Advanced Practice Registered Nurses, 33155-33160 [2016-12338]

Download as PDF Federal Register / Vol. 81, No. 101 / Wednesday, May 25, 2016 / Proposed Rules * * * * * Dated: May 19, 2016. Jacqueline C. Charlesworth, General Counsel and Associate Register of Copyrights. [FR Doc. 2016–12227 Filed 5–24–16; 8:45 am] BILLING CODE 1410–30–P DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 RIN 2900–AP44 Advanced Practice Registered Nurses Department of Veterans Affairs. Proposed rule. AGENCY: ACTION: The Department of Veterans Affairs (VA) is proposing to amend its medical regulations to permit full practice authority of all VA advanced practice registered nurses (APRNs) when they are acting within the scope of their VA employment. This rulemaking would increase veterans’ access to VA health care by expanding the pool of qualified health care professionals who are authorized to provide primary health care and other related health care services to the full extent of their education, training, and certification, without the clinical supervision of physicians. This rule would permit VA to use its health care resources more effectively and in a manner that is consistent with the role of APRNs in the non-VA health care sector, while maintaining the patientcentered, safe, high-quality health care that veterans receive from VA. The proposed rulemaking would establish additional professional qualifications an individual must possess to be appointed as an APRN within VA. The proposed rulemaking would subdivide APRN’s into four separate categories that include certified nurse practitioner, certified registered nurse anesthetist, clinical nurse specialist, and certified nurse-midwife. The proposed rulemaking would also provide the criteria under which VA may grant full practice authority to an APRN, and define the scope of full practice authority for each category of APRN. VA intends that the services to be provided by an APRN in one of the four APRN roles would be consistent with the nursing profession’s standards of practice for such roles. DATES: Comments must be received by VA on or before July 25, 2016. ADDRESSES: Written comments may be submitted: Through http:// www.Regulations.gov; by mail or hand- Lhorne on DSK30JT082PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 17:10 May 24, 2016 Jkt 238001 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 http:// www.Regulations.gov. FOR FURTHER INFORMATION CONTACT: Dr. Penny Kaye Jensen, Liaison for National APRN Practice, 810 Vermont Ave. NW., Washington, DC 20420; (202) 461–6700. (This is not a toll-free number.) SUPPLEMENTARY INFORMATION: Section 7301 of title 38 United States Code (U.S.C.) establishes the Veterans Health Administration (VHA) within VA, and establishes that its primary function is to ‘‘provide a complete medical and hospital service for the medical care and treatment of veterans, as provided in this title and in regulations prescribed by the Secretary pursuant to this title.’’ 38 U.S.C. 7301(b). In carrying out this function, VHA has an obligation to ensure that patient care is appropriate and safe and its health care practitioners meet or exceed generally-accepted professional standards for patient care. The Secretary is responsible for the proper execution and administration of all laws administered by the Department and for the control, direction, and management of the Department, to include agency personnel and management matters. See 38 U.S.C. 303. To enable the Secretary to direct, control and manage VA, Congress authorized the Secretary ‘‘to prescribe all rules and regulations which are necessary or appropriate to carry out the laws administered by the Department and are consistent with those laws.’’ 38 U.S.C. 501(a). The Under Secretary for Health is directly responsible to the Secretary for the operation of VHA (38 U.S.C. 305(b)). Unless specifically otherwise provided, the Under Secretary for Health, as the head of VHA, is authorized to ‘‘prescribe all regulations necessary to the administration of the Veterans Health Administration,’’ subject to the approval of the Secretary. 38 U.S.C. 7304. To allow VA to carry out its medical care mission, Congress PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 33155 also established a comprehensive personnel system for certain medical employees in VHA, independent of the civil service rules. See Chapters 73 and 74 of title 38, U.S.C. The Secretary was granted express statutory authority to establish the qualifications for VA’s healthcare practitioners, determine the hours and conditions of employment, take disciplinary action against employees, and otherwise regulate the professional activities of those individuals. 38 U.S.C. 7401–7464. As an integrated Federal health care system with the responsibility to provide comprehensive care under 38 U.S.C. 7301, it is essential that VHA wisely manage its resources and fully utilize the skills of its health care providers to the full extent of their education, training, and certification. By permitting APRNs throughout the VHA system a way to achieve full practice authority in order to provide advanced nursing services to the full extent of their professional competence, VHA would further its statutory mandate to provide quality health care to our nation’s veterans. This proposed regulatory change to nursing policy would permit APRNs to practice to the full extent of their education, training and certification, without the clinical supervision or mandatory collaboration of physicians. Standardization of APRN full practice authority, without regard for individual State practice regulations, would help to ensure a consistent continuum of health care across VHA by decreasing the variability in APRN practice that currently exists across VHA as a result of disparate State practice regulations. As of March 7, 2016 CRNAs have full practice authority in 17 states, while CNPs have full practice authority in almost 50% of the nation, which includes 21 states and the District of Columbia. It would also aid in fully maximizing VHA APRN staff capabilities, which would increase VA’s capacity to provide timely, efficient, and effective primary care services, as well as other services. This would increase veteran access to needed VA health care, particularly in medically-underserved areas, as well as decrease the amount of time veterans spend waiting for patient appointments. In addition, standardizing APRN practice authority would enable veterans, their families, and caregivers to understand more readily the health care services that VA APRNs are authorized to provide. This preemptive rule would increase access to care and reduce the wait times for VA appointments utilizing the current workforce already in place. E:\FR\FM\25MYP1.SGM 25MYP1 Lhorne on DSK30JT082PROD with PROPOSALS 33156 Federal Register / Vol. 81, No. 101 / Wednesday, May 25, 2016 / Proposed Rules To ensure that VA would have available highly qualified medical personnel, Congress mandated the basic qualifications for certain health care positions, including registered nurses. Sections 7401 through 7464 of title 38, U.S.C., grant VA authority to regulate the professional activities of such personnel. To be eligible for appointment as a VA employee in a health care position covered by section 7402(b) (other than Director), of title 38, U.S.C., a person must, among other requirements, be licensed, registered or certified to practice their profession in a State. The standards prescribed in section 7402(b) establish only the basic qualifications necessary ‘‘[t]o be eligible for appointment’’ and do not limit the Secretary or Under Secretary for Health from establishing other qualifications for appointment, or additional rules governing such personnel. In particular, 38 U.S.C. 7403(a)(1) provides that appointments under Chapter 74 ‘‘may be made only after qualifications have been established in accordance with regulations prescribed by the Secretary, without regard to civil-service requirements.’’ In addition, 38 U.S.C. 7421(a) directs that, ‘‘[n]otwithstanding any law, Executive order, or regulation, the Secretary shall prescribe by regulation the hours and conditions of employment and leaves of absence of employees appointed under any provision of [chapter 74] [in the specifically numerated positions] in the Veterans Health Administration’’ (including registered nurses). As the head of VHA, the Under Secretary for Health has the duty to ‘‘prescribe all regulations necessary to the administration of the Veterans Health Administration,’’ subject to approval by the Secretary. 38 U.S.C. 7304; see also 38 U.S.C. 501. Pursuant to this authority, the Under Secretary for Health is authorized to establish the qualifications and clinical practice standards of VHA’s nursing personnel and to otherwise regulate their professional conduct. To continue to provide high quality health care to veterans, VA is proposing to amend its regulations to allow APRNs to practice to the full extent of their education, training, and certification, regardless of individual State restrictions that limit such full practice authority, except for applicable State restrictions on the authority to prescribe and administer controlled substances, when such APRNs are acting within the scope of their VA employment. The proposed rule would use the term ‘‘full practice authority’’ to refer to the APRN’s authority to provide advanced VerDate Sep<11>2014 17:10 May 24, 2016 Jkt 238001 nursing services without the clinical oversight of a physician when that APRN is working within the scope of their VA employment. Such full practice authority would be granted by VA upon demonstrating that the established regulatory criteria are met. In addition, full practice authority would be granted appropriate to the clinical service setting. This proposed rule is consistent with the recommendation of the Institute of Medicine (IOM) of the National Academy of Sciences to remove scopeof-practice barriers. Specifically, the 2010 IOM report, ‘‘The Future of Nursing: Leading Change Advancing Health,’’ (IOM Report) available at http://iom.nationalacademies.org/ Reports/2010/The-Future-of-NursingLeading-Change-AdvancingHealth.aspx, recommended that ‘‘[a]dvanced practice registered nurses (APRNs) should be able to practice to the full extent of their education and training.’’ Id. at 9. More generally, the report stated that ‘‘[r]estrictions on scope of practice and professional tensions have undermined the nursing profession’s ability to provide and improve both general and advanced care’’ and asserted that ‘‘[p]roducing a health care system that delivers the right care—quality care that is patient centered, accessible, evidence based, and sustainable—at the right time will require transforming the work environment, scope of practice, education, and numbers and composition of America’s nurses.’’ Id. at 26. In addition, the proposed rule is consistent with the National Council of State Boards of Nursing (NCSBN) Consensus Model, as discussed in more detail later in this rulemaking. Significantly, many States already permit full practice authority of APRNs or are in the process of doing so. Under the proposed rulemaking, APRNs would not be authorized to replace or act as physicians or to provide any health care services that are beyond their clinical education, training, and national certification. The proposed rule would limit an APRN’s full practice authority to practice within the scope of their VA employment, and any APRN practice outside of VA employment would remain subject to applicable State laws, in the same manner as any other licensed VA practitioner in their private practice. In this rulemaking, VA is proposing to exercise Federal preemption of State nursing licensure laws to the extent such State laws conflict with the full practice authority granted to VA APRNs while acting within the scope of their VA employment. Preemption would be PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 the minimum necessary action for VA to allow APRNs full practice authority. It would be impractical for VA to lobby to each State that does not allow full practice authority to APRNs to change their laws regarding full practice authority. This process would be costly and time consuming for VA and would not guarantee the desired result of full practice authority to all APRNs. Section-by-Section Analysis of the Proposed Rule 17.415 Full Practice Authority for Advanced Practice Registered Nurses The general qualifications for a person to be appointed as a VA nurse are found in 38 U.S.C. 7402(b)(3), which requires that a person must have successfully completed a full course of nursing in a recognized school of nursing, as well as be registered as a graduate nurse in a State. VA interprets ‘‘a recognized school of nursing’’ to mean a school of professional nursing approved by the appropriate State agency and accredited by the National League for Nursing Accrediting Commission (NLNAC) or the Commission on Collegiate Nursing Education (CCNE); the completion of coursework equivalent to a nursing degree in a MSN Bridge Program that qualifies for professional nursing registration; or a foreign school of professional nursing that enables the graduate to obtain current, full, active and unrestricted registration. VA Handbook 5005/27, Part II, Appendix G6, paragraph 2, Section B.a(2). VA interprets ‘‘registered as a graduate nurse in a state’’ to mean a current, full, active and unrestricted licensure, registration or certification as a graduate professional nurse in a State, Territory, or Commonwealth (i.e., Puerto Rico) of the U.S. or in the District of Columbia (hereinafter ‘‘licensure’’). Id. Pursuant to the authorities in 38 U.S.C. 7401 through 7464 and VA’s rulemaking authorities at 38 U.S.C. 501 and 7304, VA is proposing a new § 17.415(a), which would define additional qualifications a registered nurse must possess to be appointed to one of four (4) APRN roles, i.e., Certified Nurse practitioner (CNP), Certified Registered Nurse Anesthetist (CRNA), Clinical Nurse Specialist (CNS), or Certified Nurse-Midwife (CNM). The proposed rule would require an advanced practice registered nurse to have successfully completed a nationally-accredited, graduate-level educational program that prepares the advanced practice registered nurse in one of the four APRN roles; and to possess, and maintain, national certification and State licensure in that APRN role. These additional E:\FR\FM\25MYP1.SGM 25MYP1 Lhorne on DSK30JT082PROD with PROPOSALS Federal Register / Vol. 81, No. 101 / Wednesday, May 25, 2016 / Proposed Rules qualifications are derived from criteria set forth in the IOM Report, and the National Council of State Boards of Nursing Consensus Model for APRN Regulation: Licensure, Accreditation, Certification & Education) Regulation, July 2008 (the APRN Consensus Model), which VA finds to be the criteria most widely accepted by State boards of nursing and the nursing community as necessary to practice as an APRN. Under the proposed rule, APRNs who meet these additional qualifications may be granted full practice authority within VA in one of the four recognized APRN roles. Proposed § 17.415(a)(1) would require an APRN to have successfully completed an accredited graduate-level educational program in one of the four distinct APRN roles. The Consensus Model defines these roles as CNP, CRNA, CNS, and CNM. These APRN roles are widely known and accepted by State boards of nursing and the nursing community. VA currently does not employ CNMs; however, the proposed rule includes CNMs in the event that VA has the need to hire CNMs in the future. Proposed § 17.415(a)(2) would require an APRN to have passed a national certification examination that measures the APRN’s knowledge, skills and experience demonstrated by the achievement of standards identified by the profession in one of the four APRN roles established in proposed § 17.415(a)(1). Public and private sector health care employers, State boards of nursing, and the nursing community rely on national certification through an examination process as the standard, which conveys adequate APRN knowledge, and VA’s regulation would adopt the same standard. Proposed § 17.415(a)(3) would require an APRN to possess a license from a State licensing board in one of the four recognized APRN roles. Proposed § 17.415(a)(4) would require an APRN to maintain both the national certification and licensure required in proposed paragraphs (a)(2) and (3) of § 17.415. In total, proposed paragraphs (a)(1) through (4) of § 17.415 would establish qualifications for employment within VA as a CNP, CRNA, CNS and CNM. These qualifications would ensure that VA APRNs possess and maintain the education, knowledge, national certification and State licensure necessary for VA employment in one of the four recognized APRN roles. APRNs who meet these qualifications would be granted full practice authority within VA in one of the four recognized APRN roles. VerDate Sep<11>2014 14:52 May 24, 2016 Jkt 238001 Proposed § 17.415(b) would define ‘‘full practice authority’’ to mean that an APRN working within the scope of VA employment would be authorized to provide the services described in proposed § 17.415(d), without the clinical oversight of a physician, regardless of State or local law restrictions on that authority. Further, any APRN practice established outside VA employment would be subject to applicable State law, in the same manner as private practice by any other licensed VA provider. Proposed § 17.415(c) would establish the criteria by which VA may grant full practice authority to an APRN. Proposed paragraph (c)(1), would require a VA medical facility to verify that the APRN meets the requirements established in proposed § 17.415(a). Proposed paragraph (c)(2) would require VA to confirm that the APRN has demonstrated the knowledge and skills necessary to provide the services described in proposed § 17.415(d) without the clinical oversight of a physician, and is thus qualified to be privileged for such scope of practice. Proposed § 17.415(c)(1) and (2) together would clarify that the VA processes for credentialing and privileging of licensed independent health care providers would apply to VA APRNs with full practice authority. VA anticipates that the granting of full-practice authority under proposed § 17.415(c) would be implemented through formal VHA guidance issuances. Proposed § 17.415(d)(1) would describe the role-specific services that a VA APRN would be authorized to perform under their full practice authority. This authority would be without regard to state licensure restrictions, except as provided in proposed paragraph (d)(2), which would defer to State licensure restrictions on a VA APRN’s authority to prescribe, or administer controlled substances. We emphasize that full practice authority for an APRN in this rulemaking would apply only to services provided by an APRN when working within the scope of their VA employment, as required by proposed § 17.415(b). Additionally, all full practice authority of APRNs in proposed § 17.415(d)(1) would be under approved privileges by, and within the available resources of, a VA medical facility, as required by proposed § 17.415(c). VA intends that the services to be provided by an APRN in one of the four APRN roles would be consistent with the nursing profession’s standards of practice for such roles. In proposed § 17.415(d)(1)(i), a CNP would have full practice authority to provide the following services: PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 33157 Comprehensive histories, physical examinations and other health assessment and screening activities; diagnose, treat, and manage patients with acute and chronic illnesses and diseases; order, perform, supervise, and interpret laboratory and imaging studies; prescribe medication and durable medical equipment and; make appropriate referrals for patients and families; and aid in health promotion, disease prevention, health education, and counseling as well as the diagnosis and management of acute and chronic diseases. In proposed § 17.415(d)(1)(ii), a CRNA would have full practice authority to provide a patient’s anesthesia care and anesthesia related care, to include planning and initiating anesthetic techniques (general, regional, local) and sedation, providing post-anesthesia evaluation and discharge; ordering and evaluating diagnostic tests; requesting consultations; performing point-of-care testing; and responding to emergency situations for airway management. In proposed § 17.415(d)(1)(iii), a CNS would have full practice authority to provide diagnosis and treatment of health or illness states, disease management, health promotion, and prevention of illness and risk behaviors among individuals, families, groups, and communities within their scope of practice. Lastly, in proposed § 17.415(d)(1)(iv), a CNM would have full practice authority to provide a full range of primary health care services to women veterans, including gynecologic care, family planning service, preconception care (care that women veterans receive before becoming pregnant, including reducing the risk of birth defects and other problems such as the treatment of diabetes and high blood pressure), prenatal and postpartum care, childbirth, and care of a newborn. We note that the pregnancy and delivery services described above, as well as the newborn care services, would be subject to the limitations established in 38 CFR 17.38(a)(1)(xiii) and (xiv), respectively. We also note that authorized CNM services would include treating the partner of the female patient for sexually transmitted infection and reproductive health, if the partner is enrolled in the VA healthcare system or not required to enroll to receive VA services. We would include the services of a CNM in this rulemaking in anticipation that VA would hire CNMs at a future date to improve access to health care for the increasing number of female veterans. Proposed § 17.415(d)(2) would expressly limit full practice authority. E:\FR\FM\25MYP1.SGM 25MYP1 Lhorne on DSK30JT082PROD with PROPOSALS 33158 Federal Register / Vol. 81, No. 101 / Wednesday, May 25, 2016 / Proposed Rules Congress has specifically required reliance on a specific State law under the Controlled Substance Act (CSA). Specifically, proposed § 17.415(a)(2) would provide that full practice authority within VA is subject to State licensure law with regard to the authority of an APRN to prescribe, or administer controlled substances, and to any other limitations on the provision of VA care set forth in applicable Federal law and policy. Regarding the full practice authority limitations for controlled substances, the CSA, 21 U.S.C. 801 et seq., and implementing regulations in 21 CFR part 1300, make State licensure authority to prescribe, or administer controlled substances a prerequisite for authority under the CSA to prescribe, or administer controlled substances. See 21 U.S.C. 802(21) (providing that a practitioner must be ‘‘licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.’’); See also 21 CFR 1306.03(a) (stating that a prescription for a controlled substance may be issued only by an individual practitioner who is: (1) Authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and (2) either registered or exempted from registration pursuant to §§ 1301.22(c) and 1301.23.). Proposed § 17.415(d)(2) also would make the full practice authority of an APRN subject to any other limitations on the provision of VA care set forth in Federal law or policy. Proposed § 17.415(e) would expressly state the intended preemptive effect of proposed § 17.415, to ensure it is clear that conflicting State and local laws related to the practice of APRNs would have no force or effect when such APRNs are working within the scope of their VA employment. In circumstances where there is a conflict between Federal and State Law, Federal law prevails in accordance with Article VI, clause 2, of the U.S. Constitution (Supremacy Clause). It is a wellestablished principle of constitutional law that Federal law is supreme, and States may not regulate or control the lawful actions of the Federal Government, absent Congressional consent. Therefore, where there is conflict between State law and Federal law with regard to full practice authority of APRNs working within the scope of their federal VA employment, this regulation would control. VerDate Sep<11>2014 14:52 May 24, 2016 Jkt 238001 Accordingly, State disciplinary actions that would penalize, or otherwise interfere with, an APRN’s full practice authority in the performance of their official VA duties, would likewise be effectively preempted. However, where there is no conflict between this regulation and State law, the State would retain authority to impose State regulations on its APRN licensees and take disciplinary action for any violations. We emphasize that this preemptive effect would only pertain to APRNs when they are acting within the scope of their federal VA employment; this rule would not have any effect on individual State efforts to either permit or restrict full practice authority for APRNs who are not working within a VA scope of employment. The Indian Health Service already grants full practice authority to APRNs. See Part 4, Chapter 3, Section 11, ‘‘Advanced Practice Nurses,’’ Indian Health Manual. In the Military Health System, the Services employ APRNs, which includes Nurse Midwives, Nurse Practitioners, and Nurse Anesthetists, in independent practice without oversight from physicians. They are privileged in their roles as APRNs and can adjust their scope practice (level of care) through privileging as granted by a committee of physicians and the military treatment facility commander. Nurse Practitioners specifically have an assigned group of patients for which they are responsible. Therefore, we do not anticipate that the proposed changes in this rulemaking would be completely novel or unexpected to the general public or other Federal entities that provide health care services to beneficiaries. Executive Order 13132, Federalism Section 4 of Executive Order 13132 (titled ‘‘Federalism’’) requires an agency that is publishing a regulation that preempts State law to follow certain procedures. Section 4(b) of the Executive Order requires agencies to ‘‘construe any authorization in the statute for the issuance of regulations as authorizing preemption of State law by rulemaking only when the exercise of State authority directly conflicts with the exercise of Federal authority under the Federal statute or there is clear evidence to conclude that the Congress intended the agency to have the authority to preempt State law.’’ Section 4(d) of the Executive Order requires that when an agency proposes to act through rulemaking to preempt State law, ‘‘the agency shall consult, to the extent practicable, with appropriate State and local officials in an effort to avoid such a conflict.’’ Section 4(e) of the Executive PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 Order requires that when an agency proposes to act through rulemaking to preempt State law, ‘‘the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.’’ Section 6(c) of Executive Order 13132 states that ‘‘no agency shall promulgate any regulation that has federalism implications and that preempts State law, unless the agency, prior to the formal promulgation of the regulation, (1) consulted with State and local officials early in the process of developing the proposed regulation; (2) in a separately identified portion of the preamble to the regulation as it is to be issued in the Federal Register, provides to the Director of the Office of Management and Budget a federalism summary impact statement, which consists of a description of the extent of the agency’s prior consultation with State and local officials, a summary of the nature of their concerns and the agency’s position supporting the need to issue the regulation, and a statement of the extent to which the concerns of State and local officials have been met; and (3) makes available to the Director of the Office of Management and Budget any written communications submitted to the agency by State and local officials.’’ Because this regulation would address preemption of certain State laws, VA conducted prior consultation with State officials in compliance with Executive Order 13132. VA sent a letter to the National Council of State Boards of Nursing to state VA’s intent to allow full practice authority to VA APRNs and for the National Council of State Boards of Nursing to notify every State Board of Nursing of VA’s intent and to seek feedback from such Boards of Nursing. In addition, VA solicited comments and input from State Boards of Nursing, through their representative national organization, the National Council of State Boards of Nursing (NCSBN). In response to its request for comments, VA received correspondence from the Executive Director and other relevant staff members within NCSBN, which agreed with VA’s position that this rulemaking properly identifies the areas in VA regulations that preempt State laws and regulations. VA received no other comments from the NCSBN on this rulemaking. In response to VA’s outreach to NCSBN, VA received numerous calls and correspondence from State and local officials in support of this proposed rule. Such State and local officials included State Senators from Georgia and Illinois, State Representatives from Florida, Ohio, E:\FR\FM\25MYP1.SGM 25MYP1 Lhorne on DSK30JT082PROD with PROPOSALS Federal Register / Vol. 81, No. 101 / Wednesday, May 25, 2016 / Proposed Rules Vermont, North Carolina, Georgia, and Illinois, County Commissioners from Nevada, Ohio, and North Carolina, and the State Comptroller and Secretary of State from Illinois, to name a few. VA additionally engaged other relevant external groups on the proposed changes in this rulemaking, including the American Association of Nurse Anesthetists, American Association of Nurse Practitioners, American College of Surgeons, American Academy of Family Practice Physicians, American Society of Anesthesiologists, American Medical Association, Association of American Medical Colleges, The Joint Commission-Office of Accreditation and Certification, American Association of Retired Persons, American Legion, Blinded Veterans Association, Vietnam Veterans of America, American Women Veterans, Disabled American Veterans, Paralyzed Veterans of America, Veterans of Foreign Wars. VA also engaged the Senate and House Veterans Affairs Committees and the Senate and House Armed Services Committees. Many external stakeholders expressed general support for VA’s positions taken in this proposed rule, particularly with respect to full practice authority of APRNs in primary health care. However, we also received comments opposing full practice authority for CRNAs when providing anesthetics. To aid in VA’s full consideration to this issue, VA encourages any comments regarding the proposed full practice authority. In this way, VA will be providing all affected State and local officials notice and an opportunity for appropriate participation in the proceedings. VA’s promulgation of this regulation complies with the requirements of Executive Order 13132 by (1) in the absence of explicit preemption in the authorizing statute, identifying where the exercise of State authority conflicts with the exercise of Federal authority under Federal statute; (2) limiting the preemption to only those areas where we find existence a conflict; (3) restricting the regulatory preemption to the minimum level necessary to achieve the objectives of the statute; (4) consulting with the State Boards of Nursing and other relevant external parties as indicated above; and (5) providing opportunity for comment through this rulemaking. Effect of Rulemaking Title 38 of the Code of Federal Regulations, as proposed to be revised by this rulemaking, will represent VA’s implementation of its legal authority on this subject. Other than future VerDate Sep<11>2014 14:52 May 24, 2016 Jkt 238001 amendments to this regulation or governing statutes, no contrary guidance or procedures would be authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance will be superseded by this rulemaking. Paperwork Reduction Act This proposed rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3521). Regulatory Flexibility Act The Secretary hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601–612. This proposed rule would directly affect only individuals and would not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this amendment would be exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604. Executive Orders 12866 and 13563 Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a ‘‘significant regulatory action,’’ which requires review by OMB, as ‘‘any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 33159 President’s priorities, or the principles set forth in this Executive Order.’’ The economic, interagency, budgetary, legal, and policy implications of this proposed rule have been examined, and it has been determined to be a significant regulatory action under Executive Order 12866. VA’s impact analysis can be found as a supporting document at http:// 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 http:// www.va.gov/orpm/, by following the link for ‘‘VA Regulations Published From FY 2004 Through Fiscal Year to Date.’’ Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This proposed rule would have no such effect on State, local, and tribal governments, or on the private sector. Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are: 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 64.013, Veterans Prosthetic Appliances; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care; and 64.024, VA Homeless Providers Grant and Per Diem Program. Signing Authority The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Nabors II, Chief of Staff, Department of Veterans Affairs, approved this document on January 6, 2016. E:\FR\FM\25MYP1.SGM 25MYP1 33160 Federal Register / Vol. 81, No. 101 / Wednesday, May 25, 2016 / Proposed Rules clinical oversight of a physician, regardless of State or local law Administrative practice and restrictions, when that APRN is working procedure, Alcohol abuse, Alcoholism, within the scope of their VA Claims, Day care, Dental health, Drug employment. abuse, Foreign relations, Government (c) Granting of full practice authority. contracts, Grant programs—health, VA may grant full practice authority to Grant programs—veterans, Health care, an APRN subject to the following: Health facilities, Health professions, (1) Verification that the APRN meets Health records, Homeless, Medical and the requirements established in dental schools, Medical devices, paragraph (a) of this section; and Medical research, Mental health (2) Determination that the APRN has programs, Nursing homes, Philippines, demonstrated the knowledge and skills Reporting and recordkeeping necessary to provide the services requirements, Scholarships and described in paragraph (d) of this fellowships, Travel and transportation section without the clinical oversight of expenses, Veterans. a physician, and is thus qualified to be Dated: May 20, 2016. privileged for such scope of practice. (d) Services provided by an APRN Michael Shores, with full practice authority. (1) Subject Acting Director, Office of Regulation Policy to the limitations established in & Management, Office of Secretary, Department of Veterans Affairs. paragraph (d)(2) of this section, the full practice authority for each of the four For the reasons set forth in the preamble, we propose to amend 38 CFR APRN roles includes, but is not limited to, providing the following services: part 17 as follows: (i) A CNP has full practice authority PART 17—MEDICAL to: (A) Take comprehensive histories, ■ 1. The authority citation for part 17 provide physical examinations and continues to read as follows: other health assessment and screening Authority: 38 U.S.C. 501, and as noted in activities, diagnose, treat, and manage specific sections. patients with acute and chronic illnesses and diseases; ■ 2. Amend part 17 by adding an (B) Order, perform, supervise, and undesignated center heading and interpret laboratory and imaging § 17.415 immediately after § 17.410 to studies; read as follows: (C) Prescribe medication and durable Nursing Services medical equipment; (D) Make appropriate referrals for § 17.415 Full practice authority for patients and families, and request advanced practice registered nurses. consultations; (a) Advanced practice registered nurse (E) Aid in health promotion, disease (APRN). For purposes of this section, an prevention, health education, and advanced practice registered nurse counseling as well as the diagnosis and (APRN) is an individual who: management of acute and chronic (1) Has completed a nationallydiseases. accredited, graduate-level educational (ii) A CRNA has full practice program that prepares them for one of authority to: the four APRN roles of Certified Nurse (A) Plan and initiate anesthetic Practitioner (CNP), Certified Registered techniques (general, regional, local) and Nurse Anesthetist (CRNA), Clinical sedation; Nurse Specialist (CNS), or Certified (B) Provide post-anesthesia evaluation Nurse-Midwife (CNM); and discharge; (2) Has passed a national certification (C) Order and evaluate diagnostic examination that measures knowledge tests; in one of the APRN roles described in (D) Request consultations; paragraph (a)(1) of this section; (D) Perform point-of-care testing; and (3) Has obtained a license from a State (E) Respond to emergency situations licensing board in one of four for airway management. recognized APRN roles described in (iii) A CNS has full practice authority paragraph (a)(1) of this section; and to provide diagnosis and treatment of (4) Maintains certification and health or illness states, disease licensure as required by paragraphs management, health promotion, and (a)(2) and (3) of this section. prevention of illness and risk behaviors (b) Full practice authority. For among individuals, families, groups, purposes of this section, full practice and communities within their scope of authority means the authority of an practice. APRN to provide services described in (iv) A CNM has full practice authority paragraph (d) of this section without the to provide a range of primary health Lhorne on DSK30JT082PROD with PROPOSALS List of Subjects in 38 CFR Part 17 VerDate Sep<11>2014 14:52 May 24, 2016 Jkt 238001 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 care services to women, including gynecologic care, family planning services, preconception care (care that women veterans receive before becoming pregnant, including reducing the risk of birth defects and other problems such as the treatment of diabetes and high blood pressure), prenatal and postpartum care, childbirth, and care of a newborn, and treating the partner of their female patients for sexually transmitted disease and reproductive health, if the partner is also enrolled in the VA healthcare system or is not required to enroll. (2) The full practice authority of an APRN is subject to the limitations imposed by the Controlled Substances Act, 21 U.S.C. 801 et seq., and that APRN’s State licensure on the authority to prescribe, or administer controlled substances, as well as any other limitations on the provision of VA care set forth in applicable Federal law and policy. (e) Preemption of State and local law. To achieve important Federal interests, including but not limited to the ability to provide the same comprehensive care to veterans in all States under 38 U.S.C. 7301, this section preempts conflicting State and local laws relating to the practice of APRNs when such APRNs are working within the scope of their VA employment. Any State or local law, or regulation pursuant to such law, is without any force or effect on, and State or local governments have no legal authority to enforce them in relation to this section or decisions made by VA under this section. (Authority: 38 U.S.C. 7301, 7304, 7402, and 7403) [FR Doc. 2016–12338 Filed 5–24–16; 8:45 am] BILLING CODE 8320–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R01–OAR–2014–0364; A–1–FRL– 9936–62–Region 1] Air Plan Approval; Connecticut; Sulfur Content of Fuel Oil Burned in Stationary Sources Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Connecticut on April 22, 2014, with supplemental submittals on June 18, SUMMARY: E:\FR\FM\25MYP1.SGM 25MYP1

Agencies

[Federal Register Volume 81, Number 101 (Wednesday, May 25, 2016)]
[Proposed Rules]
[Pages 33155-33160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12338]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AP44


Advanced Practice Registered Nurses

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) is proposing to amend 
its medical regulations to permit full practice authority of all VA 
advanced practice registered nurses (APRNs) when they are acting within 
the scope of their VA employment. This rulemaking would increase 
veterans' access to VA health care by expanding the pool of qualified 
health care professionals who are authorized to provide primary health 
care and other related health care services to the full extent of their 
education, training, and certification, without the clinical 
supervision of physicians. This rule would permit VA to use its health 
care resources more effectively and in a manner that is consistent with 
the role of APRNs in the non-VA health care sector, while maintaining 
the patient-centered, safe, high-quality health care that veterans 
receive from VA. The proposed rulemaking would establish additional 
professional qualifications an individual must possess to be appointed 
as an APRN within VA. The proposed rulemaking would subdivide APRN's 
into four separate categories that include certified nurse 
practitioner, certified registered nurse anesthetist, clinical nurse 
specialist, and certified nurse-midwife. The proposed rulemaking would 
also provide the criteria under which VA may grant full practice 
authority to an APRN, and define the scope of full practice authority 
for each category of APRN. VA intends that the services to be provided 
by an APRN in one of the four APRN roles would be consistent with the 
nursing profession's standards of practice for such roles.

DATES: Comments must be received by VA on or before July 25, 2016.

ADDRESSES: Written comments may be submitted: Through http://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 http://www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Penny Kaye Jensen, Liaison for 
National APRN Practice, 810 Vermont Ave. NW., Washington, DC 20420; 
(202) 461-6700. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: Section 7301 of title 38 United States Code 
(U.S.C.) establishes the Veterans Health Administration (VHA) within 
VA, and establishes that its primary function is to ``provide a 
complete medical and hospital service for the medical care and 
treatment of veterans, as provided in this title and in regulations 
prescribed by the Secretary pursuant to this title.'' 38 U.S.C. 
7301(b). In carrying out this function, VHA has an obligation to ensure 
that patient care is appropriate and safe and its health care 
practitioners meet or exceed generally-accepted professional standards 
for patient care. The Secretary is responsible for the proper execution 
and administration of all laws administered by the Department and for 
the control, direction, and management of the Department, to include 
agency personnel and management matters. See 38 U.S.C. 303. To enable 
the Secretary to direct, control and manage VA, Congress authorized the 
Secretary ``to prescribe all rules and regulations which are necessary 
or appropriate to carry out the laws administered by the Department and 
are consistent with those laws.'' 38 U.S.C. 501(a). The Under Secretary 
for Health is directly responsible to the Secretary for the operation 
of VHA (38 U.S.C. 305(b)). Unless specifically otherwise provided, the 
Under Secretary for Health, as the head of VHA, is authorized to 
``prescribe all regulations necessary to the administration of the 
Veterans Health Administration,'' subject to the approval of the 
Secretary. 38 U.S.C. 7304. To allow VA to carry out its medical care 
mission, Congress also established a comprehensive personnel system for 
certain medical employees in VHA, independent of the civil service 
rules. See Chapters 73 and 74 of title 38, U.S.C. The Secretary was 
granted express statutory authority to establish the qualifications for 
VA's healthcare practitioners, determine the hours and conditions of 
employment, take disciplinary action against employees, and otherwise 
regulate the professional activities of those individuals. 38 U.S.C. 
7401-7464. As an integrated Federal health care system with the 
responsibility to provide comprehensive care under 38 U.S.C. 7301, it 
is essential that VHA wisely manage its resources and fully utilize the 
skills of its health care providers to the full extent of their 
education, training, and certification. By permitting APRNs throughout 
the VHA system a way to achieve full practice authority in order to 
provide advanced nursing services to the full extent of their 
professional competence, VHA would further its statutory mandate to 
provide quality health care to our nation's veterans. This proposed 
regulatory change to nursing policy would permit APRNs to practice to 
the full extent of their education, training and certification, without 
the clinical supervision or mandatory collaboration of physicians. 
Standardization of APRN full practice authority, without regard for 
individual State practice regulations, would help to ensure a 
consistent continuum of health care across VHA by decreasing the 
variability in APRN practice that currently exists across VHA as a 
result of disparate State practice regulations. As of March 7, 2016 
CRNAs have full practice authority in 17 states, while CNPs have full 
practice authority in almost 50% of the nation, which includes 21 
states and the District of Columbia.
    It would also aid in fully maximizing VHA APRN staff capabilities, 
which would increase VA's capacity to provide timely, efficient, and 
effective primary care services, as well as other services. This would 
increase veteran access to needed VA health care, particularly in 
medically-underserved areas, as well as decrease the amount of time 
veterans spend waiting for patient appointments. In addition, 
standardizing APRN practice authority would enable veterans, their 
families, and caregivers to understand more readily the health care 
services that VA APRNs are authorized to provide. This preemptive rule 
would increase access to care and reduce the wait times for VA 
appointments utilizing the current workforce already in place.

[[Page 33156]]

    To ensure that VA would have available highly qualified medical 
personnel, Congress mandated the basic qualifications for certain 
health care positions, including registered nurses. Sections 7401 
through 7464 of title 38, U.S.C., grant VA authority to regulate the 
professional activities of such personnel. To be eligible for 
appointment as a VA employee in a health care position covered by 
section 7402(b) (other than Director), of title 38, U.S.C., a person 
must, among other requirements, be licensed, registered or certified to 
practice their profession in a State. The standards prescribed in 
section 7402(b) establish only the basic qualifications necessary 
``[t]o be eligible for appointment'' and do not limit the Secretary or 
Under Secretary for Health from establishing other qualifications for 
appointment, or additional rules governing such personnel. In 
particular, 38 U.S.C. 7403(a)(1) provides that appointments under 
Chapter 74 ``may be made only after qualifications have been 
established in accordance with regulations prescribed by the Secretary, 
without regard to civil-service requirements.'' In addition, 38 U.S.C. 
7421(a) directs that, ``[n]otwithstanding any law, Executive order, or 
regulation, the Secretary shall prescribe by regulation the hours and 
conditions of employment and leaves of absence of employees appointed 
under any provision of [chapter 74] [in the specifically numerated 
positions] in the Veterans Health Administration'' (including 
registered nurses). As the head of VHA, the Under Secretary for Health 
has the duty to ``prescribe all regulations necessary to the 
administration of the Veterans Health Administration,'' subject to 
approval by the Secretary. 38 U.S.C. 7304; see also 38 U.S.C. 501. 
Pursuant to this authority, the Under Secretary for Health is 
authorized to establish the qualifications and clinical practice 
standards of VHA's nursing personnel and to otherwise regulate their 
professional conduct.
    To continue to provide high quality health care to veterans, VA is 
proposing to amend its regulations to allow APRNs to practice to the 
full extent of their education, training, and certification, regardless 
of individual State restrictions that limit such full practice 
authority, except for applicable State restrictions on the authority to 
prescribe and administer controlled substances, when such APRNs are 
acting within the scope of their VA employment. The proposed rule would 
use the term ``full practice authority'' to refer to the APRN's 
authority to provide advanced nursing services without the clinical 
oversight of a physician when that APRN is working within the scope of 
their VA employment. Such full practice authority would be granted by 
VA upon demonstrating that the established regulatory criteria are met. 
In addition, full practice authority would be granted appropriate to 
the clinical service setting.
    This proposed rule is consistent with the recommendation of the 
Institute of Medicine (IOM) of the National Academy of Sciences to 
remove scope-of-practice barriers. Specifically, the 2010 IOM report, 
``The Future of Nursing: Leading Change Advancing Health,'' (IOM 
Report) available at http://iom.nationalacademies.org/Reports/2010/The-Future-of-Nursing-Leading-Change-Advancing-Health.aspx, recommended 
that ``[a]dvanced practice registered nurses (APRNs) should be able to 
practice to the full extent of their education and training.'' Id. at 
9. More generally, the report stated that ``[r]estrictions on scope of 
practice and professional tensions have undermined the nursing 
profession's ability to provide and improve both general and advanced 
care'' and asserted that ``[p]roducing a health care system that 
delivers the right care--quality care that is patient centered, 
accessible, evidence based, and sustainable--at the right time will 
require transforming the work environment, scope of practice, 
education, and numbers and composition of America's nurses.'' Id. at 
26. In addition, the proposed rule is consistent with the National 
Council of State Boards of Nursing (NCSBN) Consensus Model, as 
discussed in more detail later in this rulemaking. Significantly, many 
States already permit full practice authority of APRNs or are in the 
process of doing so. Under the proposed rulemaking, APRNs would not be 
authorized to replace or act as physicians or to provide any health 
care services that are beyond their clinical education, training, and 
national certification. The proposed rule would limit an APRN's full 
practice authority to practice within the scope of their VA employment, 
and any APRN practice outside of VA employment would remain subject to 
applicable State laws, in the same manner as any other licensed VA 
practitioner in their private practice.
    In this rulemaking, VA is proposing to exercise Federal preemption 
of State nursing licensure laws to the extent such State laws conflict 
with the full practice authority granted to VA APRNs while acting 
within the scope of their VA employment. Preemption would be the 
minimum necessary action for VA to allow APRNs full practice authority. 
It would be impractical for VA to lobby to each State that does not 
allow full practice authority to APRNs to change their laws regarding 
full practice authority. This process would be costly and time 
consuming for VA and would not guarantee the desired result of full 
practice authority to all APRNs.

Section-by-Section Analysis of the Proposed Rule

17.415 Full Practice Authority for Advanced Practice Registered Nurses

    The general qualifications for a person to be appointed as a VA 
nurse are found in 38 U.S.C. 7402(b)(3), which requires that a person 
must have successfully completed a full course of nursing in a 
recognized school of nursing, as well as be registered as a graduate 
nurse in a State. VA interprets ``a recognized school of nursing'' to 
mean a school of professional nursing approved by the appropriate State 
agency and accredited by the National League for Nursing Accrediting 
Commission (NLNAC) or the Commission on Collegiate Nursing Education 
(CCNE); the completion of coursework equivalent to a nursing degree in 
a MSN Bridge Program that qualifies for professional nursing 
registration; or a foreign school of professional nursing that enables 
the graduate to obtain current, full, active and unrestricted 
registration. VA Handbook 5005/27, Part II, Appendix G6, paragraph 2, 
Section B.a(2). VA interprets ``registered as a graduate nurse in a 
state'' to mean a current, full, active and unrestricted licensure, 
registration or certification as a graduate professional nurse in a 
State, Territory, or Commonwealth (i.e., Puerto Rico) of the U.S. or in 
the District of Columbia (hereinafter ``licensure''). Id. Pursuant to 
the authorities in 38 U.S.C. 7401 through 7464 and VA's rulemaking 
authorities at 38 U.S.C. 501 and 7304, VA is proposing a new Sec.  
17.415(a), which would define additional qualifications a registered 
nurse must possess to be appointed to one of four (4) APRN roles, i.e., 
Certified Nurse practitioner (CNP), Certified Registered Nurse 
Anesthetist (CRNA), Clinical Nurse Specialist (CNS), or Certified 
Nurse-Midwife (CNM). The proposed rule would require an advanced 
practice registered nurse to have successfully completed a nationally-
accredited, graduate-level educational program that prepares the 
advanced practice registered nurse in one of the four APRN roles; and 
to possess, and maintain, national certification and State licensure in 
that APRN role. These additional

[[Page 33157]]

qualifications are derived from criteria set forth in the IOM Report, 
and the National Council of State Boards of Nursing Consensus Model for 
APRN Regulation: Licensure, Accreditation, Certification & Education) 
Regulation, July 2008 (the APRN Consensus Model), which VA finds to be 
the criteria most widely accepted by State boards of nursing and the 
nursing community as necessary to practice as an APRN. Under the 
proposed rule, APRNs who meet these additional qualifications may be 
granted full practice authority within VA in one of the four recognized 
APRN roles.
    Proposed Sec.  17.415(a)(1) would require an APRN to have 
successfully completed an accredited graduate-level educational program 
in one of the four distinct APRN roles. The Consensus Model defines 
these roles as CNP, CRNA, CNS, and CNM. These APRN roles are widely 
known and accepted by State boards of nursing and the nursing 
community. VA currently does not employ CNMs; however, the proposed 
rule includes CNMs in the event that VA has the need to hire CNMs in 
the future.
    Proposed Sec.  17.415(a)(2) would require an APRN to have passed a 
national certification examination that measures the APRN's knowledge, 
skills and experience demonstrated by the achievement of standards 
identified by the profession in one of the four APRN roles established 
in proposed Sec.  17.415(a)(1). Public and private sector health care 
employers, State boards of nursing, and the nursing community rely on 
national certification through an examination process as the standard, 
which conveys adequate APRN knowledge, and VA's regulation would adopt 
the same standard.
    Proposed Sec.  17.415(a)(3) would require an APRN to possess a 
license from a State licensing board in one of the four recognized APRN 
roles. Proposed Sec.  17.415(a)(4) would require an APRN to maintain 
both the national certification and licensure required in proposed 
paragraphs (a)(2) and (3) of Sec.  17.415.
    In total, proposed paragraphs (a)(1) through (4) of Sec.  17.415 
would establish qualifications for employment within VA as a CNP, CRNA, 
CNS and CNM. These qualifications would ensure that VA APRNs possess 
and maintain the education, knowledge, national certification and State 
licensure necessary for VA employment in one of the four recognized 
APRN roles. APRNs who meet these qualifications would be granted full 
practice authority within VA in one of the four recognized APRN roles.
    Proposed Sec.  17.415(b) would define ``full practice authority'' 
to mean that an APRN working within the scope of VA employment would be 
authorized to provide the services described in proposed Sec.  
17.415(d), without the clinical oversight of a physician, regardless of 
State or local law restrictions on that authority. Further, any APRN 
practice established outside VA employment would be subject to 
applicable State law, in the same manner as private practice by any 
other licensed VA provider.
    Proposed Sec.  17.415(c) would establish the criteria by which VA 
may grant full practice authority to an APRN. Proposed paragraph 
(c)(1), would require a VA medical facility to verify that the APRN 
meets the requirements established in proposed Sec.  17.415(a). 
Proposed paragraph (c)(2) would require VA to confirm that the APRN has 
demonstrated the knowledge and skills necessary to provide the services 
described in proposed Sec.  17.415(d) without the clinical oversight of 
a physician, and is thus qualified to be privileged for such scope of 
practice. Proposed Sec.  17.415(c)(1) and (2) together would clarify 
that the VA processes for credentialing and privileging of licensed 
independent health care providers would apply to VA APRNs with full 
practice authority. VA anticipates that the granting of full-practice 
authority under proposed Sec.  17.415(c) would be implemented through 
formal VHA guidance issuances.
    Proposed Sec.  17.415(d)(1) would describe the role-specific 
services that a VA APRN would be authorized to perform under their full 
practice authority. This authority would be without regard to state 
licensure restrictions, except as provided in proposed paragraph 
(d)(2), which would defer to State licensure restrictions on a VA 
APRN's authority to prescribe, or administer controlled substances. We 
emphasize that full practice authority for an APRN in this rulemaking 
would apply only to services provided by an APRN when working within 
the scope of their VA employment, as required by proposed Sec.  
17.415(b). Additionally, all full practice authority of APRNs in 
proposed Sec.  17.415(d)(1) would be under approved privileges by, and 
within the available resources of, a VA medical facility, as required 
by proposed Sec.  17.415(c). VA intends that the services to be 
provided by an APRN in one of the four APRN roles would be consistent 
with the nursing profession's standards of practice for such roles.
    In proposed Sec.  17.415(d)(1)(i), a CNP would have full practice 
authority to provide the following services: Comprehensive histories, 
physical examinations and other health assessment and screening 
activities; diagnose, treat, and manage patients with acute and chronic 
illnesses and diseases; order, perform, supervise, and interpret 
laboratory and imaging studies; prescribe medication and durable 
medical equipment and; make appropriate referrals for patients and 
families; and aid in health promotion, disease prevention, health 
education, and counseling as well as the diagnosis and management of 
acute and chronic diseases.
    In proposed Sec.  17.415(d)(1)(ii), a CRNA would have full practice 
authority to provide a patient's anesthesia care and anesthesia related 
care, to include planning and initiating anesthetic techniques 
(general, regional, local) and sedation, providing post-anesthesia 
evaluation and discharge; ordering and evaluating diagnostic tests; 
requesting consultations; performing point-of-care testing; and 
responding to emergency situations for airway management.
    In proposed Sec.  17.415(d)(1)(iii), a CNS would have full practice 
authority to provide diagnosis and treatment of health or illness 
states, disease management, health promotion, and prevention of illness 
and risk behaviors among individuals, families, groups, and communities 
within their scope of practice.
    Lastly, in proposed Sec.  17.415(d)(1)(iv), a CNM would have full 
practice authority to provide a full range of primary health care 
services to women veterans, including gynecologic care, family planning 
service, preconception care (care that women veterans receive before 
becoming pregnant, including reducing the risk of birth defects and 
other problems such as the treatment of diabetes and high blood 
pressure), prenatal and postpartum care, childbirth, and care of a 
newborn. We note that the pregnancy and delivery services described 
above, as well as the newborn care services, would be subject to the 
limitations established in 38 CFR 17.38(a)(1)(xiii) and (xiv), 
respectively. We also note that authorized CNM services would include 
treating the partner of the female patient for sexually transmitted 
infection and reproductive health, if the partner is enrolled in the VA 
healthcare system or not required to enroll to receive VA services. We 
would include the services of a CNM in this rulemaking in anticipation 
that VA would hire CNMs at a future date to improve access to health 
care for the increasing number of female veterans.
    Proposed Sec.  17.415(d)(2) would expressly limit full practice 
authority.

[[Page 33158]]

Congress has specifically required reliance on a specific State law 
under the Controlled Substance Act (CSA). Specifically, proposed Sec.  
17.415(a)(2) would provide that full practice authority within VA is 
subject to State licensure law with regard to the authority of an APRN 
to prescribe, or administer controlled substances, and to any other 
limitations on the provision of VA care set forth in applicable Federal 
law and policy. Regarding the full practice authority limitations for 
controlled substances, the CSA, 21 U.S.C. 801 et seq., and implementing 
regulations in 21 CFR part 1300, make State licensure authority to 
prescribe, or administer controlled substances a prerequisite for 
authority under the CSA to prescribe, or administer controlled 
substances. See 21 U.S.C. 802(21) (providing that a practitioner must 
be ``licensed, registered, or otherwise permitted, by the United States 
or the jurisdiction in which he practices or does research, to 
distribute, conduct research with respect to, administer, or use in 
teaching or chemical analysis, a controlled substance in the course of 
professional practice or research.''); See also 21 CFR 1306.03(a) 
(stating that a prescription for a controlled substance may be issued 
only by an individual practitioner who is: (1) Authorized to prescribe 
controlled substances by the jurisdiction in which he is licensed to 
practice his profession and (2) either registered or exempted from 
registration pursuant to Sec. Sec.  1301.22(c) and 1301.23.). Proposed 
Sec.  17.415(d)(2) also would make the full practice authority of an 
APRN subject to any other limitations on the provision of VA care set 
forth in Federal law or policy.
    Proposed Sec.  17.415(e) would expressly state the intended 
preemptive effect of proposed Sec.  17.415, to ensure it is clear that 
conflicting State and local laws related to the practice of APRNs would 
have no force or effect when such APRNs are working within the scope of 
their VA employment. In circumstances where there is a conflict between 
Federal and State Law, Federal law prevails in accordance with Article 
VI, clause 2, of the U.S. Constitution (Supremacy Clause). It is a 
well-established principle of constitutional law that Federal law is 
supreme, and States may not regulate or control the lawful actions of 
the Federal Government, absent Congressional consent. Therefore, where 
there is conflict between State law and Federal law with regard to full 
practice authority of APRNs working within the scope of their federal 
VA employment, this regulation would control. Accordingly, State 
disciplinary actions that would penalize, or otherwise interfere with, 
an APRN's full practice authority in the performance of their official 
VA duties, would likewise be effectively preempted. However, where 
there is no conflict between this regulation and State law, the State 
would retain authority to impose State regulations on its APRN 
licensees and take disciplinary action for any violations. We emphasize 
that this preemptive effect would only pertain to APRNs when they are 
acting within the scope of their federal VA employment; this rule would 
not have any effect on individual State efforts to either permit or 
restrict full practice authority for APRNs who are not working within a 
VA scope of employment.
    The Indian Health Service already grants full practice authority to 
APRNs. See Part 4, Chapter 3, Section 11, ``Advanced Practice Nurses,'' 
Indian Health Manual. In the Military Health System, the Services 
employ APRNs, which includes Nurse Midwives, Nurse Practitioners, and 
Nurse Anesthetists, in independent practice without oversight from 
physicians. They are privileged in their roles as APRNs and can adjust 
their scope practice (level of care) through privileging as granted by 
a committee of physicians and the military treatment facility 
commander. Nurse Practitioners specifically have an assigned group of 
patients for which they are responsible. Therefore, we do not 
anticipate that the proposed changes in this rulemaking would be 
completely novel or unexpected to the general public or other Federal 
entities that provide health care services to beneficiaries.

Executive Order 13132, Federalism

    Section 4 of Executive Order 13132 (titled ``Federalism'') requires 
an agency that is publishing a regulation that preempts State law to 
follow certain procedures. Section 4(b) of the Executive Order requires 
agencies to ``construe any authorization in the statute for the 
issuance of regulations as authorizing preemption of State law by 
rulemaking only when the exercise of State authority directly conflicts 
with the exercise of Federal authority under the Federal statute or 
there is clear evidence to conclude that the Congress intended the 
agency to have the authority to preempt State law.'' Section 4(d) of 
the Executive Order requires that when an agency proposes to act 
through rulemaking to preempt State law, ``the agency shall consult, to 
the extent practicable, with appropriate State and local officials in 
an effort to avoid such a conflict.'' Section 4(e) of the Executive 
Order requires that when an agency proposes to act through rulemaking 
to preempt State law, ``the agency shall provide all affected State and 
local officials notice and an opportunity for appropriate participation 
in the proceedings.''
    Section 6(c) of Executive Order 13132 states that ``no agency shall 
promulgate any regulation that has federalism implications and that 
preempts State law, unless the agency, prior to the formal promulgation 
of the regulation, (1) consulted with State and local officials early 
in the process of developing the proposed regulation; (2) in a 
separately identified portion of the preamble to the regulation as it 
is to be issued in the Federal Register, provides to the Director of 
the Office of Management and Budget a federalism summary impact 
statement, which consists of a description of the extent of the 
agency's prior consultation with State and local officials, a summary 
of the nature of their concerns and the agency's position supporting 
the need to issue the regulation, and a statement of the extent to 
which the concerns of State and local officials have been met; and (3) 
makes available to the Director of the Office of Management and Budget 
any written communications submitted to the agency by State and local 
officials.''
    Because this regulation would address preemption of certain State 
laws, VA conducted prior consultation with State officials in 
compliance with Executive Order 13132. VA sent a letter to the National 
Council of State Boards of Nursing to state VA's intent to allow full 
practice authority to VA APRNs and for the National Council of State 
Boards of Nursing to notify every State Board of Nursing of VA's intent 
and to seek feedback from such Boards of Nursing.
    In addition, VA solicited comments and input from State Boards of 
Nursing, through their representative national organization, the 
National Council of State Boards of Nursing (NCSBN). In response to its 
request for comments, VA received correspondence from the Executive 
Director and other relevant staff members within NCSBN, which agreed 
with VA's position that this rulemaking properly identifies the areas 
in VA regulations that preempt State laws and regulations. VA received 
no other comments from the NCSBN on this rulemaking. In response to 
VA's outreach to NCSBN, VA received numerous calls and correspondence 
from State and local officials in support of this proposed rule. Such 
State and local officials included State Senators from Georgia and 
Illinois, State Representatives from Florida, Ohio,

[[Page 33159]]

Vermont, North Carolina, Georgia, and Illinois, County Commissioners 
from Nevada, Ohio, and North Carolina, and the State Comptroller and 
Secretary of State from Illinois, to name a few.
    VA additionally engaged other relevant external groups on the 
proposed changes in this rulemaking, including the American Association 
of Nurse Anesthetists, American Association of Nurse Practitioners, 
American College of Surgeons, American Academy of Family Practice 
Physicians, American Society of Anesthesiologists, American Medical 
Association, Association of American Medical Colleges, The Joint 
Commission-Office of Accreditation and Certification, American 
Association of Retired Persons, American Legion, Blinded Veterans 
Association, Vietnam Veterans of America, American Women Veterans, 
Disabled American Veterans, Paralyzed Veterans of America, Veterans of 
Foreign Wars. VA also engaged the Senate and House Veterans Affairs 
Committees and the Senate and House Armed Services Committees.
    Many external stakeholders expressed general support for VA's 
positions taken in this proposed rule, particularly with respect to 
full practice authority of APRNs in primary health care. However, we 
also received comments opposing full practice authority for CRNAs when 
providing anesthetics. To aid in VA's full consideration to this issue, 
VA encourages any comments regarding the proposed full practice 
authority. In this way, VA will be providing all affected State and 
local officials notice and an opportunity for appropriate participation 
in the proceedings.
    VA's promulgation of this regulation complies with the requirements 
of Executive Order 13132 by (1) in the absence of explicit preemption 
in the authorizing statute, identifying where the exercise of State 
authority conflicts with the exercise of Federal authority under 
Federal statute; (2) limiting the preemption to only those areas where 
we find existence a conflict; (3) restricting the regulatory preemption 
to the minimum level necessary to achieve the objectives of the 
statute; (4) consulting with the State Boards of Nursing and other 
relevant external parties as indicated above; and (5) providing 
opportunity for comment through this rulemaking.

Effect of Rulemaking

    Title 38 of the Code of Federal Regulations, as proposed to be 
revised by this rulemaking, will represent VA's implementation of its 
legal authority on this subject. Other than future amendments to this 
regulation or governing statutes, no contrary guidance or procedures 
would be authorized. All existing or subsequent VA guidance must be 
read to conform with this rulemaking if possible or, if not possible, 
such guidance will be superseded by this rulemaking.

Paperwork Reduction Act

    This proposed rule contains no provisions constituting a collection 
of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3521).

Regulatory Flexibility Act

    The Secretary hereby certifies that this proposed rule would not 
have a significant economic impact on a substantial number of small 
entities as they are defined in the Regulatory Flexibility Act, 5 
U.S.C. 601-612. This proposed rule would directly affect only 
individuals and would not directly affect small entities. Therefore, 
pursuant to 5 U.S.C. 605(b), this amendment would be exempt from the 
initial and final regulatory flexibility analysis requirements of 5 
U.S.C. 603 and 604.

Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility. 
Executive Order 12866 (Regulatory Planning and Review) defines a 
``significant regulatory action,'' which requires review by OMB, as 
``any regulatory action that is likely to result in a rule that may: 
(1) Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities; (2) Create a serious inconsistency or otherwise interfere 
with an action taken or planned by another agency; (3) Materially alter 
the budgetary impact of entitlements, grants, user fees, or loan 
programs or the rights and obligations of recipients thereof; or (4) 
Raise novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in this Executive 
Order.''
    The economic, interagency, budgetary, legal, and policy 
implications of this proposed rule have been examined, and it has been 
determined to be a significant regulatory action under Executive Order 
12866. VA's impact analysis can be found as a supporting document at 
http://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 
http://www.va.gov/orpm/, by following the link for ``VA Regulations 
Published From FY 2004 Through Fiscal Year to Date.''

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. This proposed rule would have no such 
effect on State, local, and tribal governments, or on the private 
sector.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are: 64.007, Blind 
Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, 
Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 
64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 
64.013, Veterans Prosthetic Appliances; 64.014, Veterans State 
Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.018, 
Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation 
Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care; 
and 64.024, VA Homeless Providers Grant and Per Diem Program.

Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this 
document and authorized the undersigned to sign and submit the document 
to the Office of the Federal Register for publication electronically as 
an official document of the Department of Veterans Affairs. Robert L. 
Nabors II, Chief of Staff, Department of Veterans Affairs, approved 
this document on January 6, 2016.

[[Page 33160]]

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Foreign relations, 
Government contracts, Grant programs--health, Grant programs--veterans, 
Health care, Health facilities, Health professions, Health records, 
Homeless, Medical and dental schools, Medical devices, Medical 
research, Mental health programs, Nursing homes, Philippines, Reporting 
and recordkeeping requirements, Scholarships and fellowships, Travel 
and transportation expenses, Veterans.

    Dated: May 20, 2016.
Michael Shores,
Acting Director, Office of Regulation Policy & Management, Office of 
Secretary, Department of Veterans Affairs.
    For the reasons set forth in the preamble, we propose to amend 38 
CFR part 17 as follows:

PART 17--MEDICAL

0
1. The authority citation for part 17 continues to read as follows:

    Authority:  38 U.S.C. 501, and as noted in specific sections.

0
2. Amend part 17 by adding an undesignated center heading and Sec.  
17.415 immediately after Sec.  17.410 to read as follows:

Nursing Services


Sec.  17.415  Full practice authority for advanced practice registered 
nurses.

    (a) Advanced practice registered nurse (APRN). For purposes of this 
section, an advanced practice registered nurse (APRN) is an individual 
who:
    (1) Has completed a nationally-accredited, graduate-level 
educational program that prepares them for one of the four APRN roles 
of Certified Nurse Practitioner (CNP), Certified Registered Nurse 
Anesthetist (CRNA), Clinical Nurse Specialist (CNS), or Certified 
Nurse-Midwife (CNM);
    (2) Has passed a national certification examination that measures 
knowledge in one of the APRN roles described in paragraph (a)(1) of 
this section;
    (3) Has obtained a license from a State licensing board in one of 
four recognized APRN roles described in paragraph (a)(1) of this 
section; and
    (4) Maintains certification and licensure as required by paragraphs 
(a)(2) and (3) of this section.
    (b) Full practice authority. For purposes of this section, full 
practice authority means the authority of an APRN to provide services 
described in paragraph (d) of this section without the clinical 
oversight of a physician, regardless of State or local law 
restrictions, when that APRN is working within the scope of their VA 
employment.
    (c) Granting of full practice authority. VA may grant full practice 
authority to an APRN subject to the following:
    (1) Verification that the APRN meets the requirements established 
in paragraph (a) of this section; and
    (2) Determination that the APRN has demonstrated the knowledge and 
skills necessary to provide the services described in paragraph (d) of 
this section without the clinical oversight of a physician, and is thus 
qualified to be privileged for such scope of practice.
    (d) Services provided by an APRN with full practice authority. (1) 
Subject to the limitations established in paragraph (d)(2) of this 
section, the full practice authority for each of the four APRN roles 
includes, but is not limited to, providing the following services:
    (i) A CNP has full practice authority to:
    (A) Take comprehensive histories, provide physical examinations and 
other health assessment and screening activities, diagnose, treat, and 
manage patients with acute and chronic illnesses and diseases;
    (B) Order, perform, supervise, and interpret laboratory and imaging 
studies;
    (C) Prescribe medication and durable medical equipment;
    (D) Make appropriate referrals for patients and families, and 
request consultations;
    (E) Aid in health promotion, disease prevention, health education, 
and counseling as well as the diagnosis and management of acute and 
chronic diseases.
    (ii) A CRNA has full practice authority to:
    (A) Plan and initiate anesthetic techniques (general, regional, 
local) and sedation;
    (B) Provide post-anesthesia evaluation and discharge;
    (C) Order and evaluate diagnostic tests;
    (D) Request consultations;
    (D) Perform point-of-care testing; and
    (E) Respond to emergency situations for airway management.
    (iii) A CNS has full practice authority to provide diagnosis and 
treatment of health or illness states, disease management, health 
promotion, and prevention of illness and risk behaviors among 
individuals, families, groups, and communities within their scope of 
practice.
    (iv) A CNM has full practice authority to provide a range of 
primary health care services to women, including gynecologic care, 
family planning services, preconception care (care that women veterans 
receive before becoming pregnant, including reducing the risk of birth 
defects and other problems such as the treatment of diabetes and high 
blood pressure), prenatal and postpartum care, childbirth, and care of 
a newborn, and treating the partner of their female patients for 
sexually transmitted disease and reproductive health, if the partner is 
also enrolled in the VA healthcare system or is not required to enroll.
    (2) The full practice authority of an APRN is subject to the 
limitations imposed by the Controlled Substances Act, 21 U.S.C. 801 et 
seq., and that APRN's State licensure on the authority to prescribe, or 
administer controlled substances, as well as any other limitations on 
the provision of VA care set forth in applicable Federal law and 
policy.
    (e) Preemption of State and local law. To achieve important Federal 
interests, including but not limited to the ability to provide the same 
comprehensive care to veterans in all States under 38 U.S.C. 7301, this 
section preempts conflicting State and local laws relating to the 
practice of APRNs when such APRNs are working within the scope of their 
VA employment. Any State or local law, or regulation pursuant to such 
law, is without any force or effect on, and State or local governments 
have no legal authority to enforce them in relation to this section or 
decisions made by VA under this section.

(Authority: 38 U.S.C. 7301, 7304, 7402, and 7403)


[FR Doc. 2016-12338 Filed 5-24-16; 8:45 am]
 BILLING CODE 8320-01-P