Supplemental Evidence and Data Request on Improving Rural Health Through Telehealth-Guided Provider-to-Provider Communication, 12190-12191 [2021-04187]
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Federal Register / Vol. 86, No. 39 / Tuesday, March 2, 2021 / Notices
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Formations of, Acquisitions by, and
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jbell on DSKJLSW7X2PROD with NOTICES
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(BHC Act), Regulation Y (12 CFR part
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System, February 25, 2021.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2021–04302 Filed 3–1–21; 8:45 am]
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Jkt 253001
Supplemental Evidence and Data
Request on Improving Rural Health
Through Telehealth-Guided Providerto-Provider Communication
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Improving Rural Health Through
Telehealth-Guided Provider-to-Provider
Communication, which is currently
being conducted by the AHRQ’s
Evidence-based Practice Centers (EPC)
Program. Access to published and
unpublished pertinent scientific
information will improve the quality of
this review.
DATES: Submission Deadline on or
before April 1, 2021.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers
Lane, Mail Stop 06E77D, Rockville,
MD 20857
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Improving Rural Health
Through Telehealth-Guided Provider-toProvider Communication. AHRQ is
conducting this systematic review
pursuant to Section 902 of the Public
Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
SUMMARY:
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Improving Rural Health
Through Telehealth-Guided Provider-toProvider Communication, including
those that describe adverse events.
Telehealth for this review of providerto-provider communication is defined
as any telecommunications facilitated
interaction among, or support for,
healthcare professionals designed to
improve access, quality of care, or
health outcomes for rural patients and
populations. This includes a wide range
of clinical applications such as remote
ICU management; consultations for
inpatient and outpatient care; and
remote rounds or group education and
case review (e.g., Project ECHO, etc.).
The entire research protocol is available
online at: https://
effectivehealthcare.ahrq.gov/products/
rural-telehealth/protocol.
This is to notify the public that the
EPC Program would find the following
information on Improving Rural Health
Through Telehealth-Guided Provider-toProvider Communication helpful:
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements: Study number, study period,
design, methodology, indication and
diagnosis, proper use instructions,
inclusion and exclusion criteria,
primary and secondary outcomes,
baseline characteristics, number of
patients screened/eligible/enrolled/lost
to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
E:\FR\FM\02MRN1.SGM
02MRN1
Federal Register / Vol. 86, No. 39 / Tuesday, March 2, 2021 / Notices
confidential; marketing materials; study
types not included in the review; or
information on indications not included
in the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://
www.effectivehealthcare.ahrq.gov/
email-updates.
The systematic review will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions.
Key Questions (KQs)
KQ 1. What is the effectiveness of
provider-to-provider telehealth for rural
patients?
a. What is the impact of provider-toprovider telehealth on rural patient and
population outcomes?
b. What is the impact of provider-toprovider telehealth on healthcare
providers?
c. What is the impact of provider-toprovider telehealth on private and
public (ex. CMS, TriCare, VA, etc.)
payers?
d. What adverse events or unintended
consequences are associated with
provider-to-provider telehealth for rural
patients?
e. What are the methodological
weaknesses of the identified
effectiveness studies of provider-toprovider telehealth for rural patients
and what improvements in study design
(e.g., focus on relevant comparisons and
outcomes) might increase the impact of
future research?
jbell on DSKJLSW7X2PROD with NOTICES
KQ 2. What is the effectiveness of
implementation strategies for providerto-provider telehealth in rural areas?
a. What is the uptake of different
types of provider-to-provider telehealth
in rural areas?
Æ Who are the current patients,
providers, and payers engaged in
provider-to-provider telehealth in rural
areas?
Æ What factors affect whether
provider-to-provider telehealth in rural
areas can be sustained?
b. Which barriers and facilitators
impact adoption and implementation of
provider-to-provider telehealth in rural
areas?
VerDate Sep<11>2014
17:11 Mar 01, 2021
Jkt 253001
c. Which strategies are effective in
sustaining provider-to-provider
telehealth in rural areas?
d. What are the methodological
weaknesses of the identified studies of
implementation and sustainability of
provider-to-provider telehealth in rural
areas and what improvements in study
design (e.g., focus on relevant
comparisons and outcomes) might
increase the impact of future research?
Populations, Interventions,
Comparators, Outcomes, Settings
• Population(s)
Æ Rural individual patients, patient
families/care partners, and patient
populations.
Æ Healthcare providers (individuals
and organizations) who provide health
care services to rural patients or
populations.
• Providers include any profession or
occupation providing formal, paid
services.
• Family or informal care partners are
not considered providers.
Æ Payers who pay for healthcare
services for rural patients or
populations.
• Interventions
Æ Provider-to-provider telehealth
defined as: Any telecommunications
facilitated interaction among, or support
for, healthcare professionals designed to
improve access, quality of care, or
health outcomes for rural patients and
populations.
• Comparators
Æ KQ1: Other telehealth facilitated
care (not provider-to-provider), usual
(in-person) provider-to-provider
supports, no interaction or no care.
Æ KQ2: Different strategies for
dissemination, implementation, or
spread; no strategies; time periods prior
to implementation.
• Outcomes
Æ KQ1: Clinical outcomes for the
identified conditions (patient-reported
outcomes, mortality, morbidity, such as
function, illness recovery, infection);
Economic outcomes such as return on
investment, cost, volume of visits, and
resource use, including length of stay
and readmissions; Intermediate
Outcomes; Patient satisfaction, behavior
(such as care-seeking and compliance),
and decisions such as completion of
treatment, or satisfaction with less travel
to access healthcare; Provider
satisfaction, behavior, and decisions
such as choice of treatment or antibiotic
stewardship; Access measures and
indicators including but not limited to
time to diagnosis or time to treatment.
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
12191
Æ KQ2: Indicators and measures of
uptake (e.g., rates of use, timing to
implementation) and characteristics of
users; categories and descriptors of
barriers and facilitators; categories and
descriptors of strategies.
• Settings
Æ Outpatient (primary care and
specialty care), inpatient, prehospital
and emergency care, post-acute and
long-term care.
Æ Civilian, Veterans Administration,
or military.
Æ Health care and non-healthcare
settings where health services are
delivered including in the home.
Æ U.S. relevant settings [Note that
studies from countries with significantly
different healthcare systems and fewer
resources (e.g., low-income countries)
are excluded.]
Dated: February 24, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–04187 Filed 3–1–21; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10175]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
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information to be collected, and the use
SUMMARY:
E:\FR\FM\02MRN1.SGM
02MRN1
Agencies
[Federal Register Volume 86, Number 39 (Tuesday, March 2, 2021)]
[Notices]
[Pages 12190-12191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04187]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Improving Rural Health
Through Telehealth-Guided Provider-to-Provider Communication
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Improving Rural
Health Through Telehealth-Guided Provider-to-Provider Communication,
which is currently being conducted by the AHRQ's Evidence-based
Practice Centers (EPC) Program. Access to published and unpublished
pertinent scientific information will improve the quality of this
review.
DATES: Submission Deadline on or before April 1, 2021.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD
20857
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Improving Rural Health
Through Telehealth-Guided Provider-to-Provider Communication. AHRQ is
conducting this systematic review pursuant to Section 902 of the Public
Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Improving Rural Health Through Telehealth-Guided
Provider-to-Provider Communication, including those that describe
adverse events. Telehealth for this review of provider-to-provider
communication is defined as any telecommunications facilitated
interaction among, or support for, healthcare professionals designed to
improve access, quality of care, or health outcomes for rural patients
and populations. This includes a wide range of clinical applications
such as remote ICU management; consultations for inpatient and
outpatient care; and remote rounds or group education and case review
(e.g., Project ECHO, etc.). The entire research protocol is available
online at: https://effectivehealthcare.ahrq.gov/products/rural-telehealth/protocol.
This is to notify the public that the EPC Program would find the
following information on Improving Rural Health Through Telehealth-
Guided Provider-to-Provider Communication helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements: Study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered
[[Page 12191]]
confidential; marketing materials; study types not included in the
review; or information on indications not included in the review cannot
be used by the EPC Program. This is a voluntary request for
information, and all costs for complying with this request must be
borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
Key Questions (KQs)
KQ 1. What is the effectiveness of provider-to-provider telehealth for
rural patients?
a. What is the impact of provider-to-provider telehealth on rural
patient and population outcomes?
b. What is the impact of provider-to-provider telehealth on
healthcare providers?
c. What is the impact of provider-to-provider telehealth on private
and public (ex. CMS, TriCare, VA, etc.) payers?
d. What adverse events or unintended consequences are associated
with provider-to-provider telehealth for rural patients?
e. What are the methodological weaknesses of the identified
effectiveness studies of provider-to-provider telehealth for rural
patients and what improvements in study design (e.g., focus on relevant
comparisons and outcomes) might increase the impact of future research?
KQ 2. What is the effectiveness of implementation strategies for
provider-to-provider telehealth in rural areas?
a. What is the uptake of different types of provider-to-provider
telehealth in rural areas?
[cir] Who are the current patients, providers, and payers engaged
in provider-to-provider telehealth in rural areas?
[cir] What factors affect whether provider-to-provider telehealth
in rural areas can be sustained?
b. Which barriers and facilitators impact adoption and
implementation of provider-to-provider telehealth in rural areas?
c. Which strategies are effective in sustaining provider-to-
provider telehealth in rural areas?
d. What are the methodological weaknesses of the identified studies
of implementation and sustainability of provider-to-provider telehealth
in rural areas and what improvements in study design (e.g., focus on
relevant comparisons and outcomes) might increase the impact of future
research?
Populations, Interventions, Comparators, Outcomes, Settings
Population(s)
[cir] Rural individual patients, patient families/care partners,
and patient populations.
[cir] Healthcare providers (individuals and organizations) who
provide health care services to rural patients or populations.
Providers include any profession or occupation providing
formal, paid services.
Family or informal care partners are not considered
providers.
[cir] Payers who pay for healthcare services for rural patients or
populations.
Interventions
[cir] Provider-to-provider telehealth defined as: Any
telecommunications facilitated interaction among, or support for,
healthcare professionals designed to improve access, quality of care,
or health outcomes for rural patients and populations.
Comparators
[cir] KQ1: Other telehealth facilitated care (not provider-to-
provider), usual (in-person) provider-to-provider supports, no
interaction or no care.
[cir] KQ2: Different strategies for dissemination, implementation,
or spread; no strategies; time periods prior to implementation.
Outcomes
[cir] KQ1: Clinical outcomes for the identified conditions
(patient-reported outcomes, mortality, morbidity, such as function,
illness recovery, infection); Economic outcomes such as return on
investment, cost, volume of visits, and resource use, including length
of stay and readmissions; Intermediate Outcomes; Patient satisfaction,
behavior (such as care-seeking and compliance), and decisions such as
completion of treatment, or satisfaction with less travel to access
healthcare; Provider satisfaction, behavior, and decisions such as
choice of treatment or antibiotic stewardship; Access measures and
indicators including but not limited to time to diagnosis or time to
treatment.
[cir] KQ2: Indicators and measures of uptake (e.g., rates of use,
timing to implementation) and characteristics of users; categories and
descriptors of barriers and facilitators; categories and descriptors of
strategies.
Settings
[cir] Outpatient (primary care and specialty care), inpatient,
prehospital and emergency care, post-acute and long-term care.
[cir] Civilian, Veterans Administration, or military.
[cir] Health care and non-healthcare settings where health services
are delivered including in the home.
[cir] U.S. relevant settings [Note that studies from countries with
significantly different healthcare systems and fewer resources (e.g.,
low-income countries) are excluded.]
Dated: February 24, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-04187 Filed 3-1-21; 8:45 am]
BILLING CODE 4160-90-P