COVID-19 guidance from CMS and HHS: A chronological list of releases
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Information for Healthcare Facilities Concerning 2019 Novel Coronavirus Illness
On February 6, CMS published a Memorandum to state survey agency directors regarding CMS recommendations for all healthcare facilities on emergency preparedness for confronting the 2019 Novel Coronavirus (2019-nCoV) and preventing its spread. The memo contains links to various CDC resources on health advisories and its response to 2019-nCoV. It also contains links on the Standard, Contact, and Airborne Precautions which the CDC recommends using for 2019-nCoV and hand hygiene reminders. There is also information on OCR guidance on ways to share patient information during the outbreak without violating the HIPAA privacy rule.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/regional office training coordinators immediately.
Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel Assay and Guidance for Use in CDC Qualified Laboratories
On February 6, CMS published a Memorandum to state survey agency directors regarding guidance on the Emergency Use Authorization (EUA) for the CDC’s 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel assay. These assays have been developed for use by CDC qualified laboratories and remain subject to CLIA regulations. Performance verification per the manufacturer’s instructions is required on site at each CDC qualified laboratory. The EUA will be in effect until the emergency declaration is terminated or until the FDA revokes authorization.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the State/CMS Locations training coordinators within 30 days of this memorandum.
CMS Develops New Code for Coronavirus Lab Test
On February 13, CMS published a Press Release regarding a new HCPCS code for testing for coronavirus. Beginning on April 1, the Medicare claims processing system will accept HCPCS code U0001 when used to report the CDC 2019 Novel Coronavirus Real Time RT-PCR Diagnostic Test Panel for dates of service on or after February 4, 2020.
New ICD-10-CM Code and Guidelines for 2019 Novel Coronavirus
On February 21, the CDC published an Announcement and Coding Advice for reporting encounters for the 2019 Novel Coronavirus (COVID-19). The WHO has created a new ICD-10-CM code, U07.1 (2019-nCoV acute respiratory disease) effective February 20, 2020. The code will be included in the October 1, 2020 update to the ICD-10 codes. The CDC also included guidance on coding associated infections, such as pneumonia, bronchitis, lower respiratory infections, and ARDS. Signs and symptoms should be assigned codes when a definitive diagnosis has not been established. Exposure to COVID-19 should also be coded with the appropriate Z codes.
Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge
On March 4, CMS published a Memorandum to state survey agency directors regarding guidance on infection control and caring for patients with COVID-19 or potential cases of COVID-19. The memorandum discusses how to handle issues such as screening visitors or patients for the virus, monitoring and/or restricting health care facility staff, how to handle the needs of patients who have been diagnosed with COVID-19, discharge planning considerations, and more. The memorandum also includes links to multiple resources on the virus. CMS published a Press Release on the memorandum on the same date.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the State/Regional Office training coordinators immediately.
Suspension of Survey Activities
On March 4, CMS published a Memorandum to state survey agency directors regarding changes to survey protocol in response to the threat of coronavirus. CMS is limiting survey activity solely to immediate jeopardy complaints, allegations of abuse and neglect, complaints involving infection control concerns, statutorily required recertification surveys, and other special situations in order to focus effort appropriately on preventing the spread of coronavirus. CMS published a Press Release on the memorandum on the same date.
On March 11, CMS published an FAQ on the suspension of survey activities to accompany the memorandum.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/regional office training coordinators within 30 days of this memorandum.
Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes
On March 4, CMS published a Memorandum to state survey agency directors regarding guidance on infection control and prevention of COVID-19 in nursing homes. The memorandum discusses how facilities should handle visitors, how to monitor or restrict staff, when to consider transferring a resident with suspected or confirmed COVID-19 to a hospital, when to accept a resident with COVID-19 from a hospital, and more. The memorandum also provides links to multiple resources on infection control and prevention of COVID-19. CMS published a Press Release on the memorandum on the same date.
On March 9, CMS revised the Memorandum to provide additional guidance on monitoring or restricting visitors. This includes definitions for the terms “restricting,” “limiting,” and “discouraging” and provides recommendations on when to limit vs. when to discourage visitation.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers and the State/Regional Office training coordinators immediately.
CMS Develops Additional Code for Coronavirus Lab Tests
On March 6, CMS published a Special Edition MLN Connects to provide information on the two new HCPCS codes for COVID-19 diagnostic tests, U0001 and U0002, as well as to provide three fact sheets and other links to relevant resources for federal health care programs in confronting the spread of coronavirus and caring for patients with the virus. HCPCS code U0001 will be used for CDC testing laboratories to bill for COVID-19, and U0002 will be used for laboratories to bill for non-CDC tests for COVID-19. Medicare claims processing systems will begin to accept both codes starting on April 1, 2020, for dates of service on or after February 4, 2020.
COVID-19 FAQs
On March 6, CMS published an FAQ on Medicare billing and payment for coronavirus-related care and testing. The FAQ covers questions for a variety of provider types and services, including diagnostic lab services, physician services, hospital services, and more. It also discusses payment and coverage for drugs, vaccines, physician care at a beneficiary’s home, and ambulance transport.
Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment
On March 6, CMS published Medicare Claims Processing Transmittal 4541 regarding the quarterly update to the clinical lab fee schedule. The updates include the addition of two new HCPCS codes for COVID-19 lab tests to the fee schedule and notes that those two codes will be contractor-priced until they are addressed at the annual Clinical Laboratory Public Meeting this summer.
Effective date: April 1, 2020
Implementation date: April 6, 2020
Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications Related to Coronavirus Disease 2019
On March 9, CMS published a Memorandum to state survey agency directors regarding the implications of COVID-19 on EMTALA requirements. Every emergency department is required to screen all individuals who come into the ED and is expected to have the capability to apply appropriate COVID-19 screening criteria to immediately identify and isolate individuals who meet the screening criteria to be a potential COVID-19 case. EDs must contact state or local public health officials when encountering a potential COVID-19 case to determine next steps. If a patient is suspected or confirmed to have COVID-19, hospitals and CAHS should consider CDC and public health official guidance to determine whether they have the capability to provide appropriate isolation required for stabilizing treatment and/or to accept appropriate transfers. The memorandum also includes guidance on alternate screening sites and other enforcement considerations.
CMS published a Press Release on this guidance on the same date.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/regional office training coordinators immediately.
Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) by Hospice Agencies
On March 9, CMS published a Memorandum to state survey agency directors regarding guidance for hospice agencies on infection control for COVID-19. The memo contains an FAQ on addressing COVID-19 in hospices and discusses how to handle visitors, staff, inpatient prevention and control practices, considerations for patient placement, when to discontinue transmission-based precautions or in-home isolation, and more. The memo also contains links to CDC, FDA, and CMS resources on COVID-19.
CMS published a Press Release on this guidance on the same date.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/regional office training coordinators immediately.
Coverage and Payment Related to COVID-19 Medicare
On March 9, CMS published a Fact Sheet on Medicare coverage for coronavirus-related care and testing. The fact sheet provides information for a variety of provider types and services, including diagnostic lab services, vaccines, inpatient hospital care services, inpatient quarantines, ambulatory services in a hospital or other location, telehealth services, and more. The fact sheet also discusses what is covered under Medicare Advantage, including a provision that may allow Medicare Advantage organizations to waive or reduce enrollee cost-sharing for COVID-19 lab tests, effective immediately, as long as this is done for all plan enrollees on a uniform basis. Medicare Advantage organizations may also waive prior authorization requirements for tests or services related to COVID-19.
CMS published a Press Release on the fact sheet on the same date.
Guidance for Infection Control and Prevention of COVID-19 in Dialysis Facilities
On March 10, CMS published a Memorandum to state survey agency directors regarding guidance for dialysis facilities on infection control for COVID-19. The memo contains an FAQ on COVID-19 management and includes questions addressing early identification of the virus among patients, staff, and visitors; how to monitor or restrict facility staff members, where to place patients with undiagnosed respiratory symptoms or suspected or confirmed COVID-19, what types of personal protective equipment to use, and more. The memo also contains links to CDC, FDA, and CMS resources on COVID-19.
CMS published a Press Release on the same date to accompany the memorandum.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/regional office training coordinators immediately.
Guidance for Infection Control and Prevention Concerning COVID-19 in Home Health Agencies
On March 10, CMS published a Memorandum to state survey agency directors regarding guidance for home health agencies on infection control for COVID-19. The memo contains an FAQ on addressing COVID-19 in home health agencies and discusses how to handle patient screening, monitoring or restricting home visits for health care staff, determining when to allow patients with confirmed COVID-19 to be treated at home, infection prevention and control practices for family member exposure, and more. The memo also contains links to CDC, FDA, and CMS resources on COVID-19.
CMS published a Press Release on the same date to accompany the memorandum.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/regional office training coordinators immediately.
Information Related to COVID-19
On March 10, CMS published a Memorandum to all Medicare Advantage organizations, Part D sponsors, and Medicare/Medicaid Plans to inform them of obligations and permissible flexibilities related to disasters and emergencies resulting from COVID-19. These flexibilities include:
- Waiving cost-sharing for COVID-19 tests
- Waiving cost-sharing for COVID-19 treatments in doctor’s offices or emergency rooms and services delivered via telehealth
- Removing prior authorizations requirements
- Waiving prescription refill limits
- Relaxing restrictions on home or mail delivery of prescription drugs
- Expanding access to certain telehealth services
CMS published a Press Release on the memorandum on the same date.
Guidance for Use of Certain Industrial Respirators by Health Care Personnel
On March 10, CMS published a Memorandum to state survey agency directors regarding guidance on the types of facemasks healthcare workers may use in situations involving COVID-19 and other respiratory infections. The CDC has updated their personal protective equipment (PPE) recommendations, and CMS surveyors will consider this to determine if Medicare and Medicaid providers and suppliers are complying with infection control protocols. The memorandum details when providers can use expanded types of facemasks and when to return to the use of respirators rather than facemasks. It also notes that surveyors will be validating the date of the last FIT test for health care workers in Medicare and Medicaid certified facilities. Any CMS guidance that explicitly, or by reference, indicates N-95 or PPE usage will automatically incorporate any any filtering facepiece respirators (FFR) authorized under this EUA and any guidance issued by the CDC.
CMS published a Press Release on the memorandum on the same date.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/regional office training coordinators within 30 days of this memorandum.
FAQs on Essential Health Benefit Coverage and COVID-19
On March 12, CMS published an FAQ on essential health benefit coverage of COVID-related services. It discusses whether isolation and quarantine for COVID-19 is covered, whether a vaccine would be covered should it become available, and more.
On March 13, CMS published a Press Release to accompany the FAQ.