45756 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules 

improve that analysis. We thus follow 

the same basic approach here. 

The full analysis of economic impacts 

is available in the docket for this 

proposed rule (Ref. 1) and at https://

www.fda.gov/AboutFDA/Reports

ManualsForms/Reports/Economic

Analyses. 

V. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(k) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

VI. Paperwork Reduction Act of 1995 

This proposed rule contains no 

collection of information. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995 is not required. 

VII. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. Section 

4(a) of the Executive Order requires 

Agencies to ‘‘construe * * * a Federal 

statute to preempt State law only where 

the statute contains an express 

preemption provision or there is some 

other clear evidence that the Congress 

intended preemption of State law, or 

where the exercise of State authority 

conflicts with the exercise of Federal 

authority under the Federal statute.’’ 

Section 403A of the FD&C Act (21 

U.S.C. 343–1) is an express preemption 

provision. Section 403A(a) of the FD&C 

Act provides that: ‘‘* * * no State or 

political subdivision of a State may 

directly or indirectly establish under 

any authority or continue in effect as to 

any food in interstate commerce—(4) 

any requirement for nutrition labeling of 

food that is not identical to the 

requirement of section 403(q) * * *.’’ 

The express preemption provision of 

section 403A(a) of the FD&C Act does 

not preempt any State or local 

requirement respecting a statement in 

the labeling of food that provides for a 

warning concerning the safety of the 

food or component of the food (section 

6(c)(2) of the Nutrition Labeling and 

Education Act of 1990, Pub. L. 101–535, 

104 Stat. 2353, 2364 (1990)). If this 

proposed rule is made final, the final 

rule would create requirements that fall 

within the scope of section 403A(a) of 

the FD&C Act. 

VIII. References 

The following reference is on display 

in the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. FDA has verified 

the Web site addresses, as of the date 

this document publishes in the Federal 

Register, but Web sites are subject to 

change over time. 

1. United States Department of Health and 

Human Services. United States Food and 

Drug Administration. Preliminary 

Regulatory Impact Analysis, Preliminary 

Regulatory Flexibility Analysis for 

Proposed Rule on ‘‘Food Labeling: 

Revision of the Nutrition and 

Supplement Facts Labels and Serving 

Sizes of Foods That Can Reasonably Be 

Consumed At One Eating Occasion; 

Dual-Column Labeling; Updating, 

Modifying, and Establishing Certain 

Reference Amounts Customarily 

Consumed; Serving Size for Breath 

Mints; and Technical Amendments; 

Extension of Compliance Dates.’’ 

September 2017. Available from http://

www.fda.gov/AboutFDA/Reports

ManualsForms/Reports/Economic

Analyses. 

Dated: September 26, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21019 Filed 9–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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 handdelivery 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.) 

Kevin.Galpin@va.gov. 

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 


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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 


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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 noninstitutional 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 VAapproved 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 § 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 


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created by a State, or authorized by a 

State in the definition. 

Last, in proposed paragraph (a)(4) of 

§ 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 § 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 § 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 § 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 


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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 inperson 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 


sradovich on DSK3GMQ082PROD with PROPOSALS
Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules 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. § 1815.5; Cal Bus & Prof Code 

§§ 2052, 2060; TX Occupation Code 

§ 151.056; TX Admin Code, Title 22, 

§ 172.12; FL Admin Code 64B8–9.0141; 

FL Admin Code 64B15–14.0081; NY 

Consolidated Law Service Public Health 

§ 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 


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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 

■ 1. The authority citation for part 17 is 

amended by adding an entry for 

§ 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)). 

■ 2. Revise the undesignated center 

heading immediately after § 17.412 to 

read as follows: 

Authority of Health Care Providers to 

Practice in the Department 

■ 3. Add § 17.417 to read as follows: 

§ 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] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R06–OAR–2016–0406; FRL–9967–77– 

Region 6] 

Approval and Promulgation of 

Implementation Plans; New Mexico; 

Albuquerque and Bernalillo County; 

Regional Haze Progress Report State 

Implementation Plan 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: Pursuant to the Federal Clean 

Air Act (CAA or the Act), the 

Environmental Protection Agency (EPA) 

is proposing to approve a revision to a 

State Implementation Plan (SIP) for the 

City of Albuquerque and Bernalillo 

County, New Mexico (the County) 

submitted by the Governor on June 24, 

2016. The SIP revision addresses 


sradovich on DSK3GMQ082PROD with PROPOSALS