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Regulations and Legislation

Provides guidance on how to implement COVID-19 vaccine rules under the CARES Act, which established a vaccine as a preventive service when recommended by ACIP

Section 3203 requires health insurance providers to cover any vaccines recommended by ACIP as a preventive service available without cost sharing within 15 business days or recommendation.

Advisory Committee on Immunization Practices (ACIP) recommendations of who should receive the vaccine and when, given limited supply.

FDA

(FDA)

(NIH)

Official Emergency Use Authorization granted for the Pfizer-BioNTech COVID-19 vaccine.

Drug Labeling information for the Pfizer-BioNTech COVID-19 vaccine.

(FDA)

(NIH)

Official Emergency Use Authorization granted for the Moderna COVID-19 vaccine.

Drug Labeling information for the Moderna COVID-19 vaccine.

The FDA has posted questions covering specific issues, such as what data the FDA used when it decided on whether to authorize the vaccine for emergency use.

Payer Toolkits and Guidance

(CMS)

CMS landing page with policies, guidance, and links to toolkits for providers, health insurance providers, issuers, state Medicaid programs, and CHIP programs.

CMS will allow plans to request certain COVAX data2 from CMS regarding their enrollees, subject to CMS approval, if that data is the minimum necessary and is requested for the plans’ health care operations such as case management, care coordination, or population-based activities to improve the health of their enrollees.

CMS Toolkits

The Centers for Medicare & Medicaid Services (CMS) is issuing blanket waivers consistent with those issued for past PHE declarations. These waivers prevent gaps in access to care for beneficiaries impacted by the emergency. You do not need to apply for an individual waiver if a blanket waiver is issued.

Set out below are frequently asked questions (FAQs) regarding implementation of the Families First Coronavirus Response Act (the FFCRA), the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act), and other health coverage issues related to Coronavirus Disease 2019 (COVID-19).

This site tracks national and local rates for COVID-19 cases and death.

CMS released a set of toolkits to describe how health care providers can enroll in Medicare to bill for administering vaccines when available, vaccine Medicare coding structure, Medicare reimbursement strategy for COVID-19 vaccine administration, and how health care providers can bill correctly for administering vaccines, including roster and centralized billing.

The Centers for Medicare & Medicaid Services (CMS) released a set of toolkits for providers, states and issuers to help the health care system prepare to swiftly administer the vaccine once it is available.

Interim playbook serves as a playbook for state, territorial, and local public health programs and their partners on how to plan and operationalize a vaccination response to COVID-19 within their jurisdictions.

Coding and Billing Guidance

(FDA)

New Current Procedural Terminology (CPT^®) codes have been created that streamline the novel coronavirus testing currently available on the United States market.

Official Emergency Use Authorization granted for the Pfizer-BioNTech COVID-19 vaccine.

(NIH)

(FDA)

Drug Labeling information for the Pfizer-BioNTech COVID-19 vaccine.

Official Emergency Use Authorization granted for the Moderna COVID-19 vaccine.

(NIH)

Drug Labeling information for the Moderna COVID-19 vaccine.

The FDA has posted questions covering specific issues, such as what data the FDA used when it decided on whether to authorize the vaccine for emergency use.

CMS guidance on payment allowances and other related information under Medicare Part B. Also includes information on payment allowances for certain monoclonal antibodies.

HRSA FAQs on claims for COVID-19 testing, treatment, and vaccine administration, including information about the Uninsured Program.

Toolkits for Providers and Consumers

(CMS)

(CDC)

CMS landing page with policies, guidance, and links to toolkits for providers, health insurance providers, issuers, state Medicaid programs, and CHIP programs.

CDC website with 8 things that the public needs to know about the COVID-19 vaccine program and vaccines, including safety, effectiveness, allocation, and who can administer the vaccine. It also has information on side effects, costs, FDA approval and authorization, and how a COVID-19 fits into the tools available to combat the pandemic.

This toolkit provides long-term care facility (LTCF) administrators and clinical leadership with information and resources to help build vaccine confidence among healthcare personnel (HCP) and residents.

CMS will allow plans to request certain COVAX data2 from CMS regarding their enrollees, subject to CMS approval, if that data is the minimum necessary and is requested for the plans’ health care operations such as case management, care coordination, or population-based activities to improve the health of their enrollees.

This table provides information on how states and territories are planning to allocate the COVID-19 vaccines.

CDC released frequently asked questions about COVID-19 vaccination in correctional and detention centers.

Information from the CDC on getting ready for the COVID-19 vaccine.

Recommendations from the American Pharmacists Association about screening patients for immunocompromised status and obtaining attestation before administering booster doses and confirming prior vaccination status.

Maps that provide state-specific vaccination data.