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The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Moderna COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 18 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

A link to the full FDA press release is here. The press release also provides information and discussion on available safety and effectiveness data.

You can review the full Moderna COVID-19 Vaccine EUA Letter of Authorization here.

In addition to the EUA letter, below are links to fact sheets from the FDA:

Fact Sheet for Healthcare Providers Administering Vaccine (Vaccine Providers)

Fact Sheet for Recipients and Caregivers

Operation Warp Speed and private sector partners now begin distributing the first allocation of doses to sites designated by the public health jurisdictions and five federal agencies with which OWS and CDC have been working to plan distribution. HHS Secretary Alex M Azar II and Acting Secretary of Defense Christopher C. Miller have issued statements on this next step, and they can be viewed here.

For more information on COVID-19 vaccines, the EUA process, and guidance to industry for developing a COVID-19 vaccine please visit:

COVID-19 Vaccines

Emergency Use Authorization for Vaccines Explained

Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry

Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry

The CDC’s Vaccine Inquiry Center for all health care providers is now available to answer vaccine questions. You may send all inquiries to: eocevent168@cdc.gov

The CDC is also pointing people to this HRSA resource: COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured | Official web site of the U.S. Health Resources & Services Administration (hrsa.gov)

CMS issued an Interim Final Rule with Comment Period, which established the New COVID-19 Treatments Add-on Payment (NCTAP) under the Medicare Inpatient Prospective Payment System (IPPS), effective from November 2, 2020, until the end of the Public Health Emergency (PHE) for COVID-19. To mitigate potential financial disincentives for hospitals to provide new COVID-19 treatments during the COVID-19 PHE, the Medicare program will provide an enhanced payment for eligible inpatient cases that involve use of certain new products with current Food and Drug Administration approval or emergency use authorization to treat COVID-19. Visit the NCTAP webpage for more information.

The National Rural Health Association (NRHA) is working to support their members with the ongoing PPE shortage by partnering with Project N95 to offer PPE.  This is the same program that is being used by other associations, such as American Medical Association. Practice Project N95 is a nonprofit 501(c)(3) organization working to get critical equipment to frontline workers. Through this collaboration, NRHA members have a special opportunity to purchase the following PPE at bulk pricing and in small quantities:

• N95 respirators (certified by FDA and NIOSH)
• 3 and 4 ml Blue Nitrile Powder Free Patient examination gloves
• ASTM Level 1 and Level 3 surgical masks
• Level 1 and Level 2 AAMI isolation gowns
• Hard surface disinfectant
• Disposable face shields

The equipment is being sourced through a limited-time campaign; therefore, you must order by 3PM EST on December 29, 2020 for this limited-time offer.

Tax exempt providers can submit the necessary documentation during registration.  Before you can access the store where the product detail and pricing information is available, you must register by clicking the link below to learn more about the products and how to purchase them:  shop.projectn95.org/registration

Additional Product Detail:

On December 11, 2020, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 for individuals 16 years of age and older. Review Pfizer’s Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) regarding the limitations of authorized use.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for the administration of the vaccine (when furnished consistent with the EUA). Review our updated payment and HCPCS Level I CPT code structure for specific COVID-19 vaccine information. Only bill for the vaccine administration codes when you submit claims to Medicare; don’t include the vaccine product codes when vaccines are free.

Related links:

• CMS COVID-19 Provider Toolkit
• CMS COVID-19 FAQs
• CDC COVID-19 Vaccination Communication Toolkit for medical centers, clinics, and clinicians
• FDA COVID-19 Vaccines webpage

NRHA highlighted the fantastic work by a group of bipartisan Senators led by Senators Manchin (D-WV), Collins (R-ME), Cassidy (R-LA), Murkowski (R-AK) and others to work toward a COVID-19 relief package. The framework of this package was made public. Included in the framework was a 20 percent carveout for rural providers in new Provider Relief Fund (PRF) and Federal Communications Commission (FCC) Telehealth Program funding. Additionally, the framework provides updated language on PRF use requirements, so it is more provider friendly. Further, the framework includes a one-year extension of current telehealth flexibilities.