[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.

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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unpublished pertinent scientific information will improve the quality 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