed Rule
17.415 Full Practice Authority for
Advanced Practice Registered Nurses
The general qualifications for a person
to be appointed as a VA nurse are found
in 38 U.S.C. 7402(b)(3), which requires
that a person must have successfully
completed a full course of nursing in a
recognized school of nursing, as well as
be registered as a graduate nurse in a
State. VA interprets ‘‘a recognized
school of nursing’’ to mean a school of
professional nursing approved by the
appropriate State agency and accredited
by the National League for Nursing
Accrediting Commission (NLNAC) or
the Commission on Collegiate Nursing
Education (CCNE); the completion of
coursework equivalent to a nursing
degree in a MSN Bridge Program that
qualifies for professional nursing
registration; or a foreign school of
professional nursing that enables the
graduate to obtain current, full, active
and unrestricted registration. VA
Handbook 5005/27, Part II, Appendix
G6, paragraph 2, Section B.a(2). VA
interprets ‘‘registered as a graduate
nurse in a state’’ to mean a current, full,
active and unrestricted licensure,
registration or certification as a graduate
professional nurse in a State, Territory,
or Commonwealth (i.e., Puerto Rico) of
the U.S. or in the District of Columbia
(hereinafter ‘‘licensure’’). Id. Pursuant to
the authorities in 38 U.S.C. 7401
through 7464 and VA’s rulemaking
authorities at 38 U.S.C. 501 and 7304,
VA is proposing a new § 17.415(a),
which would define additional
qualifications a registered nurse must
possess to be appointed to one of four
(4) APRN roles, i.e., Certified Nurse
practitioner (CNP), Certified Registered
Nurse Anesthetist (CRNA), Clinical
Nurse Specialist (CNS), or Certified
Nurse-Midwife (CNM). The proposed
rule would require an advanced practice
registered nurse to have successfully
completed a nationally-accredited,
graduate-level educational program that
prepares the advanced practice
registered nurse in one of the four APRN
roles; and to possess, and maintain,
national certification and State licensure
in that APRN role. These additional
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qualifications are derived from criteria
set forth in the IOM Report, and the
National Council of State Boards of
Nursing Consensus Model for APRN
Regulation: Licensure, Accreditation,
Certification & Education) Regulation,
July 2008 (the APRN Consensus Model),
which VA finds to be the criteria most
widely accepted by State boards of
nursing and the nursing community as
necessary to practice as an APRN.
Under the proposed rule, APRNs who
meet these additional qualifications may
be granted full practice authority within
VA in one of the four recognized APRN
roles.
Proposed § 17.415(a)(1) would require
an APRN to have successfully
completed an accredited graduate-level
educational program in one of the four
distinct APRN roles. The Consensus
Model defines these roles as CNP,
CRNA, CNS, and CNM. These APRN
roles are widely known and accepted by
State boards of nursing and the nursing
community. VA currently does not
employ CNMs; however, the proposed
rule includes CNMs in the event that
VA has the need to hire CNMs in the
future.
Proposed § 17.415(a)(2) would require
an APRN to have passed a national
certification examination that measures
the APRN’s knowledge, skills and
experience demonstrated by the
achievement of standards identified by
the profession in one of the four APRN
roles established in proposed
§ 17.415(a)(1). Public and private sector
health care employers, State boards of
nursing, and the nursing community
rely on national certification through an
examination process as the standard,
which conveys adequate APRN
knowledge, and VA’s regulation would
adopt the same standard.
Proposed § 17.415(a)(3) would require
an APRN to possess a license from a
State licensing board in one of the four
recognized APRN roles. Proposed
§ 17.415(a)(4) would require an APRN to
maintain both the national certification
and licensure required in proposed
paragraphs (a)(2) and (3) of § 17.415.
In total, proposed paragraphs (a)(1)
through (4) of § 17.415 would establish
qualifications for employment within
VA as a CNP, CRNA, CNS and CNM.
These qualifications would ensure that
VA APRNs possess and maintain the
education, knowledge, national
certification and State licensure
necessary for VA employment in one of
the four recognized APRN roles. APRNs
who meet these qualifications would be
granted full practice authority within
VA in one of the four recognized APRN
roles.
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Proposed § 17.415(b) would define
‘‘full practice authority’’ to mean that an
APRN working within the scope of VA
employment would be authorized to
provide the services described in
proposed § 17.415(d), without the
clinical oversight of a physician,
regardless of State or local law
restrictions on that authority. Further,
any APRN practice established outside
VA employment would be subject to
applicable State law, in the same
manner as private practice by any other
licensed VA provider.
Proposed § 17.415(c) would establish
the criteria by which VA may grant full
practice authority to an APRN. Proposed
paragraph (c)(1), would require a VA
medical facility to verify that the APRN
meets the requirements established in
proposed § 17.415(a). Proposed
paragraph (c)(2) would require VA to
confirm that the APRN has
demonstrated the knowledge and skills
necessary to provide the services
described in proposed § 17.415(d)
without the clinical oversight of a
physician, and is thus qualified to be
privileged for such scope of practice.
Proposed § 17.415(c)(1) and (2) together
would clarify that the VA processes for
credentialing and privileging of licensed
independent health care providers
would apply to VA APRNs with full
practice authority. VA anticipates that
the granting of full-practice authority
under proposed § 17.415(c) would be
implemented through formal VHA
guidance issuances.
Proposed § 17.415(d)(1) would
describe the role-specific services that a
VA APRN would be authorized to
perform under their full practice
authority. This authority would be
without regard to state licensure
restrictions, except as provided in
proposed paragraph (d)(2), which would
defer to State licensure restrictions on a
VA APRN’s authority to prescribe, or
administer controlled substances. We
emphasize that full practice authority
for an APRN in this rulemaking would
apply only to services provided by an
APRN when working within the scope
of their VA employment, as required by
proposed § 17.415(b). Additionally, all
full practice authority of APRNs in
proposed § 17.415(d)(1) would be under
approved privileges by, and within the
available resources of, a VA medical
facility, as required by proposed
§ 17.415(c). VA intends that the services
to be provided by an APRN in one of the
four APRN roles would be consistent
with the nursing profession’s standards
of practice for such roles.
In proposed § 17.415(d)(1)(i), a CNP
would have full practice authority to
provide the following services:
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Comprehensive histories, physical
examinations and other health
assessment and screening activities;
diagnose, treat, and manage patients
with acute and chronic illnesses and
diseases; order, perform, supervise, and
interpret laboratory and imaging
studies; prescribe medication and
durable medical equipment and; make
appropriate referrals for patients and
families; and aid in health promotion,
disease prevention, health education,
and counseling as well as the diagnosis
and management of acute and chronic
diseases.
In proposed § 17.415(d)(1)(ii), a CRNA
would have full practice authority to
provide a patient’s anesthesia care and
anesthesia related care, to include
planning and initiating anesthetic
techniques (general, regional, local) and
sedation, providing post-anesthesia
evaluation and discharge; ordering and
evaluating diagnostic tests; requesting
consultations; performing point-of-care
testing; and responding to emergency
situations for airway management.
In proposed § 17.415(d)(1)(iii), a CNS
would have full practice authority to
provide diagnosis and treatment of
health or illness states, disease
management, health promotion, and
prevention of illness and risk behaviors
among individuals, families, groups,
and communities within their scope of
practice.
Lastly, in proposed § 17.415(d)(1)(iv),
a CNM would have full practice
authority to provide a full range of
primary health care services to women
veterans, including gynecologic care,
family planning service, preconception
care (care that women veterans receive
before becoming pregnant, including
reducing the risk of birth defects and
other problems such as the treatment of
diabetes and high blood pressure),
prenatal and postpartum care,
childbirth, and care of a newborn. We
note that the pregnancy and delivery
services described above, as well as the
newborn care services, would be subject
to the limitations established in 38 CFR
17.38(a)(1)(xiii) and (xiv), respectively.
We also note that authorized CNM
services would include treating the
partner of the female patient for
sexually transmitted infection and
reproductive health, if the partner is
enrolled in the VA healthcare system or
not required to enroll to receive VA
services. We would include the services
of a CNM in this rulemaking in
anticipation that VA would hire CNMs
at a future date to improve access to
health care for the increasing number of
female veterans.
Proposed § 17.415(d)(2) would
expressly limit full practice authority.
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Congress has specifically required
reliance on a specific State law under
the Controlled Substance Act (CSA).
Specifically, proposed § 17.415(a)(2)
would provide that full practice
authority within VA is subject to State
licensure law with regard to the
authority of an APRN to prescribe, or
administer controlled substances, and to
any other limitations on the provision of
VA care set forth in applicable Federal
law and policy. Regarding the full
practice authority limitations for
controlled substances, the CSA, 21
U.S.C. 801 et seq., and implementing
regulations in 21 CFR part 1300, make
State licensure authority to prescribe, or
administer controlled substances a
prerequisite for authority under the CSA
to prescribe, or administer controlled
substances. See 21 U.S.C. 802(21)
(providing that a practitioner must be
‘‘licensed, registered, or otherwise
permitted, by the United States or the
jurisdiction in which he practices or
does research, to distribute, conduct
research with respect to, administer, or
use in teaching or chemical analysis, a
controlled substance in the course of
professional practice or research.’’); See
also 21 CFR 1306.03(a) (stating that a
prescription for a controlled substance
may be issued only by an individual
practitioner who is: (1) Authorized to
prescribe controlled substances by the
jurisdiction in which he is licensed to
practice his profession and (2) either
registered or exempted from registration
pursuant to §§ 1301.22(c) and 1301.23.).
Proposed § 17.415(d)(2) also would
make the full practice authority of an
APRN subject to any other limitations
on the provision of VA care set forth in
Federal law or policy.
Proposed § 17.415(e) would expressly
state the intended preemptive effect of
proposed § 17.415, to ensure it is clear
that conflicting State and local laws
related to the practice of APRNs would
have no force or effect when such
APRNs are working within the scope of
their VA employment. In circumstances
where there is a conflict between
Federal and State Law, Federal law
prevails in accordance with Article VI,
clause 2, of the U.S. Constitution
(Supremacy Clause). It is a wellestablished principle of constitutional
law that Federal law is supreme, and
States may not regulate or control the
lawful actions of the Federal
Government, absent Congressional
consent. Therefore, where there is
conflict between State law and Federal
law with regard to full practice
authority of APRNs working within the
scope of their federal VA employment,
this regulation would control.
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Accordingly, State disciplinary actions
that would penalize, or otherwise
interfere with, an APRN’s full practice
authority in the performance of their
official VA duties, would likewise be
effectively preempted. However, where
there is no conflict between this
regulation and State law, the State
would retain authority to impose State
regulations on its APRN licensees and
take disciplinary action for any
violations. We emphasize that this
preemptive effect would only pertain to
APRNs when they are acting within the
scope of their federal VA employment;
this rule would not have any effect on
individual State efforts to either permit
or restrict full practice authority for
APRNs who are not working within a
VA scope of employment.
The Indian Health Service already
grants full practice authority to APRNs.
See Part 4, Chapter 3, Section 11,
‘‘Advanced Practice Nurses,’’ Indian
Health Manual. In the Military Health
System, the Services employ APRNs,
which includes Nurse Midwives, Nurse
Practitioners, and Nurse Anesthetists, in
independent practice without oversight
from physicians. They are privileged in
their roles as APRNs and can adjust
their scope practice (level of care)
through privileging as granted by a
committee of physicians and the
military treatment facility commander.
Nurse Practitioners specifically have an
assigned group of patients for which
they are responsible. Therefore, we do
not anticipate that the proposed changes
in this rulemaking would be completely
novel or unexpected to the general
public or other Federal entities that
provide health care services to
beneficiaries.
Executive Order 13132, Federalism
Section 4 of Executive Order 13132
(titled ‘‘Federalism’’) requires an agency
that is publishing a regulation that
preempts State law to follow certain
procedures. Section 4(b) of the
Executive Order requires agencies to
‘‘construe any authorization in the
statute for the issuance of regulations as
authorizing preemption of State law by
rulemaking only when the exercise of
State authority directly conflicts with
the exercise of Federal authority under
the Federal statute or there is clear
evidence to conclude that the Congress
intended the agency to have the
authority to preempt State law.’’ Section
4(d) of the Executive Order requires that
when an agency proposes to act through
rulemaking to preempt State law, ‘‘the
agency shall consult, to the extent
practicable, with appropriate State and
local officials in an effort to avoid such
a conflict.’’ Section 4(e) of the Executive
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Order requires that when an agency
proposes to act through rulemaking to
preempt State law, ‘‘the agency shall
provide all affected State and local
officials notice and an opportunity for
appropriate participation in the
proceedings.’’
Section 6(c) of Executive Order 13132
states that ‘‘no agency shall promulgate
any regulation that has federalism
implications and that preempts State
law, unless the agency, prior to the
formal promulgation of the regulation,
(1) consulted with State and local
officials early in the process of
developing the proposed regulation; (2)
in a separately identified portion of the
preamble to the regulation as it is to be
issued in the Federal Register, provides
to the Director of the Office of
Management and Budget a federalism
summary impact statement, which
consists of a description of the extent of
the agency’s prior consultation with
State and local officials, a summary of
the nature of their concerns and the
agency’s position supporting the need to
issue the regulation, and a statement of
the extent to which the concerns of
State and local officials have been met;
and (3) makes available to the Director
of the Office of Management and Budget
any written communications submitted
to the agency by State and local
officials.’’
Because this regulation would address
preemption of certain State laws, VA
conducted prior consultation with State
officials in compliance with Executive
Order 13132. VA sent a letter to the
National Council of State Boards of
Nursing to state VA’s intent to allow full
practice authority to VA APRNs and for
the National Council of State Boards of
Nursing to notify every State Board of
Nursing of VA’s intent and to seek
feedback from such Boards of Nursing.
In addition, VA solicited comments
and input from State Boards of Nursing,
through their representative national
organization, the National Council of
State Boards of Nursing (NCSBN). In
response to its request for comments,
VA received correspondence from the
Executive Director and other relevant
staff members within NCSBN, which
agreed with VA’s position that this
rulemaking properly identifies the areas
in VA regulations that preempt State
laws and regulations. VA received no
other comments from the NCSBN on
this rulemaking. In response to VA’s
outreach to NCSBN, VA received
numerous calls and correspondence
from State and local officials in support
of this proposed rule. Such State and
local officials included State Senators
from Georgia and Illinois, State
Representatives from Florida, Ohio,
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Vermont, North Carolina, Georgia, and
Illinois, County Commissioners from
Nevada, Ohio, and North Carolina, and
the State Comptroller and Secretary of
State from Illinois, to name a few.
VA additionally engaged other
relevant external groups on the
proposed changes in this rulemaking,
including the American Association of
Nurse Anesthetists, American
Association of Nurse Practitioners,
American College of Surgeons,
American Academy of Family Practice
Physicians, American Society of
Anesthesiologists, American Medical
Association, Association of American
Medical Colleges, The Joint
Commission-Office of Accreditation and
Certification, American Association of
Retired Persons, American Legion,
Blinded Veterans Association, Vietnam
Veterans of America, American Women
Veterans, Disabled American Veterans,
Paralyzed Veterans of America, Veterans
of Foreign Wars. VA also engaged the
Senate and House Veterans Affairs
Committees and the Senate and House
Armed Services Committees.
Many external stakeholders expressed
general support for VA’s positions taken
in this proposed rule, particularly with
respect to full practice authority of
APRNs in primary health care.
However, we also received comments
opposing full practice authority for
CRNAs when providing anesthetics. To
aid in VA’s full consideration to this
issue, VA encourages any comments
regarding the proposed full practice
authority. In this way, VA will be
providing all affected State and local
officials notice and an opportunity for
appropriate participation in the
proceedings.
VA’s promulgation of this regulation
complies with the requirements of
Executive Order 13132 by (1) in the
absence of explicit preemption in the
authorizing statute, identifying where
the exercise of State authority conflicts
with the exercise of Federal authority
under Federal statute; (2) limiting the
preemption to only those areas where
we find existence a conflict; (3)
restricting the regulatory preemption to
the minimum level necessary to achieve
the objectives of the statute; (4)
consulting with the State Boards of
Nursing and other relevant external
parties as indicated above; and (5)
providing opportunity for comment
through this rulemaking.
Effect of Rulemaking
Title 38 of the Code of Federal
Regulations, as proposed to be revised
by this rulemaking, will represent VA’s
implementation of its legal authority on
this subject. Other than future
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amendments to this regulation or
governing statutes, no contrary guidance
or procedures would be authorized. All
existing or subsequent VA guidance
must be read to conform with this
rulemaking if possible or, if not
possible, such guidance will be
superseded by this rulemaking.
Paperwork Reduction Act
This proposed rule contains no
provisions constituting a collection of
information under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521).
Regulatory Flexibility Act
The Secretary hereby certifies that
this proposed rule would not have a
significant economic impact on a
substantial number of small entities as
they are defined in the Regulatory
Flexibility Act, 5 U.S.C. 601–612. This
proposed rule would directly affect only
individuals and would not directly
affect small entities. Therefore, pursuant
to 5 U.S.C. 605(b), this amendment
would be exempt from the initial and
final regulatory flexibility analysis
requirements of 5 U.S.C. 603 and 604.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563
direct agencies to assess the costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, and other advantages;
distributive impacts; and equity).
Executive Order 13563 (Improving
Regulation and Regulatory Review)
emphasizes the importance of
quantifying both costs and benefits,
reducing costs, harmonizing rules, and
promoting flexibility. Executive Order
12866 (Regulatory Planning and
Review) defines a ‘‘significant
regulatory action,’’ which requires
review by OMB, as ‘‘any regulatory
action that is likely to result in a rule
that may: (1) Have an annual effect on
the economy of $100 million or more or
adversely affect in a material way the
economy, a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
State, local, or tribal governments or
communities; (2) Create a serious
inconsistency or otherwise interfere
with an action taken or planned by
another agency; (3) Materially alter the
budgetary impact of entitlements,
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) Raise novel legal or policy
issues arising out of legal mandates, the
PO 00000
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33159
President’s priorities, or the principles
set forth in this Executive Order.’’
The economic, interagency,
budgetary, legal, and policy
implications of this proposed rule have
been examined, and it has been
determined to be a significant regulatory
action under Executive Order 12866.
VA’s impact analysis can be found as a
supporting document at https://
www.regulations.gov, usually within 48
hours after the rulemaking document is
published. Additionally, a copy of the
rulemaking and its impact analysis are
available on VA’s Web site at https://
www.va.gov/orpm/, by following the
link for ‘‘VA Regulations Published
From FY 2004 Through Fiscal Year to
Date.’’
Unfunded Mandates
The Unfunded Mandates Reform Act
of 1995 requires, at 2 U.S.C. 1532, that
agencies prepare an assessment of
anticipated costs and benefits before
issuing any rule that may result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $100 million or more
(adjusted annually for inflation) in any
one year. This proposed rule would
have no such effect on State, local, and
tribal governments, or on the private
sector.
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic
Assistance numbers and titles for the
programs affected by this document are:
64.007, Blind Rehabilitation Centers;
64.008, Veterans Domiciliary Care;
64.009, Veterans Medical Care Benefits;
64.010, Veterans Nursing Home Care;
64.011, Veterans Dental Care; 64.012,
Veterans Prescription Service; 64.013,
Veterans Prosthetic Appliances; 64.014,
Veterans State Domiciliary Care; 64.015,
Veterans State Nursing Home Care;
64.018, Sharing Specialized Medical
Resources; 64.019, Veterans
Rehabilitation Alcohol and Drug
Dependence; 64.022, Veterans Home
Based Primary Care; and 64.024, VA
Homeless Providers Grant and Per Diem
Program.
Signing Authority
The Secretary of Veterans Affairs, or
designee, approved this document and
authorized the undersigned to sign and
submit the document to the Office of the
Federal Register for publication
electronically as an official document of
the Department of Veterans Affairs.
Robert L. Nabors II, Chief of Staff,
Department of Veterans Affairs,
approved this document on January 6,
2016.
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Federal Register / Vol. 81, No. 101 / Wednesday, May 25, 2016 / Proposed Rules
clinical oversight of a physician,
regardless of State or local law
Administrative practice and
restrictions, when that APRN is working
procedure, Alcohol abuse, Alcoholism,
within the scope of their VA
Claims, Day care, Dental health, Drug
employment.
abuse, Foreign relations, Government
(c) Granting of full practice authority.
contracts, Grant programs—health,
VA may grant full practice authority to
Grant programs—veterans, Health care,
an APRN subject to the following:
Health facilities, Health professions,
(1) Verification that the APRN meets
Health records, Homeless, Medical and
the requirements established in
dental schools, Medical devices,
paragraph (a) of this section; and
Medical research, Mental health
(2) Determination that the APRN has
programs, Nursing homes, Philippines,
demonstrated the knowledge and skills
Reporting and recordkeeping
necessary to provide the services
requirements, Scholarships and
described in paragraph (d) of this
fellowships, Travel and transportation
section without the clinical oversight of
expenses, Veterans.
a physician, and is thus qualified to be
Dated: May 20, 2016.
privileged for such scope of practice.
(d) Services provided by an APRN
Michael Shores,
with full practice authority. (1) Subject
Acting Director, Office of Regulation Policy
to the limitations established in
& Management, Office of Secretary,
Department of Veterans Affairs.
paragraph (d)(2) of this section, the full
practice authority for each of the four
For the reasons set forth in the
preamble, we propose to amend 38 CFR APRN roles includes, but is not limited
to, providing the following services:
part 17 as follows:
(i) A CNP has full practice authority
PART 17—MEDICAL
to:
(A) Take comprehensive histories,
■ 1. The authority citation for part 17
provide physical examinations and
continues to read as follows:
other health assessment and screening
Authority: 38 U.S.C. 501, and as noted in
activities, diagnose, treat, and manage
specific sections.
patients with acute and chronic
illnesses and diseases;
■ 2. Amend part 17 by adding an
(B) Order, perform, supervise, and
undesignated center heading and
interpret laboratory and imaging
§ 17.415 immediately after § 17.410 to
studies;
read as follows:
(C) Prescribe medication and durable
Nursing Services
medical equipment;
(D) Make appropriate referrals for
§ 17.415 Full practice authority for
patients and families, and request
advanced practice registered nurses.
consultations;
(a) Advanced practice registered nurse
(E) Aid in health promotion, disease
(APRN). For purposes of this section, an prevention, health education, and
advanced practice registered nurse
counseling as well as the diagnosis and
(APRN) is an individual who:
management of acute and chronic
(1) Has completed a nationallydiseases.
accredited, graduate-level educational
(ii) A CRNA has full practice
program that prepares them for one of
authority to:
the four APRN roles of Certified Nurse
(A) Plan and initiate anesthetic
Practitioner (CNP), Certified Registered
techniques (general, regional, local) and
Nurse Anesthetist (CRNA), Clinical
sedation;
Nurse Specialist (CNS), or Certified
(B) Provide post-anesthesia evaluation
Nurse-Midwife (CNM);
and discharge;
(2) Has passed a national certification
(C) Order and evaluate diagnostic
examination that measures knowledge
tests;
in one of the APRN roles described in
(D) Request consultations;
paragraph (a)(1) of this section;
(D) Perform point-of-care testing; and
(3) Has obtained a license from a State
(E) Respond to emergency situations
licensing board in one of four
for airway management.
recognized APRN roles described in
(iii) A CNS has full practice authority
paragraph (a)(1) of this section; and
to provide diagnosis and treatment of
(4) Maintains certification and
health or illness states, disease
licensure as required by paragraphs
management, health promotion, and
(a)(2) and (3) of this section.
prevention of illness and risk behaviors
(b) Full practice authority. For
among individuals, families, groups,
purposes of this section, full practice
and communities within their scope of
authority means the authority of an
practice.
APRN to provide services described in
(iv) A CNM has full practice authority
paragraph (d) of this section without the to provide a range of primary health
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care services to women, including
gynecologic care, family planning
services, preconception care (care that
women veterans receive before
becoming pregnant, including reducing
the risk of birth defects and other
problems such as the treatment of
diabetes and high blood pressure),
prenatal and postpartum care,
childbirth, and care of a newborn, and
treating the partner of their female
patients for sexually transmitted disease
and reproductive health, if the partner
is also enrolled in the VA healthcare
system or is not required to enroll.
(2) The full practice authority of an
APRN is subject to the limitations
imposed by the Controlled Substances
Act, 21 U.S.C. 801 et seq., and that
APRN’s State licensure on the authority
to prescribe, or administer controlled
substances, as well as any other
limitations on the provision of VA care
set forth in applicable Federal law and
policy.
(e) Preemption of State and local law.
To achieve important Federal interests,
including but not limited to the ability
to provide the same comprehensive care
to veterans in all States under 38 U.S.C.
7301, this section preempts conflicting
State and local laws relating to the
practice of APRNs when such APRNs
are working within the scope of their
VA employment. Any State or local law,
or regulation pursuant to such law, is
without any force or effect on, and State
or local governments have no legal
authority to enforce them in relation to
this section or decisions made by VA
under this section.
(Authority: 38 U.S.C. 7301, 7304, 7402, and
7403)
[FR Doc. 2016–12338 Filed 5–24–16; 8:45 am]
BILLING CODE 8320–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R01–OAR–2014–0364; A–1–FRL–
9936–62–Region 1]
Air Plan Approval; Connecticut; Sulfur
Content of Fuel Oil Burned in
Stationary Sources
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to approve a
State Implementation Plan (SIP)
revision submitted by the State of
Connecticut on April 22, 2014, with
supplemental submittals on June 18,
SUMMARY:
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Agencies
[Federal Register Volume 81, Number 101 (Wednesday, May 25, 2016)]
[Proposed Rules]
[Pages 33155-33160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12338]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AP44
Advanced Practice Registered Nurses
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) is proposing to amend
its medical regulations to permit full practice authority of all VA
advanced practice registered nurses (APRNs) when they are acting within
the scope of their VA employment. This rulemaking would increase
veterans' access to VA health care by expanding the pool of qualified
health care professionals who are authorized to provide primary health
care and other related health care services to the full extent of their
education, training, and certification, without the clinical
supervision of physicians. This rule would permit VA to use its health
care resources more effectively and in a manner that is consistent with
the role of APRNs in the non-VA health care sector, while maintaining
the patient-centered, safe, high-quality health care that veterans
receive from VA. The proposed rulemaking would establish additional
professional qualifications an individual must possess to be appointed
as an APRN within VA. The proposed rulemaking would subdivide APRN's
into four separate categories that include certified nurse
practitioner, certified registered nurse anesthetist, clinical nurse
specialist, and certified nurse-midwife. The proposed rulemaking would
also provide the criteria under which VA may grant full practice
authority to an APRN, and define the scope of full practice authority
for each category of APRN. VA intends that the services to be provided
by an APRN in one of the four APRN roles would be consistent with the
nursing profession's standards of practice for such roles.
DATES: Comments must be received by VA on or before July 25, 2016.
ADDRESSES: Written comments may be submitted: Through https://www.Regulations.gov; by mail or hand-delivery to Director, Regulations
Management (02REG), Department of Veterans Affairs, 810 Vermont Avenue
NW., Room 1068, Washington, DC 20420; by fax to (202) 273-9026.
Comments should indicate that they are submitted in response to ``RIN
2900-AP44-Advanced Practice Registered Nurses.'' Copies of comments
received will be available for public inspection in the Office of
Regulation Policy and Management, Room 1068, between the hours of 8
a.m. and 4:30 p.m., Monday through Friday (except holidays). Call (202)
461-4902 for an appointment. (This is not a toll-free number.) In
addition, during the comment period, comments may be viewed online
through the Federal Docket Management System (FDMS) at https://www.Regulations.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Penny Kaye Jensen, Liaison for
National APRN Practice, 810 Vermont Ave. NW., Washington, DC 20420;
(202) 461-6700. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: Section 7301 of title 38 United States Code
(U.S.C.) establishes the Veterans Health Administration (VHA) within
VA, and establishes that its primary function is to ``provide a
complete medical and hospital service for the medical care and
treatment of veterans, as provided in this title and in regulations
prescribed by the Secretary pursuant to this title.'' 38 U.S.C.
7301(b). In carrying out this function, VHA has an obligation to ensure
that patient care is appropriate and safe and its health care
practitioners meet or exceed generally-accepted professional standards
for patient care. The Secretary is responsible for the proper execution
and administration of all laws administered by the Department and for
the control, direction, and management of the Department, to include
agency personnel and management matters. See 38 U.S.C. 303. To enable
the Secretary to direct, control and manage VA, Congress authorized the
Secretary ``to prescribe all rules and regulations which are necessary
or appropriate to carry out the laws administered by the Department and
are consistent with those laws.'' 38 U.S.C. 501(a). The Under Secretary
for Health is directly responsible to the Secretary for the operation
of VHA (38 U.S.C. 305(b)). Unless specifically otherwise provided, the
Under Secretary for Health, as the head of VHA, is authorized to
``prescribe all regulations necessary to the administration of the
Veterans Health Administration,'' subject to the approval of the
Secretary. 38 U.S.C. 7304. To allow VA to carry out its medical care
mission, Congress also established a comprehensive personnel system for
certain medical employees in VHA, independent of the civil service
rules. See Chapters 73 and 74 of title 38, U.S.C. The Secretary was
granted express statutory authority to establish the qualifications for
VA's healthcare practitioners, determine the hours and conditions of
employment, take disciplinary action against employees, and otherwise
regulate the professional activities of those individuals. 38 U.S.C.
7401-7464. As an integrated Federal health care system with the
responsibility to provide comprehensive care under 38 U.S.C. 7301, it
is essential that VHA wisely manage its resources and fully utilize the
skills of its health care providers to the full extent of their
education, training, and certification. By permitting APRNs throughout
the VHA system a way to achieve full practice authority in order to
provide advanced nursing services to the full extent of their
professional competence, VHA would further its statutory mandate to
provide quality health care to our nation's veterans. This proposed
regulatory change to nursing policy would permit APRNs to practice to
the full extent of their education, training and certification, without
the clinical supervision or mandatory collaboration of physicians.
Standardization of APRN full practice authority, without regard for
individual State practice regulations, would help to ensure a
consistent continuum of health care across VHA by decreasing the
variability in APRN practice that currently exists across VHA as a
result of disparate State practice regulations. As of March 7, 2016
CRNAs have full practice authority in 17 states, while CNPs have full
practice authority in almost 50% of the nation, which includes 21
states and the District of Columbia.
It would also aid in fully maximizing VHA APRN staff capabilities,
which would increase VA's capacity to provide timely, efficient, and
effective primary care services, as well as other services. This would
increase veteran access to needed VA health care, particularly in
medically-underserved areas, as well as decrease the amount of time
veterans spend waiting for patient appointments. In addition,
standardizing APRN practice authority would enable veterans, their
families, and caregivers to understand more readily the health care
services that VA APRNs are authorized to provide. This preemptive rule
would increase access to care and reduce the wait times for VA
appointments utilizing the current workforce already in place.
[[Page 33156]]
To ensure that VA would have available highly qualified medical
personnel, Congress mandated the basic qualifications for certain
health care positions, including registered nurses. Sections 7401
through 7464 of title 38, U.S.C., grant VA authority to regulate the
professional activities of such personnel. To be eligible for
appointment as a VA employee in a health care position covered by
section 7402(b) (other than Director), of title 38, U.S.C., a person
must, among other requirements, be licensed, registered or certified to
practice their profession in a State. The standards prescribed in
section 7402(b) establish only the basic qualifications necessary
``[t]o be eligible for appointment'' and do not limit the Secretary or
Under Secretary for Health from establishing other qualifications for
appointment, or additional rules governing such personnel. In
particular, 38 U.S.C. 7403(a)(1) provides that appointments under
Chapter 74 ``may be made only after qualifications have been
established in accordance with regulations prescribed by the Secretary,
without regard to civil-service requirements.'' In addition, 38 U.S.C.
7421(a) directs that, ``[n]otwithstanding any law, Executive order, or
regulation, the Secretary shall prescribe by regulation the hours and
conditions of employment and leaves of absence of employees appointed
under any provision of [chapter 74] [in the specifically numerated
positions] in the Veterans Health Administration'' (including
registered nurses). As the head of VHA, the Under Secretary for Health
has the duty to ``prescribe all regulations necessary to the
administration of the Veterans Health Administration,'' subject to
approval by the Secretary. 38 U.S.C. 7304; see also 38 U.S.C. 501.
Pursuant to this authority, the Under Secretary for Health is
authorized to establish the qualifications and clinical practice
standards of VHA's nursing personnel and to otherwise regulate their
professional conduct.
To continue to provide high quality health care to veterans, VA is
proposing to amend its regulations to allow APRNs to practice to the
full extent of their education, training, and certification, regardless
of individual State restrictions that limit such full practice
authority, except for applicable State restrictions on the authority to
prescribe and administer controlled substances, when such APRNs are
acting within the scope of their VA employment. The proposed rule would
use the term ``full practice authority'' to refer to the APRN's
authority to provide advanced nursing services without the clinical
oversight of a physician when that APRN is working within the scope of
their VA employment. Such full practice authority would be granted by
VA upon demonstrating that the established regulatory criteria are met.
In addition, full practice authority would be granted appropriate to
the clinical service setting.
This proposed rule is consistent with the recommendation of the
Institute of Medicine (IOM) of the National Academy of Sciences to
remove scope-of-practice barriers. Specifically, the 2010 IOM report,
``The Future of Nursing: Leading Change Advancing Health,'' (IOM
Report) available at https://iom.nationalacademies.org/Reports/2010/The-Future-of-Nursing-Leading-Change-Advancing-Health.aspx, recommended
that ``[a]dvanced practice registered nurses (APRNs) should be able to
practice to the full extent of their education and training.'' Id. at
9. More generally, the report stated that ``[r]estrictions on scope of
practice and professional tensions have undermined the nursing
profession's ability to provide and improve both general and advanced
care'' and asserted that ``[p]roducing a health care system that
delivers the right care--quality care that is patient centered,
accessible, evidence based, and sustainable--at the right time will
require transforming the work environment, scope of practice,
education, and numbers and composition of America's nurses.'' Id. at
26. In addition, the proposed rule is consistent with the National
Council of State Boards of Nursing (NCSBN) Consensus Model, as
discussed in more detail later in this rulemaking. Significantly, many
States already permit full practice authority of APRNs or are in the
process of doing so. Under the proposed rulemaking, APRNs would not be
authorized to replace or act as physicians or to provide any health
care services that are beyond their clinical education, training, and
national certification. The proposed rule would limit an APRN's full
practice authority to practice within the scope of their VA employment,
and any APRN practice outside of VA employment would remain subject to
applicable State laws, in the same manner as any other licensed VA
practitioner in their private practice.
In this rulemaking, VA is proposing to exercise Federal preemption
of State nursing licensure laws to the extent such State laws conflict
with the full practice authority granted to VA APRNs while acting
within the scope of their VA employment. Preemption would be the
minimum necessary action for VA to allow APRNs full practice authority.
It would be impractical for VA to lobby to each State that does not
allow full practice authority to APRNs to change their laws regarding
full practice authority. This process would be costly and time
consuming for VA and would not guarantee the desired result of full
practice authority to all APRNs.
Section-by-Section Analysis of the Proposed Rule
17.415 Full Practice Authority for Advanced Practice Registered Nurses
The general qualifications for a person to be appointed as a VA
nurse are found in 38 U.S.C. 7402(b)(3), which requires that a person
must have successfully completed a full course of nursing in a
recognized school of nursing, as well as be registered as a graduate
nurse in a State. VA interprets ``a recognized school of nursing'' to
mean a school of professional nursing approved by the appropriate State
agency and accredited by the National League for Nursing Accrediting
Commission (NLNAC) or the Commission on Collegiate Nursing Education
(CCNE); the completion of coursework equivalent to a nursing degree in
a MSN Bridge Program that qualifies for professional nursing
registration; or a foreign school of professional nursing that enables
the graduate to obtain current, full, active and unrestricted
registration. VA Handbook 5005/27, Part II, Appendix G6, paragraph 2,
Section B.a(2). VA interprets ``registered as a graduate nurse in a
state'' to mean a current, full, active and unrestricted licensure,
registration or certification as a graduate professional nurse in a
State, Territory, or Commonwealth (i.e., Puerto Rico) of the U.S. or in
the District of Columbia (hereinafter ``licensure''). Id. Pursuant to
the authorities in 38 U.S.C. 7401 through 7464 and VA's rulemaking
authorities at 38 U.S.C. 501 and 7304, VA is proposing a new Sec.
17.415(a), which would define additional qualifications a registered
nurse must possess to be appointed to one of four (4) APRN roles, i.e.,
Certified Nurse practitioner (CNP), Certified Registered Nurse
Anesthetist (CRNA), Clinical Nurse Specialist (CNS), or Certified
Nurse-Midwife (CNM). The proposed rule would require an advanced
practice registered nurse to have successfully completed a nationally-
accredited, graduate-level educational program that prepares the
advanced practice registered nurse in one of the four APRN roles; and
to possess, and maintain, national certification and State licensure in
that APRN role. These additional
[[Page 33157]]
qualifications are derived from criteria set forth in the IOM Report,
and the National Council of State Boards of Nursing Consensus Model for
APRN Regulation: Licensure, Accreditation, Certification & Education)
Regulation, July 2008 (the APRN Consensus Model), which VA finds to be
the criteria most widely accepted by State boards of nursing and the
nursing community as necessary to practice as an APRN. Under the
proposed rule, APRNs who meet these additional qualifications may be
granted full practice authority within VA in one of the four recognized
APRN roles.
Proposed Sec. 17.415(a)(1) would require an APRN to have
successfully completed an accredited graduate-level educational program
in one of the four distinct APRN roles. The Consensus Model defines
these roles as CNP, CRNA, CNS, and CNM. These APRN roles are widely
known and accepted by State boards of nursing and the nursing
community. VA currently does not employ CNMs; however, the proposed
rule includes CNMs in the event that VA has the need to hire CNMs in
the future.
Proposed Sec. 17.415(a)(2) would require an APRN to have passed a
national certification examination that measures the APRN's knowledge,
skills and experience demonstrated by the achievement of standards
identified by the profession in one of the four APRN roles established
in proposed Sec. 17.415(a)(1). Public and private sector health care
employers, State boards of nursing, and the nursing community rely on
national certification through an examination process as the standard,
which conveys adequate APRN knowledge, and VA's regulation would adopt
the same standard.
Proposed Sec. 17.415(a)(3) would require an APRN to possess a
license from a State licensing board in one of the four recognized APRN
roles. Proposed Sec. 17.415(a)(4) would require an APRN to maintain
both the national certification and licensure required in proposed
paragraphs (a)(2) and (3) of Sec. 17.415.
In total, proposed paragraphs (a)(1) through (4) of Sec. 17.415
would establish qualifications for employment within VA as a CNP, CRNA,
CNS and CNM. These qualifications would ensure that VA APRNs possess
and maintain the education, knowledge, national certification and State
licensure necessary for VA employment in one of the four recognized
APRN roles. APRNs who meet these qualifications would be granted full
practice authority within VA in one of the four recognized APRN roles.
Proposed Sec. 17.415(b) would define ``full practice authority''
to mean that an APRN working within the scope of VA employment would be
authorized to provide the services described in proposed Sec.
17.415(d), without the clinical oversight of a physician, regardless of
State or local law restrictions on that authority. Further, any APRN
practice established outside VA employment would be subject to
applicable State law, in the same manner as private practice by any
other licensed VA provider.
Proposed Sec. 17.415(c) would establish the criteria by which VA
may grant full practice authority to an APRN. Proposed paragraph
(c)(1), would require a VA medical facility to verify that the APRN
meets the requirements established in proposed Sec. 17.415(a).
Proposed paragraph (c)(2) would require VA to confirm that the APRN has
demonstrated the knowledge and skills necessary to provide the services
described in proposed Sec. 17.415(d) without the clinical oversight of
a physician, and is thus qualified to be privileged for such scope of
practice. Proposed Sec. 17.415(c)(1) and (2) together would clarify
that the VA processes for credentialing and privileging of licensed
independent health care providers would apply to VA APRNs with full
practice authority. VA anticipates that the granting of full-practice
authority under proposed Sec. 17.415(c) would be implemented through
formal VHA guidance issuances.
Proposed Sec. 17.415(d)(1) would describe the role-specific
services that a VA APRN would be authorized to perform under their full
practice authority. This authority would be without regard to state
licensure restrictions, except as provided in proposed paragraph
(d)(2), which would defer to State licensure restrictions on a VA
APRN's authority to prescribe, or administer controlled substances. We
emphasize that full practice authority for an APRN in this rulemaking
would apply only to services provided by an APRN when working within
the scope of their VA employment, as required by proposed Sec.
17.415(b). Additionally, all full practice authority of APRNs in
proposed Sec. 17.415(d)(1) would be under approved privileges by, and
within the available resources of, a VA medical facility, as required
by proposed Sec. 17.415(c). VA intends that the services to be
provided by an APRN in one of the four APRN roles would be consistent
with the nursing profession's standards of practice for such roles.
In proposed Sec. 17.415(d)(1)(i), a CNP would have full practice
authority to provide the following services: Comprehensive histories,
physical examinations and other health assessment and screening
activities; diagnose, treat, and manage patients with acute and chronic
illnesses and diseases; order, perform, supervise, and interpret
laboratory and imaging studies; prescribe medication and durable
medical equipment and; make appropriate referrals for patients and
families; and aid in health promotion, disease prevention, health
education, and counseling as well as the diagnosis and management of
acute and chronic diseases.
In proposed Sec. 17.415(d)(1)(ii), a CRNA would have full practice
authority to provide a patient's anesthesia care and anesthesia related
care, to include planning and initiating anesthetic techniques
(general, regional, local) and sedation, providing post-anesthesia
evaluation and discharge; ordering and evaluating diagnostic tests;
requesting consultations; performing point-of-care testing; and
responding to emergency situations for airway management.
In proposed Sec. 17.415(d)(1)(iii), a CNS would have full practice
authority to provide diagnosis and treatment of health or illness
states, disease management, health promotion, and prevention of illness
and risk behaviors among individuals, families, groups, and communities
within their scope of practice.
Lastly, in proposed Sec. 17.415(d)(1)(iv), a CNM would have full
practice authority to provide a full range of primary health care
services to women veterans, including gynecologic care, family planning
service, preconception care (care that women veterans receive before
becoming pregnant, including reducing the risk of birth defects and
other problems such as the treatment of diabetes and high blood
pressure), prenatal and postpartum care, childbirth, and care of a
newborn. We note that the pregnancy and delivery services described
above, as well as the newborn care services, would be subject to the
limitations established in 38 CFR 17.38(a)(1)(xiii) and (xiv),
respectively. We also note that authorized CNM services would include
treating the partner of the female patient for sexually transmitted
infection and reproductive health, if the partner is enrolled in the VA
healthcare system or not required to enroll to receive VA services. We
would include the services of a CNM in this rulemaking in anticipation
that VA would hire CNMs at a future date to improve access to health
care for the increasing number of female veterans.
Proposed Sec. 17.415(d)(2) would expressly limit full practice
authority.
[[Page 33158]]
Congress has specifically required reliance on a specific State law
under the Controlled Substance Act (CSA). Specifically, proposed Sec.
17.415(a)(2) would provide that full practice authority within VA is
subject to State licensure law with regard to the authority of an APRN
to prescribe, or administer controlled substances, and to any other
limitations on the provision of VA care set forth in applicable Federal
law and policy. Regarding the full practice authority limitations for
controlled substances, the CSA, 21 U.S.C. 801 et seq., and implementing
regulations in 21 CFR part 1300, make State licensure authority to
prescribe, or administer controlled substances a prerequisite for
authority under the CSA to prescribe, or administer controlled
substances. See 21 U.S.C. 802(21) (providing that a practitioner must
be ``licensed, registered, or otherwise permitted, by the United States
or the jurisdiction in which he practices or does research, to
distribute, conduct research with respect to, administer, or use in
teaching or chemical analysis, a controlled substance in the course of
professional practice or research.''); See also 21 CFR 1306.03(a)
(stating that a prescription for a controlled substance may be issued
only by an individual practitioner who is: (1) Authorized to prescribe
controlled substances by the jurisdiction in which he is licensed to
practice his profession and (2) either registered or exempted from
registration pursuant to Sec. Sec. 1301.22(c) and 1301.23.). Proposed
Sec. 17.415(d)(2) also would make the full practice authority of an
APRN subject to any other limitations on the provision of VA care set
forth in Federal law or policy.
Proposed Sec. 17.415(e) would expressly state the intended
preemptive effect of proposed Sec. 17.415, to ensure it is clear that
conflicting State and local laws related to the practice of APRNs would
have no force or effect when such APRNs are working within the scope of
their VA employment. In circumstances where there is a conflict between
Federal and State Law, Federal law prevails in accordance with Article
VI, clause 2, of the U.S. Constitution (Supremacy Clause). It is a
well-established principle of constitutional law that Federal law is
supreme, and States may not regulate or control the lawful actions of
the Federal Government, absent Congressional consent. Therefore, where
there is conflict between State law and Federal law with regard to full
practice authority of APRNs working within the scope of their federal
VA employment, this regulation would control. Accordingly, State
disciplinary actions that would penalize, or otherwise interfere with,
an APRN's full practice authority in the performance of their official
VA duties, would likewise be effectively preempted. However, where
there is no conflict between this regulation and State law, the State
would retain authority to impose State regulations on its APRN
licensees and take disciplinary action for any violations. We emphasize
that this preemptive effect would only pertain to APRNs when they are
acting within the scope of their federal VA employment; this rule would
not have any effect on individual State efforts to either permit or
restrict full practice authority for APRNs who are not working within a
VA scope of employment.
The Indian Health Service already grants full practice authority to
APRNs. See Part 4, Chapter 3, Section 11, ``Advanced Practice Nurses,''
Indian Health Manual. In the Military Health System, the Services
employ APRNs, which includes Nurse Midwives, Nurse Practitioners, and
Nurse Anesthetists, in independent practice without oversight from
physicians. They are privileged in their roles as APRNs and can adjust
their scope practice (level of care) through privileging as granted by
a committee of physicians and the military treatment facility
commander. Nurse Practitioners specifically have an assigned group of
patients for which they are responsible. Therefore, we do not
anticipate that the proposed changes in this rulemaking would be
completely novel or unexpected to the general public or other Federal
entities that provide health care services to beneficiaries.
Executive Order 13132, Federalism
Section 4 of Executive Order 13132 (titled ``Federalism'') requires
an agency that is publishing a regulation that preempts State law to
follow certain procedures. Section 4(b) of the Executive Order requires
agencies to ``construe any authorization in the statute for the
issuance of regulations as authorizing preemption of State law by
rulemaking only when the exercise of State authority directly conflicts
with the exercise of Federal authority under the Federal statute or
there is clear evidence to conclude that the Congress intended the
agency to have the authority to preempt State law.'' Section 4(d) of
the Executive Order requires that when an agency proposes to act
through rulemaking to preempt State law, ``the agency shall consult, to
the extent practicable, with appropriate State and local officials in
an effort to avoid such a conflict.'' Section 4(e) of the Executive
Order requires that when an agency proposes to act through rulemaking
to preempt State law, ``the agency shall provide all affected State and
local officials notice and an opportunity for appropriate participation
in the proceedings.''
Section 6(c) of Executive Order 13132 states that ``no agency shall
promulgate any regulation that has federalism implications and that
preempts State law, unless the agency, prior to the formal promulgation
of the regulation, (1) consulted with State and local officials early
in the process of developing the proposed regulation; (2) in a
separately identified portion of the preamble to the regulation as it
is to be issued in the Federal Register, provides to the Director of
the Office of Management and Budget a federalism summary impact
statement, which consists of a description of the extent of the
agency's prior consultation with State and local officials, a summary
of the nature of their concerns and the agency's position supporting
the need to issue the regulation, and a statement of the extent to
which the concerns of State and local officials have been met; and (3)
makes available to the Director of the Office of Management and Budget
any written communications submitted to the agency by State and local
officials.''
Because this regulation would address preemption of certain State
laws, VA conducted prior consultation with State officials in
compliance with Executive Order 13132. VA sent a letter to the National
Council of State Boards of Nursing to state VA's intent to allow full
practice authority to VA APRNs and for the National Council of State
Boards of Nursing to notify every State Board of Nursing of VA's intent
and to seek feedback from such Boards of Nursing.
In addition, VA solicited comments and input from State Boards of
Nursing, through their representative national organization, the
National Council of State Boards of Nursing (NCSBN). In response to its
request for comments, VA received correspondence from the Executive
Director and other relevant staff members within NCSBN, which agreed
with VA's position that this rulemaking properly identifies the areas
in VA regulations that preempt State laws and regulations. VA received
no other comments from the NCSBN on this rulemaking. In response to
VA's outreach to NCSBN, VA received numerous calls and correspondence
from State and local officials in support of this proposed rule. Such
State and local officials included State Senators from Georgia and
Illinois, State Representatives from Florida, Ohio,
[[Page 33159]]
Vermont, North Carolina, Georgia, and Illinois, County Commissioners
from Nevada, Ohio, and North Carolina, and the State Comptroller and
Secretary of State from Illinois, to name a few.
VA additionally engaged other relevant external groups on the
proposed changes in this rulemaking, including the American Association
of Nurse Anesthetists, American Association of Nurse Practitioners,
American College of Surgeons, American Academy of Family Practice
Physicians, American Society of Anesthesiologists, American Medical
Association, Association of American Medical Colleges, The Joint
Commission-Office of Accreditation and Certification, American
Association of Retired Persons, American Legion, Blinded Veterans
Association, Vietnam Veterans of America, American Women Veterans,
Disabled American Veterans, Paralyzed Veterans of America, Veterans of
Foreign Wars. VA also engaged the Senate and House Veterans Affairs
Committees and the Senate and House Armed Services Committees.
Many external stakeholders expressed general support for VA's
positions taken in this proposed rule, particularly with respect to
full practice authority of APRNs in primary health care. However, we
also received comments opposing full practice authority for CRNAs when
providing anesthetics. To aid in VA's full consideration to this issue,
VA encourages any comments regarding the proposed full practice
authority. In this way, VA will be providing all affected State and
local officials notice and an opportunity for appropriate participation
in the proceedings.
VA's promulgation of this regulation complies with the requirements
of Executive Order 13132 by (1) in the absence of explicit preemption
in the authorizing statute, identifying where the exercise of State
authority conflicts with the exercise of Federal authority under
Federal statute; (2) limiting the preemption to only those areas where
we find existence a conflict; (3) restricting the regulatory preemption
to the minimum level necessary to achieve the objectives of the
statute; (4) consulting with the State Boards of Nursing and other
relevant external parties as indicated above; and (5) providing
opportunity for comment through this rulemaking.
Effect of Rulemaking
Title 38 of the Code of Federal Regulations, as proposed to be
revised by this rulemaking, will represent VA's implementation of its
legal authority on this subject. Other than future amendments to this
regulation or governing statutes, no contrary guidance or procedures
would be authorized. All existing or subsequent VA guidance must be
read to conform with this rulemaking if possible or, if not possible,
such guidance will be superseded by this rulemaking.
Paperwork Reduction Act
This proposed rule contains no provisions constituting a collection
of information under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3521).
Regulatory Flexibility Act
The Secretary hereby certifies that this proposed rule would not
have a significant economic impact on a substantial number of small
entities as they are defined in the Regulatory Flexibility Act, 5
U.S.C. 601-612. This proposed rule would directly affect only
individuals and would not directly affect small entities. Therefore,
pursuant to 5 U.S.C. 605(b), this amendment would be exempt from the
initial and final regulatory flexibility analysis requirements of 5
U.S.C. 603 and 604.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, and other advantages; distributive impacts;
and equity). Executive Order 13563 (Improving Regulation and Regulatory
Review) emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Executive Order 12866 (Regulatory Planning and Review) defines a
``significant regulatory action,'' which requires review by OMB, as
``any regulatory action that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities; (2) Create a serious inconsistency or otherwise interfere
with an action taken or planned by another agency; (3) Materially alter
the budgetary impact of entitlements, grants, user fees, or loan
programs or the rights and obligations of recipients thereof; or (4)
Raise novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in this Executive
Order.''
The economic, interagency, budgetary, legal, and policy
implications of this proposed rule have been examined, and it has been
determined to be a significant regulatory action under Executive Order
12866. VA's impact analysis can be found as a supporting document at
https://www.regulations.gov, usually within 48 hours after the
rulemaking document is published. Additionally, a copy of the
rulemaking and its impact analysis are available on VA's Web site at
https://www.va.gov/orpm/, by following the link for ``VA Regulations
Published From FY 2004 Through Fiscal Year to Date.''
Unfunded Mandates
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C.
1532, that agencies prepare an assessment of anticipated costs and
benefits before issuing any rule that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation) in any one year. This proposed rule would have no such
effect on State, local, and tribal governments, or on the private
sector.
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance numbers and titles for
the programs affected by this document are: 64.007, Blind
Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009,
Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care;
64.011, Veterans Dental Care; 64.012, Veterans Prescription Service;
64.013, Veterans Prosthetic Appliances; 64.014, Veterans State
Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.018,
Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation
Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care;
and 64.024, VA Homeless Providers Grant and Per Diem Program.
Signing Authority
The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. Robert L.
Nabors II, Chief of Staff, Department of Veterans Affairs, approved
this document on January 6, 2016.
[[Page 33160]]
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Dental health, Drug abuse, Foreign relations,
Government contracts, Grant programs--health, Grant programs--veterans,
Health care, Health facilities, Health professions, Health records,
Homeless, Medical and dental schools, Medical devices, Medical
research, Mental health programs, Nursing homes, Philippines, Reporting
and recordkeeping requirements, Scholarships and fellowships, Travel
and transportation expenses, Veterans.
Dated: May 20, 2016.
Michael Shores,
Acting Director, Office of Regulation Policy & Management, Office of
Secretary, Department of Veterans Affairs.
For the reasons set forth in the preamble, we propose to amend 38
CFR part 17 as follows:
PART 17--MEDICAL
0
1. The authority citation for part 17 continues to read as follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
0
2. Amend part 17 by adding an undesignated center heading and Sec.
17.415 immediately after Sec. 17.410 to read as follows:
Nursing Services
Sec. 17.415 Full practice authority for advanced practice registered
nurses.
(a) Advanced practice registered nurse (APRN). For purposes of this
section, an advanced practice registered nurse (APRN) is an individual
who:
(1) Has completed a nationally-accredited, graduate-level
educational program that prepares them for one of the four APRN roles
of Certified Nurse Practitioner (CNP), Certified Registered Nurse
Anesthetist (CRNA), Clinical Nurse Specialist (CNS), or Certified
Nurse-Midwife (CNM);
(2) Has passed a national certification examination that measures
knowledge in one of the APRN roles described in paragraph (a)(1) of
this section;
(3) Has obtained a license from a State licensing board in one of
four recognized APRN roles described in paragraph (a)(1) of this
section; and
(4) Maintains certification and licensure as required by paragraphs
(a)(2) and (3) of this section.
(b) Full practice authority. For purposes of this section, full
practice authority means the authority of an APRN to provide services
described in paragraph (d) of this section without the clinical
oversight of a physician, regardless of State or local law
restrictions, when that APRN is working within the scope of their VA
employment.
(c) Granting of full practice authority. VA may grant full practice
authority to an APRN subject to the following:
(1) Verification that the APRN meets the requirements established
in paragraph (a) of this section; and
(2) Determination that the APRN has demonstrated the knowledge and
skills necessary to provide the services described in paragraph (d) of
this section without the clinical oversight of a physician, and is thus
qualified to be privileged for such scope of practice.
(d) Services provided by an APRN with full practice authority. (1)
Subject to the limitations established in paragraph (d)(2) of this
section, the full practice authority for each of the four APRN roles
includes, but is not limited to, providing the following services:
(i) A CNP has full practice authority to:
(A) Take comprehensive histories, provide physical examinations and
other health assessment and screening activities, diagnose, treat, and
manage patients with acute and chronic illnesses and diseases;
(B) Order, perform, supervise, and interpret laboratory and imaging
studies;
(C) Prescribe medication and durable medical equipment;
(D) Make appropriate referrals for patients and families, and
request consultations;
(E) Aid in health promotion, disease prevention, health education,
and counseling as well as the diagnosis and management of acute and
chronic diseases.
(ii) A CRNA has full practice authority to:
(A) Plan and initiate anesthetic techniques (general, regional,
local) and sedation;
(B) Provide post-anesthesia evaluation and discharge;
(C) Order and evaluate diagnostic tests;
(D) Request consultations;
(D) Perform point-of-care testing; and
(E) Respond to emergency situations for airway management.
(iii) A CNS has full practice authority to provide diagnosis and
treatment of health or illness states, disease management, health
promotion, and prevention of illness and risk behaviors among
individuals, families, groups, and communities within their scope of
practice.
(iv) A CNM has full practice authority to provide a range of
primary health care services to women, including gynecologic care,
family planning services, preconception care (care that women veterans
receive before becoming pregnant, including reducing the risk of birth
defects and other problems such as the treatment of diabetes and high
blood pressure), prenatal and postpartum care, childbirth, and care of
a newborn, and treating the partner of their female patients for
sexually transmitted disease and reproductive health, if the partner is
also enrolled in the VA healthcare system or is not required to enroll.
(2) The full practice authority of an APRN is subject to the
limitations imposed by the Controlled Substances Act, 21 U.S.C. 801 et
seq., and that APRN's State licensure on the authority to prescribe, or
administer controlled substances, as well as any other limitations on
the provision of VA care set forth in applicable Federal law and
policy.
(e) Preemption of State and local law. To achieve important Federal
interests, including but not limited to the ability to provide the same
comprehensive care to veterans in all States under 38 U.S.C. 7301, this
section preempts conflicting State and local laws relating to the
practice of APRNs when such APRNs are working within the scope of their
VA employment. Any State or local law, or regulation pursuant to such
law, is without any force or effect on, and State or local governments
have no legal authority to enforce them in relation to this section or
decisions made by VA under this section.
(Authority: 38 U.S.C. 7301, 7304, 7402, and 7403)
[FR Doc. 2016-12338 Filed 5-24-16; 8:45 am]
BILLING CODE 8320-01-P