Promoting Telehealth for Low-Income Consumers
| Published date | 30 July 2019 |
| Citation | 84 FR 36865 |
| Record Number | 2019-16077 |
| Section | Proposed rules |
| Court | Federal Communications Commission |
Federal Register, Volume 84 Issue 146 (Tuesday, July 30, 2019)
[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]
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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.
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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: http://fjallfoss.fcc.gov/ecfs2/.
Electronic Filers: Comments may be filed electronically using the
internet by accessing the ECFS: http://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 220701.
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
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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.
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
