Coverage and reimbursement for COVID-19 vaccines; new NIH research website for COVID.
- On Monday afternoon, Congress unveiled the text of a package of legislation – agreed upon Sunday evening – that includes an omnibus appropriations bill to fund the federal government through the remainder of the fiscal year, a $900 billion COVID-19 stimulus bill, and several other bills that hitched a ride onto this must-pass bill. Late Monday night, the bill was passed by both the House and Senate and sent to President Trump for his signature to sign it into law.
- We will provide separate documents summarizing the 5,593 page bill.
White House and Federal Agencies
- The Centers for Medicare and Medicaid Services (CMS) released a new update to the Coverage and Reimbursement of COVID-19 Vaccines, Vaccine Administration and Cost Sharing under Medicaid, the Children’s Health Insurance Program, and Basic Health Program Toolkit that was originally released on October 28 and was first updated on November 23. This update includes additional information regarding vaccine administration reimbursement and outlines a streamlined review process available to states looking to expeditiously adjust vaccine administration reimbursement rates in their state plans.
- ASPR TRACIE released a document with a compiled set of resources on Preventing COVID-19 in Healthcare Facilities. The document covers information related to the approval, allocation, distribution, and administration of vaccines to prevent COVID-19 within healthcare facilities.
- The Department of Health and Human Services (HHS) Office of Civil Rights issued guidance on how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) permits covered entities and their business associates to use health information exchanges (HIEs) to disclose protected health information (PHI) for the public health activities of a public health authority (PHA). The guidance provides examples relevant to the COVID-19 public health emergency on how HIPAA permits covered entities and their business associates to disclose PHI to an HIE for reporting to a PHA that is engaged in public health activities.
- The National Institutes of Health (NIH) released a new COVID-19 website to provide the research community and the public with trusted, up-to-date, accurate information about NIH research on COVID-19 across the NIH-supported research community. The website offers NIH COVID-19–related content in one location, including funding opportunities and research news on vaccines, treatments, and testing. Users can also search funding information for COVID-19 research by state, institution, Congressional district, and more.
Centers for Disease Control and Prevention (CDC) Updates
- the FAQ document on Clinical Questions about COVID-19.
- its information on Understanding mRNA Vaccines.
- its document on Things to Know about the COVID-19 Pandemic.
- information on at-home testing. You and your healthcare provider might consider either an at-home collection kit or an at-home test if you have signs and symptoms of COVID-19 or if you can’t get tested at a local healthcare facility.
- interim guidelines for healthcare providers and local and state health departments on collecting, handling, and testing clinical specimens for COVID-19.
Economy, Vaccine, Testing and Treatment
- On Friday, the FDA issued an Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine. 7.9 million doses of the vaccine are ready for distribution this week.
- Review Moderna’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 the vaccines are free.
- The CDC Advisory Committee on Immunization Practices (ACIP) recommends that adults older than 75 and frontline essential workers (teachers, firefighters, police) should be the next priority for vaccines after frontline healthcare workers. The ACIP’s recommendations are non-binding but are highly influential.
- Johnson & Johnson finished enrolling 45,000 participants into the phase 3 trial for its COVID-19 vaccine. It hopes to submit the results from this study to the FDA for approval in February.
- So far, more than 600,000 people in the U.S. have received the COVID-19 vaccine.
- The CDC issued new guidelines in response to a handful of reported allergic reactions to Pfizer’s COVID-19 vaccine.
- HHS and DoD continued their weekly Operation Warp Speed briefings to discuss the nearly 8 million COVID-19 vaccine doses allocated for states and jurisdictions this week.
- NIH released information on NIH Trials Enrolling People Hospitalized with COVID-19. Two randomized, controlled Phase 3 clinical trials have begun evaluating investigational monoclonal antibodies for their safety and efficacy in treating people hospitalized with COVID-19.
- The U.K. identified a new strain of the coronavirus that causes COVID-19 which might be more contagious than other strains.