Supplemental Evidence and Data Request on Telehealth for Acute and Chronic Care Consultations, 15057-15059 [2017-05840]
Download as PDF
<![CDATA[
Federal Register / Vol. 82, No. 56 / Friday, March 24, 2017 / Notices
comments received and may modify or
withdraw its consent to the proposed
settlement if comments received
disclose facts or considerations which
indicate that the proposed settlement is
inappropriate, improper, or inadequate.
ADDRESSES: Copies of the settlement are
available from the Agency by contacting
Ms. Paula V. Painter, Program Analyst,
using the contact information provided
in this notice. Comments may also be
submitted by referencing the Site’s
name through one of the following
methods:
Internet: https://www.epa.gov/
aboutepa/about-epa-region-4southeast#r4-public-notices.
• U.S. Mail: U.S. Environmental
Protection Agency, Superfund Division,
Attn: Paula V. Painter, 61 Forsyth Street
SW., Atlanta, Georgia 30303.
• Email: painter.paula@epa.gov.
FOR FURTHER INFORMATION CONTACT:
Paula V. Painter at (404) 562–8887.
Dated: November 10, 2016.
Anita L. Davis,
Chief, Enforcement and Community
Engagement Branch, Superfund Division.
FEDERAL RESERVE SYSTEM
jstallworth on DSK7TPTVN1PROD with NOTICES
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
Jkt 241001
Board of Governors of the Federal Reserve
System, March 21, 2017.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2017–05865 Filed 3–23–17; 8:45 am]
BILLING CODE 6210–01–P
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
BILLING CODE 6560–50–P
13:56 Mar 23, 2017
1. Feather River Bancorp, Inc., Dover,
Delaware; to become a bank holding
company by acquiring 100 percent of
Bank of Feather River, Yuba City,
California.
FEDERAL RESERVE SYSTEM
[FR Doc. 2017–05903 Filed 3–23–17; 8:45 am]
VerDate Sep<11>2014
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than April 19, 2017.
A. Federal Reserve Bank of San
Francisco (Gerald C. Tsai, Director,
Applications and Enforcement) 101
Market Street, San Francisco, California
94105–1579:
The notificants listed below have
applied under the Change in Bank
Control Act (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
notices are set forth in paragraph 7 of
the Act (12 U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the offices of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
of the Board of Governors. Comments
must be received not later than April 13,
2017.
A. Federal Reserve Bank of Dallas
(Robert L. Triplett III, Senior Vice
President) 2200 North Pearl Street,
Dallas, Texas 75201–2272:
1. Jose Quiroga and the MNB 2016
Stock Trust, Edinburg, Texas; to retain
25 percent or more of the voting shares
of MNB Ventures, Inc., and thereby
indirectly retain voting shares of Texas
National Bank, both of Mercedes, Texas;
in addition Jose Quiroga and the MNB
2016 Stock Trust have applied to join
the Ortega control group and indirectly
acquire, MNB Ventures, Inc., Mercedes,
Texas.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
15057
Board of Governors of the Federal Reserve
System, March 21, 2017.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2017–05864 Filed 3–23–17; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Telehealth for Acute and
Chronic Care Consultations
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 to inform our review on
Telehealth for Acute and Chronic Care
Consultations, which is currently being
conducted by the AHRQ’s Evidencebased Practice Centers (EPC) Program.
Access to published and unpublished
pertinent scientific information will
improve the quality of this review.
AHRQ is conducting this systematic
review pursuant to the Public Health
Service Act.
DATES: Submission Deadline on or
before April 24, 2017.
ADDRESSES:
Email submissions: SEADS@epcsrc.org.
Print submissions:
Mailing Address: Portland VA
Research Foundation, Scientific
Resource Center, ATTN: Scientific
Information Packet Coordinator, P.O.
Box 69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.):
Portland VA Research Foundation,
Scientific Resource Center, ATTN:
Scientific Information Packet
Coordinator, 3710 SW U.S. Veterans
Hospital Road, Mail Code: R&D 71,
Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT:
Ryan McKenna, Telephone: 503–220–
8262 ext. 51723 or Email: SEADS@epcsrc.org.
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 Telehealth for Acute and
Chronic Care Consultations.
The EPC Program is dedicated to
identifying as many studies as possible
SUMMARY:
E:\FR\FM\24MRN1.SGM
24MRN1
jstallworth on DSK7TPTVN1PROD with NOTICES
15058
Federal Register / Vol. 82, No. 56 / Friday, March 24, 2017 / Notices
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 Telehealth for Acute and
Chronic Care Consultations, including
those that describe adverse events. The
entire research protocol, including the
key questions, is also available online
at: https://www.effective
healthcare.ahrq.gov/index.cfm/searchfor-guides-reviews-and-reports/
?pageaction=display
product&productid=2434.
This is to notify the public that the
EPC Program would find the following
information on Telehealth for Acute and
Chronic Care Consultations 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,
please provide 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 will be very
beneficial to the EPC Program. The
contents of all submissions will be made
available to the public upon request.
Materials submitted must be publicly
available or able to be made public.
Materials that are considered
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
VerDate Sep<11>2014
13:56 Mar 23, 2017
Jkt 241001
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 Web site 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.effective
healthcare.ahrq.gov/index.cfm/join-theemail-list1/.
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.
The Key Questions
KQ 1: Are telehealth consultations
effective in improving clinical and
economic outcomes?
Telehealth consultations can be for
any acute or chronic clinical condition
across any specialty ranging from
infectious disease to psychiatry.
Clinical and economic outcomes may
include, but are not limited to, mortality
and morbidity, utilization of health
services, cost of services, and access to
services.
KQ 2: Are telehealth consultations
effective in improving intermediate
outcomes?
Intermediate outcomes include both
outcomes that precede the ultimate
outcomes of interest and secondary
outcomes.
Intermediate outcomes may include,
but are not limited to, patient and
provider satisfaction, behavior, and
decisions (e.g., patient completion of
treatment, provider antibiotic
stewardship); volume of services; and
health care processes (e.g., time to
diagnosis or treatment).
KQ 3: Have telehealth consultations
resulted in harms, adverse events, or
negative unintended consequences?
What are the characteristics of
telehealth consultations that have been
the subject of comparative studies?
The characteristics include:
(a) Clinical conditions addressed.
These can include broad categories such
as diagnosis and treatment of infectious
disease or specific conditions (e.g.,
upper respiratory infection, hepatitis C,
skin infections) or decisions (e.g.,
stewardship of antibiotics or
antimicrobials, selection of treatments).
(b) Characteristics of the providers
and patients involved.
(c) Relationships among the providers
and patients involved including
whether these are new or ongoing
relationships.
(d) Telehealth modalities and/or
methods for sharing patient data used.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
(e) Whether specifics in (d) meet
Medicare’s coverage and HIPAA
requirements.
(f) Settings including.
• Type of health care organization
including the organizational structure
(e.g., integrated delivery system, critical
access) and the type of care (e.g., longterm care, inpatient, ambulatory care).
• Country.
• Geographic and economic
characteristics such as urban or rural
areas, or areas with high vs. low
socioeconomic resources.
(g) Other circumstances (e.g.,
appropriate transportation, climate).
(h) Payment models or requirements
or limits for payment including.
• The payer/insurance for the patient
(e.g., Medicare, Medicaid, commercial).
• Any parameters for payment (e.g.,
relative value units [RVUs]) or limits on
visits.
• Any eligibility requirements for
payment based on patient, provider,
setting or context characteristics.
KQ 5: Do clinical, economic,
intermediate, or negative outcomes (i.e.,
the outcomes in Key Questions 1, 2, and
3) vary across telehealth consultation
characteristics (Key Question 4)?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Settings)
Populations
• Patients of any age, with medical
care needs for prevention, treatment, or
management of chronic or acute
conditions.
• Providers (clinicians or health care
organizations).
• Payers for health care services
(public, private, insurers, patients).
Interventions
• Telehealth consultations are
defined as the use of telehealth designed
to facilitate collaboration among
providers, often involving a specialist,
or between clinical team members,
across time and/or distance, on the
assessment, diagnosis, and/or clinical
management of a specific patient or
group of patients.
• Telehealth consultations can be for
any acute or chronic conditions. The
search will be both general as well as
focused on conditions identified as
areas of growth and policy interest such
as infection, disease, dermatology, and
critical care.
• Telehealth consultations can use
any technology (e.g., real-time video,
store and forward).
Comparator
Other locations, patients, or time
periods that use in-person consultations
E:\FR\FM\24MRN1.SGM
24MRN1
Federal Register / Vol. 82, No. 56 / Friday, March 24, 2017 / Notices
or provide usual care (which could
include no access to specific services).
but will not be included in the
systematic review.
Outcomes for Each Key Question
Sharon B. Arnold,
Acting Director.
Key Question 1: Clinical and Economic
Outcomes
• Clinical outcomes such as
mortality, morbidity, function, recovery,
infection, and access to services.
• Economic outcomes such as return
on investment, cost, volume of visits,
and resource use.
Key Question 2: Intermediate Outcomes
• Patient satisfaction, behavior, and
decisions such as completion of
treatment, or satisfaction with less travel
to access health care.
• Provider satisfaction, behavior, and
decisions such as choice of treatment or
antibiotic stewardship.
• Time to diagnosis and time to
treatment.
• Diagnostic concordance or other
measures of agreement between inperson and telehealth consultations.
Key Question 3: Adverse Effects or
Unintended Consequences
• Loss of privacy or breach of data
security.
• Misdiagnosis or delayed diagnosis.
• Inappropriate treatment.
• Increase in resource costs, negative
return on investment.
Key Question 4: Not Applicable (This is
a Descriptive Question)
Key Question 5: Clinical and Economic
Outcomes (see Key Question 1),
Intermediate Outcomes (see Key
Question 2), and Adverse Effects or
Unintended Consequences (see Key
Question 3).
Timing
• Telehealth consultations can be
used at any point in the diagnosis,
treatment, or management of a patient.
• Outcome measurement needs to
occur after the telehealth consultation.
jstallworth on DSK7TPTVN1PROD with NOTICES
Setting
The consultation can involve
providers and patients in any location.
These could include inpatient,
outpatient, or long-term care, and could
be in civilian, Veterans Administration,
or military facilities.
Study Designs
• Comparative studies, including
trials and observational studies.
• Descriptive studies may be used to
inform the decision model as needed
VerDate Sep<11>2014
13:56 Mar 23, 2017
Jkt 241001
[FR Doc. 2017–05840 Filed 3–23–17; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project ‘‘Generic
Clearance for the Collection of Data
Through ACTION III Field-Based
Investigations to Improve Health Care
Delivery.’’ In accordance with the
Paperwork Reduction Act, 44 U.S.C.
3501–3521, AHRQ invites the public to
comment on this proposed information
collection.
This proposed information collection
was previously published in the Federal
Register on December 20, 2016 and
allowed 60 days for public comment.
AHRQ did not receive any substantive
comments during this period. The
purpose of this notice is to allow an
additional 30 days for public comment.
DATES: Comments on this notice must be
received by April 24, 2017.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at OIRA_submission@
omb.eop.gov (attention: AHRQ’s desk
officer).
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov
SUPPLEMENTARY INFORMATION:
SUMMARY:
Proposed Project
Generic Clearance for the Collection of
Data Through ACTION III Field-Based
Investigations To Improve Health Care
Delivery
The Agency for Healthcare Research
and Quality (AHRQ) is requesting OMB
approval of a generic clearance for
purposes of conducting field-based
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
15059
research to improve care delivery in
diverse health care settings. More
specifically, AHRQ seeks this clearance
to support timely and meaningful
answers to research questions
investigated through AHRQ’s ACTION
Program. ACTION III research produces
field-based, stakeholder-informed
knowledge about ways to improve care
delivery, and real-world-driven
implementation and dissemination of
evidence across diverse care settings. A
generic clearance to support expedited
performance of ACTION III research
activities would enable AHRQ to more
efficiently meet agency goals while fully
meeting the intent and requirements of
the Paperwork Reduction Act in a
timely manner.
Collection of the information
described in this request is essential to
supporting AHRQ’s mission, which is to
produce evidence to make health care
safer, higher quality, more accessible,
equitable, and affordable, and to work
within HHS and with other partners to
make sure that the evidence is
understood and used. More specifically,
in support of this mission, AHRQ
initiates and oversees projects with the
following overarching aims:
• Expand knowledge about how
specific changes to processes or
structures of care delivery might
improve care quality;
• Develop and test interventions,
strategies, tools, trainings and guidance
for putting that knowledge into practice;
• Disseminate and implement
evidence-based practices across diverse
care settings.
Method of Collection
Information collections conducted
under this clearance will be collected
via the following methods:
• Interviews—Interviews (telephone
or in-person) will be conducted with
clinical or management staff from
diverse health care settings, patients, or
other providers or recipients of care
with the purposes of expanding
knowledge about how specific changes
to processes or structures of care
delivery might improve care quality;
obtaining stakeholder-informed input
about how and why an intervention or
strategy will or won’t work in a
particular real world setting; identifying
contextual factors that facilitate or
impede implementation of complex
system interventions or evidence-based
practices; and identifying needs and
challenges of intended users of tools
and/or beneficiaries of trainings and
other resources.
• Small discussion groups/focus
groups—Small discussion groups/Focus
E:\FR\FM\24MRN1.SGM
24MRN1
]]>Agencies
[Federal Register Volume 82, Number 56 (Friday, March 24, 2017)]
[Notices]
[Pages 15057-15059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05840]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Telehealth for Acute
and Chronic Care Consultations
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 to inform
our review on Telehealth for Acute and Chronic Care Consultations,
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. AHRQ is conducting this systematic review pursuant to the
Public Health Service Act.
DATES: Submission Deadline on or before April 24, 2017.
ADDRESSES:
Email submissions: src.org">SEADS@epc-src.org.
Print submissions:
Mailing Address: Portland VA Research Foundation, Scientific
Resource Center, ATTN: Scientific Information Packet Coordinator, P.O.
Box 69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.): Portland VA Research
Foundation, Scientific Resource Center, ATTN: Scientific Information
Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D
71, Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262
ext. 51723 or Email: src.org">SEADS@epc-src.org.
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 Telehealth for Acute
and Chronic Care Consultations.
The EPC Program is dedicated to identifying as many studies as
possible
[[Page 15058]]
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 Telehealth for Acute and Chronic Care Consultations,
including those that describe adverse events. The entire research
protocol, including the key questions, is also available online at:
https://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=2434.
This is to notify the public that the EPC Program would find the
following information on Telehealth for Acute and Chronic Care
Consultations 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, please provide 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 will be very beneficial to the EPC Program. The
contents of all submissions will be made available to the public upon
request. Materials submitted must be publicly available or able to be
made public. Materials that are considered 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 Web
site 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/index.cfm/join-the-email-list1/.
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.
The Key Questions
KQ 1: Are telehealth consultations effective in improving clinical
and economic outcomes?
Telehealth consultations can be for any acute or chronic clinical
condition across any specialty ranging from infectious disease to
psychiatry.
Clinical and economic outcomes may include, but are not limited to,
mortality and morbidity, utilization of health services, cost of
services, and access to services.
KQ 2: Are telehealth consultations effective in improving
intermediate outcomes?
Intermediate outcomes include both outcomes that precede the
ultimate outcomes of interest and secondary outcomes.
Intermediate outcomes may include, but are not limited to, patient
and provider satisfaction, behavior, and decisions (e.g., patient
completion of treatment, provider antibiotic stewardship); volume of
services; and health care processes (e.g., time to diagnosis or
treatment).
KQ 3: Have telehealth consultations resulted in harms, adverse
events, or negative unintended consequences?
What are the characteristics of telehealth consultations that have
been the subject of comparative studies?
The characteristics include:
(a) Clinical conditions addressed. These can include broad
categories such as diagnosis and treatment of infectious disease or
specific conditions (e.g., upper respiratory infection, hepatitis C,
skin infections) or decisions (e.g., stewardship of antibiotics or
antimicrobials, selection of treatments).
(b) Characteristics of the providers and patients involved.
(c) Relationships among the providers and patients involved
including whether these are new or ongoing relationships.
(d) Telehealth modalities and/or methods for sharing patient data
used.
(e) Whether specifics in (d) meet Medicare's coverage and HIPAA
requirements.
(f) Settings including.
Type of health care organization including the
organizational structure (e.g., integrated delivery system, critical
access) and the type of care (e.g., long-term care, inpatient,
ambulatory care).
Country.
Geographic and economic characteristics such as urban or
rural areas, or areas with high vs. low socioeconomic resources.
(g) Other circumstances (e.g., appropriate transportation,
climate).
(h) Payment models or requirements or limits for payment including.
The payer/insurance for the patient (e.g., Medicare,
Medicaid, commercial).
Any parameters for payment (e.g., relative value units
[RVUs]) or limits on visits.
Any eligibility requirements for payment based on patient,
provider, setting or context characteristics.
KQ 5: Do clinical, economic, intermediate, or negative outcomes
(i.e., the outcomes in Key Questions 1, 2, and 3) vary across
telehealth consultation characteristics (Key Question 4)?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
Settings)
Populations
Patients of any age, with medical care needs for
prevention, treatment, or management of chronic or acute conditions.
Providers (clinicians or health care organizations).
Payers for health care services (public, private,
insurers, patients).
Interventions
Telehealth consultations are defined as the use of
telehealth designed to facilitate collaboration among providers, often
involving a specialist, or between clinical team members, across time
and/or distance, on the assessment, diagnosis, and/or clinical
management of a specific patient or group of patients.
Telehealth consultations can be for any acute or chronic
conditions. The search will be both general as well as focused on
conditions identified as areas of growth and policy interest such as
infection, disease, dermatology, and critical care.
Telehealth consultations can use any technology (e.g.,
real-time video, store and forward).
Comparator
Other locations, patients, or time periods that use in-person
consultations
[[Page 15059]]
or provide usual care (which could include no access to specific
services).
Outcomes for Each Key Question
Key Question 1: Clinical and Economic Outcomes
Clinical outcomes such as mortality, morbidity, function,
recovery, infection, and access to services.
Economic outcomes such as return on investment, cost,
volume of visits, and resource use.
Key Question 2: Intermediate Outcomes
Patient satisfaction, behavior, and decisions such as
completion of treatment, or satisfaction with less travel to access
health care.
Provider satisfaction, behavior, and decisions such as
choice of treatment or antibiotic stewardship.
Time to diagnosis and time to treatment.
Diagnostic concordance or other measures of agreement
between in-person and telehealth consultations.
Key Question 3: Adverse Effects or Unintended Consequences
Loss of privacy or breach of data security.
Misdiagnosis or delayed diagnosis.
Inappropriate treatment.
Increase in resource costs, negative return on investment.
Key Question 4: Not Applicable (This is a Descriptive Question)
Key Question 5: Clinical and Economic Outcomes (see Key Question 1),
Intermediate Outcomes (see Key Question 2), and Adverse Effects or
Unintended Consequences (see Key Question 3).
Timing
Telehealth consultations can be used at any point in the
diagnosis, treatment, or management of a patient.
Outcome measurement needs to occur after the telehealth
consultation.
Setting
The consultation can involve providers and patients in any
location. These could include inpatient, outpatient, or long-term care,
and could be in civilian, Veterans Administration, or military
facilities.
Study Designs
Comparative studies, including trials and observational
studies.
Descriptive studies may be used to inform the decision
model as needed but will not be included in the systematic review.
Sharon B. Arnold,
Acting Director.
[FR Doc. 2017-05840 Filed 3-23-17; 8:45 am]
BILLING CODE 4160-90-P
