CMS Provides Billing Codes for Regeneron’s COVID-19 Antibody Drug

CMS has released Medicare billing codes for a new COVID-19 antibody drug recently approved by the FDA.

Healthcare providers are now able to use the Healthcare Common Procedural Coding System (HCPCS) code Q0243 for the injection of 2,400 milligrams of Regeneron’s investigational monoclonal antibody therapy cocktail and code M0243 for intravenous infusion and post-administration monitoring, according to an update on CMS’ Monoclonal Antibody COVID-19 Infusion webpage.

The codes allow providers to document and submit claims for the investigational monoclonal antibody therapy cocktail from Regeneron.

 The FDA granted the therapy, which leverages casirivimab and imdevimab, emergency use authorization late last month for the treatment of mild-to-moderate COVID-19 patients who are at high risk for progressing to severe COVID-19 or hospitalization.

The drug is the second monoclonal antibody therapy approved by the FDA during the pandemic. The other therapy being bamlanivimab from pharmaceutical company Eli Lilly and Company.

CMS has announced that Medicare will cover and pay for infusions of the two COVID-19 antibody therapies during the public health emergency as long as providers administer the drugs according to their respective emergency use authorizations. The program will also reimburse providers for the infusions the same way it pays for COVID-19 vaccines, which is 95 percent of the average wholesale price for many healthcare providers.

But currently, the payment allowance for the injection of casirivimab and imdevimab is a penny, CMS also stated in an updated Medicare billing webpage. Meanwhile, the payment allowance for the infusion and any post-administration monitoring of Regeneron’s therapy is $309.60.

The payment allowances went into effect on November 21, although it will be adjusted regionally, the agency added.

The payment allowance for the initial injection is so low because providers are not expected to incur a cost for Regeneron’s therapy at first, CMS explained.

Healthcare providers are slated to get initial doses of the COVID-19 antibody therapy for free, and HHS recently announced that it has started to allocate those doses to states and territorial health departments weekly based on confirmed COVID-19 cases in the regions.

Leaders of the federal department expect to distribute between 70,000 and 300,000 doses from Regeneron based on a manufacturing agreement they made with the pharmaceutical company over the summer.

The government-allocated doses are to be made available at no cost to patients, and healthcare facilities and their providers are not to charge Medicare for the doses they received for free, CMS stated.

But the agency will update the payment allowance for the initial injection of the antibody therapy when it expects providers to start incurring the costs of acquiring the novel COVID-19 therapy.

CMS also plans to do the same for injections of Eli Lilly’s bamlanivimab. The Medicare payment allowance for the infusion and any post-administration monitoring is also $309.60, which is also geographically adjusted for most providers.

More pharmaceutical companies are currently testing monoclonal antibodies, which are proteins created in laboratories to mimic the immune system’s ability to fight certain antigens, such as viruses.

Researchers are finding that the antibodies have been successful with combating COVID-19 antigens. Eli Lilly, for example, recently announced that data from an interim analysis of a Phase 2 trial showed its monoclonal antibody therapy significantly reducing the risk of hospitalization among patients who received the drug compared to a placebo group.

Regeneron has also released positive results from Phase 2/3 clinical trial evaluating its COVID-19 antibody cocktail. The results from the ongoing trial showed that the therapy significantly reduced viral load and patient medical visits, including hospitalizations, emergency room visits, urgent care visits, and physician office or telemedicine visits.

CMS hopes that Medicare coverage for the two therapies will help providers overcome the obstacles of acquiring and employing new treatments.

However, healthcare facilities and providers are still expected to encounter challenges with obtaining an adequate supply of the therapies for infected patients. Supplies will be limited through the end of the year as pharmaceutical companies ramp up production of the novel therapies.