A new investigational monoclonal antibody therapy for Medicare patients with mild to moderate COVID-19 warrants new codes. The Centers for Medicare & Medicaid Services (CMS) announced Dec. 3 that it is implementing two new HCPCS Level II codes for Regeneron’s antibody casirivimab and imdevimab (REGN-COV2), effective for dates of service on or after Nov. 21.
How To Report Regeneron’s Antibody Therapy
CMS created the new codes in response to the U.S. Food and Drug Administration (FDA) issuing an emergency use authorization (EUA) for the new therapy on Nov. 9. The two drugs are administered together, and the therapy is reported with the following new HCPCS Level II codes:
| Code | Long Descriptor | Payment Allowance |
| Q0243 | Injection, casirivimab and imdevimab, 2400 mg | $0.010 |
| M0243 | Intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring | $309.600 |
Providers can bill under Medicare Part B for the administration of this infusion therapy on a single claim or submit multiple claims on a roster bill. CMS warns, however, that the requirements for administration of this therapy are “considerably more complex” and may not lend themselves to roster billing.
Providers should make sure to document the steps they took to meet the terms of the FDA’s EUA. CMS also wants to see the name of the practitioner who ordered or made the decision to administer the infusion to each patient, even if using roster billing.
Reimbursement for REGN-COV2 and Admin
The Medicare national average payment rate of approximately $310 for the monoclonal antibody administration is based on one hour of infusion and post administration monitoring in the hospital outpatient setting. Medicare will adjust the payment allowance for M0243 based on geographic location and setting, as appropriate.
Providers should not bill Q0243 if they received the product for free. CMS says it will adjust the payment allowance if providers begin to purchase the products, and “anticipate addressing coding and payment rates for administration of monoclonal antibody products through future notice and comment rulemaking.”
There is no cost-sharing for COVID-19-related services and supplies: Copayments/coinsurance and deductibles do not apply for Medicare patients.
The ability for entities other than a skilled nursing facility (SNF) to submit claims for monoclonal antibody products and their administration furnished to Medicare Part A SNF residents is limited to an enforcement discretion notice activated by CMS in regards to SNF consolidated billing.
Appropriate Use of Regeneron’s REGN-COV2
This therapy is deemed appropriate for adults and pediatric patients (12 years and older, weighing at least 88.2 pounds) who test positive for COVID-19 and are at high risk for developing severe COVID-19 that may require hospitalization. The therapy must be administered in a setting in which healthcare providers have immediate access to medications to treat severe infusion reactions and the ability to activate the Emergency Medical System, as necessary.
Casirivimab and imdevimab are not authorized for use in patients with COVID-19 who are hospitalized, require oxygen therapy, or require an increase in baseline oxygen flow rate.
Other Covered COVID-19 Therapies
Last month, CMS created codes for another COVID-19 monoclonal antibody product and its administration. Effective Nov. 10, report Eli Lilly’s antibody bamlanivimab (LY-CoV555) therapy with Q0239 Injection, bamlanivimab-xxxx, 700 mg and M0239 Intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring. The payment allowances and billing requirements for these codes are the same as for Q0243 and M0243.
For More Information: https://www.aapc.com/blog/52407-how-to-report-regenerons-regn-cov2/