Supplemental Evidence and Data Request on Telehealth During COVID-19, 56950-56953 [2021-22239]

Download as PDF 56950 Federal Register / Vol. 86, No. 195 / Wednesday, October 13, 2021 / Notices current observations of the state of the supply chain. Written Comments: Members of the public may submit written comments to NSAC at any time. Comments would be most useful to the Committee if they address the objectives outlined in their charter. Comments should be addressed to NSAC, c/o Dylan Richmond, Federal Maritime Commission, 800 North Capitol St. NW, Washington, DC 20573 or nsac@fmc.gov. A copy of all meeting documentation will be available at www.fmc.gov following the meeting. By the Commission. Rachel E. Dickon, Secretary. [FR Doc. 2021–22200 Filed 10–12–21; 8:45 am] BILLING CODE 6730–02–P FEDERAL RESERVE SYSTEM jspears on DSK121TN23PROD with NOTICES1 Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company The notificants listed below have applied under the Change in Bank Control Act (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 applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board’s Freedom of Information Office at https://www.federalreserve.gov/foia/ request.htm. Interested persons may express their views in writing on the standards enumerated in paragraph 7 of the Act. Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551–0001, not later than October 28, 2021. A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414: 1. The Dean A. Holmes General Trust, Dean Holmes, as trustee, The Arlene E. VerDate Sep<11>2014 18:01 Oct 12, 2021 Jkt 256001 Holmes General Trust, Arlene E. Holmes, as trustee, and Neil Holmes, all of Lena, Illinois; Craig Holmes, Pearl City, Illinois; David Holmes, Erie, Pennsylvania; Kevin Holmes, Mesa, Arizona; and Kay Overson, San Diego, California; to become the Holmes family control group, a group acting in concert, to retain voting shares of First Lena Corporation, and thereby indirectly retain voting shares of Citizens State Bank, both of Lena, Illinois. B. Federal Reserve Bank of Kansas City (Jeffrey Imgarten, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001: 1. Leslie Vezner, Lewisville, Texas; to retain voting shares of Nebraska Bankshares, Inc., and thereby indirectly retain voting shares of First State Bank, both of Farnam, Nebraska. C. Federal Reserve Bank of Dallas (Karen Smith, Director, Applications) 2200 North Pearl Street, Dallas, Texas 75201–2272: 1. James Cook, San Antonio, Texas; the Sue Craft McMahan Trust, Sue Craft McMahan, individually, and as trustee, both of Austin, Texas; the Clint Creighton Craft Trust, Clint Creighton Craft, as trustee, both of Celina, Texas; Malinda R. Crumley, Kay R. Murphey, and Malinda Murphey Cowan, all of Fort Worth, Texas; Bryan Bumpas, Margaret Sue Cherryhomes, Jerry Craft, Debbie J. Reaves, Karen Buckley Rumage, Paula Williams, Mallory Tolleson, Jerry Graybill, and the Amended and Restated Voting Trust Agreement, C. Blain Rumage, individually, and as trustee, all of Jacksboro, Texas; the Davis Revocable Trust, Danna Ritter, as trustee, both of La Vernia, Texas; the Jay David Craft Trust, Jay David Craft, as trustee, both of Christiansted, Virgin Islands; Dayna Geer Gunter, Azle, Texas; Charles Tyson, Bellevue, Texas; Alan Miller, Bowie, Texas; Willis G. Stamper, Jr., Frisco, Texas; William W. Rumage, Gunter, Texas; Jennifer Louise Stayton, Murphy, Texas; Stephen Stamper, Wichita Falls, Texas; James Rhodes Murphey and Emily Loomis Murphey, both of Willow Park, Texas; Craig Anderle, Windthorst, Texas; and Stella Jeanette McClure Matthews, Medford, Oregon; to join Edwin C. Rumage, and to become members of the Voting Trust Control Group, a group acting in concert, to retain voting shares of Jacksboro National Bancshares, Inc., and thereby indirectly retain voting shares of Jacksboro National Bank, both of Jacksboro, Texas. PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Board of Governors of the Federal Reserve System, October 7, 2021. Ann E. Misback, Secretary of the Board. [FR Doc. 2021–22261 Filed 10–12–21; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Telehealth During COVID– 19 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 Telehealth During COVID–19, 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 November 12, 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 Telehealth During COVID– 19. AHRQ is conducting this technical brief 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 SUMMARY: E:\FR\FM\13OCN1.SGM 13OCN1 Federal Register / Vol. 86, No. 195 / Wednesday, October 13, 2021 / 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 During COVID–19, including those that describe adverse events. The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/ products/virtual-health-covid/protocol. This is to notify the public that the EPC Program would find the following information on Telehealth During COVID–19 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 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 (KQ) KQ 1. What are the characteristics of patient, provider, and health systems using telehealth during the COVID–19 era, specifically: a. What are the characteristics of patients (e.g., age, race/ethnicity, gender, socioeconomic status, education, geographic location (urban versus rural))? b. What are the provider and health system characteristics (e.g., specialty, geographic location, private practice, hospital-based practice)? c. How do the characteristics of patients, providers, and health systems differ between the first four months of the COVID–19 era versus the remainder of the COVID–19 era? KQ 2. What are the benefits and harms of telehealth during the COVID– 19 era? a. Does this vary by type of telehealth intervention (i.e., telephone, video visits)? 56951 b. Does this vary by patient characteristic (i.e., age, gender, race/ ethnicity, type of clinical condition or health concern, geographic location)? c. Does this vary by provider and health system characteristic (e.g., specialty, geographic location, private practice, hospital-based practice)? KQ 3. What is considered a successful telehealth intervention during the COVID–19 era: a. From the patient or caregiver perspective? b. From the provider perspective? c. From the health system perspective? KQ 4. What strategies have been used to implement telehealth interventions during the COVID–19 era? a. What are the barriers and enablers of a successful telehealth strategy (e.g., setting, reimbursement, access to technology)? Æ From the patient or caregiver perspective? Æ From the provider perspective? Æ From the health system perspective? Contextual Questions (CQ) CQ 1. What are the costs of implementation and return on investment for telehealth during the COVID–19 era to the provider/ healthcare system? CQ 2. What are the policy and reimbursement considerations for telehealth during the COVID–19 era? a. How are these policy and reimbursement considerations for telehealth changing in the post-COVID– 19 era (from March 2020, when the World Health Organization declared COVID–19 a pandemic to present); at the federal level (policies such as Medicare), state level (policies such as Medicaid), and by private insurance payers? b. How do changes in reimbursement policies impact telehealth strategies? PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting) jspears on DSK121TN23PROD with NOTICES1 TABLE 1—PICOTS: INCLUSION AND EXCLUSION CRITERIA PICOT Inclusion Exclusion Population .......... All KQ: • Patients of any age (or their caregivers for KQ3 KQ4) • Health systems • Hospitals • Providers KQ 1–3: • Remotely delivered synchronous medical services (e.g., telephone, video visits) between a patient and a healthcare provider in an ambulatory setting (e.g., outpatient and community-based clinics) or ED providing. All KQ: Patients receiving inpatient care. Providers providing inpatient care. Interventions ...... VerDate Sep<11>2014 18:01 Oct 12, 2021 Jkt 256001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 All KQ: Remotely delivered, non-synchronous medical services (e.g., remote monitoring devices, health apps, wearable devices, patient portals). E:\FR\FM\13OCN1.SGM 13OCN1 56952 Federal Register / Vol. 86, No. 195 / Wednesday, October 13, 2021 / Notices TABLE 1—PICOTS: INCLUSION AND EXCLUSION CRITERIA—Continued PICOT Inclusion Comparators ...... Outcomes .......... Timing ................ Setting ............... jspears on DSK121TN23PROD with NOTICES1 Study Design † .. Exclusion Æ acute/urgent care (e.g., symptom management); routine/ chronic care (e.g., preventive services, chronic disease management); mental health services; wellness visits; post-hospital discharge care (e.g., routine follow-up and care for nonacute issues). • Patient and specialist communications facilitated by an ED physician in an ED (particularly important in rural care setting). KQ4: Implementation strategies for telehealth. KQ 1–3: In-person care, no care, no comparison KQ 4: Implementation strategies for telehealth KQ 1: Not applicable KQs 2 and 3: Æ Patient/provider-level outcomes D Patient satisfaction/perceptions D Physician/provider satisfaction/engagement/burnout Æ System outcomes D Healthcare access (e.g., insurance coverage, WIFI and smartphone access) D Healthcare utilization (e.g., hospitalization, readmission, ED visit) D Healthcare performance and quality measures (e.g., adhering or meeting Healthcare Effectiveness Data and Information Set (HEDIS) standards or other validated quality measures), e.g.: • Practice efficiency • No-show rates • Staffing hours • Cycle times D Communication Æ Clinical outcomes(any) D Medication adherence D Up to date lab values Æ Adverse effects/patient safety issues D Inappropriate treatment D Misdiagnosis/delayed diagnosis/care D Case resolution/Duplication of services (telehealth followed immediately by in-person visit) D Privacy/confidentiality breaches Æ Cost (see Appendix A for detailed cost outcomes) KQ4: Æ Barriers and enablers All KQ: the era of COVID–19 (March 2020-present) KQ1d: During the first 4 months or beyond the initial phase.* ALL KQ: Æ Healthcare provided outside of a medical office via phone or video. Æ Healthcare provided in an ED by a specialist via phone or video. Æ U.S.-like outpatient population (including ED) (see Appendix B for a list of included countries) KQ1: Claims and EHR data KQ 2 and 4 Æ Qualitative studies: Focus groups, interviews Æ Quantitative studies: RCT, CT, observational studies, and surveys KQ3: Qualitative studies: Focus groups, interviews. NA. NA. Studies completed prior to the era of COVID–19. Inpatient setting. Non-U.S. based studies with different patient population or health system characteristics. * Studies that began before the era of COVID–19 (11 March 2020) and extend into the era of COVID–19 will be excluded unless they meet the following criteria: Data from the pre and post COVID–19 era are stratified—the stratified data will be extracted; studies initiated as early as 1 January 2020 can be included if they are studies of telehealth in response to COVID–19. † To be eligible for inclusion as a qualitative study, the Sampling, data collection, and data analyses must be systematically conducted; data must be analyzed using methods of qualitative data analysis (such as thematic analysis). CT = controlled trial; ED = emergency department; EHR = electronic health record; HEDIS = Healthcare Effectiveness Data and Information Set; KQ = key question(s); NA = not applicable, RCT = randomized controlled trial. VerDate Sep<11>2014 18:01 Oct 12, 2021 Jkt 256001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1 Federal Register / Vol. 86, No. 195 / Wednesday, October 13, 2021 / Notices Dated: October 7, 2021. Marquita Cullom, Associate Director. [FR Doc. 2021–22239 Filed 10–12–21; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Request for Information: AHRQ’s Role in Climate Change and Environmental Justice Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of request for information. AGENCY: The Agency for Healthcare Research and Quality (AHRQ) is seeking information from the public on how the agency may have the greatest impact in addressing climate change through its core competencies of health systems research, practice improvement, and data & analytics. Specifically, AHRQ wants to learn how the agency can best use its resources to help build the healthcare system’s resilience to climate threats, reduce the healthcare industry’s contribution to climate change while increasing sustainability, and address environmental justice issues in healthcare. SUMMARY: Comments on this notice must be received by December 13, 2021. AHRQ will not respond individually to responders but will consider all comments submitted by the deadline. ADDRESSES: Please submit all responses via email to ClimateChange@ AHRQ.HHS.gov as a Word document or in the body of an email. FOR FURTHER INFORMATION CONTACT: Brent Sandmeyer, Social Science Analyst, Email: Brent.Sandmeyer@ AHRQ.HHS.gov, Telephone: 301–427– 1441. DATES: The Agency for Healthcare Research and Quality’s mission is to produce evidence to make healthcare safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. In pursuit of that mission, AHRQ recognizes that climate change is a large and growing threat to public health and the ability of the U.S. healthcare system to provide high quality, equitable care. Climate change has contributed to heat jspears on DSK121TN23PROD with NOTICES1 SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 18:01 Oct 12, 2021 Jkt 256001 waves, wildfires, hurricanes, droughts, flooding, and associated infrastructure failures. All of these have detrimental physical and behavioral health consequences and place increased demands on the healthcare system as it also struggles to respond to the COVID– 19 pandemic. Both climate change and the COVID–19 pandemic have highlighted and exacerbated longstanding racial, ethnic, and economic health disparities. AHRQ is seeking the public’s input on how the agency may have the greatest impact in addressing climate change through its core competencies of health systems research, practice improvement, and data & analytics. Specifically, AHRQ wants to learn how the agency can best use its resources to help build the healthcare system’s resilience to climate threats, reduce the healthcare industry’s contribution to climate change while increasing sustainability, and address environmental justice issues in healthcare. AHRQ is requesting information from the public regarding the following broad questions: 1. What should AHRQ’s role be at the intersection of climate change, healthcare, and environmental justice to maximize the agency’s impact? 2. How can AHRQ incorporate climate change and environmental justice issues into its core competencies of healthcare systems research, practice improvement, and data & analytics? 3. What are the most pressing healthcare-related areas of climate change and environmental justice research and actions that AHRQ could address? Relatedly, what evidence do healthcare systems and policymakers need to make decisions on responding to climate change? 4. How can AHRQ help healthcare systems prepare for and respond to the impacts of climate change on patient care, especially for vulnerable populations? 5. What role could AHRQ play in identifying, gathering, and disseminating data on climate-related risks and impacts, and making the information timely and easily available for researchers, healthcare systems, and policy makers? 6. What practice improvement resources (e.g., tools, strategies) could AHRQ provide to help healthcare systems improve patient safety and system resiliency during climate-related emergencies? 7. What are the training and education needs of healthcare professionals related to climate change and what role could AHRQ play in addressing those needs? PO 00000 Frm 00069 Fmt 4703 Sfmt 9990 56953 8. What key research has been conducted to assess or mitigate the impact that healthcare has on climate change? What are effective strategies to measure and reduce the carbon footprint and other environmental impacts of the healthcare sector? 9. What has been learned about health systems’ capacity and limitations during the COVID–19 pandemic that can help care delivery organizations better address climate change impacts and reduce disparities? 10. How might AHRQ take advantage of the existing national infrastructure to advance quality and safety (e.g., measurement standards, accrediting bodies, learning networks, incentives) to accelerate work on climate health and equity? 11. Which organizations working on climate change response in healthcare should AHRQ learn from and collaborate with? Please describe the nature of the organization’s work, evidence, and solutions, as applicable. AHRQ is interested in all of the questions listed above, but respondents are welcome to address as many or as few as they choose and to address additional areas of interest not listed. This RFI is for planning purposes only and should not be construed as a policy, solicitation for applications, or as an obligation on the part of the Government to provide support for any ideas identified in response to it. AHRQ will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder’s submission. However, responses to the RFI may be reflected in future solicitation(s) or policies. The information provided will be analyzed and may appear in reports. Respondents will not be identified in any published reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The contents of all submissions will be made available to the public upon request. Materials submitted must be publicly available or can be made public. Dated: October 6, 2021. Marquita Cullom, Associate Director. [FR Doc. 2021–22166 Filed 10–12–21; 8:45 am] BILLING CODE 4160–90–P E:\FR\FM\13OCN1.SGM 13OCN1

Agencies

[Federal Register Volume 86, Number 195 (Wednesday, October 13, 2021)]
[Notices]
[Pages 56950-56953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22239]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Telehealth During 
COVID-19

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 Telehealth 
During COVID-19, 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 November 12, 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 Telehealth During 
COVID-19. AHRQ is conducting this technical brief 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

[[Page 56951]]

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 During COVID-19, including those that describe 
adverse events. The entire research protocol is available online at: 
https://effectivehealthcare.ahrq.gov/products/virtual-health-covid/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Telehealth During COVID-19 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 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 (KQ)

    KQ 1. What are the characteristics of patient, provider, and health 
systems using telehealth during the COVID-19 era, specifically:
    a. What are the characteristics of patients (e.g., age, race/
ethnicity, gender, socioeconomic status, education, geographic location 
(urban versus rural))?
    b. What are the provider and health system characteristics (e.g., 
specialty, geographic location, private practice, hospital-based 
practice)?
    c. How do the characteristics of patients, providers, and health 
systems differ between the first four months of the COVID-19 era versus 
the remainder of the COVID-19 era?
    KQ 2. What are the benefits and harms of telehealth during the 
COVID-19 era?
    a. Does this vary by type of telehealth intervention (i.e., 
telephone, video visits)?
    b. Does this vary by patient characteristic (i.e., age, gender, 
race/ethnicity, type of clinical condition or health concern, 
geographic location)?
    c. Does this vary by provider and health system characteristic 
(e.g., specialty, geographic location, private practice, hospital-based 
practice)?
    KQ 3. What is considered a successful telehealth intervention 
during the COVID-19 era:
    a. From the patient or caregiver perspective?
    b. From the provider perspective?
    c. From the health system perspective?
    KQ 4. What strategies have been used to implement telehealth 
interventions during the COVID-19 era?
    a. What are the barriers and enablers of a successful telehealth 
strategy (e.g., setting, reimbursement, access to technology)?
    [cir] From the patient or caregiver perspective?
    [cir] From the provider perspective?
    [cir] From the health system perspective?

Contextual Questions (CQ)

    CQ 1. What are the costs of implementation and return on investment 
for telehealth during the COVID-19 era to the provider/healthcare 
system?
    CQ 2. What are the policy and reimbursement considerations for 
telehealth during the COVID-19 era?
    a. How are these policy and reimbursement considerations for 
telehealth changing in the post-COVID-19 era (from March 2020, when the 
World Health Organization declared COVID-19 a pandemic to present); at 
the federal level (policies such as Medicare), state level (policies 
such as Medicaid), and by private insurance payers?
    b. How do changes in reimbursement policies impact telehealth 
strategies?

PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)

            Table 1--PICOTS: Inclusion and Exclusion Criteria
------------------------------------------------------------------------
        PICOT                   Inclusion                Exclusion
------------------------------------------------------------------------
Population...........  All KQ:                     All KQ: Patients
                        Patients of any     receiving inpatient
                        age (or their caregivers    care. Providers
                        for KQ3 KQ4).               providing inpatient
                                                    care.
                        Health systems
                        Hospitals
                        Providers
Interventions........  KQ 1-3:                     All KQ: Remotely
                        Remotely            delivered, non-
                        delivered synchronous       synchronous medical
                        medical services (e.g.,     services (e.g.,
                        telephone, video visits)    remote monitoring
                        between a patient and a     devices, health
                        healthcare provider in an   apps, wearable
                        ambulatory setting (e.g.,   devices, patient
                        outpatient and community-   portals).
                        based clinics) or ED
                        providing..
 

[[Page 56952]]

 
                       [cir] acute/urgent care
                        (e.g., symptom
                        management); routine/
                        chronic care (e.g.,
                        preventive services,
                        chronic disease
                        management); mental
                        health services; wellness
                        visits; post-hospital
                        discharge care (e.g.,
                        routine follow-up and
                        care for nonacute
                        issues).
                        Patient and
                        specialist communications
                        facilitated by an ED
                        physician in an ED
                        (particularly important
                        in rural care setting).
                       KQ4: Implementation
                        strategies for
                        telehealth.
Comparators..........  KQ 1-3: In-person care, no  NA.
                        care, no comparison
                       KQ 4: Implementation
                        strategies for telehealth.
Outcomes.............  KQ 1: Not applicable        NA.
                       KQs 2 and 3:..............
                       [cir] Patient/provider-
                        level outcomes
                       [ssquf] Patient
                        satisfaction/perceptions
                       [ssquf] Physician/provider
                        satisfaction/engagement/
                        burnout
                       [cir] System outcomes
                       [ssquf] Healthcare access
                        (e.g., insurance
                        coverage, WIFI and
                        smartphone access)
                       [ssquf] Healthcare
                        utilization (e.g.,
                        hospitalization,
                        readmission, ED visit)
                       [ssquf] Healthcare
                        performance and quality
                        measures (e.g., adhering
                        or meeting Healthcare
                        Effectiveness Data and
                        Information Set (HEDIS)
                        standards or other
                        validated quality
                        measures), e.g.:
                        Practice
                        efficiency
                        No-show rates
                        Staffing hours
                        Cycle times
                       [ssquf] Communication
                       [cir] Clinical
                        outcomes(any)
                       [ssquf] Medication
                        adherence
                       [ssquf] Up to date lab
                        values
                       [cir] Adverse effects/
                        patient safety issues
                       [ssquf] Inappropriate
                        treatment
                       [ssquf] Misdiagnosis/
                        delayed diagnosis/care
                       [ssquf] Case resolution/
                        Duplication of services
                        (telehealth followed
                        immediately by in-person
                        visit)
                       [ssquf] Privacy/
                        confidentiality breaches
                       [cir] Cost (see Appendix A
                        for detailed cost
                        outcomes)
                       KQ4:
                       [cir] Barriers and
                        enablers
Timing...............  All KQ: the era of COVID-   Studies completed
                        19 (March 2020-present)     prior to the era of
                       KQ1d: During the first 4     COVID-19.
                        months or beyond the
                        initial phase.*.
Setting..............  ALL KQ:                     Inpatient setting.
                       [cir] Healthcare provided    Non-U.S. based
                        outside of a medical        studies with
                        office via phone or         different patient
                        video..                     population or health
                                                    system
                                                    characteristics.
                       [cir] Healthcare provided
                        in an ED by a specialist
                        via phone or video.
                       [cir] U.S.-like outpatient
                        population (including ED)
                        (see Appendix B for a
                        list of included
                        countries)
Study Design [dagger]  KQ1: Claims and EHR data
                       KQ 2 and 4
                       [cir] Qualitative studies:
                        Focus groups, interviews
                       [cir] Quantitative
                        studies: RCT, CT,
                        observational studies,
                        and surveys
                       KQ3: Qualitative studies:
                        Focus groups, interviews.
------------------------------------------------------------------------
* Studies that began before the era of COVID-19 (11 March 2020) and
  extend into the era of COVID-19 will be excluded unless they meet the
  following criteria: Data from the pre and post COVID-19 era are
  stratified--the stratified data will be extracted; studies initiated
  as early as 1 January 2020 can be included if they are studies of
  telehealth in response to COVID-19.
[dagger] To be eligible for inclusion as a qualitative study, the
  Sampling, data collection, and data analyses must be systematically
  conducted; data must be analyzed using methods of qualitative data
  analysis (such as thematic analysis).
CT = controlled trial; ED = emergency department; EHR = electronic
  health record; HEDIS = Healthcare Effectiveness Data and Information
  Set; KQ = key question(s); NA = not applicable, RCT = randomized
  controlled trial.



[[Page 56953]]

    Dated: October 7, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-22239 Filed 10-12-21; 8:45 am]
BILLING CODE 4160-90-P