[Federal Register Volume 85, Number 227 (Tuesday, November 24, 2020)]
[Notices]
[Pages 75021-75025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25795]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Effective and Innovative Approaches/Best Practices in Health Care 
in Response to the COVID-19 Pandemic; Request for Information (RFI)

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Request for information (RFI).

-----------------------------------------------------------------------

SUMMARY: The U.S. Department of Health and Human Services (HHS) seeks 
to gain a comprehensive understanding of the impact of changes adopted 
by health care systems and health care providers in response to the 
COVID-19 pandemic. Many healthcare systems and clinicians have rapidly 
reengineered their policies and programs to improve access, safety, 
quality, outcomes including mortality and morbidity, cost, and value 
for both COVID-19 and non-COVID-19 related medical conditions. HHS 
plans to identify and learn from effective innovative approaches and 
best practices implemented by non-HHS organizations in order to inform 
HHS priorities and programs.

DATES: We recommend that you submit your comments through the 
Innovation RFI Response Portal (https://rfi.grants.nih.gov/?s=5f89e1e8400f00001a0036f2) to ensure consideration. Comments must be 
received through this portal no later than midnight Eastern Time (ET) 
on December 24, 2020. Submissions received after the deadline will not 
be reviewed. Comments may also be submitted in regulations.gov.

ADDRESSES: Comments, including mass comment submissions, must be 
submitted electronically using the Innovation RFI Response Portal 
(https://rfi.grants.nih.gov/?s=5f89e1e8400f00001a0036f2). Please 
respond concisely, in plain language, and in a narrative format in the 
field provided for each question, to ensure accurate interpretation and 
analysis. You may respond to some or all of the topic areas covered in 
the RFI, and/or you can also provide relevant information that may not 
have been referenced. You can also include links to online material or 
interactive presentations. Please do not include any personally 
identifiable patient information or confidential business information 
in your comment.

FOR FURTHER INFORMATION CONTACT: CAPT Meena Vythilingam, Director, 
Center for Health Innovation, Office of the Assistant Secretary for 
Health, [email protected] or 202 260 7382.

SUPPLEMENTARY INFORMATION:

I. Background

    In response to the 2019 novel coronavirus or COVID-19 pandemic, the 
Secretary of Health and Human Services (HHS) declared a public health 
emergency effective January 27, 2020, under section 319 of the Public 
Health

[[Page 75022]]

Service Act (42 U.S.C. 247d \1\) and renewed it continually since its 
issuance. The impact of the COVID-19 pandemic on the nation's 
healthcare system has been complex, widespread, and potentially 
enduring. This unprecedented pandemic has impacted the safety, quality, 
continuity, outcomes, value, and access to timely health care in 
numerous healthcare settings. Anecdotal reports as well as data from 
varied public sources confirmed that in addition to COVID-19-related 
increases in mortality and morbidity, the mortality and morbidity for 
numerous non-COVID-19-related medical conditions has also increased.\2\ 
The COVID-19 public health emergency is disproportionately affecting 
vulnerable populations, particularly the elderly, and racial and ethnic 
minorities.\3\ Local health systems with a significant burden of COVID-
19 cases have faced multiple challenges including surge capacity, 
staffing, and supply chain issues, that directly impact access, 
quality, and experience of care for all medical conditions.\4\ 
Decreases in help-seeking behaviors in the context of the COVID-19 
pandemic may have also contributed to delays in accessing timely care, 
resulting in poor outcomes.\5\ In addition to the disruption in 
healthcare, the delivery of long-term services and supports (LTSS) to 
many seniors and people with disabilities has also been disrupted 
during the pandemic.
---------------------------------------------------------------------------

    \1\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-2Oct2020.aspx.
    \2\ Weinstein E, Ragazzoni L, Burkle F, Allen M, Hogan D, Della 
Corte F. Delayed Primary and Specialty Care: The Coronavirus 
Disease--2019 Pandemic Second Wave [published online ahead of print, 
2020 May 7]. Disaster Med Public Health Prep. 2020; 1-3. 
doi:10.1017/dmp.2020.148.
    \3\ https://www.cms.gov/newsroom/press-releases/cms-updates-data-covid-19-impacts-medicare-beneficiaries.
    \4\ Francis JR. COVID-19: Implications for Supply Chain 
Management. Front Health Serv Manage. Fall 2020, 37(1):33-38. doi: 
10.1097/HAP.0000000000000092.
    \5\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6925e2.htm?s_cid=mm6925e2_e&deliveryName=USCDC_921-DM31231#F1_down.
---------------------------------------------------------------------------

    In response to the COVID-19 pandemic, medical providers, medical 
facilities, academic centers, and health systems rapidly reengineered 
healthcare policies and programs to ensure preservation of health care 
access, safety, quality, continuity, value, and outcomes. As a result, 
there has been a proliferation of innovative programs, policies, and 
best practices to prevent and mitigate the consequences of COVID-19, 
while simultaneously preserving access to routine and emergency 
healthcare services for non-COVID-19 medical conditions.\6\ An example 
of the paradigmatic shift in the delivery of health care is the rapid 
adoption and scaling of telehealth services.\7\ Although the pandemic 
disrupted the entire health care ecosystem in the U.S., it also 
provided an opportunity and impetus to innovate across the continuum of 
individual and population health, including screening, surveillance, 
prevention, treatment, supply chain management, and public health 
interventions. These changes may persist for the duration of the public 
health emergency, and potentially beyond it.
---------------------------------------------------------------------------

    \6\ Short JB, Mammen. A Pandemic Application of Creative 
Destruction in Healthcare. Fall 2020, Front Health Serv Manage.; 
37(1):4-9. doi: 10.1097/HAP.0000000000000093.
    \7\ Wosik J, Fudim M, Cameron B, et al. Telehealth 
transformation: COVID-19 and the rise of virtual care. J Am Med 
Inform Assoc. 2020; 27(6):957-962. doi:10.1093/jamia/ocaa067.
---------------------------------------------------------------------------

    HHS strongly supports innovation to preserve a resilient healthcare 
system in the face of the COVID-19 pandemic and recognizes the 
importance of learning from effective and innovative approaches and 
best practices implemented by non-HHS healthcare systems, academic 
centers, and healthcare providers. HHS will determine if these 
innovative approaches and best practices can help inform and/or improve 
HHS priorities and programs.

II. Scope and Assumptions

     The main purpose of this Request for Information (RFI) is 
for HHS to gather information on effective innovative approaches and 
best practices in health care in response to the COVID-19 pandemic by 
non-HHS health care systems and providers. The information provided 
will help inform and guide the HHS response to build a healthy and 
resilient nation.
     This RFI includes innovations and best practices in health 
care for both COVID-19 and non-COVID-19 health conditions.
     The definition of ``health'' system or services and/or 
``healthcare'' system or services, for the purposes of this RFI, is 
broad. We seek an understanding of effective best practices and 
innovations in the provision of services across the health and public 
health continuum by a variety of organizations. Responses can focus on 
select aspects or on the entire continuum of care, to include 
surveillance, screening, prevention, treatment, and/or public health 
interventions.
     We are specifically interested in novel approaches and 
best practices that are associated with data confirming efficacy and/or 
effectiveness with demonstrated improvements in one or more of the 
following measures: Patient outcomes, access to health care, safety, 
quality, and/or value.
     Responses should include the following:
    [cir] A description of the innovation/best practice.
    [cir] The rationale for the implementation of the innovation/best 
practice.
    [cir] Data and/or results confirming efficacy and/or effectiveness 
of the innovation/best practice, including demographic data; control 
conditions; outcomes measures (e.g., mortality, morbidity, health care 
access, safety, quality, cost, value, etc.); analytic strategy; and 
results. If the evaluation is currently underway, please describe the 
study design and expected timeline for completion of the study.
    [cir] Costs associated with implementing the the innovation/best 
practice.
    [cir] Have these innovations/best practices been incorporated as 
permanent organizational changes? If not, why not?
    [cir] Can the innovation/best practice be scaled to larger, diverse 
groups and/or locations for a longer period? If yes, please describe 
the potential impacts on outcomes.
    [cir] Did or could specific HHS policies or programs facilitate the 
design and implementation of an innovation/best practice? (If yes, 
please provide details of how the policy or program affects or could 
affect the innovation/best practice positively).
    [cir] By contrast, did or could specific HHS policies or programs 
hinder the design and implementation of an innovation/best practice? 
(If yes, please provide details of how the policy or program affects or 
could affect the innovation/best practice negatively).

III. Information Requested/Key Questions

    Please respond to specific topics in which you have the most amount 
of evidence and expertise. Respondents are requested to share the 
objective results of an evaluation for each topic when possible. 
Response to every item is not required.

A. Health Promotion and Prevention of COVID-19 and Non-COVID-19 Medical 
Conditions

    Please provide the following information:
    [cir] A description of the innovation/best practice.
    [cir] The rationale for the implementation of the innovation/best 
practice.

[[Page 75023]]

    [cir] Data and/or results confirming efficacy and/or effectiveness 
of the innovation/best practice, including demographic data; control 
conditions; outcomes measures (e.g., mortality, morbidity, health care 
access, safety, quality, cost, value, etc.); analytic strategy; and 
results. If the evaluation is currently underway, please describe the 
study design and expected timeline for completion of the study.
    [cir] Costs associated with implementing the the innovation/best 
practice.
    [cir] Have these innovations/best practices been incorporated as 
permanent organizational changes? If not, why not?
    [cir] Can the innovation/best practice be scaled to larger, diverse 
groups and/or locations for a longer period? If yes, please describe 
the potential impacts on outcomes.
    [cir] Did or could specific HHS policies or programs facilitate the 
design and implementation of an innovation/best practice? (If yes, 
please provide details of how the policy or program affects or could 
affect the innovation/best practice positively).
    [cir] By contrast, did or could specific HHS policies or programs 
hinder the design and implementation of an innovation/best practice? 
(If yes, please provide details of how the policy or program affects or 
could affect the innovation/best practice negatively).
    1. Describe effective innovations/best practices that prevented the 
transmission of SARS-CoV-2 infections in staff, patients and/or 
beneficiaries.
    2. Describe effective innovations/best practices to prevent SARS-
CoV-2 outbreaks among residents and staff in long-term care facilities 
including assisted living facilities, nursing homes, rehabilitation 
facilities, intermediate care facilities for individuals with 
intellectual disabilities (ICF/ID), and palliative care settings.
    3. Describe innovative programs/policies and best practices to 
ensure timely access to health care and continuity of care for patients 
with chronic illnesses that increase vulnerability to COVID-19.
    4. Provide details on innovations or best practices that prevented 
increases in morbidity and mortality due to deferred care for acute 
medical conditions (e.g., cardiac arrests, strokes, etc.).
    5. Describe effective programs or practices that helped ensure 
timely administration of immunizations to pediatric patients and other 
vulnerable populations including the elderly and individuals with 
disabilities.
    6. Elaborate on effective educational and messaging campaigns 
targeting prevention.
    7. Describe effective health promotion and prevention policies and 
programs implemented in response to COVID-19, that will continue beyond 
this pandemic.

B. Screening/Surveillance/Case Identification of COVID-19 and Non-
COVID-19 Medical Conditions

    Please provide the following information:
    [cir] A description of the innovation/best practice.
    [cir] The rationale for the implementation of the innovation/best 
practice.
    [cir] Data and/or results confirming efficacy and/or effectiveness 
of the innovation/best practice, including demographic data; control 
conditions; outcomes measures (e.g., mortality, morbidity, health care 
access, safety, quality, cost, value, etc.); analytic strategy, and 
results. If the evaluation is currently underway, please describe the 
study design and expected timeline for completion of the study.
    [cir] Costs associated with implementing the the innovation/best 
practice.
    [cir] Have these innovations/best practices been incorporated as 
permanent organizational changes? If not, why not?
    [cir] Can the innovation/best practice be scaled to larger, diverse 
groups and/or locations for a longer period? If yes, please describe 
the potential impacts on outcomes.
    [cir] Did or could specific HHS policies or programs facilitate the 
design and implementation of an innovation/best practice? (If yes, 
please provide details of how the policy or program affects or could 
affect the innovation/best practice positively).
    [cir] By contrast, did or could specific HHS policies or programs 
hinder the design and implementation of an innovation/best practice? 
(If yes, please provide details of how the policy or program affects or 
could affect the innovation/best practice negatively).
    1. Describe effective approaches to screening, surveillance and 
case identification of COVID-19.
    2. Describe efforts to ensure that patients continue to receive 
United States Preventive Services Task Force-recommended screening 
procedures on time during the COVID-19 pandemic. Please include data on 
the program's ability to prevent negative outcomes due to timely 
screening and early detection, if available.
    3. Outline innovative programs to continue screening for HIV, 
hepatitis and sexually transmitted diseases during the pandemic, (e.g., 
in syringe services programs (SSPs)).

C. Treatment for COVID-19 and Non-COVID-19 Medical Conditions

    Please provide the following information:
    [cir] A description of the innovation/best practice.
    [cir] The rationale for the implementation of the innovation/best 
practice.
    [cir] Data and/or results confirming efficacy and/or effectiveness 
of the innovation/best practice, including demographic data; control 
conditions; outcomes measures (e.g., mortality, morbidity, health care 
access, safety, quality, cost, value, etc.); analytic strategy, and 
results. If the evaluation is currently underway, please describe the 
study design and expected timeline for completion of the study.
    [cir] Costs associated with implementing the the innovation/best 
practice.
    [cir] Have these innovations/best practices been incorporated as 
permanent organizational changes? If not, why not?
    [cir] Can the innovation/best practice be scaled to larger, diverse 
groups and/or locations for a longer period? If yes, please describe 
the potential impacts on outcomes.
    [cir] Did or could specific HHS policies or programs facilitate the 
design and implementation of an innovation/best practice? (If yes, 
please provide details of how the policy or program affects or could 
affect the innovation/best practice positively).
    [cir] By contrast, did or could specific HHS policies or programs 
hinder the design and implementation of an innovation/best practice? 
(If yes, please provide details of how the policy or program affects or 
could affect the innovation/best practice negatively).
    1. Describe innovations/best practices in COVID-19 treatment that 
resulted in decreased mortality and morbidity.
    2. Describe if and how a health care system was effectively 
reengineered to ensure timely access and quality of care in the 
Emergency Department, Outpatient or Inpatient settings.
    3. Describe how appropriate utilization of emergency medical 
services was facilitated during the pandemic.
    4. Detail effective changes in intensive care unit (ICU) care and 
post-hospital care/follow-up.
    5. Detail best practices to ensure continuity of treatment for HIV, 
hepatitis and sexually transmitted diseases during the pandemic.

[[Page 75024]]

    6. Describe effective programs/policies to prevent/manage dental 
emergencies during the pandemic.
    7. Outline novel and effective approaches to ensure compliance with 
medications, including refills, during the pandemic.
    8. Please list effective treatment-related policies or programs 
that will continue beyond the COVID-19 pandemic.

D. Telehealth

    Please provide the following information:
    [cir] A description of the innovation/best practice.
    [cir] The rationale for the implementation of the innovation/best 
practice.
    [cir] Data and/or results confirming efficacy and/or effectiveness 
of the innovation/best practice, including demographic data; control 
conditions; outcomes measures (e.g., mortality, morbidity, health care 
access, safety, quality, cost, value, etc.); analytic strategy, and 
results. If the evaluation is currently underway, please describe the 
study design and expected timeline for completion of the study.
    [cir] Costs associated with implementing the the innovation/best 
practice.
    [cir] Have these innovations/best practices been incorporated as 
permanent organizational changes? If not, why not?
    [cir] Can the innovation/best practice be scaled to larger, diverse 
groups and/or locations for a longer period? If yes, please describe 
the potential impacts on outcomes.
    [cir] Did or could specific HHS policies or programs facilitate the 
design and implementation of an innovation/best practice? (If yes, 
please provide details of how the policy or program affects or could 
affect the innovation/best practice positively).
    [cir] By contrast, did or could specific HHS policies or programs 
hinder the design and implementation of an innovation/best practice? 
(If yes, please provide details of how the policy or program affects or 
could affect the innovation/best practice negatively).
    1. Describe effective best practices to deliver clinical and 
nonclinical services using telehealth (e.g., surveillance, prevention 
and treatment services, etc).
    2. Describe best practices and innovations to improve access to 
care for rural/remote populations using telehealth, during the 
pandemic.
    3. Detail effective use of remote monitoring/telemonitoring of 
chronic medical conditions including diabetes and hypertension and for 
delivering home health services.
    4. List criticial barriers to implement telehealth in healthcare 
systems.
    5. What are some of the key facilitators of telehealth?
    6. Outline innovative approaches to integrate telehealth into the 
clinical work flow.
    7. List effective telehealth programs that will continue beyond 
this pandemic.
    8. Describe technological systems that facilitate telehealth, 
including use of audio or video telehealth, telehealth programs or 
apps, or other approaches.
    9. Describe technological systems that might or might not 
facilitate telehealth, including uses of audio or video telehealth, 
telehealth programs or apps, or other approaches.

E. Mental Health/Behavioral Health and Substance Use Disorder 
Innovations/Best Practices

    Please provide the following information:
    [cir] A description of the innovation/best practice.
    [cir] The rationale for the implementation of the innovation/best 
practice.
    [cir] Data and/or results confirming efficacy and/or effectiveness 
of the innovation/best practice, including demographic data; control 
conditions; outcomes measures (e.g., mortality, morbidity, health care 
access, safety, quality, cost, value, etc.); analytic strategy, and 
results. If the evaluation is currently underway, please describe the 
study design and expected timeline for completion of the study.
    [cir] Costs associated with implementing the the innovation/best 
practice.
    [cir] Have these innovations/best practices been incorporated as 
permanent organizational changes? If not, why not?
    [cir] Can the innovation/best practice be scaled to larger, diverse 
groups and/or locations for a longer period? If yes, please describe 
the potential impacts on outcomes.
    [cir] Did or could specific HHS policies or programs facilitate the 
design and implementation of an innovation/best practice? (If yes, 
please provide details of how the policy or program affects or could 
affect the innovation/best practice positively).
    [cir] By contrast, did or could specific HHS policies or programs 
hinder the design and implementation of an innovation/best practice? 
(If yes, please provide details of how the policy or program affects or 
could affect the innovation/best practice negatively).
    1. Describe effective, novel mental health prevention and/or 
treatment programs in response to the COVID-19 pandemic.
    2. Describe effective and innovative substance use disorder 
programs during the COVID-19 pandemic.
    3. Describe innovative efforts to provide medication-assisted 
treatment, including access to counseling and support groups, during 
the pandemic.
    4. Provide information on effective suicide prevention programs 
implemented during the pandemic.
    5. Provide information on effective programs designed to identify 
childhood abuse, elder abuse and/or domestic violence during the 
pandemic.
    6. Detail effective approaches to prevent COVID transmission in 
psychiatric and substance use disorder residential and group treatment 
facilities.

F. Population-Level Interventions

    Please provide the following information:
    [cir] A description of the innovation/best practice.
    [cir] The rationale for the implementation of the innovation/best 
practice.
    [cir] Data and/or results confirming efficacy and/or effectiveness 
of the innovation/best practice, including demographic data; control 
conditions; outcomes measures (e.g., mortality, morbidity, health care 
access, safety, quality, cost, value, etc.); analytic strategy, and 
results. If the evaluation is currently underway, please describe the 
study design and expected timeline for completion of the study.
    [cir] Costs associated with implementing the the innovation/best 
practice.
    [cir] Have these innovations/best practices been incorporated as 
permanent organizational changes? If not, why not?
    [cir] Can the innovation/best practice be scaled to larger, diverse 
groups and/or locations for a longer period? If yes, please describe 
the potential impacts on outcomes.
    [cir] Did or could specific HHS policies or programs facilitate the 
design and implementation of an innovation/best practice? (If yes, 
please provide details of how the policy or program affects or could 
affect the innovation/best practice positively).
    [cir] By contrast, did or could specific HHS policies or programs 
hinder the design and implementation of an innovation/best practice? 
(If yes, please provide details of how the policy or program affects or 
could affect the innovation/best practice negatively).
    1. Describe innovations/best practices in preventing and/or 
treating COVID-19 in high risk and vulnerable populations including but 
not limited to, African-Americans, Asian Americans,

[[Page 75025]]

Hispanics/Latinos, American Indians/Alaska Natives, persons with 
disabilities, persons with limited English proficiency and others who 
might have been disproportionately impacted by COVID-19, directly or 
because treatment for other medical conditions has been disrupted.
    2. Provide details on effective, community-based, innovative 
programs to improve population health during the COVID-19 pandemic 
(e.g., programs to address social determinants of health).
    3. Outline effective and innovative approaches to address health 
disparities across the continuum of care during the COVID-19 pandemic.
    4. Detail effective approaches to address social isolation in 
vulnerable populations including older-adults and people with 
disabilities in both institutional and community settings.

G. Other Topics

    1. Please describe effective strategies to address other critical 
barriers, including work force concerns, provider well-being, supply 
chain, etc., to ensure continuity of operations in a healthcare system.
    2. Outline best practices to ensure seamless delivery of long-term 
services and supports (LTSS) to residents of group homes for 
individuals with disabilities, and other recipients of home-and-
community-based services during the pandemic.
    3. Detail new programs/policies and efforts that were implemented 
during the pandemic, but found to be ineffective in improving 
healthcare access, safety, quality, continuity, value and outcomes.
    4. Please describe other input not already covered by the previous 
topics.
    HHS encourages all potentially interested parties including 
individuals, healthcare providers, networks and/or associations, 
academic researchers and institutions, non-HHS federal healthcare 
systems, non-governmental organizations, and private sector entities to 
respond.

IV. How To Submit Your Response

    Please upload your responses to each question in this Innovation 
RFI response tool which has clearly marked sections for individual 
questions. Please respond concisely, in plain language, and in 
narrative format. You may respond to some or all of the questions 
listed in the RFI. Please ensure it is clear which question you are 
responding to. You may also include links to online material or 
interactive presentations.
    Please note that this is a request for information (RFI) only. In 
accordance with the implementing regulations of the Paperwork Reduction 
Act of 1995 (PRA), specifically 5 CFR 1320.3(h) (4), this general 
solicitation is exempt from the PRA. Facts or opinions submitted in 
response to general solicitations of comments from the public, 
published in the Federal Register or other publications, regardless of 
the form or format thereof, provided that no person is required to 
supply specific information pertaining to the commenter, other than 
that necessary for self-identification, as a condition of the agency's 
full consideration, are not generally considered information 
collections and therefore not subject to the PRA.
    This RFI is issued solely for information and planning purposes; it 
does not constitute a Request for Proposal (RFP), applications, 
proposal abstracts, or quotations. This RFI does not commit the U.S. 
Government to contract for any supplies or services or make a grant 
award. Further, we are not seeking proposals through this RFI and will 
not accept unsolicited proposals. We note that not responding to this 
RFI does not preclude participation in any future procurement, if 
conducted. It is the responsibility of the potential responders to 
monitor this RFI announcement for additional information pertaining to 
this request.
    HHS may or may not choose to contact individual responders. Such 
communications would be for the sole purpose of clarifying statements 
in written responses. Contractor support personnel may be used to 
review responses to this RFI. Responses to this notice are not offers 
and cannot be accepted by the Government to form a binding contract or 
issue a grant. Information obtained as a result of this RFI may be used 
by the Government for program planning on a non-attribution basis. This 
RFI should not be construed as a commitment or authorization to incur 
cost for which reimbursement would be required or sought. All 
submissions become U.S. Government property; and will not be returned.

    Dated: November 5, 2020.
Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services (HHS).
[FR Doc. 2020-25795 Filed 11-23-20; 8:45 am]
BILLING CODE 4150-28-P