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Home Health Agencies Used Multiple Strategies to Respond to the COVID-19 Pandemic, Although Some Challenges Persist, OEI-01-21-00110

Issuer
Office of Inspector General
Document type
Brief

Summary

An evaluation report by the U.S. Department of Health and Human Services Office of Inspector General, OEI-01-21-00110, dated October 2022, on how home health agencies (HHAs) responded to the COVID-19 pandemic. OIG surveyed a nationally representative sample of 400 HHAs, 396 of which participated in fall 2021, and interviewed 12 HHAs and CMS staff. The report finds that staffing challenges persist, that infection control challenges lessened by fall 2021, and that emergency preparedness plans fell short of fully addressing a global emergency. It recommends that CMS evaluate HHAs' telehealth use, evaluate how regulatory flexibilities affect quality of care, and work with ASPR TRACIE to update emergency preparedness trainings; CMS concurred with all three recommendations. Appendices cover flexibilities, survey responses and agency comments.

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U.S. Department of Health and Human Services

Office of Inspector General



Home Health Agencies Used
Multiple Strategies To
Respond to the COVID-19
Pandemic, Although Some
Challenges Persist




Ann Maxwell
Deputy Inspector General for Evaluation and Inspections
October 2022, OEI-01-21-00110
U.S. Department of Health and Human Services
Office of Inspector General
Report in Brief
October 2022, OEI-01-21-00110


Why OIG Did This Review                Home Health Agencies Used Multiple
The COVID-19 pandemic required
home health agencies (HHAs) to         Strategies To Respond to the COVID-19
adapt their care to respond to         Pandemic, Although Some Challenges
COVID-19’s infectious nature, as
well as other circumstances from       Persist
the pandemic. HHAs play an
important role in caring for                                                What OIG Found
Medicare beneficiaries: in 2020, the     Key Takeaway                       Like all health care providers, HHAs
first year of the COVID-19               Home health agencies (HHAs)        have experienced multiple
pandemic, HHAs cared for over            developed strategies to            challenges to providing care during
3 million beneficiaries. The Centers     respond to challenges during       the COVID-19 pandemic. HHAs
for Medicare & Medicaid Services         the COVID 19 pandemic,             have continued to experience
(CMS) requires HHAs to prepare for       including providing new            longstanding staffing challenges as
and respond to emergencies and,          incentives to maintain staff and   well as new ones resulting from the
during those emergencies, CMS can        seeking alternative sources of     pandemic, such as maintaining
offer regulatory flexibilities and       personal protective equipment.     staffing despite quarantine and
supports (which we refer to              HHAs have also benefited from      isolation protocols. These staffing
collectively as regulatory               CMS support, such as               challenges persist for many HHAs
flexibilities) for various               regulatory flexibilities and       despite efforts to address them. In
requirements. This report provides       expanded telehealth                addition, HHAs faced numerous and
insights into HHAs’ experiences that     allowances, but staffing           widespread infection control
will help stakeholders continue          challenges persist. In light of    challenges, including accessing
managing the response to COVID-          the expanded use of telehealth,    personal protective equipment
19 and prepare for future                more information is needed to      (PPE) to limit exposure and spread,
emergencies.                             determine its future use across    but these have mostly eased since
                                         different home health services.    early in the pandemic.
How OIG Did This Review
                                                                             HHAs’ own strategies to respond to
We surveyed a nationally
                                       the pandemic included offering paid leave to retain staff and finding PPE
representative sample of 400 HHAs,
                                       from nontraditional sources. HHAs have also benefited from government
396 of which participated in
                                       support—including regulatory flexibilities instituted in response to the
Medicare, in fall 2021 to ask about
                                       declaration of a public health emergency—and this support has
their experiences early in the
                                       mitigated some staffing challenges. For example, by the Federal
pandemic and at the time we
                                       government’s allowing new types of providers to certify and order home
administered the survey. We
                                       health services and complete certain patient assessments, HHAs could
projected our results to the 72
                                       more efficiently provide care. Telehealth flexibilities under the public
percent of Medicare-participating
                                       health emergency have also helped HHAs provide care while reducing
HHAs represented by our sample.
                                       COVID-19 exposure and dealing with staffing shortages. However, HHAs’
In addition, we interviewed 12
                                       challenges with telehealth raise questions about its future role in home
HHAs about notable challenges,
                                       health care, and—because of limited reporting requirements—CMS has
strategies, or other experiences
                                       limited insight into HHAs’ telehealth use. Finally, the emergency
they identified in their surveys. We
                                       preparedness plans required by CMS guided HHAs’ responses to the
also interviewed staff at CMS about
                                       pandemic but fell short of fully addressing a global emergency such as
its support of—and perspectives
on—HHAs’ provision of care during      COVID-19.
the pandemic.
What OIG Recommends and How the Agency Responded
CMS has an opportunity to assess how to best help HHAs prepare for
and respond to future emergencies, as well as to evaluate how changes
to the home health landscape can better serve patients. To that end, we
recommend that CMS evaluate how HHAs are using telehealth—
specifically, the types of services provided via telehealth and the
characteristics of patients who benefit from these services. We also
recommend that CMS—to inform decision-making—evaluate how the
regulatory flexibilities it has offered in response to the COVID-19 public
health emergency affect the quality of home health care. Finally, we
recommend that CMS—in collaboration with the Administration for
Strategic Preparedness and Response’s (ASPR’s) Technical Resources,
Assistance Center, and Information Exchange (TRACIE)—apply lessons
learned from the COVID-19 pandemic to update and/or develop
emergency preparedness trainings and materials for HHAs on
responding to infectious disease outbreaks. CMS concurred with all
three recommendations.
TABLE OF CONTENTS

BACKGROUND................................................................................................................................................ 1
FINDINGS.........................................................................................................................................................9
   Staffing challenges persist despite HHAs’ efforts to address them....................................................................... 9
   HHAs’ infection control challenges were numerous and widespread early in the pandemic, but these
   challenges lessened by fall 2021.......................................................................................................................................14
   Although most HHAs used telehealth during the pandemic, challenges that HHAs experienced raise
   questions about telehealth’s future role in home health ........................................................................................17
   Emergency preparedness (EP) plans guided HHAs’ response to the pandemic, but the plans fell short
   of fully addressing a global emergency such as COVID-19....................................................................................21
CONCLUSION AND RECOMMENDATIONS.......................................................................................... 25
   Evaluate how HHAs are using telehealth—specifically, the types of services provided via telehealth
   and the characteristics of patients who benefit from these services ..................................................................25
   To inform decision-making, evaluate how the regulatory flexibilities it has offered in response to the
   COVID-19 public health emergency affect the quality of home health care ...................................................26
   In collaboration with ASPR TRACIE, apply lessons learned from the COVID-19 pandemic to update
   and/or develop emergency preparedness trainings and materials for HHAs on responding to
   infectious disease outbreaks ..............................................................................................................................................27
AGENCY COMMENTS AND OIG RESPONSE ........................................................................................ 28
DETAILED METHODOLOGY...................................................................................................................... 29
APPENDICES.................................................................................................................................................. 31
   Appendix A: CMS Conditions of Participation (CoPs): Infection Prevention and Control ...........................31
   Appendix B: Regulatory Flexibilities and Supports for Home Health Agencies During the COVID-19
   Public Health Emergency (PHE) .........................................................................................................................................32
   Appendix C: Analysis of Nonresponse Bias...................................................................................................................36
   Appendix D: Home Health Agencies’ Responses to OIG’s Survey .......................................................................37
   Appendix E: Agency Comments ........................................................................................................................................44
ACKNOWLEDGMENTS AND CONTACT ................................................................................................ 49
   Acknowledgments ..................................................................................................................................................................49
   Contact........................................................................................................................................................................................49
ABOUT THE OFFICE OF INSPECTOR GENERAL.................................................................................... 50
ENDNOTES .................................................................................................................................................... 51
BACKGROUND

                    OBJECTIVES
                          1. To identify HHAs’ key challenges to providing patient care during the
                             COVID-19 pandemic.
                          2. To identify key strategies HHAs used to address the challenges presented by
                             COVID-19.



                    The emergence of the COVID-19 pandemic in early 2020 affected health care
                    organizations across the United States. Hospitals reported decreases in elective
                    surgeries, and nursing homes experienced devastating outbreaks among residents.
                    Home health agencies (HHAs) were likewise affected and have reported challenges
                    ranging from procuring personal protective equipment (PPE) to staffing shortages. 1, 2,
                    3
                      To continue to serve the millions of Americans who rely on home-based care during
                    the pandemic, both HHAs and the Federal government, including Congress and CMS,
                    took action to address COVID-19-related challenges. 4, 5, 6

                    CMS plays a pivotal role in supporting HHA preparations and responses to
                    emergencies, including emerging infectious disease outbreaks such as COVID-19. For
                    example, CMS has supported HHAs during the COVID-19 public health emergency by
                    offering regulatory relief for various requirements that HHAs must meet. CMS also
                    requires HHAs to incorporate internal processes and procedures to prepare for future
                    emergencies.

                    This study provides insights into HHAs’ perspectives on the challenges they
                    experienced during the first months of the COVID-19 pandemic up until the end of
                    2021, as well as the strategies they used to address these challenges. These strategies
                    include HHAs developing their own approaches to address specific challenges, using
                    emergency preparedness plans required by CMS, and using the flexibilities that the
                    government has offered during the COVID-19 public health emergency. These
                    insights will help CMS, HHAs, and other stakeholders continue managing the
                    response to COVID-19 and prepare for future emergencies to ensure that
                    beneficiaries receive needed care.

                    Home Health Agencies
                    HHAs provide skilled nursing and therapeutic services to patients in a home-based
                    setting. HHAs are a critical component of our health care system. They can provide
                    an alternative to inpatient health care settings, when appropriate and feasible.
                    Services that HHAs can provide include post-operative care, occupational therapy,
                    and chronic disease management. 7 Many home health services require hands-on

Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Background | 1
                    contact between staff and patients. For example, a physical therapist may test a
                    patient’s strength, balance, and coordination to assess rehabilitation needs. In
                    addition, a nurse may change a patient’s wound dressing and monitor for signs of
                    infection following an operation. 8 Home health may also include services that do not
                    necessarily require hands-on contact and may be completed remotely, such as
                    behavioral therapy or social services. 9

                    Beneficiaries must meet certain conditions to qualify for home health care coverage
                    under Medicare—for example, they must be homebound, which means that they have
                    trouble leaving home without assistance because of injury or illness or have a
                    condition such that leaving their home is medically contraindicated. 10 Prior to
                    receiving home health care, beneficiaries must also meet face to face with a doctor (or
                    other allowed health care provider) related to the primary reason for the home health
                    care. 11 Although beneficiaries must be homebound to be eligible for home health
                    services covered by Medicare, they do not need to be hospitalized prior to receiving
                    care. 12 In 2020, three-fourths of Medicare home health episodes were not preceded
                    by a stay at a hospital or post-acute care institution, and more than 11,400 HHAs
                    provided care to 3.1 million Medicare fee-for-service beneficiaries. 13

                    To qualify as an HHA and participate in Medicare, an HHA must demonstrate that it
                    meets regulatory health and safety requirements, or the Conditions of Participation
                    (CoPs). Each CoP covers a broad topic (e.g., emergency preparedness) and then is
                    further defined by a set of specific standards that HHAs must meet. 14, 15 To assess
                    compliance with CoPs, State survey and certification agencies and Accrediting
                    Organizations (as applicable) typically conduct onsite inspections, including observing
                    home visits, on behalf of CMS. 16, 17

                    Rural HHAs may experience different challenges to providing home health care
                    compared to HHAs in more populated settings. For example, rural HHAs’ patients
                    may be spaced farther apart, requiring more travel time between visits. Some
                    evidence also suggests that, early in the pandemic, rural HHAs experienced different
                    challenges responding to COVID-19 compared to HHAs located in urban settings.
                    This includes potential differences in access to PPE and proportion of patients with
                    COVID-19. 18

                    The COVID-19 Pandemic
                    The virus that causes the disease known as COVID-19 is highly contagious and can
                    cause symptoms including fever, cough, and shortness of breath. 19 COVID-19 can
                    sometimes result in severe illness leading to hospitalization or death. 20 The Centers
                    for Disease Control and Prevention (CDC) identified the first U.S. laboratory-confirmed
                    case of COVID-19 in the United States in Washington State on January 20, 2020, and
                    the disease has since spread nationwide. 21 On January 31, 2020, the Secretary of
                    Health and Human Services declared a public health emergency. 22 On March 11,
                    2020, the World Health Organization characterized COVID-19 as a pandemic,
                    indicating that COVID-19 had spread to several countries or continents, potentially


Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Background | 2
                    affecting a large number of people. 23, 24 On March 13, 2020, the President declared a
                    national emergency. 25

                    As of September 23, 2022, CDC had reported over 95 million cases in the United
                    States and over one million deaths. 26 Since COVID-19’s emergence within the United
                    States, rates of infection and death have varied over time and within different
                    geographic locations. Factors that can affect COVID-19 infection rates include
                    vaccination rates, population density, and the presence of more contagious variants
                    of the COVID-19 virus. 27, 28

                    HHA Care During the COVID-19 Pandemic
                    As the COVID-19 pandemic evolved, HHAs had to adapt their care to respond to
                    COVID-19’s infectious nature as well as other circumstances caused by the pandemic,
                    such as decreased staff availability. During the public health emergency, CMS has
                    offered HHAs regulatory relief for various CMS requirements to support HHAs’
                    response to the pandemic. Furthermore, CMS provided guidance to support HHAs in
                    meeting infection control and emergency preparedness requirements.

                    CMS Guidance on Infection Control. To protect patients and staff, CMS requires
                    HHAs to meet the CoP for infection prevention and control (hereinafter referred to as
                    infection control). This includes following widely accepted guidelines (e.g., hand
                    hygiene) to prevent transmitting infectious diseases as well as educating staff,
                    patients, and caregivers on preventing infections (see Appendix A). 29 During the
                    pandemic, CMS provided HHAs with additional suggestions to address COVID-19. In
                    March 2020, it issued guidance that outlined further infection control
                    recommendations, such as how to screen patients for COVID-19 and use PPE
                    appropriately. CMS also directed HHAs to CDC—with which CMS engaged
                    regularly—for further guidance on infection control for COVID-19. For example, to
                    help address emerging supply shortages due to global disruptions, CMS suggested
                    that HHAs contact local authorities and follow CDC guidelines for optimizing
                    supplies. 30

                    HHA Flexibilities During the Public Health Emergency. After declaring a national
                    emergency on March 13, 2020, the President directed the Secretary of Health and
                    Human Services to temporarily waive or modify certain Medicare requirements during
                    the public health emergency. 31, 32 (The Secretary had declared a public health
                    emergency on January 31, 2020.) Beginning in March 2020, CMS issued a series of
                    regulatory waivers and new rules to support HHAs during the public health
                    emergency. 33, 34 (In this report, we refer to regulatory flexibilities, waivers, and new
                    rules as flexibilities.) For example, CMS allowed HHAs additional time to submit
                    patient assessment information. CMS has continued to modify and add to these
                    flexibilities. These flexibilities are available to HHAs nationwide for the duration of the
                    public health emergency and target different aspects of home health care. 35, 36 See
                    Appendix B for a full list of the flexibilities.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Background | 3
                    The Coronavirus Aid, Relief, and Economic Security (CARES) Act (enacted on March 27,
                    2020) also included statutory changes to help HHAs provide care during the public
                    health emergency. Specifically, the CARES Act allowed additional types of providers
                    (nurse practitioners, clinical nurse specialists, and physician assistants) to certify
                    eligibility for home health care and order home health services. 37

                    Telehealth Flexibilities During the Public Health Emergency. Medicare telehealth
                    services refer to services that are provided remotely using technology between a
                    provider and a beneficiary. 38, 39 (Telehealth may also be referred to as telemedicine or
                    telecommunications technology.) Telehealth may include videoconferencing
                    (hereinafter, video) to conduct speech therapy visits; using a blood pressure cuff that
                    automatically sends information to a provider; or a phone call between a nurse and a
                    patient to discuss whether a patient’s worsening symptoms warrant an extra home
                    visit. 40, 41 For these technologies to qualify as telehealth, providers must use them to
                    improve a patient’s health care. 42 On the basis of this definition, CMS would not
                    consider administrative tasks, such as calling a patient to schedule an in-person
                    appointment, as telehealth. CMS specifies which services it considers telehealth as
                    covered under the Medicare home health benefit (i.e., Medicare does not cover all
                    uses of telehealth). 43, 44

                    The CARES Act directed the Department of Health and Human Services (HHS) to
                    encourage HHAs to use telehealth technology for services provided during the public
                    health emergency. 45 In response, CMS issued flexibilities that expanded HHAs’ ability
                    to use telehealth and thereby reduced infection risk. For example, CMS allowed HHAs
                    to perform certain Medicare-covered assessments and determine patients’
                    homebound status via telehealth or record review. 46 CMS also allowed the required
                    face-to-face encounter between a patient and authorized health care provider, who
                    certifies the patient as eligible for home care, to take place remotely. 47

                    In addition, effective on March 31, 2020, CMS permitted HHAs to use telehealth
                    technology services within the patient’s plan of care if these services are related to the
                    patients’ needs and do not replace needed in-person visits. 48, 49 CMS made this
                    regulatory change permanent effective January 1, 2021. (See Exhibit 1 for examples of
                    how HHAs can use telehealth—initially, limited to the duration of the public health
                    emergency, but now permanently.) 50 Although HHAs may choose to provide
                    telehealth services, HHAs cannot bill Medicare for telehealth services as equivalent to
                    an in-person visit—without a statutory change, CMS cannot directly reimburse HHAs
                    for telehealth services. 51 However, HHAs can report the costs of providing telehealth
                    services, such as the cost incurred to set up technology, as allowable administrative
                    and general costs within cost reports. 52, 53 HHAs submit cost reports to CMS each
                    year. CMS factors information reported within cost reports, including costs to provide
                    telehealth, into future Medicare payments to HHAs. 54




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Background | 4
                    Exhibit 1. Examples of how HHAs have been allowed to use telehealth under
                    the Medicare home health benefit, beginning with the COVID-19 public
                    health emergency*




                        Live video or audio visits between a                   Electronically transmitting health
                        patient and HHA provider                               information for a provider to access
                                                                               later
                        Examples include:
                                                                               Examples include:
                        • Assessing over video whether a
                                                                               • A heart rate monitor that
                          patient can move properly after a hip
                                                                                 automatically sends data to the HHA
                          surgery
                                                                                 every 30 minutes
                        • Calling to make sure that a patient
                                                                               • An HHA nurse who sends a visit
                          continues to take medication as
                                                                                 report to the patient's doctor via
                          prescribed
                                                                                 health application software for the
                        • Calling to determine whether a
                                                                                 doctor to evaluate at a later time
                          patient needs to visit their primary
                          care physician

                    * HHAs are also now able to provide these services under the Medicare home health benefit beyond the COVID-19
                    public health emergency.
                    Sources: HHS, What is telehealth?, June 29, 2022 (updated September 14, 2022); 55 CMS, COVID-19 Frequently Asked
                    Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing, updated January 7, 2021; 56 42 CFR § 409.46.


                    Since the start of the pandemic, CMS and other sources have reported a dramatic
                    increase in the use of telehealth by Medicare beneficiaries, including HHAs, from that
                    of prior years. 57, 58, 59 A previous OIG study found that Medicare beneficiaries used 88
                    times as many telehealth services during the first year of the pandemic (March 2020
                    through February 2021) as they used in the prior year. 60 However, in a recent report
                    to Congress, the Medicare Payment Advisory Commission noted that Medicare
                    beneficiaries and providers had some concerns about whether telehealth offered the
                    same quality of care as did in-person services. 61

                    CMS-Required Emergency Preparedness Plans. As of November 2017, CMS requires
                    HHAs, along with other types of providers, to meet the CoP for emergency
                    preparedness. 62 CMS includes four core elements in its emergency preparedness
                    requirements (see Exhibit 2). HHAs must review these elements and update them
                    every 2 years. 63, 64




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Background | 5
                    Exhibit 2. CMS requires emergency preparedness plans to include four core
                    elements.



                       m             Risk assessment
                                      and planning
                                                               HHAs must perform risk assessments using an all-hazards
                                                               approach, which considers those emergencies or disasters
                                                               that are most likely to occur. Individual HHA emergency
                                                               preparedness plans may therefore vary due to differences in
                                                               location (e.g., if an HHA is in a tornado-prone area).


                       II              Policies and
                                       procedures
                                                               HHAs must develop policies and procedures based on
                                                               components of the emergency p reparedness plan and risk
                                                               assessment, such as how to track patients and staff during
                                                               an emergency.


                       B             Communication
                                         plan
                                                               HHAs must develop emergency communication plans that
                                                               comply with Federa l and State laws. These plans must
                                                               include important contact information as wel l as methods
                                                               for sharing patient information during emergencies.


                       ($]             Training and
                                     testing program
                                                               HHAs must train staff and test their emergency plans via
                                                               drills.




                    Sources: CMS, “Emergency Preparedness Rule: What’s New based on the Medicare and Medicaid Programs; Regulatory
                    Provisions to Promote Program Efficiency, Transparency, and Burden Reduction Final Rule”; CMS, “Frequently Asked
                    Questions (FAQs): Emergency Preparedness Regulation,” January 2017. 65


                    As of 2019, CMS guidance on emergency planning instructs providers to include
                    emerging infectious diseases as part of their risk assessment’s all-hazards planning. 66
                    In March 2021, CMS updated that guidance to include additional information on
                    incorporating emerging infectious diseases into providers’ all-hazards planning. For
                    example, CMS added guidance on assessing PPE needs and screening patients,
                    among other considerations, during an infectious disease emergency. CMS also
                    suggested that providers develop policies to update their emergency preparedness
                    plans during emergencies that last longer than expected. 67

                    CMS directs HHAs to various resources to support emergency preparedness. For
                    example, CMS provides online training to health care providers on emergency
                    preparedness. 68, 69 CMS may also refer HHAs to the Administration for Strategic
                    Preparedness and Response’s (ASPR’s) Technical Resources, Assistance Center, and
                    Information Exchange (TRACIE), which periodically updates EP resources on its
                    website. 70

                    Related OIG Work
                    This study contributes to the Office of Inspector General’s (OIG’s) work on home
                    health care and on providers’ experiences during the COVID-19 pandemic. A 2021
                    OIG audit assessed infection control practices at eight HHAs and found that six HHAs’
                    infection control policies and procedures complied with CMS requirements and
                    COVID-19 guidance. 71 Another audit is underway to examine HHAs’ compliance with

Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Background | 6
                    CMS’s regulations for telehealth services—i.e., the regulations that were initially
                    limited to the duration of the public health emergency, but subsequently made
                    permanent. 72

                    Prior OIG home health work focused on unverified patient lists used in home health
                    surveys and common characteristics of HHAs and physicians found in OIG-
                    investigated cases of home health fraud. 73, 74 OIG has also conducted a series of
                    compliance audits of home health care providers. A complete listing of OIG’s
                    ongoing evaluations and audits is available in our online Work Plan at
                    https://www.oig.hhs.gov/.

                    Methodology
                    This study used the following data sources: (1) a survey of a random sample of HHAs;
                    (2) interviews with a purposive sample of 12 HHAs; and (3) an interview with CMS
                    staff.

                    Scope
                    This study focuses on Medicare-participating HHA experiences from early in the
                    pandemic to the point that OIG surveyed or interviewed HHAs in September through
                    December 2021. As part of the survey and interviews, we asked HHAs about
                    challenges experienced early in the pandemic and in fall 2021. We defined “early in
                    the pandemic” to mean when the respondent HHA’s geographic area experienced its
                    first wave of COVID-19 infection.

                    Data Sources and Analysis
                    Survey of HHAs. We administered a survey between September and November 2021
                    to a random sample of 400 HHAs asking about their experiences during the COVID-
                    19 pandemic. Of the 377 eligible Medicare-participating HHAs we surveyed, we
                    received responses from 271, a 72-percent response rate. 75 We analyzed the survey
                    data to determine challenges HHAs experienced during the pandemic; strategies they
                    used to address those challenges; and HHAs’ experiences with telehealth, emergency
                    preparedness plans, and regulatory flexibilities. We produce estimates from these
                    data to speak to the experiences of Medicare-participating HHAs represented by our
                    respondents. See Appendix C for a description of our nonresponse bias analysis.

                    To identify HHAs as rural, we used 2019 Medicare claims data to determine whether
                    HHAs provided services to Medicare beneficiaries in mostly rural counties. We
                    identified 41 HHA survey respondents as rural. We analyzed rural HHAs’ survey
                    responses to describe the experiences of rural HHAs in our sample and do not
                    generalize these responses to all rural HHAs.

                    Interviews with HHAs. We interviewed staff from a purposive sample of 12 HHAs in
                    November and December 2021. We asked HHAs about their experiences during the
                    COVID-19 pandemic on the basis of their responses to our survey. We selected HHAs



Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Background | 7
                    that indicated notable challenges, strategies, or other experiences during the
                    pandemic in their survey responses.

                    Interview with CMS. We conducted one interview with staff in CMS’s Center for
                    Clinical Standards and Quality and Center for Medicare regarding their perspectives
                    on HHAs’ experiences during the pandemic and the support provided to HHAs by
                    CMS. We conducted this interview on January 21, 2022.

                    See the Detailed Methodology on page 29 for additional information about our data
                    collection and analysis.

                    Limitations
                    We based our findings regarding HHAs on the information reported by HHAs in our
                    survey and during interviews. We did not independently verify the information HHAs
                    provided. We did not evaluate the effectiveness of the strategies HHAs reported
                    using to address challenges during the COVID-19 pandemic. Our results pertaining to
                    HHAs apply only to the population represented by the respondents and cannot be
                    generalized to all HHAs.


        Standards
                    We conducted this study in accordance with the Quality Standards for Inspection and
                    Evaluation issued by the Council of the Inspectors General on Integrity and Efficiency.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Background | 8
FINDINGS

        Staffing challenges persist despite HHAs’ efforts to address
        them
                    HHA staffing levels are important to ensuring that patients receive needed and high-
                    quality care. Understaffed HHAs may be not able to send health care providers to
                    patients’ homes to the extent required in each patient’s plan of care. HHAs without
                    enough staff may also struggle to accept new patient referrals, which could affect
                    beneficiaries’ access to home health care.

                    The pandemic exacerbated longstanding staffing challenges for
                    HHAs and added new ones
                   The COVID-19 pandemic further strained HHAs’ ability to hire and keep staff (see
                   Exhibit 3). HHAs described longstanding (i.e., pre-pandemic) challenges retaining and
                                                          recruiting staff, including positions that
                                                          remain vacant because candidates either do
        “We have [an] already tight market and a          not apply or do not qualify for the position.
                                                          These challenges extended into the
        limited number of nursing professionals living
                                                          pandemic. According to many HHAs,
        in this area, staffing is always an issue. In the
                                                          challenges early in the pandemic included
        light of the pandemic, [it has] made the nurse    difficulty recruiting new clinical staff due to
        shortage even more noticeable and                 increased competition from other health care
        challenging.” – Senior HHA staff                  facilities or contract agencies (71 percent)
                                                          and staff leaving to work for these facilities
                                                          and contract agencies (51 percent). Two
                                                          HHAs noted difficulty in recruiting and
                   retaining staff because other companies offered higher wages.

                    In addition to longstanding staffing challenges that were exacerbated by the
                    pandemic, many HHAs faced challenges that emerged as a result of the COVID-19
                    pandemic (see Exhibit 3). Most HHAs (85 percent) had early challenges with limited
                    staff due to personal circumstances related to the pandemic, such as school closures,
                    or because of self-quarantine/isolation requirements. About half of HHAs struggled
                    early in the pandemic to pay contracted clinical staff due to higher contracting costs.
                    Finally, three HHAs that we interviewed also noted challenges with staff uneasiness
                    with caring for COVID-19 patients, which may have resulted in these patients not
                    receiving care or overburdening the staff willing to care for COVID-19 patients. Rural
                    HHAs that responded to our survey also experienced several of these same
                    longstanding and COVID-19-specific challenges. For example, 39 of 41 rural HHAs



Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                           Findings | 9
                    reported challenges with limited staff availability to work because of a COVID-19
                    exposure.




     HHAs told us that staffing challenges made it difficult to complete patient visits and
     accept new patients:
     “We could not accept some referrals due to staffing challenges.” – Senior HHA staff
     “When schools closed [we] had to discharge clients.” – Senior HHA staff
     “We had the potential to see a lot of patients, but we didn’t always have the staff.” – Senior
     HHA staff



                    According to many HHAs, both longstanding and new staffing challenges persist,
                    despite some improvement over the period of our review (see Exhibit 3). For example,
                    in fall 2021, 62 percent of HHAs still experienced challenges with recruiting new staff
                    due to competition from other facilities or health care contract agencies, and 40
                    percent still struggled with staff leaving to work for other health care facilities.
                    Moreover, many HHAs continued to struggle with challenges that emerged due to the
                    pandemic. Despite some improvement, about half of HHAs still experienced
                    challenges with limited staff availability due to personal circumstances related to the
                    pandemic or because of self-quarantine/isolation requirements. In addition, HHAs
                    found that the challenge of paying contracted clinical staff—a challenge stemming
                    from higher contracting costs during the pandemic—decreased only slightly from
                    early in the pandemic; 44 percent of HHAs struggled with this in fall 2021.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 10
Exhibit 3. Many HHAs continued to experience staffing challenges well into the pandemic.*

                                                Early in the pandemic                      Fall 2021
                                                When an HHA 's area experienced            September 21 to November 22,
                                                its first wave of COV/O-19                 2021

   Recruiting new clinical staff due to
   increased competition from other                       71 %                                       62%
              health care providers**

     Clinical staff leaving this HHA to
            work for other health care
                            providers**
                                                      51 %
                                                                                           ..
      Paying contracted clinical staff
     due to higher contracting costs
               during the pandemic

     Limited staff availability to work
         because of self-quarantine/
          isolation due to COVID- 19
                                                                                           -       55%
                              exposure

     Limited staff availability to work
      due to personal circumstances                                                                55%
             related to the pandemic

      ■ Longstanding staffing challenges             ■ COVID-19 specif ic staffing challenges
* All differences between the two time points are significant at the 0.05 level (n=271). See Appendix D for more details.
** These providers may include health care contract agencies or other health care facilities, such as hospitals.
Source: OIG analysis of survey data, 2022.




                        Although none of the challenges were fully resolved by fall 2021,
                        HHA-developed strategies and CMS flexibilities helped HHAs to
                        mitigate some staffing challenges
                        HHAs developed their own strategies to ensure that patients received care despite
                        staffing challenges (see Exhibit 4). Many HHAs found it useful to assist staff with
                        addressing COVID-19-related concerns, including by providing paid or unpaid leaves
                        of absence (65 percent) or benefits, such as flexible schedules (59 percent). Nearly as
                        many (58 percent) also benefited from training staff to perform tasks outside of their
                        usual duties, such as administrative work or duties in a different clinical area. In
                        addition, 40 percent of HHAs created and found it helpful to have specialized care
                        teams of clinical staff who only treat COVID-19 patients. For example, one HHA that
                        we interviewed created COVID-19 care teams composed of staff who volunteered to
                        see those patients. Furthermore, HHAs reported using COVID-19 relief funds, such as
                        the Provider Relief Fund, to recruit and maintain staff. 76 Two HHAs that we
                        interviewed used these funds to pay staff who were unable to work because of the


Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 11
                         pandemic, and two HHAs used the funds to offer hazard pay. However, another two
                         HHAs that we interviewed noted that using financial support to recruit new staff, such
                         as with signing bonuses, had limited effectiveness because of the lack of candidates
                         applying for open positions.



Exhibit 4. HHAs used and found helpful various strategies that they developed to respond to
staffing challenges during the pandemic.*
   Provided paid and/or unpaid leaves of absence to
                 retain staff that are unable to work
                                                                      - - -•
          Provided staff benefits to address COVI D-19-
                                       related concerns               ---•
  Trained staff to perform tasks outside of their usual
                                                 duties
                                                                      ---•
   Created specialized care teams of clinical staff who
                         treat only COVID-19 patients

           Developed new partnerships or used existing
            partnerships with other HHAs or health care - - - - -•
               facilities to share staff to fil l staffing gaps
                                                                      --•                   ·.



* Surveyed HHAs also had the option to indicate if they used a strategy and did not find it helpful or if they did not use the strategy (see
Appendix D).
Source: OIG analysis of survey data, 2022.



                         In addition to developing their own strategies, HHAs relied on flexibilities that CMS
                         offered to help address staffing challenges (see Exhibit 5). CMS told us that it offered
                         flexibilities that increased time for staff to complete certain assessments and relaxed
                         training requirements to help with staffing constraints. About half of HHAs found
                         each of these helpful (54 percent and 41 percent, respectively). As required by
                         provisions in the CARES Act, CMS permanently amended regulations to authorize
                         nurse practitioners and physician assistants to certify and order home health services
                         in addition to physicians. HHAs told us that it made it easier and faster to admit new
                         patients. One HHA that we interviewed said that this flexibility was “huge” in getting
                         orders for home health services signed and implemented. CMS also expanded the
                         types of HHA staff who may perform initial and comprehensive patient assessments
                         to include occupational therapists (OTs), in addition to registered nurses, physical
                         therapists (PTs), and speech language pathologists (SLPs). 77 Three HHAs that we
                         interviewed told us that this flexibility helped them admit and assess patients more
                         quickly when staffing resources were stretched thin. (See Appendix B for a summary
                         of CMS flexibilities, including their status as of summer 2022.)


Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 12
                          Although CMS has taken actions to ease HHAs’ staffing challenges, it has limited
                          information on how these flexibilities have affected HHAs’ care. In March 2021, CMS
                          issued an update to the State Operation Manual’s Appendix Z—Emergency
                          Preparedness Interpretive Guidelines—to provide additional guidance for the
                          requirement that HHAs have policies and procedures that address emergency staffing
                          strategies. However, HHAs have discretion on which staffing strategies they use
                          during an emergency.

                          CMS receives feedback on the flexibilities via regular and ad hoc engagements with
                          HHA stakeholders. For example, stakeholders have told CMS that the flexibilities are
                          helpful and needed until the end of the COVID-19 public health emergency. CMS
                          told us that it used feedback from stakeholder engagements to inform decision-
                          making on which flexibilities to make permanent. However, CMS is not systematically
                          collecting data to capture how HHAs are using or benefiting from flexibilities that
                          aimed to help with staffing challenges or how flexibilities have affected the quality of
                          patient care.



Exhibit 5. HHAs used and found helpful the various flexibilities that CMS provided for them
to respond to staffing challenges during the COVID-19 public health emergency.*




                                                                           - - -•
            Authorizing additional practitioners to certify
            beneficiaries for eligibility, order home health
          services, and establish and review the care plan


            Allowing OTs, PTs, and SLPs to perform certain
             assessments for all patients receiving therapy
                                                    services               - -•
    Extending the 5-day completion requirement for the
                 comprehension assessment to 30 days
                                                                           - -•
     Waiving the requirement for onsite visits by a nurse
                                          every 2 weeks
                                                                           --•
               Postponing the deadline for certain training
                      requirements for home health aides
                                                                           - •
* Surveyed HHAs also had the option to indicate if they used a flexibility and did not find it helpful or if they did not use the flexibility (see
Appendix D).
Source: OIG analysis of survey data, 2022.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 13
        HHAs’ infection control challenges were numerous and
        widespread early in the pandemic, but these challenges
        lessened by fall 2021
                    Because of COVID-19’s infectious nature, HHAs had to quickly pivot to continue to
                    provide needed care while also protecting patients and staff. Limiting the spread of
                    disease requires an understanding of how to prevent transmission and how to
                    appropriately care for infected patients. Enhanced infection control also requires
                    adequate levels of supplies, particularly PPE. However, limited knowledge of COVID-
                    19 as well as disrupted supply chains impeded HHAs’ ability to carry out these
                    important tasks early in the pandemic.

                    Early on, HHAs struggled to understand and navigate infection
                    control for COVID-19; they relied on government guidance,
                    trainings, and new protocols to help address this
                   According to HHAs, it was a challenge to mitigate transmission and care for COVID-19
                   patients at the beginning of the pandemic (see Exhibit 6). Because COVID-19 was a
                   novel disease, information regarding how to care for patients was limited and evolved
                   as understanding of the virus grew. Indeed, early in the pandemic, most HHAs (87
                   percent) experienced challenges with navigating evolving guidance about how to
                   treat COVID-19 patients. Four HHAs that we interviewed also described struggling to
                                                    interpret changing guidance to inform their infection
                                                    control protocols (e.g., changes in appropriate PPE
         “Having to research and determine
                                                    use and post-exposure quarantine requirements). In
         what information to base [p]olicies on     addition, 88 percent of HHAs experienced challenges
         has been very time consuming.”             with unclear and conflicting Federal and/or State
         – Senior HHA staff                         government guidance about COVID-19 infection
                                                    prevention and control. Likewise, most rural HHAs
                                                    that responded to our survey (34 of 41) reported
                                                    experiencing this challenge. HHAs described having
                   to devote sometimes substantial resources to researching government websites to
                   develop infection control protocols. These challenges with guidance affected patient
                   care: 56 percent of HHAs postponed caring for patients with positive COVID-19
                   diagnoses until they had adequate infection control procedures in place.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 14
Exhibit 6. Most HHAs experienced challenges with understanding and navigating infection
control information early on, although these challenges have decreased.*

                                                       Early in the pandemic                     Fall 2021
                                                       When an HHA 's area experienced           September 27 to November 22,
                                                       its first wave of COV/0- 79               2027
   Unclear State/Federal guidance about
         how to treat COVI D-19 patients                            89%

     Unclear or conflicting State/Federal
    guidelines about COVID-19 infection                             88%
                 prevention and control

     Navigating evolving guidance about
         how to treat COVI D- 19 patients
                                                                    87%
                                                                                                i!fi
* All differences between the two time points are significant at the 0.05 level (n=271). See Appendix D for more details.
Source: OIG analysis of survey data, 2022.



                        HHAs attempted to mitigate challenges with infection control while their
                        understanding of COVID-19 increased. In addition to continuing to comply with the
                        CoPs for infection prevention and control (see Appendix A), the COVID-19 pandemic
                        required HHAs to take further action to address COVID-19 infection challenges. From
                        the perspective of HHAs, nearly all (97 percent) found it helpful to use available
                        information to develop internal COVID-19 protocols, which can include information
                        on how to respond to an exposure. Moreover, nearly all HHAs found it helpful to
                        increase or improve trainings for staff on COVID-19 treatment (95 percent) and
                        provide staff with PPE training (96 percent). Although HHAs struggled with infection
                        control information early in the pandemic, HHAs still accessed and relied on
                        government sources, including CDC guidance, to inform protocols for minimizing
                        transmission.

                        Nearly all HHAs faced challenges with accessing PPE and other
                        critical supplies to control the spread of COVID-19 early in the
                        pandemic, but these challenges eased over time
                        PPE and sanitizing products are essential for infection control. Their widespread
                        shortages early in the pandemic posed
                        challenges to safely caring for patients (see
                        Exhibit 7). According to HHAs, over 90             “[We] [n]ever thought that we
                        percent faced early challenges with accessing      would not be able to obtain PPE.”
                        supplies such as masks, other types of PPE,                          – Senior HHA staff
                        and sanitizing products (e.g., sanitizing wipes,


Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 15
                        hand sanitizer). Nearly all rural HHAs that responded to our survey also experienced
                        these challenges early in the pandemic: 37 with accessing masks, 37 with accessing
                        other types of PPE, and 38 with accessing sanitizing products (of the 41 rural HHAs
                        that responded to our survey). These challenges with accessing supplies came at a
                        time when HHAs needed to use more supplies than ever to protect patients and staff
                        from COVID-19 infection. One HHA that we interviewed described its limited access
                        to supplies early in the pandemic as “absolutely horrific.”


Exhibit 7. Almost all HHAs struggled with accessing supplies early on, but these challenges
lessened over time.*
                                                Early in the pandemic                          Fall 2021
                                                When an HHA 's area experienced its           September 21 to November 22,
                                                first wave of COV/D- 19                       2021

                        Access to masks                          93%


       Access to other types of PPE                              91%


       Access to sanitizing products                              94%


         High cost of PPE during the
                                                                89%                                 42%
                           pandemic



* All differences between the two time points are significant at the 0.05 level (n=271). See Appendix D for more details.
Source: OIG analysis of survey data, 2022.


                        Until supply chains stabilized, HHAs had to take unprecedented steps to address
                        limited supply access. Over half (57 percent) found it helpful to conserve PPE, such as
                        by re-using PPE normally meant for single use or by prioritizing PPE for the highest-
                        risk activities. In addition, almost half (42 percent) of HHAs found it helpful to
                        develop new, or use existing, partnerships with other HHAs or providers to obtain or
                        pool supplies. Finally, some
                        HHAs (31 percent) found it
                        helpful to access PPE through       “Some of my staff and myself [sic] went to stores to try
                        nontraditional sources, such                   and find 90% alcohol to clean our equipment. We
                        as nail salons. One HHA that                   made [a]lcohol wipes out of industrial paper towels, we
                        we interviewed characterized                   went to hardware stores to get N95 masks.”
                        its activities to access scarce
                                                                       – Senior HHA staff
                        supplies as follows: “we
                        [HHAs] were just doing what
                        we all could to survive.”



Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 16
        Although most HHAs used telehealth during the pandemic,
        challenges that HHAs experienced raise questions about
        telehealth’s future role in home health
                    CMS implemented telehealth flexibilities for many types of providers during the
                    COVID-19 public health emergency, including flexibilities for HHAs. Indeed, as HHAs
                    struggled with shortages of staff and supplies due to COVID-19, telehealth provided
                    an opportunity to safely care for patients while reducing risk of infection. CMS
                    updated regulations in November 2020 to permanently allow HHAs to use telehealth
                    as part of their patients’ plans of care, even after the public health emergency ends. 78
                    This regulatory change makes it vital to understand how HHAs use telehealth and its
                    potential effects on patient care.

                    HHAs used telehealth to provide a variety of services to patients
                    during the pandemic, including phone calls for status checks and
                    video visits for therapy services
                                Most HHAs (73 percent) used telehealth during the pandemic and used



     73%
                                it to conduct visits, share information, and facilitate interactions with
                                outside providers. Of the HHAs that used telehealth, just over three-
                                quarters (78 percent) provided live video or audio visits during the
                                pandemic (see Exhibit 8). 79 Three HHAs that we interviewed noted that
     of HHAs used telehealth    remote visits were particularly useful because of COVID-19’s infectious
     during the pandemic        nature. For example, HHAs were able to provide services to patients
                                who did not want providers in their homes, especially early in the
                                pandemic. HHAs also described using telehealth to supplement care,
                  such as through status checks for
                  patients with chronic illnesses or COVID-
                  19. One HHA told us that it made “daily         “[Telehealth] helped us keep patients
                  phone calls to active COVID patients who
                                                                  seen when they needed visits and keep
                  were under quarantine to assess the
                  need for an in-person visit.” Notably,          them home and healthy.”
                  two HHAs that we interviewed told us            – Senior HHA staff
                  that telehealth was useful for continuing
                  to provide patient care despite staffing
                  challenges.

                    Although Medicare does not cover this use of telehealth under the home health
                    benefit, nearly two-thirds of HHAs (63 percent) helped patients set up or participate in
                    telehealth services with a non-HHA provider such as a physician. HHAs described
                    using telehealth to facilitate remote communication with physicians and to meet
                    certain requirements for home health care. For example, one HHA that we surveyed
                    wrote that it “assisted patient[s] with telehealth visits with their physicians by setting
                    up appointments and having a clinician with them to report specific vital signs and

Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 17
                    other symptoms.” Furthermore, half of the HHAs we interviewed reported that they
                    would facilitate video calls between patients and physicians that, prior to the public
                    health emergency, were required to be conducted in person.

                    Just under half of HHAs (44 percent) electronically transmitted health information to
                    health care providers within and/or outside of the HHA. This may include
                    electronically sending information for a health care provider to later assess. HHAs
                    also reported using telehealth for remote patient monitoring, which involves leaving
                    equipment such as heart rate monitors with patients so that the HHA can continue to
                    monitor vital signs. One HHA that we surveyed told us that it used this for “vital sign
                    assessments for heart failure or other chronic conditions.”

                    Exhibit 8. HHAs used telehealth for different purposes during the
                    pandemic.*

                                           Live, real-time services between a patient and a provider (in the HHA)
                                           HHA providers helping patients set up or participate in telehealth services with
                                           a provider outside of the HHA
                                           Electronically transmitting patient health information to a provider for their
                                           assessment at a different time




                * Among HHAs that used telehealth during the pandemic.
                Source: OIG analysis of survey data, 2022.




                    Challenges using telehealth in home health care may limit its
                    future use
                    From the perspective of many HHAs that used telehealth during the pandemic,
                    providing telehealth services often came with challenges (see Exhibit 9). Some
                    challenges were due to limitations with delivering telehealth services. For example,
                    home-based telehealth requires the patient’s home to have access to phone service,
                    internet, and equipment (such as a smartphone). About two-thirds of HHAs found
                    that insufficient internet access in patients’ homes was a challenge, and five HHAs that
                    we interviewed told us that patients struggled with accessing phone service and
                    equipment. In addition, almost two-thirds of HHAs found that most home care
                    services require physical contact with patients, such as providing wound care, which


Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 18
                        may affect the quality of care provided using telehealth. Three HHAs that we
                        interviewed noted that assessing patients, for example to evaluate mobility when a
                        patient is walking, is difficult to do over video. Other HHAs said that patients may be
                        less capable of taking their own vital signs, such as blood pressure or heart rates, than
                        are health care professionals. As a result, one HHA that we interviewed told us that
                        self-reported health information, whereby patients assess their own vital signs and
                        symptoms and communicate them to the HHA, “doesn’t reflect the real situation or
                        condition of the patient… [W]e can’t get an accurate picture of our patient because of
                        those limitations.”

                        According to HHAs, they also experienced financial challenges with using telehealth
                        (see Exhibit 9). Almost half of HHAs (44 percent) struggled with the high cost of
                        telehealth. HHAs cannot bill Medicare for telehealth services as equivalent to an in-
                        person visit, and two-thirds of HHAs found that this lack of direct reimbursement was
                        a challenge. HHAs that we interviewed told us that lack of direct reimbursement
                        meant they could not afford to use telehealth more frequently. For example, three
                        HHAs that we interviewed noted that setting up and using telehealth, including
                        purchasing the required equipment, is costly.

Exhibit 9. HHAs that used telehealth during the pandemic experienced challenges in
providing telehealth services.

             Lack of direct reimbursement for                                        •
                            telehealth services - - - - - - - - - - - - - - - - - - - ·: · ·

      Insufficient internet access in patients'
                                       homes

      Requirement for physical contact with
                                                  ----•
                                                  ----•
                                                  - -•
                      patient for most care
            High cost of providing telehealth
                                      services

       ■ Challenges due to limitations            ■ Challenges due to financial
         delivering telehealth services             concerns

Source: OIG analysis of survey data, 2022.


                        Rural HHAs may experience greater challenges providing telehealth services
                        compared to HHAs in other settings. Of the 31 rural HHAs that responded to our
                        survey and used telehealth during the pandemic, 25 identified insufficient internet
                        access as a challenge. HHAs serving patients in rural settings reported that their
                        patients often live in locations with limited or no cellular service or internet access and
                        have limited access to equipment necessary to facilitate telehealth services. One rural
                        HHA that we surveyed told us: “We can't provide [t]elemedicine to patients unless
                        there is adequate equipment in the home. In rural eastern Washington state, there is



Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 19
                    often not. There is also often not internet or cell phone service in the home, making
                    [t]elemedicine impossible.”




                                                                                 43%
                    HHAs that used telehealth during the pandemic
                    were divided on whether they plan to continue
                    using it after the pandemic, although government
                    support to overcome challenges may influence
                    this. Of the HHAs that used telehealth during the
                    pandemic, 43 percent anticipated that they will         of HHAs that used telehealth
                    not use it afterwards. HHAs said that they              during the pandemic will not
                    temporarily relied on telehealth to help address        use it afterwards
                    pandemic-specific challenges, such as monitoring
                    high-risk COVID-19 patients or delivering services to patients who do not want
                    providers in their homes. Almost half of the HHAs we interviewed told us that there is
                    limited incentive to provide telehealth services, including after the pandemic, but that
                    they might reconsider if they received direct reimbursement for these services.

                    On the other hand, over half (57 percent) of HHAs that used telehealth during the
                    pandemic anticipated that they will continue to use telehealth after the pandemic,
                    including in ways that incorporate lessons learned. For example, one HHA that we
                    interviewed created a more detailed telehealth-based virtual assessment for patients
                    it considered at higher risk for rehospitalization, including COVID-19 patients. HHAs
                    also acknowledged that although telehealth is not appropriate for all HHA-based
                    care, telehealth may be better suited to certain home health services. One HHA that
                    we surveyed told us that it thought CMS should reimburse HHAs for telehealth
                    services that supplement in-person care: “provide reimbursement for virtual skilled
                    nursing visits with patients as an adjunct to in-person visits (not as a replacement).
                    This could minimize rehospitalizations.”

                    CMS lacks full insight into HHAs’ use of telehealth due to limited
                    reporting requirements
                    HHAs report limited information about their telehealth use to CMS. CMS requires
                    HHAs to report the direct costs of providing telehealth on their cost reports, but these
                    do not include further detail on the types of services for which HHAs use telehealth. 80
                    HHAs cannot bill Medicare for telehealth visits as comparable to in-person visits and
                    are currently not required to report telehealth use on their claims. Therefore, CMS is
                    unable to capture specific details on the extent and nature of how HHAs use
                    telehealth. CMS told us that these limitations affect the extent to which CMS can
                    evaluate and review HHAs’ telehealth use. For example, CMS cannot track the
                    frequency with which HHAs use telehealth over time or the types of services they
                    provide with telehealth.

                    CMS plans to assess available information on HHAs’ telehealth use and to explore
                    options to gather additional information. For example, in a calendar year (CY) 2021
                    final rule, CMS allowed HHAs to include remote patient monitoring and other

Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 20
                    telehealth technology within cost reports as allowable administrative and general
                    costs. CMS plans to assess these data when it receives those cost reports. 81 In June
                    2022, CMS issued a CY 2023 proposed rule allowing HHAs to voluntarily report
                    telehealth use on claims starting January 2023. 82 The proposed rule, if enacted, will
                    require this information by July 2023. However, Medicare could not directly
                    reimburse these services without a change in statute. CMS is also soliciting
                    comments on how it intends to capture telehealth use on claims as well as on the
                    appropriateness of telehealth in the home health context. Currently, CMS also
                    engages with HHAs and other stakeholders on both a regular and as-needed basis
                    and may receive feedback on telehealth through these engagements. CMS
                    acknowledges the importance of gaining a more complete picture of HHAs’ telehealth
                    use to inform future decision-making.


        Emergency preparedness (EP) plans guided HHAs’ response to
        the pandemic, but the plans fell short of fully addressing a
        global emergency such as COVID-19
                    CMS requires that HHAs conduct risk assessments to inform their EP plans. Risk
                    assessments must use an all-hazards approach to consider a broad range of
                    emergencies that may affect the HHA and its patient population. HHAs have wide
                    latitude to determine the contents and structure of their EP plans. Because each risk
                    assessment is specific to the HHA, EP plans vary on the basis of emergency scenarios
                    HHAs identify and how HHAs plan to address these emergencies. This includes
                    determining how to include emerging infectious diseases as part of their all-hazards
                    risk assessment, as required by CMS in 2019.

                    Almost all HHAs with EP plans found them helpful with
                    responding to the challenges of the COVID-19 pandemic
                    Nearly all HHAs (98 percent) that had an EP plan during the pandemic benefited from
                    these plans, including with challenges related to infection control guidelines and
                    accessing supplies (see Exhibit 10). Notably, 91 percent of HHAs with an EP plan
                    during the pandemic found the plan to be helpful with addressing infection control
                    challenges. One HHA that we interviewed told us that, prior to the pandemic, its EP
                    plan included infection control guidelines based on other infectious diseases such as
                    influenza and severe acute respiratory syndrome. Although these guidelines were not
                    specific to COVID-19, they were helpful for reducing its transmission. In addition, 81
                    percent of HHAs that had an EP plan found them to be helpful with addressing supply
                    challenges. For example, one HHA we spoke with explained that its local health and
                    emergency departments became important resources for help with supplies when it
                    was faced with pandemic-related shortages. That HHA developed relationships with
                    those entities prior to the pandemic through emergency drills required by CMS.



Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 21
Exhibit 10. HHAs that had EP plans during the pandemic found these EP plans helpful.



                                             Helpful overall                                        98%


  Helpful responding to challenges with infection
                                                                                                  91%
                                          control


   Helpful responding to challenges with supplies                                           81%


     Helpful responding to challenges maintaining
                                                                                        74%
                              appropriate staffing


Source: OIG analysis of survey data, 2022.


                        About three-quarters (74 percent) of HHAs also found their EP plans to be helpful
                        with addressing staffing challenges. A couple of HHAs that we interviewed described
                        how their plans supported their responses by outlining each staff member’s
                        responsibilities during an emergency. According to one HHA, “if we didn’t have an
                        emergency management infrastructure in place I don’t know if we would have had as
                        effective of a response. Everyone knew their roles.”

                        Because HHAs’ EP plans generally focused on local, temporary
                        emergencies, many fell short in a sustained, global emergency
                        Although EP plans provided a useful framework



                                                                              51%
                        for responding to the pandemic, about half of
                        HHAs that had an EP plan found it challenging
                        that their EP plans were more suitable to a local

                                                                              of HHAs with an EP plan found it
            “It’s not like a fire, or earthquake, that hits a                 challenging that their plan was
            certain area or population and you use your                       more suitable to a local emergency
            EP to get through it, clean up the aftermath                      than to a national or global
                                                                              emergency such as COVID-19
            and move on. This pandemic is a disaster like
            no other, that has infiltrated every aspect of       emergency than to a national or global
                                                                 emergency such as COVID-19. CMS
            society…” – Senior HHA staff
                                                                 instructed HHAs to include emerging


Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 22
                    infectious diseases in its 2019 EP plan guidance, and 93 percent of HHAs did so
                    before the pandemic. However, nearly half of the HHAs we interviewed told us that
                    their plans focused on emergencies that were more likely to affect their geographic
                    area, such as weather events. One HHA described how its plan included information
                    on responding to hurricanes, including contacting patients to determine plans for
                    evacuation, but noted that this did not prepare it for COVID-19. Another HHA said
                    that its EP plan did not originally cover situations in which staff could not enter
                    patients’ homes, as was the case during the COVID-19 pandemic. This HHA said that
                    prior to the pandemic, it had not considered emergency preparedness “on a global
                    platform.”

                    HHAs adjusted their emergency planning to respond to COVID-19
                    and identified how CMS could further help them with this
                    planning
                    To support their COVID-19 response, HHAs developed new, separate response plans
                    as well as adjusting their existing EP plans. In fact, 85 percent of HHAs developed a
                    separate response plan specific to COVID-19. These plans, which CMS does not
                    require, included information on testing staff and patients for COVID-19, treating
                    patients with COVID-19, and work-from-home policies, among other information.
                    One HHA that we interviewed described a flow chart included in its COVID-19 plan
                    that guides staff through determining whether an employee should isolate or
                    quarantine after an exposure. In addition, as of fall 2021, almost all HHAs (97 percent)
                    modified or planned to modify their existing EP plans to apply lessons learned during
                    the pandemic. For example, one HHA that we interviewed updated its EP plan to
                    include screening questions about whether patients had been exposed to any
                    infectious disease, such as influenza. Another updated the supply policy in its EP plan
                    to maintain a 90-day reserve of new supplies.

                   HHAs expressed that they would benefit from more support from CMS on developing
                   and using their EP plans to meet the challenges of an infectious disease emergency.
                                                            Of the HHAs that responded to our question,
                                                            two-thirds (67 percent) said that CMS could
                                                            better support HHAs by providing more
           One senior HHA staff member
                                                            information on the content and
           recommended that CMS provide
                                                            implementation of these EP plans during an
           “designated training for HHAs to follow as       infectious disease emergency. For example,
           guides for infectious disease emergencies        one HHA suggested that CMS provide
           that are at a national or global level.”         examples of guidelines that other HHAs used
                                                            and found helpful when responding to an
                                                            emerging infectious disease. Another HHA
                                                            we surveyed requested that CMS provide
                   more training on using EP plans to respond to an emerging infectious disease
                   emergency.


Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 23
                    Amidst the COVID-19 public health emergency, CMS has taken steps to help HHAs
                    with their EP plans. In March 2021, CMS issued updated guidance for EP plans and
                    prompted HHAs to include more information on emerging infectious diseases. CMS
                    also told us that it plans to solicit and use feedback from providers, including HHAs,
                    about their experiences during the public health emergency to make future changes
                    to this guidance. Finally, CMS told us that it coordinates with ASPR TRACIE to offer
                    HHAs additional guidance on emerging infectious diseases, including COVID-19.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                          Findings | 24
CONCLUSION AND RECOMMENDATIONS

                    The COVID-19 pandemic presented substantial challenges for HHAs and their
                    capacity to care for patients. The challenges included the novel nature of the
                    virus, as well as challenges with staffing, infection control, supply shortages,
                    and emergency planning, among others.

                    HHAs and CMS took steps to address these challenges as knowledge
                    regarding the pandemic evolved. The regulatory flexibilities that CMS offered
                    helped HHAs as they grappled with how to respond to the COVID-19
                    pandemic. HHAs used telehealth to fill gaps in their capacity to provide
                    services and adjusted their emergency plans, in addition to other
                    actions. Indeed, as knowledge about the virus increased, supply chains
                    stabilized, and HHAs took steps to continue caring for patients, some of the
                    earliest challenges abated.

                    However, HHAs’ experiences responding to the pandemic point to continued
                    challenges. With HHAs using telehealth in new ways, questions have emerged
                    about whether and how it can best serve beneficiaries in the home health
                    realm. In addition, staffing challenges—which were also present prior to the
                    pandemic—persist, despite HHAs’ use of regulatory flexibilities and their own
                    efforts to address staffing.

                    As the immediacy of the pandemic lessens, CMS has an opportunity to assess
                    how to best help HHAs prepare for and respond to current and future
                    infectious disease outbreaks. Furthermore, changes to the home health care
                    landscape, including expanded telehealth allowances, merit further study to
                    understand how these changes best serve patients.

                    To that end, we recommend that CMS:


        Evaluate how HHAs are using telehealth—specifically, the
        types of services provided via telehealth and the
        characteristics of patients who benefit from these services
                    CMS could use such an evaluation to refine its approach to telehealth in the
                    home health environment. With CMS permanently allowing HHAs to use
                    telehealth as part of a patient’s plan of care, understanding the strengths and
                    limitations of telehealth in home health is important to ensuring that patients
                    receive beneficial and high-quality care. For example, home health patients
                    may benefit from certain telehealth services, such as remote patient


Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                Conclusion and Recommendations | 25
                    monitoring or status checks, but may benefit less from other services through
                    telehealth, such as physical therapy visits or wound care. Examining HHAs’
                    telehealth use and its effects on access, equity, quality of care, and program
                    integrity will provide vital insights into whether and how telehealth can best
                    serve home health patients.

                    To better determine the types of services provided by telehealth and
                    characteristics of patients who benefit from these services, CMS should collect
                    and analyze data on HHAs’ telehealth use. CMS is planning to examine
                    telehealth information included on HHAs’ cost reports once HHAs submit
                    these data. CMS’s CY 2023 proposed rule for home health allows HHAs to
                    voluntarily report telehealth use on claims starting in January 2023. The
                    proposed rule, if enacted, will require this information by July 23, 2023. CMS is
                    also soliciting comments on how CMS intends to capture telehealth use on
                    claims as well as the appropriateness of home health care via telehealth given
                    the hands-on nature of many home health services. We encourage CMS to
                    analyze claims data, as well as other relevant data it collects or identifies, if
                    any, to evaluate HHAs’ use of telehealth.


        To inform decision-making, evaluate how the regulatory
        flexibilities it has offered in response to the COVID-19
        public health emergency affect the quality of home health
        care
                    CMS has limited information on how flexibilities affected patient care during
                    the public health emergency. CMS obtained feedback on the flexibilities
                    through structured and ad hoc engagements with stakeholders during the
                    public health emergency and used this feedback to inform decisions about
                    which flexibilities to make permanent. However, CMS has not systematically
                    evaluated these flexibilities, including the impact of these flexibilities on the
                    quality of patient care.

                    CMS should conduct a systematic review to gain insights into how the
                    flexibilities offered during the public health emergency—whether as a whole
                    or individually, and including those that are now permanent—affect the
                    quality of patient care. CMS could collect data from HHAs or analyze claims,
                    assessment data, and/or patient feedback to examine changes in quality of
                    care during the public health emergency that may relate to the flexibilities.
                    CMS could use this review to inform decision-making regarding which
                    flexibilities to use during future emergencies.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                Conclusion and Recommendations | 26
        In collaboration with ASPR TRACIE, apply lessons learned
        from the COVID-19 pandemic to update and/or develop
        emergency preparedness trainings and materials for HHAs
        on responding to infectious disease outbreaks
                    CMS has an opportunity to provide additional support to HHAs responding to
                    infectious disease emergencies, including those that are sustained and
                    widespread. Indeed, HHAs told us that they desire and would benefit from
                    more guidance. CMS already provides online trainings on emergency
                    preparedness for health care providers and also collaborates with ASPR
                    TRACIE to support HHAs’ emergency preparedness, including by conducting
                    technical reviews of ASPR TRACIE materials for HHAs.

                    CMS has solicited feedback from providers, including hospitals and nursing
                    homes, on their experiences using their EP plans during COVID-19. CMS
                    should also directly engage with HHAs on their experiences using their EP
                    plans. CMS should share feedback with ASPR TRACIE, and, in collaboration
                    with ASPR TRACIE, use this feedback as well as the findings of this study to
                    inform emergency preparedness trainings and materials (whether as updates
                    to existing resources or to develop new resources). These trainings and
                    materials should reflect lessons learned from the COVID-19 pandemic. To
                    guide these efforts, CMS could review existing CMS and ASPR TRACIE
                    emergency preparedness resources, including those that are currently under
                    development, to identify opportunities to incorporate lessons learned. For
                    identified opportunities, CMS could collaborate with ASPR TRACIE to develop
                    new, or modify existing, resources.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                Conclusion and Recommendations | 27
AGENCY COMMENTS AND OIG RESPONSE

                   CMS concurred with all three of our recommendations, as detailed below.

                   First, CMS concurred with our recommendation to evaluate how HHAs are using
                   telehealth—specifically, the types of services provided via telehealth and the
                   characteristics of patients who benefit from these services. In the CY 2023 Home
                   Health Prospective Payment System proposed rule, CMS stated its plans to require
                   that HHAs report the use of telehealth on home health claims beginning July 2023.
                   Collecting this information is vital to understanding the strengths and limitations of
                   telehealth in the home health environment, as well as the characteristics of patients
                   who benefit from telehealth services. We look forward to updates in CMS’s Final
                   Management Decision on both its evaluation of HHAs’ use of telehealth as well as
                   how patients have benefited from these services.

                   Second, CMS concurred with our recommendation to evaluate how regulatory
                   flexibilities offered during the COVID-19 public health emergency affect the quality of
                   home health care. CMS stated that it is holding listening sessions seeking feedback
                   from providers, including HHAs, on what flexibilities have been the most or least
                   helpful during the public health emergency. In its Final Management Decision, CMS
                   should detail its efforts to systematically review how the flexibilities offered during the
                   COVID-19 public health emergency, either individually or as a whole, affected the
                   quality of patient care.

                   Third, CMS concurred with our recommendation to collaborate with ASPR TRACIE to
                   apply lessons learned from the COVID-19 pandemic to update and/or develop
                   emergency preparedness trainings and materials for HHAs on responding to
                   infectious disease outbreaks. CMS stated that it recently published case studies of
                   how 30 nursing homes and hospitals responded to challenges during the onset of the
                   COVID-19 pandemic. In this report, we recommend that CMS engage directly with
                   HHAs on their experiences using EP plans during the pandemic. In its Final
                   Management Decision, CMS should describe its direct engagement with HHAs, as well
                   as its steps to collaborate with ASPR TRACIE, to update and/or develop emergency
                   preparedness trainings and materials for the home health environment.

                   For the full text of CMS’s comments, see the appendix at the end of this report.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                              Agency Comments and OIG Response | 28
DETAILED METHODOLOGY

                    This study used the following data sources: (1) a survey of a random sample of HHAs;
                    (2) interviews with a purposive sample of 12 HHAs; and (3) an interview with CMS
                    staff.

                    Scope
                    This study focuses on Medicare-participating HHA experiences from early in the
                    pandemic to the point that OIG surveyed or interviewed HHAs in September through
                    December 2021. As part of the survey and interviews, we asked HHAs about
                    challenges experienced early in the pandemic and in fall 2021. We defined “early in
                    the pandemic” to mean when the respondent HHA’s geographic area experienced its
                    first wave of COVID-19 infection.

                    Sample
                    We selected a nationally representative, simple random sample of 400
                    Medicare/Medicaid-participating HHAs to ask about their experiences during the
                    COVID-19 pandemic. We selected the random sample from among the 11,418 HHAs
                    listed in CMS’s Certification and Survey Provider Enhanced Reporting (CASPER)
                    system as of June 2021. 83 Of the 400 sampled HHAs, we removed 19 closed HHAs
                    and 4 HHAs that participated only in Medicaid, bringing the total to 377 HHAs
                    included in our sample. 84

                    Survey
                    We sent an electronic survey to the sampled HHAs between September 21, 2021, and
                    November 22, 2021; 271 HHAs responded, for a 72-percent response rate. We
                    contacted each HHA with at least two letters and a phone call before determining that
                    an HHA was a nonrespondent. 85 We project our sample to the 72 percent of the
                    11,265 Medicare-participating HHAs represented by our respondents. We conducted
                    a nonresponse analysis to assess whether nonresponding and responding HHAs in
                    our sample differed with regard to certain variables. See Appendix C for a description
                    of our nonresponse bias analysis.

                    The survey included questions about HHAs’ challenges during the COVID-19
                    pandemic; strategies to address these challenges; and the use of telehealth,
                    regulatory flexibilities, and emergency preparedness plans during the pandemic. It
                    also collected background information about the HHA. We produced estimates from
                    these survey data to describe the experiences of Medicare-participating HHAs
                    represented by our respondents during the pandemic. We performed t-tests to
                    determine statistically significant differences in the proportions of HHAs experiencing
                    challenges early in the pandemic compared to at the time of the survey. Significant


Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                             Detailed Methodology | 29
                    differences were determined at the 0.05 level. See Appendix D for estimates and p-
                    values, where appropriate.

                    We analyzed open-ended survey responses by categorizing these responses by
                    theme. We used open-ended survey responses to add context to our survey
                    estimates and provide insight into HHAs’ experiences during the COVID-19 pandemic,
                    including challenges and strategies used to address challenges. We counted the
                    number of responses that directly answered the survey question to produce estimates
                    from these data.

                    Rural HHA Analysis
                    To identify HHAs as rural, we obtained 2019 Medicare claims data for the HHAs in our
                    sample and determined the percentage of care episodes HHAs provided to Medicare
                    beneficiaries in rural Core Based Statistical Areas (CBSAs). We used 2019 Medicare
                    claims data because 2019 is the most recent year for which claims are complete. 86 We
                    defined rural HHAs as HHAs that provided 50 percent or more of their care episodes
                    in rural CBSAs. 87 We identified 41 rural HHAs that responded to our survey (18
                    percent of respondents with 2019 Medicare claims). 88

                    We analyzed rural HHAs’ survey responses to describe the experiences of rural HHAs
                    in our sample during the COVID-19 pandemic. We do not generalize these responses
                    to all rural HHAs.

                    Stakeholder Interviews
                    We interviewed staff from a purposive sample of 12 HHAs in November and
                    December 2021. We selected these HHAs on the basis of survey responses that
                    indicated notable challenges, strategies, or other experiences that may be useful to
                    CMS, the HHA industry, and other stakeholders. We use data from these interviews to
                    add context to our survey data and provide insight into HHAs’ experiences during the
                    COVID-19 pandemic. We do not use these interviews to generalize to all HHAs. Of
                    the 12 HHAs we interviewed, we identified 4 as rural on the basis of their 2019
                    Medicare claims.

                    We also interviewed CMS staff in the Center for Clinical Standards and Quality and
                    Center for Medicare on January 21, 2022. We asked about CMS’s support of, and
                    perspectives on, HHAs providing care during the pandemic, including (1) guidance
                    that CMS provided to HHAs; (2) HHAs’ use of regulatory flexibilities provided by CMS;
                    (3) HHAs’ challenges with staffing and PPE; (4) HHAs’ use of telehealth; and (5) HHAs’
                    use of emergency preparedness plans and development of COVID-19-specific
                    response plans.




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OEI-01-21-00110                                                                             Detailed Methodology | 30
APPENDICES

        Appendix A: CMS Conditions of Participation (CoPs): Infection
        Prevention and Control
                    CMS requires HHAs to maintain and document an infection control program to
                    prevent and control infections and communicable diseases. 89 To achieve compliance
                    with the CoP for infection prevention and control, HHAs must meet four standards:

                        •   Prevention: HHAs must follow accepted standards of practice, including the
                            use of standard precautions, to prevent the transmission of infections and
                            communicable diseases.

                        •   Control: HHAs must maintain a coordinated agency-wide program for the
                            surveillance, identification, prevention, control, and investigation of infectious
                            and communicable diseases.

                        •   Education: HHAs must provide infection control education to staff, patients,
                            and caregivers.

                        •   COVID-19 vaccination of home health agency staff: As of December 6, 2021,
                            CMS requires COVID-19 vaccinations for HHA staff. HHAs must develop and
                            implement policies and procedures to ensure that all staff receive required
                            vaccinations for COVID-19. 90




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OEI-01-21-00110                                                                                      Appendix A | 31
        Appendix B: Regulatory Flexibilities and Supports for Home
        Health Agencies During the COVID-19 Public Health Emergency
        (PHE)
          Regulatory flexibility or                Relevant regulation        Status as of summer 2022
          support                                  (if applicable)
          Extend the 5-day completion              42 CFR § 484.55(b)(1)      Waiver in effect for the
          requirement for the                                                 duration of the PHE for
          comprehensive assessment to 30                                      COVID-19. 91
          days

          Waive the 30-day Outcome and             42 CFR § 484.45(a)         Waiver in effect for the
          Assessment Information Set                                          duration of the PHE for
          (OASIS) submission requirement.                                     COVID-19. 92
          HHAs must submit OASIS data
          prior to submitting their final
          claim in order to receive
          Medicare payment.

          Allow HHAs to perform                    42 CFR § 484.55(a)         Waiver in effect for the
          Medicare-covered initial                                            duration of the PHE for
          assessments and determine                                           COVID-19. 93
          patients’ homebound status
          remotely or by record review

          Allow the required face-to-face          42 CFR §                   Waiver in effect for the
          encounter for home health                424.22(a)(1)(v)(B)         duration of the PHE for
          services to be conducted via                                        COVID-19. 94
          two-way audio-visual
          telecommunications technology
          from the patients’ home

          Waive requirement for an onsite          42 CFR § 484.80(h)         Waiver in effect for the
          visit by a nurse every two weeks                                    duration of the PHE for
                                                                              COVID-19. 95

          Waive requirement for a nurse            42 CFR § 484.80(h)(1)      Waiver in effect for the
          supervisory assessment of home                                      duration of the PHE for
          health aide services every two                                      COVID-19. 96
          weeks




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OEI-01-21-00110                                                                                       Appendix B | 32
          Authorize “allowed                       42 CFR § 484.55(a)(2)      Flexibility made permanent in
          practitioners,” in addition to           and § 484.55(b)(3)         the Coronavirus Aid, Relief,
          physicians, to certify                                              and Economic Security Act. 97
          beneficiaries for eligibility, order
          home health services, and
          establish and review the care
          plan. (Allowed practitioners are
          defined at 42 § CFR 484.2 as
          physician assistants, nurse
          practitioners, or clinical nurse
          specialists.)

          Postpone deadline to                     42 CFR § 484.80(d)         Waiver in effect for the
          completing requirement that                                         duration of the PHE for
          each home health aide receive                                       COVID-19. 98
          12 hours of in-service training in
          a 12-month period

          Allow occupational therapists,           42 CFR § 484.55(a)(2)      Occupational therapist
          physical therapists, and speech          and § 484.55(b)(3)         flexibility made permanent in
          language pathologists to                                            the Consolidated
          perform initial and                                                 Appropriations Act, 2021. 99
          comprehensive assessment for
          all patients receiving therapy                                      Specifically, the rule made
          services                                                            permanent the flexibility
                                                                              allowing occupational
                                                                              therapists to complete the
                                                                              initial and comprehensive
                                                                              assessments for patients when
                                                                              occupational therapy is on the
                                                                              home health plan of care, with
                                                                              either physical therapy or
                                                                              speech therapy, and when
                                                                              skilled nursing services are not
                                                                              initially in the plan of care.

          Allow HHAs to use telehealth for         42 CFR § 409.43(a)         Flexibility made permanent in
          visits and services within the                                      Calendar Year 2021 Home
          patient’s plan of care, as long as                                  Health Prospective Payment
          the telehealth services do not                                      System Final Rule. 100
          replace needed in-person visits




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Appendix B | 33
          Waive requirements to provide            42 CFR § 484.58(a)         Waiver in effect for the
          detailed information regarding                                      duration of the PHE for
          discharge planning to patients                                      COVID-19. 101
          and their caregivers, or the
          patient’s representative in
          selecting a post-acute care
          provider, by using and sharing
          data that includes, but is not
          limited to, (another) HHA, skilled
          nursing facility, inpatient
          rehabilitation facility, and long-
          term care hospital quality
          measures and resource use
          measures

          Extend deadline to provide a             42 CFR § 484.110(e)        Waiver in effect for the
          patient with a copy of their                                        duration of the PHE for
          clinical record from 4 days to 10                                   COVID-19. 102
          days

          Postpone requirement for nurse           42 CFR §                   Waiver in effect for the
          to make an annual onsite                 484.80(h)(1)(iv)           duration of the PHE for
          supervisory visit (direct                                           COVID-19. 103
          observation) of home health
          aide services

          Narrow scope of Quality                  42 CFR § 484.65(a)–        Waiver in effect for the
          Assurance and Performance                (d)                        duration of the PHE for
          Improvement (QAPI) to                                               COVID-19. 104
          concentrate on infection control
          issues

          Exempt HHAs from the Home                42 CFR § 484.245           Waiver no longer in effect.
          Health Quality Reporting                                            HHAs were required to resume
          Program (QRP) reporting                                             quality reporting data
          requirements. The time period                                       submission on July 1, 2020. 105
          covered by this exemption is
          October 1, 2019, through June
          30, 2020.

          Implement a policy to align              42 CFR § 484.315(b)        Waiver in effect for the
          Home Health Value-Based                                             duration of the PHE. 106
          Purchasing (HHVBP) Model data
          submission requirements with
          any exceptions or extensions
          granted for purposes of the

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OEI-01-21-00110                                                                                       Appendix B | 34
          Home Health QRP during the
          PHE for the COVID-19 pandemic,
          as well as a policy for granting
          exceptions to the New Measures
          data reporting requirements
          under the HHVBP Model during
          the PHE for the COVID-19
          pandemic

          Allow Medicare Administrative            42 CFR §                   Waiver in effect for the
          Contractors to extend the auto-          484.205(h)(2)(iv)          duration of the PHE for
          cancellation date of Requests for                                   COVID-19. 107
          Anticipated Payments during
          emergencies

          Allow HHAs that participate in                                      Waiver no longer in effect.
          the Review Choice                                                   CMS resumed RCD operations
          Demonstration (RCD) for Home                                        on August 3, 2020. 108
          Health Services to pause their
          participation for the duration of
          the PHE

          Delay cost report filing deadlines       42 CFR §                   Waiver no longer in effect.
          for cost reporting periods               413.24(f)(2)(i)            CMS resumed regular cost
          ending between October 1,                                           report deadlines. 109
          2019, and December 31, 2020




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OEI-01-21-00110                                                                                       Appendix B | 35
        Appendix C: Analysis of Nonresponse Bias
                    To examine the extent of potential nonresponse bias, we compared whether our 271
                    respondent HHAs differed from the nonrespondents and the population of 11,265
                    Medicare-participating HHAs (as of June 2021) on certain characteristics. Specifically,
                    we examined the number of branches operated by HHAs, the location of HHAs in
                    rural or urban Core Based Statistical Areas, and the number of staff employed by
                    HHAs. These characteristics did not significantly differ between our respondent
                    HHAs, nonrespondent HHAs, and all HHAs within our scope. Although these
                    comparisons do not preclude the possibility of nonresponse bias, they suggest that
                    our respondent HHAs are similar to the nonrespondents and the population of
                    Medicare-participating HHAs.

                    We also examined how our survey results would have changed if all nonrespondent
                    HHAs in our sample had responded differently from our respondent HHAs (e.g., the
                    worst-case scenario). For, example, our projection pertaining to telehealth usage (73
                    percent) would have changed from 73 percent to 52 percent, which is still a majority.
                    Given that the nonrespondents were similar to the respondents in the characteristics
                    we examined, a more reasonable scenario is that some of the nonrespondents would
                    have agreed with the respondents and the realized bias may be small.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                      Appendix C | 36
        Appendix D: Home Health Agencies’ Responses to OIG’s Survey
        HHA experiences with staffing during the COVID-19 pandemic

                                                                        Sample         Point        95% confidence
         Description
                                                                          size       estimate          interval

         Challenges with HHAs’ staffing during the COVID 19 pandemic

         Clinical staff leaving this HHA to work for other health care facilities or health care contract agencies
             Early pandemic challenge                                     271           50.9%             45.1-56.8%
             Pandemic challenge as of fall 2021                           271           40.2%             34.6-46.1%
                                                                                                       p-value <0.0001
         Recruiting new clinical staff due to increased competition from other health care facilities or health care
         contract agencies
             Early pandemic challenge                                   271         70.8%              65.2-75.9%
             Pandemic challenge as of fall 2021                         271         62.4%              56.5-67.9%
                                                                                                     p-value=0.0018

         Paying contracted clinical staff due to higher contracting costs during the pandemic
             Early pandemic challenge                                     271         48.7%             42.9-54.6%
             Pandemic challenge as of fall 2021                           271         43.5%             37.8-49.4%
                                                                                                      p-value=0.0475

         Limited staff availability to work due to personal circumstances related to the pandemic (e.g., lack of
         childcare due to school closures)
             Early pandemic challenge                                    271          84.5%           79.8-88.3%
             Pandemic challenge as of fall 2021                          271          55.4%           49.5-61.1%
                                                                                                   p-value <0.0001

         Limited staff availability to work because of self-quarantine/isolation due to COVID-19 exposure
             Early pandemic challenge                                     271         85.2%          80.6-88.9%
             Pandemic challenge as of fall 2021                           271         55.4%          49.5-61.1%
                                                                                                   p-value <0.0001

         Strategies used to address challenges with HHAs’ staffing during the COVID 19 pandemic

         Provided staff benefits to address COVID-19-related concerns (e.g., childcare, flex time, transportation
         assistance)
               Used and found helpful                                  271          59.4%              53.5-65.0%
               Used but did not find helpful                           271           6.3%               4.0-9.8%
               Did not use                                             271          34.3%              29.0-40.1%

         Trained staff to perform tasks outside of their usual duties (e.g., administrative work or duties in a different
         clinical area)
               Used and found helpful                                     271          57.6%            51.7-63.2%
               Used but did not find helpful                              271           4.4%             2.6-7.6%
               Did not use                                                271          38.0%            32.5-43.8%

         Provided paid and/or unpaid leaves of absence to retain staff that are unable to work
              Used and found helpful                                    271         64.6%               58.8-70.0%
              Used but did not find helpful                             271         10.0%                7.0-14.1%
              Did not use                                               271         25.5%               20.7-30.9%



Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                      Appendix D | 37
         Created specialized care teams of clinical staff who only treat COVID-19 patients
              Used and found helpful                                      271       39.9%              34.3-45.7%
              Used but did not find helpful                               271        5.2%               3.1-8.5%
              Did not use                                                 271       55.0%              49.1-60.7%
         Developed new or used existing partnerships with other HHAs or health care facilities to share staff to fill
         staffing gaps
               Used and found helpful                                271         26.6%               21.7-32.1%
               Used but did not find helpful                         271          6.6%                4.3-10.2%
               Did not use                                           271         66.8%               61.0-72.1%




         Use of CMS regulatory flexibilities and supports to help address staffing challenges

         Extend the 5-day completion requirement for the comprehensive assessment to 30 days
              Used and found helpful                                271             54.2%                 48.4-60.0%
              Used but did not find helpful                         271              3.7%                  2.0-6.7%
              Did not use                                           271             42.1%                 36.4-47.9%

         Authorize additional practitioners to certify beneficiaries for eligibility, order home health services, and
         establish and review the care plan
              Used and found helpful                                       271               80.1%         75.0-84.4%
              Used but did not find helpful                                271                1.5%           0.6-3.8%
              Did not use                                                  271               18.5%         14.3-23.4%

         Waive requirement for onsite visits by a nurse every 2 weeks
             Used and found helpful                                       271              48.0%          42.2-53.8%
             Used but did not find helpful                                271               3.3%           1.8-6.2%
             Did not use                                                  271              48.7%          42.9-54.6%
         Allow occupational therapists, physical therapists, and speech language pathologists to perform initial and
         comprehensive assessment for all patients receiving therapy services
              Used and found helpful                                     271            64.2%          58.4-69.6%
              Used but did not find helpful                              271             4.8%           2.8-8.0%
              Did not use                                                271            31.0%          25.8-36.7%
         Postpone deadline to completing requirement that each home health aide receives 12 hours of in-service
         training in a 12-month period
               Used and found helpful                               271              40.6%         35.0-46.5%
               Used but did not find helpful                        271               3.0%           1.5-5.7%
               Did not use                                          271              56.5%         50.6-62.2%




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                      Appendix D | 38
        HHA experiences with infection control during the COVID-19 pandemic

                                                                                                        95%
                                                                                       Point
         Description                                                  Sample size                    confidence
                                                                                     estimate
                                                                                                      interval

         Challenges with infection control during the COVID 19 pandemic


         Unclear State/Federal guidance about how to treat COVID-19 patients
             Early pandemic challenge                                271               88.6%         84.3-91.8%
             Pandemic challenge as of fall 2021                      271               19.6%         15.3-24.6%
                                                                                                   p-value <0.0001

         Navigating evolving guidance about how to treat COVID-19 patients
            Early pandemic challenge                                 271               87.1%         82.6-90.5%
            Pandemic challenge as of fall 2021                       271               25.5%         20.7-30.9%
                                                                                                   p-value <0.0001
         Unclear or conflicting State/Federal guidelines about COVID-19 infection prevention and control
             Early pandemic challenge                                  271             88.2%         83.8-91.5%
             Pandemic challenge as of fall 2021                        271             24.4%         19.7-29.7%
                                                                                                   p-value <0.0001

         Access to masks (not other types of personal protective equipment (PPE))
             Early pandemic challenge                                  271             92.6%         88.9-95.2%
             Pandemic challenge as of fall 2021                        271             13.7%         10.1-18.2%
                                                                                                   p-value <0.0001

         Access to other types of PPE (not masks)
             Early pandemic challenge                                      271         91.1%         87.2-94.0%
             Pandemic challenge as of fall 2021                            271         15.1%         11.4-19.8%
                                                                                                   p-value <0.0001
         Access to sanitizing products (e.g., sanitizing wipes, hand sanitizer)
             Early pandemic challenge                                      271         94.5%         91.1-96.6%
             Pandemic challenge as of fall 2021                            271         8.9%           6.0-12.8%
                                                                                                   p-value <0.0001
         High cost of PPE during the pandemic
             Early pandemic challenge                                      271         88.6%          84.3-91.8%
             Pandemic challenge as of fall 2021                            271         42.4%          36.8-48.3%
                                                                                                   p-value <0.0001



         Strategies used to address infection control challenges during the COVID 19 pandemic


         Developed internal COVID-19 infection control protocols for staff
            Used and found helpful                                     271            96.7%          93.8-98.2%
            Used but did not find helpful                              271            1.5%            0.6-3.8%
            Did not use                                                271            1.8%            0.8-4.3%
         Increased or improved clinical staff training on COVID-19 treatment
              Used and found helpful                                    271           94.8%          91.5-96.9%
              Used but did not find helpful                             271            3.3%           1.8-6.2%
              Did not use                                               271            1.8%           0.8-4.3%




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                      Appendix D | 39
         Provided PPE training for clinical staff

              Used and found helpful                                         271              95.9%           92.9-97.7%
              Used but did not find helpful                                  271               1.5%            0.6-3.8%
              Did not use                                                    271               2.6%            1.2-5.3%

         Found nontraditional sources for PPE (e.g., nail salons, tattoo parlors)
             Used and found helpful                                       271                 31.4%           26.2-37.1%
             Used but did not find helpful                                271                  4.8%            2.8-8.0%
             Did not use                                                  271                 63.8%           58.0-69.3%
         Conserved PPE (e.g., re-used PPE normally meant for single use, prioritized certain types of PPE for
         highest-risk activities)
             Used and found helpful                                    271              57.2%          51.3-62.9%
             Used but did not find helpful                             271               8.5%           5.7-12.4%
             Did not use                                               271              34.3%          29.0-40.1%

         Developed new or used existing partnerships with other HHAs or health care facilities to obtain or pool
         supplies
             Used and found helpful                                  271              42.4%           36.8-48.3%
             Used but did not find helpful                           271               7.4%            4.8-11.1%
             Did not use                                             271              50.2%           44.3-56.0%
         Postponed accepting patients with positive COVID-19 diagnosis until HHA had adequate infection control
         protocols
             Did not use                                             271            44.3%         38.6-50.2%
             Used (combined)                                         271            55.7%         49.8-61.4%



        Telehealth use during the COVID-19 pandemic

                                                                                               Point       95% confidence
         Description                                                     Sample size
                                                                                             estimate         interval
         HHA used telehealth during the pandemic                             271              72.7%            67.2-77.6%

         HHA did not use telehealth during the pandemic                      271              27.3%            22.4-32.8%



         HHAs that provided telehealth services during the COVID 19 pandemic


         Mode of telehealth services during the pandemic
             Live, real-time services between a patient and a health care provider (in the HHA)
                  Used                                                        197             78.2%            72.0-83.3%
                  Did not use                                                 197             21.8%            16.7-28.0%
             Patient health information is electronically transmitted to a health care provider for their assessment at a
             different time
                  Used                                                          197             44.2%            37.5-51.1%
                  Did not use                                                   197             55.8%            48.9-62.5%
             HHA providers helped patients set up or participate in telehealth services with another provider (outside of the
             HHA)
                Used                                                         197               62.9%          56.1-69.3%
                Did not use                                                  197               37.1%          30.7-43.9%




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                      Appendix D | 40
         Challenges using telehealth during the pandemic
             High cost of providing telehealth services
                 Challenge                                                    197              44.2%        37.5-51.1%
                 Not a challenge                                              197              55.8%        48.9-62.5%

             Insufficient internet access in patients’ homes
                 Challenge                                                    197              66.5%        59.7-72.7%
                 Not a challenge                                              197              33.5%        27.3-40.3%
             Lack of direct reimbursement for telehealth services (other than for administrative costs)
                 Challenge                                                    197              67.5%        60.8-73.6%
                 Not a challenge                                              197              32.5%        26.4-39.2%

             Most care required physical contact with patient
                Challenge                                                     197              63.5%        56.6-69.8%
                Not a challenge                                               197              36.5%        30.2-43.4%

         Will this HHA continue to use telehealth after the pandemic?
             Yes                                                              197              56.9%        49.9-63.5%
             No                                                               197              43.1%        36.5-50.1%

        Note: In the survey, we used the term “telemedicine” rather than “telehealth.”

        Emergency preparedness and response

                                                                                              Point       95% confidence
         Description                                                     Sample size
                                                                                            estimate         interval

         COVID 19-specific response plans


         HHAs that had a COVID-19 response plan
         HHA had a COVID-19 response plan                                    271              84.9%         80.2-88.6%

         HHA did not have a COVID-19 response plan                           271              15.1%         11.4-19.8%


         CMS required emergency preparedness (EP) plan


         Overall, EP plan helpfulness in responding to the pandemic (of those with an EP plan during the pandemic)
            Helpful                                                     267             98.1%          95.6-99.2%
            Not helpful                                                 267              1.9%           0.8-4.4%

         EP plan helpfulness in responding to infection control challenges due to the pandemic (of those with an EP
         plan during the pandemic)
             Helpful                                                     267            90.6%         86.6-93.6%
             Not helpful                                                 267             3.7%           2.0-6.8%
             Not applicable                                              267             5.6%           3.4-9.1%

         EP plan helpfulness in responding to supply challenges due to the pandemic (of those with an EP plan
         during the pandemic)
             Helpful                                                     267           80.9%          75.8-85.1%
             Not helpful                                                 267           12.7%          9.3-17.2%
             Not applicable                                              267            6.4%           4.0-9.9%



Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                      Appendix D | 41
         EP plan helpfulness in responding to staffing challenges due to the pandemic (of those with an EP plan
         during the pandemic)
             Helpful                                                      267           74.2%         68.7-79.0%
             Not helpful                                                  267           14.6%         10.9-19.3%
             Not applicable                                               267           11.2%          8.0-15.5%

         HHAs that experienced the challenge that their EP plan was more suitable to a local emergency than a
         national or global emergency such as the pandemic (of those with an EP plan during the pandemic)
             Challenge                                                 267              50.6%         44.7-56.4%
             Not a challenge                                           267              49.4%         43.6-55.3%

         HHAs that will modify or have modified their EP plan to include lessons learned from the COVID-19
         pandemic (of those with an EP plan during the pandemic)
            HHA has already modified OR will modify its EP plan to
                                                                        267             96.6%         93.7-98.2%
            include lessons learned from the pandemic
            HHA has not modified and will not modify its EP plan to
                                                                        267              3.4%          1.8-6.3%
            include lessons learned from the pandemic
         HHAs with an EP plan that included an infectious disease component prior to the pandemic.
         Note: Among HHAs that had an EP plan prior to the pandemic.
            HHA did not have an EP plan with an infectious
                                                                        254              7.1%         4.5-10.9%
            disease component
            HHA had an EP plan with an infectious disease
                                                                        254             92.9%        89.1-95.5%
            component

         How could CMS better support HHAs in using EP plans to respond to emerging infectious
         diseases? (open ended responses)
         HHA suggested information about EP plan content and/or
                                                                        88             67.0%           56.8-75.9%
         implementation in response to this question
         HHA did not suggest information about EP plan content
                                                                        88             33.0%           24.1-43.2%
         and/or implementation in response to this question



        Rural HHA experiences*


         Rural HHA experiences with staffing challenges

         Limited staff availability to work because of self-quarantine/isolation due to COVID-19 exposure
              Challenge                                                                        39
              Not a challenge                                                                  2



         Rural HHA experiences with infection control and prevention challenges

         Unclear or conflicting State/Federal guidelines about COVID-19 infection prevention and control
              Early challenge                                                                34
              Not an early challenge                                                          7
         Access to masks (not other types of personal protective equipment (PPE))
              Early challenge                                                                37
              Not an early challenge                                                          4
         Access to other types of PPE (not masks)
              Early challenge                                                                37
              Not an early challenge                                                          4


Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                      Appendix D | 42
         Access to sanitizing products (e.g., sanitizing wipes, hand sanitizer)
              Early challenge                                                                38
              Not an early challenge                                                          3


         Rural HHA experiences with telehealth during the pandemic
         HHA used telehealth during the pandemic                                             31
         HHA did not use telehealth during the pandemic                                      10

         Challenges with insufficient internal access in patients’ homes
              Challenge                                                                      25
              Not a challenge                                                                 6

                * We were unable to project due to limited sample size.

        Note: Because of rounding, not all percentages may add up to 100 percent.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                      Appendix D | 43
        Appendix E: Agency Comments
                    Following this page are the official comments from CMS.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Appendix E | 44
            DEPARTMENT OF HEALTH & HUMAN SERVICES                                        Centers for Medicare & Medicaid Services


                                                                                         Administrator
                                                                                         Washington , DC 20201

    DATE:            September 22, 2022

    TO:              Suzanne Murrin
                     Deputy Inspector General for Evaluation and Inspections
                     Office of Inspector General

    FROM:            Chiquita Brooks-LaSure
                     Administrator
                     Centers for Medicare & Medicaid Services

    SUBJECT:         Office of Inspector General (OIG) Draft Report: Home Health Agencies Used
                     Multiple Strategies to Respond to the COVID-19 Pandemic, Although Some
                     Challenges Persist (OEI-01-21-00110)

    The Centers for Medicare & Medicaid Services (CMS) appreciates the opportunity to review and
    comment on the Office of Inspector General’s (OIG) draft report. CMS is committed to
    supporting home health agencies (HHAs) during health emergencies so they may care for people
    with Medicare in the home setting while protecting them from the spread of infectious diseases.
    CMS is using lessons learned during the COVID-19 public health emergency (PHE) to improve
    quality of care and equitable access to CMS benefits, services, and supports.

    Throughout the COVID-19 PHE, CMS has used a combination of emergency authority waivers,
    regulations, enforcement discretion, survey flexibilities, and sub-regulatory guidance to help ensure
    access to care, give health care providers the flexibilities needed to respond to COVID-19, and help
    keep people safer. Flexibilities offered during the COVID-19 PHE supported HHAs in addressing
    staffing challenges, especially early on in the COVID-19 PHE. For example, a statutory change
    enabled CMS to allow additional practitioners to certify beneficiaries for eligibility, order home
    health services, and establish and review care plans. The use of telehealth to furnish home health
    services was finalized on a permanent basis in the calendar year (CY) 2021 Home Health
    Prospective Payment System final rule. 1 However, such services cannot be reported as a visit on
    home health claims for the purposes of eligibility or payment.

    Many of the waivers and flexibilities will terminate at the end of the COVID-19 PHE or after the
    151st day after the end of the PHE, as they were intended to address the acute and extraordinary
    circumstances of a rapidly evolving pandemic and not replace existing requirements. Some were
    made permanent through the passage of new laws. For example, Division CC, section 115 of the
    Consolidated Appropriations Act of 2021, made permanent the flexibility that occupational
    therapists could conduct initial and comprehensive assessments for patients when certain
    requirements relating to the plan of care are met.


    1
     Federal Register: “Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment System Rate
    Update, Home Health Quality Reporting Program Requirements, and Home Infusion Therapy Services and Supplier
    Enrollment Requirements; and Home Health Value-Based Purchasing Model Data Submission Requirements; Final
    Rule (85 FR 70298) (November 4, 2020).”

Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Appendix E | 45
    CMS continues to support stakeholders and the people we serve during the current phase of the
    COVID-19 PHE while looking forward to a health system that successfully emerges from the
    COVID-19 PHE focused on improving quality and safety. CMS is also monitoring the status of the
    COVID-19 PHE and has begun phasing out certain flexibilities that are generally no longer needed.
    To understand how blanket flexibilities and those specific to HHAs were used on the front lines
    during the COVID-19 PHE, CMS received feedback from the HHA industry, national HHA
    organizations, and from subject matter experts. This information helped inform waiver disposition
    decisions and identify groups of waivers that may be helpful in future PHE response activities.
    CMS recently released fact sheets to summarize the current status of Medicare blanket waivers and
    flexibilities by provider type, including HHAs. 2

    Long before the COVID-19 PHE began, CMS had acted to strengthen infection prevention and
    control practices for HHAs and other provider types. CMS took pivotal actions in the 2016 final
    rule, “Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and
    Medicaid Participating Providers and Suppliers,” which outlined the need for providers to prepare
    for infectious disease threats. 3 In March 2020, CMS issued guidance to HHAs encouraging them to
    take appropriate action to address potential and confirmed COVID-19 cases and mitigate
    transmission, including screening, treatment and transfer to higher level care (when appropriate).4
    CMS also held Open Door Forum calls specific to HHAs since 2016 and added additional COVID-
    19 calls during the COVID-19 PHE, which continue to date. CMS meets regularly with
    stakeholders, such as the National Association for Home Care and Hospice, to discuss issues
    affecting the HHA community. In addition, CMS’s Quality Safety and Education Portal provides
    current trainings on various CMS survey and certification requirements. 5 These trainings are used
    by surveyors but are also free of charge and available to the public by choosing the “public access”
    link on the portal.

    CMS thanks OIG for its efforts on this important issue and looks forward to working with OIG
    on this and other issues in the future. OIG’s recommendations and CMS's responses are below.

    OIG Recommendation
    Evaluate how HHAs are using telehealth—specifically, the types of services provided via
    telehealth and the characteristics of patients who benefit from these services.

    CMS Response
    CMS concurs with this recommendation. CMS finalized policy changes regarding the use of
    services furnished via telecommunications systems in the CY 2021 Home Health Prospective
    Payment System final rule.6 HHAs can utilize telecommunications technologies in providing care to
    beneficiaries under the Medicare home health benefit, as long as any provision of remote patient
    monitoring or other services furnished via a telecommunications system or audio-only technology
    are included on the plan of care. The use of such telecommunications technology or audio-only
    2
      CMS, Home Health Agencies: CMS Flexibilities to Fight COVID-19. August, 18, 2022. Accessed at
    https://www.cms.gov/files/document/home-health-agencies-cms-flexibilities-fight-covid-19.pdf
    3
      Medicare and Medicaid Programs; Emergency Preparedness Requirements, 81 FR 63860, 63862 (Sept. 16, 2016).
    Accessed at https://www.federalregister.gov/documents/2016/09/16/2016-21404/medicare-and-medicaid-programs-
    emergency-preparedness-requirements-for-medicare-and-medicaid
    4
      CMS, Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home
    Health Agencies (HHAs). March 10, 2020. Accessed at https://www.cms.gov/files/document/qso-20-18-hha.pdf
    5
      CMS, Quality, Safety & Education Portal (QSEP). Accessed at https://qsep.cms.gov/
    6
      Federal Register: “Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment System Rate
    Update, Home Health Quality Reporting Program Requirements, and Home Infusion Therapy Services and Supplier
    Enrollment Requirements; and Home Health Value-Based Purchasing Model Data Submission Requirements; Final
    Rule (85 FR 70298) (November 4, 2020)”

Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Appendix E | 46
    technology must be tied to patient-specific needs as identified in the comprehensive assessment,
    and may not substitute for an in-person home visit that is ordered on the plan of care. In addition,
    the law 7 explicitly states that home health services furnished via telecommunications technology
    cannot be considered a visit for the purpose of patient eligibility or payment.

    Currently, the collection of data on the use of telecommunications technology under the home
    health benefit is limited to a broad category of telecommunications technology costs under
    administrative costs on the HHA cost reports (reported at the agency level). The CY 2023 Home
    Health Prospective Payment System proposed rule solicited comments on the collection of data on
    the use of such services furnished using telecommunications technology on the home health claims
    (at the individual beneficiary level).8 Collecting data on the use of telecommunications technology
    on home health claims would allow CMS to analyze the characteristics of the beneficiaries utilizing
    services furnished remotely, and could provide a broader understanding of the social determinants
    that affect who benefits most from these services, including what barriers may potentially exist for
    certain subsets of beneficiaries. CMS aims to collect such data on home health claims by January 1,
    2023 on a voluntary basis by HHAs, and plans begin to requiring this information to be reported on
    claims beginning July 2023. CMS will consider OIG’s recommendation along with comments
    submitted on the proposed rule when finalizing the rule.

    OIG Recommendation
    To inform decision-making, evaluate how regulatory flexibilities offered during the COVID-19
    pandemic affect quality of home health care.

    CMS Response
    CMS concurs with this recommendation to evaluate the effects of waivers to the extent it is possible
    to do so. While it may be difficult to make direct links from waivers to quality and health outcomes,
    CMS is using lessons learned during the COVID-19 PHE to improve quality of care in home care
    settings to ensure equitable access to CMS benefits, services and supports. CMS is monitoring the
    status of the COVID-19 PHE and has begun phasing out certain flexibilities that are generally no
    longer needed. CMS released fact sheets to summarize the current status of Medicare blanket
    waivers and flexibilities by provider type, including HHAs. 9

    Given the unprecedented length and scope of the COVID-19 PHE, CMS has systematically
    reviewed all the emergency measures, regulatory flexibilities, and related programs enacted during
    the COVID-19 PHE on an ongoing basis since 2020 to assess the appropriateness of continuing
    those flexibilities or of retaining some as a permanent part of CMS programs, as permitted under
    the law. To understand how HHAs used flexibilities during the COVID-19 PHE, CMS received
    feedback from the HHA industry, national HHA organizations, and from subject matter experts.
    This information helped inform waiver disposition decisions and identify groups of waivers that
    may be helpful in future PHE response activity. For example, as part of the CY 2022 Home Health
    Prospective Payment System final rule, CMS finalized the provision for aide supervision for



    7
      Section 1895(e)(1)(A) of the Social Security Act. Accessed at
    https://www.ssa.gov/OP_Home/ssact/title18/1895.htm
    8
      Federal Register: “Medicare Program; Calendar Year (CY) 2023 Home Health Prospective Payment System Rate
    Update; Home Health Quality Reporting Program Requirements; Home Health Value-Based Purchasing Expanded
    Model Requirements; and Home Infusion Therapy Services Requirements; Proposed Rule (87 FR 37600) (June 23,
    2022)”
    9
      CMS, Home Health Agencies: CMS Flexibilities to Fight COVID-19, September 1, 2022. Accessed at
    https://www.cms.gov/files/document/home-health-agencies-cms-flexibilities-fight-covid-19.pdf

Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Appendix E | 47
    patients receiving skilled care every 14 days to now allow for one virtual visit per 60-day episode
    per patient and only in rare circumstances. 10

    CMS is also in the process of holding a series of listening sessions seeking feedback from
    providers, including HHAs, on what specific flexibilities, if any, have been the most or least
    helpful. While it is challenging to isolate the many compounding factors that affect quality of
    care and conclude that individual waivers were the sole contributor to changes in patient
    outcomes, especially given the unique circumstances of the COVID-19 PHE and data limitations
    during this time, CMS is reviewing waivers as part of larger efforts to ensure health care quality
    and safety. CMS remains steadfast in its commitment to keeping the HHA community and public
    informed throughout the COVID-19 PHE.

    OIG Recommendation
    In collaboration with Administration for Strategic Preparedness and Response (ASPR) Technical
    Resources, Assistance Center, and Information Exchange (TRACIE), apply lessons learned from
    the COVID-19 PHE to update and/or develop emergency preparedness trainings and materials
    for HHAs on responding to infectious disease outbreaks.

    CMS Response
    CMS concurs with this recommendation. ASPR TRACIE and CMS have a long history of working
    together to support providers in responding to emergencies, including emerging infectious diseases,
    such as COVID-19. CMS has provided education and outreach to HHAs on CMS quality and safety
    standards to support their infection prevention and control efforts. In addition, CMS has
    collaborated with ASPR TRACIE on homecare related resources, including a resource on HHA
    requirements relating to the emergency preparedness rule.11 This resource was updated in March
    2021 to reflect updates from the COVID-19 PHE.

    CMS recently published case studies of 30 providers (nursing homes and hospitals) on their
    responses to challenges during the onset of COVID-19.12 The study focused on understanding how
    these providers prepared for and responded to the COVID-19 PHE. The discussions and
    engagement focused on whether or not the facilities had risk assessments which included emerging
    infectious diseases prior to the PHE, their input on individual preparedness within their facilities,
    and discussion on some of the challenges and burdens. The study found that locally developed
    emergency preparedness plans and staff training were key factors in dealing with the COVID-19
    PHE. While this study focused on nursing homes and hospitals, the information gained from the
    study would apply across provider and supplier types.

    CMS will continue to collaborate with ASPR TRACIE and share information based on lessons
    learned from the COVID-19 PHE with the HHA industry. However, CMS does not provide funding
    to ASPR TRACIE. While our agencies will continue to collaborate, CMS does not have the
    authority over ASPR TRACIE work products.

    10
       Federal Register: “Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate
    Update; Home Health Value-Based Purchasing Model Requirements and Model Expansion; Home Health and Other
    Quality Reporting Program Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement
    Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; and COVID-19 Reporting
    Requirements for Long-Term Care Facilities; Final Rule (86 FR 62240) (November 9, 2021)”
    11
       CMS, Home Health Agency Requirements CMS Emergency Preparedness Final Rule, March 26, 2021. Accessed
    at https://files.asprtracie.hhs.gov/documents/aspr-tracie-cms-ep-rule-home-health-agency-requirements.pdf
    12
       Blackstock, S.C., Moody-Williams, J.D., Fleisher, L.A., Learnings Regarding Emergency Preparedness During
    the Public Health Emergency: A Mixed-Methods Study of Hospitals and Long-Term Care Facilities, NEJM
    Catalyst, August 24, 2022. Accessed at https://catalyst.nejm.org/doi/full/10.1056/CAT.22.0152

Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                       Appendix E | 48
ACKNOWLEDGMENTS AND CONTACT

        Acknowledgments
                    Sarah Hijaz and Shanna Weitz served as the team leaders for this study, and Caitlin
                    Foster served as the lead analyst. Office of Evaluation and Inspections headquarters
                    staff who provided support include Joseph Chiarenzelli, Althea Hosein, Christine
                    Moritz, and Sara Swisher.

                    This report was prepared under the direction of Joyce Greenleaf, Regional Inspector
                    General for Evaluation and Inspections in the Boston regional office, and Danielle
                    Fletcher, Deputy Regional Inspector General.


        Contact
                    To obtain additional information concerning this report, contact the Office of Public
                    Affairs at Public.Affairs@oig.hhs.gov. OIG reports and other information can be found
                    on the OIG website at oig.hhs.gov.

                    Office of Inspector General
                    U.S. Department of Health and Human Services
                    330 Independence Avenue, SW
                    Washington, DC 20201




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                     Acknowledgments and Contact | 49
ABOUT THE OFFICE OF INSPECTOR GENERAL

                    The mission of the Office of Inspector General (OIG), as mandated by Public Law
                    95-452, as amended, is to protect the integrity of the Department of Health and
                    Human Services (HHS) programs, as well as the health and welfare of beneficiaries
                    served by those programs. This statutory mission is carried out through a nationwide
                    network of audits, investigations, and inspections conducted by the following
                    operating components:

                    The Office of Audit Services (OAS) provides auditing services for HHS,
                    either by conducting audits with its own audit resources or by overseeing audit work
                    done by others. Audits examine the performance of HHS programs and/or its
                    grantees and contractors in carrying out their respective responsibilities and are
                    intended to provide independent assessments of HHS programs and operations.
                    These audits help reduce waste, abuse, and mismanagement and promote economy
                    and efficiency throughout HHS.

                    The Office of Evaluation and Inspections (OEI) conducts national
                    evaluations to provide HHS, Congress, and the public with timely, useful, and reliable
                    information on significant issues. These evaluations focus on preventing fraud, waste,
                    or abuse and promoting economy, efficiency, and effectiveness of departmental
                    programs. To promote impact, OEI reports also present practical recommendations
                    for improving program operations.

                    The Office of Investigations (OI) conducts criminal, civil, and administrative
                    investigations of fraud and misconduct related to HHS programs, operations, and
                    beneficiaries. With investigators working in all 50 States and the District of Columbia,
                    OI utilizes its resources by actively coordinating with the Department of Justice and
                    other Federal, State, and local law enforcement authorities. The investigative efforts
                    of OI often lead to criminal convictions, administrative sanctions, and/or civil
                    monetary penalties.

                    The Office of Counsel to the Inspector General (OCIG) provides
                    general legal services to OIG, rendering advice and opinions on HHS programs and
                    operations and providing all legal support for OIG’s internal operations. OCIG
                    represents OIG in all civil and administrative fraud and abuse cases involving HHS
                    programs, including False Claims Act, program exclusion, and civil monetary penalty
                    cases. In connection with these cases, OCIG also negotiates and monitors corporate
                    integrity agreements. OCIG renders advisory opinions, issues compliance program
                    guidance, publishes fraud alerts, and provides other guidance to the health care
                    industry concerning the anti-kickback statute and other OIG enforcement authorities.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                               About the Office of Inspector General | 50
ENDNOTES

 1 National Association for Home Care and Hospice, National Study Shows How Home Care Is in a Fragile State, April 27, 2020.

 Accessed at https://www.nahc.org/wp-content/uploads/2020/03/NATIONAL-STUDY-SHOWS-HOME-HEALTH-CARE-IS-IN-A-
 FRAGILE-STATE.pdf on August 17, 2022.
 2 Robert Holly, “Small Home Health Agencies Fighting to Stay Afloat Amid COVID-19 Crisis, Regulatory Uncertainty,” Home

 Health Care News, April 19, 2020. Accessed at https://homehealthcarenews.com/2020/04/small-home-health-agencies-
 fighting-to-stay-afloat-amid-covid-19-crisis-regulatory-uncertainty/ on March 8, 2022.
 3 Jingding Shang, Ashley M. Chastain, Uduwanage Gayani E. Perera, et al., “COVID-19 Preparedness in US Home Health Care

 Agencies,” Journal of the American Medical Directors Association, July 2020, Vol. 21, Issue 7, pp. 924-927, DOI:
 10.1016/j.jamda.2020.06.002. Accessed at https://pubmed.ncbi.nlm.nih.gov/32674820/ on May 2, 2022.
 4 Andrew Donlan, “House Passes CARES Act, Fast Forwarding Home Health Care Innovation Beyond COVID-19,” Home Health

 Care News, March 27, 2020. Accessed at https://homehealthcarenews.com/2020/03/house-passes-cares-act-fast-forwarding-
 home-health-care-innovation-beyond-covid-19/ on March 8, 2022.
 5 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, updated May 24, 2021.
                                                                                                    Accessed at
 https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf on March 8, 2022.
 6 Adara Home Health, Inc., COVID-19 Preparedness Plan.
                                                    Accessed at https://adarahomehealth.com/wp-
 content/uploads/2020/07/Adara-COVID-19-Plan_6-29-20.pdf on March 8, 2022.
 7 Courtney Harold Van Houtven and Walter D. Dawson, “Medicare and Home Health: Taking Stock in the COVID-19 Era,” The

 Commonwealth Fund, October 21, 2020. Accessed at https://www.commonwealthfund.org/publications/issue-
 briefs/2020/oct/medicare-home-health-taking-stock-covid-19-era on March 8, 2022.
 8 CMS, “Chapter 7 - Home Health Services.” Medicare Benefit Policy Manual.
                                                                      Accessed at https://www.cms.gov/Regulations-
 and-Guidance/Guidance/Manuals/Downloads/bp102c07.pdf on April 29, 2022.
 9 CMS, “Chapter 7 - Home Health Services,” Medicare Benefit Policy Manual.
                                                                      Accessed at https://www.cms.gov/Regulations-
 and-Guidance/Guidance/Manuals/Downloads/bp102c07.pdf on April 29, 2022.
 10 Social Security Act (the Act) §§ 1814(a)(2)(C) and (a)(concluding paragraph), and 1835(a)(2)(A) and (a)(concluding

 paragraph); 42 CFR § 409.42(a).
 11 The Act §§ 1814(a)(2)(C) and (a)(concluding paragraph), and 1835(a)(2)(A) and (a)(concluding paragraph); 42 CFR §

 424.22(a)(1)(v).
 12 The Act §§ 1814(a)(2)(C) and (a)(concluding paragraph), and 1835(a)(2)(A) and (a)(concluding paragraph); 42 CFR §

 424.22(c)).
 13 MedPAC, “Chapter 8 - Home health care services,” Report to the Congress: Medicare Payment Policy, March 2022, pp. 275,

 279, 282. Accessed at https://www.medpac.gov/wp-content/uploads/2022/03/Mar22_MedPAC_ReportToCongress_SEC.pdf
 on August 17, 2022.
 14 42 CFR § 484, subparts A-C.

 15 CMS, “Appendix B- Guidance to Surveyors: Home Health Agencies,” State Operations Manual, Rev. 200, February 21, 2020.

 Accessed at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_b_hha.pdf on March
 8, 2022.
 16 42 CFR § 488, subpart I.

 17 CMS, “Chapter 2 - The Certification Process,” State Operations Manual, Rev. 205, March 11, 2022.
                                                                                         Accessed at
 https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c02.pdf on April 11, 2022.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                         Endnotes | 51
 18 Jingding Shang, Ashley M. Chastain, Uduwanage Gayani E. Perera, et al., “COVID-19 Preparedness in US Home Health Care

 Agencies,” Journal of the American Medical Directors Association, July 2020, Vol. 21, Issue 7, pp. 924-927, DOI:
 10.1016/j.jamda.2020.06.002. Accessed at https://pubmed.ncbi.nlm.nih.gov/32674820/ on May 2, 2022.
 19 CDC, Symptoms of COVID-19, updated March 22, 2022.       Accessed at https://www.cdc.gov/coronavirus/2019-
 ncov/symptoms-testing/symptoms.html on July 11, 2002.
 20 CDC, Symptoms of COVID-19, updated March 22, 2022.       Accessed at https://www.cdc.gov/coronavirus/2019-
 ncov/symptoms-testing/symptoms.html on July 11, 2022.
 21 CDC, CDC Museum COVID-19 Timeline.       Accessed at https://www.cdc.gov/museum/timeline/covid19.html on March 8,
 2022.
 22 HHS, Determination That A Public Health Emergency Exists, January 31, 2020.   Accessed at
 https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx on September 29, 2022.
 23 World Health Organization, Timeline: WHO’s COVID-19 response.Accessed at
 https://www.who.int/emergencies/diseases/novel-coronavirus-2019/interactive-timeline#! on March 8, 2022.
 24 CDC, Lesson 1: Introduction to Epidemiology, Section 11: Epidemic Disease Occurrence.   Accessed at
 https://www.cdc.gov/csels/dsepd/ss1978/lesson1/section11.html on August 18, 2022.
 25 85 Fed. Reg. 15337 (March 18, 2020).

 26 CDC, Trends in Number of COVID-19 Cases and Deaths in the US Reported to CDC, by State/Territory.      Accessed at
 https://covid.cdc.gov/covid-data-tracker/#trends_dailycases on September 23, 2022.
 27 Satyaki Roy and Preetam Ghosh, “Factors affecting COVID-19 infected and death rates inform lockdown-related

 policymaking,” PLOS One, October 23, 2020. Accessed at https://doi.org/10.1371/journal.pone.0241165 on March 8, 2022.
 28 CDC, CDC COVID-19 Study Shows mRNA Vaccines Reduce Risk of Infection by 91 Percent for Fully Vaccinated People, June 7,

 2021. Accessed at https://www.cdc.gov/media/releases/2021/p0607-mrna-reduce-risks.html on March 8, 2022.
 29 42 CFR § 484.70.

 30 CMS, Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health

 Agencies (HHAs) and Religious Nonmedical Healthcare Institutions (RNHCIs), March 10, 2020, revised April 23, 2020. Accessed
 at https://www.cms.gov/files/document/qso-20-18-hha-revised.pdf on March 8, 2022.
 31 The Secretary may exercise this authority under section 1135 of the Social Security Act.


 32 85 Fed. Reg. 15337 (March 18, 2020).

 33 Seema Verma, “Early Impact Of CMS Expansion Of Medicare Telehealth During COVID-19,” Health Affairs Forefront, July 15,

 2020, DOI: 10.1377/forefront.20200715.454789. Accessed at
 https://www.healthaffairs.org/do/10.1377/forefront.20200715.454789/full/ on March 8, 2022.
 34 85 Fed. Reg. 19230 (April 6, 2020).

 35 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, updated May 24, 2021.
                                                                                                     Accessed at
 https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf on March 8, 2022.
 36 85 Fed. Reg. 19230 (April 6, 2020).


 37 P.L. No. 116-136, § 3708, March 27, 2020.

 38 CMS, Medicare Telemedicine Health Care Provider Fact Sheet, March 17, 2020.
                                                                           Accessed at
 https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet on August 18, 2022.
 39 OIG, Telehealth Was Critical for Providing Services to Medicare Beneficiaries During the First Year of the COVID-19 Pandemic,

 OEI-02-20-00520, March 15, 2022. Accessed at https://oig.hhs.gov/oei/reports/OEI-02-20-00520.asp on March 29, 2022.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                         Endnotes | 52
 40 Videoconferencing involves live audiovisual communication between participants, in this case the health care provider and

 the patient. Examples include Facetime or Zoom video calls.
 41 HHS, What is telehealth?   Accessed at https://telehealth.hhs.gov/patients/understanding-telehealth/ on May 17, 2022.
 42 CMS, Medicare Telemedicine Health Care Provider Fact Sheet, March 17, 2020.
                                                                           Accessed at
 https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet on March 18, 2022.
 43 42 CFR § 409.43(a)(3)(i)(B); 42 CFR § 409.46(e).


 44 85 Fed. Reg. 70298, 70322-70325 (November 4, 2020).

 45 P.L. No. 116-136, § 3707, March 27, 2020.

 46 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, updated May 24, 2021.
                                                                                                     Accessed at
 https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf on March 18, 2022.
 47 CMS, Medicare Telemedicine Health Care Provider Fact Sheet, March 17, 2020.
                                                                              Accessed at
 https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet on March 18, 2022;
 CMS, COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing, § AA, Question 1, updated
 February 28, 2022.
 48 85 Fed. Reg. 19230, 19285 (April 6, 2020).

 49 CMS, COVID-19 Frequently Asked Questions (FAQ) on Medicare Fee-for-Service (FFS) Billing, § AA, Question 2, updated

 January 7, 2021, p. 116. Accessed at https://edit.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-
 faqs-31720.pdf on March 8, 2022.
 50 85 Fed. Reg. 70298, 70354 (November 4, 2020).


 51 Social Security Act § 1895(e)(1).

 52 42 CFR § 409.46(e).

 53 Cost reports are reports submitted to CMS that include important statistical and financial data.
                                                                                              CMS uses cost reports to
 understand each HHA’s financial situation, among other purposes. CMS requires HHAs to submit cost reports annually.
 Providers must submit them no later than 5 months after the end of the year covered.
 54 85 Fed. Reg. 70298, 70312 (November 4, 2020).


 55 Accessed at https://telehealth.hhs.gov/patients/understanding-telehealth on July 25, 2022.

 56 Accessed at https://edit.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-faqs-31720.pdf on July

 29, 2022.
 57 Seema Verma, “Early Impact Of CMS Expansion Of Medicare Telehealth During COVID-19,” Health Affairs Forefront, July 15,

 2020, DOI: 10.1377/forefront.20200715.454789. Accessed at
 https://www.healthaffairs.org/do/10.1377/forefront.20200715.454789/full/ on March 8, 2022.
 58 OIG, Telehealth Was Critical for Providing Services to Medicare Beneficiaries During the First Year of the COVID-19 Pandemic,

 OEI-02-20-00520, March 15, 2022. Accessed at https://oig.hhs.gov/oei/reports/OEI-02-20-00520.asp on August 19, 2022.
 59 MedPAC, “Chapter 8 - Home health care services,” Report to the Congress: Medicare Payment Policy, March 2022, pp. 285-

 286. Accessed at https://www.medpac.gov/wp-content/uploads/2022/03/Mar22_MedPAC_ReportToCongress_SEC.pdf on
 August 17, 2022.
 60 OIG, Telehealth Was Critical for Providing Services to Medicare Beneficiaries During the First Year of the COVID-19 Pandemic,

 OEI-02-20-00520, March 2022. Accessed at https://oig.hhs.gov/oei/reports/OEI-02-20-00520.pdf on April 29, 2022.
 61 MedPAC, “Chapter 4 – Physician and other health professional services,” Report to the Congress: Medicare Payment Policy,

 March 2022, pp. 129-130. Accessed at https://www.medpac.gov/wp-
 content/uploads/2022/03/Mar22_MedPAC_ReportToCongress_SEC.pdf on August 17, 2022.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                         Endnotes | 53
 62 81 Fed. Reg. 63860 (September 16, 2016).

 63 CMS, “Appendix Z- Emergency Preparedness for All Provider and Certified Supplier Types, Interpretive Guidance,” State

 Operations Manual, Rev. 204, April 16, 2021. Accessed at https://www.cms.gov/Regulations-and-
 Guidance/Guidance/Manuals/Downloads/som107ap_z_emergprep.pdf on April 11, 2022.
 64 42 CFR § 484.102.

 65 Accessed at https://www.cms.gov/Medicare/Provider-Enrollment-and-

 Certification/SurveyCertEmergPrep/Downloads/CMS-Understanding-the-EP-Final-Rule-Update-BRIII-2019.pdf and
 https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Downloads/FAQ-Round-Four-
 Definitions.pdf on April 29, 2022.
 66 CMS, “Appendix Z- Emergency Preparedness for All Provider and Certified Supplier Types, Interpretive Guidance,” State

 Operations Manual, Rev. 204, April 16, 2021. Accessed at https://www.cms.gov/Regulations-and-
 Guidance/Guidance/Manuals/Downloads/som107ap_z_emergprep.pdf on April 11, 2022.
 67 CMS, “Appendix Z- Emergency Preparedness for All Provider and Certified Supplier Types, Interpretive Guidance,” State

 Operations Manual, Rev. 204, April 16, 2021. Accessed at https://www.cms.gov/Regulations-and-
 Guidance/Guidance/Manuals/Downloads/som107ap_z_emergprep.pdf on April 11, 2022.
 68 CMS, Emergency Preparedness: Provider Readiness (EP_PR).
                                                          Accessed at
 https://qsep.cms.gov/pubs/ClassInformation.aspx?cid=0CMSEPPR_WEB on July 27, 2022.
 69 CMS, Emergency Preparedness Basic Training.
                                             Accessed at
 https://qsep.cms.gov/pubs/CourseMenu.aspx?cid=0CMSEmPrep_ONL on July 27, 2022.
 70 ASPR was formerly known as the Office of the Assistant Secretary for Preparedness and Response.

 71 OIG, Six of Eight Home Health Agency Providers Had Infection Control Policies and Procedures That Complied With CMS

 Requirements and Followed CMS COVID-19 Guidance To Safeguard Medicare Beneficiaries, Caregivers, and Staff During the
 COVID-19 Pandemic, A-01-20-00508, September 24, 2021. Accessed at
 https://oig.hhs.gov/oas/reports/region1/12000508.asp on March 8, 2022.
 72 OIG, Audit of Home Health Services Provided as Telehealth During the COVID-19 Public Health Emergency.
                                                                                                    Accessed at
 https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000553.asp on March 8, 2022.
 73 OIG, Reliance on Unverified Patient Lists Creates a Vulnerability in Home Health Surveys, OEI-05-16-00510, March 5, 2018.

 Accessed at https://oig.hhs.gov/oei/reports/oei-05-16-00510.asp on March 8, 2022.
 74 OIG, Nationwide Analysis of Common Characteristics in OIG Home Health Fraud Cases, OEI-05-16-00031, June 21, 2016.

 Accessed at https://oig.hhs.gov/oei/reports/oei-05-16-00031.asp on March 8, 2022.
 75 Of the 400 sampled HHAs, 19 were closed and 4 did not participate in Medicare at the time of our survey.

 76 The HHS Health Resources and Services Administration (HRSA) administers the Provider Relief Fund, which is funding that

 is distributed to health care providers affected by the COVID-19 pandemic. Any HHA may apply to receive financial
 assistance. HRSA, Provider Relief Fund. Accessed at https://www.hrsa.gov/sites/default/files/hrsa/provider-relief/phase4-arp-
 toolkit.pdf on August 18, 2022.
 77 86 Fed. Reg. 62240, 62421 (November 9, 2021).

 78 85 Fed. Reg. 70298, 70354 (November 4, 2020).


 79 All references to telehealth in this section are specific to HHAs that used telehealth during the pandemic.

 80 85 Fed. Reg. 70298, 70325 (November 4, 2020).

 81 HHAs submit their cost reports no later than 5 months after the end of the year that the cost report covers.For example,
 an HHA may submit a cost report covering January 1, 2021, to December 31, 2021, in May 2022. After submission, Medicare
 Administrative Contractors audit the cost reports, which regulations specify should happen within one year of receiving the
 cost report. (42 CFR § 413.24(f)(2)(i) and 42 CFR § 405.1835(c)(1).)




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                         Endnotes | 54
 82 87 Fed. Reg. 37600, 37658-37659 (June 23, 2022).

 83 We removed five HHAs from our scope because of their concurrent involvement in another OIG study.

 84 We considered an HHA closed if either (1) the HHA’s corporate office told us that the HHA was closed or (2) the HHA’s

 number was disconnected and mail sent to the HHA was returned to us.
 85 During our contact attempts, we noted that at least 21 nonresponding HHAs had changed their address and 13 had phone

 connection issues (e.g., disconnected phone line). Challenges accessing these HHAs may at least partially explain our
 response rate.
 86 We identified 314 HHAs that submitted 2019 Medicare claims in our sample, 225 of which responded to the survey.

 87 We based our definition of rural HHAs on MedPAC’s analysis of “majority rural” freestanding HHAs in the March 2021

 Medicare Payment Policy report. MedPAC calculated that 18 percent of freestanding HHAs were majority rural in 2019, the
 same percentage of rural HHAs with 2019 Medicare claims that responded to our survey. For MedPAC’s definition of
 “majority rural” HHAs: MedPAC, “Chapter 8 - Home health care services,” Report to the Congress: Medicare Payment Policy,
 March 2021, p. 243, table 8-7. Accessed at https://www.medpac.gov/wp-
 content/uploads/import_data/scrape_files/docs/default-source/reports/mar21_medpac_report_to_the_congress_sec.pdf on
 August 17, 2022.
 88 Of the 314 HHAs with 2019 Medicare claims in our sample, 53 were rural (17 percent).


 89 42 CFR § 484.70 and 86 Fed. Reg. 61555, 61621-61622 (November 5, 2021).

 90 42 CFR § 484.70 and 86 Fed. Reg. 61555, 61621-61622 (November 5, 2021).


 91 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, April 7, 2022, updated August 18, 2022.

 Accessed at https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf on October 4, 2022.
 92 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, April 7, 2022, updated August 18, 2022.

 Accessed at https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf on October 4, 2022.
 93 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, April 7, 2022, updated August 18, 2022.

 Accessed at https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf on October 4, 2022.
 94 CMS, Medicare Telemedicine Health Care Provider Fact Sheet, March 17, 2020.Accessed at
 https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet on July 11, 2022; CMS,
 COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing, § AA, Question 1, updated February 28,
 2022.
 95 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, April 7, 2022, updated August 18, 2022.

 Accessed at https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf on October 4, 2022.
 96 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, April 7, 2022, updated August 18, 2022.

 Accessed at https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf on October 4, 2022.
 97 P. L No. 116-136, § 3708(f), March 27, 2020.

 98 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, April 7, 2022, updated August 18, 2022.

 Accessed at https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf on October 4, 2022.
 99 P.L. No. 116-260, division CC, § 115, December 27, 2020.

 100 85 Fed. Reg. 70298, 70354 (November 4, 2020).

 101 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, April 7, 2022, updated August 18, 2022.

 Accessed at https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf on October 4, 2022.
 102 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, April 7, 2022, updated August 18, 2022.

 Accessed at https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf on October 4, 2022.




Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist
OEI-01-21-00110                                                                                         Endnotes | 55
 103 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, April 7, 2022, updated August 18, 2022.

 Accessed at https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf on October 4, 2022.
 104 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, April 7, 2022, updated August 18, 2022.

 Accessed at https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf on October 4, 2022.
 105 CMS, Home Health Quality Reporting Program (HH QRP) COVID-19 Public Health Emergency (PHE) Tip Sheet.      Accessed at
 https://www.cms.gov/files/document/hhqrp-covid19phetipsheet-july2020v2.pdf on January 26, 2022.
 106 85 Fed. Reg. 27550, 27629 (May 8, 2020).

 107 CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, April 7, 2022, updated August 18, 2022.

 Accessed at https://www.cms.gov/files/document/covid-19-emergency-declaration-waivers.pdf on October 4, 2022.
 108 CMS, Review Choice Demonstration for Home Health Services: Resumption of Demonstration Activities Update: 07/07/2020.

 Accessed at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-
 Programs/Review-Choice-Demonstration/Review-Choice-Demonstration-for-Home-Health-Services on January 22, 2022.
 109 CMS, COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing, § V, Question 1, updated

 February 28, 2022.




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OEI-01-21-00110                                                                                         Endnotes | 56


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