Promoting Telehealth for Low-Income Consumers, 36865-36883 [2019-16077]
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Federal Register / Vol. 84, No. 146 / Tuesday, July 30, 2019 / Proposed Rules
environmental health or safety risks that
the EPA has reason to believe may
disproportionately affect children, per
the definition of ‘‘covered regulatory
action’’ in section 2–202 of the
Executive Order. This action is not
subject to Executive Order 13045
because it does not impose additional
requirements beyond those imposed by
state law.
I. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211, because it is not a
significant regulatory action under
Executive Order 12866.
J. National Technology Transfer and
Advancement Act (NTTAA)
Section 12(d) of the NTTAA directs
the EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. The EPA believes that this
action is not subject to the requirements
of section 12(d) of the NTTAA because
application of those requirements would
be inconsistent with the CAA.
K. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Population
The EPA lacks the discretionary
authority to address environmental
justice in this rulemaking.
List of Subjects in 40 CFR Part 62
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Landfills, Methane, Ozone, Reporting
and recordkeeping requirements, Sulfur
oxides, Volatile organic compounds.
Authority: 42 U.S.C. 7401 et seq.
Dated: July 23, 2019
Michael B. Stoker,
Regional Administrator, Region IX.
[FR Doc. 2019–16184 Filed 7–29–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
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40 CFR Part 300
[EPA–HQ–SFUND–1998–0006; FRL–9997–
19–Region 2]
National Oil and Hazardous
Substances Pollution Contingency
Plan; National Priorities List: Deletion
of the Peter Cooper Superfund Site
Environmental Protection
Agency (EPA).
AGENCY:
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ACTION:
Proposed rule; notice of intent.
The Environmental Protection
Agency (EPA) Region 2 is issuing a
Notice of Intent to Delete the Peter
Cooper Superfund Site (Site) located in
the Village of Gowanda, Cattaraugus
County, New York, from the National
Priorities List (NPL) and requests public
comments on this proposed action. The
NPL, promulgated pursuant to section
105 of the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA) of 1980, as amended, is an
appendix of the National Oil and
Hazardous Substances Pollution
Contingency Plan (NCP). The EPA and
the State of New York, through the
Department of Environmental
Conservation (NYSDEC), have
determined that all appropriate
response actions under CERCLA, other
than operation and maintenance,
monitoring and five-year reviews, have
been completed. However, this deletion
does not preclude future actions under
Superfund.
DATES: Comments must be received by
August 29, 2019.
ADDRESSES: Submit your comments,
identified by Docket ID no. EPA–HQ–
SFUND–1998–0006, by mail to Sherrel
Henry, Remedial Project Manager, U.S.
Environmental Protection Agency,
Region 2, 290 Broadway, 20th Floor,
New York, New York 10007–1866.
Comments may also be submitted
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courier by following the detailed
instructions in the ADDRESSES section of
the direct final rule located in the Rules
and Regulations section of this issue of
the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Sherrel Henry, Remedial Project
Manager, U.S. Environmental Protection
Agency, Region 2, 290 Broadway, 20th
Floor, New York, New York 10007–
1866, (212) 637–4273, email:
henry.sherrel@epa.gov.
SUPPLEMENTARY INFORMATION: In the
‘‘Rules and Regulations’’ section of this
issue of the Federal Register, we are
publishing a direct final Notice of
Deletion of the Peter Cooper Superfund
Site without prior Notice of Intent to
Delete because we view this as a
noncontroversial revision and anticipate
no adverse comment. We have
explained our reasons for this deletion
in the preamble to the direct final
Notice of Deletion, and those reasons
are incorporated herein. If we receive no
adverse comment(s) on this deletion
action, we will not take further action
on this Notice of Intent to Delete. If we
receive adverse comment(s), we will
SUMMARY:
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withdraw the direct final Notice of
Deletion, and it will not take effect. We
will, as appropriate, address all public
comments in a subsequent final Notice
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List of Subjects in 40 CFR Part 300
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pollution control, Chemicals, Hazardous
substances, Hazardous waste,
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Reporting and recordkeeping
requirements, Superfund, Water
pollution control, Water supply.
Authority: 33 U.S.C. 1321(d); 42 U.S.C.
9601–9657; E.O. 13626, 77 FR 56749, 3 CFR,
2013 Comp., p. 306; E.O. 12777, 56 FR 54757,
3 CFR, 1991 Comp., p. 351; E.O. 12580, 52
FR 2923, 3 CFR, 1987 Comp., p. 193.
Dated: July 16, 2019.
Peter D. Lopez,
Regional Administrator, Region 2.
[FR Doc. 2019–16063 Filed 7–29–19; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 54
[WC Docket No. 18–213; FCC 19–64]
Promoting Telehealth for Low-Income
Consumers
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
In this document, the Federal
Communications Commission
(Commission) seeks to propose a Pilot
program within the Universal Service
Fund (USF or Fund) to support
connected care for low-income
Americans and veterans. The
Commission specifically seeks to better
understand how the Fund can play a
role in helping patients stay directly
connected to health care providers
through telehealth services and improve
health outcomes among medically
underserved populations that are
missing out on vital technologies.
DATES: Comments are due on or before
August 29, 2019 and reply comments
are due on or before September 30,
2019. If you anticipate that you will be
submitting comments but find it
SUMMARY:
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difficult to do so within the period of
time allowed by this document, you
should advise the contact listed in the
following as soon as possible.
ADDRESSES: You may submit comments,
identified by WC Docket No. 18–213, by
any of the following methods:
• Federal Communications
Commission’s Website: https://
fjallfoss.fcc.gov/ecfs2/.
Electronic Filers: Comments may be
filed electronically using the internet by
accessing the ECFS: https://
fjallfoss.fcc.gov/ecfs2/.
• Paper Filers: Parties who choose to
file by paper must file an original and
one copy of each filing.
• Filings can be sent by hand or
messenger delivery, by commercial
overnight courier, or by first-class or
overnight U.S. Postal Service mail. All
filings must be addressed to the
Commission’s Secretary, Office of the
Secretary, Federal Communications
Commission.
• All hand-delivered or messengerdelivered paper filings for the
Commission’s Secretary must be
delivered to FCC Headquarters at 445
12th St. SW, Room TW–A325,
Washington, DC 20554. The filing hours
are 8:00 a.m. to 7:00 p.m. All hand
deliveries must be held together with
rubber bands or fasteners. Any
envelopes and boxes must be disposed
of before entering the building.
• Commercial overnight mail (other
than U.S. Postal Service Express Mail
and Priority Mail) must be sent to 9050
Junction Drive, Annapolis Junction, MD
20701.
• U.S. Postal Service first-class,
Express, and Priority mail must be
addressed to 445 12th St. SW,
Washington, DC 20554.
• Availability of Documents.
Comments, reply comments, and ex
parte submissions will be publicly
available online via ECFS. These
documents will also be available for
public inspection during regular
business hours in the FCC Reference
Information Center, which is located in
Room CYA257 at FCC Headquarters,
445 12th Street SW, Washington, DC
20554. The Reference Information
Center is open to the public Monday
through Thursday from 8:00 a.m. to 4:30
p.m. and Friday from 8:00 a.m. to 11:30
a.m.
• People with Disabilities. To request
materials in accessible formats for
people with disabilities (braille, large
print, electronic files, audio format),
send an email to fcc504@fcc.gov or call
the Consumer & Governmental Affairs
Bureau at 202–418–0530 (voice), 202–
418–0432 (tty).
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For detailed instructions for
submitting comments and additional
information on the rulemaking process,
see the SUPPLEMENTARY INFORMATION
section of this document.
FOR FURTHER INFORMATION CONTACT:
Jodie Griffin, Wireline Competition
Bureau, (202) 418–7550 or TTY: (202)
418–0484.
SUPPLEMENTARY INFORMATION: This is a
synopsis of the Commission’s Notice of
Proposed Rulemaking (NPRM) in WC
Docket No. 18–213; FCC 19–64, adopted
on July 10, 2019 and released on July
11, 2019. The full text of this document
is available for public inspection during
regular business hours in the FCC
Reference Center, Room CY–A257, 445
12th SW, Washington, DC 20554 or at
the following internet address: https://
docs.fcc.gov/public/attachments/FCC19-64A1.pdf.
I. Introduction
1. Telemedicine has assumed an
increasingly critical role in health care
delivery as technology and improved
broadband connectivity have enabled
patients to access health care services
even when they cannot access a health
care provider’s physical location.
Advances in telemedicine are
transforming health care from a service
delivered solely through traditional
brick and mortar health care facilities to
connected care options delivered via a
broadband internet access connection
directly to the patient’s home or mobile
location. Despite the numerous benefits
of connected care services to patients
and health care providers alike, patients
who cannot afford or who otherwise
lack reliable, robust broadband internet
access connectivity are not enjoying the
benefits of these innovative telehealth
technologies. The Commission proposes
a Pilot program within the USF to
support connected care for low-income
Americans and veterans. This Pilot
program would help the Commission
better understand how the Fund can
play a role in helping patients stay
directly connected to health care
providers through telehealth services
and improve health outcomes among
medically underserved populations that
are missing out on these vital
technologies.
2. Specifically, in the NPRM, the
Commission proposes the creation of a
Pilot program that would allow the
Commission to obtain valuable data
concerning connected care services and
also help to better understand the
relationship of affordable patient
broadband internet access service to the
availability of quality health care, the
health care cost savings that result from
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connected care services, and the role of
connected care on patient health
outcomes. The Commission’s proposal
seeks to bring these innovative
telemedicine technologies to medically
underserved populations, including
low-income communities and veterans,
by empowering health care providers to
connect directly with their patients.
3. As discussed more fully in the
following, the Commission proposes
that the Connected Care Pilot program
will operate as a new program within
the USF, which would provide funding
to eligible health care providers to
defray the qualifying costs of providing
connected care services to low-income
Americans and veterans.
4. The Commission expects this Pilot
could benefit Americans that are
responding to a wide breadth of health
challenges, including diabetes
management, opioid dependency, highrisk pregnancies, pediatric heart disease,
mental health conditions, and cancer.
Data gathered from the Pilot program
will help the Commission understand
whether and how USF funds can be
used to promote health care provider
and consumer adoption and use of
connected care services. The data and
information collected through this Pilot
program might also aid in the
consideration of broader reforms—
whether statutory changes or updates to
rules administered by other agencies—
that could support this trend towards
connected care.
II. Discussion
5. To the extent that lack of affordable
and robust broadband internet access
service is an obstacle to the adoption of
connected care services by health care
providers and patients, the Commission
believes universal service support could
help address that obstacle. Further, by
encouraging more health care providers
to make use of connected care
technologies, the Commission may help
create a model for the nationwide
adoption of such technologies, which
could lead to improved health outcomes
for patients and savings to the country’s
health care system overall.
6. Thus, the Commission proposes a
three-year Connected Care Pilot program
(Pilot) with a $100 million budget that
would provide support for eligible
health care providers to obtain universal
service support to offer connected care
technologies to low-income patients and
veterans. Through this Pilot program,
the Commission seeks to develop a
record that will help to understand the
benefits that subsidization of broadband
service for connected care brings.
7. The Commission seeks to design a
cost-effective and efficient Pilot program
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that incentivizes participation from a
wide range of eligible health care
providers and broadband service
providers, provides meaningful data
about the use of connected care services
provided over broadband for lowincome Americans and veterans, and
provides insight into how universal
service funds could better promote the
adoption of connected care services
among low-income Americans and
veterans and their health care providers.
8. The Commission proposes
implementing a flexible Pilot program
that will give health care providers
some latitude to determine specific
health conditions and geographic areas
that will be the focus of the proposed
projects. Under this proposal, the Pilot
program would provide funding to
selected Pilot project health care
providers to defray the costs of
purchasing broadband internet access
service necessary for providing
connected care services directly to
qualifying patients. The Commission
seeks comment on this proposal. The
Commission believes its proposed
approach will increase the variety of
projects without discouraging or
prejudging any applicants considering
whether to participate. Nevertheless, the
Commission proposes limiting the Pilot
program to projects that primarily focus
on health conditions that typically
require at least several months or more
to treat—such as behavioral health,
opioid dependency, chronic health
conditions (e.g., diabetes, kidney
disease, heart disease, stroke recovery),
mental health conditions, and high-risk
pregnancies. The Commission believes
that collecting data across at least
several months would provide more
meaningful, statistically significant data
to track health outcomes and cost
savings—health conditions that do not
require at least several months of
treatment, therefore, may not provide
the type of meaningful data the
Commission seeks to collect through the
Pilot program.
9. The Notice of Inquiry (FCC 18–112)
sought comment on whether the Pilot
program should focus on certain health
conditions or geographic regions. Many
commenters asserted that the Pilot
program should not be limited to
projects that treat specific health
conditions. In addition, the record
identifies numerous health conditions
that can benefit from connected care
services. To ensure that Pilot program
funding is used for legitimate medical
conditions and to guard against
potential waste, fraud, and abuse,
should the Commission adopt a specific
definition of ‘‘health condition’’ for
purposes of the Pilot program? If so, is
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there a generally accepted authority that
provides a definition of ‘‘health
condition’’ that would be appropriate to
adopt for the Pilot program? The
Commission also seeks information
from commenters regarding the
marketplace for connected care services,
specifically whether health care
providers typically purchase complete
packages or suites of services that
include patient broadband internet
access service and other functionality
necessary to provide connected care
services, or whether health care
providers typically purchase broadband
internet access service connections for
connected care as a stand-alone product.
Additionally, the Commission seeks
comment on the costs health care
providers incur to purchase such
services.
10. Supported Services. The Notice of
Inquiry sought comment on providing
funding for the costs of: (1) The
broadband connectivity that eligible
low-income patients of participating
hospitals and clinics would use to
receive connected care services; and (2)
the broadband connectivity that a
participating hospital or clinic would
need to conduct its proposed connected
care pilot project. The record
demonstrates that many patients lack
home broadband service or lack
sufficient broadband service to receive
connected care services, and evidences
widespread support for funding
broadband internet access connections
for connected care through the Pilot
program. Many commenters also
expressed support for funding both
fixed and mobile broadband for
connected care. The record indicates
that the VA’s tablet program, which
provides patient broadband connections
for a small fraction of veterans who
receive care through the VA, is the only
federal agency program that currently
funds patient broadband connections
specifically for connected care.
11. The record indicates that health
care providers typically purchase
broadband internet access service that
enables connected care through a
broadband carrier or a connected care
company (for example, a remote patient
monitoring company). The health care
provider then provides a connected care
service, including the broadband
internet access service underlying that
connected care service, to the patient
directly. To what extent are health care
providers already funding patient
broadband connections for connected
care services and what are the costs
associated with funding those
connections? To what degree would
providing universal service funding to
offset these costs enable health care
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providers to extend service to additional
patients or treat additional health
conditions? Several health care
providers asserted that the Pilot
program should not fund internet
connections between health care
providers. The Commission agrees, as
doing so would be duplicative with the
existing Rural Health Care (RHC)
programs and propose to exclude such
connections from the Pilot program.
12. The Commission considers
‘‘telehealth’’ for the purposes of this
proceeding to include a wide variety of
remote health care services beyond the
doctor-patient relationship; for example,
involving services provided by nurses,
pharmacists, or social workers. The
Commission also defines the term
‘‘telemedicine’’ as using broadband
internet access service-enabled
technologies to support the delivery of
medical, diagnostic, and treatmentrelated services, usually by doctors. The
Commission seeks comment on these
definitions and their applicability to the
Connected Care Pilot program. In
addition, the Commission also proposes
to define the term ‘‘connected care’’ as
a subset of telehealth that is focused on
delivering remote medical, diagnostic,
and treatment-related services directly
to patients outside of traditional brick
and mortar facilities. The Commission
seeks comment on this proposed
definition of connected care. Should the
Commission place any additional
qualifiers on this definition to ensure
that the Pilot program is focused on
medical services delivered directly to
patients outside of traditional medical
facilities through broadband-enabled
technologies?
13. The Commission seeks comment
on common existing uses of connected
care technologies, such as remote
patient monitoring devices. The record
indicates that such devices are generally
single-purpose, meaning that they
cannot be used to access the public
internet or for uses outside of the health
care context. Are there other
circumstances where health care
providers are providing patient
connectivity that enables them to access
the internet for non-health care
purposes? Are there any barriers to
receiving connected care services for
low-income patients and veterans, and,
if so, what are those barriers? Would
this Pilot enable additional connectivity
not currently available to low-income
patients and veterans?
14. The Commission also seeks
comment on whether there are packages
or suites of services that health care
providers use to provide connected care
services (such as a turnkey solution that
includes software, remote patient
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monitoring and remote monitoring
devices, and patient broadband internet
access) that are not currently funded
under the existing RHC support
programs that could be funded through
the Pilot program as information
services. What types of services would
be considered information services, as
well as any applicable precedents and
should be funded through the Pilot
program? How do service providers
currently fund these types of services
and what are the typical costs? Are
specific types of health care providers or
provider locations more likely to be
unable to purchase these types of
information services? Are there any
federal or other grant programs or other
funding sources that provide health care
providers support for purchasing these
types of services? Should the
Commission provide support for
internal connections for eligible health
care providers through the Pilot
program? Is such support needed for
connected care services?
15. Network Equipment. The Notice of
Inquiry sought comment on whether the
Pilot program should fund ‘‘network
equipment necessary to make a
broadband service functional’’ and for
consortia applicants ‘‘equipment
necessary to manage, control or
maintain an eligible service or a
dedicated health care broadband
network’’ as is done in the Healthcare
Connect Fund program. At least one
commenter supported funding this type
of network equipment through the Pilot.
Because the Commission currently
funds the types of network equipment
that are eligible for support through the
Healthcare Connect Fund program, the
Commission believes it has the
authority to provide funding for similar
equipment here, to the degree it is
necessary to enable connectivity for the
purposes of connected care. However,
the Commission proposes not to permit
duplication of funding for this
equipment and equipment funded
through the Healthcare Connect Fund
program. The Commission seeks
comment on this interpretation and
approach. Would such network
equipment be necessary to providing the
broadband service underlying
connected care, or part of a health care
provider’s purchase of a telehealth
information service? Would health care
providers still be interested in and be
able to participate in the Pilot program
if the Pilot program did not fund the
types of health care provider network
equipment that is eligible for support
under the Healthcare Connect Fund
program? If the Commission were to
fund this type of equipment, how could
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the Commission ensure that the health
care provider actually needs this
equipment for the Pilot program and
would not have needed or purchased
this equipment but for participating in
the Pilot program?
16. The Commission also
acknowledged that a few commenters
stated that the Pilot program should
support health care provider
administrative and outreach costs
associated with participating in the Pilot
program (such as personnel costs, and
program management costs). Consistent
with the existing RHC support programs
and the RHC Pilot program, however,
the Commission does not propose
funding these expenses as part of the
Pilot. As the Commission has previously
explained, past experience in the RHC
support programs and RHC Pilot
program demonstrates that ‘‘[health care
providers] will participate even without
the program funding administrative
expenses.’’ The Commission seeks
comment on this approach.
17. End-User Devices, Medical
Equipment, Mobile Applications, and
Health Care Provider Administrative
Expenses. The Notice of Inquiry also
sought comment on whether the Pilot
program should fund end-user
equipment, medical devices, or mobile
applications for connected care. Many
commenters supported funding such
items. That said, traditionally, the
Commission has declined to fund these
items through the Universal Service
Fund because of section 254’s focus on
the availability of and access to services.
As such, the Commission proposes to
make end-user devices, medical devices,
or mobile applications (excepting those
applications that may be part of a
service that could be considered an
information service) ineligible for
support in the Pilot program. Based on
the record and other sources, some
health care providers may be able to
self-fund or obtain outside funding for
end-user devices, medical devices, and
connected care applications needed for
their connected care pilot projects. The
Commission seeks comment on the
extent to which health care providers
participating in the Pilot program may
be able to obtain outside funding for
end-user devices, medical devices, or
mobile applications necessary to
provide connected care services. Would
health care providers still be interested
in and be able to participate in the Pilot
program if the Pilot program does not
fund end-user devices, connected care
medical devices, or connected care
mobile applications?
18. Other Program Structure
Considerations. The Commission seeks
comment on whether there are any
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medical licensing laws or regulations, or
medical reimbursement laws or
regulations that would have a bearing
on how the Commission structures the
Pilot program. If so, how would those
specific laws or regulations impact the
Pilot program, and how should the
Commission design the structure of the
Pilot program in light of those impacts?
For example, commenters in the record
identify reimbursement as a major
barrier to telehealth adoption. They urge
the Commission to coordinate with the
Centers for Medicare and Medicaid
Services (CMS)—whether through a
Memorandum of Understanding or other
means—to implement reforms to
reimbursement policies for telehealth.
How should the Commission structure
the Pilot to best ensure coordination
between the Commission and other
federal agencies, such as CMS? How can
the Commission most easily obtain data
through the Pilot that would be
informative on issues such as
reimbursement and licensure?
Additionally, the Commission seeks
comment on whether the provision of
USF support to health care providers to
provide connected care to low-income
patients (or any other Pilot program
funded item used by individual patients
as part of the Pilot program) raises any
issues under the Medicare and Medicaid
Anti-Kick Back Statute, the Civil
Monetary Penalties Act, or any other
federal statutes.
19. Budget. The Notice of Inquiry
sought comment on a potential $100
million budget for the Pilot program.
Based on the broad support in the
record, the Commission believes that
targeting this amount of funding for the
broadband underlying connected care
technologies is substantial and
sufficient to allow it to obtain
meaningful data and ensure significant
interest from a wide range of
participants. The Commission therefore
proposes to adopt that budget for the
Pilot program. As discussed in the
following, the Commission also
proposes a three-year funding period for
the Pilot program, during which
selected projects would receive funding.
The Commission seeks comment on
these proposals. How should the total
Pilot program budget be distributed over
the three-year funding period? Should
each selected project’s funding
commitment be divided evenly across
the Pilot program duration? For
example, if a selected project requests
and receives a $9 million funding
commitment and the funding period is
three years, should the project receive
$3 million for each year?
20. Several commenters expressed
concern that the budget for the Pilot
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program could be debited against the
existing budgets for the Lifeline or Rural
Health Care programs. However, the
proposed Pilot program would not
divert resources from the existing
universal service support programs.
Instead, the Commission proposes
requiring the Universal Service
Administrative Company (USAC) to
separately collect on a quarterly basis
the funds needed for the duration of the
Pilot program. The Commission expects
that funding the Pilot program in this
manner would not significantly increase
the contributions burden on consumers.
This approach also would not impact
the budgets or disbursements for the
other universal service programs. The
Commission seeks comment on this
approach. Should the collection be
based on the quarterly demand for the
Pilot program? The Commission also
proposes to have excess collected
contributions for a particular quarter
carried forward to the following quarter
to reduce collections. Under this
approach, the Commission also
proposes to return to the Fund any
funds that remain at the end of the Pilot
program. Are there other approaches the
Commission should consider for
funding the Pilot program?
21. Number of Pilot Projects and
Amount of Funding per Project. The
Notice of Inquiry sought comment on
funding up to 20 projects with awards
of $5 million each. First, the
Commission proposes to provide a
uniform percentage of eligible services
or equipment to be funded, rather than
fully funding any Pilot projects,
consistent with the Healthcare Connect
Fund program and the RHC Pilot
program. Several commenters similarly
suggest that the Pilot program should
not fund 100% of the eligible costs for
each project. Based on the
Commission’s experience with the
E-Rate and Rural Health Care programs,
there are significant advantages to
providing a set discount percentage that
requires participants to contribute a
portion of the costs, including being
administratively simple, predictable,
and equitable, and incentivizing
participants to choose the most costeffective services and equipment and
refrain from purchasing a higher level of
service or equipment than needed. In
addition, the Commission believes that
funding less than 100% of the costs
minimizes the risk of non-usage of the
supported services. The Commission
seeks comment on this approach.
22. For services supported under this
structure, the Commission proposes a
discount level of 85%—the discount
amount participants received in the
Rural Health Care Pilot Program—and
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seeks comment on whether this amount
would strike the right balance between
requiring a health care provider
contribution for such services and
encouraging a wide range of eligible
health care providers to participate in
the Pilot program. Are there other grant
or support programs or data that the
Commission could look to in order to
determine an appropriate discount level
for these types of services that could be
funded under this structure? For
example, in the E-Rate program, the
lowest discount level is 20% and ranges
up to 90%. In contrast, the discount
level for the Healthcare Connect Fund is
65%. To further ensure the costeffective use of Pilot funds, in addition
to adopting a flat, uniform discount
percentage, should the Commission cap
the monthly amount of support that can
be paid for broadband internet access
service to a health care provider for each
participating patient? If so, what would
be an appropriate cap, and what data
and specific information would support
this cap amount?
23. For the Healthcare Connect Fund
program, the health care provider is
required to pay the non-discounted
share of the eligible costs from eligible
sources (e.g., the applicant, eligible
health care provider, or state, federal, or
Tribal funding or grants), and is
prohibited from paying the nondiscounted share of eligible costs from
ineligible sources (e.g., direct payments
from vendors or service providers). The
Commission seeks comment on whether
it should apply this same limitation to
health care providers participating in
the Pilot program. If so, should
participating patients also be considered
an eligible source of the non-discounted
share for services funded under the
Pilot? Should the Commission limit the
portion of the non-discounted costs that
health care providers can require
participating patients to pay for the
supported broadband internet access
service? If so, what would be an
appropriate limit on the patient share of
the costs? For purposes of the Pilot
program, should the Commission place
any limitation at all on the source of
funding for the non-discounted share of
the costs? Are there any other
approaches the Commission should
consider for limiting the source of
funding that are not tied to the
Healthcare Connect Fund program
rules?
24. Next, the Commission addresses
the number of projects and the perproject budget cap. Some commenters
agreed that the Commission should fund
up to 20 projects with awards of $5
million per project. Other commenters
argued for the selection of fewer projects
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with larger funding amounts, or for the
selection of a larger number of projects
with varied or smaller funding amounts.
On further consideration of the record,
the Commission proposes not to
expressly limit the number of funded
Pilot projects, and to permit flexible and
varied funding for each selected Pilot
project. The Commission believes
setting a fixed number of funded
projects would not serve the goals of the
Pilot program because it would
artificially limit the number of funded
projects before any proposals are even
submitted. In addition, not setting a
fixed number of projects to be funded
will allow the Commission to better
focus on selecting quality projects that
can provide meaningful data rather than
selecting a pre-determined number of
projects. The Commission seeks
comment on this view. The record
likewise indicates that a uniform $5
million funding amount per project
could artificially limit the scope of
potential pilot projects and the data
collected. While the Commission
proposes allowing varied funding
amounts for selected projects, the
Commission does not anticipate
spending all of the Pilot program funds
on one or two large projects. Should the
Commission establish a ceiling on the
amount of the total budget that can be
allocated to a single project and, if so,
what would be an appropriate
maximum funding amount for a single
project?
25. Cost Allocation. The Commission
also seeks comment on whether cost
allocation should be required for
services or other items supported
through the Pilot program that are used
for non-health care purposes or include
ineligible components. For example, if a
Pilot project permits patients to use the
supported broadband service for nonhealth care purposes, should the
Commission require cost allocation of
the non-health care usage? If so, how
should the cost allocation work? For
supported patient broadband internet
access service, should the cost
allocations be based solely on the
percentage of the service that is used for
health care purposes? Should the cost
allocations instead take into account the
health care providers’ savings associated
with the use of the supported patient
broadband internet access for health
care purposes? If a health care provider
contracts with a remote patient
monitoring solution provider for a
package that includes end-user devices
and other items that are not broadband
internet access service, how should cost
allocation work for those devices or
items? Should cost allocations for all
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Pilot-supported costs follow the cost
allocation rules and processes for the
Healthcare Connect Fund? Which entity
or entities (e.g., the health care provider
or service provider) should be
responsible for providing the cost
allocation and supporting
documentation? What type of
documentation should the Commission
require to support the cost allocation?
26. Duration. The Notice of Inquiry
sought comment on whether the Pilot
program should have a two- or threeyear funding duration and six-month
ramp-up and wind-down periods. Many
commenters asserted that a three-year
duration is appropriate and would allow
the Commission to obtain sufficient,
meaningful data from the selected
projects. A few commenters argued that
more than three years would be
necessary if broadband deployment was
a Pilot program goal, or that the Pilot
program duration should be as long as
four or five years. USTelecom cautioned
that a duration longer than three years
(plus a ramp-up and wind-down and
evaluation period) ‘‘risks having the
findings become obsolete by the time
they could be effectuated . . . .’’ Other
commenters separately assert that a sixmonth ramp-up and six-month winddown period should be part of the
funding period.
27. Based on the record and the
proposed Pilot program goals (which do
not include broadband deployment), the
Commission proposes a three-year
funding period and separate ramp-up
and wind-down periods of up to six
months in order to give projects time to
complete set up and other
administrative matters related to the
Pilot program. The Commission seeks
comment on these proposals. When
should the ramp-up period begin?
Should the clock for the ramp-up period
start after the selected project has been
notified of its selection, or is there
another event that should trigger the
start of the ramp-up period? Should
there be a uniform start date for funding
under the Pilot program, and if so, how
should the Commission determine that
start date? Should the proposed threeyear funding period for the Pilot
program use a funding-year approach,
with a fixed start date and end date for
each Pilot program funding year, as is
done in the E-Rate and Rural Health
Care programs? If so, how would the
ramp-up and wind-down periods work
with a funding-year approach (e.g.,
would the ramp-up period precede the
start of the funding year)? Should
funding disbursements begin during the
ramp-up period, and if so how should
funding be split between the ramp-up
period and the Pilot project term? The
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Commission proposes setting a fixed
end date for the Pilot program, with the
possibility of extensions where
circumstances warrant. The
Commission seeks comment on this
proposal.
28. Eligible Health Care Providers.
The Commission proposes to limit
health care provider participation in the
Pilot program to non-profit or public
health care providers within section
254(h)(7)(B): (i) Post-secondary
educational institutions offering health
care instruction, teaching hospitals, and
medical schools; (ii) community health
centers or health centers providing
health care to migrants; (iii) local health
departments or agencies; (iv)
community mental health centers; (v)
not-for-profit hospitals; (vi) rural health
clinics; (vii) skilled nursing facilities;
(viii) and consortia of health care
providers consisting of one or more
entities described in clauses (i) through
(vii).
29. The Commission seeks comment
on whether section 254 requires it to
limit health care provider participation
to these categories of providers. And if
not, the Commission believes that
applying this limitation to the Pilot
program would provide significant
benefits: Leveraging the statutory
definition of health care provider used
for the Rural Health Care program
would focus Pilot program funding on
health care providers most in need of
additional funding to reach eligible
patients through connected care
services, and would also realize
administrative efficiencies by using
existing definitions and application
processes that parties are already
familiar with through the Rural Health
Care program. In addition, having a
single uniform definition of ‘‘health care
provider’’ would provide clarity for
potential participants and facilitate the
administration of the Pilot program.
30. While the statutory definition of
‘‘health care provider’’ may exclude
certain health care providers, the
Commission believes that it would still
allow for a wide range of health care
providers to participate in the Pilot
program. For example, the Healthcare
Connect Fund program is subject to this
definition and over 8,600 distinct health
care providers received funding
commitments in the Healthcare Connect
Fund program for funding year 2018.
Additionally, the statutory definition
encompasses many facilities serving
medically underserved communities,
including VA health administration
facilities and facilities run by the Indian
Health Service. The Commission seeks
comment on this interpretation. Is there
an interpretation of section 254(h)(7)(B)
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that would allow the Commission to
provide funding to Emergency Medical
Technicians, health kiosks, and school
clinics through the Pilot program, as
commenters request? Would the
definition of ‘‘health care provider’’
under section 254(h)(7)(B) preclude
sites like the VA’s Virtual Living Room
sites, community center or similar sites
that provide dedicated rooms in
convenient locations with broadband
connections for patients to engage with
technology and connect with the
professionals providing them with
medical care? The Commission seeks
comment on whether limitations on
eligible entities could limit the
effectiveness of the Pilot program and
the ability to obtain meaningful data on
connected care services. Finally, are the
proposed eligible health care providers
sufficiently well versed in medical
research methods to be able to properly
evaluate the health outcomes linked to
the provision of connected care?
31. In the event that the Commission
limits Pilot program participants to the
statutory definition of ‘‘health care
provider’’ under section 254, the
Commission proposes requiring
interested health care providers to
indicate their respective category(ies)
for eligibility by submitting FCC Form
460, which USAC uses to determine the
eligibility of health care providers in the
Healthcare Connect Fund Program. The
Commission proposes requiring eligible
health care providers to have prior
experience with telehealth and longterm patient care.
32. The Commission also proposes to
borrow additional administrative
procedures from the RHC programs in
implementing the Pilot program. For
example, the Commission proposes to
have consortia applicants file FCC Form
460 identifying all sites that would
participate in the Pilot program,
including off-site data centers and
administrative offices, and propose
permitting consortia applicants to file
FCC Form 460 on behalf of any site in
the consortium that would participate in
the Pilot program to determine that
site’s eligibility. Consistent with the
Healthcare Connect Fund program, the
Commission proposes requiring
consortia applicants to have in place a
Letter of Agency, which provides a
consortium leader with authority to act
on behalf of the participating health care
providers. Additionally, the
Commission proposes permitting third
parties to ‘‘submit forms and other
documentation on behalf of the
applicant’’ if USAC receives written
authorization from an ‘‘officer, director,
or other authorized employee stating
that the [health care provider] or
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Consortium Leader accepts all potential
liability from any errors, omissions, or
misrepresentations on the forms and/or
documents being submitted by the third
party.’’ The Commission proposes that
consortium applicants must update
their FCC Form 460s if any information
on their FCC Form 460 changes.
Similarly, the Commission proposes
that an eligible health care provider
participating in the Pilot program,
including those participating in
consortia, submit an updated FCC Form
460 within 30 days of a material change.
The Commission seeks comment on
these proposals.
33. The Commission also proposes
that the Pilot program be open to both
urban and rural eligible health care
providers. Several commenters assert
that the Pilot should not be limited to
projects serving only rural areas. To the
extent that section 254(h)(2)(A) applies
to the Pilot program, it does not limit
universal service support to rural health
care providers, and the Commission
believes the Pilot program should not be
limited to rural health care providers.
The Fifth Circuit has found ‘‘the
language in section 254(h)(2)(A)
demonstrates Congress’s intent to
authorize expanding support of
‘advanced services,’ when possible, for
non-rural health [care] providers.’’
Likewise, section 254(h)(2)(A)
authorizes the Commission ‘‘to enhance
public and non-profit health care
providers’ access’’ to broadband
services. The Commission seeks
comment on this proposal.
34. To promote geographic diversity,
the Commission seeks comment on
limiting participation in the Pilot
program to health care providers that
are located in or serve an area that has
received the Health Resources and
Services Administration’s Health
Professional Shortage Areas designation
or Medically Underserved Areas
designation, which correlate with
professional shortages and lowerincome areas, respectively, within a
defined geographic area. What are the
benefits and drawbacks of limiting
participation by using these
designations? Should the Commission
also, or alternatively, consider limiting
participation in the Pilot program only
to eligible health care providers that
currently provide care to at least a
certain percentage of uninsured and
underinsured patients, or to a certain
percentage of Medicaid patients? The
Commission seeks comment on these
ideas. Would these types of limitations
impact the interest and participation of
health care providers in the Pilot
program?
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35. As connected care services
continue to grow, health care providers
that only offer connected care have
entered the marketplace. These new
market entrants may bring innovative
new services and inject competition that
benefits patients, but it is not clear
whether they would qualify as eligible
health care providers under section
254(h)(7)(B). The Commission seeks
comment on this question. Additionally,
the record indicates that these types of
providers may not be involved in longterm patient treatment. What steps
should the Commission take to ensure
that participating health care providers
have significant experience with
providing long-term patient care, in
order to guard against waste, fraud, and
abuse in the Pilot program? The
Commission also seeks comment on
determining criteria that would
demonstrate health care providers’
experience with long-term care for
patients. Are there types of connected
care only companies that could
demonstrate the level of experience
with long-term patient care needed for
the Pilot?
36. To ensure projects meet the goals
of the Pilot program, should the
Commission require participating health
care providers to have experience
integrating remote monitoring and
telehealth services? Specifically, should
the Commission limit eligibility in the
Pilot program to health care providers
that are federally designated as
Telehealth Resource Centers or as
Telehealth Centers of Excellence, or to
otherwise demonstrate their experience
providing telehealth services? Should
the Commission exclude health care
providers that have no prior connected
care experience? Should participating
health care providers have experience,
or be required to partner with research
bodies or firms with experience,
conducting clinical trials in order to
ensure statistically sound evaluation of
patient outcomes?
37. Eligible Service Providers. In the
RHC Program, the statute permits noneligible telecommunications carriers
(ETCs) to receive support; section
254(c)(3) makes clear that, in addition to
the supported services included in the
definition of universal service in section
254(c), ‘‘the Commission may designate
additional services for such support
mechanisms for . . . health care
providers for the purposes of subsection
(h).’’ Further, section 254(h)(2)(A)
directs the Commission ‘‘to enhance to
the extent technically feasible and
economically reasonable, access to
advanced telecommunications services
and information services’’ for health
care providers and, thus, allows support
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for non-ETCs. The Commission has
previously explained that the ETC
limitation in section 254(e) applies to
the section 254(c) supported services,
but not to additional supported services
under section 254(h)(2)(A).
38. The Notice of Inquiry sought
comment on whether the Pilot should
be limited to ETCs, including facilitiesbased ETCs. Numerous parties opposed
limiting the Pilot program to ETCs or
facilities-based ETCs and explained that
such a limitation would artificially limit
participation in the Pilot program and
could also limit the effectiveness of the
Pilot program. The Commission
proposes not to limit Pilot program
funding to only ETCs. The Commission
anticipates that it would provide
funding to eligible health care providers
to purchase broadband internet access
service that would be provided to the
patient through a connected care
offering, or that the health care provider
would use USF funding to purchase
telehealth services that qualify as
information services. As such, the
Commission does not believe that health
care providers should be restricted to
purchasing broadband internet access
service from only ETCs.
39. The Commission hopes that this
will help incent participation in the
program by a diverse range of both
health care providers and service
providers. The Commission seeks
comment on this approach. What
impact would this approach have on
service provider and health care
provider interest in participating in the
Pilot program? If, instead, the
Commission were to conclude that only
ETCs would be able to receive support
for providing broadband internet access
service to patients participating in the
Pilot, what impact would this approach
have on service provider and health care
provider participation in the Pilot
program? As a practical matter, how
could the Commission ensure that the
Pilot program still leverages and
supports the expertise of the health care
provider as the main driver of each Pilot
project, even if the monetary support
must be paid to an ETC?
40. Application Process. The Notice of
Inquiry requested comment on the
application process for the Pilot
program and proposed several
categories of information that should be
contained in the application. The
Commission proposes that interested
health care providers first submit an
application describing the proposed
pilot project and providing information
that will facilitate the selection of highquality projects that will best further the
goals of the Pilot program. At the time
of the application, should the
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Commission require participating health
care providers to have already identified
specific broadband providers from
which the health care provider will
receive service? If the Commission
requires broadband providers to be
ETCs, should the Commission require
all designations to be obtained prior to
the application process? Or should the
Commission require that if the project is
selected, the service provider would
obtain the necessary ETC designations
before the project commences?
41. Based on the Commission’s review
of the record and prior experience with
Pilot programs, it proposes that
applications contain, at a minimum, the
following information:
• Names and addresses of all health
care providers that would participate in
the proposed project and the lead health
care provider for proposals involving
multiple health care providers.
• Contact information for the
individual(s) that would run the
proposed pilot project (telephone and
email).
• Health care provider number(s) and
type(s) (e.g., non-profit hospital,
community mental health center,
community health center, rural health
clinic, community mental health
center), for each health care provider
included in proposal.
• Description of each participating
health care provider’s experience with
providing connected care services and
conducting clinical trials or the
experience of a partnering health care
provider.
• Description of the connected care
services the proposed project will
provide, the conditions to be treated, the
health care provider’s experience with
treating those conditions, the goals and
objectives of the proposed project
(including the health care provider’s
anticipated goals with respect to
reaching new or additional patients,
improved patient health outcomes, or
cost savings), and how the project will
achieve the goals of the Pilot program.
• Description of the clinical trial
design intended to measure the effect of
the connected care pilot on health
outcomes.
• Description of the estimated
number of eligible low-income patients
to be served.
• Description of the plan for
implementing and operating the project,
including how the project intends to
recruit eligible patients, plans to obtain
the end-user and medical devices for the
connected care services that the project
would provide, and transition plans for
participating patients after Pilot
program funding ends.
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• List of all Department of Health and
Human Services, Health Resources and
Services Administration (HRSA)
designated Health Care Professional
Shortage Areas (for primary care or
mental health care only) or HRSA
designated Medically Underserved
Areas that will be served by the
proposed project.
• Description of whether the health
care provider will primarily serve
veterans or patients located in a rural
area, or the provider is located in a rural
area, on Tribal lands, or is associated
with a Tribe, or part of the Indian
Health Service.
• Description of the anticipated level
of broadband service required for the
proposed project, including the
necessary speeds/technologies and
relevant service characteristics (e.g., 10/
1 Mbps, or 4G).
• Detailed estimated break-down of
the total estimated costs for the
broadband internet access services and
any other eligible costs.
• Estimated total ineligible costs and
description of the anticipated sources of
financial support for the project’s
ineligible costs.
• Description of how the participating
health care provider will ensure
compliance with the Health Insurance
Portability and Accountability Act
(HIPAA) and other applicable privacy
and reimbursement laws and
regulations, and applicable medical
licensing laws and regulations, and how
it will safeguard the collected patient
information against data security
breaches.
• Description of the health outcome
metrics that the proposed project will
measure and report on, and how those
metrics will demonstrate whether the
supported connected care services have
improved health outcomes.
• Description of how the health care
provider intends to collect and track the
required Pilot program data.
42. Is there any additional
information that the Commission should
require health care providers to submit
in the application? What types of
information or documentation should
the Commission require health care
providers to include in their
applications to demonstrate that the
supported services would enhance the
health care provider’s access to
advanced telecommunications and
information services? Is there a
minimum number of patients that a
project must serve to provide
statistically significant data? Is the
proposed application information
sufficient to determine whether projects
have processes in place to ensure
compliance with the applicable medical
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licensing laws and regulations, HIPAA
and any other applicable privacy laws,
and guard against data security
breaches? Is there anything in HIPAA or
privacy laws and regulations that would
limit the Commission’s ability to
structure the Pilot program or collect
data needed to evaluate the Pilot’s
success?
43. Should the Commission require
health care providers to submit a selfcertification regarding their patient care
and telehealth qualifications with their
applications? Moreover, should the
Commission require applicants to
certify that they are financially
qualified? If so, what information
should the Commission rely on to make
that determination? Is there any
supporting documentation the
Commission should require to
demonstrate that applicants are
financially qualified? Likewise, should
the Commission require health care
providers to submit a self-certification
that specifies that they will be able to
meet patients’ long-term care needs as
well as provide the appropriate
technology to help meet those needs?
Should the Commission require
applicants to certify that they have the
capacity to conduct a valid clinical
trial? If so, are there specific criteria the
Commission should rely on to make
such a showing? Should the
Commission require applicants to
certify that all information in their
application is true and accurate?
44. The Commission intends to
establish a deadline for submitting
applications for the Pilot program. If the
Commission ultimately issues an order
establishing the proposed Pilot program,
would requiring that applications be
submitted within 120 days from the
release of such an order give health care
providers sufficient time to develop and
submit a meaningful application for the
Pilot program?
45. The Commission proposes to
direct the Wireline Competition Bureau
(Bureau) to review applications in
coordination with the FCC’s Office of
Economics and Analytics, Office of
Managing Director, Office of General
Counsel, and the Connect2Health Task
Force. The Commission proposes that it
will then make any final selection
decisions. To facilitate the review and
selection of proposals, should the
Commission also seek advice from other
expert health care entities with
telehealth expertise? For example,
should the Commission consult with the
federally designated Telehealth
Resource Centers or Telehealth Centers
of Excellence? Are there other
organizations with whom the
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Commission should consult during the
application and selection process?
46. Evaluation of Proposals and
Selection of Projects. The Commission
seeks comment on the factors to
evaluate the applications and select
Pilot program projects. At a minimum,
the Commission proposes considering
whether each project would serve the
Pilot program goals and whether the
applicant is able to successfully
implement, operate, and evaluate the
outcomes of the project. The
Commission also proposes considering
the cost of the proposed project
compared to the total Pilot program
budget. What other objective factors
should be used to evaluate the proposals
and what should be the relative
importance of each objective evaluation
factor? For example, should a project’s
ability to further the goals of the Pilot
program be more important than the
estimated cost of the project compared
to the total Pilot program budget?
Should the Commission decline to
consider proposals that do not have a
plan for how participating patients will
obtain the necessary connected care
medical devices, end user devices (e.g.,
smartphones or tablets), or connected
care applications? Should the
Commission decline to consider projects
that cannot provide statistically sound
evaluations of their proposed
interventions?
47. To promote the selection of a
diverse range of projects, the
Commission proposes awarding
additional points to proposed projects
that would serve geographic areas or
populations where there are welldocumented health care disparities
(Tribal lands, rural areas, or veteran
populations) or that treat certain health
crises or chronic conditions that
significantly impact many Americans
and are documented to benefit from
connected care, such as opioid
dependency, diabetes, heart disease,
mental health conditions, and high-risk
pregnancy. For all of the additional
point factors the Commission proposes
in the following, to seek comment on
the relative importance of these factors
compared to each other and compared
to the other standard objective
evaluation factors. Are there any other
factors for which additional points
should be awarded to a particular
project?
48. It is well documented that there
are significant health care shortages in
rural areas and Tribal lands. In addition,
the Department of Health and Human
Services’ Health Resources and Services
Administration (HRSA) designates areas
that are Healthcare Provider Shortage
Areas (HPSA) or are Medically
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Underserved Areas (MUA)—these areas
can be urban or rural. Given the
significant health care disparities in
these areas and potential benefits of
increasing the adoption of connected
care in these areas, the Commission
proposes awarding extra points during
the evaluation process to proposals that
satisfy the following factors: (a) The
health care provider is located in a rural
area; (b) the project would primarily
serve patients who reside in rural areas;
(c) the project would serve patients
located in five or more Health
Professional Shortage areas (for primary
care or mental health care only) or
Medically Underserved Areas as
designated by HRSA by geography; (d)
the health care provider is located on
Tribal lands, is affiliated with a Tribe,
or is part of the Indian Health Service;
or (e) the health care provider would
primarily serve patients who are
veterans. How should the relative
importance of these additional factors
be compared to each other and to the
other proposed standard objective
factors for evaluating proposals? Should
projects receive additional points for
each factor that they satisfy? What
criteria should determine whether a
health care provider is located in a rural
area for purposes of these additional
points? Would the definition of ‘‘rural
area’’ in section 54.600 of the Rural
Health Care program rules or the
definition of ‘‘urban area’’ in section
54.505(b)(3)(i) of the E-Rate rules be
appropriate for determining whether a
project qualifies for additional points
based on rurality? Is there another
definition of ‘‘rural area’’ that the
Commission should consider and, if so,
what geographic level (e.g., Census
block, Census tract, Census block group)
should the Commission use to
determine eligibility for extra points
based on rurality? How should this
proposal apply to consortia?
49. The Commission also seeks
comment on the criteria that should be
used to determine whether a project
would primarily serve patients who
reside in rural areas. The Commission
believes that relying on individual
patient addresses for this purpose
would be too complex to administer
because of the potential volume of
individual patient addresses. Are there
other, non-patient address measures that
could be used instead? For example,
should the Commission use a metric
that estimates average patient travel
distance to the health care provider’s
facility?
50. The Commission proposes relying
on the health care provider’s
certification that it is located on Tribal
lands, affiliated with a Tribe or is part
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of the Indian Health Service. The
Commission seeks comment on this
proposal. For purposes of the additional
points, should the Commission apply
the definition of Tribal lands in section
54.400(e) of the Lifeline rules? Is there
another definition that the Commission
should consider? To receive the extra
Tribal points, should the Commission
require that the health care provider be
located in a rural area as defined for the
Pilot program? If so, how should rurality
be defined? Should the Commission use
the same definition for ‘‘rural’’ areas as
that found in section 54.505(b)(3)(i) of
the Commission’s rules, or instead use
a population density measure for a
given geographic unit?
51. Similarly, the Commission seeks
comment on the criteria that should be
used to determine whether a project
would primarily serve veterans. What
threshold would be appropriate? For
example, the Commission seeks
comment on whether a project
‘‘primarily serves’’ veterans if more than
50% of its patient base are veterans.
What documentation, if any, is
appropriate to define a veteran
population? Many veterans receive
disability compensation from the VA,
for instance, or cost-free health care
based on certain factors. Would receipt
of these benefits be sufficient to identify
veteran status for purposes of the
application?
52. The Commission seeks comment
on awarding additional points for
projects that are primarily focused on
treating certain chronic health
conditions or conditions that are
considered health crises, such as opioid
dependency, high-risk pregnancies,
heart disease, diabetes, or mental health
conditions. Opioid dependency is a
well-documented epidemic in America
and has had a particularly devastating
impact in rural America where there are
fewer opioid treatment centers. The
Notice of Inquiry explains that
connected care services have been
frequently used to treat opioid
dependency; thus, the Commission
believes that it would be appropriate to
award extra points for proposals that
seek to use connected care to treat
opioid dependency. Maternal mortality
is also a crisis in America—the maternal
mortality rate in the U.S. is higher than
most other high-income countries and
has increased over the last few decades.
This crisis impacts both rural and urban
areas and is particularly acute in rural
areas where there is a significant
shortage of hospitals and health care
providers offering obstetric care, and
also disproportionately impacts lowincome, African-American women. In
December 2018, Congress took action to
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address the maternal mortality crises by
passing the Preventing Maternal Deaths
Act to create a federal infrastructure and
resources for collecting and analyzing
data on every maternal death in the
United States. Accordingly, the
Commission believes that it would be
appropriate to award additional points
for projects focused on treating high-risk
pregnancy. Connected care has been
used to treat heart disease and
diabetes—two of the leading causes of
death in America that are also
associated with very high costs for
patients and the health care system.
Therefore, the Commission believes that
it would also be appropriate to award
additional points to proposals that seek
to treat these conditions. Some
organizations also have indicated that
there is a mental health crisis in
America—many Americans need mental
health care but lack access or the ability
to find it, particularly Americans who
are low-income or reside in rural areas.
Therefore, the Commission also believes
that it would be appropriate to award
additional points to proposals that seek
to treat mental health conditions. The
Commission seeks comment on these
proposals. Are there any other health
conditions that would warrant awarding
additional points to specific project
proposals during the selection process?
Should the Commission expressly limit
eligible health conditions in advance of
receiving applications for Pilot projects?
53. Are there any other criteria the
Commission should consider in the
evaluation and selection of pilot
projects? For example, the Commission
seeks comment on whether to permit a
project to serve a patient population that
is primarily, but not entirely lowincome? If so, should the Commission
require health care providers to conduct
a project where more than 50% of the
patients are low-income? Or 75%?
Similarly, how would the Commission
evaluate whether a project includes lowincome individuals? Should the
Commission, for example, rely on the
health care provider to identify patients
for their project who are enrolled in
Medicaid, receive cost-free health care
from the VA, or who are uninsured or
underinsured?
54. Consistent with the Commission’s
other universal service support
programs, it is critical that the
Commission ensures that the Pilot
program funds are spent wisely and
appropriately and that the Commission
guards the Pilot program from waste,
fraud, and abuse. At the same time, the
Commission seeks to minimize the
administrative burdens on service
providers and health care providers
participating in the Pilot program. In
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this section, the Commission proposes
and seeks comment on potential
requirements for Pilot program
participants, including requirements for
the vendor selection for Pilot-eligible
costs, requesting funding, and
requesting disbursements. For the
Healthcare Connect Fund program, the
Commission has developed robust rules
and processes that are designed to
minimize waste, fraud, and abuse. To
promote the efficient and cost-effective
use of Pilot program funds and guard
against waste, fraud, and abuse, the
Commission proposes extending many
of these rules and processes to the
proposed Pilot program.
55. Selecting Service Providers. The
Commission proposes that participating
health care providers, and not the
participating patients, procure the
services and equipment that could be
funded through the Pilot program. The
Commission believes that having
participating health care providers
select the service provider would be a
better approach because health care
providers are in the best position to
know the specific service and
performance requirements necessary to
provide the specific connected care
services supported by their particular
Pilot project. In addition, aggregating
eligible subscribers and streamlining
benefit payments may lead to cost
efficiencies and/or better service
arrangements. The Commission seeks
comment on this approach.
56. Consistent with the Commission’s
other universal service support
programs, it is important that the
Commission ensures the cost-effective,
efficient use of Pilot program funds. To
appropriately tailor the vendor selection
requirements to the marketplace, the
Commission requests additional
information on how health care
providers typically purchase broadband
internet access service connections for
connected care efforts. Do health care
providers typically select and contract
directly with a broadband service
provider for patient broadband internet
access service, or is the broadband
service provider typically determined
by a connected care service vendor,
such as a remote patient monitoring
service provider? Is the broadband
internet access service for connected
care, whether purchased as a standalone product or as part of a package, a
commercially available product that is
purchased at publicly-available rates?
Are these rates typically negotiable?
What is the typical contract term (e.g.,
month-to-month, annual contract or
multi-year contract) for these services?
Are the health care provider costs for
connectivity services for connected care
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determined on a per patient basis?
Where health care providers purchase
services for connected care as part of a
complete package or suite of services,
can the costs for the individual
components be broken out separately?
For example, for such a package or suite
of services, is it possible to isolate the
costs for the included software, or the
broadband internet access service?
57. For all of the costs that could
potentially be supported through the
Pilot program, the Commission proposes
requiring the participating health care
providers to conduct a competitive
bidding process, and select the most
cost-effective service, as is required by
the Healthcare Connect Fund program.
For the E-Rate and Rural Health Care
support programs, the Commission has
traditionally required schools and
libraries and health care providers to
competitively bid for the supported
services and equipment, with limited
exemptions. These competitive bidding
requirements are designed to ensure that
applicants select the most cost-effective
method of providing the requested
service, ensure that service providers
have sufficient information to submit a
responsive proposal, seek the most costeffective pricing for eligible services,
and guard against waste, fraud, and
abuse.
58. If the Commission requires health
care providers to competitively bid any
services and equipment that could be
funded through the Pilot program,
should the Commission use the existing
Request for Services Form (Form 461)
for the Healthcare Connect Fund
program and, if so, what modifications
would the Commission need to make to
that form for purposes of the Pilot
program? The Commission also
proposes requiring the lead health care
provider for projects involving multiple
health care providers to secure a Letter
of Agency from all participating
providers before submitting a request for
services. The Commission seeks
comment on these proposals. Should
the Commission allow exemptions from
competitive bidding rules, as done in
other USF programs? For example,
should the Commission allow an
exemption in the Pilot program if the
health care provider is requesting
commercially available services
purchased at publicly-available rates
and/or the total cost of the eligible
services or equipment is below a
specific monetary threshold (e.g., total
annual cost under $10,000 or monthly
per-patient cost of $50 or below)? The
Commission seeks comment on whether
the other exemptions to the competitive
bidding requirements for the Healthcare
Connect Fund program should also be
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extended to the Pilot program. Are there
any other competitive bidding
exemptions or alternatives to
competitive bidding that the
Commission should consider applying
to the Pilot program?
59. Where an exemption to
competitive bidding applies, are there
public resources or entities that could
help health care providers identify
potential vendors or service providers?
Should the Commission require ETCs to
indicate their interest in participating in
the Pilot program and their service
areas, and make this information
publicly available before the application
deadline for the Pilot program? How can
the Commission share similar interests
to participate in the Pilot program from
telecommunications providers that are
not ETCs?
60. The Commission also proposes
prohibiting gifts from participating
service providers to participating health
care providers. Are there any aspects of
the competitive bidding requirements
for the Healthcare Connect Fund
program that would not work for the
Pilot program and, if so, why not? If the
Commission requires competitive
bidding for the Pilot program, the
Commission proposes requiring
participating health care providers to
submit the same competitive bidding
information, make the same
certifications, and use the same
processes that are required for the
Healthcare Connect Fund program,
including any changes that may be
made as a result of the 2017 Promoting
Telehealth Order and Notice (FCC 17–
164).
61. Requesting Funding. The
Commission further seeks comment on
the most efficient methods for Pilot
program participants to request funding.
Should the Commission require selected
Pilot projects to request funding under
the Pilot program using the same forms
and processes and making the same
certifications that are required for the
Healthcare Connect Fund program,
including any changes that may be
made as a result of the 2017 Promoting
Telehealth Order and Notice? Requiring
health care providers to submit funding
requests for the Pilot program would
allow USAC to ensure that the Pilot
projects only request funding for eligible
services and that the health care
providers requesting funding are in fact
eligible. What modifications to the
Healthcare Connect Fund funding
request form, if any, are necessary to use
for the Pilot program? Are there other
HCF certifications or processes to
import to the Pilot program as well?
And how should the Commission
modify these requirements, if at all?
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Would these modifications vary
depending on the legal authority on
which the Pilot program is based? If
competitive bidding is required for the
Pilot program, the Commission proposes
requiring selected projects to submit a
copy of their contract and supporting
competitive bidding documentation
with their funding request, as is
currently required for the Healthcare
Connect Fund program.
62. For purposes of administrative
efficiency and to ensure that Pilot
projects are not unreasonably delayed,
the Commission proposes requiring
Pilot program applicants who are
selected to submit funding requests
within six months of the date of their
respective selection notices for the Pilot
program. The Commission anticipates
that USAC would promptly review
funding requests of selected Pilot
program health care providers on a
rolling basis, irrespective of when they
submit their funding requests within the
six-month window. Would this
proposed deadline for submitting the
initial funding request give participating
health care providers sufficient time to
select a vendor and submit a funding
request? Should the Commission require
participating health care providers to
submit a new funding request for each
year of the Pilot program?
63. The Commission also proposes
requiring selected projects to certify that
the provided funding will only be used
for the eligible Pilot program purposes
for which the support is intended.
Should the Commission also require
participating health care providers to
certify that the supported services and
equipment will only be used for
purposes reasonably related to the
provision of health care services or
instruction that the health care provider
is legally authorized to provide under
law? Additionally, the Commission
proposes requiring projects involving
multiple health care providers to
identify the name and contact
information for the organization that
will be legally and financially
responsible for the activities supported
through the Pilot (e.g., submitting
funding requests, submitting invoicing
and disbursement forms, submitting
competitive bidding forms (if required)),
as is required for consortia participating
in the Healthcare Connect Fund
program. This requirement would
identify the responsible party if
disbursements must be recovered for
violations of program rules or
requirements. The Commission seeks
comment on these proposals.
64. Disbursements. The Notice of
Inquiry sought comment on how
disbursements should be issued for the
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Pilot program. Few commenters
specifically addressed the issue of how
often disbursements should be issued
and which entity should receive
disbursements through the Pilot
program. One commenter supported
monthly disbursements. Another
commenter asserted that disbursements
should be issued to service providers to
minimize health care providers’
administrative burdens, while two other
commenters asserted that the
disbursements should be issued directly
to health care providers. Another
commenter recommended issuing
disbursements in the form of vouchers
directly to participating patients, but
other commenters argued that this
approach would complicate the
administration of the Pilot program,
create unnecessary consumer burdens,
and raise potential program integrity
concerns.
65. The Commission proposes issuing
disbursements to the service provider,
as is the current practice for the RHC
programs, for the purchase of
connectivity or other eligible items
pursuant to its legal authority. In
practice, this would equate to monthly
discounts paid towards the cost of
service or eligible equipment purchased
by the health care provider. The
Commission seeks comment on this
proposal and any alternatives that
commenters may provide. The
Commission also proposes requiring
that all reimbursement requests for any
health care provider-purchased services
funded through the Pilot program be
submitted within six months of the date
of receipt of the eligible service or
network equipment, and allow for
extensions to this deadline where good
cause exists. Based on the Commission’s
experience with the existing RHC
programs, establishing deadlines for
submitting invoices would facilitate
effective administration of the Pilot
program.
66. For all services supported through
the Pilot program, should the project’s
compliance with the data reporting
requirements discussed in the following
be a requirement for issuing each
disbursement to the service provider?
Since the purpose of Pilot program is to
collect data and test the efficacy of a
connected universal service support
mechanism, would delay or failure to
comply with data reporting
requirements create sufficient reason to
hold disbursements until the error is
corrected? The Commission seeks
comment on the best methods to ensure
participants are regularly reporting
useful and required program data
including whether and how to tie the
data submission requirement to the
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reimbursement of Pilot program
support.
67. Ensuring Effective and
Responsible Use of Funds. Consistent
with the other existing universal service
support programs, to ensure the fiscally
responsible use of Pilot program funds
and guard against waste, fraud, and
abuse, the Commission proposes
adopting document retention and
production requirements for health care
providers and service providers
participating in the Pilot program, and
also proposes making individual
projects subject to random compliance
audits. Specifically, the Commission
proposes applying to the Pilot program
(1) section 54.648(a) of the Healthcare
Connect Fund program rules, which
makes participating health care
providers and service providers subject
to random compliance audits, and (2)
section 54.648(b)(1)–(3) of the
Healthcare Connect Fund program rules,
which require participating health care
providers and service providers to retain
documentation sufficient to establish
compliance with the rules and
requirements for the Pilot program for at
least five years and produce such
documents to the Commission, any
auditor appointed by the Administrator
or the Commission, or any other state or
federal agency with jurisdiction. Are
there any other rules or requirements for
the RHC support programs, the E-Rate
program, or the Lifeline program not
specifically mentioned in the NPRM
that the Commission should apply to
the Pilot program?
68. With respect to audits, the Office
of the Managing Director and the Bureau
would have the authority to direct
USAC to conduct targeted audits as
necessary to ensure Pilot program funds
are being used consistent with the
program. The Commission believes that
a five-year document retention period
after the final disbursement is made
would provide sufficient time to
conduct audits and any other
investigations related to the Pilot
program. The Commission seeks
comment on this proposal.
69. The Notice of Inquiry sought
comment on several potential goals for
the Pilot program. In addition, the
Notice of Inquiry proposed several
metrics and methodologies for gathering
data and measuring progress towards
the proposed goals. The Commission
proposes to focus on four primary
program goals and seeks comment on
this approach: (1) Improving health
outcomes through connected care; (2)
reducing health care costs for patients,
facilities, and the health care system; (3)
supporting the trend towards connected
care everywhere; and (4) determining
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how USF funding can positively impact
existing telehealth initiatives. Further,
the Commission seeks comment on
appropriate metrics and methodologies
to measure Pilot projects’ progress
towards these goals.
70. The Commission believes these
constitute sound goals for the Pilot
program and they are consistent with
our statutory obligation to promote
universal service. Section 254(c)(1), for
example, directs the Commission to
keep in mind when establishing the
definition of services supported by USF
‘‘the extent to which such
telecommunications services are
essential to education, public health, or
public safety.’’ Moreover, section
254(h)(2)(A) directs the Commission to
establish rules to enhance access to
advanced telecommunications and
information services for health care
providers. Additionally, section
254(b)(3) provides that ‘‘[c]onsumers in
all regions of the Nation, including lowincome consumers and those in rural,
insular, and high cost areas, should
have access to advanced
telecommunications and information
services . . . that are reasonably
comparable to those services provided
in urban areas and that are available at
rates that are reasonably comparable to
rates charged for similar services in
urban areas.’’ The Commission believes
the proposed goals will help advance
these principles, and seeks comment on
that conclusion.
71. Proposed Program Goals. First, the
Commission intends that the Pilot will
help improve health outcomes through
connected care. Several comments in
the record expressed support for
including this as a program goal. For
example, Hughes stated that the
‘‘provision of telehealth services
expands access to high-level care and
closes geographic barriers experienced
by patients.’’ TruConnect stated that the
‘‘use of telemedicine applications on
smartphones and devices benefits those
who use them and will especially help
rural patients who must travel great
distances to health care providers.’’
According to the American Heart
Association, a ‘‘strong and growing body
of evidence identifies telehealth and
remote patient monitoring as
cornerstones of advanced healthcare
systems.’’
72. Commenters also identified
several specific ways in which
broadband access can improve health
outcomes. For example, the Medical
University of South Carolina (MUSC)
and Gila River Telecommunications,
Inc. (GRTI) both note that greater access
to telehealth can enable health care
providers to more easily engage their
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patients in the daily management of
chronic conditions. Commenters also
note that broadband access for
telehealth purposes increases the
likelihood that patients will seek out
medical care, and also increases the
likelihood that patients will follow a
prescribed course of treatment.
Commenters stated that telehealth can
reduce emergency room visits and
hospital admissions and readmissions,
and can lead to increased contact with
specialists. The Commission agrees with
these assessments and therefore
proposes to include improvement of
health outcomes through connected care
as a goal of the Pilot program.
73. The Commission also believes the
Pilot program can ultimately help
reduce health care costs for patients,
facilities, and the health care system,
and proposes to adopt that program
goal. The Commission seeks comment
on this proposal. In the Notice of
Inquiry, the Commission asked how the
Pilot program could help identify
effective means of improving health care
affordability for patients, including by
reducing the burden of out-of-pocket
expenses like transportation costs for
rural and remote patients. Similarly, the
Commission stated that the Pilot
program could help identify the
circumstances in which support for
telehealth services could create savings
for health care providers and the
Medicaid program.
74. Many commenters noted the
potential for the Pilot program to greatly
reduce travel time for rural and remote
patients, significantly reducing out-ofpocket costs for patients, in addition to
reducing the need to miss work or
school to see a health care provider.
Commenters also noted that reduction
in travel times could lower costs for
physicians and health care providers.
The University of Arkansas for Medical
Sciences stated that insurers will
‘‘witness cost savings when fewer
beneficiaries experience long-term,
costly morbidities.’’ The Medical Home
Network described the ability of
telemedicine to increase communication
between a primary care physician and a
specialist, ‘‘expediting wait times for
patient appointments, and reducing
unnecessary referrals and emergency
room visits.’’ In particular, Hughes,
citing to videoconferencing capabilities
at the University of California, Davis,
found that ‘‘patients avoided nearly 5
million miles of travel and $3 million in
travel expenses by being able to
videoconference the treatment center in
Sacramento.’’ CHRISTUS Health
provided data on a remote monitoring
pilot in partnership with a carrier and
vendor in Texas, and found that after
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one year of study, the pilot program
reduced the cost of care by an estimated
$236,000 per year for congestive heart
failure patients enrolled in the pilot.
Thus, based on the record, the
Commission believes the program could
help reduce health care costs for
patients, facilities, and the health care
system overall and seeks comment on
this program goal.
75. Next, the Commission proposes to
establish a goal of supporting the trend
toward bringing health care directly to
the consumer. The Notice of Inquiry
observed that there is a trend away from
relying on connectivity solely within
and between physical health care
centers and towards a ‘‘connected care
everywhere’’ model—a trend that has
shown promising results for patients,
communities, and the health care
system. The Notice of Inquiry sought
comment on using the Pilot program to
support the current movement towards
direct-to-consumer health care to ensure
that low-income Americans can realize
the benefits of this trend.
76. Commenters broadly support
making this a program goal for the Pilot.
GRTI, for example, noted that the
Commission ‘‘has an opportunity to
support the trend towards greater use of
connected care and the benefits of such
a policy,’’ and supports the goal of
evaluating success of the Pilot program
based in part on how it furthers this
trend. The American Heart Association,
commenting on the benefits and costs of
the move towards ubiquitous connected
care, noted the ability of telehealth to
provide ‘‘instant healthcare at a fraction
of the cost regardless of the patient’s
health care status or geographic
location,’’ but also noted potential
ethical issues, including questions of
trust, confidentiality, privacy, and
informed consent. MUSC stated that as
part of the movement towards
connected care everywhere, the Pilot
program should support the
participation of rural and underserved
consumers in the direct-to-consumer
health care market. The Commission
seeks comment on adopting this
program goal. The Commission
encourages commenters to specifically
address how making USF dollars
available to support the connectivity
that enables telehealth applications can
promote access to health care services
for patients outside of the confines of
brick-and-mortar medical facilities.
77. Finally, the Commission
anticipates that the Pilot will help to
determine how USF funding can
positively impact existing telehealth
initiatives, and the Commission
proposes to include this as a goal of the
Pilot program. In the Notice of Inquiry,
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the Commission stated that it sought ‘‘to
ensure that the pilot program enhances
existing telehealth initiatives by the
Commission and other federal
agencies.’’ The Commission observed
that it currently has several initiatives to
assist with the expansion of health care
connectivity in rural and underserved
areas including through the Rural
Health Care programs and the
Connect2Health Task Force. In addition,
the Commission noted various other
telehealth programs established by other
federal agencies, for example, the VA’s
Home Telehealth Program and several
initiatives run by the Department of
Health and Human Services (HHS).
78. Numerous commenters assert that
the Commission should consider
working with HHS, in particular CMS,
the National Coordinator for Health
Information Technology (ONC), the
Health Resources and Services
Administration (HRSA), and the Indian
Health Service. The Virginia Telehealth
Network similarly proposed that the
Commission consider collaborating with
private sector entities that are providing
broadband internet access service to
vulnerable populations that might
benefit from connected care services.
79. The Commission seeks comment
on this proposed goal. How can the
funding of connectivity for telehealth
through the Connected Care Pilot
complement other Commission
initiatives, such as the Rural Health
Care Program and the Connect2Health
Task Force? How can the Pilot program
complement other Commission
programs to provide connectivity to
low-income consumers, like the Lifeline
Program, and rural and remote
consumers, like the High Cost Fund?
Other than the VA’s Home Telehealth
program, what existing federal
programs, if any, specifically fund
connectivity for patients to enable the
provision of telehealth? How can the
Commission best collaborate with other
federal agencies pursuing this goal?
80. Metrics. The Commission seeks
comment on the best metrics and
methodologies for measuring progress
towards its proposed program goals. For
example, are there specific ways in
which broadband-enabled telehealth
applications can improve health
outcomes that could be demonstrated
through the Pilot program? In the Notice
of Inquiry, the Commission proposed
several metrics: Reductions in
emergency room or urgent care visits in
a particular geographic area or among a
certain class of patients; decreases in
hospital admissions or re-admissions for
a certain patient group; conditionspecific outcomes such as reductions in
premature births or acute incidents
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among sufferers of a chronic illness; and
patient satisfaction as to health status.
Are there other metrics for measuring
this goal? For example, commenters
suggested measuring adherence to
medication and care plans as a possible
metric, because of the correlation with
reducing morbidity and mortality. How
can the Commission best measure
whether and to what extent telehealth
can promote adherence to medication
and care plans? Similarly, how can the
Commission measure patient
satisfaction as to health status?
81. The Commission also encourages
commenters to explain the specific ways
itmeasures how universal service
support for connectivity will improve
health outcomes through telehealth. Do
low-income consumers face budget
constraints that are not adequately
addressed by existing programs that
prevent them from adopting connected
care services via broadband internet
access service? In such cases, what
alternatives do those consumers use to
obtain medical care, and do those
alternatives result in poorer health
outcomes? Do health care providers face
budgetary shortfalls with respect to
funding broadband internet access
connections for connected care services,
or other information services or
equipment that health care providers
need to provide connected care services
such that the Fund can help serve a
crucial funding need? In what other
ways will universal service funding for
connectivity promote improved health
outcomes through telehealth?
82. The Commission also asks
commenters to provide, where available,
data and other information to help
evaluate the potential for cost savings
through telehealth. In addition to the
specific areas of cost savings discussed
in this document, in what other ways
can the provision of telehealth produce
cost savings for patients, facilities, and
the health care system? The
Commission further asks commenters to
provide information on the specific way
in which universal service support for
connectivity to enable telehealth will
produce cost savings. And the
Commission seeks comment on the best
metrics to evaluate progress towards
this goal. How can the Commission best
measure the savings from, for example,
reduction in travel miles and travel time
for patients and physicians? How can
the Commission measure the effect of
healthier patients on costs faced by
health care providers and insurers? To
what extent do these measures depend
on accurate metrics on the health
outcomes of the patients of pilot
programs? What metrics exist to
determine the cost savings from a
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reduction in hospital admissions or readmissions, or a reduction in emergency
room visits?
83. How can the Commission measure
its progress in supporting the trend
toward bringing health care directly to
the consumer? Will that funding enable
access for patients and providers that
would not otherwise have access to
telehealth, perhaps by bringing
telehealth into new geographic areas or
attracting new funding for existing
telehealth services? Will funding
connected care pilots draw attention to,
and increase the effectiveness of, future
connected care applications, thereby
promoting the development of
connected care? Would it help incent
more health care providers to purchase
broadband, in order to bring connected
care services to more patients? The
Commission also seeks comment on any
potential costs of ubiquitous connected
care, including the ethical issues raised
by the American Heart Association.
How should these issues impact
whether the Commission sets increased
use of connected care as a goal of the
Pilot program?
84. Finally, the Commission seeks
comment on how it can determine
whether the Pilot program supports
existing Commission and federal efforts
to promote telehealth. How can the
Commission avoid duplicating existing
efforts or otherwise overlap with
programs that promote connectivity for
telehealth? The Commission proposes to
require Pilot program proposals to
identify non-USF sources of funding or
support, and to also require reporting
from Pilot program participants to help
the Commission identify how USF
support for connected care broadband
connectivity can leverage existing or
new efforts to support other components
of successful telehealth services. The
Commission seeks comment on this
approach.
85. For the Commission to evaluate
the success of the Pilot program, it is
critical to establish tools and procedures
to gather data from the Pilot program
participants on progress toward
achieving the stated Pilot program goals.
In addition, this information will allow
the Commission to evaluate the progress
of each project and ensure that Pilot
program funds are being used efficiently
and effectively. Ultimately, this data
will determine the success of the Pilot
program and will help inform the
Commission about the long-term
viability of a connected care program.
86. Reporting Intervals. The
Commission proposes requiring
participating health care providers to
submit regular reports with
anonymized, aggregated data that will
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enable the Commission to monitor the
progress of each project and ultimately
evaluate the Pilot program, as a
condition of receiving the proposed
support. The Commission seeks
comment on the required reporting
intervals (e.g., quarterly, annually) and
the information that should be included
in the reports. For example,
TeleHealthCare America proposed
quarterly reports, and the Commission
seeks comment on whether quarterly
intervals would be sufficient. Is there a
shorter or longer reporting interval that
would be more appropriate when
analyzing outcomes from clinical trials?
Do clinical trials commonly report
interim results before completion of the
trial? What types of information are
reported on an interim basis and would
such results provide reliable
information? Or should the Commission
delay reporting of health outcomes until
the study is completed? What is the
standard practice in medical research?
Could such reports create difficulties for
blinding protocols?
87. Clinical Trials. The Commission
seeks comment on the appropriate
methods for measuring the health effects
of the connected care Pilot projects.
Should all projects be required to
conduct randomized controlled trials to
determine the effect of the treatments on
patients’ health? Are there alternative,
less costly methods that are statistically
sound and can accurately measure the
effect of the treatment? Are these
alternative methods generally accepted
in the scientific and medical
communities? If the proposed treatment
in a Pilot project has already been
extensively studied and the health
benefits are generally accepted by the
medical community, and the pilot’s
purpose is to uncover other effects, such
as the impact on the costs of providing
health care or the broader impacts of
subsidized access to broadband internet
access services for connected care, is
there any need to require the reporting
of health outcomes?
88. Would different clinical trials be
better served by different reporting
requirements and, if so, could these be
judged as part of the proposed project
methods? Should the Commission
require participants to file a detailed
annual report, and shorter reports on a
quarterly basis? The Commission is
mindful of the burden that reporting can
create for participants, particularly
those that do not regularly report
information to the Commission and seek
to minimize this burden while still
providing a mechanism for participants
to provide valuable information. The
Commission encourages commenters to
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discuss the burdens and the best
methods to alleviate them.
89. Data Fields. The Commission
proposes that the regular reports from
each participating project include
information on a number of data fields
that will enable the Commission to
monitor the progress of each project
towards the overall goals of the Pilot
program. The Commission seeks
comment on the data Pilot program
participants should provide in regular
reports to enable measuring progress
towards these goals. The Commission
proposes several data fields that should
be part of regular reporting from Pilot
participants. These fields include: The
number of patients participating in the
pilot project each month; the number of
patients participating in the pilot project
being treated for specific health
conditions; the types of connected care
services provided for each condition;
average frequency of patient use of each
type of connected care service; health
outcomes for patients; and average costsavings per patient. The Commission
seeks comment on the proposed use of
these data fields. Are there other types
of information the Commission should
require Pilot program participants to
report on a regular basis? Should the
Commission require pilot beneficiaries
to submit raw health data on study
participants or is it sufficient for
beneficiaries to provide estimates of the
effect of the treatment? Should the
Commission require any type of
certification as to the accuracy of the
information provided?
90. To obtain information regarding
patient experience, the Commission
proposes requiring health care providers
to conduct regular surveys of
participating patients. The purpose of
these surveys is to collect information
regarding data such as patient cost
savings, saved travel miles, patient
satisfaction and comfort with the
provided connected care services. Given
the additional time and expense in
administering patient surveys,
reviewing data, and reporting it to the
Commission, should health care
providers conduct these surveys on a
quarterly basis, or on a longer
timeframe, such as after the completion
of the clinical trial?
91. The Commission also proposes
collecting additional information from
Pilot program patient participants at the
time of enrollment to better understand
the impact of the Pilot program on the
goals identified in this document,
including whether the patient already
has a mobile and/or home broadband
connection, the speed, technology and
broadband data usage for any broadband
connection the patient already has, and
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what devices the patient uses to connect
to the internet. What other information
might be important to know at the time
of enrollment to help establish a
baseline for measuring the impact of the
Pilot program? Which party would be in
the best position to collect this
information from participants?
92. As noted in this document, the
Commission proposes that all data
provided by Pilot program participants
should be anonymized and aggregated,
and if that is impossible, for example,
because there are so few participants
within a reporting area their data could
be used to identify individuals, then
masked. Should the regular reports from
each pilot project be made publicly
available? If so, is the Commission’s
website, or USAC’s website, the best
place to host this information? Should
the Commission allow project
participants to request delay of
publication until the project is
completed if publication might impact
the experiment? The Commission
anticipates that these reports would not
raise any HIPAA or other privacy
concerns because the proposed required
data would be submitted on an
aggregated, anonymized basis. The
Commission seeks comment on this
conclusion. Further, are there other
privacy or security measures that the
Commission and USAC should take to
ensure proper receipt, storage, and use
of the data? The Commission is acutely
aware of the data protections and
sensitivities surrounding health data
and seeks comment on the best ways to
ensure proper handling of this
information.
93. The Commission also proposes
that Pilot program participants provide
information regarding their experience
with the Pilot program. For example, the
Commission is interested in measuring
the costs that Pilot program participants
experience in designing their programs,
submitting applications to the
Commission, and ensuring ongoing
compliance with the Pilot’s rules and
procedures. The Commission proposes
to ask on a regular basis for these types
of cost and time estimates to evaluate
whether the Pilot program is an
administratively feasible method of
distributing funding for connected care
services. This information will be
critical if, following the Pilot, the
Commission chooses to make a
connected care program permanent, and
seeks to minimize applicant burdens in
so doing.
94. Forms. In addition, the
Commission seeks comment on the
forms that participants will use to
provide this information. Are there
existing Commission forms from other
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USF programs, in particular the Rural
Health Care program, that can be used
to report data for the Pilot program?
Should the Commission establish new
forms for the purposes of the Pilot
program?
95. The Commission’s stewardship of
the universal service support
mechanisms and determinations
concerning the services that are eligible
for universal service funding are bound
by section 254 of the Act, as amended
by the 1996 Act. The Notice of Inquiry
sought comment on the Commission’s
legal authority to establish the Pilot
program. In the following, the
Commission proposes and seeks
comment on itssources of legal authority
for the Pilot program. The Commission
seeks comment on the potential impact
of its legal authority on the structure,
administrability, and effectiveness and
efficiency of the Pilot program. Are
there any additional potential sources of
legal authority that the Commission
should consider?
96. Based on review of the record and
reading of the statute, the Commission
believes that the Commission’s rural
health care legal authority in section
254(h)(2)(A) of the Act supports the
proposed Pilot program. Section
254(h)(2)(A) directs the Commission to
‘‘establish competitively neutral rules,
(A) to enhance, to the extent technically
feasible and economically reasonable,
access to advanced telecommunications
and information services for all public
and non-profit . . . health care
providers. . . .’’ The Commission has
previously explained that it has ‘‘broad
discretion regarding how to fulfill this
statutory mandate.’’ The Commission
seeks comment on whether to rely on
the rural health care legal authority in
section 254(h)(2)(A) as its authority to
create the proposed Pilot program, and
how relying on this legal authority
would impact the structure of the Pilot
program.
97. Several commenters argued that
section 254(h)(2)(A) provides the
Commission with legal authority to
establish the proposed Pilot program.
The Commission previously relied on
this statutory provision as its legal
authority for the RHC Pilot program and
the Healthcare Connect Fund program,
which were designed to develop
dedicated health care provider networks
and fund broadband internet access
services used directly by health care
providers, and network equipment
necessary to make the supported
services functional. The Commission
has not previously relied on this
statutory provision to provide support
for connectivity between patients and
health care providers, however. The
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Commission believes the most feasible
way to structure the Pilot program
would be to have the health care
provider purchase the broadband
internet access service needed by the
patient to access connected care services
from a broadband carrier or a connected
care company (e.g., a remote patient
monitoring company) and then provide
the telehealth service, including the
underlying internet broadband access
service, to the patient directly. The
Commission therefore seeks comment
on whether and how section
254(h)(2)(A) could be interpreted to
authorize the creation of a Pilot program
that would support patient broadband
internet access service connections for
connected care.
98. The Commission requests
information on how providing health
care providers support for patientcentered connected care enhances
health care provider ‘‘access to
advanced telecommunications and
information services’’ consistent with
section 254(h)(2)(A). Is there an
argument that patient broadband
internet access service falls within
section 254(h)(2)(A) when it is
purchased by a health care provider and
used for medical purposes? Is the legal
argument for supporting connectivity
underlying technologies such as remote
patient monitoring under section
254(h)(2)(A) stronger where the health
care provider purchases the residential
broadband internet access service as
part of a complete solution or package
and provides the connected care
services to the patient? Does the fact
that a health care provider cannot serve
a patient at the patient’s location
through connected care unless the
patient has a broadband internet access
connection provide a basis for relying
on the rural health care authority in
section 254(h)(2)(A)? Is there an
argument that individual patient
broadband connections for connected
care services fall within the scope of
section 254(h)(2)(A) because they
extend the health care provider’s
network by allowing the health care
provider to send and receive
communications to its patients
wherever the patients are located, and
thus would enhance access to advanced
service ‘‘for’’ the health care provider, as
required by section 254(h)(2)(A)?
99. The Commission also seeks
comment on whether section
254(h)(2)(A) would also authorize the
Commission to provide funding under
the Pilot program for health care
provider purchases of services—other
than patient connectivity—that are used
to provide connected care services but
that are not already eligible for support
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through the Healthcare Connect Fund
program. For example, companies may
offer cloud-based solutions, finished
service packages, or complete suites of
services that allow health care providers
to provide telehealth, including
connected care. Are these services
‘‘information services’’ under section
254(h)(2)(A), for which the Commission
is required to develop competitively
neutral rules to enhance access for
health care providers? Are there other
types of services that qualify as
‘‘information services’’ under section
254(h)(2)(A)? The Commission seeks
additional information about, and
examples of, these services and the
components of these services, including
any network equipment required to
make these services functional. The
Commission also seeks specific
information and data that would help it
to determine whether these types of
services could qualify as supportable
information services under section
254(h)(2)(A). Finally, the Commission
seeks information on how these types of
services help health care providers
provide connected care services, and
whether health care providers have
difficulty affording these types of
services without USF support.
100. The Commission believes that
the universal service principles in
sections 254(b)(1) and (b)(3) of the Act,
and section 254(j) of the Act provide
additional statutory support for a Pilot
program that would provide USF
support to enable health care providers
to provide connected care technologies
to eligible low-income consumers.
Sections 254(b)(1) and (b)(3), provide,
respectively, that the Commission’s
universal service policies must be based
on the principles that ‘‘[q]uality services
should be available at just, reasonable,
and affordable rates’’ and ‘‘[c]onsumers
in all regions of the Nation, including
low-income consumers . . . should
have access to telecommunications and
information services . . . that are
reasonably comparable to those services
provided in urban areas and that are
available at rates that are reasonably
comparable to those services provided
in urban areas.’’ Section 254(j) ensures
the continuation of the Lifeline program
through any subsequent changes to the
Universal Service Fund. In addition,
section 154(i) also authorizes the
Commission to ‘‘perform any and all
acts, make such rules and regulations,
and issue such orders, not inconsistent
with this chapter, as may be necessary
in the execution of its functions.’’
101. The Commission believes that
using a discrete, time-limited Pilot
program to obtain additional data about
the benefits of broadband-enabled
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connected care services, and how
universal service funds could better
support the adoption of broadbandenabled connected care services, as well
as broadband internet access service
more generally, is consistent with these
statutory provisions. The Commission
notes that it has previously relied on
sections 254(b)(1) and (b)(3) and 154(i)
to establish the limited Lifeline
Broadband Pilot program, which
provided participating low-income
consumers support for bundled
broadband service or stand-alone
broadband service to test the impact of
Lifeline support on broadband adoption.
The Commission seeks comment on
relying in part on the low-income legal
authority for the proposed Pilot program
and how relying on the low-income
legal authority would impact the
structure of the Pilot program. For
example, would relying on the low
income legal authority require the
Commission to limit Pilot projects to
those serving exclusively low-income
individuals?
102. The Commission also seeks
comment on whether it should rely on
its low-income legal authority to
provide support for broadband internet
access connections for connected care
services through the Pilot program, and
rely on its rural health care legal
authority to provide support for
information services not already funded
through the Healthcare Connect Fund
program that health care providers use
to provide connected care services. How
would this approach impact the
structure and administrability of the
Pilot program? Would it result in a Pilot
program structure that incentivizes
participation from eligible health care
providers, service providers, and
patients better than under the other
proposed legal authorities?
103. For example, if a health care
provider contracts with a remote patient
monitoring solution provider for a
package that includes broadband
connectivity for patients, patient remote
monitoring equipment, and software for
the health care provider to process data
received by the patient’s remote
monitoring equipment, could the
Commission fund some parts of that
overall package via its Rural Health Care
legal authority and other parts through
its low-income legal authority? If the
health care provider needed additional
broadband capacity to its location to
support that remote monitoring service,
could the Commission also support that
additional capacity through this Pilot
program?
104. Are there other services the
Commission should consider supporting
consistent with its legal authority? For
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example, in the Commission’s Rural
Health Care Pilot Program, participants
were permitted to purchase equipment
integral to running their broadband
networks, such as servers, routers,
firewalls, and switches, or to upgrade
their existing equipment and increase
bandwidth. The Commission seeks
comment on its legal authority to fund
such services here.
III. Procedural Matters
A. Initial Paperwork Reduction Act
Analysis
105. This document contains
proposed information collection
requirements. The Commission, as part
of its continuing effort to reduce
paperwork burdens, invites the general
public and the OMB to comment on the
information collection requirements
contained in this document, as required
by the Paperwork Reduction Act of
1995, Public Law 104–13. In addition,
pursuant to the Small Business
Paperwork Relief Act of 2002, Public
Law 107–198, see 44 U.S.C. 3506(c)(4),
the Commission seeks specific comment
on how to further reduce the
information collection burden for small
business concerns with fewer than 25
employees.
106. Ex Parte Rules—Permit-ButDisclose. The proceeding the NPRM
initiates shall be treated as a ‘‘permitbut-disclose’’ proceeding in accordance
with the Commission’s ex parte rules.
Persons making ex parte presentations
must file a copy of any written
presentation or a memorandum
summarizing any oral presentation
within two business days after the
presentation (unless a different deadline
applicable to the Sunshine period
applies). Persons making oral ex parte
presentations are reminded that
memoranda summarizing the
presentation must (1) list all persons
attending or otherwise participating in
the meeting at which the ex parte
presentation was made, and (2)
summarize all data presented and
arguments made during the
presentation. If the presentation
consisted in whole or in part of the
presentation of data or arguments
already reflected in the presenter’s
written comments, memoranda, or other
filings in the proceeding, the presenter
may provide citations to such data or
arguments in his or her prior comments,
memoranda, or other filings (specifying
the relevant page and/or paragraph
numbers where such data or arguments
can be found) in lieu of summarizing
them in the memorandum. Documents
shown or given to Commission staff
during ex parte meetings are deemed to
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be written ex parte presentations and
must be filed consistent with rule
1.1206(b). In proceedings governed by
rule 1.49(f) or for which the
Commission has made available a
method of electronic filing, written ex
parte presentations and memoranda
summarizing oral ex parte
presentations, and all attachments
thereto, must be filed through the
electronic comment filing system
available for that proceeding, and must
be filed in their native format (e.g., .doc,
.xml, .ppt, searchable .pdf). Participants
in this proceeding should familiarize
themselves with the Commission’s ex
parte rules.
107. Initial Regulatory Flexibility
Analysis. As required by the Regulatory
Flexibility Act of 1980, as amended, the
Commission has prepared an Initial
Regulatory Flexibility Analysis (IRFA)
for the NRPM, of the possible significant
economic impact on a substantial
number of small entities by the policies
and rules proposed in the NPRM.
Written public comments are requested
on this IRFA. Comments must be
identified as responses to the IRFA and
must be filed by the deadlines for
comments on the NPRM. The
Commission will send a copy of the
NPRM, including this IRFA, to the Chief
Counsel for Advocacy of the Small
Business Administration. In addition,
the NPRM and IRFA (or summaries
thereof) will be published in the Federal
Register.
108. Need for, and Objectives of, the
Proposed Rules. The Commission is
required by section 254 of the
Communications Act of 1934, as
amended, to promulgate rules to
implement the universal service
provisions of section 254 and ‘‘to
establish competitively neutral rules—
(A) to enhance to the extend technically
feasible and economically reasonable,
access to advanced telecommunications
and information services for all public
and nonprofit . . . health care providers
. . . .’’ The Commission is also
required to base policies for the
preservation and advancement of
universal services on principles
including ‘‘[q]uality rates should be
available at just, reasonable, and
affordable rates’’ and ‘‘[c]onsumers in
all regions of the Nation, including lowincome consumers . . . should have
access to telecommunications service
and information services . . . that are
reasonably comparable to those services
provided in urban areas and that are
available at rates that are reasonably
comparable to rates charged for similar
services in urban areas.’’ In the NPRM,
the Commission proposes a Connected
Care Pilot program (Pilot) that will assist
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in satisfying these requirements by
providing support for eligible health
care providers to provide connected
care to low-income patients, including
veterans and those in medically
underserved communities. The
Commission seeks comment on whether
the Pilot program should fund
broadband internet access services or
other information services used by
health care providers to provide
connected care services and network
equipment necessary to make the
supported services functional. The
Commission expects that the data
gathered from the Pilot program will
help to understand how and whether
USF funds could be used to promote
health care provider and low-income
patient adoption and use of connected
care services.
109. The Commission proposes four
goals for the proposed Pilot program
and also propose a three-year duration
and budget of $100 million for the Pilot
program. The Commission also proposes
and seeks comment on the application
process and the objective criteria for
selecting projects among the
applications the Commission receives
for the Pilot program, and proposes and
seeks comment on awarding additional
points during the evaluation process for
proposed projects that would primarily
serve veterans or rural or Tribal areas or
populations or primarily treat diabetes,
heart disease, opioid addiction, mental
health conditions, or high-risk
pregnancy. The Commission should be
able to fund a range of diverse projects
throughout the country. The
Commission proposes the specific
requirements for health care providers,
including vendor selection
requirements, requirements for
requesting funding and reimbursements,
and audit and document retention
requirements, and data reporting
requirements. Finally, the Commission
proposes specific requirements for
participating service providers
including indicating interest in
participating in the Pilot program,
requesting disbursements, and
document retention and audit
requirements. Participating consumers
may also be required to complete
consumer surveys.
110. Legal Basis. The legal basis for
the Notice of Proposed Rulemaking is
contained in sections 1 through 4, 201,
254, and 403 of the Communications
Act of 1934, as amended by the
Telecommunications Act of 1996, 47
U.S.C. 151 through 154, 201, 254, and
403.
111. Description and Estimate of the
Number of Small Entities to Which the
Proposed Rules Will Apply. The RFA
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directs agencies to provide a description
of and, where feasible, an estimate of
the number of small entities that may be
affected by the proposed rules, if
adopted. The RFA generally defines the
term ‘‘small entity’’ as having the same
meaning as the terms ‘‘small business,’’
‘‘small organization,’’ and ‘‘small
governmental jurisdiction.’’ In addition,
the term ‘‘small business’’ has the same
meaning as the term ‘‘small business
concern’’ under the Small Business Act.
A small business concern is one that: (1)
Is independently owned and operated;
(2) is not dominant in its field of
operation; and (3) satisfies any
additional criteria established by the
Small Business Administration (SBA).
Nationwide, there are a total of
approximately 29.6 million small
businesses, according to the SBA. A
‘‘small organization’’ is generally ‘‘any
not-for-profit enterprise which is
independently owned and operated and
is not dominant in its field.’’
112. Small Businesses, Small
Organizations, Small Governmental
Jurisdictions. The Commission’s actions,
over time, may affect small entities that
are not easily categorized at present.
The Commission therefore describes
here, at the outset, three broad groups of
small entities that could be directly
affected herein. First, while there are
industry specific size standards for
small businesses that are used in the
regulatory flexibility analysis, according
to data from the SBA’s Office of
Advocacy, in general a small business is
an independent business having fewer
than 500 employees. These types of
small businesses represent 99.9% of all
businesses in the United States which
translates to 29.6 million businesses.
113. Next, the type of small entity
described as a ‘‘small organization’’ is
generally ‘‘any not-for-profit enterprise
which is independently owned and
operated and is not dominant in its
field.’’ Nationwide, as of August 2016,
there were approximately 356,494 small
organizations based on registration and
tax data filed by nonprofits with the
Internal Revenue Service (IRS).
114. Finally, the small entity
described as a ‘‘small governmental
jurisdiction’’ is defined generally as
‘‘governments of cities, counties, towns,
townships, villages, school districts, or
special districts, with a population of
less than fifty thousand.’’ U.S. Census
Bureau data from the 2012 Census of
Governments indicates that there were
90,056 local governmental jurisdictions
consisting of general purpose
governments and special purpose
governments in the United States. Of
this number there were 37,132 general
purpose governments (county,
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municipal and town or township) with
populations of less than 50,000 and
12,184 special purpose governments
(independent school districts and
special districts) with populations of
less than 50,000. The 2012 U.S. Census
Bureau data for most types of
governments in the local government
category show that the majority of these
governments have populations of less
than 50,000. Based on this data the
Commission estimates that at least
49,316 local government jurisdictions
fall in the category of ‘‘small
governmental jurisdictions.’’
115. Small entities potentially
affected by the proposals herein include
eligible non-profit and public health
care providers and the service providers
offering them services, including
telecommunications service providers,
internet Service Providers (ISPs), and
vendors of the eligible services and
equipment that would be supported by
the Pilot program.
116. Description of Projected
Reporting, Recordkeeping, and Other
Compliance Requirements for Small
Entities. In the NPRM, the Commission
seeks comment on a proposed
Connected Care Pilot program with a
$100 million budget and three-year
duration, that would provide support
for eligible low-income patients to
receive discounts on residential
broadband service for purposes of
connected care.
117. To participate in the Pilot
program, the Commission proposes that
health care providers satisfy the
definition of an eligible health care
provider under section 254(h)(7)(B) of
the Act and submit an application by
the application deadline that the
Commission ultimately adopts for the
Pilot program. The NPRM proposes
specific information that health care
providers would be required to submit
in an application for each pilot project
proposal, including, but not limited to,
information on the participating health
care provider(s), description of the
project and how it would further the
goals of the Pilot program, estimated
project budget, patient populations and
the geographic areas to be served and
health conditions to be treated. The
NPRM also proposes that the
applications be made publicly available.
118. The NPRM proposes
requirements for participating health
care providers to select service
providers for the supported services and
other potential Pilot-program supported
items, including the possibility of
requiring health care providers to
competitively bid the supported
services. In addition, the NPRM
proposes requiring health care providers
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for participating projects to submit
funding requests and invoices for
services and other items that are eligible
for support through the Pilot program,
and reports at regular intervals that
would allow the Commission to monitor
the status of each project and how each
project is using the funding and seeks
comment on the appropriate interval
and contents of those reports.
Participating service providers may also
have requirements related to requesting
disbursements. The NPRM also
proposes that participating health care
providers and service providers be
subject to random compliance audits,
and a three or five-year document
retention period.
119. Steps Taken to Minimize the
Significant Economic Impact on Small
Entities, and Significant Alternatives
Considered. The RFA requires an
agency to describe any significant,
specifically small business, alternatives
that it has considered in reaching its
proposed approach, which may include
the following four alternatives (among
others): ‘‘(1) the establishment of
differing compliance or reporting
requirements or timetables that take into
account the resources available to small
entities; (2) the clarification,
consolidation, or simplification of
compliance and reporting requirements
under the rule for such small entities;
(3) the use of performance rather than
design standards; and (4) an exemption
from coverage of the rule, or any part
thereof, for such small entities.’’
120. The Commission does not expect
the requirements for the Pilot program
to have a significant economic impact
on eligible service providers or eligible
health care providers because service
providers and health care providers
have a choice of participating. The
Commission also does not expect small
entities to be disproportionately
impacted. The Bureau will consider
whether the proposed projects will
promote entrepreneurs and other small
businesses in the provision and
ownership of telecommunications and
information services, consistent with
section 257 of the Communications Act,
including those that may be socially and
economically disadvantaged businesses.
All eligible health care providers that
choose to participate may be required to
collect and submit data at regular
intervals during the Pilot program and
at the end of the Pilot program to USAC
and the Commission, as described in
section III(E) of the NPRM. The
collection of this information is
necessary to evaluate the impact of the
Pilot program, including whether the
Pilot program achieves its goals. The
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benefits of collecting this information
outweigh any costs.
121. The NPRM proposes an
application process that would
encourage a wide variety of eligible
health care providers and eligible
service providers to participate,
including small entities. The
Commission seeks to strike a balance
between requiring applicants to submit
enough information that would allow
the selection of high-quality, costeffective projects that would best further
the goals of the Pilot program, but also
minimizing the administrative burdens
on entities that seek to apply.
122. The Commission proposes
awarding additional points during the
application process for projects that are
located in a rural area, would primarily
serve rural patients or veterans, would
serve five or more Medically
Underserved Areas and Healthcare
Provider Shortage Areas, as designated
by the Health Resources and Services
Administration by geography, or are
located on Tribal lands, associated with
a Tribe, or part of the Indian Health
Service. This recognizes the disparities
in health care in rural areas and Tribal
areas, and areas that are designated as
Medically Underserved Areas and
Healthcare Provider Shortage Areas and
is aimed at increasing the likelihood
projects serving these areas will be
selected.
123. The reporting requirements,
compliance audit requirements, and
document retention requirements the
Commission proposes are tailored to
ensure that Pilot program funding is
used for its intended purposes and so
that the Commission can obtain
meaningful data to evaluate the Pilot
program and inform its policy decisions.
The proposed compliance audit and
document retention requirements the
Commission proposes are the same
measures that apply to health care
providers and service providers that
participate in the Healthcare Connect
Fund program. The proposed reporting
requirements are tailored to ensure that
the Commission receive regular,
meaningful data about each project. The
Commission finds that ensuring that
participating health care providers and
service providers, including small
entities, are accountable in the use of
Pilot program funds and that
participating health care providers
submit regular, meaningful information
about their projects outweighs the
burdens associated with these
requirements.
IV. Ordering Clauses
124. It is ordered that, pursuant to the
authority contained in sections 1
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through 4, 201, 254, and 403 of the
Communications Act of 1934, as
amended by the Telecommunications
Act of 1996, 47 U.S.C. 151 through 154,
201, 254, and 403 the Notice of
Proposed Rulemaking is adopted.
125. It is further ordered that,
pursuant to applicable procedures set
forth in sections 1.415 and 1.419 of the
Commission’s rules, 47 CFR 1.415,
1.419, interested parties may file
comments on the NPRM on or before
August 29, 2019, and reply comments
September 30, 2019.
Federal Communications Commission.
Marlene Dortch,
Secretary.
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Agencies
[Federal Register Volume 84, Number 146 (Tuesday, July 30, 2019)]
[Proposed Rules]
[Pages 36865-36883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16077]
=======================================================================
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 54
[WC Docket No. 18-213; FCC 19-64]
Promoting Telehealth for Low-Income Consumers
AGENCY: Federal Communications Commission.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: In this document, the Federal Communications Commission
(Commission) seeks to propose a Pilot program within the Universal
Service Fund (USF or Fund) to support connected care for low-income
Americans and veterans. The Commission specifically seeks to better
understand how the Fund can play a role in helping patients stay
directly connected to health care providers through telehealth services
and improve health outcomes among medically underserved populations
that are missing out on vital technologies.
DATES: Comments are due on or before August 29, 2019 and reply comments
are due on or before September 30, 2019. If you anticipate that you
will be submitting comments but find it
[[Page 36866]]
difficult to do so within the period of time allowed by this document,
you should advise the contact listed in the following as soon as
possible.
ADDRESSES: You may submit comments, identified by WC Docket No. 18-213,
by any of the following methods:
Federal Communications Commission's Website: https://fjallfoss.fcc.gov/ecfs2/.
Electronic Filers: Comments may be filed electronically using the
internet by accessing the ECFS: https://fjallfoss.fcc.gov/ecfs2/.
Paper Filers: Parties who choose to file by paper must
file an original and one copy of each filing.
Filings can be sent by hand or messenger delivery, by
commercial overnight courier, or by first-class or overnight U.S.
Postal Service mail. All filings must be addressed to the Commission's
Secretary, Office of the Secretary, Federal Communications Commission.
All hand-delivered or messenger-delivered paper filings
for the Commission's Secretary must be delivered to FCC Headquarters at
445 12th St. SW, Room TW-A325, Washington, DC 20554. The filing hours
are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together
with rubber bands or fasteners. Any envelopes and boxes must be
disposed of before entering the building.
Commercial overnight mail (other than U.S. Postal Service
Express Mail and Priority Mail) must be sent to 9050 Junction Drive,
Annapolis Junction, MD 20701.
U.S. Postal Service first-class, Express, and Priority
mail must be addressed to 445 12th St. SW, Washington, DC 20554.
Availability of Documents. Comments, reply comments, and
ex parte submissions will be publicly available online via ECFS. These
documents will also be available for public inspection during regular
business hours in the FCC Reference Information Center, which is
located in Room CYA257 at FCC Headquarters, 445 12th Street SW,
Washington, DC 20554. The Reference Information Center is open to the
public Monday through Thursday from 8:00 a.m. to 4:30 p.m. and Friday
from 8:00 a.m. to 11:30 a.m.
People with Disabilities. To request materials in
accessible formats for people with disabilities (braille, large print,
electronic files, audio format), send an email to [email protected] or
call the Consumer & Governmental Affairs Bureau at 202-418-0530
(voice), 202-418-0432 (tty).
For detailed instructions for submitting comments and additional
information on the rulemaking process, see the SUPPLEMENTARY
INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Jodie Griffin, Wireline Competition
Bureau, (202) 418-7550 or TTY: (202) 418-0484.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Notice of Proposed Rulemaking (NPRM) in WC Docket No. 18-213; FCC 19-
64, adopted on July 10, 2019 and released on July 11, 2019. The full
text of this document is available for public inspection during regular
business hours in the FCC Reference Center, Room CY-A257, 445 12th SW,
Washington, DC 20554 or at the following internet address: https://docs.fcc.gov/public/attachments/FCC-19-64A1.pdf.
I. Introduction
1. Telemedicine has assumed an increasingly critical role in health
care delivery as technology and improved broadband connectivity have
enabled patients to access health care services even when they cannot
access a health care provider's physical location. Advances in
telemedicine are transforming health care from a service delivered
solely through traditional brick and mortar health care facilities to
connected care options delivered via a broadband internet access
connection directly to the patient's home or mobile location. Despite
the numerous benefits of connected care services to patients and health
care providers alike, patients who cannot afford or who otherwise lack
reliable, robust broadband internet access connectivity are not
enjoying the benefits of these innovative telehealth technologies. The
Commission proposes a Pilot program within the USF to support connected
care for low-income Americans and veterans. This Pilot program would
help the Commission better understand how the Fund can play a role in
helping patients stay directly connected to health care providers
through telehealth services and improve health outcomes among medically
underserved populations that are missing out on these vital
technologies.
2. Specifically, in the NPRM, the Commission proposes the creation
of a Pilot program that would allow the Commission to obtain valuable
data concerning connected care services and also help to better
understand the relationship of affordable patient broadband internet
access service to the availability of quality health care, the health
care cost savings that result from connected care services, and the
role of connected care on patient health outcomes. The Commission's
proposal seeks to bring these innovative telemedicine technologies to
medically underserved populations, including low-income communities and
veterans, by empowering health care providers to connect directly with
their patients.
3. As discussed more fully in the following, the Commission
proposes that the Connected Care Pilot program will operate as a new
program within the USF, which would provide funding to eligible health
care providers to defray the qualifying costs of providing connected
care services to low-income Americans and veterans.
4. The Commission expects this Pilot could benefit Americans that
are responding to a wide breadth of health challenges, including
diabetes management, opioid dependency, high-risk pregnancies,
pediatric heart disease, mental health conditions, and cancer. Data
gathered from the Pilot program will help the Commission understand
whether and how USF funds can be used to promote health care provider
and consumer adoption and use of connected care services. The data and
information collected through this Pilot program might also aid in the
consideration of broader reforms--whether statutory changes or updates
to rules administered by other agencies--that could support this trend
towards connected care.
II. Discussion
5. To the extent that lack of affordable and robust broadband
internet access service is an obstacle to the adoption of connected
care services by health care providers and patients, the Commission
believes universal service support could help address that obstacle.
Further, by encouraging more health care providers to make use of
connected care technologies, the Commission may help create a model for
the nationwide adoption of such technologies, which could lead to
improved health outcomes for patients and savings to the country's
health care system overall.
6. Thus, the Commission proposes a three-year Connected Care Pilot
program (Pilot) with a $100 million budget that would provide support
for eligible health care providers to obtain universal service support
to offer connected care technologies to low-income patients and
veterans. Through this Pilot program, the Commission seeks to develop a
record that will help to understand the benefits that subsidization of
broadband service for connected care brings.
7. The Commission seeks to design a cost-effective and efficient
Pilot program
[[Page 36867]]
that incentivizes participation from a wide range of eligible health
care providers and broadband service providers, provides meaningful
data about the use of connected care services provided over broadband
for low-income Americans and veterans, and provides insight into how
universal service funds could better promote the adoption of connected
care services among low-income Americans and veterans and their health
care providers.
8. The Commission proposes implementing a flexible Pilot program
that will give health care providers some latitude to determine
specific health conditions and geographic areas that will be the focus
of the proposed projects. Under this proposal, the Pilot program would
provide funding to selected Pilot project health care providers to
defray the costs of purchasing broadband internet access service
necessary for providing connected care services directly to qualifying
patients. The Commission seeks comment on this proposal. The Commission
believes its proposed approach will increase the variety of projects
without discouraging or prejudging any applicants considering whether
to participate. Nevertheless, the Commission proposes limiting the
Pilot program to projects that primarily focus on health conditions
that typically require at least several months or more to treat--such
as behavioral health, opioid dependency, chronic health conditions
(e.g., diabetes, kidney disease, heart disease, stroke recovery),
mental health conditions, and high-risk pregnancies. The Commission
believes that collecting data across at least several months would
provide more meaningful, statistically significant data to track health
outcomes and cost savings--health conditions that do not require at
least several months of treatment, therefore, may not provide the type
of meaningful data the Commission seeks to collect through the Pilot
program.
9. The Notice of Inquiry (FCC 18-112) sought comment on whether the
Pilot program should focus on certain health conditions or geographic
regions. Many commenters asserted that the Pilot program should not be
limited to projects that treat specific health conditions. In addition,
the record identifies numerous health conditions that can benefit from
connected care services. To ensure that Pilot program funding is used
for legitimate medical conditions and to guard against potential waste,
fraud, and abuse, should the Commission adopt a specific definition of
``health condition'' for purposes of the Pilot program? If so, is there
a generally accepted authority that provides a definition of ``health
condition'' that would be appropriate to adopt for the Pilot program?
The Commission also seeks information from commenters regarding the
marketplace for connected care services, specifically whether health
care providers typically purchase complete packages or suites of
services that include patient broadband internet access service and
other functionality necessary to provide connected care services, or
whether health care providers typically purchase broadband internet
access service connections for connected care as a stand-alone product.
Additionally, the Commission seeks comment on the costs health care
providers incur to purchase such services.
10. Supported Services. The Notice of Inquiry sought comment on
providing funding for the costs of: (1) The broadband connectivity that
eligible low-income patients of participating hospitals and clinics
would use to receive connected care services; and (2) the broadband
connectivity that a participating hospital or clinic would need to
conduct its proposed connected care pilot project. The record
demonstrates that many patients lack home broadband service or lack
sufficient broadband service to receive connected care services, and
evidences widespread support for funding broadband internet access
connections for connected care through the Pilot program. Many
commenters also expressed support for funding both fixed and mobile
broadband for connected care. The record indicates that the VA's tablet
program, which provides patient broadband connections for a small
fraction of veterans who receive care through the VA, is the only
federal agency program that currently funds patient broadband
connections specifically for connected care.
11. The record indicates that health care providers typically
purchase broadband internet access service that enables connected care
through a broadband carrier or a connected care company (for example, a
remote patient monitoring company). The health care provider then
provides a connected care service, including the broadband internet
access service underlying that connected care service, to the patient
directly. To what extent are health care providers already funding
patient broadband connections for connected care services and what are
the costs associated with funding those connections? To what degree
would providing universal service funding to offset these costs enable
health care providers to extend service to additional patients or treat
additional health conditions? Several health care providers asserted
that the Pilot program should not fund internet connections between
health care providers. The Commission agrees, as doing so would be
duplicative with the existing Rural Health Care (RHC) programs and
propose to exclude such connections from the Pilot program.
12. The Commission considers ``telehealth'' for the purposes of
this proceeding to include a wide variety of remote health care
services beyond the doctor-patient relationship; for example, involving
services provided by nurses, pharmacists, or social workers. The
Commission also defines the term ``telemedicine'' as using broadband
internet access service-enabled technologies to support the delivery of
medical, diagnostic, and treatment-related services, usually by
doctors. The Commission seeks comment on these definitions and their
applicability to the Connected Care Pilot program. In addition, the
Commission also proposes to define the term ``connected care'' as a
subset of telehealth that is focused on delivering remote medical,
diagnostic, and treatment-related services directly to patients outside
of traditional brick and mortar facilities. The Commission seeks
comment on this proposed definition of connected care. Should the
Commission place any additional qualifiers on this definition to ensure
that the Pilot program is focused on medical services delivered
directly to patients outside of traditional medical facilities through
broadband-enabled technologies?
13. The Commission seeks comment on common existing uses of
connected care technologies, such as remote patient monitoring devices.
The record indicates that such devices are generally single-purpose,
meaning that they cannot be used to access the public internet or for
uses outside of the health care context. Are there other circumstances
where health care providers are providing patient connectivity that
enables them to access the internet for non-health care purposes? Are
there any barriers to receiving connected care services for low-income
patients and veterans, and, if so, what are those barriers? Would this
Pilot enable additional connectivity not currently available to low-
income patients and veterans?
14. The Commission also seeks comment on whether there are packages
or suites of services that health care providers use to provide
connected care services (such as a turnkey solution that includes
software, remote patient
[[Page 36868]]
monitoring and remote monitoring devices, and patient broadband
internet access) that are not currently funded under the existing RHC
support programs that could be funded through the Pilot program as
information services. What types of services would be considered
information services, as well as any applicable precedents and should
be funded through the Pilot program? How do service providers currently
fund these types of services and what are the typical costs? Are
specific types of health care providers or provider locations more
likely to be unable to purchase these types of information services?
Are there any federal or other grant programs or other funding sources
that provide health care providers support for purchasing these types
of services? Should the Commission provide support for internal
connections for eligible health care providers through the Pilot
program? Is such support needed for connected care services?
15. Network Equipment. The Notice of Inquiry sought comment on
whether the Pilot program should fund ``network equipment necessary to
make a broadband service functional'' and for consortia applicants
``equipment necessary to manage, control or maintain an eligible
service or a dedicated health care broadband network'' as is done in
the Healthcare Connect Fund program. At least one commenter supported
funding this type of network equipment through the Pilot. Because the
Commission currently funds the types of network equipment that are
eligible for support through the Healthcare Connect Fund program, the
Commission believes it has the authority to provide funding for similar
equipment here, to the degree it is necessary to enable connectivity
for the purposes of connected care. However, the Commission proposes
not to permit duplication of funding for this equipment and equipment
funded through the Healthcare Connect Fund program. The Commission
seeks comment on this interpretation and approach. Would such network
equipment be necessary to providing the broadband service underlying
connected care, or part of a health care provider's purchase of a
telehealth information service? Would health care providers still be
interested in and be able to participate in the Pilot program if the
Pilot program did not fund the types of health care provider network
equipment that is eligible for support under the Healthcare Connect
Fund program? If the Commission were to fund this type of equipment,
how could the Commission ensure that the health care provider actually
needs this equipment for the Pilot program and would not have needed or
purchased this equipment but for participating in the Pilot program?
16. The Commission also acknowledged that a few commenters stated
that the Pilot program should support health care provider
administrative and outreach costs associated with participating in the
Pilot program (such as personnel costs, and program management costs).
Consistent with the existing RHC support programs and the RHC Pilot
program, however, the Commission does not propose funding these
expenses as part of the Pilot. As the Commission has previously
explained, past experience in the RHC support programs and RHC Pilot
program demonstrates that ``[health care providers] will participate
even without the program funding administrative expenses.'' The
Commission seeks comment on this approach.
17. End-User Devices, Medical Equipment, Mobile Applications, and
Health Care Provider Administrative Expenses. The Notice of Inquiry
also sought comment on whether the Pilot program should fund end-user
equipment, medical devices, or mobile applications for connected care.
Many commenters supported funding such items. That said, traditionally,
the Commission has declined to fund these items through the Universal
Service Fund because of section 254's focus on the availability of and
access to services. As such, the Commission proposes to make end-user
devices, medical devices, or mobile applications (excepting those
applications that may be part of a service that could be considered an
information service) ineligible for support in the Pilot program. Based
on the record and other sources, some health care providers may be able
to self-fund or obtain outside funding for end-user devices, medical
devices, and connected care applications needed for their connected
care pilot projects. The Commission seeks comment on the extent to
which health care providers participating in the Pilot program may be
able to obtain outside funding for end-user devices, medical devices,
or mobile applications necessary to provide connected care services.
Would health care providers still be interested in and be able to
participate in the Pilot program if the Pilot program does not fund
end-user devices, connected care medical devices, or connected care
mobile applications?
18. Other Program Structure Considerations. The Commission seeks
comment on whether there are any medical licensing laws or regulations,
or medical reimbursement laws or regulations that would have a bearing
on how the Commission structures the Pilot program. If so, how would
those specific laws or regulations impact the Pilot program, and how
should the Commission design the structure of the Pilot program in
light of those impacts? For example, commenters in the record identify
reimbursement as a major barrier to telehealth adoption. They urge the
Commission to coordinate with the Centers for Medicare and Medicaid
Services (CMS)--whether through a Memorandum of Understanding or other
means--to implement reforms to reimbursement policies for telehealth.
How should the Commission structure the Pilot to best ensure
coordination between the Commission and other federal agencies, such as
CMS? How can the Commission most easily obtain data through the Pilot
that would be informative on issues such as reimbursement and
licensure? Additionally, the Commission seeks comment on whether the
provision of USF support to health care providers to provide connected
care to low-income patients (or any other Pilot program funded item
used by individual patients as part of the Pilot program) raises any
issues under the Medicare and Medicaid Anti-Kick Back Statute, the
Civil Monetary Penalties Act, or any other federal statutes.
19. Budget. The Notice of Inquiry sought comment on a potential
$100 million budget for the Pilot program. Based on the broad support
in the record, the Commission believes that targeting this amount of
funding for the broadband underlying connected care technologies is
substantial and sufficient to allow it to obtain meaningful data and
ensure significant interest from a wide range of participants. The
Commission therefore proposes to adopt that budget for the Pilot
program. As discussed in the following, the Commission also proposes a
three-year funding period for the Pilot program, during which selected
projects would receive funding. The Commission seeks comment on these
proposals. How should the total Pilot program budget be distributed
over the three-year funding period? Should each selected project's
funding commitment be divided evenly across the Pilot program duration?
For example, if a selected project requests and receives a $9 million
funding commitment and the funding period is three years, should the
project receive $3 million for each year?
20. Several commenters expressed concern that the budget for the
Pilot
[[Page 36869]]
program could be debited against the existing budgets for the Lifeline
or Rural Health Care programs. However, the proposed Pilot program
would not divert resources from the existing universal service support
programs. Instead, the Commission proposes requiring the Universal
Service Administrative Company (USAC) to separately collect on a
quarterly basis the funds needed for the duration of the Pilot program.
The Commission expects that funding the Pilot program in this manner
would not significantly increase the contributions burden on consumers.
This approach also would not impact the budgets or disbursements for
the other universal service programs. The Commission seeks comment on
this approach. Should the collection be based on the quarterly demand
for the Pilot program? The Commission also proposes to have excess
collected contributions for a particular quarter carried forward to the
following quarter to reduce collections. Under this approach, the
Commission also proposes to return to the Fund any funds that remain at
the end of the Pilot program. Are there other approaches the Commission
should consider for funding the Pilot program?
21. Number of Pilot Projects and Amount of Funding per Project. The
Notice of Inquiry sought comment on funding up to 20 projects with
awards of $5 million each. First, the Commission proposes to provide a
uniform percentage of eligible services or equipment to be funded,
rather than fully funding any Pilot projects, consistent with the
Healthcare Connect Fund program and the RHC Pilot program. Several
commenters similarly suggest that the Pilot program should not fund
100% of the eligible costs for each project. Based on the Commission's
experience with the E-Rate and Rural Health Care programs, there are
significant advantages to providing a set discount percentage that
requires participants to contribute a portion of the costs, including
being administratively simple, predictable, and equitable, and
incentivizing participants to choose the most cost-effective services
and equipment and refrain from purchasing a higher level of service or
equipment than needed. In addition, the Commission believes that
funding less than 100% of the costs minimizes the risk of non-usage of
the supported services. The Commission seeks comment on this approach.
22. For services supported under this structure, the Commission
proposes a discount level of 85%--the discount amount participants
received in the Rural Health Care Pilot Program--and seeks comment on
whether this amount would strike the right balance between requiring a
health care provider contribution for such services and encouraging a
wide range of eligible health care providers to participate in the
Pilot program. Are there other grant or support programs or data that
the Commission could look to in order to determine an appropriate
discount level for these types of services that could be funded under
this structure? For example, in the E-Rate program, the lowest discount
level is 20% and ranges up to 90%. In contrast, the discount level for
the Healthcare Connect Fund is 65%. To further ensure the cost-
effective use of Pilot funds, in addition to adopting a flat, uniform
discount percentage, should the Commission cap the monthly amount of
support that can be paid for broadband internet access service to a
health care provider for each participating patient? If so, what would
be an appropriate cap, and what data and specific information would
support this cap amount?
23. For the Healthcare Connect Fund program, the health care
provider is required to pay the non-discounted share of the eligible
costs from eligible sources (e.g., the applicant, eligible health care
provider, or state, federal, or Tribal funding or grants), and is
prohibited from paying the non-discounted share of eligible costs from
ineligible sources (e.g., direct payments from vendors or service
providers). The Commission seeks comment on whether it should apply
this same limitation to health care providers participating in the
Pilot program. If so, should participating patients also be considered
an eligible source of the non-discounted share for services funded
under the Pilot? Should the Commission limit the portion of the non-
discounted costs that health care providers can require participating
patients to pay for the supported broadband internet access service? If
so, what would be an appropriate limit on the patient share of the
costs? For purposes of the Pilot program, should the Commission place
any limitation at all on the source of funding for the non-discounted
share of the costs? Are there any other approaches the Commission
should consider for limiting the source of funding that are not tied to
the Healthcare Connect Fund program rules?
24. Next, the Commission addresses the number of projects and the
per-project budget cap. Some commenters agreed that the Commission
should fund up to 20 projects with awards of $5 million per project.
Other commenters argued for the selection of fewer projects with larger
funding amounts, or for the selection of a larger number of projects
with varied or smaller funding amounts. On further consideration of the
record, the Commission proposes not to expressly limit the number of
funded Pilot projects, and to permit flexible and varied funding for
each selected Pilot project. The Commission believes setting a fixed
number of funded projects would not serve the goals of the Pilot
program because it would artificially limit the number of funded
projects before any proposals are even submitted. In addition, not
setting a fixed number of projects to be funded will allow the
Commission to better focus on selecting quality projects that can
provide meaningful data rather than selecting a pre-determined number
of projects. The Commission seeks comment on this view. The record
likewise indicates that a uniform $5 million funding amount per project
could artificially limit the scope of potential pilot projects and the
data collected. While the Commission proposes allowing varied funding
amounts for selected projects, the Commission does not anticipate
spending all of the Pilot program funds on one or two large projects.
Should the Commission establish a ceiling on the amount of the total
budget that can be allocated to a single project and, if so, what would
be an appropriate maximum funding amount for a single project?
25. Cost Allocation. The Commission also seeks comment on whether
cost allocation should be required for services or other items
supported through the Pilot program that are used for non-health care
purposes or include ineligible components. For example, if a Pilot
project permits patients to use the supported broadband service for
non-health care purposes, should the Commission require cost allocation
of the non-health care usage? If so, how should the cost allocation
work? For supported patient broadband internet access service, should
the cost allocations be based solely on the percentage of the service
that is used for health care purposes? Should the cost allocations
instead take into account the health care providers' savings associated
with the use of the supported patient broadband internet access for
health care purposes? If a health care provider contracts with a remote
patient monitoring solution provider for a package that includes end-
user devices and other items that are not broadband internet access
service, how should cost allocation work for those devices or items?
Should cost allocations for all
[[Page 36870]]
Pilot-supported costs follow the cost allocation rules and processes
for the Healthcare Connect Fund? Which entity or entities (e.g., the
health care provider or service provider) should be responsible for
providing the cost allocation and supporting documentation? What type
of documentation should the Commission require to support the cost
allocation?
26. Duration. The Notice of Inquiry sought comment on whether the
Pilot program should have a two- or three-year funding duration and
six-month ramp-up and wind-down periods. Many commenters asserted that
a three-year duration is appropriate and would allow the Commission to
obtain sufficient, meaningful data from the selected projects. A few
commenters argued that more than three years would be necessary if
broadband deployment was a Pilot program goal, or that the Pilot
program duration should be as long as four or five years. USTelecom
cautioned that a duration longer than three years (plus a ramp-up and
wind-down and evaluation period) ``risks having the findings become
obsolete by the time they could be effectuated . . . .'' Other
commenters separately assert that a six-month ramp-up and six-month
wind-down period should be part of the funding period.
27. Based on the record and the proposed Pilot program goals (which
do not include broadband deployment), the Commission proposes a three-
year funding period and separate ramp-up and wind-down periods of up to
six months in order to give projects time to complete set up and other
administrative matters related to the Pilot program. The Commission
seeks comment on these proposals. When should the ramp-up period begin?
Should the clock for the ramp-up period start after the selected
project has been notified of its selection, or is there another event
that should trigger the start of the ramp-up period? Should there be a
uniform start date for funding under the Pilot program, and if so, how
should the Commission determine that start date? Should the proposed
three-year funding period for the Pilot program use a funding-year
approach, with a fixed start date and end date for each Pilot program
funding year, as is done in the E-Rate and Rural Health Care programs?
If so, how would the ramp-up and wind-down periods work with a funding-
year approach (e.g., would the ramp-up period precede the start of the
funding year)? Should funding disbursements begin during the ramp-up
period, and if so how should funding be split between the ramp-up
period and the Pilot project term? The Commission proposes setting a
fixed end date for the Pilot program, with the possibility of
extensions where circumstances warrant. The Commission seeks comment on
this proposal.
28. Eligible Health Care Providers. The Commission proposes to
limit health care provider participation in the Pilot program to non-
profit or public health care providers within section 254(h)(7)(B): (i)
Post-secondary educational institutions offering health care
instruction, teaching hospitals, and medical schools; (ii) community
health centers or health centers providing health care to migrants;
(iii) local health departments or agencies; (iv) community mental
health centers; (v) not-for-profit hospitals; (vi) rural health
clinics; (vii) skilled nursing facilities; (viii) and consortia of
health care providers consisting of one or more entities described in
clauses (i) through (vii).
29. The Commission seeks comment on whether section 254 requires it
to limit health care provider participation to these categories of
providers. And if not, the Commission believes that applying this
limitation to the Pilot program would provide significant benefits:
Leveraging the statutory definition of health care provider used for
the Rural Health Care program would focus Pilot program funding on
health care providers most in need of additional funding to reach
eligible patients through connected care services, and would also
realize administrative efficiencies by using existing definitions and
application processes that parties are already familiar with through
the Rural Health Care program. In addition, having a single uniform
definition of ``health care provider'' would provide clarity for
potential participants and facilitate the administration of the Pilot
program.
30. While the statutory definition of ``health care provider'' may
exclude certain health care providers, the Commission believes that it
would still allow for a wide range of health care providers to
participate in the Pilot program. For example, the Healthcare Connect
Fund program is subject to this definition and over 8,600 distinct
health care providers received funding commitments in the Healthcare
Connect Fund program for funding year 2018. Additionally, the statutory
definition encompasses many facilities serving medically underserved
communities, including VA health administration facilities and
facilities run by the Indian Health Service. The Commission seeks
comment on this interpretation. Is there an interpretation of section
254(h)(7)(B) that would allow the Commission to provide funding to
Emergency Medical Technicians, health kiosks, and school clinics
through the Pilot program, as commenters request? Would the definition
of ``health care provider'' under section 254(h)(7)(B) preclude sites
like the VA's Virtual Living Room sites, community center or similar
sites that provide dedicated rooms in convenient locations with
broadband connections for patients to engage with technology and
connect with the professionals providing them with medical care? The
Commission seeks comment on whether limitations on eligible entities
could limit the effectiveness of the Pilot program and the ability to
obtain meaningful data on connected care services. Finally, are the
proposed eligible health care providers sufficiently well versed in
medical research methods to be able to properly evaluate the health
outcomes linked to the provision of connected care?
31. In the event that the Commission limits Pilot program
participants to the statutory definition of ``health care provider''
under section 254, the Commission proposes requiring interested health
care providers to indicate their respective category(ies) for
eligibility by submitting FCC Form 460, which USAC uses to determine
the eligibility of health care providers in the Healthcare Connect Fund
Program. The Commission proposes requiring eligible health care
providers to have prior experience with telehealth and long-term
patient care.
32. The Commission also proposes to borrow additional
administrative procedures from the RHC programs in implementing the
Pilot program. For example, the Commission proposes to have consortia
applicants file FCC Form 460 identifying all sites that would
participate in the Pilot program, including off-site data centers and
administrative offices, and propose permitting consortia applicants to
file FCC Form 460 on behalf of any site in the consortium that would
participate in the Pilot program to determine that site's eligibility.
Consistent with the Healthcare Connect Fund program, the Commission
proposes requiring consortia applicants to have in place a Letter of
Agency, which provides a consortium leader with authority to act on
behalf of the participating health care providers. Additionally, the
Commission proposes permitting third parties to ``submit forms and
other documentation on behalf of the applicant'' if USAC receives
written authorization from an ``officer, director, or other authorized
employee stating that the [health care provider] or
[[Page 36871]]
Consortium Leader accepts all potential liability from any errors,
omissions, or misrepresentations on the forms and/or documents being
submitted by the third party.'' The Commission proposes that consortium
applicants must update their FCC Form 460s if any information on their
FCC Form 460 changes. Similarly, the Commission proposes that an
eligible health care provider participating in the Pilot program,
including those participating in consortia, submit an updated FCC Form
460 within 30 days of a material change. The Commission seeks comment
on these proposals.
33. The Commission also proposes that the Pilot program be open to
both urban and rural eligible health care providers. Several commenters
assert that the Pilot should not be limited to projects serving only
rural areas. To the extent that section 254(h)(2)(A) applies to the
Pilot program, it does not limit universal service support to rural
health care providers, and the Commission believes the Pilot program
should not be limited to rural health care providers. The Fifth Circuit
has found ``the language in section 254(h)(2)(A) demonstrates
Congress's intent to authorize expanding support of `advanced
services,' when possible, for non-rural health [care] providers.''
Likewise, section 254(h)(2)(A) authorizes the Commission ``to enhance
public and non-profit health care providers' access'' to broadband
services. The Commission seeks comment on this proposal.
34. To promote geographic diversity, the Commission seeks comment
on limiting participation in the Pilot program to health care providers
that are located in or serve an area that has received the Health
Resources and Services Administration's Health Professional Shortage
Areas designation or Medically Underserved Areas designation, which
correlate with professional shortages and lower-income areas,
respectively, within a defined geographic area. What are the benefits
and drawbacks of limiting participation by using these designations?
Should the Commission also, or alternatively, consider limiting
participation in the Pilot program only to eligible health care
providers that currently provide care to at least a certain percentage
of uninsured and underinsured patients, or to a certain percentage of
Medicaid patients? The Commission seeks comment on these ideas. Would
these types of limitations impact the interest and participation of
health care providers in the Pilot program?
35. As connected care services continue to grow, health care
providers that only offer connected care have entered the marketplace.
These new market entrants may bring innovative new services and inject
competition that benefits patients, but it is not clear whether they
would qualify as eligible health care providers under section
254(h)(7)(B). The Commission seeks comment on this question.
Additionally, the record indicates that these types of providers may
not be involved in long-term patient treatment. What steps should the
Commission take to ensure that participating health care providers have
significant experience with providing long-term patient care, in order
to guard against waste, fraud, and abuse in the Pilot program? The
Commission also seeks comment on determining criteria that would
demonstrate health care providers' experience with long-term care for
patients. Are there types of connected care only companies that could
demonstrate the level of experience with long-term patient care needed
for the Pilot?
36. To ensure projects meet the goals of the Pilot program, should
the Commission require participating health care providers to have
experience integrating remote monitoring and telehealth services?
Specifically, should the Commission limit eligibility in the Pilot
program to health care providers that are federally designated as
Telehealth Resource Centers or as Telehealth Centers of Excellence, or
to otherwise demonstrate their experience providing telehealth
services? Should the Commission exclude health care providers that have
no prior connected care experience? Should participating health care
providers have experience, or be required to partner with research
bodies or firms with experience, conducting clinical trials in order to
ensure statistically sound evaluation of patient outcomes?
37. Eligible Service Providers. In the RHC Program, the statute
permits non-eligible telecommunications carriers (ETCs) to receive
support; section 254(c)(3) makes clear that, in addition to the
supported services included in the definition of universal service in
section 254(c), ``the Commission may designate additional services for
such support mechanisms for . . . health care providers for the
purposes of subsection (h).'' Further, section 254(h)(2)(A) directs the
Commission ``to enhance to the extent technically feasible and
economically reasonable, access to advanced telecommunications services
and information services'' for health care providers and, thus, allows
support for non-ETCs. The Commission has previously explained that the
ETC limitation in section 254(e) applies to the section 254(c)
supported services, but not to additional supported services under
section 254(h)(2)(A).
38. The Notice of Inquiry sought comment on whether the Pilot
should be limited to ETCs, including facilities-based ETCs. Numerous
parties opposed limiting the Pilot program to ETCs or facilities-based
ETCs and explained that such a limitation would artificially limit
participation in the Pilot program and could also limit the
effectiveness of the Pilot program. The Commission proposes not to
limit Pilot program funding to only ETCs. The Commission anticipates
that it would provide funding to eligible health care providers to
purchase broadband internet access service that would be provided to
the patient through a connected care offering, or that the health care
provider would use USF funding to purchase telehealth services that
qualify as information services. As such, the Commission does not
believe that health care providers should be restricted to purchasing
broadband internet access service from only ETCs.
39. The Commission hopes that this will help incent participation
in the program by a diverse range of both health care providers and
service providers. The Commission seeks comment on this approach. What
impact would this approach have on service provider and health care
provider interest in participating in the Pilot program? If, instead,
the Commission were to conclude that only ETCs would be able to receive
support for providing broadband internet access service to patients
participating in the Pilot, what impact would this approach have on
service provider and health care provider participation in the Pilot
program? As a practical matter, how could the Commission ensure that
the Pilot program still leverages and supports the expertise of the
health care provider as the main driver of each Pilot project, even if
the monetary support must be paid to an ETC?
40. Application Process. The Notice of Inquiry requested comment on
the application process for the Pilot program and proposed several
categories of information that should be contained in the application.
The Commission proposes that interested health care providers first
submit an application describing the proposed pilot project and
providing information that will facilitate the selection of high-
quality projects that will best further the goals of the Pilot program.
At the time of the application, should the
[[Page 36872]]
Commission require participating health care providers to have already
identified specific broadband providers from which the health care
provider will receive service? If the Commission requires broadband
providers to be ETCs, should the Commission require all designations to
be obtained prior to the application process? Or should the Commission
require that if the project is selected, the service provider would
obtain the necessary ETC designations before the project commences?
41. Based on the Commission's review of the record and prior
experience with Pilot programs, it proposes that applications contain,
at a minimum, the following information:
Names and addresses of all health care providers that
would participate in the proposed project and the lead health care
provider for proposals involving multiple health care providers.
Contact information for the individual(s) that would run
the proposed pilot project (telephone and email).
Health care provider number(s) and type(s) (e.g., non-
profit hospital, community mental health center, community health
center, rural health clinic, community mental health center), for each
health care provider included in proposal.
Description of each participating health care provider's
experience with providing connected care services and conducting
clinical trials or the experience of a partnering health care provider.
Description of the connected care services the proposed
project will provide, the conditions to be treated, the health care
provider's experience with treating those conditions, the goals and
objectives of the proposed project (including the health care
provider's anticipated goals with respect to reaching new or additional
patients, improved patient health outcomes, or cost savings), and how
the project will achieve the goals of the Pilot program.
Description of the clinical trial design intended to
measure the effect of the connected care pilot on health outcomes.
Description of the estimated number of eligible low-income
patients to be served.
Description of the plan for implementing and operating the
project, including how the project intends to recruit eligible
patients, plans to obtain the end-user and medical devices for the
connected care services that the project would provide, and transition
plans for participating patients after Pilot program funding ends.
List of all Department of Health and Human Services,
Health Resources and Services Administration (HRSA) designated Health
Care Professional Shortage Areas (for primary care or mental health
care only) or HRSA designated Medically Underserved Areas that will be
served by the proposed project.
Description of whether the health care provider will
primarily serve veterans or patients located in a rural area, or the
provider is located in a rural area, on Tribal lands, or is associated
with a Tribe, or part of the Indian Health Service.
Description of the anticipated level of broadband service
required for the proposed project, including the necessary speeds/
technologies and relevant service characteristics (e.g., 10/1 Mbps, or
4G).
Detailed estimated break-down of the total estimated costs
for the broadband internet access services and any other eligible
costs.
Estimated total ineligible costs and description of the
anticipated sources of financial support for the project's ineligible
costs.
Description of how the participating health care provider
will ensure compliance with the Health Insurance Portability and
Accountability Act (HIPAA) and other applicable privacy and
reimbursement laws and regulations, and applicable medical licensing
laws and regulations, and how it will safeguard the collected patient
information against data security breaches.
Description of the health outcome metrics that the
proposed project will measure and report on, and how those metrics will
demonstrate whether the supported connected care services have improved
health outcomes.
Description of how the health care provider intends to
collect and track the required Pilot program data.
42. Is there any additional information that the Commission should
require health care providers to submit in the application? What types
of information or documentation should the Commission require health
care providers to include in their applications to demonstrate that the
supported services would enhance the health care provider's access to
advanced telecommunications and information services? Is there a
minimum number of patients that a project must serve to provide
statistically significant data? Is the proposed application information
sufficient to determine whether projects have processes in place to
ensure compliance with the applicable medical licensing laws and
regulations, HIPAA and any other applicable privacy laws, and guard
against data security breaches? Is there anything in HIPAA or privacy
laws and regulations that would limit the Commission's ability to
structure the Pilot program or collect data needed to evaluate the
Pilot's success?
43. Should the Commission require health care providers to submit a
self-certification regarding their patient care and telehealth
qualifications with their applications? Moreover, should the Commission
require applicants to certify that they are financially qualified? If
so, what information should the Commission rely on to make that
determination? Is there any supporting documentation the Commission
should require to demonstrate that applicants are financially
qualified? Likewise, should the Commission require health care
providers to submit a self-certification that specifies that they will
be able to meet patients' long-term care needs as well as provide the
appropriate technology to help meet those needs? Should the Commission
require applicants to certify that they have the capacity to conduct a
valid clinical trial? If so, are there specific criteria the Commission
should rely on to make such a showing? Should the Commission require
applicants to certify that all information in their application is true
and accurate?
44. The Commission intends to establish a deadline for submitting
applications for the Pilot program. If the Commission ultimately issues
an order establishing the proposed Pilot program, would requiring that
applications be submitted within 120 days from the release of such an
order give health care providers sufficient time to develop and submit
a meaningful application for the Pilot program?
45. The Commission proposes to direct the Wireline Competition
Bureau (Bureau) to review applications in coordination with the FCC's
Office of Economics and Analytics, Office of Managing Director, Office
of General Counsel, and the Connect2Health Task Force. The Commission
proposes that it will then make any final selection decisions. To
facilitate the review and selection of proposals, should the Commission
also seek advice from other expert health care entities with telehealth
expertise? For example, should the Commission consult with the
federally designated Telehealth Resource Centers or Telehealth Centers
of Excellence? Are there other organizations with whom the
[[Page 36873]]
Commission should consult during the application and selection process?
46. Evaluation of Proposals and Selection of Projects. The
Commission seeks comment on the factors to evaluate the applications
and select Pilot program projects. At a minimum, the Commission
proposes considering whether each project would serve the Pilot program
goals and whether the applicant is able to successfully implement,
operate, and evaluate the outcomes of the project. The Commission also
proposes considering the cost of the proposed project compared to the
total Pilot program budget. What other objective factors should be used
to evaluate the proposals and what should be the relative importance of
each objective evaluation factor? For example, should a project's
ability to further the goals of the Pilot program be more important
than the estimated cost of the project compared to the total Pilot
program budget? Should the Commission decline to consider proposals
that do not have a plan for how participating patients will obtain the
necessary connected care medical devices, end user devices (e.g.,
smartphones or tablets), or connected care applications? Should the
Commission decline to consider projects that cannot provide
statistically sound evaluations of their proposed interventions?
47. To promote the selection of a diverse range of projects, the
Commission proposes awarding additional points to proposed projects
that would serve geographic areas or populations where there are well-
documented health care disparities (Tribal lands, rural areas, or
veteran populations) or that treat certain health crises or chronic
conditions that significantly impact many Americans and are documented
to benefit from connected care, such as opioid dependency, diabetes,
heart disease, mental health conditions, and high-risk pregnancy. For
all of the additional point factors the Commission proposes in the
following, to seek comment on the relative importance of these factors
compared to each other and compared to the other standard objective
evaluation factors. Are there any other factors for which additional
points should be awarded to a particular project?
48. It is well documented that there are significant health care
shortages in rural areas and Tribal lands. In addition, the Department
of Health and Human Services' Health Resources and Services
Administration (HRSA) designates areas that are Healthcare Provider
Shortage Areas (HPSA) or are Medically Underserved Areas (MUA)--these
areas can be urban or rural. Given the significant health care
disparities in these areas and potential benefits of increasing the
adoption of connected care in these areas, the Commission proposes
awarding extra points during the evaluation process to proposals that
satisfy the following factors: (a) The health care provider is located
in a rural area; (b) the project would primarily serve patients who
reside in rural areas; (c) the project would serve patients located in
five or more Health Professional Shortage areas (for primary care or
mental health care only) or Medically Underserved Areas as designated
by HRSA by geography; (d) the health care provider is located on Tribal
lands, is affiliated with a Tribe, or is part of the Indian Health
Service; or (e) the health care provider would primarily serve patients
who are veterans. How should the relative importance of these
additional factors be compared to each other and to the other proposed
standard objective factors for evaluating proposals? Should projects
receive additional points for each factor that they satisfy? What
criteria should determine whether a health care provider is located in
a rural area for purposes of these additional points? Would the
definition of ``rural area'' in section 54.600 of the Rural Health Care
program rules or the definition of ``urban area'' in section
54.505(b)(3)(i) of the E-Rate rules be appropriate for determining
whether a project qualifies for additional points based on rurality? Is
there another definition of ``rural area'' that the Commission should
consider and, if so, what geographic level (e.g., Census block, Census
tract, Census block group) should the Commission use to determine
eligibility for extra points based on rurality? How should this
proposal apply to consortia?
49. The Commission also seeks comment on the criteria that should
be used to determine whether a project would primarily serve patients
who reside in rural areas. The Commission believes that relying on
individual patient addresses for this purpose would be too complex to
administer because of the potential volume of individual patient
addresses. Are there other, non-patient address measures that could be
used instead? For example, should the Commission use a metric that
estimates average patient travel distance to the health care provider's
facility?
50. The Commission proposes relying on the health care provider's
certification that it is located on Tribal lands, affiliated with a
Tribe or is part of the Indian Health Service. The Commission seeks
comment on this proposal. For purposes of the additional points, should
the Commission apply the definition of Tribal lands in section
54.400(e) of the Lifeline rules? Is there another definition that the
Commission should consider? To receive the extra Tribal points, should
the Commission require that the health care provider be located in a
rural area as defined for the Pilot program? If so, how should rurality
be defined? Should the Commission use the same definition for ``rural''
areas as that found in section 54.505(b)(3)(i) of the Commission's
rules, or instead use a population density measure for a given
geographic unit?
51. Similarly, the Commission seeks comment on the criteria that
should be used to determine whether a project would primarily serve
veterans. What threshold would be appropriate? For example, the
Commission seeks comment on whether a project ``primarily serves''
veterans if more than 50% of its patient base are veterans. What
documentation, if any, is appropriate to define a veteran population?
Many veterans receive disability compensation from the VA, for
instance, or cost-free health care based on certain factors. Would
receipt of these benefits be sufficient to identify veteran status for
purposes of the application?
52. The Commission seeks comment on awarding additional points for
projects that are primarily focused on treating certain chronic health
conditions or conditions that are considered health crises, such as
opioid dependency, high-risk pregnancies, heart disease, diabetes, or
mental health conditions. Opioid dependency is a well-documented
epidemic in America and has had a particularly devastating impact in
rural America where there are fewer opioid treatment centers. The
Notice of Inquiry explains that connected care services have been
frequently used to treat opioid dependency; thus, the Commission
believes that it would be appropriate to award extra points for
proposals that seek to use connected care to treat opioid dependency.
Maternal mortality is also a crisis in America--the maternal mortality
rate in the U.S. is higher than most other high-income countries and
has increased over the last few decades. This crisis impacts both rural
and urban areas and is particularly acute in rural areas where there is
a significant shortage of hospitals and health care providers offering
obstetric care, and also disproportionately impacts low-income,
African-American women. In December 2018, Congress took action to
[[Page 36874]]
address the maternal mortality crises by passing the Preventing
Maternal Deaths Act to create a federal infrastructure and resources
for collecting and analyzing data on every maternal death in the United
States. Accordingly, the Commission believes that it would be
appropriate to award additional points for projects focused on treating
high-risk pregnancy. Connected care has been used to treat heart
disease and diabetes--two of the leading causes of death in America
that are also associated with very high costs for patients and the
health care system. Therefore, the Commission believes that it would
also be appropriate to award additional points to proposals that seek
to treat these conditions. Some organizations also have indicated that
there is a mental health crisis in America--many Americans need mental
health care but lack access or the ability to find it, particularly
Americans who are low-income or reside in rural areas. Therefore, the
Commission also believes that it would be appropriate to award
additional points to proposals that seek to treat mental health
conditions. The Commission seeks comment on these proposals. Are there
any other health conditions that would warrant awarding additional
points to specific project proposals during the selection process?
Should the Commission expressly limit eligible health conditions in
advance of receiving applications for Pilot projects?
53. Are there any other criteria the Commission should consider in
the evaluation and selection of pilot projects? For example, the
Commission seeks comment on whether to permit a project to serve a
patient population that is primarily, but not entirely low-income? If
so, should the Commission require health care providers to conduct a
project where more than 50% of the patients are low-income? Or 75%?
Similarly, how would the Commission evaluate whether a project includes
low-income individuals? Should the Commission, for example, rely on the
health care provider to identify patients for their project who are
enrolled in Medicaid, receive cost-free health care from the VA, or who
are uninsured or underinsured?
54. Consistent with the Commission's other universal service
support programs, it is critical that the Commission ensures that the
Pilot program funds are spent wisely and appropriately and that the
Commission guards the Pilot program from waste, fraud, and abuse. At
the same time, the Commission seeks to minimize the administrative
burdens on service providers and health care providers participating in
the Pilot program. In this section, the Commission proposes and seeks
comment on potential requirements for Pilot program participants,
including requirements for the vendor selection for Pilot-eligible
costs, requesting funding, and requesting disbursements. For the
Healthcare Connect Fund program, the Commission has developed robust
rules and processes that are designed to minimize waste, fraud, and
abuse. To promote the efficient and cost-effective use of Pilot program
funds and guard against waste, fraud, and abuse, the Commission
proposes extending many of these rules and processes to the proposed
Pilot program.
55. Selecting Service Providers. The Commission proposes that
participating health care providers, and not the participating
patients, procure the services and equipment that could be funded
through the Pilot program. The Commission believes that having
participating health care providers select the service provider would
be a better approach because health care providers are in the best
position to know the specific service and performance requirements
necessary to provide the specific connected care services supported by
their particular Pilot project. In addition, aggregating eligible
subscribers and streamlining benefit payments may lead to cost
efficiencies and/or better service arrangements. The Commission seeks
comment on this approach.
56. Consistent with the Commission's other universal service
support programs, it is important that the Commission ensures the cost-
effective, efficient use of Pilot program funds. To appropriately
tailor the vendor selection requirements to the marketplace, the
Commission requests additional information on how health care providers
typically purchase broadband internet access service connections for
connected care efforts. Do health care providers typically select and
contract directly with a broadband service provider for patient
broadband internet access service, or is the broadband service provider
typically determined by a connected care service vendor, such as a
remote patient monitoring service provider? Is the broadband internet
access service for connected care, whether purchased as a stand-alone
product or as part of a package, a commercially available product that
is purchased at publicly-available rates? Are these rates typically
negotiable? What is the typical contract term (e.g., month-to-month,
annual contract or multi-year contract) for these services? Are the
health care provider costs for connectivity services for connected care
determined on a per patient basis? Where health care providers purchase
services for connected care as part of a complete package or suite of
services, can the costs for the individual components be broken out
separately? For example, for such a package or suite of services, is it
possible to isolate the costs for the included software, or the
broadband internet access service?
57. For all of the costs that could potentially be supported
through the Pilot program, the Commission proposes requiring the
participating health care providers to conduct a competitive bidding
process, and select the most cost-effective service, as is required by
the Healthcare Connect Fund program. For the E-Rate and Rural Health
Care support programs, the Commission has traditionally required
schools and libraries and health care providers to competitively bid
for the supported services and equipment, with limited exemptions.
These competitive bidding requirements are designed to ensure that
applicants select the most cost-effective method of providing the
requested service, ensure that service providers have sufficient
information to submit a responsive proposal, seek the most cost-
effective pricing for eligible services, and guard against waste,
fraud, and abuse.
58. If the Commission requires health care providers to
competitively bid any services and equipment that could be funded
through the Pilot program, should the Commission use the existing
Request for Services Form (Form 461) for the Healthcare Connect Fund
program and, if so, what modifications would the Commission need to
make to that form for purposes of the Pilot program? The Commission
also proposes requiring the lead health care provider for projects
involving multiple health care providers to secure a Letter of Agency
from all participating providers before submitting a request for
services. The Commission seeks comment on these proposals. Should the
Commission allow exemptions from competitive bidding rules, as done in
other USF programs? For example, should the Commission allow an
exemption in the Pilot program if the health care provider is
requesting commercially available services purchased at publicly-
available rates and/or the total cost of the eligible services or
equipment is below a specific monetary threshold (e.g., total annual
cost under $10,000 or monthly per-patient cost of $50 or below)? The
Commission seeks comment on whether the other exemptions to the
competitive bidding requirements for the Healthcare Connect Fund
program should also be
[[Page 36875]]
extended to the Pilot program. Are there any other competitive bidding
exemptions or alternatives to competitive bidding that the Commission
should consider applying to the Pilot program?
59. Where an exemption to competitive bidding applies, are there
public resources or entities that could help health care providers
identify potential vendors or service providers? Should the Commission
require ETCs to indicate their interest in participating in the Pilot
program and their service areas, and make this information publicly
available before the application deadline for the Pilot program? How
can the Commission share similar interests to participate in the Pilot
program from telecommunications providers that are not ETCs?
60. The Commission also proposes prohibiting gifts from
participating service providers to participating health care providers.
Are there any aspects of the competitive bidding requirements for the
Healthcare Connect Fund program that would not work for the Pilot
program and, if so, why not? If the Commission requires competitive
bidding for the Pilot program, the Commission proposes requiring
participating health care providers to submit the same competitive
bidding information, make the same certifications, and use the same
processes that are required for the Healthcare Connect Fund program,
including any changes that may be made as a result of the 2017
Promoting Telehealth Order and Notice (FCC 17-164).
61. Requesting Funding. The Commission further seeks comment on the
most efficient methods for Pilot program participants to request
funding. Should the Commission require selected Pilot projects to
request funding under the Pilot program using the same forms and
processes and making the same certifications that are required for the
Healthcare Connect Fund program, including any changes that may be made
as a result of the 2017 Promoting Telehealth Order and Notice?
Requiring health care providers to submit funding requests for the
Pilot program would allow USAC to ensure that the Pilot projects only
request funding for eligible services and that the health care
providers requesting funding are in fact eligible. What modifications
to the Healthcare Connect Fund funding request form, if any, are
necessary to use for the Pilot program? Are there other HCF
certifications or processes to import to the Pilot program as well? And
how should the Commission modify these requirements, if at all? Would
these modifications vary depending on the legal authority on which the
Pilot program is based? If competitive bidding is required for the
Pilot program, the Commission proposes requiring selected projects to
submit a copy of their contract and supporting competitive bidding
documentation with their funding request, as is currently required for
the Healthcare Connect Fund program.
62. For purposes of administrative efficiency and to ensure that
Pilot projects are not unreasonably delayed, the Commission proposes
requiring Pilot program applicants who are selected to submit funding
requests within six months of the date of their respective selection
notices for the Pilot program. The Commission anticipates that USAC
would promptly review funding requests of selected Pilot program health
care providers on a rolling basis, irrespective of when they submit
their funding requests within the six-month window. Would this proposed
deadline for submitting the initial funding request give participating
health care providers sufficient time to select a vendor and submit a
funding request? Should the Commission require participating health
care providers to submit a new funding request for each year of the
Pilot program?
63. The Commission also proposes requiring selected projects to
certify that the provided funding will only be used for the eligible
Pilot program purposes for which the support is intended. Should the
Commission also require participating health care providers to certify
that the supported services and equipment will only be used for
purposes reasonably related to the provision of health care services or
instruction that the health care provider is legally authorized to
provide under law? Additionally, the Commission proposes requiring
projects involving multiple health care providers to identify the name
and contact information for the organization that will be legally and
financially responsible for the activities supported through the Pilot
(e.g., submitting funding requests, submitting invoicing and
disbursement forms, submitting competitive bidding forms (if
required)), as is required for consortia participating in the
Healthcare Connect Fund program. This requirement would identify the
responsible party if disbursements must be recovered for violations of
program rules or requirements. The Commission seeks comment on these
proposals.
64. Disbursements. The Notice of Inquiry sought comment on how
disbursements should be issued for the Pilot program. Few commenters
specifically addressed the issue of how often disbursements should be
issued and which entity should receive disbursements through the Pilot
program. One commenter supported monthly disbursements. Another
commenter asserted that disbursements should be issued to service
providers to minimize health care providers' administrative burdens,
while two other commenters asserted that the disbursements should be
issued directly to health care providers. Another commenter recommended
issuing disbursements in the form of vouchers directly to participating
patients, but other commenters argued that this approach would
complicate the administration of the Pilot program, create unnecessary
consumer burdens, and raise potential program integrity concerns.
65. The Commission proposes issuing disbursements to the service
provider, as is the current practice for the RHC programs, for the
purchase of connectivity or other eligible items pursuant to its legal
authority. In practice, this would equate to monthly discounts paid
towards the cost of service or eligible equipment purchased by the
health care provider. The Commission seeks comment on this proposal and
any alternatives that commenters may provide. The Commission also
proposes requiring that all reimbursement requests for any health care
provider-purchased services funded through the Pilot program be
submitted within six months of the date of receipt of the eligible
service or network equipment, and allow for extensions to this deadline
where good cause exists. Based on the Commission's experience with the
existing RHC programs, establishing deadlines for submitting invoices
would facilitate effective administration of the Pilot program.
66. For all services supported through the Pilot program, should
the project's compliance with the data reporting requirements discussed
in the following be a requirement for issuing each disbursement to the
service provider? Since the purpose of Pilot program is to collect data
and test the efficacy of a connected universal service support
mechanism, would delay or failure to comply with data reporting
requirements create sufficient reason to hold disbursements until the
error is corrected? The Commission seeks comment on the best methods to
ensure participants are regularly reporting useful and required program
data including whether and how to tie the data submission requirement
to the
[[Page 36876]]
reimbursement of Pilot program support.
67. Ensuring Effective and Responsible Use of Funds. Consistent
with the other existing universal service support programs, to ensure
the fiscally responsible use of Pilot program funds and guard against
waste, fraud, and abuse, the Commission proposes adopting document
retention and production requirements for health care providers and
service providers participating in the Pilot program, and also proposes
making individual projects subject to random compliance audits.
Specifically, the Commission proposes applying to the Pilot program (1)
section 54.648(a) of the Healthcare Connect Fund program rules, which
makes participating health care providers and service providers subject
to random compliance audits, and (2) section 54.648(b)(1)-(3) of the
Healthcare Connect Fund program rules, which require participating
health care providers and service providers to retain documentation
sufficient to establish compliance with the rules and requirements for
the Pilot program for at least five years and produce such documents to
the Commission, any auditor appointed by the Administrator or the
Commission, or any other state or federal agency with jurisdiction. Are
there any other rules or requirements for the RHC support programs, the
E-Rate program, or the Lifeline program not specifically mentioned in
the NPRM that the Commission should apply to the Pilot program?
68. With respect to audits, the Office of the Managing Director and
the Bureau would have the authority to direct USAC to conduct targeted
audits as necessary to ensure Pilot program funds are being used
consistent with the program. The Commission believes that a five-year
document retention period after the final disbursement is made would
provide sufficient time to conduct audits and any other investigations
related to the Pilot program. The Commission seeks comment on this
proposal.
69. The Notice of Inquiry sought comment on several potential goals
for the Pilot program. In addition, the Notice of Inquiry proposed
several metrics and methodologies for gathering data and measuring
progress towards the proposed goals. The Commission proposes to focus
on four primary program goals and seeks comment on this approach: (1)
Improving health outcomes through connected care; (2) reducing health
care costs for patients, facilities, and the health care system; (3)
supporting the trend towards connected care everywhere; and (4)
determining how USF funding can positively impact existing telehealth
initiatives. Further, the Commission seeks comment on appropriate
metrics and methodologies to measure Pilot projects' progress towards
these goals.
70. The Commission believes these constitute sound goals for the
Pilot program and they are consistent with our statutory obligation to
promote universal service. Section 254(c)(1), for example, directs the
Commission to keep in mind when establishing the definition of services
supported by USF ``the extent to which such telecommunications services
are essential to education, public health, or public safety.''
Moreover, section 254(h)(2)(A) directs the Commission to establish
rules to enhance access to advanced telecommunications and information
services for health care providers. Additionally, section 254(b)(3)
provides that ``[c]onsumers in all regions of the Nation, including
low-income consumers and those in rural, insular, and high cost areas,
should have access to advanced telecommunications and information
services . . . that are reasonably comparable to those services
provided in urban areas and that are available at rates that are
reasonably comparable to rates charged for similar services in urban
areas.'' The Commission believes the proposed goals will help advance
these principles, and seeks comment on that conclusion.
71. Proposed Program Goals. First, the Commission intends that the
Pilot will help improve health outcomes through connected care. Several
comments in the record expressed support for including this as a
program goal. For example, Hughes stated that the ``provision of
telehealth services expands access to high-level care and closes
geographic barriers experienced by patients.'' TruConnect stated that
the ``use of telemedicine applications on smartphones and devices
benefits those who use them and will especially help rural patients who
must travel great distances to health care providers.'' According to
the American Heart Association, a ``strong and growing body of evidence
identifies telehealth and remote patient monitoring as cornerstones of
advanced healthcare systems.''
72. Commenters also identified several specific ways in which
broadband access can improve health outcomes. For example, the Medical
University of South Carolina (MUSC) and Gila River Telecommunications,
Inc. (GRTI) both note that greater access to telehealth can enable
health care providers to more easily engage their patients in the daily
management of chronic conditions. Commenters also note that broadband
access for telehealth purposes increases the likelihood that patients
will seek out medical care, and also increases the likelihood that
patients will follow a prescribed course of treatment. Commenters
stated that telehealth can reduce emergency room visits and hospital
admissions and readmissions, and can lead to increased contact with
specialists. The Commission agrees with these assessments and therefore
proposes to include improvement of health outcomes through connected
care as a goal of the Pilot program.
73. The Commission also believes the Pilot program can ultimately
help reduce health care costs for patients, facilities, and the health
care system, and proposes to adopt that program goal. The Commission
seeks comment on this proposal. In the Notice of Inquiry, the
Commission asked how the Pilot program could help identify effective
means of improving health care affordability for patients, including by
reducing the burden of out-of-pocket expenses like transportation costs
for rural and remote patients. Similarly, the Commission stated that
the Pilot program could help identify the circumstances in which
support for telehealth services could create savings for health care
providers and the Medicaid program.
74. Many commenters noted the potential for the Pilot program to
greatly reduce travel time for rural and remote patients, significantly
reducing out-of-pocket costs for patients, in addition to reducing the
need to miss work or school to see a health care provider. Commenters
also noted that reduction in travel times could lower costs for
physicians and health care providers. The University of Arkansas for
Medical Sciences stated that insurers will ``witness cost savings when
fewer beneficiaries experience long-term, costly morbidities.'' The
Medical Home Network described the ability of telemedicine to increase
communication between a primary care physician and a specialist,
``expediting wait times for patient appointments, and reducing
unnecessary referrals and emergency room visits.'' In particular,
Hughes, citing to videoconferencing capabilities at the University of
California, Davis, found that ``patients avoided nearly 5 million miles
of travel and $3 million in travel expenses by being able to
videoconference the treatment center in Sacramento.'' CHRISTUS Health
provided data on a remote monitoring pilot in partnership with a
carrier and vendor in Texas, and found that after
[[Page 36877]]
one year of study, the pilot program reduced the cost of care by an
estimated $236,000 per year for congestive heart failure patients
enrolled in the pilot. Thus, based on the record, the Commission
believes the program could help reduce health care costs for patients,
facilities, and the health care system overall and seeks comment on
this program goal.
75. Next, the Commission proposes to establish a goal of supporting
the trend toward bringing health care directly to the consumer. The
Notice of Inquiry observed that there is a trend away from relying on
connectivity solely within and between physical health care centers and
towards a ``connected care everywhere'' model--a trend that has shown
promising results for patients, communities, and the health care
system. The Notice of Inquiry sought comment on using the Pilot program
to support the current movement towards direct-to-consumer health care
to ensure that low-income Americans can realize the benefits of this
trend.
76. Commenters broadly support making this a program goal for the
Pilot. GRTI, for example, noted that the Commission ``has an
opportunity to support the trend towards greater use of connected care
and the benefits of such a policy,'' and supports the goal of
evaluating success of the Pilot program based in part on how it
furthers this trend. The American Heart Association, commenting on the
benefits and costs of the move towards ubiquitous connected care, noted
the ability of telehealth to provide ``instant healthcare at a fraction
of the cost regardless of the patient's health care status or
geographic location,'' but also noted potential ethical issues,
including questions of trust, confidentiality, privacy, and informed
consent. MUSC stated that as part of the movement towards connected
care everywhere, the Pilot program should support the participation of
rural and underserved consumers in the direct-to-consumer health care
market. The Commission seeks comment on adopting this program goal. The
Commission encourages commenters to specifically address how making USF
dollars available to support the connectivity that enables telehealth
applications can promote access to health care services for patients
outside of the confines of brick-and-mortar medical facilities.
77. Finally, the Commission anticipates that the Pilot will help to
determine how USF funding can positively impact existing telehealth
initiatives, and the Commission proposes to include this as a goal of
the Pilot program. In the Notice of Inquiry, the Commission stated that
it sought ``to ensure that the pilot program enhances existing
telehealth initiatives by the Commission and other federal agencies.''
The Commission observed that it currently has several initiatives to
assist with the expansion of health care connectivity in rural and
underserved areas including through the Rural Health Care programs and
the Connect2Health Task Force. In addition, the Commission noted
various other telehealth programs established by other federal
agencies, for example, the VA's Home Telehealth Program and several
initiatives run by the Department of Health and Human Services (HHS).
78. Numerous commenters assert that the Commission should consider
working with HHS, in particular CMS, the National Coordinator for
Health Information Technology (ONC), the Health Resources and Services
Administration (HRSA), and the Indian Health Service. The Virginia
Telehealth Network similarly proposed that the Commission consider
collaborating with private sector entities that are providing broadband
internet access service to vulnerable populations that might benefit
from connected care services.
79. The Commission seeks comment on this proposed goal. How can the
funding of connectivity for telehealth through the Connected Care Pilot
complement other Commission initiatives, such as the Rural Health Care
Program and the Connect2Health Task Force? How can the Pilot program
complement other Commission programs to provide connectivity to low-
income consumers, like the Lifeline Program, and rural and remote
consumers, like the High Cost Fund? Other than the VA's Home Telehealth
program, what existing federal programs, if any, specifically fund
connectivity for patients to enable the provision of telehealth? How
can the Commission best collaborate with other federal agencies
pursuing this goal?
80. Metrics. The Commission seeks comment on the best metrics and
methodologies for measuring progress towards its proposed program
goals. For example, are there specific ways in which broadband-enabled
telehealth applications can improve health outcomes that could be
demonstrated through the Pilot program? In the Notice of Inquiry, the
Commission proposed several metrics: Reductions in emergency room or
urgent care visits in a particular geographic area or among a certain
class of patients; decreases in hospital admissions or re-admissions
for a certain patient group; condition-specific outcomes such as
reductions in premature births or acute incidents among sufferers of a
chronic illness; and patient satisfaction as to health status. Are
there other metrics for measuring this goal? For example, commenters
suggested measuring adherence to medication and care plans as a
possible metric, because of the correlation with reducing morbidity and
mortality. How can the Commission best measure whether and to what
extent telehealth can promote adherence to medication and care plans?
Similarly, how can the Commission measure patient satisfaction as to
health status?
81. The Commission also encourages commenters to explain the
specific ways itmeasures how universal service support for connectivity
will improve health outcomes through telehealth. Do low-income
consumers face budget constraints that are not adequately addressed by
existing programs that prevent them from adopting connected care
services via broadband internet access service? In such cases, what
alternatives do those consumers use to obtain medical care, and do
those alternatives result in poorer health outcomes? Do health care
providers face budgetary shortfalls with respect to funding broadband
internet access connections for connected care services, or other
information services or equipment that health care providers need to
provide connected care services such that the Fund can help serve a
crucial funding need? In what other ways will universal service funding
for connectivity promote improved health outcomes through telehealth?
82. The Commission also asks commenters to provide, where
available, data and other information to help evaluate the potential
for cost savings through telehealth. In addition to the specific areas
of cost savings discussed in this document, in what other ways can the
provision of telehealth produce cost savings for patients, facilities,
and the health care system? The Commission further asks commenters to
provide information on the specific way in which universal service
support for connectivity to enable telehealth will produce cost
savings. And the Commission seeks comment on the best metrics to
evaluate progress towards this goal. How can the Commission best
measure the savings from, for example, reduction in travel miles and
travel time for patients and physicians? How can the Commission measure
the effect of healthier patients on costs faced by health care
providers and insurers? To what extent do these measures depend on
accurate metrics on the health outcomes of the patients of pilot
programs? What metrics exist to determine the cost savings from a
[[Page 36878]]
reduction in hospital admissions or re-admissions, or a reduction in
emergency room visits?
83. How can the Commission measure its progress in supporting the
trend toward bringing health care directly to the consumer? Will that
funding enable access for patients and providers that would not
otherwise have access to telehealth, perhaps by bringing telehealth
into new geographic areas or attracting new funding for existing
telehealth services? Will funding connected care pilots draw attention
to, and increase the effectiveness of, future connected care
applications, thereby promoting the development of connected care?
Would it help incent more health care providers to purchase broadband,
in order to bring connected care services to more patients? The
Commission also seeks comment on any potential costs of ubiquitous
connected care, including the ethical issues raised by the American
Heart Association. How should these issues impact whether the
Commission sets increased use of connected care as a goal of the Pilot
program?
84. Finally, the Commission seeks comment on how it can determine
whether the Pilot program supports existing Commission and federal
efforts to promote telehealth. How can the Commission avoid duplicating
existing efforts or otherwise overlap with programs that promote
connectivity for telehealth? The Commission proposes to require Pilot
program proposals to identify non-USF sources of funding or support,
and to also require reporting from Pilot program participants to help
the Commission identify how USF support for connected care broadband
connectivity can leverage existing or new efforts to support other
components of successful telehealth services. The Commission seeks
comment on this approach.
85. For the Commission to evaluate the success of the Pilot
program, it is critical to establish tools and procedures to gather
data from the Pilot program participants on progress toward achieving
the stated Pilot program goals. In addition, this information will
allow the Commission to evaluate the progress of each project and
ensure that Pilot program funds are being used efficiently and
effectively. Ultimately, this data will determine the success of the
Pilot program and will help inform the Commission about the long-term
viability of a connected care program.
86. Reporting Intervals. The Commission proposes requiring
participating health care providers to submit regular reports with
anonymized, aggregated data that will enable the Commission to monitor
the progress of each project and ultimately evaluate the Pilot program,
as a condition of receiving the proposed support. The Commission seeks
comment on the required reporting intervals (e.g., quarterly, annually)
and the information that should be included in the reports. For
example, TeleHealthCare America proposed quarterly reports, and the
Commission seeks comment on whether quarterly intervals would be
sufficient. Is there a shorter or longer reporting interval that would
be more appropriate when analyzing outcomes from clinical trials? Do
clinical trials commonly report interim results before completion of
the trial? What types of information are reported on an interim basis
and would such results provide reliable information? Or should the
Commission delay reporting of health outcomes until the study is
completed? What is the standard practice in medical research? Could
such reports create difficulties for blinding protocols?
87. Clinical Trials. The Commission seeks comment on the
appropriate methods for measuring the health effects of the connected
care Pilot projects. Should all projects be required to conduct
randomized controlled trials to determine the effect of the treatments
on patients' health? Are there alternative, less costly methods that
are statistically sound and can accurately measure the effect of the
treatment? Are these alternative methods generally accepted in the
scientific and medical communities? If the proposed treatment in a
Pilot project has already been extensively studied and the health
benefits are generally accepted by the medical community, and the
pilot's purpose is to uncover other effects, such as the impact on the
costs of providing health care or the broader impacts of subsidized
access to broadband internet access services for connected care, is
there any need to require the reporting of health outcomes?
88. Would different clinical trials be better served by different
reporting requirements and, if so, could these be judged as part of the
proposed project methods? Should the Commission require participants to
file a detailed annual report, and shorter reports on a quarterly
basis? The Commission is mindful of the burden that reporting can
create for participants, particularly those that do not regularly
report information to the Commission and seek to minimize this burden
while still providing a mechanism for participants to provide valuable
information. The Commission encourages commenters to discuss the
burdens and the best methods to alleviate them.
89. Data Fields. The Commission proposes that the regular reports
from each participating project include information on a number of data
fields that will enable the Commission to monitor the progress of each
project towards the overall goals of the Pilot program. The Commission
seeks comment on the data Pilot program participants should provide in
regular reports to enable measuring progress towards these goals. The
Commission proposes several data fields that should be part of regular
reporting from Pilot participants. These fields include: The number of
patients participating in the pilot project each month; the number of
patients participating in the pilot project being treated for specific
health conditions; the types of connected care services provided for
each condition; average frequency of patient use of each type of
connected care service; health outcomes for patients; and average cost-
savings per patient. The Commission seeks comment on the proposed use
of these data fields. Are there other types of information the
Commission should require Pilot program participants to report on a
regular basis? Should the Commission require pilot beneficiaries to
submit raw health data on study participants or is it sufficient for
beneficiaries to provide estimates of the effect of the treatment?
Should the Commission require any type of certification as to the
accuracy of the information provided?
90. To obtain information regarding patient experience, the
Commission proposes requiring health care providers to conduct regular
surveys of participating patients. The purpose of these surveys is to
collect information regarding data such as patient cost savings, saved
travel miles, patient satisfaction and comfort with the provided
connected care services. Given the additional time and expense in
administering patient surveys, reviewing data, and reporting it to the
Commission, should health care providers conduct these surveys on a
quarterly basis, or on a longer timeframe, such as after the completion
of the clinical trial?
91. The Commission also proposes collecting additional information
from Pilot program patient participants at the time of enrollment to
better understand the impact of the Pilot program on the goals
identified in this document, including whether the patient already has
a mobile and/or home broadband connection, the speed, technology and
broadband data usage for any broadband connection the patient already
has, and
[[Page 36879]]
what devices the patient uses to connect to the internet. What other
information might be important to know at the time of enrollment to
help establish a baseline for measuring the impact of the Pilot
program? Which party would be in the best position to collect this
information from participants?
92. As noted in this document, the Commission proposes that all
data provided by Pilot program participants should be anonymized and
aggregated, and if that is impossible, for example, because there are
so few participants within a reporting area their data could be used to
identify individuals, then masked. Should the regular reports from each
pilot project be made publicly available? If so, is the Commission's
website, or USAC's website, the best place to host this information?
Should the Commission allow project participants to request delay of
publication until the project is completed if publication might impact
the experiment? The Commission anticipates that these reports would not
raise any HIPAA or other privacy concerns because the proposed required
data would be submitted on an aggregated, anonymized basis. The
Commission seeks comment on this conclusion. Further, are there other
privacy or security measures that the Commission and USAC should take
to ensure proper receipt, storage, and use of the data? The Commission
is acutely aware of the data protections and sensitivities surrounding
health data and seeks comment on the best ways to ensure proper
handling of this information.
93. The Commission also proposes that Pilot program participants
provide information regarding their experience with the Pilot program.
For example, the Commission is interested in measuring the costs that
Pilot program participants experience in designing their programs,
submitting applications to the Commission, and ensuring ongoing
compliance with the Pilot's rules and procedures. The Commission
proposes to ask on a regular basis for these types of cost and time
estimates to evaluate whether the Pilot program is an administratively
feasible method of distributing funding for connected care services.
This information will be critical if, following the Pilot, the
Commission chooses to make a connected care program permanent, and
seeks to minimize applicant burdens in so doing.
94. Forms. In addition, the Commission seeks comment on the forms
that participants will use to provide this information. Are there
existing Commission forms from other USF programs, in particular the
Rural Health Care program, that can be used to report data for the
Pilot program? Should the Commission establish new forms for the
purposes of the Pilot program?
95. The Commission's stewardship of the universal service support
mechanisms and determinations concerning the services that are eligible
for universal service funding are bound by section 254 of the Act, as
amended by the 1996 Act. The Notice of Inquiry sought comment on the
Commission's legal authority to establish the Pilot program. In the
following, the Commission proposes and seeks comment on itssources of
legal authority for the Pilot program. The Commission seeks comment on
the potential impact of its legal authority on the structure,
administrability, and effectiveness and efficiency of the Pilot
program. Are there any additional potential sources of legal authority
that the Commission should consider?
96. Based on review of the record and reading of the statute, the
Commission believes that the Commission's rural health care legal
authority in section 254(h)(2)(A) of the Act supports the proposed
Pilot program. Section 254(h)(2)(A) directs the Commission to
``establish competitively neutral rules, (A) to enhance, to the extent
technically feasible and economically reasonable, access to advanced
telecommunications and information services for all public and non-
profit . . . health care providers. . . .'' The Commission has
previously explained that it has ``broad discretion regarding how to
fulfill this statutory mandate.'' The Commission seeks comment on
whether to rely on the rural health care legal authority in section
254(h)(2)(A) as its authority to create the proposed Pilot program, and
how relying on this legal authority would impact the structure of the
Pilot program.
97. Several commenters argued that section 254(h)(2)(A) provides
the Commission with legal authority to establish the proposed Pilot
program. The Commission previously relied on this statutory provision
as its legal authority for the RHC Pilot program and the Healthcare
Connect Fund program, which were designed to develop dedicated health
care provider networks and fund broadband internet access services used
directly by health care providers, and network equipment necessary to
make the supported services functional. The Commission has not
previously relied on this statutory provision to provide support for
connectivity between patients and health care providers, however. The
Commission believes the most feasible way to structure the Pilot
program would be to have the health care provider purchase the
broadband internet access service needed by the patient to access
connected care services from a broadband carrier or a connected care
company (e.g., a remote patient monitoring company) and then provide
the telehealth service, including the underlying internet broadband
access service, to the patient directly. The Commission therefore seeks
comment on whether and how section 254(h)(2)(A) could be interpreted to
authorize the creation of a Pilot program that would support patient
broadband internet access service connections for connected care.
98. The Commission requests information on how providing health
care providers support for patient-centered connected care enhances
health care provider ``access to advanced telecommunications and
information services'' consistent with section 254(h)(2)(A). Is there
an argument that patient broadband internet access service falls within
section 254(h)(2)(A) when it is purchased by a health care provider and
used for medical purposes? Is the legal argument for supporting
connectivity underlying technologies such as remote patient monitoring
under section 254(h)(2)(A) stronger where the health care provider
purchases the residential broadband internet access service as part of
a complete solution or package and provides the connected care services
to the patient? Does the fact that a health care provider cannot serve
a patient at the patient's location through connected care unless the
patient has a broadband internet access connection provide a basis for
relying on the rural health care authority in section 254(h)(2)(A)? Is
there an argument that individual patient broadband connections for
connected care services fall within the scope of section 254(h)(2)(A)
because they extend the health care provider's network by allowing the
health care provider to send and receive communications to its patients
wherever the patients are located, and thus would enhance access to
advanced service ``for'' the health care provider, as required by
section 254(h)(2)(A)?
99. The Commission also seeks comment on whether section
254(h)(2)(A) would also authorize the Commission to provide funding
under the Pilot program for health care provider purchases of
services--other than patient connectivity--that are used to provide
connected care services but that are not already eligible for support
[[Page 36880]]
through the Healthcare Connect Fund program. For example, companies may
offer cloud-based solutions, finished service packages, or complete
suites of services that allow health care providers to provide
telehealth, including connected care. Are these services ``information
services'' under section 254(h)(2)(A), for which the Commission is
required to develop competitively neutral rules to enhance access for
health care providers? Are there other types of services that qualify
as ``information services'' under section 254(h)(2)(A)? The Commission
seeks additional information about, and examples of, these services and
the components of these services, including any network equipment
required to make these services functional. The Commission also seeks
specific information and data that would help it to determine whether
these types of services could qualify as supportable information
services under section 254(h)(2)(A). Finally, the Commission seeks
information on how these types of services help health care providers
provide connected care services, and whether health care providers have
difficulty affording these types of services without USF support.
100. The Commission believes that the universal service principles
in sections 254(b)(1) and (b)(3) of the Act, and section 254(j) of the
Act provide additional statutory support for a Pilot program that would
provide USF support to enable health care providers to provide
connected care technologies to eligible low-income consumers. Sections
254(b)(1) and (b)(3), provide, respectively, that the Commission's
universal service policies must be based on the principles that
``[q]uality services should be available at just, reasonable, and
affordable rates'' and ``[c]onsumers in all regions of the Nation,
including low-income consumers . . . should have access to
telecommunications and information services . . . that are reasonably
comparable to those services provided in urban areas and that are
available at rates that are reasonably comparable to those services
provided in urban areas.'' Section 254(j) ensures the continuation of
the Lifeline program through any subsequent changes to the Universal
Service Fund. In addition, section 154(i) also authorizes the
Commission to ``perform any and all acts, make such rules and
regulations, and issue such orders, not inconsistent with this chapter,
as may be necessary in the execution of its functions.''
101. The Commission believes that using a discrete, time-limited
Pilot program to obtain additional data about the benefits of
broadband-enabled connected care services, and how universal service
funds could better support the adoption of broadband-enabled connected
care services, as well as broadband internet access service more
generally, is consistent with these statutory provisions. The
Commission notes that it has previously relied on sections 254(b)(1)
and (b)(3) and 154(i) to establish the limited Lifeline Broadband Pilot
program, which provided participating low-income consumers support for
bundled broadband service or stand-alone broadband service to test the
impact of Lifeline support on broadband adoption. The Commission seeks
comment on relying in part on the low-income legal authority for the
proposed Pilot program and how relying on the low-income legal
authority would impact the structure of the Pilot program. For example,
would relying on the low income legal authority require the Commission
to limit Pilot projects to those serving exclusively low-income
individuals?
102. The Commission also seeks comment on whether it should rely on
its low-income legal authority to provide support for broadband
internet access connections for connected care services through the
Pilot program, and rely on its rural health care legal authority to
provide support for information services not already funded through the
Healthcare Connect Fund program that health care providers use to
provide connected care services. How would this approach impact the
structure and administrability of the Pilot program? Would it result in
a Pilot program structure that incentivizes participation from eligible
health care providers, service providers, and patients better than
under the other proposed legal authorities?
103. For example, if a health care provider contracts with a remote
patient monitoring solution provider for a package that includes
broadband connectivity for patients, patient remote monitoring
equipment, and software for the health care provider to process data
received by the patient's remote monitoring equipment, could the
Commission fund some parts of that overall package via its Rural Health
Care legal authority and other parts through its low-income legal
authority? If the health care provider needed additional broadband
capacity to its location to support that remote monitoring service,
could the Commission also support that additional capacity through this
Pilot program?
104. Are there other services the Commission should consider
supporting consistent with its legal authority? For example, in the
Commission's Rural Health Care Pilot Program, participants were
permitted to purchase equipment integral to running their broadband
networks, such as servers, routers, firewalls, and switches, or to
upgrade their existing equipment and increase bandwidth. The Commission
seeks comment on its legal authority to fund such services here.
III. Procedural Matters
A. Initial Paperwork Reduction Act Analysis
105. This document contains proposed information collection
requirements. The Commission, as part of its continuing effort to
reduce paperwork burdens, invites the general public and the OMB to
comment on the information collection requirements contained in this
document, as required by the Paperwork Reduction Act of 1995, Public
Law 104-13. In addition, pursuant to the Small Business Paperwork
Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the
Commission seeks specific comment on how to further reduce the
information collection burden for small business concerns with fewer
than 25 employees.
106. Ex Parte Rules--Permit-But-Disclose. The proceeding the NPRM
initiates shall be treated as a ``permit-but-disclose'' proceeding in
accordance with the Commission's ex parte rules. Persons making ex
parte presentations must file a copy of any written presentation or a
memorandum summarizing any oral presentation within two business days
after the presentation (unless a different deadline applicable to the
Sunshine period applies). Persons making oral ex parte presentations
are reminded that memoranda summarizing the presentation must (1) list
all persons attending or otherwise participating in the meeting at
which the ex parte presentation was made, and (2) summarize all data
presented and arguments made during the presentation. If the
presentation consisted in whole or in part of the presentation of data
or arguments already reflected in the presenter's written comments,
memoranda, or other filings in the proceeding, the presenter may
provide citations to such data or arguments in his or her prior
comments, memoranda, or other filings (specifying the relevant page
and/or paragraph numbers where such data or arguments can be found) in
lieu of summarizing them in the memorandum. Documents shown or given to
Commission staff during ex parte meetings are deemed to
[[Page 36881]]
be written ex parte presentations and must be filed consistent with
rule 1.1206(b). In proceedings governed by rule 1.49(f) or for which
the Commission has made available a method of electronic filing,
written ex parte presentations and memoranda summarizing oral ex parte
presentations, and all attachments thereto, must be filed through the
electronic comment filing system available for that proceeding, and
must be filed in their native format (e.g., .doc, .xml, .ppt,
searchable .pdf). Participants in this proceeding should familiarize
themselves with the Commission's ex parte rules.
107. Initial Regulatory Flexibility Analysis. As required by the
Regulatory Flexibility Act of 1980, as amended, the Commission has
prepared an Initial Regulatory Flexibility Analysis (IRFA) for the
NRPM, of the possible significant economic impact on a substantial
number of small entities by the policies and rules proposed in the
NPRM. Written public comments are requested on this IRFA. Comments must
be identified as responses to the IRFA and must be filed by the
deadlines for comments on the NPRM. The Commission will send a copy of
the NPRM, including this IRFA, to the Chief Counsel for Advocacy of the
Small Business Administration. In addition, the NPRM and IRFA (or
summaries thereof) will be published in the Federal Register.
108. Need for, and Objectives of, the Proposed Rules. The
Commission is required by section 254 of the Communications Act of
1934, as amended, to promulgate rules to implement the universal
service provisions of section 254 and ``to establish competitively
neutral rules--(A) to enhance to the extend technically feasible and
economically reasonable, access to advanced telecommunications and
information services for all public and nonprofit . . . health care
providers . . . .'' The Commission is also required to base policies
for the preservation and advancement of universal services on
principles including ``[q]uality rates should be available at just,
reasonable, and affordable rates'' and ``[c]onsumers in all regions of
the Nation, including low-income consumers . . . should have access to
telecommunications service and information services . . . that are
reasonably comparable to those services provided in urban areas and
that are available at rates that are reasonably comparable to rates
charged for similar services in urban areas.'' In the NPRM, the
Commission proposes a Connected Care Pilot program (Pilot) that will
assist in satisfying these requirements by providing support for
eligible health care providers to provide connected care to low-income
patients, including veterans and those in medically underserved
communities. The Commission seeks comment on whether the Pilot program
should fund broadband internet access services or other information
services used by health care providers to provide connected care
services and network equipment necessary to make the supported services
functional. The Commission expects that the data gathered from the
Pilot program will help to understand how and whether USF funds could
be used to promote health care provider and low-income patient adoption
and use of connected care services.
109. The Commission proposes four goals for the proposed Pilot
program and also propose a three-year duration and budget of $100
million for the Pilot program. The Commission also proposes and seeks
comment on the application process and the objective criteria for
selecting projects among the applications the Commission receives for
the Pilot program, and proposes and seeks comment on awarding
additional points during the evaluation process for proposed projects
that would primarily serve veterans or rural or Tribal areas or
populations or primarily treat diabetes, heart disease, opioid
addiction, mental health conditions, or high-risk pregnancy. The
Commission should be able to fund a range of diverse projects
throughout the country. The Commission proposes the specific
requirements for health care providers, including vendor selection
requirements, requirements for requesting funding and reimbursements,
and audit and document retention requirements, and data reporting
requirements. Finally, the Commission proposes specific requirements
for participating service providers including indicating interest in
participating in the Pilot program, requesting disbursements, and
document retention and audit requirements. Participating consumers may
also be required to complete consumer surveys.
110. Legal Basis. The legal basis for the Notice of Proposed
Rulemaking is contained in sections 1 through 4, 201, 254, and 403 of
the Communications Act of 1934, as amended by the Telecommunications
Act of 1996, 47 U.S.C. 151 through 154, 201, 254, and 403.
111. Description and Estimate of the Number of Small Entities to
Which the Proposed Rules Will Apply. The RFA directs agencies to
provide a description of and, where feasible, an estimate of the number
of small entities that may be affected by the proposed rules, if
adopted. The RFA generally defines the term ``small entity'' as having
the same meaning as the terms ``small business,'' ``small
organization,'' and ``small governmental jurisdiction.'' In addition,
the term ``small business'' has the same meaning as the term ``small
business concern'' under the Small Business Act. A small business
concern is one that: (1) Is independently owned and operated; (2) is
not dominant in its field of operation; and (3) satisfies any
additional criteria established by the Small Business Administration
(SBA). Nationwide, there are a total of approximately 29.6 million
small businesses, according to the SBA. A ``small organization'' is
generally ``any not-for-profit enterprise which is independently owned
and operated and is not dominant in its field.''
112. Small Businesses, Small Organizations, Small Governmental
Jurisdictions. The Commission's actions, over time, may affect small
entities that are not easily categorized at present. The Commission
therefore describes here, at the outset, three broad groups of small
entities that could be directly affected herein. First, while there are
industry specific size standards for small businesses that are used in
the regulatory flexibility analysis, according to data from the SBA's
Office of Advocacy, in general a small business is an independent
business having fewer than 500 employees. These types of small
businesses represent 99.9% of all businesses in the United States which
translates to 29.6 million businesses.
113. Next, the type of small entity described as a ``small
organization'' is generally ``any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.''
Nationwide, as of August 2016, there were approximately 356,494 small
organizations based on registration and tax data filed by nonprofits
with the Internal Revenue Service (IRS).
114. Finally, the small entity described as a ``small governmental
jurisdiction'' is defined generally as ``governments of cities,
counties, towns, townships, villages, school districts, or special
districts, with a population of less than fifty thousand.'' U.S. Census
Bureau data from the 2012 Census of Governments indicates that there
were 90,056 local governmental jurisdictions consisting of general
purpose governments and special purpose governments in the United
States. Of this number there were 37,132 general purpose governments
(county,
[[Page 36882]]
municipal and town or township) with populations of less than 50,000
and 12,184 special purpose governments (independent school districts
and special districts) with populations of less than 50,000. The 2012
U.S. Census Bureau data for most types of governments in the local
government category show that the majority of these governments have
populations of less than 50,000. Based on this data the Commission
estimates that at least 49,316 local government jurisdictions fall in
the category of ``small governmental jurisdictions.''
115. Small entities potentially affected by the proposals herein
include eligible non-profit and public health care providers and the
service providers offering them services, including telecommunications
service providers, internet Service Providers (ISPs), and vendors of
the eligible services and equipment that would be supported by the
Pilot program.
116. Description of Projected Reporting, Recordkeeping, and Other
Compliance Requirements for Small Entities. In the NPRM, the Commission
seeks comment on a proposed Connected Care Pilot program with a $100
million budget and three-year duration, that would provide support for
eligible low-income patients to receive discounts on residential
broadband service for purposes of connected care.
117. To participate in the Pilot program, the Commission proposes
that health care providers satisfy the definition of an eligible health
care provider under section 254(h)(7)(B) of the Act and submit an
application by the application deadline that the Commission ultimately
adopts for the Pilot program. The NPRM proposes specific information
that health care providers would be required to submit in an
application for each pilot project proposal, including, but not limited
to, information on the participating health care provider(s),
description of the project and how it would further the goals of the
Pilot program, estimated project budget, patient populations and the
geographic areas to be served and health conditions to be treated. The
NPRM also proposes that the applications be made publicly available.
118. The NPRM proposes requirements for participating health care
providers to select service providers for the supported services and
other potential Pilot-program supported items, including the
possibility of requiring health care providers to competitively bid the
supported services. In addition, the NPRM proposes requiring health
care providers for participating projects to submit funding requests
and invoices for services and other items that are eligible for support
through the Pilot program, and reports at regular intervals that would
allow the Commission to monitor the status of each project and how each
project is using the funding and seeks comment on the appropriate
interval and contents of those reports. Participating service providers
may also have requirements related to requesting disbursements. The
NPRM also proposes that participating health care providers and service
providers be subject to random compliance audits, and a three or five-
year document retention period.
119. Steps Taken to Minimize the Significant Economic Impact on
Small Entities, and Significant Alternatives Considered. The RFA
requires an agency to describe any significant, specifically small
business, alternatives that it has considered in reaching its proposed
approach, which may include the following four alternatives (among
others): ``(1) the establishment of differing compliance or reporting
requirements or timetables that take into account the resources
available to small entities; (2) the clarification, consolidation, or
simplification of compliance and reporting requirements under the rule
for such small entities; (3) the use of performance rather than design
standards; and (4) an exemption from coverage of the rule, or any part
thereof, for such small entities.''
120. The Commission does not expect the requirements for the Pilot
program to have a significant economic impact on eligible service
providers or eligible health care providers because service providers
and health care providers have a choice of participating. The
Commission also does not expect small entities to be disproportionately
impacted. The Bureau will consider whether the proposed projects will
promote entrepreneurs and other small businesses in the provision and
ownership of telecommunications and information services, consistent
with section 257 of the Communications Act, including those that may be
socially and economically disadvantaged businesses. All eligible health
care providers that choose to participate may be required to collect
and submit data at regular intervals during the Pilot program and at
the end of the Pilot program to USAC and the Commission, as described
in section III(E) of the NPRM. The collection of this information is
necessary to evaluate the impact of the Pilot program, including
whether the Pilot program achieves its goals. The benefits of
collecting this information outweigh any costs.
121. The NPRM proposes an application process that would encourage
a wide variety of eligible health care providers and eligible service
providers to participate, including small entities. The Commission
seeks to strike a balance between requiring applicants to submit enough
information that would allow the selection of high-quality, cost-
effective projects that would best further the goals of the Pilot
program, but also minimizing the administrative burdens on entities
that seek to apply.
122. The Commission proposes awarding additional points during the
application process for projects that are located in a rural area,
would primarily serve rural patients or veterans, would serve five or
more Medically Underserved Areas and Healthcare Provider Shortage
Areas, as designated by the Health Resources and Services
Administration by geography, or are located on Tribal lands, associated
with a Tribe, or part of the Indian Health Service. This recognizes the
disparities in health care in rural areas and Tribal areas, and areas
that are designated as Medically Underserved Areas and Healthcare
Provider Shortage Areas and is aimed at increasing the likelihood
projects serving these areas will be selected.
123. The reporting requirements, compliance audit requirements, and
document retention requirements the Commission proposes are tailored to
ensure that Pilot program funding is used for its intended purposes and
so that the Commission can obtain meaningful data to evaluate the Pilot
program and inform its policy decisions. The proposed compliance audit
and document retention requirements the Commission proposes are the
same measures that apply to health care providers and service providers
that participate in the Healthcare Connect Fund program. The proposed
reporting requirements are tailored to ensure that the Commission
receive regular, meaningful data about each project. The Commission
finds that ensuring that participating health care providers and
service providers, including small entities, are accountable in the use
of Pilot program funds and that participating health care providers
submit regular, meaningful information about their projects outweighs
the burdens associated with these requirements.
IV. Ordering Clauses
124. It is ordered that, pursuant to the authority contained in
sections 1
[[Page 36883]]
through 4, 201, 254, and 403 of the Communications Act of 1934, as
amended by the Telecommunications Act of 1996, 47 U.S.C. 151 through
154, 201, 254, and 403 the Notice of Proposed Rulemaking is adopted.
125. It is further ordered that, pursuant to applicable procedures
set forth in sections 1.415 and 1.419 of the Commission's rules, 47 CFR
1.415, 1.419, interested parties may file comments on the NPRM on or
before August 29, 2019, and reply comments September 30, 2019.
Federal Communications Commission.
Marlene Dortch,
Secretary.
[FR Doc. 2019-16077 Filed 7-29-19; 8:45 am]
BILLING CODE 6712-01-P