Supplemental Evidence and Data Request on Telehealth for Acute and Chronic Care Consultations, 15057-15059 [2017-05840]

Download as PDF 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