Advanced Practice Registered Nurses, 90198-90207 [2016-29950]
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90198
Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Rules and Regulations
issues arising out of legal mandates, the
President’s priorities, or the principles
set forth in Executive Order 12866.
Therefore, no economic impact analysis
under Section 6(a)(3)(C) of Executive
Order 12866 has been prepared. For the
same reason, and because no notice of
proposed rulemaking has been
published, no statement is required
under Section 202 of the Unfunded
Mandates Reform Act of 1995, 2 U.S.C.
1532. In any event, this rulemaking is
procedural and interpretive in nature
and is thus not expected to have a
significant economic impact. Finally,
this rule does not have ‘‘federalism
implications.’’ The rule does not have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government’’ and therefore is
not subject to Executive Order 13132
(Federalism).
PART 1988—PROCEDURES FOR
HANDLING RETALIATION
COMPLAINTS UNDER SECTION 31307
OF THE MOVING AHEAD FOR
PROGRESS IN THE 21ST CENTURY
ACT (MAP–21)
For the reasons set out in the
preamble, the interim final rule adding
29 CFR part 1988, which was published
at 81 FR 13976 on March 16, 2016, is
adopted as a final rule without change.
■
Signed at Washington, DC, on December 8,
2016.
David Michaels,
Assistant Secretary of Labor for Occupational
Safety and Health.
[FR Doc. 2016–29914 Filed 12–13–16; 8:45 am]
BILLING CODE 4510–26–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
VI. Regulatory Flexibility Analysis
33 CFR Part 117
The notice and comment rulemaking
procedures of Section 553 of the APA
do not apply ‘‘to interpretative rules,
general statements of policy, or rules of
agency organization, procedure, or
practice.’’ 5 U.S.C. 553(b)(A). Rules that
are exempt from APA notice and
comment requirements are also exempt
from the Regulatory Flexibility Act
(RFA). See SBA Office of Advocacy, A
Guide for Government Agencies: How to
Comply with the Regulatory Flexibility
Act, at 9; also found at: https://
www.sba.gov/advocacy/guidegovernment-agencies-how-complyregulatory-flexibility-act. This is a rule
of agency procedure, practice, and
interpretation within the meaning of 5
U.S.C. 553; and, therefore, the rule is
exempt from both the notice and
comment rulemaking procedures of the
APA and the requirements under the
RFA. Nonetheless OSHA, in the IFR,
provided interested persons 60 days to
comment on the procedures applicable
to retaliation complaints under MAP–21
and considered the one comment
pertinent to the IFR that it received in
deciding to finalize without change the
procedures in the IFR.
[Docket No. USCG–2016–1044]
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List of Subjects in 29 CFR Part 1988
Administrative practice and
procedure, Automobile dealers,
Employment, Investigations, Motor
vehicle defects, Motor vehicle
manufacturers, Part suppliers, Reporting
and recordkeeping requirements,
Whistleblower.
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Drawbridge Operation Regulation;
Sacramento River, Sacramento, CA
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the Tower
Drawbridge across the Sacramento
River, mile 59.0, at Sacramento, CA. The
deviation is necessary to allow the
community to participate in the New
Year’s Eve fireworks. This deviation
allows the bridge to remain in the
closed-to-navigation position during the
deviation period.
DATES: This deviation is effective from
8:30 p.m. on December 31, 2016 to 12:15
a.m. on January 1, 2017.
ADDRESSES: The docket for this
deviation, [USCG–2016–1044], is
available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH’’.
Click on Open Docket Folder on the line
associated with this deviation.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email David H.
Sulouff, Chief, Bridge Section, Eleventh
Coast Guard District; telephone 510–
437–3516, email
David.H.Sulouff@uscg.mil.
SUMMARY:
California
Department of Transportation has
requested a temporary change to the
SUPPLEMENTARY INFORMATION:
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operation of the Tower Drawbridge,
mile 59.0, over Sacramento River, at
Sacramento, CA. The vertical lift bridge
navigation span provides a vertical
clearance of 30 feet above Mean High
Water in the closed-to-navigation
position. The draw operates as required
by 33 CFR 117.189(a). Navigation on the
waterway is commercial and
recreational.
The drawspan will be secured in the
closed-to-navigation position from 8:30
p.m. on December 31, 2016 to 12:15 a.m.
on January 1, 2017, to allow the
community to participate in the New
Year’s Eve fireworks. This temporary
deviation has been coordinated with the
waterway users. No objections to the
proposed temporary deviation were
raised.
Vessels able to pass through the
bridge in the closed position may do so
at any time. The bridge will not be able
to open for emergencies and there is no
immediate alternate route for vessels to
pass. The Coast Guard will also inform
the users of the waterway through our
Local and Broadcast Notices to Mariners
of the change in operating schedule for
the bridge so that vessel operators can
arrange their transits to minimize any
impact caused by the temporary
deviation.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
Dated: December 9, 2016.
D.H. Sulouff,
District Bridge Chief, Eleventh Coast Guard
District.
[FR Doc. 2016–29986 Filed 12–13–16; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
RIN 2900–AP44
Advanced Practice Registered Nurses
Department of Veterans Affairs.
Final rule with comment period.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) is amending its medical
regulations to permit full practice
authority of three roles of VA advanced
practice registered nurses (APRN) when
they are acting within the scope of their
VA employment. Certified Registered
Nurse Anesthetists (CRNA) will not be
included in VA’s full practice authority
SUMMARY:
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under this final rule, but comment is
requested on whether there are access
issues or other unconsidered
circumstances that might warrant their
inclusion in a future rulemaking. The
final rulemaking establishes the
professional qualifications an individual
must possess to be appointed as an
APRN within VA, establishes the
criteria under which VA may grant full
practice authority to an APRN, and
defines the scope of full practice
authority for each of the three roles of
APRN. The services provided by an
APRN under full practice authority in
VA are consistent with the nursing
profession’s standards of practice for
such roles. This rulemaking increases
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, and it
permits 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.
DATES: This final rule is effective
January 13, 2017. Comments on full
practice authority for CRNAs must be
received by VA on or before January 13,
2017.
ADDRESSES: Written comments may be
submitted: Through https://
www.Regulations.gov; by mail or handdelivery 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:
David J. Shulkin, M.D., Under Secretary
for Health, (202) 461–7000 or Linda M.
McConnell, Office of Nursing Services,
(202) 461–6700, 810 Vermont Avenue
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NW., Washington, DC 20420. (These are
not toll-free numbers.)
SUPPLEMENTARY INFORMATION: In a
document published in the Federal
Register on May 25, 2016 (81 FR 33155),
VA proposed to amend its medical
regulations in part 17 of Title 38, Code
of Federal Regulations (CFR) to permit
full practice authority of four roles of
VA advanced practice registered nurses
(APRN) when they were acting within
the scope of their VA employment. We
provided a 60-day comment period,
which ended on July 25, 2016. We
received 223,296 comments on the
proposed rule.
The Office of the Federal Register has
prepared a document, A Guide to the
Rulemaking Process, that states that an
agency is not permitted to base its final
rule on the number of comments
received in support of the rule over
those in opposition to it or vice versa.
The document further states that an
agency must base its reasoning and
conclusions on the rulemaking record,
which consists of the comments
received, scientific data, expert
opinions, and facts accumulated during
the pre-rule and proposed rule stages.
This final rule adheres to the guidance
established by the Office of the Federal
Register.
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.’’ 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. 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 the three APRN roles,
Certified Nurse Practitioner (CNP),
Clinical Nurse Specialist (CNS), or
Certified Nurse-Midwife (CNM),
throughout the VHA system with a way
to achieve full practice authority in
order to provide advanced nursing
services to the full extent of their
professional competence, VHA furthers
its statutory mandate to provide quality
health care to our nation’s veterans.
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This regulatory change to nursing policy
permits three roles of 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, helps to
ensure a consistent delivery of health
care across VHA by decreasing the
variability in APRN practice that
currently exists as a result of disparate
State practice regulations. Certified
Registered Nurse Anesthetists (CRNA)
will not be included in VA’s full
practice authority under this final rule,
but comment is requested on whether
there are access issues or other
unconsidered circumstances that might
warrant their inclusion in a future
rulemaking.
Standardization of full practice
authority to the three APRN roles also
aids VA in making the most efficient use
of VHA APRN staff capabilities, which
increases VA’s capacity to provide
timely, efficient, and effective primary
care services, as well as other services.
This increases veteran access to needed
VA health care, particularly in
medically-underserved areas and
decreases the amount of time veterans
spend waiting for patient appointments.
In addition, standardizing APRN
practice authority enables veterans,
their families, and caregivers to
understand more readily the health care
services that VA APRNs are authorized
to provide. This preemptive rule
increases access to care and reduces the
wait times for VA appointments
utilizing the current workforce already
in place. VA’s position to not include
the CRNAs in this final rule does not
stem from the CRNAs’ inability to
practice to the full extent of their
professional competence, but rather
from VA’s lack of access problems in the
area of anesthesiology.
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 (other than
Director) covered by section 7402(b), 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
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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.’’ 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. See 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, this final rule
will allow three roles of APRNs to
practice to the full extent of their
education, training, and certification
when acting within the scope of their
VA employment, regardless of State
restrictions that limit such full practice
authority, except for applicable State
restrictions on the authority to prescribe
and administer controlled substances.
The proposed rule stated that VA was
proposing to grant full practice
authority to four APRN roles. We
received 104,256 comments against
granting full practice authority to VA
CRNAs. The American Society of
Anesthesiologists lobbied heavily
against VA CRNAs having full practice
authority. They established a Web site
that would facilitate comments against
the CRNAs, which went as far as
providing the language for the comment.
These comments were not substantive
in nature and were akin to votes in a
ballot box. The main argument against
the VA CRNAs was that by granting
CRNAs full practice authority VA would
be eliminating the team based concept
of care in anesthesia, which is currently
established in VA policy via VHA
Handbook 1123, Anesthesia Service.
Team based care was not addressed in
the proposed rule because we consider
it to be an integral part in addressing all
of a veteran’s health care needs.
Establishing full practice authority to
VA APRNs, including CRNAs, would
not eliminate any well-established team
based care. The second argument posed
against granting full practice authority
to VA CRNAs was that there is ‘‘no
shortage of physician anesthesiologists
in VA and the current system allows for
sufficient flexibility to address the
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needs of all VA hospitals.’’ Again, most
of these comments were not
substantiated by evidence, though as
discussed further below, VA does
believe that evidence exists that there is
not currently a shortage of
anesthesiologists that critically impacts
access to care, and therefore VA agrees
with the sentiment of this argument.
We similarly received 45,915
comments in support of full practice
authority for APRNs as a whole without
specific mention of CRNAs. We received
9,613 comments in support of full
practice authority for CRNAs. The
CRNA-specific commenters stated that
‘‘CRNAs currently exercise their full
scope of practice in 17 states and in the
Army, Navy, Air Force, Combat Support
Hospitals, Forward Surgical Teams, and
the Indian Health Services, even in
some VAs where CRNAs are the only
anesthesia providers. Evidence shows
that APRN provided care increases
access, improves quality, and reduces
costs for all Americans. By extending
Full Practice authority to CRNAs and
other APRNs at the VHA, we can help
end delays to high-quality, safe, and
cost-effective care for America’s
Veterans. Implement this well
researched policy change promptly.’’
The commenters also stated that
‘‘APRN’s and CRNAs practicing in a
manner which they have been educated
and trained to provide expert care has
been backed by decades of research.’’
Several other commenters stated ‘‘Over
900 CRNAs provide every type of
anesthesia care, as well as chronic pain
management services, for our Veterans
in the VHA. The safety of CRNA
services has long been recognized by the
VHA and underscored by peer-reviewed
scientific studies, including a major
study published in Health Affairs which
found that anesthesia care by CRNAs
was equally safe with or without
physician supervision.’’ VA agrees with
these comments, but has chosen not to
include CRNAs in this final rule due to
VA’s lack of access problems in the area
of anesthesiology.
Commenters raised anesthesia issues
related to the RAND Assessment, which
the public can view at https://
www.va.gov/opa/choiceact/documents/
assessments/Assessment_B_Health_
Care_Capabilities.pdf. Specifically, the
Department of Veterans Affairs
Independent Assessment B, Appendix
E–I reported on qualitative interviews
with Chiefs of Staff at VA facilities;
fourteen comments discussed lack of
anesthesia service/support as a barrier
to providing care, including for urgent
and non-urgent cardiovascular surgeries
(three comments), as well as colon
cancer/gastrointestinal services such as
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endoscopy and colonoscopy (eleven
comments).1 As discussed further
below, VA understands that there are
difficulties hiring and retaining
anesthesia providers, but generally
believes that this situation is improving.
VA reviewed the qualitative interviews
with Chiefs of Staff at VA facilities
contained in the RAND Assessment but
did not determine that data supported
granting FPA to CRNAs to solve access
issues. Nonetheless, VA is requesting
further comments on whether advanced
practice authority for CRNAs would
bring further improvements.
We reviewed the Veterans Health
Administration payroll data revealed
that, as of August 31, 2016, VHA
employs 940 Physician
Anesthesiologists (physicians), 5,444
Nurse Practitioners, 937 CRNAs, and
386 Nurse Specialists. Nurse
Practitioner is currently #3 in the top 5
difficult to recruit and retain nurse
specialties. Additional workforce trend
data is available in the Regulatory
Impact Analysis.
In a 2015 independent survey of VA
general facility Chief of Staffs conducted
by the Rand Corporation, approx. 38%
(43 of 111) reported problems recruiting
or hiring advanced practice providers,
such as Nurse Practitioners, and 50%
reported problems recruiting or hiring
nurses such as clinical specialists.2 The
most commonly reported barriers to
recruitment and hiring for these medical
experts were: Non-competitive wages
(72% of 43 responses for advanced
practice providers; 64% of 56 responses
percent for nurses), Human Resources
process (42% for advanced practice
providers; 45% for nurses), geographic
location of facility (35% for advanced
practice providers; 23% for nurses), and
lack of qualified applicants (26% for
advanced practice providers; 32% for
nurses).3
Similarly, nearly 30% (33 of 111) of
Chiefs of Staffs reported problems
retaining advanced practice providers,
such as NPs, and almost half reported
problems retaining nurses, such as
clinical specialists.4 The most
commonly reported reasons for
problems with retention of these
medical experts were: Dissatisfaction
1 VA Independent Assessment, Appendices E–I,
https://www.va.gov/opa/choiceact/documents/
assessments/Assessment_B_Health_Care_
Capabilities_Appendices_E-I.pdf.
2 RAND, Independent Assessment B, Appendix
G.1.1 Chief of Staff, 2015 Survey of VA Capabilities
and Resources, G–5.
3 Id. at G–6. (Totals greater than 100 due to option
to select the two most important factors affecting
recruiting and hiring. Only respondents who
reported problems recruiting specific personnel
categories were asked to respond.)
4 Id. at G–7.
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with supervision/management support
(61% of 31 responses for advanced
practice providers; 57% of 49 responses
percent for nurses) and dissatisfaction
with pay (36% of advanced practice
providers; 27% of nurses).5 Chiefs of
Staff rarely selected lack of opportunity
for professional growth/promotion as a
top two reason for retention problems,
only 6% selected this option for
advanced practice providers and 8% for
nurses. Lack of professional autonomy
was also not viewed as a significant
contributor to retention issues (3% for
advanced practice providers, 0% for
nurses).
In fiscal years 2011 through 2015,
CRNAs were in the top 10 VHA
Occupations of Critical Need, but
dropped to 12th place in FY 2015.
Despite the challenges discussed above,
within VHA the occupation has grown
approximately 27% between FY 2010
and FY 2014 (166 employees). Total loss
rates decreased from 6.6% in FY 2013
to 6.2% in FY 2014, but have ranged
from 9.4% to 6.2% between FY 2009
and FY 2014. Voluntary retirements
decreased from 3.2% in FY 2013 to
2.7% in FY 2014. Quits increased from
1.9% in FY 2013 to 2.6% in FY 2014.
VA has taken steps to improve
recruitment of CRNAs, including
partnering with the U.S. Army to
educate interested and qualified VA
registered nurses in the field of nurse
anesthesia.6 Also, as previously stated
in this rulemaking, VA CRNAs are a
crucial part of the team based anesthesia
care. VHA Handbook 1123, Anesthesia
Service, states in paragraph 4.a. ‘‘In
facilities with both anesthesiologists
and nurse anesthetists, care needs to be
approached in a team fashion taking
into account the education, training,
and licensure of all practitioners.’’
Anesthesiology is not in the top 5
difficult to recruit and retain physician
specialties. However, in a 2015
independent survey of VA general
facility Chief of Staffs conducted by the
Rand Corporation, 25% (27 of 111)
reported problems recruiting or hiring
anesthesiologists.7 The most commonly
reported barriers to recruitment and
hiring for these medical experts were:
Non-competitive wages (78% of 27
respondents), Human Resources process
(25%), and geographic location of
5 Id.
at G–9.
Patient Care Services, Nurse Anesthetist
Education Program, available at: https://
www.patientcare.va.gov/CRNA_Education/Pages/
Certified_Registered_Nurse_Anesthetists.asp (last
accessed Oct. 18, 2016).
7 RAND, Independent Assessment B, Appendix
G.1.1 Chief of Staff, 2015 Survey of VA Capabilities
and Resources, G–5.
6 VA,
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facility (22.2%).8 Nearly 10% of Chiefs
of Staff (11/111) reported difficulties
retaining anesthesiologists.9 The most
commonly reported reason for staff
retention problems for these medical
experts were: Dissatisfaction with
supervision/management support (27%)
and dissatisfaction with pay (55%).10
Despite these challenges, over the past
5 years, the number of anesthesiologists
VHA hired increased from 87 in FY11
to 149 in FY15. The FY15 turnover rate
for anesthesiologists is slightly lower
than the turnover rate for physicians
overall. VHA has had recent successes
in hiring or contracting for
Anesthesiology services.
Recruiting, hiring, and retention
challenges, as reported by VA facility
Chiefs of Staffs struggling with these
issues, are similar among advanced
practice or specialist nurses and
anesthesiologists. These managers did
not view lack of advancement
opportunity or practice autonomy as
significant barriers to retention, which
may indicate that increased use of
advanced practice authority is unlikely
to fully resolve this challenge—both
because it may not address the root
causes of these problems and because
similar challenges constrain hiring of
both doctors and nurses. On the other
hand, the perceptions of potential
applicants and staff may not be fully
reflected by a survey of facility
management. Further, it is possible that
resources might be available to address
some of these underlying issues if
efficiencies were realized as a result of
advanced practice nursing authority. VA
welcomes comment on whether lack of
advanced practice authority is a hiring,
recruitment, or retention barrier for
CRNAs, as well as on the extent to
which advanced practice authority
could help to resolve these issues either
directly or indirectly.
Based on this analysis, VHA believes
that VA does not have immediate and
broad access problems in the area of
anesthesia care across the full VA health
care system that require full practice
authority for all CRNAs.
However, VA requests comment on
the question of whether there are
current anesthesia care access issues for
particular states or VA facilities and
whether permitting CRNAs to practice
to the full extent of their advanced
authority would resolve these issues.
VA also requests comment on potential
future anesthesia care access issues,
particularly in light of projected
8 Id.
at G–6.
at G–8.
10 Id. at G–9.
9 Id.
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90201
increases in demand for VA care,
including surgical care, in coming years.
We will, therefore, not finalize the
provision including CRNAs in the rule
as one of the APRN roles that may be
granted full practice authority at this
time. However, we request comment on
this decision. If we learn of access
problems in the area of anesthesia care
in specific facilities or more generally
that would benefit from advanced
practice authority, now or in the future,
or if other relevant circumstances
change, we will consider a follow-up
rulemaking to address granting full
practice authority to CRNAs.
VA CRNAs that have already been
granted full practice authority by their
State license will continue to practice in
VA in accordance with their State
license and subject to credentialing and
privileging by a VA medical facility’s
medical executive committee. VA will
not restrict or eliminate these CRNAs’
full practice authority.
This final rule uses 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 is granted by VA
upon demonstrating that the advanced
educational, testing, and licensing
requirements established in this
rulemaking are met and upon the
recommendation and approval of the
medical executive committee when the
provider is credentialed and privileged.
In this rulemaking, VA is exercising
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 is the
minimum necessary action for VA to
allow APRNs full practice authority. It
is impractical for VA to consult with
each State that does not allow full
practice authority to APRNs to change
their laws regarding full practice
authority.
The campaign in support of the
proposed rule was not as extensive as
the campaign against granting full
practice authority to CRNAs. The main
lobbyists in support of the proposed
rule were the American Nurses
Association and the American
Association of Nurse Practitioners, who
supported a letter campaign. We
received 45,915 comments in support of
the proposed rule. Of these 45,915, we
received specific support of individual
APRN roles as follows: 9,613 in support
of CRNAs, 1,079 in support of CNM,
and 495 in support of CNPs. These
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commenters agreed that the proposed
rule aligns with the Institute of
Medicine (IOM) of the National
Academy of Sciences 2010 IOM Report
in that the rule removes scope ofpractice barriers and increases access to
VA care. The commenters also agreed
that the APRNs are highly skilled in
their particular APRN role, as
demonstrated by their education and
hours of skilled training. Several
commenters stated that ‘‘APRNs will
deliver care to the full scope of their
education and training and ensure that
the VA has the flexibility to utilize all
providers within the healthcare team,
maximizing the effective use of
resources and providing optimal care for
the men and women who have served
our country in uniform.’’ Other
commenters supported the proposed
rule by stating ‘‘this proposal supports
the VHA team model of care and
promotes efficiency in healthcare
delivery by making smarter use of the
6,000 APRNs’’ that are employed by VA.
‘‘Most importantly, this proposal has the
ability to make real and significant
improvements to the availability of
high-quality care for millions of
Veterans.’’ The commenters also stated
that ‘‘APRN full practice authority
within the VA would create nationwide
consistency, thereby improving upon
the current patchwork of state
regulations and making the most
effective use of these health care
professionals.’’ We thank the
commenters for their support of the
proposed rule.
We received a comment in support of
the proposed rule from the Federal
Trade Commission (FTC). The FTC
focuses on the ‘‘impact of regulation on
competition in the private sector and,
ultimately, on consumers.’’ The FTC’s
main interest in the proposed rule was
‘‘the extent that the VA’s actions may
encourage entry into health care service
provider markets, broaden the
availability of health care services
outside the VHA system, as well as
within it, and yield information about
new models of health care delivery.’’
The FTC believes that its experience
‘‘may inform and support the VA’s
endeavor.’’ The FTC staff supports the
granting of full practice authority to
APRNs, which will benefit ‘‘VA’s
patients and the institution itself, by
improving access to care, containing
costs, and expanding innovation in
health care delivery.’’ VA’s actions
could also spur competition among
‘‘health care providers and generate
additional data in support of safe APRN
practice,’’ which could also spill into
the private health care sector. We thank
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the FTC for their support of the
proposed rule and make no edits based
on this comment.
Several commenters stated that they
were concerned with proposed
§ 17.415(d)(1)(i)(B), where we stated that
a Certified Nurse Practitioner (CNP) may
order, perform, or supervise laboratory
studies. The commenters stated that the
proposed language does not ‘‘adequately
appreciate the levels of complexity
involved in laboratory testing’’ and that
there are rigid standards for laboratory
tests that require rigorous academic and
practical training, which are not part of
the training for APRNs. Another
commenter stated, ‘‘While the VHA uses
the word ‘interpret’ in reference to
laboratory and imaging studies,’’ the
commenter ‘‘. . . infers that the VA’s
intent is to grant the ability for CNPs to
interpret laboratory and imaging results,
not to interpret or report raw images or
data.’’ The commenter suggested that
VA amend the term ‘‘‘interpret’ and
recommends instead to use ‘integrate
results into clinical decision making,’ or
some other phrase’’ in order to avoid
confusion between the duties of an
APRN and those of a laboratory
specialist. We agree with the commenter
in that the proposed language might be
construed as allowing CNPs the ability
to perform laboratory studies. It is not
VA’s intent to have APRNs take over the
role of laboratory specialists. These
specialists perform a crucial role at VA
medical facilities and are skillfully
trained in performing the various testing
techniques that allow health care
professionals to properly treat a
veteran’s medical condition. We are
amending proposed § 17.415(d)(1)(i)(B)
to now state that a CNP may be granted
full practice authority to ‘‘Order
laboratory and imaging studies and
integrate the results into clinical
decision making.’’
Other commenters were similarly
concerned with the language in
proposed § 17.415(d)(1)(i)(B), but as it
refers to ordering, performing,
supervising and interpreting imaging
studies. The commenters stated that
only trained radiologists, who undergo
10 years of comprehensive training to
accurately interpret high-tech imaging
exams and safely account for the
radiation used in many scans should
perform these duties. The commenters
further stated that imaging exams
should only be performed by registered
radiological technologists. It is not VA’s
intent to replace our highly qualified
radiologists or radiological
technologists. VA is committed to
providing high quality health care for
our nation’s veterans and is proud of the
outstanding work performed by
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radiologists in our system. We note,
however, that during the course of care,
other health care providers may review
radiology exams and make evaluations
based upon the radiologist’s findings.
These health care providers include
providers in emergency departments,
primary care clinics, and specialty
clinics throughout the VA health care
system. All radiology studies are
formally performed and read by
individuals who are credentialed in
radiology. This rulemaking will not
change this practice. In order to avoid
confusion, we are amending
§ 17.415(d)(1)(i)(B) by removing
performing, supervising, and
interpreting imaging studies and
replacing it with ‘‘Order laboratory and
imaging studies and integrate the results
into clinical decision making.’’
Some commenters were also
concerned that CNPs ‘‘may order more
imaging studies, which increases the
total cost and the radiation dose to the
patient.’’ One commenter cited a study
that indicated that CNPs may order
imaging more frequently than primary
care physicians. However, the study
defined advanced practice clinicians to
include CNPs and physician assistants,
and did not differentiate between these
two different types of health care
providers in the study. This rulemaking
only addresses APRNs, and it is unclear
how the study was influenced by
including physician assistants. It’s also
unclear whether there is actually a
significantly higher rate of ordering
imaging among these groups. We found
no other significant evidence provided
by the commenters to support the claim
that CNPs order more imaging studies
than physicians. For these reasons, we
make no changes based on this
comment.
Several commenters were concerned
that the value of team-based care would
be undermined by granting full practice
authority to APRNs. They stated that
physicians and other members of a
health care team bring unique value to
patient care that is based on the
individual member’s education, skill,
and training. The commenters argued
that by eliminating team-based care,
patients would be placed at risk. Teambased care is an integral part of VA
health care and is used in a wide range
of settings, which include polytrauma
care, nutrition support, and primary
care. VA will continue to provide the
already established team-based care to
properly treat the veteran’s individual
health care needs. The proposed rule
only addressed the granting of full
practice authority to APRNs and does
not address team-based care. Any
change to current VA team-based health
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care is beyond the scope of this
rulemaking. We are not making any
edits based on these comments.
Other commenters questioned an
APRN’s years of training versus those of
a physician, citing an American Medical
Association statement that ‘‘physicians
typically receive a combined total of
over 10,000 hours of training and
patient experience prior to beginning
practice, whereas the typical APRN
receives less than 1,000 hours of
training and patient experience.’’ The
commenters added that trained
physicians should be taking care of the
veterans’ medical needs as opposed to a
nurse who has not received the same
training and education as physicians.
APRN education is competency based
and APRNs must demonstrate that they
have integrated the knowledge and skill
to provide safe patient care. Entry into
APRN practice is predicated on the
requirement to attain national
certification. APRNs are held to the
same standard as physicians in
measuring patient outcomes for safe and
effective care. VHA acknowledges the
fact there are differences in physician
and APRN educational and training
models and is not planning on replacing
physicians with APRNs in any health
care setting within VHA.
APRNs are valuable members of VA’s
health care system and provide a degree
of much needed experience to alleviate
the current access problems that are
affecting VA. APRNs, like physicians,
are required to maintain their State
license and their health care skills are
continuously assessed through the
privileging process. As we stated in the
proposed rule ‘‘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’’ and an APRN will require
approval of their credentials and
privileges by the VA medical facility’s
medical executive committee. An APRN
will refer patients to a physician for care
that goes beyond that of the APRN’s
training. We will not make any edits
based on these comments.
Several commenters stated that they
would like all veterans to receive the
best and safest medical care in VA and
do not believe that granting APRNs full
practice authority will lead to such care.
As previously stated in this final rule,
VHA’s primary function is to ‘‘provide
a complete medical and hospital service
for the medical care and treatment of
veterans’’ under 38 U.S.C. 7301(b). We
also stated in the proposed rule that in
carrying out this function, VHA has an
obligation to ensure that patient care is
appropriate and safe and its health care
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practitioners meet or exceed generallyaccepted professional standards for
patient care. The general qualifications
for a person to be appointed as a VA
nurse are found in 38 U.S.C. 7402(b)(3).
In addition to these general
qualifications, the proposed rule stated
that APRNs would now be required 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.’’ VA believes that these
additional qualifications for APRNs
ensure that VA has highly qualified
health care personnel to provide safe
health care to veterans. In addition, the
VA medical facility’s medical executive
committee will be responsible for the
quality and oversight of the health care
provider. Additionally, the IOM Report
states that ‘‘the contention that APRNs
are less able than physicians to deliver
care that is safe, effective, and efficient
is not supported by the decades of
research that has examined this
question (Brown and Grimes, 1995;
Fairman, 2008; Groth et al., 2010; Hatem
et al., 2008; Hogan et al., 2010; Horrocks
et al., 2002; Hughes et al., 2010; Laurant
et al., 2004; Mundinger et al., 2000;
Office of Technology Assessment, 1986).
No studies suggest that care is better in
states that have more restrictive scopeof-practice regulations for APRNs than
in those that do not.’’ We will not make
any edits based on these comments.
Several commenters stated that the
proposed rule would undermine the
State requirement that CNPs need to
collaborate with or be supervised by
physicians. They were also concerned
that the rule would eliminate local
control of licensing and regulation of
physicians and health care providers,
which would result in lower standard of
care. We note that there may be
discrepancies between State practice
acts and this final rule which is why
this regulation preempts conflicting
state and local law. As we stated in the
proposed rule, ‘‘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).’’ We also stated ‘‘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.’’ Again,
we emphasize that this rule only
preempts State law for VA employees
practicing within the scope of their VA
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employment, and that as a result, any
such infringement upon State authority
would be limited. Further, this final rule
does not eliminate the APRN’s need to
possess a license from a State licensing
board in one of the recognized APRN
roles. This is a requirement in proposed
§ 17.415(a)(3). Proposed § 17.415(a)(4)
also requires an APRN to maintain both
the national certification and licensure.
In addition to these requirements, an
APRN must demonstrate 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 by the medical executive
committee. These measures will ensure
that patients receive care from an APRN
that is credentialed and privileged to
perform the specified tasks and will
promote patient safety. We will not
make any edits based on these
comments.
Several commenters were concerned
that APRNs would be at a higher risk of
malpractice, especially when the
APRN’s State license does not grant full
practice authority. A commenter
asserted that the APRN’s defense would
be diminished when the ‘‘state in which
the APRN is practicing in deems an act
beyond the provider’s scope of practice,
but the Federal government has given
all APRNs the broadest rights
available.’’ Under the Federal Tort
Claims Act, 28 U.S.C. 1346(b), 2401(b),
2671–2680, and the Westfall Act, 28
U.S.C. 2679(b)–(d), employees
furnishing medical care or services in
the exercise of their duties for VHA are
immune from personal liability for
malpractice in the scope of their
employment; the rule clarifies the intent
of VA that APRNs will be acting within
the scope of employment when
performing their duties in the capacities
set forth herein. The commenters further
stated that the preemption of State law
would create a discrepancy with VA
policy in that VA states in the proposed
rule that an APRN must be licensed by
a State. As previously stated in this
rulemaking, 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 employment, this
regulation would control. In doing so,
VA is better able to protect the APRNs
against any challenge of their State
license when practicing within the
scope of their VA employment. VA does
not see a disconnect between
preemption and the requirement that an
APRN must have a State license. Such
requirement is established in statute
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under 38 U.S.C. 7402 for the
qualifications of appointment as a
health care provider in VA. As we stated
in the proposed rule, we are establishing
‘‘additional professional qualifications
an individual must possess to be
appointed as an APRN within VA.’’
These additional requirements go
beyond the requirements of some State
licenses and ensure consistency for
health care provided within VA. We are
not making any edits to the rule based
on these comments.
One commenter indicated that the
proposed rule stated ‘‘Section 4 of
Executive Order 13132 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
conflict.’ ’’ [Emphasis added.] The
commenter further stated that ‘‘VA did
not provide affected state and local
officials with such notice.’’ Specifically,
‘‘no state medical boards (whether
osteopathic or allopathic) were
consulted. By the very nature of the
Notice of Proposed Rule Making
(NPRM), these state medical boards,
who are charged with overseeing
independent medical practice and
assuring patient safety, are ‘affected
State officials.’ ’’ Initially, we note that
section 1(d) of the Executive Order
defines State and local officials as
including only elected officials, and we
do not believe the officials overseeing
State medical boards are elected.
Additionally, section 4 of the Executive
Order, as cited by the commenter, states
that the ‘‘agency shall consult, to the
extent practicable’’ with affected State
and local officials (emphasis added).
Because advanced practice registered
nurses, particularly NPs, are typically
regulated by state Boards of Nursing
rather than by State medical board we
believe they are most affected by this
rule.11 Although VA did not specifically
engage State medical boards, VA
reached out to several medical
associations, including the American
College of Surgeons, American
Academy of Family Practice Physicians,
American Society of Anesthesiologists,
American Medical Association,
Association of American Medical
Colleges, and, although not a medical
association, The Joint CommissionOffice of Accreditation and
Certification. VA consulted with elected
State officials, as required by Executive
Order 13132, when it received
11 Carolyn Buppert, Nurse Practitioner’s Business
Practice and Legal Guide, Appendix 3–A (5th Ed.
2015). (Delaware and Alabama, with joint oversight
authority, are rare exceptions to this general rule.)
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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,
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. We
also consulted with the National
Council of State Boards of Nursing. We
believe that VA’s efforts to consult with
State and local officials meet the
requirements of section 4(d) of
Executive Order 13132. Furthermore,
the proposed rule encouraged any
comments regarding the granting of full
practice authority, which afforded the
‘‘affected State and local officials notice
and an opportunity for appropriate
participation in the proceedings.’’ As we
state in the Federalism paragraph in this
rule, at least twelve States responded to
VA’s outreach efforts prior to
publication of the proposed rule. It
would have been impracticable for VA
to have consulted with all State medical
boards as an outreach effort prior to
publication of the proposed rule. We are
not making edits based on this
comment.
Another commenter stated that the
proposed rule ‘‘will directly affect many
individuals and will directly affect
small entities.’’ The commenter further
stated that the rule should not be
exempt from the initial regulatory
flexibility analysis as stated in the
Regulatory Flexibility Act (5 U.S.C. 603
and 604), will not maximize net benefits
and equity and will raise novel and
legal policy issues. Another comment
emphasizes only that ‘‘some privatesector anesthesiology services’’ are
provided by small physician practices,
which ‘‘may’’ include nurse
anesthetists. It further notes that in a
‘‘limited’’ number of states, there is a
‘‘possibility’’ that private sector
anesthetists could be induced to work at
VA instead of in the private sector.
None of these claims demonstrate that
the regulation would have a significant
economic effect on a substantial number
of small entities; VA found no such
effect would result in its proposed rule,
and certified this finding as required by
5 U.S.C. 605(b). We further note that
private sector providers are not subject
to the proposed regulation, which
would only regulate the activities of VA
employees, and hence would be outside
the scope of a required analysis under
the Regulatory Flexibility Act. See, e.g.,
Mid-Tex Electric Cooperative v. FERC,
773 F.2d 327, 342–3 (D.C. Cir. 1985);
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Cement Kiln Recycling Coalition v. EPA,
255 F.3d 855, 868–9 (D.C. Cir. 2001);
and Aeronautical Repair Station Ass’n
v. F.A.A., 494 F.3d 161, 174–7. We are
not making any edits based on these
comments.
Another commenter was in support of
the proposed rule, but had concerns
regarding prescriptive authority, namely
that in some States the prescriptive
authority regulations ‘‘are linked to
scope of practice laws which would
create confusion in VA facilities
operating within those states.’’ The
commenter further stated that
‘‘collaborative agreements may limit the
scope of practice of the advanced
practice registered nurse and inhibit full
practice authority.’’ VA understands
that the proposed change could create
confusion, and as a result, VA will train
and educate its APRNs in their
authorities based upon this rule to
reduce the potential for confusion and
to ensure they can practice to the full
extent of their authority. We make no
edits based on this comment.
A commenter stated a belief that there
is a distinction ‘‘between the ability of
APRNs to perform tasks autonomously
and their ability to practice
independently. The former is a wellestablished practice, while the latter is
controversial.’’ The commenter
distinguished ‘‘ ‘autonomy’ from
‘independence,’ the latter referring to
practitioners acting alone and not in a
team-based model.’’ The commenter
stated that they support ‘‘highly trained
APPs who are part of a care team
practicing autonomously within the
scope and ability of their licensure. This
is generally accomplished with
collaborative practice between a
collaborating physician and APPs on the
care team.’’ We previously stated in this
final rule that team-based care was not
addressed in the proposed rule. Teambased care is an integral part of VA
health care, and we will continue to
adhere to the already established teambased models of care within VA. We are
not making any edits based on this
comment.
Several commenters stated that VA
should include physician assistants
(PA) in the final rule and grant them full
practice authority as well. Other
commenters were opposed to the
granting of full practice authority to
PAs. We similarly received comments
requesting that we include pharmacist
practitioners in the rule. The granting of
full practice authority to PAs and
pharmacist practitioners was not
addressed in the proposed rule and
granting such authority in this final rule
is beyond the scope of the proposed
rule. VA would only be able to address
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the granting of full practice authority to
PAs and pharmacist assistants in a
future rulemaking.
One commenter opposed the
proposed rule and urged VA ‘‘to instead
focus on ways to improve access to care
provided to veterans in community
settings through the Choice Program.
This would reduce wait times for
appointments for all veterans, and free
up VA clinicians to care for sicker and
more complex patients in VA facilities
prepared to address their unique
needs.’’ The Veterans Choice Program is
authorized by section 101 of the
Veterans Access, Choice, and
Accountability Act of 2014. The
program is implemented in 38 CFR
17.1500 through 17.1540. The proposed
rule did not address the Veterans Choice
Program, and in no way affects the
Veterans Choice Program. This
comment is beyond the scope of this
rulemaking. We are not making any
edits based on this comment.
One commenter suggested that VA
amend its application process for hiring
physicians citing that there are delays in
the usajobs.gov job portal that often
leads physicians to remove themselves
from job contention. The application
process for physician positions was not
addressed in the proposed rule, and this
issue is beyond the scope of this
rulemaking. We are not making any
edits based on this comment.
VA received many comments that
expressed general support or opposition
to this rulemaking and raised various
issues related to administration of the
VA health care system or VA benefits
that are beyond the scope of this
rulemaking. We make no changes based
on these comments.
We are making a minor typographical
edit by adding a comma in proposed
§ 17.415(e) to correct an error in the
proposed rule. We are also amending
the last sentence of the paragraph to
now read ‘‘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,
activities performed under this section
or decisions made by VA under this
section.’’ The proposed rule
inadvertently did not include the phrase
‘‘activities performed under’’. We are
now adding this clarifying language.
Based on the rationale set forth in the
Supplementary Information to the
proposed rule and in this final rule, VA
is amending the proposed rule with the
edits stated in this final rule.
Executive Order 13132, Federalism
Section 4 of Executive Order 13132
(titled ‘‘Federalism’’) requires an agency
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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 addresses
preemption of certain State laws, VA
conducted prior consultation with State
officials in compliance with Executive
Order 13132. Such State officials
include State Senators from Georgia and
Illinois, State Representatives from
Florida, Ohio, 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. Although not
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necessarily required by the Executive
Order, 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 (NCSBN) to notify every State
Board of Nursing of VA’s intent and to
seek feedback from such Boards of
Nursing. 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 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, and
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 the 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 encouraged any comments
regarding the proposed full practice
authority. In this way, VA provided 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 a conflict exists; (3) restricting
the regulatory preemption to the
minimum level necessary to achieve the
objectives of the statute; (4) receiving
and considering input from State and
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local officials as indicated above; and
(5) providing opportunity for comment
through this rulemaking.
Effect of Rulemaking
Title 38 of the Code of Federal
Regulations, as revised by this final
rulemaking, represents 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 are authorized. All
existing or subsequent VA guidance
must be read to conform with this
rulemaking if possible or, if not
possible, such guidance is superseded
by this rulemaking.
Paperwork Reduction Act
This final rule contains no provisions
constituting a collection of information
under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501–3521).
rmajette on DSK2TPTVN1PROD with RULES
Regulatory Flexibility Act
The Secretary hereby certifies that
this final rule will 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 final rule
directly affects only individuals and
would not directly affect small entities.
Therefore, pursuant to 5 U.S.C. 605(b),
this amendment is 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,’’ requiring review by
the Office of Management and Budget
(OMB), unless OMB waives such
review, 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,
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15:29 Dec 13, 2016
Jkt 241001
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 regulatory action
have been examined, and it has been
determined to be a significant regulatory
action under Executive Order 12866
because it is likely to result in a rule that
may raise novel legal or policy issues
arising out of legal mandates, the
President’s priorities, or the principles
set forth in this Executive Order. 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 final rule has 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
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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 D. Snyder, Chief of Staff,
Department of Veterans Affairs,
approved this document on September
2, 2016, for publication.
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: December 8, 2016.
Jeffrey Martin,
Office Program Manager, Regulation Policy
& Management, Office of the Secretary,
Department of Veterans Affairs.
For the reasons set forth in the
preamble, we amend 38 CFR part 17 as
follows:
PART 17—MEDICAL
1. The authority citation for part 17 is
revised to read as follows:
■
Authority: 38 U.S.C. 501, and as noted in
specific sections.
Section 17.415 is also issued under 38
U.S.C. 7301, 7304, 7402, and 7403.
2. Add an undesignated center
heading immediately after § 17.410 and
add new § 17.415 to read as follows:
■
Nursing Services
§ 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 nationallyaccredited, graduate-level educational
program that prepares them for one of
the three APRN roles of Certified Nurse
Practitioner (CNP), Clinical Nurse
Specialist (CNS), or Certified NurseMidwife (CNM);
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(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 three
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 three
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 laboratory and imaging
studies and integrate the results into
clinical decision making;
(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 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,
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15:29 Dec 13, 2016
Jkt 241001
and communities within their scope of
practice.
(iii) 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,
activities performed under this section
or decisions made by VA under this
section.
[FR Doc. 2016–29950 Filed 12–13–16; 8:45 am]
BILLING CODE 8320–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 81
[EPA–R06–OAR–2016–0275; FRL–9956–08–
Region 6]
Determination of Nonattainment and
Reclassification of the HoustonGalveston-Brazoria 2008 8-hour Ozone
Nonattainment Area; Texas
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is determining that the
Houston-Galveston-Brazoria, Texas 2008
SUMMARY:
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
90207
8-hour ozone nonattainment area (HGB
area) failed to attain the 2008 8-hour
ozone national ambient air quality
standard (NAAQS) by the applicable
attainment deadline of July 20, 2016,
and thus is classified by operation of
law as ‘‘Moderate’’. In this action, EPA
is also determining January 1, 2017 as
the deadline by which Texas must
submit to the EPA the State
Implementation Plan (SIP) revisions that
meet the Clean Air Act (CAA) statutory
and regulatory requirements that apply
to 2008 ozone NAAQS nonattainment
areas reclassified as Moderate.
DATES: This rule is effective December
14, 2016.
ADDRESSES: The EPA has established a
docket for this action under Docket ID
No. EPA–R06–OAR–2016–0275. All
documents in the docket are listed on
the https://www.regulations.gov Web
site. Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
or other information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically through https://
www.regulations.gov or in hard copy at
the EPA Region 6, 1445 Ross Avenue,
Suite 700, Dallas, Texas 75202–2733.
FOR FURTHER INFORMATION CONTACT: Ms.
Nevine Salem, (214) 665–7222,
salem.nevine@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document ‘‘we,’’ ‘‘us,’’
and ‘‘our’’ means the EPA.
I. Background
The background for this action is
discussed in detail in our September 27,
2016, (81 FR 66240) proposal. In that
document, we proposed to determine
that the HGB area failed to attain the
2008 ozone NAAQS by the applicable
attainment deadline of July 20, 2016,1
and to reclassify the area as Moderate.
We also proposed that Texas must
submit to us the SIP revisions to address
the Moderate ozone nonattainment area
requirements of the CAA section 182(b),
as interpreted by 40 CFR part 51
Subpart AA, by January 1, 2017. We
received comments on the proposal
1 The attainment date of July 20, 2016, was
established for the Houston-Galveston-Brazoria, TX
2008 ozone Marginal nonattainment area in EPA’s
final rule, Determinations of Attainment by the
Attainment Date, Extensions of the Attainment
Date, and Reclassification of Several Areas for the
2008 Ozone National Ambient Air Quality
Standards, 81 FR 26697, May 4, 2016.
E:\FR\FM\14DER1.SGM
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Agencies
[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)]
[Rules and Regulations]
[Pages 90198-90207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29950]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AP44
Advanced Practice Registered Nurses
AGENCY: Department of Veterans Affairs.
ACTION: Final rule with comment period.
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) is amending its
medical regulations to permit full practice authority of three roles of
VA advanced practice registered nurses (APRN) when they are acting
within the scope of their VA employment. Certified Registered Nurse
Anesthetists (CRNA) will not be included in VA's full practice
authority
[[Page 90199]]
under this final rule, but comment is requested on whether there are
access issues or other unconsidered circumstances that might warrant
their inclusion in a future rulemaking. The final rulemaking
establishes the professional qualifications an individual must possess
to be appointed as an APRN within VA, establishes the criteria under
which VA may grant full practice authority to an APRN, and defines the
scope of full practice authority for each of the three roles of APRN.
The services provided by an APRN under full practice authority in VA
are consistent with the nursing profession's standards of practice for
such roles. This rulemaking increases 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, and it
permits 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.
DATES: This final rule is effective January 13, 2017. Comments on full
practice authority for CRNAs must be received by VA on or before
January 13, 2017.
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: David J. Shulkin, M.D., Under
Secretary for Health, (202) 461-7000 or Linda M. McConnell, Office of
Nursing Services, (202) 461-6700, 810 Vermont Avenue NW., Washington,
DC 20420. (These are not toll-free numbers.)
SUPPLEMENTARY INFORMATION: In a document published in the Federal
Register on May 25, 2016 (81 FR 33155), VA proposed to amend its
medical regulations in part 17 of Title 38, Code of Federal Regulations
(CFR) to permit full practice authority of four roles of VA advanced
practice registered nurses (APRN) when they were acting within the
scope of their VA employment. We provided a 60-day comment period,
which ended on July 25, 2016. We received 223,296 comments on the
proposed rule.
The Office of the Federal Register has prepared a document, A Guide
to the Rulemaking Process, that states that an agency is not permitted
to base its final rule on the number of comments received in support of
the rule over those in opposition to it or vice versa. The document
further states that an agency must base its reasoning and conclusions
on the rulemaking record, which consists of the comments received,
scientific data, expert opinions, and facts accumulated during the pre-
rule and proposed rule stages. This final rule adheres to the guidance
established by the Office of the Federal Register.
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.'' 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. 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 the three APRN roles, Certified Nurse Practitioner
(CNP), Clinical Nurse Specialist (CNS), or Certified Nurse-Midwife
(CNM), throughout the VHA system with a way to achieve full practice
authority in order to provide advanced nursing services to the full
extent of their professional competence, VHA furthers its statutory
mandate to provide quality health care to our nation's veterans. This
regulatory change to nursing policy permits three roles of 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,
helps to ensure a consistent delivery of health care across VHA by
decreasing the variability in APRN practice that currently exists as a
result of disparate State practice regulations. Certified Registered
Nurse Anesthetists (CRNA) will not be included in VA's full practice
authority under this final rule, but comment is requested on whether
there are access issues or other unconsidered circumstances that might
warrant their inclusion in a future rulemaking.
Standardization of full practice authority to the three APRN roles
also aids VA in making the most efficient use of VHA APRN staff
capabilities, which increases VA's capacity to provide timely,
efficient, and effective primary care services, as well as other
services. This increases veteran access to needed VA health care,
particularly in medically-underserved areas and decreases the amount of
time veterans spend waiting for patient appointments. In addition,
standardizing APRN practice authority enables veterans, their families,
and caregivers to understand more readily the health care services that
VA APRNs are authorized to provide. This preemptive rule increases
access to care and reduces the wait times for VA appointments utilizing
the current workforce already in place. VA's position to not include
the CRNAs in this final rule does not stem from the CRNAs' inability to
practice to the full extent of their professional competence, but
rather from VA's lack of access problems in the area of anesthesiology.
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 (other than
Director) covered by section 7402(b), 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
[[Page 90200]]
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.'' 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. See 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, this
final rule will allow three roles of APRNs to practice to the full
extent of their education, training, and certification when acting
within the scope of their VA employment, regardless of State
restrictions that limit such full practice authority, except for
applicable State restrictions on the authority to prescribe and
administer controlled substances.
The proposed rule stated that VA was proposing to grant full
practice authority to four APRN roles. We received 104,256 comments
against granting full practice authority to VA CRNAs. The American
Society of Anesthesiologists lobbied heavily against VA CRNAs having
full practice authority. They established a Web site that would
facilitate comments against the CRNAs, which went as far as providing
the language for the comment. These comments were not substantive in
nature and were akin to votes in a ballot box. The main argument
against the VA CRNAs was that by granting CRNAs full practice authority
VA would be eliminating the team based concept of care in anesthesia,
which is currently established in VA policy via VHA Handbook 1123,
Anesthesia Service. Team based care was not addressed in the proposed
rule because we consider it to be an integral part in addressing all of
a veteran's health care needs. Establishing full practice authority to
VA APRNs, including CRNAs, would not eliminate any well-established
team based care. The second argument posed against granting full
practice authority to VA CRNAs was that there is ``no shortage of
physician anesthesiologists in VA and the current system allows for
sufficient flexibility to address the needs of all VA hospitals.''
Again, most of these comments were not substantiated by evidence,
though as discussed further below, VA does believe that evidence exists
that there is not currently a shortage of anesthesiologists that
critically impacts access to care, and therefore VA agrees with the
sentiment of this argument.
We similarly received 45,915 comments in support of full practice
authority for APRNs as a whole without specific mention of CRNAs. We
received 9,613 comments in support of full practice authority for
CRNAs. The CRNA-specific commenters stated that ``CRNAs currently
exercise their full scope of practice in 17 states and in the Army,
Navy, Air Force, Combat Support Hospitals, Forward Surgical Teams, and
the Indian Health Services, even in some VAs where CRNAs are the only
anesthesia providers. Evidence shows that APRN provided care increases
access, improves quality, and reduces costs for all Americans. By
extending Full Practice authority to CRNAs and other APRNs at the VHA,
we can help end delays to high-quality, safe, and cost-effective care
for America's Veterans. Implement this well researched policy change
promptly.'' The commenters also stated that ``APRN's and CRNAs
practicing in a manner which they have been educated and trained to
provide expert care has been backed by decades of research.'' Several
other commenters stated ``Over 900 CRNAs provide every type of
anesthesia care, as well as chronic pain management services, for our
Veterans in the VHA. The safety of CRNA services has long been
recognized by the VHA and underscored by peer-reviewed scientific
studies, including a major study published in Health Affairs which
found that anesthesia care by CRNAs was equally safe with or without
physician supervision.'' VA agrees with these comments, but has chosen
not to include CRNAs in this final rule due to VA's lack of access
problems in the area of anesthesiology.
Commenters raised anesthesia issues related to the RAND Assessment,
which the public can view at https://www.va.gov/opa/choiceact/documents/assessments/Assessment_B_Health_Care_Capabilities.pdf. Specifically,
the Department of Veterans Affairs Independent Assessment B, Appendix
E-I reported on qualitative interviews with Chiefs of Staff at VA
facilities; fourteen comments discussed lack of anesthesia service/
support as a barrier to providing care, including for urgent and non-
urgent cardiovascular surgeries (three comments), as well as colon
cancer/gastrointestinal services such as endoscopy and colonoscopy
(eleven comments).\1\ As discussed further below, VA understands that
there are difficulties hiring and retaining anesthesia providers, but
generally believes that this situation is improving. VA reviewed the
qualitative interviews with Chiefs of Staff at VA facilities contained
in the RAND Assessment but did not determine that data supported
granting FPA to CRNAs to solve access issues. Nonetheless, VA is
requesting further comments on whether advanced practice authority for
CRNAs would bring further improvements.
---------------------------------------------------------------------------
\1\ VA Independent Assessment, Appendices E-I, https://www.va.gov/opa/choiceact/documents/assessments/Assessment_B_Health_Care_Capabilities_Appendices_E-I.pdf.
---------------------------------------------------------------------------
We reviewed the Veterans Health Administration payroll data
revealed that, as of August 31, 2016, VHA employs 940 Physician
Anesthesiologists (physicians), 5,444 Nurse Practitioners, 937 CRNAs,
and 386 Nurse Specialists. Nurse Practitioner is currently #3 in the
top 5 difficult to recruit and retain nurse specialties. Additional
workforce trend data is available in the Regulatory Impact Analysis.
In a 2015 independent survey of VA general facility Chief of Staffs
conducted by the Rand Corporation, approx. 38% (43 of 111) reported
problems recruiting or hiring advanced practice providers, such as
Nurse Practitioners, and 50% reported problems recruiting or hiring
nurses such as clinical specialists.\2\ The most commonly reported
barriers to recruitment and hiring for these medical experts were: Non-
competitive wages (72% of 43 responses for advanced practice providers;
64% of 56 responses percent for nurses), Human Resources process (42%
for advanced practice providers; 45% for nurses), geographic location
of facility (35% for advanced practice providers; 23% for nurses), and
lack of qualified applicants (26% for advanced practice providers; 32%
for nurses).\3\
---------------------------------------------------------------------------
\2\ RAND, Independent Assessment B, Appendix G.1.1 Chief of
Staff, 2015 Survey of VA Capabilities and Resources, G-5.
\3\ Id. at G-6. (Totals greater than 100 due to option to select
the two most important factors affecting recruiting and hiring. Only
respondents who reported problems recruiting specific personnel
categories were asked to respond.)
---------------------------------------------------------------------------
Similarly, nearly 30% (33 of 111) of Chiefs of Staffs reported
problems retaining advanced practice providers, such as NPs, and almost
half reported problems retaining nurses, such as clinical
specialists.\4\ The most commonly reported reasons for problems with
retention of these medical experts were: Dissatisfaction
[[Page 90201]]
with supervision/management support (61% of 31 responses for advanced
practice providers; 57% of 49 responses percent for nurses) and
dissatisfaction with pay (36% of advanced practice providers; 27% of
nurses).\5\ Chiefs of Staff rarely selected lack of opportunity for
professional growth/promotion as a top two reason for retention
problems, only 6% selected this option for advanced practice providers
and 8% for nurses. Lack of professional autonomy was also not viewed as
a significant contributor to retention issues (3% for advanced practice
providers, 0% for nurses).
---------------------------------------------------------------------------
\4\ Id. at G-7.
\5\ Id. at G-9.
---------------------------------------------------------------------------
In fiscal years 2011 through 2015, CRNAs were in the top 10 VHA
Occupations of Critical Need, but dropped to 12th place in FY 2015.
Despite the challenges discussed above, within VHA the occupation has
grown approximately 27% between FY 2010 and FY 2014 (166 employees).
Total loss rates decreased from 6.6% in FY 2013 to 6.2% in FY 2014, but
have ranged from 9.4% to 6.2% between FY 2009 and FY 2014. Voluntary
retirements decreased from 3.2% in FY 2013 to 2.7% in FY 2014. Quits
increased from 1.9% in FY 2013 to 2.6% in FY 2014. VA has taken steps
to improve recruitment of CRNAs, including partnering with the U.S.
Army to educate interested and qualified VA registered nurses in the
field of nurse anesthesia.\6\ Also, as previously stated in this
rulemaking, VA CRNAs are a crucial part of the team based anesthesia
care. VHA Handbook 1123, Anesthesia Service, states in paragraph 4.a.
``In facilities with both anesthesiologists and nurse anesthetists,
care needs to be approached in a team fashion taking into account the
education, training, and licensure of all practitioners.''
---------------------------------------------------------------------------
\6\ VA, Patient Care Services, Nurse Anesthetist Education
Program, available at: https://www.patientcare.va.gov/CRNA_Education/Pages/Certified_Registered_Nurse_Anesthetists.asp (last accessed
Oct. 18, 2016).
---------------------------------------------------------------------------
Anesthesiology is not in the top 5 difficult to recruit and retain
physician specialties. However, in a 2015 independent survey of VA
general facility Chief of Staffs conducted by the Rand Corporation, 25%
(27 of 111) reported problems recruiting or hiring
anesthesiologists.\7\ The most commonly reported barriers to
recruitment and hiring for these medical experts were: Non-competitive
wages (78% of 27 respondents), Human Resources process (25%), and
geographic location of facility (22.2%).\8\ Nearly 10% of Chiefs of
Staff (11/111) reported difficulties retaining anesthesiologists.\9\
The most commonly reported reason for staff retention problems for
these medical experts were: Dissatisfaction with supervision/management
support (27%) and dissatisfaction with pay (55%).\10\ Despite these
challenges, over the past 5 years, the number of anesthesiologists VHA
hired increased from 87 in FY11 to 149 in FY15. The FY15 turnover rate
for anesthesiologists is slightly lower than the turnover rate for
physicians overall. VHA has had recent successes in hiring or
contracting for Anesthesiology services.
---------------------------------------------------------------------------
\7\ RAND, Independent Assessment B, Appendix G.1.1 Chief of
Staff, 2015 Survey of VA Capabilities and Resources, G-5.
\8\ Id. at G-6.
\9\ Id. at G-8.
\10\ Id. at G-9.
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Recruiting, hiring, and retention challenges, as reported by VA
facility Chiefs of Staffs struggling with these issues, are similar
among advanced practice or specialist nurses and anesthesiologists.
These managers did not view lack of advancement opportunity or practice
autonomy as significant barriers to retention, which may indicate that
increased use of advanced practice authority is unlikely to fully
resolve this challenge--both because it may not address the root causes
of these problems and because similar challenges constrain hiring of
both doctors and nurses. On the other hand, the perceptions of
potential applicants and staff may not be fully reflected by a survey
of facility management. Further, it is possible that resources might be
available to address some of these underlying issues if efficiencies
were realized as a result of advanced practice nursing authority. VA
welcomes comment on whether lack of advanced practice authority is a
hiring, recruitment, or retention barrier for CRNAs, as well as on the
extent to which advanced practice authority could help to resolve these
issues either directly or indirectly.
Based on this analysis, VHA believes that VA does not have
immediate and broad access problems in the area of anesthesia care
across the full VA health care system that require full practice
authority for all CRNAs.
However, VA requests comment on the question of whether there are
current anesthesia care access issues for particular states or VA
facilities and whether permitting CRNAs to practice to the full extent
of their advanced authority would resolve these issues. VA also
requests comment on potential future anesthesia care access issues,
particularly in light of projected increases in demand for VA care,
including surgical care, in coming years.
We will, therefore, not finalize the provision including CRNAs in
the rule as one of the APRN roles that may be granted full practice
authority at this time. However, we request comment on this decision.
If we learn of access problems in the area of anesthesia care in
specific facilities or more generally that would benefit from advanced
practice authority, now or in the future, or if other relevant
circumstances change, we will consider a follow-up rulemaking to
address granting full practice authority to CRNAs.
VA CRNAs that have already been granted full practice authority by
their State license will continue to practice in VA in accordance with
their State license and subject to credentialing and privileging by a
VA medical facility's medical executive committee. VA will not restrict
or eliminate these CRNAs' full practice authority.
This final rule uses 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 is
granted by VA upon demonstrating that the advanced educational,
testing, and licensing requirements established in this rulemaking are
met and upon the recommendation and approval of the medical executive
committee when the provider is credentialed and privileged.
In this rulemaking, VA is exercising 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 is the minimum necessary
action for VA to allow APRNs full practice authority. It is impractical
for VA to consult with each State that does not allow full practice
authority to APRNs to change their laws regarding full practice
authority.
The campaign in support of the proposed rule was not as extensive
as the campaign against granting full practice authority to CRNAs. The
main lobbyists in support of the proposed rule were the American Nurses
Association and the American Association of Nurse Practitioners, who
supported a letter campaign. We received 45,915 comments in support of
the proposed rule. Of these 45,915, we received specific support of
individual APRN roles as follows: 9,613 in support of CRNAs, 1,079 in
support of CNM, and 495 in support of CNPs. These
[[Page 90202]]
commenters agreed that the proposed rule aligns with the Institute of
Medicine (IOM) of the National Academy of Sciences 2010 IOM Report in
that the rule removes scope of-practice barriers and increases access
to VA care. The commenters also agreed that the APRNs are highly
skilled in their particular APRN role, as demonstrated by their
education and hours of skilled training. Several commenters stated that
``APRNs will deliver care to the full scope of their education and
training and ensure that the VA has the flexibility to utilize all
providers within the healthcare team, maximizing the effective use of
resources and providing optimal care for the men and women who have
served our country in uniform.'' Other commenters supported the
proposed rule by stating ``this proposal supports the VHA team model of
care and promotes efficiency in healthcare delivery by making smarter
use of the 6,000 APRNs'' that are employed by VA. ``Most importantly,
this proposal has the ability to make real and significant improvements
to the availability of high-quality care for millions of Veterans.''
The commenters also stated that ``APRN full practice authority within
the VA would create nationwide consistency, thereby improving upon the
current patchwork of state regulations and making the most effective
use of these health care professionals.'' We thank the commenters for
their support of the proposed rule.
We received a comment in support of the proposed rule from the
Federal Trade Commission (FTC). The FTC focuses on the ``impact of
regulation on competition in the private sector and, ultimately, on
consumers.'' The FTC's main interest in the proposed rule was ``the
extent that the VA's actions may encourage entry into health care
service provider markets, broaden the availability of health care
services outside the VHA system, as well as within it, and yield
information about new models of health care delivery.'' The FTC
believes that its experience ``may inform and support the VA's
endeavor.'' The FTC staff supports the granting of full practice
authority to APRNs, which will benefit ``VA's patients and the
institution itself, by improving access to care, containing costs, and
expanding innovation in health care delivery.'' VA's actions could also
spur competition among ``health care providers and generate additional
data in support of safe APRN practice,'' which could also spill into
the private health care sector. We thank the FTC for their support of
the proposed rule and make no edits based on this comment.
Several commenters stated that they were concerned with proposed
Sec. 17.415(d)(1)(i)(B), where we stated that a Certified Nurse
Practitioner (CNP) may order, perform, or supervise laboratory studies.
The commenters stated that the proposed language does not ``adequately
appreciate the levels of complexity involved in laboratory testing''
and that there are rigid standards for laboratory tests that require
rigorous academic and practical training, which are not part of the
training for APRNs. Another commenter stated, ``While the VHA uses the
word `interpret' in reference to laboratory and imaging studies,'' the
commenter ``. . . infers that the VA's intent is to grant the ability
for CNPs to interpret laboratory and imaging results, not to interpret
or report raw images or data.'' The commenter suggested that VA amend
the term ```interpret' and recommends instead to use `integrate results
into clinical decision making,' or some other phrase'' in order to
avoid confusion between the duties of an APRN and those of a laboratory
specialist. We agree with the commenter in that the proposed language
might be construed as allowing CNPs the ability to perform laboratory
studies. It is not VA's intent to have APRNs take over the role of
laboratory specialists. These specialists perform a crucial role at VA
medical facilities and are skillfully trained in performing the various
testing techniques that allow health care professionals to properly
treat a veteran's medical condition. We are amending proposed Sec.
17.415(d)(1)(i)(B) to now state that a CNP may be granted full practice
authority to ``Order laboratory and imaging studies and integrate the
results into clinical decision making.''
Other commenters were similarly concerned with the language in
proposed Sec. 17.415(d)(1)(i)(B), but as it refers to ordering,
performing, supervising and interpreting imaging studies. The
commenters stated that only trained radiologists, who undergo 10 years
of comprehensive training to accurately interpret high-tech imaging
exams and safely account for the radiation used in many scans should
perform these duties. The commenters further stated that imaging exams
should only be performed by registered radiological technologists. It
is not VA's intent to replace our highly qualified radiologists or
radiological technologists. VA is committed to providing high quality
health care for our nation's veterans and is proud of the outstanding
work performed by radiologists in our system. We note, however, that
during the course of care, other health care providers may review
radiology exams and make evaluations based upon the radiologist's
findings. These health care providers include providers in emergency
departments, primary care clinics, and specialty clinics throughout the
VA health care system. All radiology studies are formally performed and
read by individuals who are credentialed in radiology. This rulemaking
will not change this practice. In order to avoid confusion, we are
amending Sec. 17.415(d)(1)(i)(B) by removing performing, supervising,
and interpreting imaging studies and replacing it with ``Order
laboratory and imaging studies and integrate the results into clinical
decision making.''
Some commenters were also concerned that CNPs ``may order more
imaging studies, which increases the total cost and the radiation dose
to the patient.'' One commenter cited a study that indicated that CNPs
may order imaging more frequently than primary care physicians.
However, the study defined advanced practice clinicians to include CNPs
and physician assistants, and did not differentiate between these two
different types of health care providers in the study. This rulemaking
only addresses APRNs, and it is unclear how the study was influenced by
including physician assistants. It's also unclear whether there is
actually a significantly higher rate of ordering imaging among these
groups. We found no other significant evidence provided by the
commenters to support the claim that CNPs order more imaging studies
than physicians. For these reasons, we make no changes based on this
comment.
Several commenters were concerned that the value of team-based care
would be undermined by granting full practice authority to APRNs. They
stated that physicians and other members of a health care team bring
unique value to patient care that is based on the individual member's
education, skill, and training. The commenters argued that by
eliminating team-based care, patients would be placed at risk. Team-
based care is an integral part of VA health care and is used in a wide
range of settings, which include polytrauma care, nutrition support,
and primary care. VA will continue to provide the already established
team-based care to properly treat the veteran's individual health care
needs. The proposed rule only addressed the granting of full practice
authority to APRNs and does not address team-based care. Any change to
current VA team-based health
[[Page 90203]]
care is beyond the scope of this rulemaking. We are not making any
edits based on these comments.
Other commenters questioned an APRN's years of training versus
those of a physician, citing an American Medical Association statement
that ``physicians typically receive a combined total of over 10,000
hours of training and patient experience prior to beginning practice,
whereas the typical APRN receives less than 1,000 hours of training and
patient experience.'' The commenters added that trained physicians
should be taking care of the veterans' medical needs as opposed to a
nurse who has not received the same training and education as
physicians. APRN education is competency based and APRNs must
demonstrate that they have integrated the knowledge and skill to
provide safe patient care. Entry into APRN practice is predicated on
the requirement to attain national certification. APRNs are held to the
same standard as physicians in measuring patient outcomes for safe and
effective care. VHA acknowledges the fact there are differences in
physician and APRN educational and training models and is not planning
on replacing physicians with APRNs in any health care setting within
VHA.
APRNs are valuable members of VA's health care system and provide a
degree of much needed experience to alleviate the current access
problems that are affecting VA. APRNs, like physicians, are required to
maintain their State license and their health care skills are
continuously assessed through the privileging process. As we stated in
the proposed rule ``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'' and an APRN
will require approval of their credentials and privileges by the VA
medical facility's medical executive committee. An APRN will refer
patients to a physician for care that goes beyond that of the APRN's
training. We will not make any edits based on these comments.
Several commenters stated that they would like all veterans to
receive the best and safest medical care in VA and do not believe that
granting APRNs full practice authority will lead to such care. As
previously stated in this final rule, VHA's primary function is to
``provide a complete medical and hospital service for the medical care
and treatment of veterans'' under 38 U.S.C. 7301(b). We also stated in
the proposed rule that 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 general qualifications for
a person to be appointed as a VA nurse are found in 38 U.S.C.
7402(b)(3). In addition to these general qualifications, the proposed
rule stated that APRNs would now be required 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.'' VA believes that these additional
qualifications for APRNs ensure that VA has highly qualified health
care personnel to provide safe health care to veterans. In addition,
the VA medical facility's medical executive committee will be
responsible for the quality and oversight of the health care provider.
Additionally, the IOM Report states that ``the contention that APRNs
are less able than physicians to deliver care that is safe, effective,
and efficient is not supported by the decades of research that has
examined this question (Brown and Grimes, 1995; Fairman, 2008; Groth et
al., 2010; Hatem et al., 2008; Hogan et al., 2010; Horrocks et al.,
2002; Hughes et al., 2010; Laurant et al., 2004; Mundinger et al.,
2000; Office of Technology Assessment, 1986). No studies suggest that
care is better in states that have more restrictive scope-of-practice
regulations for APRNs than in those that do not.'' We will not make any
edits based on these comments.
Several commenters stated that the proposed rule would undermine
the State requirement that CNPs need to collaborate with or be
supervised by physicians. They were also concerned that the rule would
eliminate local control of licensing and regulation of physicians and
health care providers, which would result in lower standard of care. We
note that there may be discrepancies between State practice acts and
this final rule which is why this regulation preempts conflicting state
and local law. As we stated in the proposed rule, ``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).'' We also stated ``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.'' Again, we emphasize that
this rule only preempts State law for VA employees practicing within
the scope of their VA employment, and that as a result, any such
infringement upon State authority would be limited. Further, this final
rule does not eliminate the APRN's need to possess a license from a
State licensing board in one of the recognized APRN roles. This is a
requirement in proposed Sec. 17.415(a)(3). Proposed Sec. 17.415(a)(4)
also requires an APRN to maintain both the national certification and
licensure. In addition to these requirements, an APRN must demonstrate
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 by
the medical executive committee. These measures will ensure that
patients receive care from an APRN that is credentialed and privileged
to perform the specified tasks and will promote patient safety. We will
not make any edits based on these comments.
Several commenters were concerned that APRNs would be at a higher
risk of malpractice, especially when the APRN's State license does not
grant full practice authority. A commenter asserted that the APRN's
defense would be diminished when the ``state in which the APRN is
practicing in deems an act beyond the provider's scope of practice, but
the Federal government has given all APRNs the broadest rights
available.'' Under the Federal Tort Claims Act, 28 U.S.C. 1346(b),
2401(b), 2671-2680, and the Westfall Act, 28 U.S.C. 2679(b)-(d),
employees furnishing medical care or services in the exercise of their
duties for VHA are immune from personal liability for malpractice in
the scope of their employment; the rule clarifies the intent of VA that
APRNs will be acting within the scope of employment when performing
their duties in the capacities set forth herein. The commenters further
stated that the preemption of State law would create a discrepancy with
VA policy in that VA states in the proposed rule that an APRN must be
licensed by a State. As previously stated in this rulemaking, 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
employment, this regulation would control. In doing so, VA is better
able to protect the APRNs against any challenge of their State license
when practicing within the scope of their VA employment. VA does not
see a disconnect between preemption and the requirement that an APRN
must have a State license. Such requirement is established in statute
[[Page 90204]]
under 38 U.S.C. 7402 for the qualifications of appointment as a health
care provider in VA. As we stated in the proposed rule, we are
establishing ``additional professional qualifications an individual
must possess to be appointed as an APRN within VA.'' These additional
requirements go beyond the requirements of some State licenses and
ensure consistency for health care provided within VA. We are not
making any edits to the rule based on these comments.
One commenter indicated that the proposed rule stated ``Section 4
of Executive Order 13132 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 conflict.' '' [Emphasis added.] The commenter
further stated that ``VA did not provide affected state and local
officials with such notice.'' Specifically, ``no state medical boards
(whether osteopathic or allopathic) were consulted. By the very nature
of the Notice of Proposed Rule Making (NPRM), these state medical
boards, who are charged with overseeing independent medical practice
and assuring patient safety, are `affected State officials.' ''
Initially, we note that section 1(d) of the Executive Order defines
State and local officials as including only elected officials, and we
do not believe the officials overseeing State medical boards are
elected. Additionally, section 4 of the Executive Order, as cited by
the commenter, states that the ``agency shall consult, to the extent
practicable'' with affected State and local officials (emphasis added).
Because advanced practice registered nurses, particularly NPs, are
typically regulated by state Boards of Nursing rather than by State
medical board we believe they are most affected by this rule.\11\
Although VA did not specifically engage State medical boards, VA
reached out to several medical associations, including the American
College of Surgeons, American Academy of Family Practice Physicians,
American Society of Anesthesiologists, American Medical Association,
Association of American Medical Colleges, and, although not a medical
association, The Joint Commission-Office of Accreditation and
Certification. VA consulted with elected State officials, as required
by Executive Order 13132, when it 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,
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. We also consulted with
the National Council of State Boards of Nursing. We believe that VA's
efforts to consult with State and local officials meet the requirements
of section 4(d) of Executive Order 13132. Furthermore, the proposed
rule encouraged any comments regarding the granting of full practice
authority, which afforded the ``affected State and local officials
notice and an opportunity for appropriate participation in the
proceedings.'' As we state in the Federalism paragraph in this rule, at
least twelve States responded to VA's outreach efforts prior to
publication of the proposed rule. It would have been impracticable for
VA to have consulted with all State medical boards as an outreach
effort prior to publication of the proposed rule. We are not making
edits based on this comment.
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\11\ Carolyn Buppert, Nurse Practitioner's Business Practice and
Legal Guide, Appendix 3-A (5th Ed. 2015). (Delaware and Alabama,
with joint oversight authority, are rare exceptions to this general
rule.)
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Another commenter stated that the proposed rule ``will directly
affect many individuals and will directly affect small entities.'' The
commenter further stated that the rule should not be exempt from the
initial regulatory flexibility analysis as stated in the Regulatory
Flexibility Act (5 U.S.C. 603 and 604), will not maximize net benefits
and equity and will raise novel and legal policy issues. Another
comment emphasizes only that ``some private-sector anesthesiology
services'' are provided by small physician practices, which ``may''
include nurse anesthetists. It further notes that in a ``limited''
number of states, there is a ``possibility'' that private sector
anesthetists could be induced to work at VA instead of in the private
sector. None of these claims demonstrate that the regulation would have
a significant economic effect on a substantial number of small
entities; VA found no such effect would result in its proposed rule,
and certified this finding as required by 5 U.S.C. 605(b). We further
note that private sector providers are not subject to the proposed
regulation, which would only regulate the activities of VA employees,
and hence would be outside the scope of a required analysis under the
Regulatory Flexibility Act. See, e.g., Mid-Tex Electric Cooperative v.
FERC, 773 F.2d 327, 342-3 (D.C. Cir. 1985); Cement Kiln Recycling
Coalition v. EPA, 255 F.3d 855, 868-9 (D.C. Cir. 2001); and
Aeronautical Repair Station Ass'n v. F.A.A., 494 F.3d 161, 174-7. We
are not making any edits based on these comments.
Another commenter was in support of the proposed rule, but had
concerns regarding prescriptive authority, namely that in some States
the prescriptive authority regulations ``are linked to scope of
practice laws which would create confusion in VA facilities operating
within those states.'' The commenter further stated that
``collaborative agreements may limit the scope of practice of the
advanced practice registered nurse and inhibit full practice
authority.'' VA understands that the proposed change could create
confusion, and as a result, VA will train and educate its APRNs in
their authorities based upon this rule to reduce the potential for
confusion and to ensure they can practice to the full extent of their
authority. We make no edits based on this comment.
A commenter stated a belief that there is a distinction ``between
the ability of APRNs to perform tasks autonomously and their ability to
practice independently. The former is a well-established practice,
while the latter is controversial.'' The commenter distinguished ``
`autonomy' from `independence,' the latter referring to practitioners
acting alone and not in a team-based model.'' The commenter stated that
they support ``highly trained APPs who are part of a care team
practicing autonomously within the scope and ability of their
licensure. This is generally accomplished with collaborative practice
between a collaborating physician and APPs on the care team.'' We
previously stated in this final rule that team-based care was not
addressed in the proposed rule. Team-based care is an integral part of
VA health care, and we will continue to adhere to the already
established team-based models of care within VA. We are not making any
edits based on this comment.
Several commenters stated that VA should include physician
assistants (PA) in the final rule and grant them full practice
authority as well. Other commenters were opposed to the granting of
full practice authority to PAs. We similarly received comments
requesting that we include pharmacist practitioners in the rule. The
granting of full practice authority to PAs and pharmacist practitioners
was not addressed in the proposed rule and granting such authority in
this final rule is beyond the scope of the proposed rule. VA would only
be able to address
[[Page 90205]]
the granting of full practice authority to PAs and pharmacist
assistants in a future rulemaking.
One commenter opposed the proposed rule and urged VA ``to instead
focus on ways to improve access to care provided to veterans in
community settings through the Choice Program. This would reduce wait
times for appointments for all veterans, and free up VA clinicians to
care for sicker and more complex patients in VA facilities prepared to
address their unique needs.'' The Veterans Choice Program is authorized
by section 101 of the Veterans Access, Choice, and Accountability Act
of 2014. The program is implemented in 38 CFR 17.1500 through 17.1540.
The proposed rule did not address the Veterans Choice Program, and in
no way affects the Veterans Choice Program. This comment is beyond the
scope of this rulemaking. We are not making any edits based on this
comment.
One commenter suggested that VA amend its application process for
hiring physicians citing that there are delays in the usajobs.gov job
portal that often leads physicians to remove themselves from job
contention. The application process for physician positions was not
addressed in the proposed rule, and this issue is beyond the scope of
this rulemaking. We are not making any edits based on this comment.
VA received many comments that expressed general support or
opposition to this rulemaking and raised various issues related to
administration of the VA health care system or VA benefits that are
beyond the scope of this rulemaking. We make no changes based on these
comments.
We are making a minor typographical edit by adding a comma in
proposed Sec. 17.415(e) to correct an error in the proposed rule. We
are also amending the last sentence of the paragraph to now read ``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, activities performed under
this section or decisions made by VA under this section.'' The proposed
rule inadvertently did not include the phrase ``activities performed
under''. We are now adding this clarifying language.
Based on the rationale set forth in the Supplementary Information
to the proposed rule and in this final rule, VA is amending the
proposed rule with the edits stated in this final rule.
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 addresses preemption of certain State laws,
VA conducted prior consultation with State officials in compliance with
Executive Order 13132. Such State officials include State Senators from
Georgia and Illinois, State Representatives from Florida, Ohio,
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. Although not
necessarily required by the Executive Order, 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 (NCSBN) to notify every State Board of
Nursing of VA's intent and to seek feedback from such Boards of
Nursing. 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 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, and 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 the 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 encouraged any comments regarding the proposed full practice
authority. In this way, VA provided 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 a conflict exists; (3) restricting the regulatory preemption to
the minimum level necessary to achieve the objectives of the statute;
(4) receiving and considering input from State and
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local officials as indicated above; and (5) providing opportunity for
comment through this rulemaking.
Effect of Rulemaking
Title 38 of the Code of Federal Regulations, as revised by this
final rulemaking, represents 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 are authorized.
All existing or subsequent VA guidance must be read to conform with
this rulemaking if possible or, if not possible, such guidance is
superseded by this rulemaking.
Paperwork Reduction Act
This final 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 final rule will 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 final rule directly affects only individuals and would not
directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b),
this amendment is 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,'' requiring review by the Office of
Management and Budget (OMB), unless OMB waives such review, 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 regulatory action have been examined, and it has
been determined to be a significant regulatory action under Executive
Order 12866 because it is likely to result in a rule that may raise
novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in this Executive
Order. 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 final rule has 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 D.
Snyder, Chief of Staff, Department of Veterans Affairs, approved this
document on September 2, 2016, for publication.
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: December 8, 2016.
Jeffrey Martin,
Office Program Manager, Regulation Policy & Management, Office of the
Secretary, Department of Veterans Affairs.
For the reasons set forth in the preamble, we amend 38 CFR part 17
as follows:
PART 17--MEDICAL
0
1. The authority citation for part 17 is revised to read as follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
Section 17.415 is also issued under 38 U.S.C. 7301, 7304, 7402,
and 7403.
0
2. Add an undesignated center heading immediately after Sec. 17.410
and add new Sec. 17.415 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 three APRN roles
of Certified Nurse Practitioner (CNP), Clinical Nurse Specialist (CNS),
or Certified Nurse-Midwife (CNM);
[[Page 90207]]
(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
three 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 three 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 laboratory and imaging studies and integrate the results
into clinical decision making;
(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 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.
(iii) 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, activities
performed under this section or decisions made by VA under this
section.
[FR Doc. 2016-29950 Filed 12-13-16; 8:45 am]
BILLING CODE 8320-01-P