Federal Policies and Guidance

 

The following are links to COVID-19 policy information from the U.S. Department of Health and Human Services and its relevant agency subcomponents, including the Centers for Medicare and Medicaid Services (CMS) and CMS’ Center for Clinical Standards and Quality (CCSQ).

White House

• Biden Administration Investing $250 Million to Encourage COVID-19 Safety and Vaccination Among Underserved Populations (March 8, 2021)
• Community Health Center Vaccination Program Fact Sheet (Feb. 9, 2021)
• Biden Administration’s National Strategy for COVID-19 Response and Pandemic Preparedness (Jan. 21, 2021)

 

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Department of Health & Human Services (HHS)

• Operation Warp Speed Vaccine Funding and Distribution [+] 
  • HHS Partners with Chain, Independent Pharmacies on COVID-19 Vaccine Distributionnbsp;(Nov. 12, 2020)
  • HHS, DOD to Buy Lilly’s Investigational Therapeutic to Treat COVID-19 (Oct. 28, 2020)
  • HHS Expands Manufacturing Capacity with Cytiva for COVID-19 Vaccine Components (Oct. 13, 2020)
  • HHS Funds Phase III Clinical Trials for AstraZeneca’s Investigational Monoclonal Antibody (Oct. 9, 2020)
  • Operation Warp Speed Strategy for Distributing COVID-19 Vaccine  (Sept. 16, 2020)
  • McKesson Selected to Be Central Distributor of Vaccines, Supplies  (Aug. 14, 2020)
  • Operation Warp Speed: Updated Fact Sheet on Vaccine Development and Distribution
• HHS Expands List of Professionals Qualified to Perform Vaccinations (March 12, 2021)
• Biden Administration Announces Initiatives to Expand COVID-19 Testing (Feb. 17, 2021)
• Expanded Categories of Health Professionals authorized to administer COVID-19 vaccines (Jan. 28, 2021)
• Healthcare.gov Special Enrollment Period Announced (Jan. 28, 2021)
• HHS Updates COVID-19 Data Reporting Guidance for Hospitals (January 12, 2021)
• Web-Based Outpatient Treatment Locator for Monoclonal Antibodies (Jan. 11, 2021)
• COVID-19 Vaccine Distribution Landing Page
• HHS Telehealth Information for Providers
• CARES Act Provider Relief Fund:
• Assistant Secretary for Preparedness and Response COVD-19 Resources
  • COVID-19 Healthcare Planning Checklist
• HHS Office of Inspector General – COVID-19 Portal
  • FAQs: Application of OIG's Administrative Enforcement Authorities to Arrangements Directly Connected to COVID-19 (as of May 14, 2020)
  • HHS Office of Inspector General Policy Statement on Waivers of Beneficiary Payments for Telehealth Services (March 17, 2020); Fact Sheet on Telehealth Waiver
• U.S. Public Health Service – Optimizing Ventilator Use during the COVID-19 Pandemic (March 31, 2020)

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HHS Office for Civil Rights

• Guidance on HIPAA and Contacting Former COVID-19 Patients About Blood and Plasma Donation (Updated August, 2020)
• Bulletin HIPAA and Corona Virus (February 2020)

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Centers for Disease Control & Prevention (CDC)

• Recommendation to Pause Use of Johnson & Johnson Vaccine (April 13, 2021)
• Vaccine Finder: COVID-19 Information for Jurisdictions and Healthcare Providers
• Customizable COVID-19 Content for Essential Workers
• Interim Infection Prevention and Control Recommendations for Healthcare Personnel
• National Forum on COVID-19 Vaccine (February 22-24, 2021)
• Interactive Map: US COVID-19 Cases Caused by Variants
• Training for Healthcare Professionals—Vaccinations
• Vaccine Communication Toolkit for Essential Workers: Getting Started
• COVID-19 Vaccination Communication Toolkit
• Science Briefs: Emerging SARS-CoV-2 Variants
• CDC Resources for Providers: Talking to Patients About COVID-19 Vaccines
• COVID-19 Vaccine Development and Distribution FAQs (Nov. 4, 2020)
• Project Firstline National Training Collaborative for Healthcare Infection Prevention and Control
• COVID-19 Data Tracker: Cases and Deaths by State
• COVID-19 Landing Page (General Resources)
• Symptom-Based Guidance for Patient Isolation, Health Care Worker Return to Work
• Criteria for Evaluating and Testing Patients for COVID-19
• Information for Health Professionals
• Resources for Clinics and Healthcare Facilities  
• Symptoms & Testing Self-Checker Tool

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Centers for Medicare & Medicaid Services (CMS)

• Medicare COVID-19 Vaccine Shot Payment
• Medicare Billing for COVID-19 Vaccine Shot Administration Toolkit
• MIPS Automatic Extreme and Uncontrollable Circumstances (EUC): 2020 Performance Year  (Feb. 25, 2021)
• Revised COVID-19-Focused Infection Control Survey Tool for Acute and Continuing Care (Dec. 30, 2020)
• CMS Frequently Asked Questions on Medicare Fee-for-Service Billing
• COVID-19 Vaccines and Monoclonal Antibodies: Payment Allowances and Related Information
• Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction (Dec. 3, 2020)
• Infographic: Coverage of Monoclonal Antibodies to Treat COVID-19 (December 2020)
• CMS Launches Acute Hospital Care At Home Program to Expand Hospital Capacity (Nov. 25, 2020)
• Acute Hospital Care At Home Online Waiver Portal
• CMS Releases Nursing Home COVID-19 Training Data with Urgent Call to Action (Nov. 17, 2020)
• CMS Releases Interim Final Rule on Vaccine Coverage and Payment (Oct. 28, 2020)
• CMS COVID-19 Vaccine Policies and Guidance
• New Payment Policy Rewards Labs for Faster COVID-19 Test Results in 2021 (Oct. 15, 2020)
• CMS Revises Repayment Terms for Medicare Loans Made to Providers (Oct. 8, 2020)
• Guidance on Mandatory Reporting of COVID-19 Data by Hospitals (Oct. 6, 2020)
• Guidance for Emergency Preparedness Testing Exercise for COVID-19 (Sept. 30, 2020)
• CMS Updates Guidance for Visitation in Nursing Homes (Sept. 17, 2020)
• Long-Term Care Hospital Quality Reporting Program: COVID-19 Tip Sheet (Sept. 8, 2020)
• CMS Issues Interim Final Rule for COVID-19 Testing in Nursing Homes (Aug. 25, 2020)(PPT Overview)
• Rural Crosswalk: CMS Flexibilities to Fight COVID-19 (August 2020)
• CMS Announces Resumption of Routine Inspections for All Providers and Suppliers (August 17, 2020)
• Provider Reimbursement Available for Counseling Patients to Self-Isolate for COVID-19 Testing; Counseling Checklist (July 30, 2020)
• CMS Announces New Infection Control Resources for Nursing Homes (July 22, 2020)
• Home Health Quality Reporting COVID-19 PHE Tip Sheet (July 2020)
• Medicare Beneficiaries Diagnosed With COVID-19 Data Snapshot
• CMS Innovation Center COVID-19 Flexibilities Landing Page
  • CMS Innovation Center Models COVID-19 Related Adjustments (June 3, 2020)
• CMS Programs and Payments for Care in Hospital Alternate Care Sites (May 26, 2020)
• Requirements for Providers to Make Public Cash Prices for COVID-19 Diagnostic Testing (FAQs) (May 12, 2020)
• Second Round of Regulatory Waivers to Support U.S. Health System (includes provider licensure, hospitals without walls, and telehealth for Medicare) (Interim Final Rule) (April 30, 2020) CMS Physicians and Other Clinicians Summary; CMS Hospitals Summary; AMGA Summary
• Quality Payment Program: COVD-19 Response Fact Sheet (Continually Updated); Quality Reporting Guidance Memo (March 27, 2020)
• COVID-19 Clinical Trials Improvement Activity Added to Quality Payment Program (April 28, 2020)
• Guidance Allowing Independent Freestanding Emergency Departments to Provide Care to Medicare and Medicaid Beneficiaries (April 21, 2020)
• Enforcement Discretion Policy for Interoperability Final Rules (April 21, 2020, Joint Statement by CMS, ONC, and HHS OIG)
• Medicare and Medicaid Policy and Regulatory Revisions Interim Final Rule (March 30, 2020); AMGA Executive Summary
• CMS Coronavirus Current Emergencies Landing Page
  • CMS Reevaluates Accelerated Payment Program, Suspends Advance Payment Program (April 26, 2020)
  • CMS Fact Sheet: Expansion of the Accelerated and Advance Payments Program for Providers and Suppliers During COVID-19 Emergency (April 26, 2020)
  • CMS Approves $34 Billion for Healthcare Providers in One Week (April 7, 2020) State-by-State Distribution (Updated April 24, 2020)
  • Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications Related to Coronavirus Disease 2029 (COVID-19)
  • Dear Clinician Letter (Explains CMS COVID-19 Policies for Providers) (April 6, 2020)
  • CMS Elective Surgery and Procedures Recommendations (Updated April 6, 2020)
  • COVID-19 Stakeholder Calls (Podcasts and Transcripts)
• CMS Coronavirus Waivers and Flexibilities [+]
  • COVD-19 Emergency Declaration Blanket Waivers for Healthcare Providers
  • Medicare Payment for Virtual Care Services (CMS Video) (May 8, 2020)
  • New and Expanded Flexibilities for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (MLN article April 17, 2020)
  • COVD-19 Emergency Declaration Blanket Waivers for Healthcare Providers (April 15, 2020) MLN Matters Article  (April 15, 2020)
  • CMS Coronavirus Waivers and Flexibilities Landing Page
  • CMS Waivers and COVID-19 Response (April 7, 2020)
  • General Provider Telehealth and Telemedicine Toolkit
  • Medicare and Medicaid Policy and Regulatory Revisions Interim Final Rule  (March 30, 2020)
  • Physicians and Other Clinicians Summary
  • Hospitals Summary
• Coverage, Billing & Coding Guidance [+]
  • Medlearn Matters Article: Medicare Fee-for-Service Response to COVID-19 (June 19, 2020)
  • * Frequently Asked Questions to Assist Medicare Providers on Fee-for-Service Billing * , Including Telehealth * (PDF) * (Updated Oct. 20, 2020)
  • Medicare Administrative Contractor (MAC) COVID-19 Test Pricing Pollcy (May 19, 2020)
  • Relaxed Billing Requirements for COVID-19 Laboratory Tests (PDF) (April 30, 2020)
  • Medlearn Video on Coverage and Payment of Virtual Services (April 10, 2020)
  • 2019-Novel Coronavirus (COVID-19) Medicare Provider Enrollment Relief (FAQs) (Updated March 30, 2020)
  • Long-Term Care Nursing Homes Telehealth and Telemedicine Toolkit (PDF) (March 27, 2020)
  • Medicare Coverage and Payment Related to COVID-19 (PDF) (Updated March 23, 2020)
  • COVID-19 Medicare Provider Enrollment Relief Frequently Asked Questions (FAQs) (March 23, 2020)
  • General Provider Telehealth & Telemedicine Toolkit (March 20, 2020)
  • Medicare Telemedicine Health Care Provider Fact Sheet (March 17, 2020)
  • Medicare Telehealth Frequently Asked Questions (FAQs) (March 17, 2020)
  • Frequently asked questions about Medicare fee-for-service emergency-related policies and procedures without an 1135 waiver (PDF) (March 16, 2020)
  • Frequently asked questions about Medicare fee-for-service emergency-related policies and procedures with an 1135 waiver (PDF) (March 16, 2020)
  • Medicare Administrative Contractor (MAC) COVID-19 Test Pricing (PDF) (March 13, 2020) 
  • FAQs on Essential Health Benefit Coverage and the Coronavirus (COVID-19) (PDF) (March 13, 2020)
  • Guidance to help Medicare Advantage and Part D Plans Respond to COVID-19 (PDF) (March 13, 2020)
  • Frequently Asked Questions to Assist Medicare Providers (PDF) (March 9, 2020)
  • Medicare Coverage and Payment Related to COVID-19 (PDF) (March 5, 2020)
  • Medicaid and CHIP Coverage and Payment Related to COVID-19 (PDF) (March 5, 2020)
  • Individual and Small Group Market Insurance Coverage (PDF) (March 5, 2020)
  • Medicare Coverage and Payment Related to COVID-19 (PDF) (March 5, 2020)
  • Medicaid and CHIP Coverage and Payment Related to COVID-19 (PDF) (March 5, 2020)
  • COVID-19: New ICD-10-CM Code and Interim Coding Guidance (February 20, 2020)
• Guidance on Reopening Facilities [+]
  • Phase II Hospital Visitation for Patients who are COVID-19 Negative (June 26, 2020)
  • Reopening America: What Patients Should Know About Seeking Health Care (June 9, 2020)
  • Recommendations for Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase II (June 8, 2020)
  • Opening Up America Again: CMS Recommendations for Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I (April 19, 2020); AMGA Executive Summary
• Infection Control Guidance [+]
  Healthcare facility infection control guidance
  • COVID-19 Long-Term Care Facility Transfer Scenarios (April 13, 2020) 
  • Guidance for Infection Control and Prevention of Coronavirus Disease (COVID-19) in Hospitals, Psychiatric Hospitals, and Critical Access Hospitals (CAHs): FAQs, Considerations for Patient Triage, Placement, Limits to Visitation and Availability of 1135 waivers (April 8, 2020)
  • Guidance for Infection Control and Prevention of Coronavirus Disease (COVID-19) in Outpatient Settings: FAQs and Considerations (April 8, 2020)
  • Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IIDs) and Psychiatric Residential Treatment Facilities (PRTFs) (April 8, 2020)
  • CMS Long-Term Care Facility Guidance (April 2, 2020)
  • Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes-REVISED (PDF) (March 13, 2020)
  • Guidance for Use of Certain Industrial Respirators by Health Care Personnel (March 10, 2020)
  • Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health Agencies (March 10, 2020)
  • Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Dialysis Facilities (March 10, 2020)
  • Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) by Hospice Agencies (March 9, 2020)
  • Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge (March 4, 2020)
  • Information for Healthcare Facilities Concerning 2019 Novel Coronavirus Illness (2019-nCoV) (February 6, 2020)
• Additional CMS Guidance [+]
  • End-Stage Renal Disease Quality Incentive Programs FAQs (Updated July 14, 2020)
  • Nursing Home COVID-19 Data and Inspection Results
  • COVID-19 Survey Activities, CARES Act Funding, Enhanced Enforcement for Infection Control deficiencies, and Quality Improvement Activities in Nursing Homes  (June 01, 2020)
  • Nursing Home Reopening Recommendations FAQs  (May 18, 2020)
  • CMS Toolkit: Mitigating COVID-19 in Nursing Homes (May 13, 2020)
  • Requirements for Notification of Confirmed and Suspected COVID-19 Cases Among Residents and Staff in Nursing Homes Interim Final Rule (May 6, 2020)
  • Attestations for ASCs Temporarily Enrolling as Hospitals (April 3, 2020)
  • CMS Announces Relief for Clinicians, Providers, Hospitals and Facilities Participating in Quality Reporting Programs in Response to COVID-19 (March 22, 2020)

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Federal Communications Commission

• COVID-19 Telehealth Program; AMGA summary

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Food and Drug Administration

• Johnson & Johnson COVID-19 Vaccine Fact Sheet for Providers (Feb. 27, 2021)
• Letter to Providers: Using Ventilator Splitters During the COVID-19 Pandemic (Feb. 9, 2021)
• Alert on SARS-CoV-2 Viral Mutation to Providers, Clinical Labs (Jan. 8, 2021)
• Providers Urged to Follow Authorized Dosing Schedules for COVID-19 Vaccines (Jan. 4, 2020)
• COVID-19 Communications Toolkits
• Moderna COVID-19 Vaccine Fact Sheet for Providers (Dec. 18, 2020)
• Instructions for Providers on Administering Pfizer, BioNTech Vaccine (Dec. 12, 2020)
• FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators (Nov. 25, 2020)
• Q&A: Face Masks, Including Surgical Masks, and Respirators for COVID-19 (Nov. 24, 2020)
• FDA Authorizes First COVID-19 Test for Self-Testing at Home (Nov. 17, 2020)
• Investigational COVID-19 Convalescent Plasma Guidance for Industry (Nov. 16, 2020)
• A Closer Look at COVID-19 Diagnostic Testing (Nov. 16, 2020)
• FDA approves first treatment (remdesivir) for COVID-19 (Oct. 22, 2020)
• Guidance documents on emergency use authorizations for COVID-19 vaccines (Oct. 6, 2020)
• FDA Tool to Help Health Facilities Select Respirators (August 19, 2020)
• Guidance Document: Development and Licensure of Vaccines to Prevent COVID-19 (June, 2020)
• Revised Provider Fact Sheet: Remdesivir Interaction with Chloroquine, Hydroxychloroquine (June 15, 2020)
• COVID-19 Resources for Health Professionals
• FDA Coronavirus Landing Page
• Emergency Use Authorizations [+] 
  • FDA Authorizes Quidel QuickVue At-Home COVID-19 Test (March 1, 2021)
  • EUA Issued for Johnson & Johnson COVID-19 Vaccine (Feb. 27, 2021)
  • FDA Authorizes Monoclonal Antibodies for Treating COVID-19 (Feb. 10, 2021)
  • EUA Granted for Moderna Inc.’s COVID-19 Vaccine (Dec. 18, 2020)
  • EUA Issued for First COVID-19 Vaccine from Pfizer, BioNTech (Dec. 11, 2020)
  • First COVID-19 and Flu Combination Test Authorized for Home Use (Dec. 4, 2020)
  • Regeneron granted EUA for casirivimab and imdevimab for mild to moderate COVID-19 (Nov. 21, 2020)
  • FDA authorizes monoclonal antibodies for treating COVID-19 (Nov. 21, 2020)
  • FDA authorizes combination of baricitinib with remdesivir for certain patients (Nov. 19, 2020)
  • EUA Granted for Test to Detect Neutralizing Anitibodies from Recent or Prior SARS-CoV-2 Infection (Nov. 6, 2020)
  • EUA Granted to Eli Lilly’s Monoclonal Antibody Bamlanivimab to Treat Mild to Moderate COVID-19 Disease (Nov. 10, 2020)
  • FDA Authorized First Point-of-Care Antibody Test for COVID-19​ (Sept. 23, 2020)
  • Remdesivir EUA Broadened to Include All Hospitalized Patients (Aug. 28, 2020)
  • EUA Issued for Antigen Test Allowing Results to Be Read From Testing Card (Aug. 26, 2020)
  • EUA Issued for Convalescent Plasma as Potential COVID-19 Treatment (Aug. 23, 2020)
  • EUA Issued for Yale School of Public Health Saliva Direct Diagnostic Test(
  • EUA Issued for Yale School of Public Health Saliva Direct Diagnostic Test( (August 15, 2020)
  • FDA Authorizes First Two Serology Tests That Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection (July 30, 2020)
  • FDA Authorizes First Diagnostic Test for Those Without Known Infection (July 24, 2020)
  • Emergency Use Authorization Issued for Becton Dickinson Point-of-Care Antigen Test (July 6, 2020)
  • FDA authorizes additional COVID-19 combination diagnostic test ahead of flu season (July 2, 2020)
  • Emergency Use Authorization Revoked for Chloroquine, Hydroxychloroquine (June 15, 2020)
  • Emergency Use Authorization for First Next Generation Sequence Test to Diagnose COVID-19 (June 10, 2020)
  • Revised Emergency Use Authorizations on Decontaminating Respirators for Reuse (June 7, 2020)
  • Guidance on Individual Access Requests for Investigational Drugs and Biologics During COVID-19 Emergency (June 2, 2020)
  • Emergency Use Authorization for Certain Gowns and Other Apparel (May 22, 2020)
  • Emergency Use Authorization for First Standalone At-Home Sample Collection Kit (May 16, 2020)
  • Emergency Use Authorization for Wireless teleCARE IP Nurse Call System (May 11, 2020)
  • Emergency Use Authorization for First Antigen Test to Detect COVID-19 Virus (May 9, 2020)
  • Revised Guidance on Antibody Tests (May 4, 2020)
  • Remdesivir Emergency Use Authorization: letter to Gilead Sciences; fact sheets for providers and patients/parent caregivers (May 1, 2020)
  • Investigational COVID-19 Guidance for Industry: Convalescent Plasma (Updated April 13, 2020)
  • FAQs on Diagnostic Testing for SARS-CoV-2
  • COVID-19 Emergency Use Declarations for Medical Devices (Ventilators, PPE, In Vitro Diagnostics)

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Health Resources and Services Administration

• HRSA $2 billion Provider Relief Fund (PRF) Rewards Nursing Homes for Performance (Sept. 3, 2020)
• COVID-19 Preparedness and Recovery Resources for Health Centers
• Additional Resources [+] 
  • HHS Announces Over $4 Billion in Additional Relief Payments to Providers (July 10, 2020)
  • Enhanced Provider Portal, Relief Fund Payments for Safety Net Hospitals, Medicaid, and CHIP Providers; Updated FAQs (June 9, 2020)
  • HHS Provides $225 Million for COVID-19 Testing in Rural Communities (May 20, 2020)
  • HHS Awards $15 Million to Support Telehealth Providers (May 13, 2020)
  • HHS Awards $583 Million to Health Centers to Expand Testing (May 7, 2020)
  • HRSA Awards $20 Million to Combat COVID-19 Pandemic Through Telehealth (April 30, 2020)
  • COVID-19 Claims Reimbursement for Testing and Treatment to Health Care Providers and Facilities Serving the Uninsured

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National Institutes of Health

• COVID-19 Treatment Guidelines
• Coronavirus (COVID-19) Resources Page
• See also AMGA COVID-19 Population Health and Medical Research Resources

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Office of the National Coordinator for Health IT

• COVID-19 Response: Tools and Resources for the Health IT and Clinical Community

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U.S. Small Business Administration

• Coronavirus (COVID-19) Small Business Guidance and Loan Resources