CMS Issues Addition Guidance on Emergency Preparedness Testing The Quality, Safety & Oversight (QSO) Group at the Centers for Medicare & Medicaid Services (CMS) has issued a revised QSO -20-41-All memo to provide additional guidance and clarifications on the emergency preparedness standard for testing requirements due to the ongoing...
Read moreCOVID-19: New Codes for Moderna Vaccine Booster Doses On March 29, 2022, the FDA amended the Moderna COVID-19 vaccine emergency use authorization (PDF), including new packaging for vaccine boosters (blue cap). CMS issued new codes, effective March 29, 2022, for the vaccine booster and administration: Code: 91309 Long descriptor: Severe acute...
Read moreEligible Individuals Can Receive Second COVID-19 Booster Shot at No Cost On April 6, CMS announced it will pay for a second COVID-19 booster shot of either the Pfizer-BioNTech or Moderna COVID-19 vaccines without cost sharing, as it continues to provide coverage for this critical protection from the virus....
Read moreCOVID-19 Monoclonal Antibodies: Revised Emergency Use Authorization for EVUSHELD On February 24, the FDA revised the emergency use authorization for tixagevimab co-packaged with cilgavimab (EVUSHELD™) to change the initial dose for the authorized use as pre-exposure prophylaxis of COVID-19 in certain adults and pediatric patients. For more information about...
Read moreCOVID-19 Monoclonal Antibodies: FDA Authorized Bebtelovimab On February 11, the FDA authorized the emergency use (PDF) of the monoclonal antibody bebtelovimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients when all of these apply: They have a positive COVID-19 test result They’re at high-risk for progression to severe...
Read moreCOVID-19: New HCPCS Code for Convalescent Plasma in Outpatient Setting On December 28, the FDA revised the emergency use authorization for COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies. It’s authorized for treatment of COVID-19 in patients with immunosuppressive disease or getting immunosuppressive treatment, in the outpatient or inpatient setting....
Read moreBiden-Harris Administration Will Cover Free Over-the-Counter COVID-19 Tests Through Medicare CMS Developing Initiative to Enable Access to Eight Free Over-the-Counter COVID-19 Tests for Medicare Beneficiaries in Early Spring As part of the Biden-Harris Administration’s ongoing efforts to expand Americans’ access to free testing, people in either Original Medicare or...
Read moreCOVID-19: New HCPCS Code for Remdesivir Antiviral Medication – Updated NIH Treatment Guidelines Panel Link Following the recent statement from the National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel about therapies for the COVID-19 Omicron variant, CMS created HCPCS code J0248 for VEKLURY™ (remdesivir) antiviral medication when administered in an...
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