Full text
Department of Health and Human Services
OFFICE OF
INSPECTOR GENERAL
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
Amy J. Frontz
Deputy Inspector General
for Audit Services
September 2021
A-01-20-00508
Inquiries about this report may be addressed to the Office of Public Affairs at
Public.Affairs@oig.hhs.gov.
Office of Inspector General
https://oig.hhs.gov
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:
Office of Audit Services
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.
Office of Evaluation and Inspections
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.
Office of Investigations
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.
Office of Counsel to the Inspector General
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.
Notices
THIS REPORT IS AVAILABLE TO THE PUBLIC
at https://oig.hhs.gov
Section 8M of the Inspector General Act, 5 U.S.C. App., requires
that OIG post its publicly available reports on the OIG website.
OFFICE OF AUDIT SERVICES FINDINGS AND OPINIONS
The designation of financial or management practices as
questionable, a recommendation for the disallowance of costs
incurred or claimed, and any other conclusions and
recommendations in this report represent the findings and
opinions of OAS. Authorized officials of the HHS operating
divisions will make final determination on these matters.
Report in Brief
Date: September 2021
Report No. A-01-20-00508
Why OIG Did This Audit
Medicare beneficiaries receiving
home health services may be at a
high risk of developing severe illness
from COVID-19. Home health
agencies (HHAs) must comply with
the Centers for Medicare & Medicaid
Services’ (CMS’s) infection prevention
and control requirements and follow
CMS guidance by having policies and
procedures to protect HHA staff,
Medicare beneficiaries, and
caregivers during the pandemic.
Our objective was to determine
whether eight selected HHAs had
infection control policies and
procedures that complied with CMS
requirements and followed CMS
guidance to safeguard HHA staff,
Medicare beneficiaries, and
caregivers during the COVID‐19
pandemic.
How OIG Did This Audit
Our audit covered the infection
prevention and control policies and
procedures for eight HHA providers.
We reviewed each HHA provider’s
policies and procedures to determine
whether they include: (1) guidance
for following standards of practice,
(2) a coordinated agencywide
infection control program, and
(3) infection control education for
HHA staff, Medicare beneficiaries,
and caregivers. We also determined
whether the HHA providers’ policies
and procedures followed CMS
COVID-19 guidance for: (1) screening
patients, (2) screening staff, and
(3) treating patients with known or
suspected COVID-19.
The full report can be found at https://oig.hhs.gov/oas/reports/region1/12000508.asp.
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
What OIG Found
Six of the eight selected HHA providers had infection control policies and
procedures that complied with CMS requirements and followed CMS
guidance to safeguard HHA staff, Medicare beneficiaries, and caregivers
during the COVID‐19 pandemic. However, one HHA provider did not comply
with CMS requirements or follow CMS COVID-19 guidance. Specifically, this
HHA provider’s infection control policies and procedures did not: (1) require
staff to follow one of the standard precautions to prevent the transmission of
infections and communicable diseases, (2) include documentation of
surveillance methods used for identifying and tracking infections and
improvement activities to prevent infection, (3) include COVID-19 screening
protocols for staff in accordance with CMS guidance, and (4) include
information about how to care for patients with known or suspected
COVID-19 in accordance with CMS guidance. In addition, this provider and
another HHA provider’s COVID-19 screening protocols for patients were not
consistent with CMS guidance. As a result, the patients and staff at these two
HHA providers were at an increased risk of infection. We did not determine
whether these HHA providers had infection prevention and control issues
related to the implementation of the policies and procedures. However,
State survey agencies identified issues with implementation at several of
these HHA providers, as indicated by infection prevention and control
deficiencies found during surveys conducted in 2019 and 2020.
What OIG Recommends and CMS Comments
We recommend that CMS develop and share with the HHA industry
information on COVID-19 infection prevention and control best practices that
HHA providers can use to comply with CMS requirements and follow CMS
guidance.
CMS concurred with our recommendation. CMS stated that it has provided
education and outreach to HHAs on CMS quality and safety standards to
support their infection prevention and control efforts. CMS also stated that it
will continue to share information on best practices with the HHA industry.
HHA Providers Complied With CMS Infection Control Requirements During the Pandemic (A-01-20-00508)
TABLE OF CONTENTS
INTRODUCTION ............................................................................................................................1
Why We Did This Audit ....................................................................................................1
Objective ..........................................................................................................................1
Background ......................................................................................................................1
The Medicare Program and Home Health Services .............................................1
Medicare Requirements for Infection Control at Home Health Agencies ..........2
Survey and Certification of Home Health Agencies .............................................2
CMS and CDC Guidance During the COVID-19 Pandemic ....................................2
Medicare Home Health Claims With COVID-19 Diagnosis Codes........................3
How We Conducted This Audit ........................................................................................3
FINDINGS ......................................................................................................................................4
Seven of Eight Home Health Agency Providers Had Infection Prevention and
Control Policies and Procedures That Complied With CMS Requirements .............5
Seven of Eight Home Health Agency Providers Had Infection Control
Policies and Procedures That Complied With CMS Requirements
for Infection Prevention ...............................................................................5
Seven of Eight Home Health Agency Providers Had Infection Control
Policies and Procedures That Complied With CMS Requirements
for Infection Control .....................................................................................5
Eight Home Health Agency Providers Had Infection Control Policies and
Procedures That Complied With CMS Requirements for Infection
Control Education .........................................................................................6
Six of Eight Home Health Agency Providers Had Infection Control Policies and
Procedures That Followed CMS COVID-19 Guidance ..............................................7
Seven of the Eight Home Health Agency Providers Had Infection
Control Policies and Procedures That Followed CMS Guidance for
Screening Staff for COVID-19 .......................................................................7
Seven of the Eight Home Health Agency Providers Had Infection Control
Policies and Procedures That Followed CMS Guidance for Treating
Patients With Known or Suspected COVID-19 .............................................7
Six of the Eight Home Health Agency Providers Had Infection Control
Policies and Procedures That Followed CMS Guidance for Screening
Patients for COVID-19 ..................................................................................8
CONCLUSION ................................................................................................................................9
HHA Providers Complied With CMS Infection Control Requirements During the Pandemic (A-01-20-00508)
RECOMMENDATION ....................................................................................................................10
CMS COMMENTS .........................................................................................................................10
OTHER MATTERS: POTENTIAL HOME HEALTH AGENCY INFECTION PREVENTION AND
CONTROL BEST PRACTICES DURING THE COVID-19 PANDEMIC .............................................10
Screening Staff for COVID-19 ...........................................................................................10
Caring for Patients With Known or Suspected COVID-19 ................................................11
Screening Patients for COVID-19 .....................................................................................11
APPENDICES
A: Audit Scope and Methodology ....................................................................................12
B: Medicare Home Health Claims With a COVID-19 Diagnosis Code by State ................14
C: CMS Comments ...........................................................................................................16
HHA Providers Complied With CMS Infection Control Requirements During the Pandemic (A-01-20-00508)
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INTRODUCTION
WHY WE DID THIS AUDIT
Medicare covers home health services for the elderly and for people with disabilities. Medicare
beneficiaries who receive home health services often have underlying medical conditions.
COVID-19 is especially dangerous for such individuals. Additionally, because home health
agency (HHA) staff see several patients in their homes each week, the staff’s risk of exposure to
COVID-19 increases. This also increases the risk that they expose their patients and their
patients’ caregivers, such as family members, friends, or neighbors, to the virus. Because home
health patients are vulnerable and the risk of exposure to COVID-19 is high, it is critical that
HHA providers comply with the Centers for Medicare & Medicaid Services’ (CMS’s) infection
prevention and control requirements and COVID-19 guidance by having policies and procedures
to protect HHA staff, Medicare beneficiaries, and caregivers during the COVID-19 pandemic.
OBJECTIVE
Our objective was to determine whether eight selected HHA providers had infection control
policies and procedures that complied with CMS requirements and followed CMS guidance to
safeguard HHA staff, Medicare beneficiaries, and caregivers during the COVID‐19 pandemic.
BACKGROUND
The Medicare Program and Home Health Services
The Medicare program, established by Title XVIII of the Social Security Act, provides health
insurance coverage to people aged 65 and over, people with disabilities, and people with
end-stage renal disease. CMS administers the Medicare program. Medicare Part A provides
inpatient hospital insurance benefits and coverage of extended care services for patients after
hospital discharge, and Medicare Part B provides supplementary medical insurance for medical
and other health services, including coverage of hospital outpatient services.
HHA services are covered for the elderly and people with disabilities under Medicare Parts A
and B. These services, provided under a plan of care that is established and periodically
reviewed by a physician, must be furnished by, or under arrangement with, an HHA provider
that participates in the Medicare or Medicaid programs. HHA services provided by a visiting
HHA worker in the beneficiary’s home may include, but are not limited to, skilled nursing care,
physical therapy, speech-language pathology, and occupational therapy.
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Medicare Requirements for Infection Control at Home Health Agencies
HHA providers must meet certain conditions of participation (CoPs) to participate in the
Medicare and Medicaid programs, including meeting infection prevention and control
standards. Federal regulations (42 CFR § 484.70) state:
[T]he HHA must maintain and document an infection control program which has as its
goal the prevention and control of infections and communicable diseases. (a) The HHA
must follow accepted standards of practice, including the use of standard precautions,
to prevent the transmission of infections and communicable diseases. (b) The HHA
must maintain a coordinated agency-wide program for the surveillance, identification,
prevention, control, and investigation of infectious and communicable diseases that is
an integral part of the HHA’s quality assessment and performance improvement (QAPI)
program. The infection control program must include: (1) A method for identifying
infectious and communicable disease problems; and (2) a plan for the appropriate
actions that are expected to result in improvement and disease prevention. (c) The HHA
must provide infection control education to staff, patients, and caregiver(s).
Survey and Certification of Home Health Agencies
CMS is responsible for overseeing compliance with Medicare health and safety standards. CMS
delegates a variety of tasks related to this oversight to the State survey agencies (the Social
Security Act § 1864). One of these tasks is to conduct investigations and fact-finding surveys to
determine how well health care providers, including HHA providers, comply with their
applicable CoPs. Standard surveys of HHA providers must occur no later than 36 months after
the previous survey. The State survey agencies cite HHA providers with deficiencies when they
do not meet the CoPs, including not following infection prevention and control requirements.
CMS and CDC Guidance During the COVID-19 Pandemic
On March 10, 2020, CMS issued a State Survey Directors’ Letter (CMS Letter) to provide HHA
providers with guidance on minimizing the transmission of COVID-19.1 The CMS Letter stated
that HHA providers should monitor the health status of patients and staff in the home care
setting for signs or symptoms of COVID-19.2 CMS also recommended that HHA providers
monitor the Centers for Disease Control and Prevention (CDC) website for information and
1 The CMS Letter is titled: Guidance for Infection Control and Prevention Concerning [COVID-19] in [HHA providers]
and Religious Nonmedical Healthcare Institutions (RNHCIs) (QSO-20-18-HHA). This CMS Letter was revised on April
23, 2020, to include guidance for RNHCIs. Available online at https://www.cms.gov/files/document/qso-20-18-
hha-revised.pdf.
2 State survey agencies conducted surveys and investigated complaints during the COVID-19 pandemic. State
survey agencies assessed whether HHA providers were following COVID-19 infection control guidance, including
whether they screened patients and staff for COVID-19 and tracked patient and staff COVID-19 infections.
HHA Providers Complied With CMS Infection Control Requirements During the Pandemic (A-01-20-00508)
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resources and follow CDC’s Interim Guidance for Public Health Personnel Evaluating Persons
Under Investigation (PUIs) and Asymptomatic Close Contacts of Confirmed Cases at Their Home
or Non-Home Residential Settings for information on recommended personal protective
equipment (PPE) when treating patients with known or suspected COVID-19.
Medicare Home Health Claims With COVID-19 Diagnosis Codes
There are approximately 11,100 HHA providers participating in the Medicare program. During
2020, 4,854 HHA providers submitted 79,131 Medicare claims with a COVID-19 principal
diagnosis code for 54,849 beneficiaries from 54 States and U.S. Territories. Appendix B contains
a table showing the number of HHA claims containing a COVID-19 diagnosis code by State for
calendar year 2020.
HOW WE CONDUCTED THIS AUDIT
Our audit covered the infection prevention and control policies and procedures for eight HHA
providers.3 We selected three of the largest HHA providers in the country, and we
judgmentally selected five HHA providers that were cited for infection prevention and control
deficiencies during surveys conducted in 2019 and 2020 for review.4 We had the eight HHA
providers complete a questionnaire on their infection prevention and control programs and
COVID-19 responses and provide us with their infection control policies and procedures. We
reviewed each HHA provider’s questionnaire responses and policies and procedures to
determine whether they include: (1) guidance for following standards of practice, including all
standard precautions; (2) a coordinated agencywide program for the surveillance,
identification, prevention, control, and investigation of infections and communicable diseases;
and
(3) infection control education for HHA staff, Medicare beneficiaries, and caregivers. We also
determined whether the HHA providers developed additional infection control measures in
accordance with CMS guidance in response to the COVID-19 pandemic. Specifically, we
determined whether each HHA provider’s policies and procedures included guidance for:
(1) screening patients, (2) screening staff, and (3) treating patients with known or suspected
COVID-19 in accordance with CMS guidance.
3 Our review was limited to policies and procedures documented by the HHA providers selected for review. We
did not determine how those policies and procedures were implemented.
4 Seven of the eight selected HHA providers submitted Medicare claims containing a principal diagnosis code for
COVID-19 in 2020. Additionally, the five judgmentally selected HHA providers were cited for various reasons
including failure to: (1) follow standard precautions; (2) properly document infections and resolution; (3) provide
or document infection prevention and control education; and (4) document or maintain an infection surveillance
program. Two of these five HHA providers were cited for immediate jeopardy for failing to properly prevent
infections and ensure the health and safety of patients. Immediate jeopardy means a situation in which the
provider’s or supplier’s noncompliance with one or more Medicare requirements, CoPs, or conditions for coverage
or certification has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident or patient
(42 CFR § 488.1).
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We conducted this performance audit in accordance with generally accepted government
auditing standards. Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions
based on our audit objectives. We believe that the evidence obtained provides a reasonable
basis for our findings and conclusions based on our audit objectives.
Appendix A contains the details of our audit scope and methodology.
FINDINGS
Six of the eight selected HHA providers had infection control policies and procedures that
complied with CMS requirements and followed CMS guidance to safeguard HHA staff, Medicare
beneficiaries, and caregivers during the COVID‐19 pandemic. However, one HHA provider did
not have infection control policies and procedures that complied with CMS requirements or
followed CMS COVID-19 guidance. Specifically, this HHA provider’s infection control policies
and procedures did not:
• require staff to follow one of the standard precautions to prevent the transmission of
infections and communicable diseases,
• include documentation of surveillance methods used for identifying and tracking
infections and improvement activities to prevent infection,
• include COVID-19 screening protocols for staff in accordance with CMS guidance, and
• include information about how to care for patients with known or suspected COVID-19
in accordance with CMS guidance.
In addition, this provider and another HHA provider’s COVID-19 screening protocols for patients
were not consistent with CMS guidance. As a result, the patients and staff associated with the
two HHA providers were at an increased risk of infection.
We did not determine whether these HHA providers had infection prevention and control
issues related to the implementation of the policies and procedures. However, State survey
agencies identified issues with implementation at several of these HHA providers, as indicated
by infection prevention and control deficiencies found during surveys conducted in 2019 and
2020.5
5 These previous deficiencies were sometimes the result of HHA staff failing to properly implement provider
policies and procedures. For example, one of these HHA providers was cited with an infection prevention
deficiency because staff did not follow CMS and agency policy for proper hand hygiene while caring for patients.
Therefore, while the policy was in place, the HHA provider did not ensure that the staff followed it to prevent
infection. Our review of the State survey agencies’ infection prevention and control deficiencies was limited to the
five judgmentally selected HHA providers.
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SEVEN OF EIGHT HOME HEALTH AGENCY PROVIDERS HAD INFECTION PREVENTION AND
CONTROL POLICIES AND PROCEDURES THAT COMPLIED WITH CMS REQUIREMENTS
Seven of Eight Home Health Agency Providers Had Infection Control Policies and Procedures
That Complied With CMS Requirements for Infection Prevention
HHA providers must maintain and document an infection control program with the goals of
prevention and control of infections and communicable diseases (42 CFR § 484.70). HHA
providers must follow accepted standards of practice, including the use of standard
precautions, to prevent infection and disease (42 CFR § 484.70 (a)). HHA providers must follow
six standard precautions during any episode of patient care. The standard precautions include
hand hygiene, environmental cleaning and disinfection, injection and medication safety,
appropriate use of PPE, minimizing potential exposures, and reprocessing of reusable medical
equipment between each patient when soiled. The HHA providers must have written infection
prevention policies and procedures that are widely available and based on current standards of
practice (Medicare State Operations Manual (SOM), Appendix B—Guidance to Surveyors: Home
Health Agencies).
We determined that seven of the eight HHA providers had policies and procedures that
instructed staff to follow standards of practice, including the use of all standard precautions.6
These HHA providers had polices for proper hand hygiene, environmental cleaning and
disinfection, injection and medication safety, appropriate use of PPE, minimizing potential
exposures, and reprocessing of reusable medical equipment. However, one HHA provider’s
infection control policies and procedures did not include guidelines for safe injection practices.
The HHA provider stated that injection and medication safety was not applicable to the
infection control program.7 The HHA provider also did not respond to our requests for further
explanation on why injection and medication safety was not applicable or documented in its
infection control policies and procedures.
Seven of Eight Home Health Agency Providers Had Infection Control Policies and Procedures
That Complied With CMS Requirements for Infection Control
HHA providers must maintain coordinated agencywide programs for the surveillance,
identification, prevention, control, and investigation of infectious and communicable diseases
that are an integral part of the HHA provider’s QAPI program (42 CFR § 484.70 (b)). Infection
control programs must include methods for identifying infectious and communicable disease
problems and plans for the appropriate actions that are expected to result in improvement and
6 Three of the five judgmentally selected HHA providers were cited by State survey agencies in 2019 for infection
prevention deficiencies. However, the HHA providers’ policies and procedures that we reviewed complied with
CMS requirements for infection prevention.
7 The HHA provider indicated that the standard precaution for reprocessing of reusable medical equipment
between each patient when soiled was also not applicable to its infection control program. However, the HHA
provider’s infection control policies included guidelines for cleaning and reusing medical equipment.
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disease prevention (42 CFR § 484.70 (b) (1-2)). Actions that facilitate improvement and disease
prevention may include changing policies and procedures to improve care and educating
patients, caregivers, and HHA staff to prevent infections (SOM, Appendix B—Guidance to
Surveyors: Home Health Agencies).
We found that seven of the eight HHA providers’ policies and procedures included a
coordinated agencywide program for the surveillance, identification, prevention, control, and
investigation of infectious and communicable diseases.8 These HHA providers had
documentation of the methods they used to identify and track infections. However, we
determined that one of the HHA providers did not provide documentation or information on its
surveillance methods for identifying and tracking infections. This HHA provider was also cited
by the State survey agency in 2019 for failure to maintain a coordinated agencywide program
for surveillance, identification, prevention, control, and investigation of infectious and
communicable diseases that was part of its quality assessment and QAPI program. The HHA
provider’s infection control policy included requirements for staff to report infections and take
appropriate performance-improvement actions. However, the HHA provider did not respond
to our requests for additional information on how it tracks and analyzes infection data or
evidence that it implements performance-improvement actions as part of its QAPI program.
Eight Home Health Agency Providers Had Infection Control Policies and Procedures That
Complied With CMS Requirements for Infection Control Education
HHA providers must provide infection control education to staff, patients, and caregiver(s)
(42 CFR § 484.70 (c)). HHA providers must provide education at orientation, annually, and as
needed to meet the staff’s learning needs to: provide adequate care; identify infection signs
and symptoms; identify routes of infection transmission; appropriately disinfect, sanitize, and
transport equipment and devices used for patient care; and use proper medical waste disposal
techniques. Such education must include instructions on how to implement current infection
prevention and treatment practices in the home setting (SOM, Appendix B).
All eight HHA providers had policies and procedures requiring staff to receive education at
orientation, annually, and as needed to meet their learning needs.9 The HHA providers
documented a variety of education methods for staff, patients, and caregivers including online
learning course schedules, onsite supervision checklists, written policies and procedures, and
informational handouts for patients and caregivers. The HHA providers informed us that they
track staff training requirements through attendance records and personnel files.
8 Two of the five judgmentally selected HHA providers were cited by State survey agencies in 2019 for infection
control deficiencies. Furthermore, only one of these HHA provider’s policies and procedures that we reviewed
complied with CMS requirements for infection control.
9 One of the five judgmentally selected HHA providers was cited by the State survey agency in 2020 for an infection
control education deficiency. However, the HHA provider’s policies and procedures that we reviewed complied
with CMS requirements for infection control education.
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SIX OF EIGHT HOME HEALTH AGENCY PROVIDERS HAD INFECTION CONTROL POLICIES AND
PROCEDURES THAT FOLLOWED CMS COVID-19 GUIDANCE
Seven of the Eight HHA Providers Had Infection Control Policies and Procedures That
Followed CMS Guidance for Screening Staff for COVID-19
HHA staff with signs and symptoms of a respiratory infection should not report to work. Staff
that develop signs and symptoms during work, should immediately stop, inform the clinical
manager, and self-isolate at home. Clinical managers should obtain information from the staff
about recent contact with individuals and equipment for contact tracing to identify patients and
staff who may also have been exposed (CMS Letter).
We determined that seven of the eight HHA providers developed policies and procedures that
require staff to self-assess symptoms and report symptoms and exposures to management.10
These HHA providers documented actions for staff to take if they are exposed or experience
COVID-19 symptoms, including stopping work, testing for COVID-19, and quarantining at home.
These HHA providers also developed guidelines for returning to work after quarantining for
COVID-19. These HHA providers had a variety of tools including online reporting systems and
questionnaires that require staff to report whether they have any symptoms or were exposed
to COVID-19. (See Other Matters for a list of potential best practices for HHA providers during
the COVID-19 pandemic.) One of the HHA providers did not develop policies and procedures
for staff to self-assess for COVID-19. However, this HHA provider had a policy that required
staff to self-quarantine before returning if they traveled outside their work area. This HHA
provider did not respond to our requests for additional information on actions taken to
safeguard patients and staff during the COVID-19 pandemic.
Seven of the Eight Home Health Agency Providers Had Infection Control Policies and
Procedures That Followed CMS Guidance for Treating Patients With Known or Suspected
COVID-19
HHA providers should continue to provide appropriate patient care for the severity of a
patient’s illness and overall clinical condition for the patient with known or suspected
COVID-19. HHA providers should limit the number of staff to essential personnel and ensure
that supplies are cleaned and disinfected in accordance with environmental infection control
guidelines. Hand hygiene should be performed before putting on and after removing PPE using
alcohol-based hand sanitizer with greater than 60 percent ethanol or 70 percent isopropanol or
washing hands with soap and water for at least 20 seconds. CMS recommends that HHA staff
put on PPE outside of the home prior to entry, if possible. PPE should ideally be removed
outside of the home and discarded by placing in an external trash can before departing the
location (CMS Letter). When treating patients with known or suspected COVID-19, CMS
recommends that HHA staff wear all PPE recommended by CDC. CDC recommends that public
10 We determined that none of the five judgmentally selected HHA providers were cited by State survey agencies
for infection prevention and control deficiencies related to CMS guidance for screening staff for COVID-19.
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health personnel wear gowns, gloves, eye protection such as goggles or a disposable face
shields that cover the front and sides of the face, and respiratory protection such as an
N-95 or higher-level respirator or facemask approved by the National Institute for Occupational
Safety and Health.11
We found that seven of the eight HHA providers developed policies and procedures for treating
patients with known or suspected COVID-19.12 The seven HHA providers developed education
material for cleaning and disinfecting equipment and properly donning and doffing PPE, reusing
PPE when supplies were low, and properly disposing of PPE. The HHA providers had charts,
diagrams, and instructions to educate staff, patients, and caregivers. One of the eight HHA
providers did not develop policies and procedures for treating patients with known or
suspected COVID-19. This HHA provider did not update its guidelines for properly using PPE to
prevent infection during the COVID-19 pandemic. The HHA provider’s policies and procedures
focused on helping patients and staff identify COVID-19 symptoms. These policies and
procedures also provided general information about steps to take to prevent the spread of the
virus, including limiting travel and staying home when possible. The HHA provider did not
respond to our requests for additional information on actions taken to safeguard staff, patients,
and caregivers during the COVID-19 pandemic.
Six of the Eight Home Health Agency Providers Had Infection Control Policies and Procedures
That Followed CMS Guidance for Screening Patients for COVID-19
HHA providers should monitor the health status of patients and staff for signs or symptoms of
COVID-19. HHA providers should identify patients at risk for having COVID-19 infections before
or immediately upon arrival to the home. HHA staff should screen patients by asking about
whether the patient:
• traveled internationally within the last 14 days to countries with sustained community
transmission;
• had signs or symptoms of a respiratory infection, such as a fever, cough, and sore
throat;
• had contact with someone with or under investigation for COVID-19 or who is ill with
respiratory illness within the last 14 days; or
11 CDC guidance, “Interim Infection Control Guidance for Public Health Personnel Evaluating Persons Under
Investigation (PUIs) and Asymptomatic Close Contacts of Confirmed Cases at Their Home or Non-Home Residential
Settings Evaluating PUIs Residential” (updated April 10, 2020).
12 We determined that none of the five judgmentally selected HHA providers were cited by State survey agencies
for infection prevention and control deficiencies related to CMS guidance for treating patients with known or
suspected COVID-19.
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• resided in a community where community-based spread of COVID-19 is occurring.
HHA staff should inform the clinical manager and local and State public health authorities about
the presence of a person under investigation for COVID-19 (CMS Letter).
We determined that six of the eight HHA providers developed policies and procedures to screen
patients for COVID-19 in accordance with CMS guidance.13 These HHA providers’ policies and
procedures required staff to screen patients via telephone calls prior to the home visit through
a series of questions. Screening questions include asking patients about signs and symptoms,
recent exposure to someone with or under investigation for COVID-19, and recent travel to
areas with a high risk of transmission. These HHA providers had a variety of tools to screen
patients including online reporting systems to submit patient answers and document HHA
followup actions, checklists, and decision trees to determine how to proceed with caring for the
patient. These HHA providers’ policies and procedures required COVID-19 infections to be
reported to management and tracked.
We determined that the other two HHA providers’ patient screening protocols were not
consistent with CMS guidance. These two HHA providers had questionnaires to screen patients
for COVID-19 symptoms only. These HHA providers’ screening tools did not include asking
patients about recent exposure to someone with or under investigation for COVID-19 or about
recent travel. One HHA provider did not respond to our requests for additional information on
actions taken to safeguard patients and staff during the COVID-19 pandemic. The other HHA
provider informed us that it used the CMS Letter as a resource for staff. However, the HHA
provider did not incorporate the screening questions recommended in the letter into its
screening questionnaire.
CONCLUSION
The Medicare beneficiaries and staff associated with the two HHA providers that did not follow
CMS requirements and guidance for infection prevention and control were at an increased risk
of infection. Since we selected a judgmental sample of HHA providers, we cannot project the
results of our audit to HHA providers not included in our sample. However, other HHA
providers may or may not have developed additional infection prevention and control policies
and procedures consistent with CMS COVID-19 guidance. HHA providers should continue to
review and update infection control policies and procedures as needed and ensure HHA staff
are following them to reduce the risk of infection. The Other Matters section contains some
COVID-19 potential best practices identified as part of our review of the eight selected HHA
providers.
13 We determined that none of the five judgmentally selected HHA providers were cited by State survey agencies
for infection prevention and control deficiencies related to CMS guidance for screening patients for COVID-19.
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RECOMMENDATION
We recommend that the Centers for Medicare & Medicaid Services develop and share with the
HHA industry information on COVID-19 infection prevention and control best practices that
HHA providers can use to comply with CMS requirements and follow CMS guidance.
CMS COMMENTS
CMS concurred with our recommendation. CMS stated that it has provided education and
outreach to HHAs on CMS quality and safety standards to support their infection prevention
and control efforts. CMS also stated that it will continue to share information on best practices
with the HHA industry.
CMS also provided technical comments on our draft report, which we addressed as
appropriate. CMS’s comments, excluding the technical comments, are included as Appendix C.
OTHER MATTERS: POTENTIAL HOME HEALTH AGENCY INFECTION PREVENTION AND
CONTROL BEST PRACTICES DURING THE COVID-19 PANDEMIC
As part of our review of the infection prevention and control at the eight selected HHA
providers, we assessed the various policies and procedures, reporting tools, and education
material that the HHA providers developed in response to the COVID-19 pandemic that were
consistent with CMS guidance for screening staff, caring for patients with known or suspected
COVID-19, and screening patients. We identified potential best practices to the COVID-19
pandemic that other HHA providers not included in our sample could use to improve their own
infection prevention and control programs.
SCREENING STAFF FOR COVID-19
• Seven of the eight HHA providers had policies and procedures that required daily
COVID-19 screenings for staff conducted and documented prior to starting the workday
to assess for symptoms, possible exposure, and recent travel.
• Seven of the eight HHA providers informed us that they used a variety of methods to
instruct staff on the appropriate actions to take if they develop symptoms or are
exposed to a person with known or suspected COVID-19. These HHA providers
developed policies and procedures, COVID-19 exposure decision trees, and reporting
systems to record symptoms and infections and track actions taken by staff and
management. These HHA providers required staff to self-isolate immediately and notify
the supervisor for exposure tracking. They required staff to remain out of work until
they met appropriate return-to-work criteria set by CMS and CDC.
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CARING FOR PATIENTS WITH KNOWN OR SUSPECTED COVID-19
• Seven of the eight HHA providers had policies and procedures for using PPE while
treating Medicare patients during the COVID-19 pandemic.
• Seven of the eight HHA providers informed us that they used a variety of tools to
instruct staff on using PPE properly. These HHA providers developed policies and
procedures, PPE flow charts, and diagrams to clarify the appropriate PPE for staff.
These policies and procedures included instructions for properly using, reusing, and
disposing of PPE and the protocol for PPE when supplies are low.
• Seven of the eight HHA providers informed us that they updated their infection control
education for staff, patients, and caregivers to be consistent with the latest guidance
from CMS and CDC. These HHA providers informed us that they provided infection
control education through onsite supervision, online training, inservices, and posters
and handouts for patients and caregivers.
SCREENING PATIENTS FOR COVID-19
• Six of the eight HHA providers had policies and procedures that require COVID-19
screening for patients and caregivers to assess for symptoms, possible exposure, and
recent travel. These policies and procedures required patients to be screened via a
telephone call prior to the HHA visit, if possible. These HHA providers’ screening tools
included online reporting systems, questionnaires, and checklists.
• Six of the eight HHA providers informed us that they use a variety of tools to document
patient screening. These HHA providers developed policies and procedures, COVID-19
exposure decision trees, and reporting systems to record symptoms and infections and
track actions taken by staff to safeguard the patient. These HHA providers used patient
exposure decision trees and guidance to clarify the appropriate actions staff should take
if patients report symptoms or are exposed to a person with known or suspected
COVID-19.
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APPENDIX A: SCOPE AND METHODOLOGY
SCOPE
Our audit covered the infection prevention and control policies and procedures for eight HHA
providers. We selected three of the largest HHA providers in the country, and we judgmentally
selected five HHA providers that were cited for infection prevention and control deficiencies
during surveys conducted in 2019 and 2020 for review.14 We had the eight HHA providers
complete a questionnaire on their infection prevention and control programs and COVID-19
responses and provide us with their infection control policies and procedures. We reviewed
each HHA provider’s questionnaire responses and policies and procedures to determine
whether they include: (1) guidance for following standards of practice, including all standard
precautions; (2) a coordinated agencywide program for the surveillance, identification,
prevention, control, and investigation of infections and communicable diseases; and
(3) infection control education for staff and patients. We also reviewed the HHA providers’
questionnaire responses and supporting documentation to determine whether they
implemented additional infection control measures in accordance with CMS guidance in
response to the COVID-19 pandemic. Specifically, we determined whether each HHA provider’s
policies and procedures include guidance for: (1) screening patients, (2) screening staff, and
(3) treating patients with known or suspected COVID-19.
We determined that a review of CMS’s internal controls was not significant to accomplishing
our audit objective.
We conducted our audit from October 2020 to August 2021.
METHODOLOGY
To accomplish our objective, we:
• reviewed applicable Medicare laws, regulations, and guidance;
14 Seven of the eight selected HHA providers submitted Medicare claims containing a principal diagnosis code for
COVID-19 in 2020. Additionally, these five judgmentally selected HHA providers were cited for various reasons
including failure to: (1) follow standard precautions, (2) properly document infections and resolution, (3) provide
or document infection prevention and control education, and (4) document or maintain an infection surveillance
program. Two of these five HHA providers were cited for immediate jeopardy for failing to properly prevent
infections and ensure the health and safety of patients. Immediate jeopardy means a situation in which the
provider or supplier’s noncompliance with one or more Medicare requirements, CoPs, or conditions for coverage
or certification has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident or patient
(42 CFR § 488.1).
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• met with CMS program officials to gain an understanding of Medicare requirements and
guidance for infection prevention and control at HHA providers during the COVID-19
pandemic;
• obtained from CMS’s National Claims History file 79,131 HHA claims containing a
principal diagnosis code for COVID-19 for calendar year 2020;
• identified 53 HHA providers that were cited for infection control deficiencies during
State surveys conducted in 2019 and 2020;
• identified the HHA providers with the largest market share in the country in 2019;
• judgmentally selected three of the largest HHA providers in the country and five HHA
providers that were cited for infection control deficiencies in 2019 and 2020;
• developed a questionnaire to obtain information from the selected HHA providers on
their infection prevention, infection control, infection control education, and COVID-19
policies and procedures;
• reviewed the HHA providers’ responses to our questionnaire on infection prevention
and control, infection control education, and COVID-19 response;
• reviewed selected HHA providers’ infection prevention and control policies and
procedures to determine whether they complied with CMS requirements;
• reviewed selected HHA providers’ COVID-19 policies and procedures to determine
whether they complied with CMS guidance; and
• discussed the results of our audit with CMS officials.
We conducted this performance audit in accordance with generally accepted government
auditing standards. Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions
based on our audit objectives. We believe that the evidence obtained provides a reasonable
basis for our findings and conclusions based on our audit objectives.
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APPENDIX B: MEDICARE HOME HEALTH CLAIMS WITH A COVID-19 DIAGNOSIS CODE BY STATE
State
Number of Medicare HHA Claims With
COVID-19 Diagnosis*
Florida
5,973
Texas
5,487
New York
4,925
California
4,443
Illinois
3,982
Pennsylvania
3,320
New Jersey
3,004
Georgia
2,992
Michigan
2,884
Mississippi
2,826
Massachusetts
2,684
Louisiana
2,375
Alabama
2,215
South Carolina
2,194
Tennessee
2,163
North Carolina
2,062
Virginia
2,051
Maryland
1,981
Ohio
1,974
Missouri
1,830
Oklahoma
1,684
Indiana
1,675
Wisconsin
1,391
Connecticut
1,301
Arizona
1,180
Iowa
1,044
Kentucky
967
Minnesota
957
Kansas
843
Arkansas
787
Nebraska
617
Idaho
580
Colorado
567
Washington
553
Utah
529
Nevada
525
Delaware
405
South Dakota
274
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State
Number of Medicare HHA Claims With
COVID-19 Diagnosis
New Mexico
269
North Dakota
240
Rhode Island
216
West Virginia
209
New Hampshire
191
Oregon
157
Montana
154
Maine
121
Wyoming
112
District of Columbia
97
Vermont
50
Alaska
38
Hawaii
24
Puerto Rico
5
Guam
3
Virgin Islands
1
Total
79,131
* We obtained these data from CMS’s National Claims History file. We identified
79,131 HHA claims containing a principal diagnosis code for COVID-19 for calendar
year 2020.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
Administrator
Washington, DC 20201
APPENDIX C: CMS COMMENTS
DATE:
September 14, 2021
TO:
Amy Frontz
Deputy Inspector General for Audit Services
Office of Inspector General
FROM:
Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
SUBJECT:
Office of Inspector General (OIG) Draft Report: 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)
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
protecting beneficiaries in the home care setting from the spread of infectious diseases.
Home Health Agencies (HHAs) receiving Medicare or Medicaid payments are required to
comply with CMS quality and safety standards, including those relating to infection prevention
and control. CMS shares responsibility of HHA oversight with State Survey Agencies (SSAs)
who conduct onsite surveys to assess compliance with CMS requirements and investigate facility
complaints. SSAs serve as the front-line responders to address health and safety concerns raised
by residents, their families, and facility staff.
Since the COVID-19 public health emergency declaration in early 2020, CMS has taken a
number of actions to address COVID-19 within HHAs. 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). CMS also instructed SSAs to prioritize surveys related to complaints in
which the beneficiary was in immediate jeopardy of harm. In addition, CMS provided surveyors
a streamlined review tool to conduct targeted infection control surveys of providers identified
through collaboration with the Centers for Disease Control and Prevention (CDC) and the
Assistant Secretary for Preparedness and Response (ASPR). When onsite survey activity was
warranted, SSA’s used the tool to assess HHA infection control practices. CMS also shared the
infection control survey tool with HHAs to use as a voluntary self-assessment to review their
own compliance with federal infection control requirements. As the public health emergency
continues, the infection control survey has been revised, most recently in December 2020, to
incorporate new infection control requirements to address the spread of COVID-19.
16
HHA Providers Complied With CMS Infection Control Requirements During the Pandemic (A-01-20-00508)
In addition to the survey process used to enforce CMS policies, CMS has provided education and
outreach to HHAs on CMS quality and safety standards to support their infection prevention and
control efforts. For example, in 2016, CMS released targeted infection control training for
providers through the Medicare Learning Network. CMS also held Open Door Forum calls
specific to HHAs since 2016 and added additional COVID-19 calls during the pandemic, which
continue to date. CMS meets quarterly 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 (QSEP) provides current trainings on various CMS survey
and certification requirements. These trainings are used by surveyors but are also free of charge
and available to the public by choosing the “public access” link on QSEP.
OIG’s recommendation and CMS's response is below.
OIG Recommendation
Develop and share with the HHA industry information on COVID-19 infection prevention and
control best practices that HHA providers can use to comply with CMS requirements and follow
CMS guidance.
CMS Response
CMS concurs with this recommendation. CMS has provided education and outreach to HHAs on
CMS quality and safety standards to support their infection prevention and control efforts. CMS
will continue to share information on best practices with the HHA industry.
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