bamlanivimab

The FDA revoke Emergency Use Authorization for bamlanivimab; Issues identified at a Janssen manufacturing facility; Merck halts trials for investigational COVID-19 therapy; A new contraceptive is approved; And Ragwitek has approval expanded.

This week’s stories include a caution about remdesivir; New and updated Emergency Use Authorizations; And new approvals in sleep apnea and for Botox.

On this week’s pod: The Moderna vaccine and what we know about its effectiveness against emerging variants; Merck ends it’s development of two vaccines; Two separate treatment combos show promise in reducing hospitalizations and preventing COVID, respectivel; And the FDA approve a new treatment for lupus nephritis. 

Likely, you just heard of Bamlanivimab, and like wildfire it is being repeated in meeting after meeting within your organization. On November 9th, the FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy, bamlanivimab for the treatment of mild-to-moderate COVID-19 patients. The monoclonal antibody is expected to be distributed within the next week. Unlike the investigational therapies before it, this infusion will target your outpatient sites of care and add a layer of complexity with billing in which we have outlined.

• Bamlanivimab EUA is extended to patients with a positive SARS-CoV-2 test, >12 years, weighs at least 40kg, and who are at high risk of progressing to severe COVID-19 and/or hospitalization. The authorization does not extend to patients hospitalized, requiring oxygen therapy due to COVID-19, or individuals with increased oxygen requirements due to COVID-19. Additionally, bamlanivimab may only be administered in a location in which the healthcare provider has immediate access to treat a severe infusion reaction.

• In the CMS bulletin, two codes have been published to represent the drug and the administration of the drug.

1) Q0239, injection, bamlanivimab-xxxx 700 mg to be used to represent the drug 

2) M0239, intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring

The administration code is inclusive of the one hour infusion and post infusion monitoring in a hospital outpatient setting.

• CMS has established a payment rate for the administration of the intravenous infusion, M0239, of $309.60 (not inclusive of the geographical adjustments). This payment rate is aligned with a level 4 drug administration. 

• When bamlanivimab is provided free of charge, CMS has directed providers to ONLY bill for the administration and the Q0239 should NOT be included on the claim. This is different from other drugs provided free of charge in which the HCPCS representing the drug code should be listed on the claim with a token charge to allow the claim to bypass claim edits.

• Services for beneficiaries covered under Medicare Advantage Plans should have claims billed directly to the Original Medicare (Medicare Fee For Service) for bamlanivimab administration through 2020 and 2021.

SHOUT-OUTS!

1. CDM and Billing Teams. When provided free of charge, validate the Q0239 for the drug is not listed on the claim. This is a different practice from other drugs provided free of charge. Consider holding claims until the MAC, claim processors and alike have the time to update their software to accept the new codes.

2. Pharmacy Teams. Ensure documentation in the patients’ medical record includes a positive COVID-19 test documented and they meet the criteria outlined in the EUA. 

3. Billing Teams. Validate claims are being sent to Original Medicare for all Medicare Advantage Plans and monitor a few claims to ensure they are processed correctly. Additionally, validate the billing code or charge is set up to not drop to patient responsibility for the copay or deductible.  

PLEASE NOTE: This information is current as of the publication date of this newsletter (11/16/2020). The FDA and CMS may publish additional instructions which may supersede the information in this article.

Major developments in COVID-19 vaccine and antibody treatments: Are we close to having a vaccine gain Emergency Use Authorization? The antibody bamlanivimab is given Emergency Use Authorization; An NIH study concluded that hydroxychloroquine has no clinical benefit; And unrelated to COVID, but still big news, the Advisory Committee have voted on what would-be the first Alzheimer disease treatment in decades.

This week on the pod; the latest COVID news, including encouraging news on antibody therapies; Updated on Emergency Use Authorization guidelines for vaccines; Remdesivir distribution; A HIV drug fails to have an impact; And why the FDA want a preterm birth treatment withdrawn from the market.