DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Medicare & Medicaid Services

7500 Security Boulevard, Mail Stop C2-21-16

Baltimore, Maryland 21244-1850

Center for Clinical Standards and Quality/Quality, Safety & Oversight Group

Ref: QSO-20-18-HHA

DATE: March 10, 2020

TO: State Survey Agency Directors

FROM: Director

Quality, Safety & Oversight Group

SUBJECT: Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health Agencies (HHAs)

Memorandum Summary

CMS is committed to protecting American patients and residents by ensuring health care facilities have up-to-date information to adequately respond to COVID-19 concerns.

• Coordination with the Centers for Disease Control and Prevention (CDC) and local public health departments – We encourage all Home Health Agencies to monitor the CDC website for information and resources and contact their local health department when needed (CDC Resources for Health Care Facilities: https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/index.html).

• Home Health Guidance and Actions – CMS regulations and guidance support Home Health Agencies taking appropriate action to address potential and confirmed COVID cases and mitigate transmission including screening, treatment, and transfer to higher level care (when appropriate). This guidance applies to both Medicare and Medicaid providers.

Background

The Centers for Medicare & Medicaid Services (CMS) is committed to the protection of patients in the home care setting from the spread of infectious disease. This memorandum responds to questions we have received and provides important guidance for all Medicare and Medicaid participating Home Health Agencies (HHAs) in addressing the COVID-19 outbreak and minimizing transmission to other individuals.

Guidance

HHAs should monitor the CDC website (see links below) for information and resources and contact their local health department when needed. Also, HHAs should be monitoring the health status of everyone (patients/residents/visitors/staff/etc.) in the homecare setting for signs or

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symptoms of COVID-19. Per CDC, prompt detection, triage and isolation of potentially infectious patients are essential to prevent unnecessary exposures among patients, healthcare personnel, and visitors.

In addition to the overarching regulations and guidance, we have provided the following information (Frequently Asked Questions) about some specific areas related to COVID-19.

This guidance is applicable to all Medicare and Medicaid HHA providers.

HHA Guidance for Admitting and Treating Patients with known or suspected COVID-19

Which patients are at risk for severe disease for COVID-19?

Based upon CDC data, older adults or those with underlying chronic medical conditions may be most at risk for severe outcomes.

How should HHAs screen patients for COVID-19?

When making a home visit, HHAs should identify patients at risk for having COVID-19 infection before or immediately upon arrival to the home. They should ask patients about the following:

1. International travel within the last 14 days to countries with sustained community transmission. For updated information on affected countries visit: https://www.cdc.gov/coronavirus/2019-ncov/travelers/index.html

2. Signs or symptoms of a respiratory infection, such as a fever, cough, and sore throat.

3. In the last 14 days, has had contact with someone with or under investigation for COVID-19, or are ill with respiratory illness.

4. Residing in a community where community-based spread of COVID-19 is occurring.

For ill patients, implement source control measures (i.e., placing a facemask over the patient’s nose and mouth if that has not already been done).

Inform the HHA clinical manager, local and state public health authorities about the presence of a person under investigation (PUI) for COVID-19. Additional guidance for evaluating patients in U.S. for COVID-19 infection can be found on the CDC COVID-19 website.

CMS regulations requires that home health agencies provide the types of services, supplies and equipment required by the individualized plan of care. HHA’s are normally expected to provide supplies for respiratory hygiene and cough etiquette, including 60%-95% alcohol-based hand sanitizer (ABHS). State and Federal surveyors should not cite home health agencies for not providing certain supplies (e.g., personal protective equipment (PPE) such as gowns, respirators, surgical masks and alcohol-based hand rubs (ABHR)) if they are having difficulty obtaining these supplies for reasons outside of their control. However, we do expect providers/suppliers to take actions to mitigate any resource shortages and show they are taking all appropriate steps to obtain the necessary supplies as soon as possible.

How should HHAs monitor or restrict home visits for health care staff?

• Health care providers (HCP) who have signs and symptoms of a respiratory infection should not report to work.

• Any staff that develop signs and symptoms of a respiratory infection while on-the-job, should:

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o Immediately stop work, put on a facemask, and self-isolate at home;

o Inform the HHA clinical manager of information on individuals, equipment, and locations the person came in contact with; and

o Contact and follow the local health department recommendations for next steps (e.g., testing, locations for treatment).

• Refer to the CDC guidance for exposures that might warrant restricting asymptomatic healthcare personnel from reporting to work (https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html)

HHAs should contact their local health department for questions, and frequently review the CDC website dedicated to COVID-19 for health care professionals: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html

Do all patients with known or suspected COVID-19 infection require hospitalization?

Patients may not require hospitalization and can be managed at home if they are able to comply with monitoring requests. More information is available here: https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-home-care.html

What are the considerations for determining when patients confirmed with COVID-19 are safe to be treated at home?

Although COVID-19 patients with mild symptoms may be managed at home, the decision to remain in the home should consider the patient’s ability to adhere to isolation recommendations, as well as the potential risk of secondary transmission to household members with immunocompromising conditions. More information is available here: https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-home-care.html

When should patients confirmed with COVID-19 who are receiving HHA services be considered for transfer to a hospital?

Initially, symptoms maybe mild and not require transfer to a hospital as long as the individual with support of the HHA can follow the infection prevention and control practices recommended by CDC. (https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html)

The patient may develop more severe symptoms and require transfer to a hospital for a higher level of care. Prior to transfer, emergency medical services and the receiving hospital should be alerted to the patient’s diagnosis, and precautions to be taken including placing a facemask on the patient during transfer. If the patient does not require hospitalization they can be discharged back to home (in consultation with state or local public health authorities) if deemed medically and environmentally appropriate. Pending transfer or discharge, place a facemask on the patient and isolate him/her in a room with the door closed.

What are the implications of the Medicare HHA Discharge Planning Regulations for Patients with COVID-19?

Medicare’s Discharge Planning Regulations (which were updated in November 2019)

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requires that HHA assess the patient’s needs for post-HHA services, and the availability of such services. When a patient is discharged, all necessary medical information (including communicable diseases) must be provided to any other service provider. For COVID-19 patients, this must be communicated to the receiving service provider prior to the discharge/transfer and to the healthcare transport personnel.

What are recommended infection prevention and control practices, including considerations for family member exposure, when evaluating and caring for patients with known or suspected COVID-19?

The CDC advises the patient to stay home except to get medical care, separate yourself from other people and animals in the home as much as possible (in a separate room with the door closed), call ahead before visiting your doctor, and wear a facemask in the presence of others when out of the patient room.

For everyone in the home, CDC advises covering coughs and sneezes followed by hand washing or using an alcohol-based hand rub, not sharing personal items (dishes, eating utensils, bedding) with individuals with known or suspected COVID-19, cleaning all “high-touch” surfaces daily, and monitoring for symptoms. We would ask that HHA’s share additional information with families. Please see https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-prevent-spread.html and https://www.cdc.gov/coronavirus/2019-ncov/community/home/index.html.

Detailed infection prevention and control recommendations are available in the CDC Interim Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) or Persons under Investigation for COVID-19 in Healthcare Settings: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html

Are there specific considerations for patients requiring therapeutic interventions?

Patients with known or suspected COVID-19 should continue to receive the intervention appropriate for the severity of their illness and overall clinical condition. Because some procedures create high risks for transmission (close patient contact during care) precautions include: 1) HCP should wear all recommended PPE, 2) the number of HCP present should be limited to essential personnel, and 3) any supplies brought into, used, and removed from the home must be cleaned and disinfected in accordance with environmental infection control guidelines.

What Personal Protective Equipment should home care staff routinely use when visiting the home of a patient suspected of COVID-19 exposure or confirmed exposure?

If care to patients with respiratory or gastrointestinal symptoms who are confirmed or presumed to be COVID-19 positive is anticipated, then HHAs should refer to the 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: https://www.cdc.gov/coronavirus/2019-ncov/php/guidance-evaluating-pui.html

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Hand hygiene should be performed before putting on and after removing PPE using alcohol-based hand sanitizer that contains 60 to 95% alcohol.

PPE should ideally be put on outside of the home prior to entry into the home. If unable to put on all PPE outside of the home, it is still preferred that face protection (i.e., respirator and eye protection) be put on before entering the home. Alert persons within the home that the public health personnel will be entering the home and ask them to move to a different room, if possible, or keep a 6-foot distance in the same room. Once the entry area is clear, enter the home and put on a gown and gloves.

Ask person being tested if an external trash can is present at the home, or if one can be left outside for the disposal of PPE. PPE should ideally be removed outside of the home and discarded by placing in external trash can before departing location. PPE should not be taken from the home of the person being tested in public health personnel’s vehicle.

If unable to remove all PPE outside of the home, it is still preferred that face protection (i.e., respirator and eye protection) be removed after exiting the home. If gown and gloves must be removed in the home, ask persons within the home to move to a different room, if possible, or keep a 6-foot distance in the same room. Once the entry area is clear, remove gown and gloves and exit the home. Once outside the home, perform hand hygiene with alcohol-based hand sanitizer that contains 60 to 95% alcohol, remove face protection and discard PPE by placing in external trash can before departing location. Perform hand hygiene again.

When is it safe to discontinue Transmission-based Precautions for home care patients with COVID-19?

The decision to discontinue Transmission-Based Precautions for home care patients with COVID-19 should be made in consultation with clinicians, infection prevention and control specialists, and public health officials. This decision should consider disease severity, illness signs and symptoms, and results of laboratory testing for COVID-19 in respiratory specimens. For more details, please refer to: https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html.

Considerations to discontinue in-home isolation include all of the following:

o Resolution of fever, without use of antipyretic medication

o Improvement in illness signs and symptoms

o Negative results of an FDA Emergency Use Authorized molecular assay for COVID-19 from at least two consecutive sets of paired nasopharyngeal and throat swabs specimens collected ≥24 hours apart* (total of four negative specimens—two nasopharyngeal and two throat). See Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Patients Under Investigation (PUIs) for 2019 Novel Coronavirus (2019-nCoV) for specimen collection guidance.

*Initial guidance is based upon limited information and is subject to change as more information becomes available. In persons with a persistent productive cough, SARS-CoV-2-RNA might be detected for longer periods in sputum specimens than in upper respiratory tract (nasopharyngeal swab and throat swab) specimens.

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Protocols for Coordination and Investigation of Home Health Agencies with Actual or Suspected COVID-19 Cases

During a home health agency survey, when a COVID-19 confirmed case or suspected case (including PUI) is identified, the surveyors will confirm that the agency has reported the case to public health officials as required by state law and will work with the agency to review infection prevention and education practices. Confirm that the HHA has the most recent information provided by the CDC.

• The State should notify the appropriate CMS Regional Office of the HHA who has been identified as providing services to a person with confirmed or suspected COVID-19 (including persons under investigation) who do not need to be hospitalized;

• The State should notify the appropriate CMS Regional Office of the HHA who has been identified as providing services to a person with confirmed COVID-19 who were hospitalized and determined to be medically stable to go home.

CMS is aware of that there is a scarcity of some supplies in certain areas of the country. State and Federal surveyors should not cite providers/suppliers for not having certain supplies (e.g., personal protective equipment (PPE) such as gowns, respirators, surgical masks and alcohol-based hand rubs (ABHR)) if they are having difficulty obtaining these supplies for reasons outside of their control. However, we do expect providers/suppliers to take actions to mitigate any resource shortages and show they are taking all appropriate steps to obtain the necessary supplies as soon as possible. For example, if there is a shortage of ABHR, we expect staff to practice effective hand washing with soap and water. Similarly, if there is a shortage of PPE (e.g., due to supplier(s) shortage which may be a regional or national issue), the facility should contact the appropriate local authorities notifying them of the shortage, follow national guidelines for optimizing their current supply, or identify the next best option to care for patients. If a surveyor believes a facility should be cited for not having or providing the necessary supplies, the state agency should contact the CMS Regional Office.

Important CDC Resources:

CDC Resources for Health Care Facilities and Home and Commuity Based Settings:

• CDC Resources for Health Care Facilities: https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/index.html

• CDC FAQ for COVID-19: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/infection-prevention-control-faq.html

• CDC Guidance for Preventing Spread in Home and Commuity Settings https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-prevent-spread.html

• Strategies for Optimizing the Supply of N95 Respirators: https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Frespirator-supply-strategies.html

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• CDC guidance for Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html

• Resources for Households https://www.cdc.gov/coronavirus/2019-ncov/community/home/index.html

FDA Resources:

Emergency Use Authorizations: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

CMS Resources:

Home Health Agency Infection Control and Prevention regulations and guidance: 42 CFR 484.70, Infection Prevention and Control, Appendix B of the State Operations Manual, Infection Prevention and Control. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_b_hha.pdf

CDC Updates:

https://www.cdc.gov/coronavirus/2019-ncov/whats-new-all.html

Sign up for the newsletter to receive weekly emails about the coronavirus disease 2019 (COVID-19) https://tools.cdc.gov/campaignproxyservice/subscriptions.aspx?topic_id=USCDC_2067

Contact: Questions about this memorandum should be addressed to [email protected]. Questions about COVID-19 guidance/screening criteria should be addressed to the State Epidemiologist or other responsible state or local public health officials in your state.

Effective Date: Immediately. This policy should be communicated with all survey and certification staff, their managers and the State/Regional Office training coordinators immediately.

/s/

David R. Wright

cc: Survey and Operations Group Management