Authority of Health Care Providers To Practice Telehealth, 21897-21907 [2018-10114]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Rules and Regulations]
[Pages 21897-21907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10114]


-----------------------------------------------------------------------

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: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Department of Veterans Affairs (VA) is amending its 
medical regulations by standardizing the delivery of care by VA health 
care providers through telehealth. This rule ensures that VA health 
care providers can offer 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 final rule achieves important Federal 
interests by increasing the availability of mental health, specialty, 
and general clinical care for all beneficiaries.

DATES: This final rule is effective June 11, 2018.

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: In a document published in the Federal 
Register on October 2, 2017, VA proposed to amend its medical 
regulations by standardizing the delivery of health care by VA health 
care providers through telehealth. 82 FR 45756. VA provided a 30-day 
comment period, which ended on November 1, 2017. We received 75 
comments on the proposed rule.
    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.'' See 38 U.S.C. 7301(b). 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 consistent 
with those laws.'' See 38 U.S.C. 501(a). The Under Secretary for Health 
is directly responsible to the Secretary for the operation of VHA. See 
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. See 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.

[[Page 21898]]

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. See 38 U.S.C. 7401-7464.
    To be eligible for appointment as a VA employee in a health care 
position covered by 38 U.S.C. 7402(b) (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 
developed a telehealth program as a modern, beneficiary- and family-
centered health care delivery model that leverages electronic 
information or telecommunication technologies to support clinical 
health care, patient and professional health-related education, public 
health, and health administration, 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 
certain 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. 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 that includes 
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.'' See 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.'' See 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.'' See Public Law 114-286, sec. 
3(a)(2).
    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 located, licensed, 
registered, certified, or otherwise authorized by the State. Without 
this rulemaking, 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 requirements for licensure, 
registration, certification, that restrict the practice of telehealth. 
A number of States have already enacted legislation or regulations that 
restrict the practice of interstate telehealth.
    This final rulemaking clarifies that VA health care providers may 
exercise their authority to provide health care through the use of 
telehealth, notwithstanding any State laws, rules, licensure, 
registration, or certification requirements to the contrary. In so 
doing, VA is exercising Federal preemption of conflicting State laws 
relating to the practice of health care providers; laws, rules, 
regulations, or other requirements are preempted 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 is the minimum necessary action for VA 
to furnish effective telehealth services because it would be 
impractical for VA to lobby each State to remove any 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 does not expand the scope of practice for VA health 
care providers beyond what is required or authorized by Federal law and 
regulations or as statutorily defined in the laws and practice acts of 
the health care provider's State of licensure. Additionally, 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. To further clarify 
this point, we have changed subsection (b) to clearly state that this 
section does not otherwise grant health care providers additional 
authorities that go beyond what is required or authorized by Federal 
law and regulations or as defined in the laws and practice acts of the 
health care providers' State license, registration, or certification. 
This is simply a clearer statement of the policy articulated in the 
proposed rule, but is being added because of the public comments we 
received expressing differing views on this matter.
    For these reasons, VA is establishing a new regulation, 38 CFR 
17.417, that authorizes VA health care providers to treat beneficiaries 
through telehealth irrespective of the State, or of the location in a 
State, of the VA health care provider or the beneficiary.
    Most of the comments that were received on the proposed rule 
support

[[Page 21899]]

the rule and are summarized as follows. We received several comments 
supporting the rule saying that it would increase access to health 
care, specifically for those beneficiaries who live in rural and 
medically underserved areas who are not able to go to a VA medical 
facility either because of their location or their medical conditions. 
We also received many comments in support of the rule stating that 
telehealth has been shown to improve clinical outcomes and would 
improve the quality of care at VA. The commenters stated that the 
telehealth program would be successful in treating beneficiaries with a 
variety of conditions, including respiratory conditions, cardiovascular 
conditions, psychotherapy, post-traumatic stress disorder, traumatic 
brain injuries, Parkinson's disease, multiple sclerosis, vision loss, 
sleep disorders, and audiological conditions. One commenter summarized 
key clinical studies demonstrating the benefits of telehealth 
technologies. Similarly, commenters stated that more convenient access 
to health care would result in more personalized care, more engagement 
by beneficiaries and their caregivers, better health outcomes, and an 
improved quality of life. Several commenters stated that the proposed 
rule would help streamline health care for veterans and would 
facilitate modern, beneficiary and family centered health care.
    In addition to the benefits for VA beneficiaries, many commenters 
supported the rule because it would benefit VA more generally and VA's 
health care providers. A commenter supported the rule, saying that it 
would protect health care providers while they are practicing within 
the scope of their VA employment. Multiple commenters supported the 
rule citing its cost effectiveness. In addition, a commenter said that 
it would result in shorter appointments for patients and physicians and 
would also decrease appointment no-show rates. Other commenters said 
that the rule would reduce the use and cost of transportation, save 
beneficiaries and their caregivers hours of their time and lost wages, 
result in hospital cost savings through decreased emergency room and 
hospital visits, and increase local revenues for laboratories and 
pharmacies. In addition, multiple commenters supported the rule stating 
that State licensing barriers hindered telehealth and that it was 
necessary to remove artificial and geographic State barriers. A 
commenter also stated that they supported the proposed rule because it 
would provide opportunities for the medical students and residents who 
train at VA to become familiar with telehealth and be exposed to its 
optimal uses.
    Several commenters supported the rule because it did not include 
contract physicians. In particular, one commenter stated that contract 
physicians are not subject to the same accountability, oversight, 
training, and quality control as those employed directly by VA. We are 
not making any edits based on these positive comments.
    In addition to the previously discussed comments supporting the 
rule, the Federal Trade Commission (FTC) also submitted a supportive 
comment. Specifically, the FTC said that the rule would likely increase 
access to telehealth services, increase the supply of telehealth 
providers, increase the range of choices available to patients, improve 
health care outcomes, reduce long-term costs by reducing 
hospitalizations and treatment of advanced disease, and reduce travel 
costs incurred by VA. The rule would also enhance price and non-price 
competition and improve the ability of VA to compete more effectively 
by hiring qualified providers and reducing VA's health care costs. FTC 
also stated that the rule would provide an important example to non-VA 
health care providers, state legislatures, employers, patients, and 
others of telehealth's potential benefits and may spur innovation among 
other health care providers and, thereby, promote competition and 
improve access to care. In addition, FTC stated that the rule may 
afford a valuable opportunity to gather data and provide additional 
evidence for VA and outside policymakers to assess the effects of 
telehealth expansion, thereby benefitting VA beneficiaries and health 
care consumers generally. We are not making any edits based on these 
comments.
    We received multiple comments that favored VA's proposed rule and 
that focused on how VA could utilize specific commercially available 
software and company products. The commenters believed that these 
products could improve the telehealth services described in the 
proposed rule. We appreciate the commenters' suggestions and innovative 
solutions, but these comments are beyond the scope of the proposed 
rule, which does not address the specific technology or platforms VA 
uses in furnishing telehealth. We are not making any edits based on 
these comments.
    A commenter was in support of the proposed rule but added that the 
rule should extend to all VA-funded health services. The proposed rule 
only addressed the protection of VA health care providers while 
providing telehealth services within the scope of their VA employment. 
We do not believe it is prudent or necessary at this time to include 
contract providers within the scope of this rule. We are not making any 
edits based on this comment.
    A commenter supported the rule, but indicated that VA should have a 
mechanism in place to monitor the overall satisfaction and health of 
the beneficiaries who receive care via telehealth. VA is committed to 
ensuring that beneficiaries receive high quality health care. VA has 
controls in place to continuously monitor the health care provided by 
all VA health care providers, including telehealth providers. This rule 
will not affect the quality of the health care provided or the internal 
controls currently in place. We are not making any edits based on this 
comment.
    Several commenters indicated that the rule should be extended to 
cover health care providers who participate in the Veterans Choice 
Program, authorized by section 101 of the Veterans Access, Choice, and 
Accountability Act of 2014 or other health care furnished by non-
Department providers. Similarly, another commenter said that the rule 
restricts VA ``regarding contracting with an outside entity that may be 
able to fill a need through Choice or any other community care 
program.'' The commenter stated that VA can ensure that a contractor 
meets the full standard of VA appointees by requiring that the 
contractor be a VA appointee and requiring that the contractor meet the 
licensure and credentialing requirements of 38 U.S.C. 7402(b).
    VA acknowledges that the rule does not provide the same protection 
for community health care providers furnishing care for VA, including 
health care providers who participate in the Choice Program, as it does 
for VA health care providers. The proposed rule stated that a health 
care provider must be appointed by VA and cannot be a VA-contracted 
health care provider. Community health care providers may practice 
telehealth; however, they would be required to adhere to their 
individual State license, registration, or certification requirements 
and would not be otherwise covered by this rule. We do not believe it 
is prudent or necessary at this time to include contract providers 
within the scope of this rule. Additionally, contractors are not given 
an appointment to VA; only employees are given appointments. To

[[Page 21900]]

further clarify this point, we have changed subsection (a)(2)(iv) to 
clearly state that this section does not apply to VA-contracted health 
care providers. This is simply a clearer statement of the policy 
articulated in the proposed rule, but is being added because of the 
public comments in which there is confusion as to whether a contractor 
is a VA employee. Finally, community providers may be unable or 
unwilling to furnish telehealth across State lines. The Federal Tort 
Claims Act (FTCA) would cover VA providers in the event of a 
malpractice claim, but FTCA does not cover community providers. It is 
unclear whether or not the insurers or State level tort claims acts 
would cover community providers in the case of malpractice. We are not 
making any other edits based on these comments.
    A commenter stated that VA should pay physicians under the Veterans 
Choice Program at or above the Medicare rate, and that VA should 
include rural health clinics in the Veterans Choice Program. These 
issues are related to administration of the Veterans Choice Program and 
not to this rule, which governs VA employees' authority to practice 
telehealth. This comment is, therefore, beyond the scope of the 
proposed rule. We are not making any edits based on this comment.
    Several commenters indicated that VA should take further efforts to 
combat States' laws restricting telehealth. We stated in the proposed 
rule that 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.'' We understand the commenters' concerns and agree 
that having equitable State laws relating to telehealth would be ideal. 
However, such action is beyond the scope of this rulemaking. We are not 
making any edits based on these comments.
    Several commenters were in favor of the rule but stated that 
registered nurses, nurse practitioners, physician assistants, and 
advanced practice registered nurses should be allowed to practice to 
the full extent of their clinical education, training, and national 
certificates. Several commenters also indicated that VA should prohibit 
the supervision of certified registered nurse anesthetist services from 
being included as part of the expansion of telehealth services in VA. 
The granting of full practice authority to certain advanced practice 
registered nurses has already been addressed via rulemaking. See 38 CFR 
17.415 and 81 FR 90198. Moreover, the proposed rule only addressed the 
types of settings where VA health care providers could provide 
telehealth services and established that all VA health care providers 
may be allowed to practice telehealth. As previously said in this 
rulemaking, the proposed rule does not expand VA health care providers' 
authority beyond what is required or authorized by Federal law and 
regulations or as defined in the laws and practice acts of the health 
care provider's State of licensure. Any changes except preempting State 
laws, rules, regulations and requirements that restrict VA's telehealth 
authority are beyond the scope of the proposed rule. We are not making 
any edits based on these comments.
    One commenter was concerned that health care providers would not be 
protected under their medical malpractice insurance plans. This 
rulemaking will allow VA to better protect its health care providers 
who practice telehealth within the scope of their VA employment, 
regardless of conflicting State laws or regulations. The FTCA is the 
exclusive remedy ``for damages for personal injury, including death, 
allegedly arising from malpractice or negligence of a health care 
employee of the [Veterans Health] Administration in furnishing health 
care or treatment while in the exercise of that employee's duties in or 
for the Administration.'' See 38 U.S.C. 7316. Subsection (c) of the 
statute provides in part: ``Upon a certification by the Attorney 
General that the defendant was acting in the scope of such person's 
employment in or for the Administration at the time of the incident out 
of which the suit arose, any such civil action or proceeding commenced 
in a State court shall be . . . deemed a tort action brought against 
the United States under the provisions of title 28 and all references 
thereto.'' VA health care providers would, therefore, be protected from 
personal liability while providing care within the scope of their VA 
employment, including the provision of telehealth services. We are not 
making any edits based on this comment.
    Several commenters were concerned that a health care provider would 
not be protected from all individual actions by the State against the 
provider's license, registration, or certification by the proposed 
rule. Another commenter indicated that a health care provider would be 
engaged in unauthorized health care practice unless the provider was 
licensed, registered, or certified in the State where they practice. As 
we said in the proposed rule, ``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.'' 
We also said that ``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).'' 
Therefore, VA health care providers are protected by this final rule 
from any actions by individual States or State licensing boards to 
enforce a State law, rule, regulation or requirement while VA health 
care providers are practicing telehealth within the scope of their VA 
employment. We are not making any edits based on these comments.
    A commenter strongly supported States' ability to regulate the 
practice of telehealth within their State, saying that ``only 
physicians and surgeons licensed in [a State] should be allowed to 
practice medicine in [in that State], in order to ensure the highest 
quality medical care is being provided to health care consumers.'' The 
commenter further said that the proposed rule ``would undermine [the 
State's] ability to protect health care consumers, as the Board will 
have no ability to discipline VA providers that are licensed in another 
state and providing telehealth outside of a VA facility in [that 
State], as they do not hold a license to practice medicine in [their 
State].'' VA disagrees that this rulemaking will undermine the States' 
abilities to protect their health care consumers. VA has robust 
requirements for disciplining providers who fail to provide adequate 
health care, which includes reporting that provider to his or her 
licensing board, if applicable. We are not making any edits based on 
this comment.
    One commenter recommended that VA work to improve the system for 
investigating, removing, and reporting bad providers to State licensing 
boards and also recommended that this be part of the policy that would 
implement this rulemaking. Another commenter also expressed concern 
that if a State cannot discipline a physician practicing medicine 
within its borders, it undermines the medical licensure system. VA 
currently has a system in place for reporting health care providers to 
State licensing boards whose behavior or clinical practice so 
substantially failed to meet generally-accepted standards of clinical 
practice as to raise reasonable concern for the safety of patients. VA 
continues to work closely with State licensing boards to further 
improve the reporting of VA

[[Page 21901]]

health care providers who have failed in VA's mission of providing safe 
care to its beneficiaries. Patients would still have the ability to 
file a tort claim and States would still have ability to prosecute for 
criminal offenses. However, this rulemaking only focuses on the 
expansion of VA telehealth services and only prohibits States from 
taking actions to enforce a State law, rule, regulation or requirement 
against VA health care providers while practicing telehealth. We are 
not making any edits based on these comments.
    One commenter indicated that telehealth may not be the appropriate 
means of delivering health care to beneficiaries with some mental 
health conditions. Another commenter said that telehealth would not 
benefit homeless beneficiaries who suffer from mental conditions. We 
agree with the commenters that telehealth may not be the most 
appropriate means for the delivery of health care for all 
beneficiaries. However, health care providers and beneficiaries will 
have the opportunity to determine the best treatment option for the 
delivery of health care in each individual situation. We also agree 
that the delivery of health care via telehealth in a beneficiary's home 
may not be a viable means of health care for a homeless beneficiary. 
However, homeless beneficiaries may still benefit from telehealth 
visits from their local VA medical facility. A homeless beneficiary can 
be seen in a VA medical facility and be treated for his or her health 
condition from a health care specialist who is remotely performing the 
health care visit from another VA medical facility. We are not making 
any edits based on these comments.
    Several commenters were concerned that the health care provider 
would rely on verbal communication and not be able to observe symptoms 
such as manic behaviors, tremors, cuts, bruises, or other possible 
signs of self-imposed injuries that would have otherwise been visible 
in an in person exam. A commenter said that health care providers would 
get a limited medical history by examining a beneficiary via 
telehealth, especially if the beneficiary has comorbidities and 
addictions that may not be obvious via telehealth. The commenter 
further said that beneficiaries could be misdiagnosed and some health 
care conditions missed if the beneficiary was only seen via telehealth. 
Another commenter said that a face to face interview helps a health 
care provider gain a better rapport with a patient. Another commenter 
was also concerned that the continuity of health care would be affected 
because the primary care provider would not have access to the 
telehealth records and thus be presented with an incomplete medical 
history of the patient. This would especially be detrimental if the 
beneficiary had been prescribed medications during the telehealth 
visit. The commenter indicated that the beneficiary would receive a 
lower quality of care via telehealth than what they would have received 
in an in-person health care visit. Another commenter said that the use 
of telehealth for eye care services should not substitute the benefits 
of an in-person eye examination. This rulemaking authorizes VA 
providers to offer telehealth services as an option for beneficiaries 
irrespective of the location of the health care provider or the 
beneficiary. The rule enhances the accessibility of VA health care by 
providing beneficiaries an additional option through which they can 
engage in the health care system. The rule does not create a 
requirement for service delivery through telehealth; instead, it 
empowers health care providers and beneficiaries to choose when 
telehealth is appropriate. VA believes that the health care provider 
and the beneficiary are in the best position to make decisions about 
the risks and benefits of any health care decision and will ultimately 
decide the best option for the delivery of such care. Also, VA health 
care providers will have access to a beneficiary's health record during 
a telehealth visit and the telehealth visit will become part of the 
health record. We are not making any edits based on these comments.
    Several commenters questioned the privacy of the beneficiary when 
video-conferencing was used. The commenters were concerned that the 
telehealth visit would be intercepted by a third party, which would 
violate the beneficiary's privacy. A commenter was also concerned that 
putting the beneficiary's information on an online database would give 
rise to Health Insurance Portability and Accountability Act (HIPAA) and 
security concerns. Another commenter said that the proposed rule did 
not ``identify security standards or other requirements VA health care 
providers are expected to abide by when providing services via 
telehealth.'' Information security and privacy are critical priorities 
for VA. The Veterans Health Administration, and its telehealth program, 
work hand in hand with the VA Office of Information Technology and 
Information Security when implementing telehealth programs. Equipment, 
software, and process choices are made to mitigate security risks and 
ensure adherence to the Federal Government's stringent information 
security and privacy requirements, including standards defined by the 
Federal Information Security Management Act, the National Institute of 
Standards and Technology, the Privacy Act, and HIPAA. As an example of 
one measure to protect privacy, clinical video data is encrypted to 
mitigate the risk of third party interception during video visits. 
Beneficiary data will not be stored outside VA, nor will it persist on 
the beneficiary's device following the telehealth session. All VA 
employees, including health care providers, have to adhere to the 
privacy and security standards implemented by VA. We are not making any 
edits based on these comments.
    Another commenter strongly felt that beneficiaries should be seen 
in-person at least once before being prescribed medication, including 
controlled substances. Several commenters encouraged VA to establish an 
interagency working group between VA, the Food and Drug Administration, 
and the Drug Enforcement Administration (DEA) to ensure that 
beneficiaries have safe access to care by modernizing rules regarding 
advanced practice registered nurses prescriptive authority. The 
proposed rule said that the rule ``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.'' We also said in the proposed rule that health 
care providers will 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.'' Any change to the Controlled 
Substances Act or the creation of a working group is outside the scope 
of the proposed rule. We are not making any edits based on these 
comments.
    One commenter was concerned that there might be insurance fraud on 
the part of health care providers who practice in one State and deliver 
health care services via telehealth in another State. VA health care 
providers would not directly engage in third party insurance claims. 
Moreover, billing is beyond the scope of this rulemaking. We are not 
making any edits based on this comment.
    Another commenter said that VA does not allow for ``potential and 
applicable

[[Page 21902]]

copayments and deductibles to be collected at the time of service for 
eligible veterans receiving care or services.'' The commenter finds 
that not allowing this type of copayment collection is ``unworkable and 
contrary to medical office billing practices.'' We stated in the 
Supplementary Information paragraph of the proposed rule that 
``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.'' See 38 U.S.C. 
1722B.'' Also, under 38 CFR 17.108(e)(16), in-home video telehealth 
care is not subject to the collection of copayments. We are not making 
any edits based on these comments.
    Several commenters expressed concern that beneficiaries may not 
have access to a computer or the internet. The commenters were 
concerned that these beneficiaries would not be able to access health 
care via telehealth because of the lack of technology in the 
beneficiary's home. Another commenter was concerned that there might be 
potential connectivity issues in rural areas due to limited access to 
broadband internet. A commenter questioned whether VA would assist a 
beneficiary in setting up the telehealth services or provide financial 
assistance for the equipment or internet access. A commenter requested 
that VA clarify whether electronic information or telecommunications 
technologies includes video conferencing and telephone. VA continues to 
look into solutions to resolve technical difficulties in its expansion 
of telehealth services. This rulemaking addresses one critical barrier 
to standardizing service availability via telehealth, inclusive of 
video conferencing, telephone, and other telecommunication 
technologies, but does not address all barriers, including the access 
to technology. We are not making any edits based on these comments.
    A commenter questioned how the proposed rule would be affected by 
another proposed rule on Prosthetic and Rehabilitative Items and 
Services and how this other rule would impact telehealth service 
provision of certain equipment and services. The proposed rule does not 
address how VA would provide equipment used in telehealth visits. The 
provision of telehealth equipment is beyond the scope of the proposed 
rule. We are not making any edits based on this comment.
    A commenter asked whether VA would offer ``cyber-clinical rooms'' 
in VA medical facilities to provide telehealth services. Where 
beneficial, VA will equip space for telehealth assessments. We are not 
making any edits based on this comment.
    One commenter questioned how the beneficiary will know if 
telehealth is available to them for their health care needs. As 
previously said in this final rule, telehealth enhances the 
accessibility of VA health care by providing beneficiaries an 
additional option through which they can engage in the VA health care 
system. The rulemaking leaves the discussion about the health care 
modality chosen to the health care provider and the beneficiary. Also 
neither this final rule nor the proposed rule prescribe the details of 
how the telehealth program will be further implemented. We are not 
making any edits based on this comment.
    One commenter was concerned that the proposed rule did not address 
how a ``potential emergent situation would be addressed in situations 
where neither party is located at a VA medical center or other clinical 
site especially if the telehealth encounter occurs across state 
lines.'' The commenter stressed that VA should evaluate its protocols 
on telehealth to ensure continued patient safety, including having a 
back-up plan in case of an emergent situation, identifying a family 
member or other individual as a point of contact if the beneficiary 
experiences a crisis, and other types of local assistance for the 
beneficiary. VA has standard guidance to address emergent situations 
when providers and beneficiaries are not located at a VA medical 
facility or other clinical site, including when the telehealth visit 
occurs across State lines. A specific example of emergency management 
guidance is that health care providers are trained to have emergency 
contact information at the onset of video appointments for use in the 
event of an emergency. We are not making any edits based on this 
comment.
    One commenter expressed multiple concerns with the proposed rule. 
The commenter expressed concern that technology is necessary to utilize 
telehealth and that some beneficiaries may not want to use the 
technology while others may not be able to. The commenter felt that it 
was not fair to give beneficiaries the opportunity to have more access 
to health care by a means that they do not know how to use or do not 
want to use. We reiterate that the health care provider and the 
beneficiary will determine whether telehealth is appropriate in each 
individual situation; VA will not require telehealth. While we 
acknowledge the commenter's concern, VA believes that the health care 
provider and the beneficiary are in the best position to make decisions 
about the risks and benefits of any health care decision and will 
ultimately decide the best option for the delivery of such care. 
Moreover, allowing willing beneficiaries to participate in telehealth 
should increase the availability of in-person visits for those 
beneficiaries who prefer that option.
    Second, the commenter questioned authority VA has to override the 
State laws. The commenter said that in the absence of a specific 
mandate by Congress, this rule is an arbitrary agency action. The 
commenter explained that the Non-Delegation Doctrine prohibits Congress 
from delegating legislative powers to Federal agencies and that the 
Federal agency can only use those powers that Congress has chosen to 
give them in an enabling act. The commenter cited Executive Order 13132 
and quoted portions from Section 4(a) and 4(c). Specifically, the 
commenter said, ``[t]here has to be a federal statute that: `contains 
an express preemption provision or . . . some other clear evidence that 
Congress intended preemption of State law'. It follows: `Any regulatory 
preemption of State law shall be restricted to the minimal level 
necessary . . .' ''
    VA disagrees that we lack authority for this action. As explained 
in the proposed rule, Section 4(b) of Executive Order 13132 allows 
agencies to preempt State law so long as the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.
    Here, the exercise of a State's authority directly conflicts with 
the exercise of Federal authority under the Federal statue. 
Specifically, a State rule limiting telehealth directly conflicts with 
VA's authority under 38 U.S.C. 7401-7464 to establish the 
qualifications for VA's health care providers and otherwise regulate 
the professional activities of those individuals (i.e., allow its 
health care providers to practice telehealth anywhere). As previously 
mentioned in this rulemaking, 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'' and has otherwise required or authorized the use of 
telehealth by VA. See, e.g., 38 U.S.C. 1709A(a)(1).
    As to the commenter's citation to Section 4(c) of Executive Order 
13132, which limits pre-emption to the minimum level needed to achieve 
the objectives of the statutes, VA believes

[[Page 21903]]

that this final rule is restricted to the minimum level necessary to 
support its telehealth program. In particular, VA explicitly limited 
the scope of the rule to only allow its health care providers to 
practice telehealth anywhere. VA did not expand the scope of the rule 
to more generally allow its health care providers to practice beyond 
what is required or authorized by Federal law and regulations or as 
defined in the laws and practice acts of the health care provider's 
State of licensure, registration or certification.
    Finally, the commenter said that the Veterans E-Health and 
Telemedicine Support (VETS) Act of 2017 was introduced into the United 
States Senate in April 2017 and that it had not been approved by 
Congress or signed by the President. The commenter did not request that 
any changes be made to the regulation in light of the proposed 
legislation, nor did the commenter say that the final rule should not 
be published as a result of the proposed legislation. While legislative 
action would resolve any ambiguity as to VA's authority in this matter, 
the introduction of a piece of legislation is not evidence that VA does 
not already have authority in this area. VA has adequate authority for 
this rulemaking as described above and in the proposed rule. We make no 
edits to the rule based on this comment.
    Another commenter expressed concern that this rule was being 
implemented without clear direction from Congress and with an 
abbreviated comment period. As previously explained, an express mandate 
from Congress is not necessary for VA to regulate on this topic. In 
addition, although the period for public comment for this rule was 30 
days instead of 60 days, VA determined that it was against public 
interest and the health and safety of VA beneficiaries to have the 60 
day comment period, for the reasons specified in the proposed rule. 
Moreover, in compliance with Executive Order 13132 (Federalism), VA 
officially started consulting with State officials on July 12, 2017, 
well over 60 days prior to the publication of the rule. Therefore, the 
stakeholders most invested in the rule had more than 3 months to 
provide feedback to VA, and the majority of their comments supported 
the rule.
    The commenter also said that specific clarifications and additions 
are necessary to the rule. The commenter listed five criteria: (1) The 
standard of care must remain the same regardless of whether the 
services are provided via telehealth or in person; (2) eye and vision 
telehealth services cannot replace an in-person comprehensive eye 
examination; (3) the use of eye and vision telehealth may be 
appropriate for only certain uses that may be extended as new 
technologies are made available; (4) the use of eye and vision 
telehealth is not appropriate for establishing the doctor-patient 
relationship, for initial diagnosis, as a replacement for recommended 
face-to-face interactions, or as a replacement for partial or entire 
categories of care; and (5) screening for specific or groups of eye 
health issues using telehealth for direct-to-patient eye and vision-
related applications should not be used to diagnose eye health 
conditions or as a replacement or replication for a comprehensive 
dilated eye examination. VA appreciates the commenter's specific 
suggestions for when telehealth is most appropriate for vision and eye 
care; however, the commenter's request for clarification is beyond the 
scope of this rulemaking. This rulemaking does not establish 
requirements for when telehealth will be used nor does it establish 
criteria that must be met for a beneficiary to seek health care via 
telehealth. Instead, this rulemaking allows VA health care providers to 
practice telehealth regardless of their location or the location of the 
beneficiary. VA will make determinations on when the use of telehealth 
(i.e., vision/eye care and the like) will be appropriate outside of 
this rule. As such, the commenter's requested suggestions are beyond 
the scope of the rulemaking.
    Similarly, the commenter expressed concern regarding the standard 
of care and how to best ensure patient safety when telehealth is used. 
The commenter provided examples of how various jurisdictions addressed 
this concern. The commenter also said that a ``one-size-fits-all 
approach'' would be a step backwards and that at any point in the 
diagnosis and care continuum the patient should have the right to 
choose in-person care. The commenter recommended that VA ensure that 
all beneficiaries are aware that they can choose between telehealth or 
in-person care at any point. To ensure beneficiaries are apprised of 
their rights, the commenter recommended that VA require beneficiaries 
to sign an informed consent form. VA reiterates that this rulemaking is 
narrowly tailored to clarify the authority of VA health care providers 
to practice telehealth within the scope of their VA employment. The 
rulemaking does not establish the criteria for beneficiaries to 
participate in the telehealth program nor does it authorize a lower 
standard of care for patients who choose to receive service via 
telehealth. Accordingly, the commenter's suggestions are beyond the 
scope of the rule.
    The commenter also said that, in the absence of a true mandate by 
Congress, it is critical that VA consider the most recent statutory 
actions from Congress related to telehealth. The commenter then 
suggested that VA incorporate additional language from the 21st Century 
Cures Act (Pub. L. 114-255) into VA's definition of telehealth. The 
commenter quoted the following language from the Act (section 4012(c), 
130 Stat 1033, 1187-8).

    (c) Sense of Congress.--It is the sense of Congress that--. . . 
(2) any expansion of telehealth services under the Medicare program 
under title XVIII of such Act should--(A) recognize that 
telemedicine is the delivery of safe, effective, quality health care 
services, by a health care provider, using technology as the mode of 
care delivery; (B) meet or exceed the conditions of coverage and 
payment with respect to the Medicare program if the service was 
furnished in person, including standards of care, unless 
specifically addressed in subsequent legislation; and (C) involve 
clinically appropriate means to furnish such services.

VA has considered the language in the Act, but finds that it is beyond 
the scope of this rulemaking. We make no edits to the rule based on 
this comment.
    We are making several minor revisions from the proposed rule. We 
said in the proposed rule that we would revise the undesignated center 
heading immediately after Sec.  17.412 to read Authority of Health Care 
Providers to Practice in the Department. However, in order to maintain 
consistency in terminology we are amending the undesignated center 
heading by removing the term ``Department'' and adding in its place 
``VA.'' We are not making any edits to the meaning of the language in 
the proposed rule.
    We said in the proposed rule that the title of new Sec.  17.417 
would be ``Health care providers.'' However, because this rule 
addresses health care providers practicing telehealth, we are revising 
the title of Sec.  17.417 to now read ``Health care providers 
practicing via telehealth.'' We are similarly revising the title of 
paragraph (b) from ``Health care provider's practice'' to now read 
``Health care provider's practice via telehealth.'' We are not making 
any edits to the meaning of the language in the proposed rule.
    We said in proposed paragraph (a)(2)(iii) that a health care 
provider was an individual who ``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).'' In order to maintain

[[Page 21904]]

consistency in terminology within this section, we are amending 
paragraph (a)(2)(iii) by removing the term ``medical specialty'' and 
adding in its place health care specialty. We are making a similar 
amendment to paragraph (c) by removing the term ``medical and hospital 
care'' and adding in its place ``health care and hospital services.'' 
We are not making any edits to the meaning of the language in the 
proposed rule.
    Proposed paragraph (b)(1) said, in part, ``telehealth services, 
within their scope of practice and in accordance with privileges 
granted to them by the Department . . .''. However, in order to 
maintain consistency in terminology within this section, we are 
amending paragraph (b)(1) by removing the term ``Department'' and 
adding in its place ``VA.'' We are also adding the term ``functional 
statement'' and replacing ``and'' with ``and/or'' when describing when 
health care providers can provide telehealth services. Health care 
providers practice in accordance with their functional statement or 
scope of practice (for those not granted privileges) or privileges 
granted to them by VA; as such, we consider these clarifying revisions. 
We are not making any edits to the meaning of the language in the 
proposed rule.
    Based on the rationale set forth in the Supplementary Information 
to the proposed rule and in this final rule, VA is adopting the 
proposed rule with the edits discussed in this final rule.

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 final rule preempts 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 
notify them of 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 saying 
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 that issue, we said in the 
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 said that the Utah 
Occupations and Professions Licensing Act exempts from licensure 
requirements in Utah physicians, physician assistants, advanced 
practice nurses, psychologists or other health care providers 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's 
efforts to enhance telehealth services to all veterans. The Florida 
Board of Medicine said 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 final rule supersedes 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. NASDVA also formally responded to our letter, and 
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) 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. We said in the proposed rulemaking 
that VA contractors would not be permitted to practice telehealth 
services beyond what

[[Page 21905]]

is authorized by their State license, certification, or registration, 
and that has not changed in this final rule.
    The Chief Executive Officer of the Association of State and 
Provincial Psychology Boards formally responded to our letter and 
indicated that this rule aligns 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 said that these services will assist 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 said 
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 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 said 
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 said 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 said that their 
telehealth law was written to protect patients and indicated that 
veterans deserved the same high quality care. As we stated in the 
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, and that has not changed in this final rule.
    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 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 in a VA facility. 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 indicated in the proposed rule, VA preempts State law as it 
applies to health care providers who practice telehealth while acting 
within the scope of their VA employment, and that has not changed in 
this final rule.
    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 were placed on Regulations.gov for 
public inspection during the comment period. Stakeholders also had an 
opportunity to provide comments during the notice and comment period.
    This final 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 final rulemaking.

Effect of Rulemaking

    Title 38 of the Code of Federal Regulations, as revised by this 
final 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 final rule contains no provisions constituting a collection of 
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).

Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612. This final rule directly affects only individuals 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)

[[Page 21906]]

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 this is a significant regulatory action 
under Executive Order 12866 because of the policy implications. This 
final rule is considered an E.O. 13771 deregulatory action. Details on 
the estimated cost savings of this final rule can be found in the 
rule's economic analysis. VA's impact analysis can be found as a 
supporting document at https://www.regulations.gov, usually within 48 
hours after the rulemaking document is published. Additionally, a copy 
of the rulemaking and its impact analysis are available on VA's website 
at https://www.va.gov/orpm/, by following the link for ``VA Regulations 
Published from FY 2004 Through Fiscal Year to Date.''

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995, 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 final 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 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.

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.

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 February 6, 2018, for publication.

    Dated: May 8, 2018.
Consuela Benjamin,
Regulations Development Coordinator, Office of Regulation Policy & 
Management, Office of the Secretary, Department of Veterans Affairs.

    For the reasons set forth in the preamble, we are amending 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 VA

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


Sec.  17.417   Health care providers practicing via telehealth.

    (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 health 
care specialty as identified under 38 U.S.C. 7402(b); and
    (iv) Is not a VA-contracted health care provider.
    (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 via telehealth. (1) Health care 
providers may provide telehealth services, within their scope of 
practice, functional statement, and/or in accordance with privileges 
granted to them by VA, 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

[[Page 21907]]

grant health care providers additional authorities that go beyond what 
is required or authorized by Federal law and regulations or as defined 
in the laws and practice acts 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 health care 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. 2018-10114 Filed 5-10-18; 8:45 am]
 BILLING CODE 8320-01-P