82_FR_45945 82 FR 45756 - Authority of Health Care Providers To Practice Telehealth

82 FR 45756 - Authority of Health Care Providers To Practice Telehealth

DEPARTMENT OF VETERANS AFFAIRS

Federal Register Volume 82, Issue 189 (October 2, 2017)

Page Range45756-45762
FR Document2017-20951

The Department of Veterans Affairs (VA) proposes to amend its medical regulations by standardizing the delivery of care by VA health care providers through telehealth. This rule would ensure that VA health care providers provide the same level of care to all beneficiaries, irrespective of the State or location in a State of the VA health care provider or the beneficiary. This proposed rule would achieve important Federal interests by increasing the availability of mental health, specialty, and general clinical care for all beneficiaries.

Federal Register, Volume 82 Issue 189 (Monday, October 2, 2017)
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Proposed Rules]
[Pages 45756-45762]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20951]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AQ06


Authority of Health Care Providers To Practice Telehealth

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) proposes to amend its 
medical regulations by standardizing the delivery of care by VA health 
care providers through telehealth. This rule would ensure that VA 
health care providers provide the same level of care to all 
beneficiaries, irrespective of the State or location in a State of the 
VA health care provider or the beneficiary. This proposed rule would 
achieve important Federal interests by increasing the availability of 
mental health, specialty, and general clinical care for all 
beneficiaries.

DATES: Comments must be received on or before November 1, 2017.

ADDRESSES: Written comments may be submitted through http://www.Regulations.gov by mail or hand-delivery to: Director, Regulation 
Policy and Management (00REG), Department of Veterans Affairs, 810 
Vermont Ave. NW., Room 1063B, Washington, DC 20420; or by fax to (202) 
273-9026. (This is not a toll-free telephone number.) Comments should 
indicate that they are submitted in response to ``RIN 2900-AQ06-
Authority of Health Care Providers to Practice Telehealth.'' Copies of 
comments received will be available for public inspection in the Office 
of Regulation Policy and Management, Room 1068, between the hours of 
8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays). 
Please call (202) 461-4902 for an appointment. (This is not a toll-free 
telephone 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: Kevin Galpin, MD, Executive Director 
Telehealth Services, Veterans Health Administration Office of Connected 
Care, 810 Vermont Avenue NW., Washington, DC 20420. (404) 771-8794. 
(This is not a toll-free number.) [email protected].

SUPPLEMENTARY INFORMATION: Section 7301 of title 38, United States Code 
(U.S.C.), establishes the general functions of 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 [of Veterans Affairs 
(Secretary)] pursuant to this title.'' 38 U.S.C. 7301(b). In carrying 
out this function, VHA must ensure that patient care is appropriate and 
safe and its health care providers meet or exceed generally accepted 
professional standards for patient care. In addition, because VA is a 
national health care provider, VHA must ensure that beneficiaries 
receive the same high level of care and access to care no matter where, 
in a State, a beneficiary or health care provider is located at the 
time the health care is provided.
    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, including agency 
personnel and management matters. See 38 U.S.C. 303. To this end, 
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

[[Page 45757]]

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 VA health care 
providers, independent of the civil service rules. See 38 U.S.C. 
chapters 73-74. Congress granted the Secretary express statutory 
authority to establish the qualifications for VA's health care 
providers, 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.
    To be eligible for appointment as a VA employee in a health care 
position covered by section 7402(b) of title 38, U.S.C. (other than a 
medical facility Director appointed under section 7402(b)(4)), a person 
must, among other requirements, be licensed, registered, or certified 
to practice his or her 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, section 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.'' Such authority is necessary to ensure 
the viability of our national health care system, which is designed to 
ensure the well-being of those who have ``borne the battle.''
    Just as it is critical to ensure there are qualified health care 
providers on-site at all VA medical facilities, VA must ensure that all 
beneficiaries, specifically including beneficiaries in remote, rural, 
or medically underserved areas, have the greatest possible access to 
mental health care, specialty care, and general clinical care. Thus, VA 
has developed a telehealth program as a modern, beneficiary- and 
family-centered health care delivery model that leverages information 
and telecommunication technologies to connect beneficiaries with health 
care providers, irrespective of the State or location within a State 
where the health care provider or the beneficiary is physically located 
at the time the health care is provided. Telehealth enhances VA's 
capacity to deliver essential and critical health care services to 
beneficiaries located in areas where health care providers may be 
unavailable or to beneficiaries who may be unable to travel to the 
nearest VA medical facility for care because of their medical 
conditions. Telehealth increases the accessibility of VA health care, 
bringing VA medical services to locations convenient for beneficiaries, 
including clinics in remote communities and beneficiaries' homes. By 
providing health care services by telehealth from one State to a 
beneficiary located in another State or within the same State, whether 
that beneficiary is located at a VA medical facility or in his or her 
own home, VA can use its limited health care resources most 
efficiently.
    Congress has required other Departments and agencies to conduct 
telehealth programs. See, e.g., Public Law 114-328, sec. 718(a)(1) 
(``the Secretary of Defense shall incorporate, throughout the direct 
care and purchased care components of the military health system, the 
use of telehealth services''). While VA does not have an analogous 
mandate, several statutes confirm that Congress intends for VA to 
operate a national health care system for beneficiaries including 
through telehealth. Congress has required the Secretary ``to carry out 
an initiative of teleconsultation for the provision of remote mental 
health and traumatic brain injury assessments in facilities of the 
Department that are not otherwise able to provide such assessments 
without contracting with third-party providers or reimbursing providers 
through a fee basis system.'' 38 U.S.C. 1709A(a)(1). Congress has 
authorized the Secretary to ``waive the imposition or collection of 
copayments for telehealth and telemedicine visits of veterans under the 
laws administered by the Secretary.'' 38 U.S.C. 1722B. And, as recently 
as December 2016, Congress required VA to initiate a pilot program to 
provide veterans a self-scheduling, online appointment system; this 
pilot program must ``support appointments for the provision of health 
care regardless of whether such care is provided in person or through 
telehealth services.'' Public Law 114-286, sec. 3(a)(2).
    As noted above, VA only has legal authority to hire health care 
providers who are licensed, registered, or certified in a State. To 
continue practicing in VA, providers must maintain those credentials in 
accordance with their health care specialty as stated in 38 U.S.C. 
7402(b).
    In an effort to furnish care to all beneficiaries and use its 
resources most efficiently, VA needs to operate its telehealth program 
with health care providers who will provide services via telehealth to 
beneficiaries in States in which they are not licensed, registered, 
certified, or located, or where they are not authorized to furnish care 
using telehealth. Currently, doing so may jeopardize these providers' 
credentials, including fines and imprisonment for unauthorized practice 
of medicine, because of conflicts between VA's need to provide 
telehealth across the VA system and some States' laws or licensure, 
registration, certification, or other requirements that restrict or 
limit the practice of telehealth. A number of States have already 
enacted legislation or regulations that restrict the practice of 
interstate telehealth, as discussed below in the Administrative 
Procedure Act section.
    To protect VA health care providers from potential adverse actions 
by States, many VA medical centers (VAMC) are currently not expanding 
some critical telehealth services if the health care service is 
provided outside Federal property (such as when the beneficiary is 
receiving telehealth care in his or her home or when the VA provider is 
delivering telehealth care from his or her home) or across State lines. 
In addition, many individual VA health care providers refuse to 
practice telehealth because of concerns over States taking action 
against the health care provider's State license, State laws, or the 
shifting regulatory landscape that creates legal ambiguity and 
unacceptable State licensing risk. The current disparities between VA 
health care practice in telehealth and State laws have effectively 
stopped or inhibited VA's expansion of telehealth services to certain 
locations, thereby reducing the availability and accessibility of care 
for beneficiaries.
    This proposed rulemaking would clarify that VA health care 
providers may exercise their authority to provide care through the use 
of telehealth, notwithstanding any State laws, rules, or licensure, 
registration, or certification requirements to the contrary. In so 
doing, VA would exercise Federal preemption of State licensure, 
registration, and certification laws, rules, regulations, or 
requirements to the extent such State laws conflict with the ability of 
VA health care providers to engage in the practice of telehealth while 
acting within the scope of their VA employment. Preemption would be the 
minimum necessary action for VA to

[[Page 45758]]

furnish effectively telehealth services because it would be impractical 
for VA to lobby each State to remove its restrictions that impair VA's 
ability to furnish telehealth services to beneficiaries and then wait 
for the State to implement appropriate changes. That process would 
delay the growth of telehealth services in VA, thereby delaying 
delivery of health care to beneficiaries. It would be costly and time-
consuming for VA and would not guarantee a successful result. We note 
that, apart from the limited action of authorizing telehealth across 
and within jurisdictions in furtherance of important Federal interests, 
this rulemaking would not expand the scope of practice for VA health 
care providers beyond what is statutorily defined in the laws and 
practice acts of the health care provider's state of licensure. That 
is, this rulemaking does not affect VA's existing requirement that all 
VA health care providers adhere to restrictions imposed by their State 
license, registration, or certification regarding the professional's 
authority to prescribe and administer controlled substances.
    As VA's telehealth program expands and successfully provides 
increased access to high quality health care to all beneficiaries, it 
is increasingly important for VA health care providers to be able to 
practice telehealth across State lines and within states free of 
restrictions imposed by State law or regulations, including conditions 
attached to their State licenses. For fiscal year (FY) 2016, VA health 
care providers had 2.17 million telehealth episodes of health care 
(meaning a clinical encounter or a period of time in which care was 
monitored), which served over 702,000 veterans (approximately 12 
percent of the total patient population), with 45 percent of those 
veterans living in rural communities. By increasing VA's capabilities 
to provide telehealth services, VA would be able to expand these 
services.
    Eliminating veteran suicide and providing access to mental health 
care is VA's number one clinical priority, and this proposed rulemaking 
would improve VA's ability to reach its most vulnerable beneficiaries. 
Some mental health patients suffer from conditions, such as anxiety and 
agoraphobia, which make it incredibly difficult to leave their houses 
to receive necessary mental and general health care. Furthermore, some 
of our beneficiaries live in areas that are Federally designated as 
mental health provider shortage areas. Therefore, even if beneficiaries 
feel comfortable leaving their home to seek care, there may not be 
sufficient mental health care providers at a VA medical facility or in 
the community to address their health care needs. Given the difficulty 
in providing mental health care under these circumstances, the most 
practical way to consistently provide all VA beneficiaries with access 
to high-quality mental health care is through the telehealth program. 
The data collected in FY 2016 demonstrates that telehealth, 
particularly in the mental health context, improves patient care and 
improves patient outcomes. In FY 2016, there was a 31 percent decrease 
in VA hospital admissions for beneficiaries enrolled in the Home 
Telehealth monitoring program for non-institutional care needs and 
chronic care management. Also, beneficiaries who received mental health 
services through synchronous video telehealth in FY 2016 saw a 
reduction in the number of acute psychiatric VA bed days of care by 39 
percent.
    In addition, monitoring general medical conditions in the 
beneficiaries' home empowers beneficiaries to take a more active role 
in their overall health care without adding the stress of commuting to 
a medical facility to receive the same type of care. Telehealth is 
particularly important for beneficiaries with limited mobility, or for 
whom travel to a health care provider would be a personal hardship. For 
example, beneficiaries who have conditions such as a history of stroke, 
traumatic brain injuries, seizure disorders, and amyotrophic lateral 
sclerosis (ALS) may find it difficult to leave their home in order to 
receive much-needed health care. VA also is able to provide health care 
services to more beneficiaries in localities that are more convenient 
for them, which may lead to the beneficiary taking a more proactive 
approach to their care, thereby increasing the likelihood of positive 
clinical outcomes.
    Other benefits of expanding VA telehealth include serving as a 
recruitment incentive for VA health care providers and allowing VA to 
address recruitment shortages in various parts of the country. For 
example, the Charleston, South Carolina VAMC serves as one of the VA's 
National TeleMental Health Hubs and provides mental health services to 
beneficiaries across eight States with a team of approximately 30 full-
time health care providers. There are currently multiple vacancies for 
TeleMental Health psychiatrists at the Charleston Hub, and in the past 
six months, applicants have only expressed interest in telework 
positions. Several VA health care providers have also left their 
positions within the past year because they were seeking telework 
positions. If the health care providers were able to practice 
telehealth while working from VA-approved alternate worksites and still 
deliver the telehealth services where needed, the Charleston TeleMental 
Hub would be able to fill its vacancies and retain needed health care 
professionals.
    These are just some examples of how expanding telehealth, and 
thereby expanding the locations where VA provides health care services, 
would allow VA to reach underserved areas or beneficiaries who are 
unable to travel, improving health outcomes for beneficiaries and 
allowing VA to better utilize its health care resources. For these 
reasons, VA proposes to establish a new regulation, 38 CFR 17.417 that 
would authorize VA health care providers to treat beneficiaries through 
telehealth irrespective of the location, in a State, of the VA health 
care provider or the beneficiary.
    Proposed paragraph (a) of Sec.  17.417 would contain the 
definitions that would apply to the new section. We would define the 
term ``beneficiary'' to mean ``a veteran and any other individual 
receiving care under title 38 of the United States Code.'' We would use 
this definition because VA provides health care to veterans, certain 
family members of veterans, servicemembers, and others. This is VA's 
standard use of this term.
    We propose to define the term ``health care provider'' consistent 
with the qualifications of appointees within the Veterans Health 
Administration under 38 U.S.C. 7402(b). We would incorporate the 
licensure, registration, or certification requirement from section 
7402(b) and would state that health care providers must maintain 
``credentials (e.g., license, registration, or certification) in 
accordance with the requirements of their health care specialty as 
identified under 38 U.S.C. 7402(b).'' This standard would ensure that 
VA health care providers are qualified to practice their individual 
health care specialty and also ensure patient safety. A health care 
provider as defined in this regulation cannot be a VA-contracted 
employee. Contract health care providers would be required to adhere to 
their individual State license, registration, or certification 
requirements.
    We propose to define the term ``State'' consistent with 38 U.S.C. 
101(20), and including political subdivisions of such States. We 
include political subdivisions in the definition because subdivisions 
of a State are granted legal authority from the State itself, so it 
would make sense to include entities

[[Page 45759]]

created by a State, or authorized by a State in the definition.
    Last, in proposed paragraph (a)(4) of Sec.  17.417, we would define 
the term ``telehealth'' to mean ``the use of electronic information or 
telecommunications technologies to support clinical health care, 
patient and professional health-related education, public health, and 
health administration.'' This definition would be consistent with other 
statutory definitions, such as a provision in the Public Health Service 
Act regarding mental health services delivered by telehealth in 42 
U.S.C. 254c-16(a)(4).
    As we have mentioned in this rulemaking, currently, individual 
States can restrict and limit where a health care provider can practice 
under a State license, certification, or registration. This proposed 
rulemaking would authorize VA health care providers to furnish 
telehealth services without regard to any State restriction that would 
prevent the provider from delivering care via telehealth. Proposed 
paragraph (b)(1) of Sec.  17.417 would state that VA health care 
providers could provide ``telehealth services, within their scope of 
practice and in accordance with privileges granted to them by the 
Department, irrespective of the State or location within a State where 
the health care provider or the beneficiary is physically located.'' 
This would authorize VA health care providers to furnish care, 
consistent with their employment obligations, through telehealth, 
without fear of adverse action by any State. A health care provider's 
practice within VA, however, would continue to be subject to the 
limitations ``imposed by the Controlled Substances Act, 21 U.S.C. 801 
et seq., 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.'' This would 
ensure that providers would still be in compliance with critical laws 
concerning the prescribing and administering of controlled substances. 
We would also state that this rulemaking ``only grants health care 
providers the ability to practice telehealth within the scope of their 
VA employment and does not otherwise grant health care providers 
additional authorities that go beyond the scope of the health care 
providers' State license, registration, or certification.''
    In proposed paragraph (b)(2)(i) through (vii) of Sec.  17.417, we 
would provide situations where a health care provider's practice of 
telehealth could be inconsistent with a State law or State license, 
registration, or certification requirements while engaging in the 
practice of telehealth in VA. These examples would be consistent with 
the reasons VA is proposing to take this rulemaking action, as 
described above.
    Proposed paragraph (c) would expressly state the intended 
preemptive effect of Sec.  17.417, to ensure that conflicting State and 
local laws, rules, regulations, and requirements related to health care 
providers' practice would have no force or effect when such providers 
are practicing telehealth while working within the scope of their VA 
employment. In circumstances where there is a conflict between Federal 
and State law, Federal law would prevail in accordance with Article VI, 
clause 2, of the U.S. Constitution (Supremacy Clause).

Executive Order 13132, Federalism

    Section 4 of Executive Order 13132 (Federalism) requires an agency 
that is publishing a regulation that preempts State law to follow 
certain procedures. Section 4(b) 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(c) states ``Any regulatory preemption 
of State law shall be restricted to the minimum level necessary to 
achieve the objectives of the statute pursuant to which the regulations 
are promulgated.'' Section 4(d) requires that when an agency ``foresees 
the possibility of a conflict between State law and Federally protected 
interests within its area of regulatory responsibility, 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) 
requires that when an agency ``proposes to act through adjudication or 
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) states that ``To the 
extent practicable and permitted by law, 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 proposed rule would preempt certain State laws, VA 
consulted with State officials in compliance with sections 4(d) and 
(e), as well as section 6(c) of Executive Order 13132. VA sent a letter 
to the National Governor's Association, Association of State and 
Provincial Psychology, National Council of State Boards of Nursing, 
Federation of State Medical Boards, Association of Social Work Boards, 
and National Association of State Directors of Veterans Affairs on July 
12, 2017, to state VA's intent to allow VA health care providers to 
practice telehealth irrespective of the location of the health care 
provider or beneficiary in any State and regardless of State telehealth 
restrictions. In addition, the Director of the Federation of State 
Medical Boards solicited comments and input from the nation's State 
Medical Boards. The Wisconsin Medical Examining Board unanimously 
passed a motion in support of the rule. The Rhode Island Board of 
Medical Licensure & Discipline (BMLD) responded to our letter by 
stating that BMLD considers physicians employed by VA to be exempt from 
license requirements as long as such physician maintains a valid 
license in another U.S. jurisdiction. BMLD also indicated that the 
exemption does not necessarily extend to prescribing controlled 
substances without an appropriate DEA registration. In response to this 
caveat, we have stated in this proposed rule that, if finalized, VA 
health care providers would be subject to ``the limitations imposed by 
the Controlled Substances Act, 21 U.S.C. 801, et seq., 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.'' The State of Utah Department of Commerce also stated 
that the Utah Occupations and Professions Licensing Act exempts from 
licensure requirements in Utah

[[Page 45760]]

physicians, physician assistants, advanced practice nurses, 
psychologists or other health care provider who provide telehealth 
services as part of their VA employment as long as such health care 
provider is licensed in any State. Utah supports VA efforts to enhance 
telehealth services to all veterans. The Florida Board of Medicine 
stated that Florida does not prohibit the practice of telehealth except 
in certain circumstances and provided as an example that an in-person 
examination is required each time a physician issues a certification 
for medical marijuana. This proposed rule would supersede any State 
requirement regarding the practice of telehealth, such as the in-person 
examination requirement in Florida, and would maintain the restrictions 
imposed by Federal law and policy regarding the prescription of 
controlled substances. The North Carolina Medical Board recognizes the 
shortage of psychiatric care in rural and medically underserved 
communities and supports VA's initiative.
    The President of the National Association of State Directors of 
Veterans Affairs (NASDVA) sent an email to all of its State directors 
informing the directors of the association's intent to fully support 
VA's initiative. The NASDVA also formally responded to our letter, 
which fully supports VA's plans to amend its regulations and enhance 
access to health care via telehealth services. The National Council of 
State Boards of Nursing (NCSBN) fully supports VA's initiative for 
health care providers to deliver services via telehealth as long as 
such providers maintain a valid State license. However, the NCSBN does 
not support expanding VA State licensure exemptions to personal 
services contractors who practice telehealth. As stated in this 
proposed rulemaking, VA contractors would be excluded from providing 
telehealth services.
    The Chief Executive Officer of the Association of State and 
Provincial Psychology Boards formally responded to our letter and 
indicated that the proposed rule is in alignment with their current 
initiatives, specifically, Psychology Interjurisdictional Compact 
(PSYPACT) legislation, which has been adopted in three jurisdictions 
and is under active consideration in many more States. The PSYPACT 
legislation allows psychologists to provide telepsychology services 
across State lines via a compact without obtaining additional licenses. 
The Chief Executive Officer further stated that these services will be 
of assistance in addressing the delivery of telehealth services to 
veterans.
    The Veterans' Rural Health Advisory Committee (VRHAC) formally 
submitted a letter in support of the proposed rule. The letter stated 
that although VA leads the way in being the largest provider of 
telehealth in the country, there are barriers that affect many rural 
and highly rural areas, which includes limited internet or cellular 
access with sufficient bandwidth to support the required applications 
and also State legislations that restrict the practice of telehealth 
across State lines or into a veteran's home. The commenter strongly 
supports the proposed rule and further adds that expanding telehealth 
to rural and highly rural veterans across State lines would strengthen 
the delivery of care to enrolled veterans who live in rural and highly 
rural areas and supports the critical need for access to mental health 
care.
    The West Virginia Board of Osteopathic Medicine responded to VA's 
letter and indicated that West Virginia has made legislative changes to 
encourage physician participation in the VA system. The commenter 
stated that W.Va. Code 30-14-12c authorizes the West Virginia licensing 
boards to issue a license to a physician licensed in another State via 
reciprocity when the applicant presents proof that they are a VA 
employee working in a VA medical facility that is located in a county 
where a nursing home is operated by the West Virginia Department of 
Veteran's Assistance. Also, W.Va. Code 30-14-12d states the 
requirements for practicing telemedicine in West Virginia and defines 
that the practice of medicine occurs where the patient is located and 
defines what constitutes a physician-patient relationship. The 
commenter stated that the West Virginia Board of Osteopathic Medicine 
rarely knows when a VA physician is practicing in West Virginia without 
a West Virginia State license. However, the commenter cautioned that if 
a VA physician is licensed in West Virginia and does not follow state 
law and such action becomes known to the Board, the Board would file a 
complaint and investigate such action. The commenter stated that their 
telehealth law was written to protect patients and indicated that 
veterans deserved the same high quality care. As we have stated in this 
proposed rule, we are preempting State law as it applies to health care 
providers who practice telehealth while acting within the scope of 
their VA employment.
    The Pennsylvania State Board of Medicine responded to VA's letter 
and acknowledged the potential value for telehealth to expand access to 
health care, especially in rural and underserved areas. The commenter 
further stated that Pennsylvania law on the Interstate Medical 
Licensure Compact affirms that the practice of medicine occurs where 
the patient is located at the time of the health care encounter, which 
requires the physician to be under the jurisdiction of the State 
medical board where the patient is located. The commenter indicated 
that VA has oversight of its health care providers, however, the 
foundational principle that the physician should be licensed where the 
patient is located helps to assure the safety, quality, and 
accountability of the care provided. This proposed rule preempts State 
law as it applies to health care providers who practice telehealth 
while acting within the scope of their VA employment.
    The Michigan Department of Licensing and Regulatory Affairs 
responded to VA's letter by stating that Michigan law does not require 
a VA health care provider to hold a Michigan State license in the 
discharge of official duties. The commenter also stated that telehealth 
at a VA medical facility would be permitted. However, if the health 
care provider is delivering care to the beneficiary's home, such 
provider would need a Michigan State license. As we have indicated in 
this proposed rule, VA would preempt State law as it applies to health 
care providers who practice telehealth while acting within the scope of 
their VA employment.
    The Virginia Board of Medicine responded to VA's letter by stating 
that the Executive Committee of the Board met and supported the 
enhancement of access to care for veterans. The commenter stated that 
the proposed rule should benefit many beneficiaries that have little or 
no access to health care.
    The comments provided above will be placed on Regulations.gov for 
public inspection during the comment period. Stakeholders will also 
have an opportunity to provide comments during the notice and comment 
period.
    This proposed rule complies with Executive Order 13132 by (1) 
identifying where the exercise of State authority would directly 
conflict with the rule; (2) limiting preemption to these areas of 
conflict; (3) restricting preemption to the minimum level necessary to 
achieve the objectives of the statutes pursuant to which the rule is 
promulgated; (4) consulting with the external stakeholders listed in 
this rule; and (5) providing opportunity for all affected State and 
local officials to comment on this proposed rulemaking.

Effect of Rulemaking

    Title 38 of the Code of Federal Regulations, as revised by this 
proposed

[[Page 45761]]

rule, represents VA's implementation of its legal authority on this 
subject. Other than future amendments to this rule or governing 
statutes, no contrary guidance or procedures are authorized. All 
existing or subsequent VA guidance must be read to conform with this 
rule if possible. If not possible, such guidance is superseded by this 
rule.

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 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 proposed rule directly affects only individuals 
who are VA employees and will not directly affect small entities. 
Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from 
the initial and final regulatory flexibility analysis requirements of 5 
U.S.C. 603 and 604.

Executive Orders 12866, 13563, and 13771

    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.''
    OMB has determined that it is a significant regulatory action under 
Executive Order 12866 given the policy implications. In addition, under 
Executive Order 13771 (Reducing Regulation and Controlling Regulatory 
Costs), this proposed rule is expected to be an E.O. 13771 deregulatory 
action, though VA is not able to quantify any cost savings associated 
with it. 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.''
    Executive Order 12866 also directs agencies to ``include a comment 
period of not less than 60 days.'' Given the importance of telehealth 
in providing critical, and potentially lifesaving, access to health 
care for our beneficiaries, VA must act expeditiously, through this 
rulemaking, to ensure that it can expand its telehealth program. The 
primary barrier to the expansion of VA's telehealth program is that 
States' licensing boards have placed explicit restrictions on the use 
of telehealth in their States and have not made exceptions for VA 
providers, which ultimately inhibits VA providers from delivering VA 
health care to beneficiaries. Five of the States with the largest 
veteran populations, California, Texas, Florida, New York, and Ohio, 
have enacted laws and rules that restrict health care providers' 
ability to practice telehealth across State lines. See, 16 C.C.R. Sec.  
1815.5; Cal Bus & Prof Code Sec. Sec.  2052, 2060; TX Occupation Code 
Sec.  151.056; TX Admin Code, Title 22, Sec.  172.12; FL Admin Code 
64B8-9.0141; FL Admin Code 64B15-14.0081; NY Consolidated Law Service 
Public Health Sec.  2805-u; OH Revised Code Annotated, Sec. 
4731.296(C). As telehealth capabilities continue to expand, new State 
legislation and regulations across the country are enacted relating to 
the practice of telehealth. The possibility of sanctions to VA health 
care providers' State license, including fines and imprisonment for 
unauthorized practice of medicine has hindered VA's ability to expand 
its telehealth program. To protect VA health care providers from 
potential adverse actions by States, many VAMCs are currently not 
expanding some critical telehealth services if the health care service 
is provided outside Federal property (such as when the VA provider is 
delivering telehealth care from his or her home) or across State lines, 
or the care is delivered in a beneficiary's home. In addition many 
individual VA health care providers refuse to practice telehealth 
because of concerns over States taking action against their State 
license. This rule will supersede State restrictions on the practice of 
telehealth and allow VA health care providers to practice telehealth 
anywhere within a State (such as from the residence of the health care 
provider) and across State lines.
    In sum, providing a 60 day public comment period instead of a 30 
day public comment period would be against public interest and the 
health and safety of VA beneficiaries because any restriction from a 
State or State licensing board on practicing telehealth, within the 
State or across State lines, could impede beneficiaries' access to 
health care, which will ultimately impact the health of the 
beneficiary. For the above reasons, the Secretary issues this rule with 
a 30 day public comment period. VA will consider and address comments 
that are received within 30 days of the date this proposed rule is 
published in the Federal Register.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532, requires 
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 will 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; 64.018, Sharing Specialized 
Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug 
Dependence; 64.022, Veterans Home Based Primary Care; 64.039 CHAMPVA; 
64.040 VHA Inpatient Medicine; 64.041 VHA Outpatient

[[Page 45762]]

Specialty Care; 64.042 VHA Inpatient Surgery; 64.043 VHA Mental Health 
Residential; 64.044 VHA Home Care; 64.045 VHA Outpatient Ancillary 
Services; 64.046 VHA Inpatient Psychiatry; 64.047 VHA Primary Care; 
64.048 VHA Mental Health Clinics; 64.049 VHA Community Living Center; 
and 64.050 VHA Diagnostic Care.

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. Gina S. 
Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, 
approved this document on July 28, 2017 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, Reporting and 
recordkeeping requirements, Scholarships and fellowships, Travel and 
transportation expenses, Veterans.

    Dated: September 26, 2017.
Michael Shores,
Director, Regulation Policy & Management, Office of the 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 is amended by adding an entry for 
Sec.  17.417 in numerical order to read in part as follows:

    Authority: 38 U.S.C. 501, and as noted in specific sections.
* * * * *
    Section 17.417 also issued under 38 U.S.C. 1701 (note), 1709A, 
1712A (note), 1722B, 7301, 7330A, 7401-7403; 7406 (note)).

0
2. Revise the undesignated center heading immediately after Sec.  
17.412 to read as follows:

Authority of Health Care Providers to Practice in the Department

0
3. Add Sec.  17.417 to read as follows:


Sec.  17.417  Health care providers.

    (a) Definitions. The following definitions apply to this section.
    (1) Beneficiary. The term beneficiary means a veteran or any other 
individual receiving health care under title 38 of the United States 
Code.
    (2) Health care provider. The term health care provider means an 
individual who:
    (i) Is licensed, registered, or certified in a State to practice a 
health care specialty identified under 38 U.S.C. 7402(b);
    (ii) Is appointed to an occupation in the Veterans Health 
Administration that is listed in or authorized under 38 U.S.C. 7401(1) 
or (3);
    (iii) Maintains credentials (e.g., a license, registration, or 
certification) in accordance with the requirements of his or her 
medical specialty as identified under 38 U.S.C. 7402(b); and
    (iv) Is not a VA-contracted employee.
    (3) State. The term State means a State as defined in 38 U.S.C. 
101(20), or a political subdivision of such a State.
    (4) Telehealth. The term telehealth means the use of electronic 
information or telecommunications technologies to support clinical 
health care, patient and professional health-related education, public 
health, and health administration.
    (b) Health care provider's practice. (1) Health care providers may 
provide telehealth services, within their scope of practice and in 
accordance with privileges granted to them by the Department, 
irrespective of the State or location within a State where the health 
care provider or the beneficiary is physically located. Health care 
providers' practice is subject to the limitations imposed by the 
Controlled Substances Act, 21 U.S.C. 801, et seq., 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. This section only grants health care providers the 
ability to practice telehealth within the scope of their VA employment 
and does not otherwise grant health care providers additional 
authorities that go beyond the scope of the health care providers' 
State license, registration, or certification.
    (2) Situations where a health care provider's VA practice of 
telehealth may be inconsistent with a State law or State license, 
registration, or certification requirements related to telehealth 
include when:
    (i) The beneficiary and the health care provider are physically 
located in different States during the episode of care;
    (ii) The beneficiary is receiving services in a State other than 
the health care provider's State of licensure, registration, or 
certification;
    (iii) The health care provider is delivering services in a State 
other than the health care provider's State of licensure, registration, 
or certification;
    (iv) The health care provider is delivering services either on or 
outside VA property;
    (v) The beneficiary is receiving services while she or he is 
located either on or outside VA property;
    (vi) The beneficiary has or has not previously been assessed, in 
person, by the health care provider; or
    (vii) Other State requirements would prevent or impede the practice 
of health care providers delivering telehealth to VA beneficiaries.
    (c) Preemption of State law. To achieve important Federal 
interests, including, but not limited to, the ability to provide the 
same complete medical and hospital service to beneficiaries in all 
States under 38 U.S.C. 7301, this section preempts conflicting State 
laws relating to the practice of health care providers when such health 
care providers are practicing telehealth within the scope of their VA 
employment. Any State law, rule, regulation or requirement pursuant to 
such law, is without any force or effect on, and State governments have 
no legal authority to enforce them in relation to, this section or 
decisions made by VA under this section.

[FR Doc. 2017-20951 Filed 9-29-17; 8:45 am]
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                                                  45756                  Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules

                                                  improve that analysis. We thus follow                   ADDRESSES) and is available for viewing               delivery to: Director, Regulation Policy
                                                  the same basic approach here.                           by interested persons between 9 a.m.                  and Management (00REG), Department
                                                     The full analysis of economic impacts                and 4 p.m., Monday through Friday; it                 of Veterans Affairs, 810 Vermont Ave.
                                                  is available in the docket for this                     is also available electronically at https://          NW., Room 1063B, Washington, DC
                                                  proposed rule (Ref. 1) and at https://                  www.regulations.gov. FDA has verified                 20420; or by fax to (202) 273–9026.
                                                  www.fda.gov/AboutFDA/Reports                            the Web site addresses, as of the date                (This is not a toll-free telephone
                                                  ManualsForms/Reports/Economic                           this document publishes in the Federal                number.) Comments should indicate
                                                  Analyses.                                               Register, but Web sites are subject to                that they are submitted in response to
                                                  V. Analysis of Environmental Impact                     change over time.                                     ‘‘RIN 2900–AQ06-Authority of Health
                                                                                                          1. United States Department of Health and             Care Providers to Practice Telehealth.’’
                                                    We have determined under 21 CFR                                                                             Copies of comments received will be
                                                                                                              Human Services. United States Food and
                                                  25.30(k) that this action is of a type that                 Drug Administration. Preliminary                  available for public inspection in the
                                                  does not individually or cumulatively                       Regulatory Impact Analysis, Preliminary           Office of Regulation Policy and
                                                  have a significant effect on the human                      Regulatory Flexibility Analysis for               Management, Room 1068, between the
                                                  environment. Therefore, neither an                          Proposed Rule on ‘‘Food Labeling:                 hours of 8:00 a.m. and 4:30 p.m.,
                                                  environmental assessment nor an                             Revision of the Nutrition and                     Monday through Friday (except
                                                  environmental impact statement is                           Supplement Facts Labels and Serving               holidays). Please call (202) 461–4902 for
                                                  required.                                                   Sizes of Foods That Can Reasonably Be
                                                                                                              Consumed At One Eating Occasion;
                                                                                                                                                                an appointment. (This is not a toll-free
                                                  VI. Paperwork Reduction Act of 1995                         Dual-Column Labeling; Updating,                   telephone number.) In addition, during
                                                                                                              Modifying, and Establishing Certain               the comment period, comments may be
                                                    This proposed rule contains no                                                                              viewed online through the Federal
                                                                                                              Reference Amounts Customarily
                                                  collection of information. Therefore,                       Consumed; Serving Size for Breath                 Docket Management System (FDMS) at
                                                  clearance by the Office of Management                       Mints; and Technical Amendments;                  http://www.regulations.gov.
                                                  and Budget under the Paperwork                              Extension of Compliance Dates.’’                  FOR FURTHER INFORMATION CONTACT:
                                                  Reduction Act of 1995 is not required.                      September 2017. Available from http://
                                                                                                                                                                Kevin Galpin, MD, Executive Director
                                                                                                              www.fda.gov/AboutFDA/Reports
                                                  VII. Federalism                                             ManualsForms/Reports/Economic                     Telehealth Services, Veterans Health
                                                    We have analyzed this proposed rule                       Analyses.                                         Administration Office of Connected
                                                  in accordance with the principles set                                                                         Care, 810 Vermont Avenue NW.,
                                                                                                            Dated: September 26, 2017.
                                                  forth in Executive Order 13132. Section                                                                       Washington, DC 20420. (404) 771–8794.
                                                                                                          Anna K. Abram,                                        (This is not a toll-free number.)
                                                  4(a) of the Executive Order requires
                                                                                                          Deputy Commissioner for Policy, Planning,             Kevin.Galpin@va.gov.
                                                  Agencies to ‘‘construe * * * a Federal                  Legislation, and Analysis.
                                                  statute to preempt State law only where                                                                       SUPPLEMENTARY INFORMATION: Section
                                                                                                          [FR Doc. 2017–21019 Filed 9–29–17; 8:45 am]
                                                  the statute contains an express                                                                               7301 of title 38, United States Code
                                                                                                          BILLING CODE 4164–01–P                                (U.S.C.), establishes the general
                                                  preemption provision or there is some
                                                  other clear evidence that the Congress                                                                        functions of the Veterans Health
                                                  intended preemption of State law, or                                                                          Administration (VHA) within VA, and
                                                  where the exercise of State authority                   DEPARTMENT OF VETERANS                                establishes that its primary function is
                                                  conflicts with the exercise of Federal                  AFFAIRS                                               to ‘‘provide a complete medical and
                                                  authority under the Federal statute.’’                                                                        hospital service for the medical care and
                                                  Section 403A of the FD&C Act (21                        38 CFR Part 17                                        treatment of veterans, as provided in
                                                  U.S.C. 343–1) is an express preemption                  RIN 2900–AQ06                                         this title and in regulations prescribed
                                                  provision. Section 403A(a) of the FD&C                                                                        by the Secretary [of Veterans Affairs
                                                  Act provides that: ‘‘* * * no State or                  Authority of Health Care Providers To                 (Secretary)] pursuant to this title.’’ 38
                                                  political subdivision of a State may                    Practice Telehealth                                   U.S.C. 7301(b). In carrying out this
                                                  directly or indirectly establish under                                                                        function, VHA must ensure that patient
                                                                                                          AGENCY:    Department of Veterans Affairs.            care is appropriate and safe and its
                                                  any authority or continue in effect as to
                                                  any food in interstate commerce—(4)                     ACTION:   Proposed rule.                              health care providers meet or exceed
                                                  any requirement for nutrition labeling of                                                                     generally accepted professional
                                                                                                          SUMMARY:    The Department of Veterans
                                                  food that is not identical to the                                                                             standards for patient care. In addition,
                                                                                                          Affairs (VA) proposes to amend its
                                                  requirement of section 403(q) * * *.’’                                                                        because VA is a national health care
                                                                                                          medical regulations by standardizing
                                                  The express preemption provision of                                                                           provider, VHA must ensure that
                                                                                                          the delivery of care by VA health care
                                                  section 403A(a) of the FD&C Act does                                                                          beneficiaries receive the same high level
                                                                                                          providers through telehealth. This rule
                                                  not preempt any State or local                                                                                of care and access to care no matter
                                                                                                          would ensure that VA health care
                                                  requirement respecting a statement in                                                                         where, in a State, a beneficiary or health
                                                                                                          providers provide the same level of care
                                                  the labeling of food that provides for a                                                                      care provider is located at the time the
                                                                                                          to all beneficiaries, irrespective of the
                                                  warning concerning the safety of the                                                                          health care is provided.
                                                                                                          State or location in a State of the VA                   The Secretary is responsible for the
                                                  food or component of the food (section                  health care provider or the beneficiary.
                                                  6(c)(2) of the Nutrition Labeling and                                                                         proper execution and administration of
                                                                                                          This proposed rule would achieve                      all laws administered by the Department
                                                  Education Act of 1990, Pub. L. 101–535,                 important Federal interests by                        and for the control, direction, and
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                                                  104 Stat. 2353, 2364 (1990)). If this                   increasing the availability of mental
                                                  proposed rule is made final, the final                                                                        management of the Department,
                                                                                                          health, specialty, and general clinical               including agency personnel and
                                                  rule would create requirements that fall                care for all beneficiaries.
                                                  within the scope of section 403A(a) of                                                                        management matters. See 38 U.S.C. 303.
                                                                                                          DATES: Comments must be received on                   To this end, Congress authorized the
                                                  the FD&C Act.
                                                                                                          or before November 1, 2017.                           Secretary ‘‘to prescribe all rules and
                                                  VIII. References                                        ADDRESSES: Written comments may be                    regulations which are necessary or
                                                    The following reference is on display                 submitted through http://                             appropriate to carry out the laws
                                                  in the Dockets Management Staff (see                    www.Regulations.gov by mail or hand-                  administered by the Department and are


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                                                                         Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules                                             45757

                                                  consistent with those laws.’’ 38 U.S.C.                 where the health care provider or the                 health care specialty as stated in 38
                                                  501(a). The Under Secretary for Health                  beneficiary is physically located at the              U.S.C. 7402(b).
                                                  is directly responsible to the Secretary                time the health care is provided.                        In an effort to furnish care to all
                                                  for the operation of VHA. 38 U.S.C.                     Telehealth enhances VA’s capacity to                  beneficiaries and use its resources most
                                                  305(b). Unless specifically otherwise                   deliver essential and critical health care            efficiently, VA needs to operate its
                                                  provided, the Under Secretary for                       services to beneficiaries located in areas            telehealth program with health care
                                                  Health, as the head of VHA, is                          where health care providers may be                    providers who will provide services via
                                                  authorized to ‘‘prescribe all regulations               unavailable or to beneficiaries who may               telehealth to beneficiaries in States in
                                                  necessary to the administration of the                  be unable to travel to the nearest VA                 which they are not licensed, registered,
                                                  Veterans Health Administration,’’                       medical facility for care because of their            certified, or located, or where they are
                                                  subject to the approval of the Secretary.               medical conditions. Telehealth                        not authorized to furnish care using
                                                  38 U.S.C. 7304.                                         increases the accessibility of VA health              telehealth. Currently, doing so may
                                                     To allow VA to carry out its medical                 care, bringing VA medical services to                 jeopardize these providers’ credentials,
                                                  care mission, Congress also established                 locations convenient for beneficiaries,               including fines and imprisonment for
                                                  a comprehensive personnel system for                    including clinics in remote                           unauthorized practice of medicine,
                                                  certain VA health care providers,                       communities and beneficiaries’ homes.                 because of conflicts between VA’s need
                                                  independent of the civil service rules.                 By providing health care services by                  to provide telehealth across the VA
                                                  See 38 U.S.C. chapters 73–74. Congress                  telehealth from one State to a                        system and some States’ laws or
                                                  granted the Secretary express statutory                 beneficiary located in another State or               licensure, registration, certification, or
                                                  authority to establish the qualifications               within the same State, whether that                   other requirements that restrict or limit
                                                  for VA’s health care providers,                         beneficiary is located at a VA medical                the practice of telehealth. A number of
                                                  determine the hours and conditions of                   facility or in his or her own home, VA                States have already enacted legislation
                                                  employment, take disciplinary action                    can use its limited health care resources             or regulations that restrict the practice
                                                  against employees, and otherwise                        most efficiently.                                     of interstate telehealth, as discussed
                                                  regulate the professional activities of                    Congress has required other                        below in the Administrative Procedure
                                                  those individuals. 38 U.S.C. 7401–7464.                 Departments and agencies to conduct                   Act section.
                                                     To be eligible for appointment as a                  telehealth programs. See, e.g., Public                   To protect VA health care providers
                                                  VA employee in a health care position                   Law 114–328, sec. 718(a)(1) (‘‘the                    from potential adverse actions by States,
                                                  covered by section 7402(b) of title 38,                 Secretary of Defense shall incorporate,               many VA medical centers (VAMC) are
                                                  U.S.C. (other than a medical facility                   throughout the direct care and                        currently not expanding some critical
                                                  Director appointed under section                        purchased care components of the                      telehealth services if the health care
                                                  7402(b)(4)), a person must, among other                 military health system, the use of                    service is provided outside Federal
                                                  requirements, be licensed, registered, or               telehealth services’’). While VA does not             property (such as when the beneficiary
                                                  certified to practice his or her profession             have an analogous mandate, several                    is receiving telehealth care in his or her
                                                  in a State. The standards prescribed in                 statutes confirm that Congress intends                home or when the VA provider is
                                                  section 7402(b) establish only the basic                for VA to operate a national health care              delivering telehealth care from his or
                                                  qualifications necessary ‘‘[t]o be eligible             system for beneficiaries including                    her home) or across State lines. In
                                                  for appointment’’ and do not limit the                  through telehealth. Congress has                      addition, many individual VA health
                                                  Secretary or Under Secretary for Health                 required the Secretary ‘‘to carry out an              care providers refuse to practice
                                                  from establishing other qualifications                  initiative of teleconsultation for the                telehealth because of concerns over
                                                  for appointment, or additional rules                    provision of remote mental health and                 States taking action against the health
                                                  governing such personnel. In particular,                traumatic brain injury assessments in                 care provider’s State license, State laws,
                                                  section 7403(a)(1) provides that                        facilities of the Department that are not             or the shifting regulatory landscape that
                                                  appointments under chapter 74 ‘‘may be                  otherwise able to provide such                        creates legal ambiguity and
                                                  made only after qualifications have been                assessments without contracting with                  unacceptable State licensing risk. The
                                                  established in accordance with                          third-party providers or reimbursing                  current disparities between VA health
                                                  regulations prescribed by the Secretary,                providers through a fee basis system.’’               care practice in telehealth and State
                                                  without regard to civil-service                         38 U.S.C. 1709A(a)(1). Congress has                   laws have effectively stopped or
                                                  requirements.’’ Such authority is                       authorized the Secretary to ‘‘waive the               inhibited VA’s expansion of telehealth
                                                  necessary to ensure the viability of our                imposition or collection of copayments                services to certain locations, thereby
                                                  national health care system, which is                   for telehealth and telemedicine visits of             reducing the availability and
                                                  designed to ensure the well-being of                    veterans under the laws administered by               accessibility of care for beneficiaries.
                                                  those who have ‘‘borne the battle.’’                    the Secretary.’’ 38 U.S.C. 1722B. And, as                This proposed rulemaking would
                                                     Just as it is critical to ensure there are           recently as December 2016, Congress                   clarify that VA health care providers
                                                  qualified health care providers on-site at              required VA to initiate a pilot program               may exercise their authority to provide
                                                  all VA medical facilities, VA must                      to provide veterans a self-scheduling,                care through the use of telehealth,
                                                  ensure that all beneficiaries, specifically             online appointment system; this pilot                 notwithstanding any State laws, rules,
                                                  including beneficiaries in remote, rural,               program must ‘‘support appointments                   or licensure, registration, or certification
                                                  or medically underserved areas, have                    for the provision of health care                      requirements to the contrary. In so
                                                  the greatest possible access to mental                  regardless of whether such care is                    doing, VA would exercise Federal
                                                  health care, specialty care, and general                provided in person or through                         preemption of State licensure,
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                                                  clinical care. Thus, VA has developed a                 telehealth services.’’ Public Law 114–                registration, and certification laws,
                                                  telehealth program as a modern,                         286, sec. 3(a)(2).                                    rules, regulations, or requirements to the
                                                  beneficiary- and family-centered health                    As noted above, VA only has legal                  extent such State laws conflict with the
                                                  care delivery model that leverages                      authority to hire health care providers               ability of VA health care providers to
                                                  information and telecommunication                       who are licensed, registered, or certified            engage in the practice of telehealth
                                                  technologies to connect beneficiaries                   in a State. To continue practicing in VA,             while acting within the scope of their
                                                  with health care providers, irrespective                providers must maintain those                         VA employment. Preemption would be
                                                  of the State or location within a State                 credentials in accordance with their                  the minimum necessary action for VA to


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                                                  45758                  Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules

                                                  furnish effectively telehealth services                 providers at a VA medical facility or in              seeking telework positions. If the health
                                                  because it would be impractical for VA                  the community to address their health                 care providers were able to practice
                                                  to lobby each State to remove its                       care needs. Given the difficulty in                   telehealth while working from VA-
                                                  restrictions that impair VA’s ability to                providing mental health care under                    approved alternate worksites and still
                                                  furnish telehealth services to                          these circumstances, the most practical               deliver the telehealth services where
                                                  beneficiaries and then wait for the State               way to consistently provide all VA                    needed, the Charleston TeleMental Hub
                                                  to implement appropriate changes. That                  beneficiaries with access to high-quality             would be able to fill its vacancies and
                                                  process would delay the growth of                       mental health care is through the                     retain needed health care professionals.
                                                  telehealth services in VA, thereby                      telehealth program. The data collected                   These are just some examples of how
                                                  delaying delivery of health care to                     in FY 2016 demonstrates that telehealth,              expanding telehealth, and thereby
                                                  beneficiaries. It would be costly and                   particularly in the mental health                     expanding the locations where VA
                                                  time-consuming for VA and would not                     context, improves patient care and                    provides health care services, would
                                                  guarantee a successful result. We note                  improves patient outcomes. In FY 2016,                allow VA to reach underserved areas or
                                                  that, apart from the limited action of                  there was a 31 percent decrease in VA                 beneficiaries who are unable to travel,
                                                  authorizing telehealth across and within                hospital admissions for beneficiaries                 improving health outcomes for
                                                  jurisdictions in furtherance of important               enrolled in the Home Telehealth                       beneficiaries and allowing VA to better
                                                  Federal interests, this rulemaking would                monitoring program for non-                           utilize its health care resources. For
                                                  not expand the scope of practice for VA                 institutional care needs and chronic                  these reasons, VA proposes to establish
                                                  health care providers beyond what is                    care management. Also, beneficiaries                  a new regulation, 38 CFR 17.417 that
                                                  statutorily defined in the laws and                     who received mental health services                   would authorize VA health care
                                                  practice acts of the health care                        through synchronous video telehealth in               providers to treat beneficiaries through
                                                  provider’s state of licensure. That is,                 FY 2016 saw a reduction in the number                 telehealth irrespective of the location, in
                                                  this rulemaking does not affect VA’s                    of acute psychiatric VA bed days of care              a State, of the VA health care provider
                                                  existing requirement that all VA health                 by 39 percent.                                        or the beneficiary.
                                                  care providers adhere to restrictions                      In addition, monitoring general                       Proposed paragraph (a) of § 17.417
                                                  imposed by their State license,                         medical conditions in the beneficiaries’              would contain the definitions that
                                                  registration, or certification regarding                home empowers beneficiaries to take a                 would apply to the new section. We
                                                  the professional’s authority to prescribe               more active role in their overall health              would define the term ‘‘beneficiary’’ to
                                                  and administer controlled substances.                   care without adding the stress of                     mean ‘‘a veteran and any other
                                                     As VA’s telehealth program expands                   commuting to a medical facility to
                                                                                                                                                                individual receiving care under title 38
                                                  and successfully provides increased                     receive the same type of care. Telehealth
                                                                                                                                                                of the United States Code.’’ We would
                                                  access to high quality health care to all               is particularly important for
                                                                                                                                                                use this definition because VA provides
                                                  beneficiaries, it is increasingly                       beneficiaries with limited mobility, or
                                                                                                                                                                health care to veterans, certain family
                                                  important for VA health care providers                  for whom travel to a health care
                                                                                                                                                                members of veterans, servicemembers,
                                                  to be able to practice telehealth across                provider would be a personal hardship.
                                                                                                                                                                and others. This is VA’s standard use of
                                                  State lines and within states free of                   For example, beneficiaries who have
                                                                                                                                                                this term.
                                                  restrictions imposed by State law or                    conditions such as a history of stroke,
                                                  regulations, including conditions                       traumatic brain injuries, seizure                        We propose to define the term ‘‘health
                                                  attached to their State licenses. For                   disorders, and amyotrophic lateral                    care provider’’ consistent with the
                                                  fiscal year (FY) 2016, VA health care                   sclerosis (ALS) may find it difficult to              qualifications of appointees within the
                                                  providers had 2.17 million telehealth                   leave their home in order to receive                  Veterans Health Administration under
                                                  episodes of health care (meaning a                      much-needed health care. VA also is                   38 U.S.C. 7402(b). We would
                                                  clinical encounter or a period of time in               able to provide health care services to               incorporate the licensure, registration,
                                                  which care was monitored), which                        more beneficiaries in localities that are             or certification requirement from section
                                                  served over 702,000 veterans                            more convenient for them, which may                   7402(b) and would state that health care
                                                  (approximately 12 percent of the total                  lead to the beneficiary taking a more                 providers must maintain ‘‘credentials
                                                  patient population), with 45 percent of                 proactive approach to their care, thereby             (e.g., license, registration, or
                                                  those veterans living in rural                          increasing the likelihood of positive                 certification) in accordance with the
                                                  communities. By increasing VA’s                         clinical outcomes.                                    requirements of their health care
                                                  capabilities to provide telehealth                         Other benefits of expanding VA                     specialty as identified under 38 U.S.C.
                                                  services, VA would be able to expand                    telehealth include serving as a                       7402(b).’’ This standard would ensure
                                                  these services.                                         recruitment incentive for VA health care              that VA health care providers are
                                                     Eliminating veteran suicide and                      providers and allowing VA to address                  qualified to practice their individual
                                                  providing access to mental health care                  recruitment shortages in various parts of             health care specialty and also ensure
                                                  is VA’s number one clinical priority,                   the country. For example, the                         patient safety. A health care provider as
                                                  and this proposed rulemaking would                      Charleston, South Carolina VAMC                       defined in this regulation cannot be a
                                                  improve VA’s ability to reach its most                  serves as one of the VA’s National                    VA-contracted employee. Contract
                                                  vulnerable beneficiaries. Some mental                   TeleMental Health Hubs and provides                   health care providers would be required
                                                  health patients suffer from conditions,                 mental health services to beneficiaries               to adhere to their individual State
                                                  such as anxiety and agoraphobia, which                  across eight States with a team of                    license, registration, or certification
                                                  make it incredibly difficult to leave their             approximately 30 full-time health care                requirements.
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                                                  houses to receive necessary mental and                  providers. There are currently multiple                  We propose to define the term ‘‘State’’
                                                  general health care. Furthermore, some                  vacancies for TeleMental Health                       consistent with 38 U.S.C. 101(20), and
                                                  of our beneficiaries live in areas that are             psychiatrists at the Charleston Hub, and              including political subdivisions of such
                                                  Federally designated as mental health                   in the past six months, applicants have               States. We include political
                                                  provider shortage areas. Therefore, even                only expressed interest in telework                   subdivisions in the definition because
                                                  if beneficiaries feel comfortable leaving               positions. Several VA health care                     subdivisions of a State are granted legal
                                                  their home to seek care, there may not                  providers have also left their positions              authority from the State itself, so it
                                                  be sufficient mental health care                        within the past year because they were                would make sense to include entities


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                                                                         Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules                                           45759

                                                  created by a State, or authorized by a                  requirements while engaging in the                    issued in the Federal Register, provides
                                                  State in the definition.                                practice of telehealth in VA. These                   to the Director of the Office of
                                                     Last, in proposed paragraph (a)(4) of                examples would be consistent with the                 Management and Budget a federalism
                                                  § 17.417, we would define the term                      reasons VA is proposing to take this                  summary impact statement, which
                                                  ‘‘telehealth’’ to mean ‘‘the use of                     rulemaking action, as described above.                consists of a description of the extent of
                                                  electronic information or                                  Proposed paragraph (c) would                       the agency’s prior consultation with
                                                  telecommunications technologies to                      expressly state the intended preemptive               State and local officials, a summary of
                                                  support clinical health care, patient and               effect of § 17.417, to ensure that                    the nature of their concerns and the
                                                  professional health-related education,                  conflicting State and local laws, rules,              agency’s position supporting the need to
                                                  public health, and health                               regulations, and requirements related to              issue the regulation, and a statement of
                                                  administration.’’ This definition would                 health care providers’ practice would                 the extent to which the concerns of
                                                  be consistent with other statutory                      have no force or effect when such                     State and local officials have been met;
                                                  definitions, such as a provision in the                 providers are practicing telehealth while             and (3) makes available to the Director
                                                  Public Health Service Act regarding                     working within the scope of their VA                  of the Office of Management and Budget
                                                  mental health services delivered by                     employment. In circumstances where                    any written communications submitted
                                                  telehealth in 42 U.S.C. 254c–16(a)(4).                  there is a conflict between Federal and               to the agency by State and local
                                                     As we have mentioned in this                         State law, Federal law would prevail in               officials.’’
                                                  rulemaking, currently, individual States                accordance with Article VI, clause 2, of                 Because this proposed rule would
                                                  can restrict and limit where a health                   the U.S. Constitution (Supremacy                      preempt certain State laws, VA
                                                  care provider can practice under a State                Clause).
                                                                                                                                                                consulted with State officials in
                                                  license, certification, or registration.
                                                                                                          Executive Order 13132, Federalism                     compliance with sections 4(d) and (e),
                                                  This proposed rulemaking would
                                                  authorize VA health care providers to                      Section 4 of Executive Order 13132                 as well as section 6(c) of Executive
                                                  furnish telehealth services without                     (Federalism) requires an agency that is               Order 13132. VA sent a letter to the
                                                  regard to any State restriction that                    publishing a regulation that preempts                 National Governor’s Association,
                                                  would prevent the provider from                         State law to follow certain procedures.               Association of State and Provincial
                                                  delivering care via telehealth. Proposed                Section 4(b) requires agencies to                     Psychology, National Council of State
                                                  paragraph (b)(1) of § 17.417 would state                ‘‘construe any authorization in the                   Boards of Nursing, Federation of State
                                                  that VA health care providers could                     statute for the issuance of regulations as            Medical Boards, Association of Social
                                                  provide ‘‘telehealth services, within                   authorizing preemption of State law by                Work Boards, and National Association
                                                  their scope of practice and in                          rulemaking only when the exercise of                  of State Directors of Veterans Affairs on
                                                  accordance with privileges granted to                   State authority directly conflicts with               July 12, 2017, to state VA’s intent to
                                                  them by the Department, irrespective of                 the exercise of Federal authority under               allow VA health care providers to
                                                  the State or location within a State                    the Federal statute or there is clear                 practice telehealth irrespective of the
                                                  where the health care provider or the                   evidence to conclude that the Congress                location of the health care provider or
                                                  beneficiary is physically located.’’ This               intended the agency to have the                       beneficiary in any State and regardless
                                                  would authorize VA health care                          authority to preempt State law.’’ Section             of State telehealth restrictions. In
                                                  providers to furnish care, consistent                   4(c) states ‘‘Any regulatory preemption               addition, the Director of the Federation
                                                  with their employment obligations,                      of State law shall be restricted to the               of State Medical Boards solicited
                                                  through telehealth, without fear of                     minimum level necessary to achieve the                comments and input from the nation’s
                                                  adverse action by any State. A health                   objectives of the statute pursuant to                 State Medical Boards. The Wisconsin
                                                  care provider’s practice within VA,                     which the regulations are promulgated.’’              Medical Examining Board unanimously
                                                  however, would continue to be subject                   Section 4(d) requires that when an                    passed a motion in support of the rule.
                                                  to the limitations ‘‘imposed by the                     agency ‘‘foresees the possibility of a                The Rhode Island Board of Medical
                                                  Controlled Substances Act, 21 U.S.C.                    conflict between State law and                        Licensure & Discipline (BMLD)
                                                  801 et seq., on the authority to prescribe              Federally protected interests within its              responded to our letter by stating that
                                                  or administer controlled substances, as                 area of regulatory responsibility, the                BMLD considers physicians employed
                                                  well as any other limitations on the                    agency shall consult, to the extent                   by VA to be exempt from license
                                                  provision of VA care set forth in                       practicable, with appropriate State and               requirements as long as such physician
                                                  applicable Federal law and policy.’’                    local officials in an effort to avoid such            maintains a valid license in another U.S.
                                                  This would ensure that providers would                  a conflict.’’ Section 4(e) requires that              jurisdiction. BMLD also indicated that
                                                  still be in compliance with critical laws               when an agency ‘‘proposes to act                      the exemption does not necessarily
                                                  concerning the prescribing and                          through adjudication or rulemaking to                 extend to prescribing controlled
                                                  administering of controlled substances.                 preempt State law, the agency shall                   substances without an appropriate DEA
                                                  We would also state that this                           provide all affected State and local                  registration. In response to this caveat,
                                                  rulemaking ‘‘only grants health care                    officials notice and an opportunity for               we have stated in this proposed rule
                                                  providers the ability to practice                       appropriate participation in the                      that, if finalized, VA health care
                                                  telehealth within the scope of their VA                 proceedings.’’ Section 6(c) states that               providers would be subject to ‘‘the
                                                  employment and does not otherwise                       ‘‘To the extent practicable and                       limitations imposed by the Controlled
                                                  grant health care providers additional                  permitted by law, no agency shall                     Substances Act, 21 U.S.C. 801, et seq.,
                                                  authorities that go beyond the scope of                 promulgate any regulation that has                    on the authority to prescribe or
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                                                  the health care providers’ State license,               federalism implications and that                      administer controlled substances, as
                                                  registration, or certification.’’                       preempts State law, unless the agency,                well as any other limitations on the
                                                     In proposed paragraph (b)(2)(i)                      prior to the formal promulgation of the               provision of VA care set forth in
                                                  through (vii) of § 17.417, we would                     regulation, (1) consulted with State and              applicable Federal law and policy.’’ The
                                                  provide situations where a health care                  local officials early in the process of               State of Utah Department of Commerce
                                                  provider’s practice of telehealth could                 developing the proposed regulation; (2)               also stated that the Utah Occupations
                                                  be inconsistent with a State law or State               in a separately identified portion of the             and Professions Licensing Act exempts
                                                  license, registration, or certification                 preamble to the regulation as it is to be             from licensure requirements in Utah


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                                                  45760                  Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules

                                                  physicians, physician assistants,                          The Veterans’ Rural Health Advisory                underserved areas. The commenter
                                                  advanced practice nurses, psychologists                 Committee (VRHAC) formally submitted                  further stated that Pennsylvania law on
                                                  or other health care provider who                       a letter in support of the proposed rule.             the Interstate Medical Licensure
                                                  provide telehealth services as part of                  The letter stated that although VA leads              Compact affirms that the practice of
                                                  their VA employment as long as such                     the way in being the largest provider of              medicine occurs where the patient is
                                                  health care provider is licensed in any                 telehealth in the country, there are                  located at the time of the health care
                                                  State. Utah supports VA efforts to                      barriers that affect many rural and                   encounter, which requires the physician
                                                  enhance telehealth services to all                      highly rural areas, which includes                    to be under the jurisdiction of the State
                                                  veterans. The Florida Board of Medicine                 limited internet or cellular access with              medical board where the patient is
                                                  stated that Florida does not prohibit the               sufficient bandwidth to support the                   located. The commenter indicated that
                                                  practice of telehealth except in certain                required applications and also State                  VA has oversight of its health care
                                                  circumstances and provided as an                        legislations that restrict the practice of            providers, however, the foundational
                                                  example that an in-person examination                   telehealth across State lines or into a               principle that the physician should be
                                                  is required each time a physician issues                veteran’s home. The commenter                         licensed where the patient is located
                                                  a certification for medical marijuana.                  strongly supports the proposed rule and               helps to assure the safety, quality, and
                                                  This proposed rule would supersede                      further adds that expanding telehealth                accountability of the care provided. This
                                                  any State requirement regarding the                     to rural and highly rural veterans across             proposed rule preempts State law as it
                                                  practice of telehealth, such as the in-                 State lines would strengthen the                      applies to health care providers who
                                                  person examination requirement in                       delivery of care to enrolled veterans                 practice telehealth while acting within
                                                  Florida, and would maintain the                         who live in rural and highly rural areas              the scope of their VA employment.
                                                  restrictions imposed by Federal law and                 and supports the critical need for access                The Michigan Department of
                                                  policy regarding the prescription of                    to mental health care.                                Licensing and Regulatory Affairs
                                                  controlled substances. The North                           The West Virginia Board of                         responded to VA’s letter by stating that
                                                  Carolina Medical Board recognizes the                   Osteopathic Medicine responded to                     Michigan law does not require a VA
                                                  shortage of psychiatric care in rural and               VA’s letter and indicated that West                   health care provider to hold a Michigan
                                                  medically underserved communities                       Virginia has made legislative changes to              State license in the discharge of official
                                                  and supports VA’s initiative.                           encourage physician participation in the              duties. The commenter also stated that
                                                     The President of the National                        VA system. The commenter stated that                  telehealth at a VA medical facility
                                                  Association of State Directors of                       W.Va. Code 30–14–12c authorizes the                   would be permitted. However, if the
                                                  Veterans Affairs (NASDVA) sent an                       West Virginia licensing boards to issue               health care provider is delivering care to
                                                  email to all of its State directors                     a license to a physician licensed in                  the beneficiary’s home, such provider
                                                  informing the directors of the                          another State via reciprocity when the                would need a Michigan State license. As
                                                  association’s intent to fully support                   applicant presents proof that they are a              we have indicated in this proposed rule,
                                                  VA’s initiative. The NASDVA also                        VA employee working in a VA medical                   VA would preempt State law as it
                                                  formally responded to our letter, which                 facility that is located in a county where            applies to health care providers who
                                                  fully supports VA’s plans to amend its                  a nursing home is operated by the West                practice telehealth while acting within
                                                  regulations and enhance access to                       Virginia Department of Veteran’s                      the scope of their VA employment.
                                                  health care via telehealth services. The                Assistance. Also, W.Va. Code 30–14–                      The Virginia Board of Medicine
                                                  National Council of State Boards of                     12d states the requirements for                       responded to VA’s letter by stating that
                                                  Nursing (NCSBN) fully supports VA’s                     practicing telemedicine in West Virginia              the Executive Committee of the Board
                                                  initiative for health care providers to                 and defines that the practice of                      met and supported the enhancement of
                                                  deliver services via telehealth as long as              medicine occurs where the patient is                  access to care for veterans. The
                                                  such providers maintain a valid State                   located and defines what constitutes a                commenter stated that the proposed rule
                                                  license. However, the NCSBN does not                    physician-patient relationship. The                   should benefit many beneficiaries that
                                                  support expanding VA State licensure                    commenter stated that the West Virginia               have little or no access to health care.
                                                  exemptions to personal services                         Board of Osteopathic Medicine rarely                     The comments provided above will be
                                                  contractors who practice telehealth. As                 knows when a VA physician is                          placed on Regulations.gov for public
                                                  stated in this proposed rulemaking, VA                  practicing in West Virginia without a                 inspection during the comment period.
                                                  contractors would be excluded from                      West Virginia State license. However,                 Stakeholders will also have an
                                                  providing telehealth services.                          the commenter cautioned that if a VA                  opportunity to provide comments
                                                     The Chief Executive Officer of the                   physician is licensed in West Virginia                during the notice and comment period.
                                                  Association of State and Provincial                     and does not follow state law and such                   This proposed rule complies with
                                                  Psychology Boards formally responded                    action becomes known to the Board, the                Executive Order 13132 by (1)
                                                  to our letter and indicated that the                    Board would file a complaint and                      identifying where the exercise of State
                                                  proposed rule is in alignment with their                investigate such action. The commenter                authority would directly conflict with
                                                  current initiatives, specifically,                      stated that their telehealth law was                  the rule; (2) limiting preemption to
                                                  Psychology Interjurisdictional Compact                  written to protect patients and indicated             these areas of conflict; (3) restricting
                                                  (PSYPACT) legislation, which has been                   that veterans deserved the same high                  preemption to the minimum level
                                                  adopted in three jurisdictions and is                   quality care. As we have stated in this               necessary to achieve the objectives of
                                                  under active consideration in many                      proposed rule, we are preempting State                the statutes pursuant to which the rule
                                                  more States. The PSYPACT legislation                    law as it applies to health care providers
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                                                                                                                                                                is promulgated; (4) consulting with the
                                                  allows psychologists to provide                         who practice telehealth while acting                  external stakeholders listed in this rule;
                                                  telepsychology services across State                    within the scope of their VA                          and (5) providing opportunity for all
                                                  lines via a compact without obtaining                   employment.                                           affected State and local officials to
                                                  additional licenses. The Chief Executive                   The Pennsylvania State Board of                    comment on this proposed rulemaking.
                                                  Officer further stated that these services              Medicine responded to VA’s letter and
                                                  will be of assistance in addressing the                 acknowledged the potential value for                  Effect of Rulemaking
                                                  delivery of telehealth services to                      telehealth to expand access to health                   Title 38 of the Code of Federal
                                                  veterans.                                               care, especially in rural and                         Regulations, as revised by this proposed


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                                                                         Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules                                            45761

                                                  rule, represents VA’s implementation of                 entitlements, grants, user fees, or loan              potential adverse actions by States,
                                                  its legal authority on this subject. Other              programs or the rights and obligations of             many VAMCs are currently not
                                                  than future amendments to this rule or                  recipients thereof; or (4) Raise novel                expanding some critical telehealth
                                                  governing statutes, no contrary guidance                legal or policy issues arising out of legal           services if the health care service is
                                                  or procedures are authorized. All                       mandates, the President’s priorities, or              provided outside Federal property (such
                                                  existing or subsequent VA guidance                      the principles set forth in this Executive            as when the VA provider is delivering
                                                  must be read to conform with this rule                  Order.’’                                              telehealth care from his or her home) or
                                                  if possible. If not possible, such                         OMB has determined that it is a                    across State lines, or the care is
                                                  guidance is superseded by this rule.                    significant regulatory action under                   delivered in a beneficiary’s home. In
                                                                                                          Executive Order 12866 given the policy                addition many individual VA health
                                                  Paperwork Reduction Act                                 implications. In addition, under                      care providers refuse to practice
                                                    This proposed rule contains no                        Executive Order 13771 (Reducing                       telehealth because of concerns over
                                                  provisions constituting a collection of                 Regulation and Controlling Regulatory                 States taking action against their State
                                                  information under the Paperwork                         Costs), this proposed rule is expected to             license. This rule will supersede State
                                                  Reduction Act of 1995 (44 U.S.C. 3501–                  be an E.O. 13771 deregulatory action,                 restrictions on the practice of telehealth
                                                  3521).                                                  though VA is not able to quantify any                 and allow VA health care providers to
                                                  Regulatory Flexibility Act                              cost savings associated with it. VA’s                 practice telehealth anywhere within a
                                                                                                          impact analysis can be found as a                     State (such as from the residence of the
                                                    The Secretary hereby certifies that                   supporting document at http://                        health care provider) and across State
                                                  this proposed rule will not have a                      www.regulations.gov, usually within 48                lines.
                                                  significant economic impact on a                        hours after the rulemaking document is                   In sum, providing a 60 day public
                                                  substantial number of small entities as                 published. Additionally, a copy of the                comment period instead of a 30 day
                                                  they are defined in the Regulatory                      rulemaking and its impact analysis are                public comment period would be
                                                  Flexibility Act, 5 U.S.C. 601–612. This                 available on VA’s Web site at http://                 against public interest and the health
                                                  proposed rule directly affects only                     www.va.gov/orpm/, by following the                    and safety of VA beneficiaries because
                                                  individuals who are VA employees and                    link for ‘‘VA Regulations Published                   any restriction from a State or State
                                                  will not directly affect small entities.                from FY 2004 Through Fiscal Year to                   licensing board on practicing telehealth,
                                                  Therefore, pursuant to 5 U.S.C. 605(b),                 Date.’’                                               within the State or across State lines,
                                                  this rulemaking is exempt from the                         Executive Order 12866 also directs                 could impede beneficiaries’ access to
                                                  initial and final regulatory flexibility                agencies to ‘‘include a comment period                health care, which will ultimately
                                                  analysis requirements of 5 U.S.C. 603                   of not less than 60 days.’’ Given the                 impact the health of the beneficiary. For
                                                  and 604.                                                importance of telehealth in providing                 the above reasons, the Secretary issues
                                                  Executive Orders 12866, 13563, and                      critical, and potentially lifesaving,                 this rule with a 30 day public comment
                                                  13771                                                   access to health care for our                         period. VA will consider and address
                                                                                                          beneficiaries, VA must act                            comments that are received within 30
                                                     Executive Orders 12866 and 13563                     expeditiously, through this rulemaking,               days of the date this proposed rule is
                                                  direct agencies to assess the costs and                 to ensure that it can expand its                      published in the Federal Register.
                                                  benefits of available regulatory                        telehealth program. The primary barrier
                                                  alternatives and, when regulation is                    to the expansion of VA’s telehealth                   Unfunded Mandates
                                                  necessary, to select regulatory                         program is that States’ licensing boards                 The Unfunded Mandates Reform Act
                                                  approaches that maximize net benefits                   have placed explicit restrictions on the              of 1995, 2 U.S.C. 1532, requires that
                                                  (including potential economic,                          use of telehealth in their States and have            agencies prepare an assessment of
                                                  environmental, public health and safety                 not made exceptions for VA providers,                 anticipated costs and benefits before
                                                  effects, and other advantages;                          which ultimately inhibits VA providers                issuing any rule that may result in the
                                                  distributive impacts; and equity).                      from delivering VA health care to                     expenditure by State, local, and tribal
                                                  Executive Order 13563 (Improving                        beneficiaries. Five of the States with the            governments, in the aggregate, or by the
                                                  Regulation and Regulatory Review)                       largest veteran populations, California,              private sector, of $100 million or more
                                                  emphasizes the importance of                            Texas, Florida, New York, and Ohio,                   (adjusted annually for inflation) in any
                                                  quantifying both costs and benefits,                    have enacted laws and rules that restrict             one year. This proposed rule will have
                                                  reducing costs, harmonizing rules, and                  health care providers’ ability to practice            no such effect on State, local, and tribal
                                                  promoting flexibility. Executive Order                  telehealth across State lines. See, 16                governments, or on the private sector.
                                                  12866 (Regulatory Planning and                          C.C.R. § 1815.5; Cal Bus & Prof Code
                                                  Review) defines a ‘‘significant                                                                               Catalog of Federal Domestic Assistance
                                                                                                          §§ 2052, 2060; TX Occupation Code
                                                  regulatory action,’’ requiring review by                § 151.056; TX Admin Code, Title 22,                     The Catalog of Federal Domestic
                                                  the Office of Management and Budget                     § 172.12; FL Admin Code 64B8–9.0141;                  Assistance numbers and titles for the
                                                  (OMB), unless OMB waives such                           FL Admin Code 64B15–14.0081; NY                       programs affected by this document are:
                                                  review, as ‘‘any regulatory action that is              Consolidated Law Service Public Health                64.007, Blind Rehabilitation Centers;
                                                  likely to result in a rule that may: (1)                § 2805–u; OH Revised Code Annotated,                  64.008, Veterans Domiciliary Care;
                                                  Have an annual effect on the economy                    Sec. 4731.296(C). As telehealth                       64.009, Veterans Medical Care Benefits;
                                                  of $100 million or more or adversely                    capabilities continue to expand, new                  64.010, Veterans Nursing Home Care;
                                                  affect in a material way the economy, a                 State legislation and regulations across              64.011, Veterans Dental Care; 64.012,
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                                                  sector of the economy, productivity,                    the country are enacted relating to the               Veterans Prescription Service; 64.013,
                                                  competition, jobs, the environment,                     practice of telehealth. The possibility of            Veterans Prosthetic Appliances; 64.018,
                                                  public health or safety, or State, local,               sanctions to VA health care providers’                Sharing Specialized Medical Resources;
                                                  or tribal governments or communities;                   State license, including fines and                    64.019, Veterans Rehabilitation Alcohol
                                                  (2) Create a serious inconsistency or                   imprisonment for unauthorized practice                and Drug Dependence; 64.022, Veterans
                                                  otherwise interfere with an action taken                of medicine has hindered VA’s ability to              Home Based Primary Care; 64.039
                                                  or planned by another agency; (3)                       expand its telehealth program. To                     CHAMPVA; 64.040 VHA Inpatient
                                                  Materially alter the budgetary impact of                protect VA health care providers from                 Medicine; 64.041 VHA Outpatient


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                                                  45762                    Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules

                                                  Specialty Care; 64.042 VHA Inpatient                    § 17.417    Health care providers.                       (ii) The beneficiary is receiving
                                                  Surgery; 64.043 VHA Mental Health                          (a) Definitions. The following                     services in a State other than the health
                                                  Residential; 64.044 VHA Home Care;                      definitions apply to this section.                    care provider’s State of licensure,
                                                  64.045 VHA Outpatient Ancillary                            (1) Beneficiary. The term beneficiary              registration, or certification;
                                                  Services; 64.046 VHA Inpatient                          means a veteran or any other individual                  (iii) The health care provider is
                                                  Psychiatry; 64.047 VHA Primary Care;                    receiving health care under title 38 of               delivering services in a State other than
                                                  64.048 VHA Mental Health Clinics;                       the United States Code.                               the health care provider’s State of
                                                  64.049 VHA Community Living Center;                        (2) Health care provider. The term                 licensure, registration, or certification;
                                                  and 64.050 VHA Diagnostic Care.                         health care provider means an                            (iv) The health care provider is
                                                                                                          individual who:                                       delivering services either on or outside
                                                  Signing Authority                                          (i) Is licensed, registered, or certified          VA property;
                                                                                                          in a State to practice a health care                     (v) The beneficiary is receiving
                                                    The Secretary of Veterans Affairs, or
                                                                                                          specialty identified under 38 U.S.C.                  services while she or he is located either
                                                  designee, approved this document and
                                                                                                          7402(b);                                              on or outside VA property;
                                                  authorized the undersigned to sign and
                                                                                                             (ii) Is appointed to an occupation in                 (vi) The beneficiary has or has not
                                                  submit the document to the Office of the
                                                                                                          the Veterans Health Administration that               previously been assessed, in person, by
                                                  Federal Register for publication
                                                                                                          is listed in or authorized under 38                   the health care provider; or
                                                  electronically as an official document of                                                                        (vii) Other State requirements would
                                                                                                          U.S.C. 7401(1) or (3);
                                                  the Department of Veterans Affairs. Gina                   (iii) Maintains credentials (e.g., a               prevent or impede the practice of health
                                                  S. Farrisee, Deputy Chief of Staff,                     license, registration, or certification) in           care providers delivering telehealth to
                                                  Department of Veterans Affairs,                         accordance with the requirements of his               VA beneficiaries.
                                                  approved this document on July 28,                      or her medical specialty as identified                   (c) Preemption of State law. To
                                                  2017 for publication.                                   under 38 U.S.C. 7402(b); and                          achieve important Federal interests,
                                                  List of Subjects in 38 CFR Part 17                         (iv) Is not a VA-contracted employee.              including, but not limited to, the ability
                                                                                                             (3) State. The term State means a State            to provide the same complete medical
                                                    Administrative practice and                           as defined in 38 U.S.C. 101(20), or a                 and hospital service to beneficiaries in
                                                  procedure, Alcohol abuse, Alcoholism,                   political subdivision of such a State.                all States under 38 U.S.C. 7301, this
                                                  Claims, Day care, Dental health, Drug                      (4) Telehealth. The term telehealth                section preempts conflicting State laws
                                                  abuse, Foreign relations, Government                    means the use of electronic information               relating to the practice of health care
                                                  contracts, Grant programs—health,                       or telecommunications technologies to                 providers when such health care
                                                  Grant programs—veterans, Health care,                   support clinical health care, patient and             providers are practicing telehealth
                                                  Health facilities, Health professions,                  professional health-related education,                within the scope of their VA
                                                  Health records, Homeless, Medical and                   public health, and health                             employment. Any State law, rule,
                                                  dental schools, Medical devices,                        administration.                                       regulation or requirement pursuant to
                                                  Medical research, Mental health                            (b) Health care provider’s practice. (1)           such law, is without any force or effect
                                                  programs, Nursing homes, Reporting                      Health care providers may provide                     on, and State governments have no legal
                                                  and recordkeeping requirements,                         telehealth services, within their scope of            authority to enforce them in relation to,
                                                  Scholarships and fellowships, Travel                    practice and in accordance with                       this section or decisions made by VA
                                                  and transportation expenses, Veterans.                  privileges granted to them by the                     under this section.
                                                    Dated: September 26, 2017.
                                                                                                          Department, irrespective of the State or              [FR Doc. 2017–20951 Filed 9–29–17; 8:45 am]
                                                                                                          location within a State where the health
                                                  Michael Shores,                                                                                               BILLING CODE 8320–01–P
                                                                                                          care provider or the beneficiary is
                                                  Director, Regulation Policy & Management,               physically located. Health care
                                                  Office of the Secretary, Department of
                                                  Veterans Affairs.
                                                                                                          providers’ practice is subject to the
                                                                                                          limitations imposed by the Controlled                 ENVIRONMENTAL PROTECTION
                                                                                                          Substances Act, 21 U.S.C. 801, et seq.,               AGENCY
                                                    For the reasons set forth in the
                                                  preamble, we propose to amend 38 CFR                    on the authority to prescribe or                      40 CFR Part 52
                                                  part 17 as follows:                                     administer controlled substances, as
                                                                                                          well as any other limitations on the                  [EPA–R06–OAR–2016–0406; FRL–9967–77–
                                                  PART 17—MEDICAL                                         provision of VA care set forth in                     Region 6]
                                                                                                          applicable Federal law and policy. This
                                                                                                                                                                Approval and Promulgation of
                                                  ■ 1. The authority citation for part 17 is              section only grants health care providers
                                                                                                                                                                Implementation Plans; New Mexico;
                                                  amended by adding an entry for                          the ability to practice telehealth within
                                                                                                                                                                Albuquerque and Bernalillo County;
                                                  § 17.417 in numerical order to read in                  the scope of their VA employment and
                                                                                                                                                                Regional Haze Progress Report State
                                                  part as follows:                                        does not otherwise grant health care
                                                                                                                                                                Implementation Plan
                                                    Authority: 38 U.S.C. 501, and as noted in             providers additional authorities that go
                                                  specific sections.                                      beyond the scope of the health care                   AGENCY:  Environmental Protection
                                                  *      *     *       *      *                           providers’ State license, registration, or            Agency (EPA).
                                                    Section 17.417 also issued under 38 U.S.C.            certification.                                        ACTION: Proposed rule.
                                                  1701 (note), 1709A, 1712A (note), 1722B,                   (2) Situations where a health care
                                                                                                          provider’s VA practice of telehealth may              SUMMARY:   Pursuant to the Federal Clean
sradovich on DSK3GMQ082PROD with PROPOSALS




                                                  7301, 7330A, 7401–7403; 7406 (note)).
                                                                                                          be inconsistent with a State law or State             Air Act (CAA or the Act), the
                                                  ■ 2. Revise the undesignated center                     license, registration, or certification               Environmental Protection Agency (EPA)
                                                  heading immediately after § 17.412 to                   requirements related to telehealth                    is proposing to approve a revision to a
                                                  read as follows:                                        include when:                                         State Implementation Plan (SIP) for the
                                                  Authority of Health Care Providers to                      (i) The beneficiary and the health care            City of Albuquerque and Bernalillo
                                                  Practice in the Department                              provider are physically located in                    County, New Mexico (the County)
                                                                                                          different States during the episode of                submitted by the Governor on June 24,
                                                  ■   3. Add § 17.417 to read as follows:                 care;                                                 2016. The SIP revision addresses


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Document Created: 2017-09-30 04:41:48
Document Modified: 2017-09-30 04:41:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesComments must be received on or before November 1, 2017.
ContactKevin Galpin, MD, Executive Director Telehealth Services, Veterans Health Administration Office of Connected Care, 810 Vermont Avenue NW., Washington, DC 20420. (404) 771-8794. (This is not a toll-free number.) [email protected]
FR Citation82 FR 45756 
RIN Number2900-AQ06
CFR AssociatedAdministrative 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; Reporting and Recordkeeping Requirements; Scholarships and Fellowships; Travel and Transportation Expenses and Veterans

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