Latest Updates Related to COVID-19 Coding and Billing

The COVID-19 public health emergency continues to inspire changes to coding and billing practices and guidelines that impact physicians, healthcare providers, and coding and billing professionals. Several organizations recently announced changes related to COVID-19 that could impact all healthcare professionals.

On May 4, 2021, the American Medical Association (AMA) announced the addition of three new provisional CPT® codes to report the COVID-19 vaccine and administration, which Novavax is developing. The effective date of the new codes will depend on Federal Drug Administration (FDA) approval. Novavax has indicated it plans to file for an Emergency Use Authorization (EUA) for the vaccine in the third quarter of 2021.

The new vaccine and its administration will be reimbursed using the same methodology currently used for reimbursement for the existing two-dose vaccines from Moderna and Pfizer. Specifically, administration of the first dose has a payment rate of $16.94, while administration of the final dose has a payment rate of $28.39, subject to geographic adjustment. Because the vaccine is provided free of charge, there is currently no reimbursement for the vaccine itself.

The three new codes are the following:

• 0041A – Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19}) vaccine, recombinant spike protein nanoparticle, saponin-based adjuvant, preservative free, 5 mcg/0.5mL dosage; first dose.
• 0042A – Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19}) vaccine, recombinant spike protein nanoparticle, saponin-based adjuvant, preservative free, 5 mcg/0.5mL dosage; second dose.
• 91304 – Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19}) vaccine, recombinant spike protein nanoparticle, saponin-based adjuvant, preservative free, 5 mcg/0.5mL dosage, for intramuscular use.

On May 26, 2021, the FDA issued an EUA for the emergency use of sotrovimab, a monoclonocal antibody, for the treatment of mid-to-moderate COVID-19 disease for patients who meet the following criteria:

• 12 years of age or older.
• Weight of at least 40 kg.
• Positive results for COVID-19.
• At high risk for progression to severe COVID-19, including hospitalization or death.

The EUA for sotrovimab prohibits administration of the drug for patients who are hospitalized due to COVID-19, require oxygen therapy due to COVID-19, or are on chronic oxygen therapy due to underlying conditions other than COVID-19.

On June 8, 2021, CMS announced the creation of three new codes to report sotrovimab and its administration. Because the FDA approved the use of sotrovimab on May 26, 2021, all three codes are effective for use on or after May 26, 2021.

The three new codes for sotrovimab are the following:

• M0247 – Intravenous infusion, sotrovimab, includes infusion and post administration monitoring.
• M0248 – Intravenous infusion, sotrovimab, includes infusion and post administration monitoring in the home or residence; this includes a beneficiary’s home that has been made provider-based to the hospital during the COVID-19 Public Health Emergency.
• Q0247 – Injection, sotrovimab, 500 mg.

In accordance with previously released reimbursement information, monoclonal antibodies furnished on or after May 6, 2021, will have an average payment rate of $450 per administration with an average payment rate of $750 for home. Because the drugs are currently provided free of charge to providers, there will be no separate reimbursement for the drugs themselves, but CMS will update reimbursement once healthcare providers incur a cost for the drugs.

As of May 2021, there are three active EUAs for the following monoclonal antibody products: sotrovimab, casirivimab and imdevimab when administered together, and bamlanivimab and etesevima when administered together. On April 16, 2021, the FDA revoked the EUA for the administration of bamlanivimab when administered alone. As a result, HCPCS codes M0239, Intravenous infusion, bamlanivimab, includes infusion and post administration monitoring, and Q0239, Injection, bamlanivimab, 700 mg, are inactivate as of 4/16/2021.

In conjunction with the monoclonal antibody changes, CMS updated the COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing document to clarify coding, billing, and documentation requirements related to monoclonal antibody products and infusions. These requirements include guidance on roster billing and site of service considerations.

Because COVID-19 continues to alter the landscape for healthcare providers and for patients, Vitalware will continue to keep you apprised of pertinent changes.