Infectious diseases

Coronavirus Disease 2019 (COVID-19)

The Public Health Service Act was used to declare a public health emergency (PHE) in the entire United States on January 31, 2020 giving us the flexibility to support our beneficiaries, effective January 27, 2020.  The PHE was renewed on April 21, 2020, July 23, 2020, October 2, 2020, January 7, 2021,  April 15, 2021, July 19, 2021,  October 15, 2021, January 7, 2022, April 12, 2022 effective April 16, 2022, July 15, 2022, October 13, 2022, January 11, 2023, and February 9, 2023. When the national emergency was declared on March 13, 2020, we took action nationwide to aggressively respond to COVID-19. When a national emergency was declared on March 13, 2020, we took action nationwide to aggressively respond to COVID-19. 

The links below provide information on past COVID-19 guidance. 

For Healthcare Facilities

• Updated Nursing Home Guidance with Revised Visitation Recommendations (3/10/21)
• Nursing Home Facilities Training 50% Achievement List (PDF) (11/17/20)
• AQs About Visitation Considerations for Nursing Home Residents (PDF) UPDATED (3/10/21)
• Trump Administration Response to Commission Recommendations (PDF) (9/16/20)
• Guidance and Updates for Nursing Homes during COVID-19 (PDF) (9/16/20)
• Memo to States and Nursing Home Stakeholders About Changes to Staffing Information and Quality Measures (6/25/20)
• OVID Nursing Home Compare Data (6/4/20)
• Nursing Home Data Release FAQs (PDF) (6/4/20)
• Infographic: Nursing Home Reporting Numbers for 5/31/20 (PDF) (6/4/20)
• Posting Nursing Home Inspections (6/4/20)
• Nursing Home Reopening Recommendation FAQs (PDF) (5/18/20)
• CMS letter to Nursing Home Facility Management & Staff (PDF) (PDF) (5/11/20)
• COVID-19 Long-Term Care Facility Guidance (PDF) (4/3/20)
• Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes-REVISED (PDF) (3/13/20)
• Hospital Capacity Letter to Governors (PDF) (12/7/20)
• Acute Hospital Care At Home waiver request (11/25/20)
• How facilities can safely recognize holidays (PDF) (11/18/20)

For Labs

• SARS-CoV-2 Laboratory Testing Comparison Graphic (PDF) (4/30/20)
• Announcement: Medicare increases payment for high-production Coronavirus lab tests (PDF) (4/15/20)
• Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel Assay and Guidance for Authorized Laboratories (2/6/20)

Survey & Certification Guidance

• Revised COVID-19 Focused Infection Control Survey Tool for Acute and Continuing Care (12/30/20)
• CARES Act Financial Guidance to State Survey Agencies (PDF) (4/30/20)
• Coronavirus Commission for Safety and Quality in Nursing Homes (PDF)  (4/30/20)
• Nursing Home Five-Star Quality Rating Updates, Nursing Home Staff Counts, and Frequently Asked Questions  (4/24/20)
• Frequently Asked Questions for State Survey Agency and Accrediting Organization Coronavirus Disease 2019 (COVID-19) (PDF)  (3/10/20)
• Suspension of Survey Activities (3/4/20)
• Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency (3/27/20)
• Prioritization of Survey Activities (PDF) (3/23/20)
• Frequently Asked Questions for State Survey Agency and Accrediting Organization Coronavirus Disease 2019 (COVID-19) (PDF) (3/10/20)
• Frequently Asked Questions and Answers on EMTALA (PDF) (3/9/20)

 

Other Guidance Documents

• Waiver for Medicare Ground Ambulance Services Treatment in Place (PDF) (5/5/21)
• COVID-19 Emergency Declaration Blanket Waivers & Flexibilities for Health Care Providers (PDF) UPDATED (10/13/22)
• Blanket waivers of Section 1877(g) of the Social Security Act (3/30/20)
• Medicare and Medicaid IFC: Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-9912 IFC) (PDF) (10/28/20)  
  • CMS-9912 Interim Final Rule with Comment Factsheet on Updated Policy for Maintaining Medicaid Enrollment during the Public Health Emergency for COVID-19 (10/28/20)
• Medicare and Medicaid IFC: Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-3401 IFC) (PDF) (8/25/20)
  • Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID-19 Focused Survey Tool (8/26/20)
  • Interim Final Rule (IFC), CMS-3401-IFC, Updating Requirements for Reporting of SARS-CoV-2 Test Results by (CLIA) of 1988 Laboratories, and Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (8/26/20)
• Medicare and Medicaid IFC: Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-5531 IFC) (PDF) (4/30/20)
  • IFC Federal Register Announcement (5/4/20)
  • PRA Disclosure Statement (PDF) (5/21/20)
• Acute Hospital Care At Home waiver request (11/25/20)
• List of Hospital Outpatient Services and List of Partial Hospitalization Program Services Accompanying the 4/30/2020 IFC (ZIP) (4/30/20)
• Innovation Model COVID-19 Adjustments (PDF) (6/3/20)
• List of lab test codes for COVID-19, Influenza, RSV (PDF) (5/12/20)
• Medicare IFC: Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC) (PDF) (3/30/20)
  • IFC Federal Register Announcement (4/1/20)
• COVID-19 Regulations & Waivers To Enable Health System Expansion (PDF) UPDATED (1/19/21)
• Graphic Overview of Flexibilities (PDF) (3/30/20)
• Frequently Asked Questions to Assist Medicare Providers (PDF) UPDATED (3/5/21)
• Provider Burden Relief Frequently Asked Questions (PDF) UPDATED (7/7/20)
• Provider Enrollment Relief Frequently Asked Questions (PDF) (3/30/20)
• Updates for State Surveyors and Accrediting Organizations (EMTALA and Infection Control) (3/30/20)
• Reprioritization of PACE, Medicare Parts C and D Program, and Risk Adjustment Data Validation (RADV) Audit Activities (HPMS Memo) (3/30/20)
• Rural Providers (PDF) (8/20/20)

Telehealth guidance:

• FAQs on Availability and Usage of Telehealth Services through Private Health Insurance Coverage in Response to Coronavirus Disease 2019 (COVID-19) (PDF) (3/26/20)

Clinical & technical guidance:

• For all health care providers
  • CMS Omnibus COVID-19 Health Care Staff Vaccination Rule- Implementation Timeline (PDF) (1/19/22)
  • Guidance for the Interim Final Rule – Medicare and Medicaid Programs – Omnibus COVID-19 Health Care Staff Vaccination (1/19/22)
  • COVID-19 Health Care Staff Vaccination Requirements Infographic (PDF) (1/19/22)
  • COVID-19 Health Care Staff Vaccination Requirements Decision Tree Graphic  (PDF) (1/25/22)
  • Over The Counter (OTC) Home Testing and CLIA Applicability (PDF) (11/22/21, revised 3/4/22)
  • CMS Omnibus COVID-19 Health Care Staff Vaccination Requirements FAQ (PDF) (2/3/22) UPDATED
  • COVID-19 Health Care Staff Vaccination IFC-6 National Stakeholder Call Slides (PDF) (11/5/21)
  • COVID-19 Health Care Staff Vaccination IFC-6 National Stakeholder Call Video (11/5/21)
  • Infographic:  Coverage of Monoclonal Antibody Products to Treat COVID-19 (PDF) (5/6/21)
  • Recommendations for Reopening Facilities to Provide Non-Emergent Non-COVID-19 Health Care (PDF) (6/9/20)
  • CMS Recommendations for Re-opening Facilities to Provide Essential Non-COVID-19 Healthcare (PDF) (4/19/20)
• For health care facilities 
  • Health care facility administrator COVID-19 vaccine letter (PDF) (02/01/22)
  • How to safely visit nursing homes (PDF) (01/25/22)
  • Nursing Home Visitation FAQ (PDF) UPDATED (03/10/22)
  • Nursing Home Visitation - COVID-19 UPDATED (4/27/21)
  • New COVID 19 Testing and Reporting Requirements (PDF) UPDATED (4/27/21)
  • Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID-19 Focused Survey Tool (4/27/21)
  • Interim Final Rule (IFC), COVID-19 Vaccine Immunization Requirements for Residents and Staff (5/11/21)
  • SARS-CoV-2 Point of Care Testing and CLIA Certificate of Waiver Applications (PDF) (12/11/20)
  • Podcast:  Nursing Home Series for Front Line Clinicians and Staff (11/19/20)
  • Enforcement Discretion Relating to Certain Pharmacy Billing (PDF) (10/16/20)
  • Compliance with Residents’ Rights Requirement related to Nursing Home Residents’ Right to Vote (10/5/20)
  • COVID-19 Survey Activities, CARES Act Funding, Enhanced Enforcement for Infection Control Deficiencies, and Quality Improvement Activities in Nursing Homes (6/1/20)
  • Nursing Home Five-Star Quality Rating Updates, Nursing Home Staff Counts, and Frequently Asked Questions (4/24/20)
  • New Nursing Home Requirements for Notification of Confirmed COVID-19 Among Residents and Staff (PDF) (4/19/20)
  • 2019 Novel Coronavirus (COVID-19) Long-Term Care Facility Transfer Scenarios (PDF)  (4/13/20)
• For labs 
  • Frequently Asked Questions About SARS-CoV-2 Surveillance Testing (PDF) UPDATED (10/21/21)
  • Clinical Laboratory Improvement Amendments of 1988 (CLIA) Laboratories Surveyor Guidance for New and Modified CLIA Requirements Related to SARS-CoV-2 Test Result Reporting (4/15/22)
  • Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency (PDF) UPDATED (12/17/20)
  • SARS-CoV-2 Point of Care Testing and CLIA Certificate of Waiver Applications (PDF) (12/11/20)
  • Laboratory Quick Start Guide to CMS CLIA Certification (PDF) (9/25/20)
  • More information about CLIA & CLIA Certification Fee secure platform link (9/25/20)
  • Point of Care Antigen Testing FAQ (PDF) (10/07/22)
  • CLIA and University Laboratory Testing FAQ (8/31/20)
  • Interim Final Rule (IFC), CMS-3401-IFC, Updating Requirements for Reporting of SARS-CoV-2 Test Results by (CLIA) of 1988 Laboratories, and Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (8/26/20)
  • HHS Announces New Laboratory Data Reporting Guidance for COVID-19 Testing (6/5/20)
  • CLIA SARS-CoV-2 Variant FAQ (PDF) (3/19/21)

• For Programs of All-Inclusive Care for the Elderly (PACE) Organizations

  • Frequently Asked Questions from the PACE Community (PDF) UPDATED (1/8/21)
  • Guidance for PACE Organizations Regarding Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) (PDF) (3/17/20)

• For Schools

  • Quick Start Guide to CLIA Certification for COVID-19 Testing in Schools (PDF) (6/7/21)
  • How To Get Certification for In-School COVID-19 Testing Factsheet (PDF) (6/7/21)
  • Achieving Quality COVID-19 Testing in Schools Infographic (PDF) (6/7/21)

• For Employers

  • CLIA COVID quick start guide (PDF) (11/4/2021)
  • CLIA COVID fact sheet (PDF) (11/4/2021)

Billing & coding guidance:

• Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction (PDF) (2/16/21)
• Infographic:  Coverage of Monoclonal Antibody Products to Treat COVID-19 (PDF) (12/9/20)
• Frequently Asked Questions about Medicare Fee-for-Service Emergency-Related Policies and Procedures With an 1135 Waiver (PDF) (3/16/20)
• Fact sheet:  Medicare Administrative Contractor (MAC) COVID-19 Test Pricing (PDF) (1/25/21) 

Survey & certification guidance:

• Clinical Laboratory Improvement Amendments of 1988 (CLIA) Laboratories Surveyor Guidance for New and Modified CLIA Requirements Related to SARS-CoV-2 Test Result Reporting (1/8/21)
• COVID-19 Survey Activities, CARES Act Funding, Enhanced Enforcement for Infection Control Deficiencies, and Quality Improvement Activities in Nursing Homes (1/4/21)

Coverage guidance:

• Medicare Payment for COVID-19 Vaccination Administration in the Home (PDF) | Spanish (PDF) UPDATED (8/24/21)
• Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction (PDF) (2/16/21)
• HPMS Memo: COVID Access to COVID-19 Vaccine Data for Parts C & D Enrollees (PDF) (1/7/21)
• Infographic:  Coverage of Monoclonal Antibody Products to Treat COVID-19 (PDF) (12/9/20)
• Guidance to help Medicare Advantage and Part D Plans Respond to COVID-19 (PDF) (3/10/20)

Provider enrollment guidance:

• Medicare Provider Enrollment Relief Frequently Asked Questions (FAQs) (PDF) UPDATED (3/21/22)

Marketplace plan guidance:

• Technical Fact Sheet: CCIIO Premium Reductions:  Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (PDF) (8/25/20)
• Temporary Policy on 2020 Premium Credits Associated with the COVID-19 Public Health Emergency (PDF) (8/4/20)
• Risk Adjustment Telehealth and Telephone Services During COVID-19 FAQs (PDF) (8/3/20-Replaces April 27th, 2020 guidance)
• FAQs About Families First Coronavirus Response Act & Coronavirus Aid, Relief, & Economic Security Act Implementation Part 43 (6/23/20)
• Payment and Grace Period Flexibilities Associated with the COVID-19 National Emergency (PDF) (3/26/20)
• FAQs on Availability and Usage of Telehealth Services through Private Health Insurance Coverage in Response to Coronavirus Disease 2019 (COVID-19) (PDF) (3/26/20)

Medicare Advantage and Part D plan guidance:

• HPMS Memo: Permissible Flexibilities Related to Oral Antiviral Drugs for Treatment of COVID-19 (PDF) (11/29/21)
• HPMS Memo:  COVID Access to COVID-19 Vaccine Data for Parts C & D Enrollees (PDF) (1/7/21)

Consumer information:

• Clinical Laboratory Improvement Amendments (CLIA) Consumer Complaints FAQ (PDF) (2/17/22)
• Consumer Infographic on Temporary Laboratory Testing Sites (PDF) (2/24/22)
• COVID Over The Counter Test Coverage (English PDF) (Spanish PDF) (4/28/2023)

Zika virus outbreak (2016)

A member of the virus family Flaviviridae, Zika virus (ZIKV) is spread by daytime-active Aedes albopictus and Aedes aegypti mosquitoes. Zika virus is related to the Dengue, Yellow Fever, Encephalitis, and West Nile viruses. Since the 1950s, it has been known to occur within a narrow equatorial belt from Africa to Asia. From 2007 to 2016, the virus spread eastward, across the Pacific Ocean to the Americas, leading to the 2015–16 Zika virus epidemic.

On January 18, 2017, CMS announced $66.1 million in funding to health departments in American Samoa, Puerto Rico, the U.S. Virgin Islands, and Florida to help combat the Zika virus. (PDF)

The links below provide information on the Health and Human Services (HHS) Public Health Emergency Declaration and its subsequent renewal.  Additional information on the ZIKV is found in the Centers for Disease Control and Prevention (CDC) link, found in the Related Link section. 

• November 4, 2016: Renewal of determination that a Public Health Emergency exists
• January 31, 2017:  Determination that a Public Health Emergency exists in Puerto Rico as a consequence of the Zika Virus outbreak