Medicare beneficiaries won't have to pay out-of-pocket for monoclonal antibody treatments of COVID-19 for the duration of the public health emergency, the Centers of Medicare and Medicaid announced Tuesday.
The agency's coverage includes bamlanivimab, Eli Lilly and Company's therapy that received an emergency use authorization from the U.S. Food and Drug Administration earlier this week. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test who are at high risk for progressing to severe COVID-19 and/or hospitalization.
WHAT'S THE IMPACT
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The U.S. has purchased 300,000 doses of bamlanivimab, which will likely be given to healthcare providers at no charge, CMS said in its release. Although Medicare won't pay for monoclonal antibody treatments that providers receive for free, it will reimburse for the infusion.
Once providers begin to purchase the doses themselves, CMS said it will set the payment rate the same as for COVID-19 vaccines – 95% of the average wholesale price.
CMS anticipates that this announcement will allow providers such as those in infusion centers, home health agencies and nursing homes to administer the treatment in accordance with the EUA and bill Medicare for the infusion.
The agency said it plans to issue further billing and coding instructions in the coming days.
THE LARGER TREND
Earlier this fall, the FDA approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years old and older and weighing at least 88 pounds for COVID-19 treatments requiring hospitalization.
Veklury, along with an experimental antibody cocktail being developed by the drug maker Regeneron, was used to treat President Trump when he was hospitalized with COVID-19.
CMS implemented two new payment initiatives to track the effectiveness of COVID-19 therapeutics and to use counseling to help stop the spread of the virus. The new procedure codes will enable CMS to conduct real-time surveillance and obtain data on the drugs' effectiveness. They can be reported to Medicare, and other insurers may also use the codes to identify the use of COVID-19 therapies to help facilitate monitoring and data collection on their use.
The timeline for a COVID-19 vaccine is still up in the air, but Pfizer recently announced its vaccine candidate was found to be more than 90% effective in preventing the coronavirus in participants without prior infection. The drugmaker also said it expects the U.S government to authorize its emergency use this month after reporting the candidate has yet to show serious safety concerns.
ON THE RECORD
"Today, CMS is announcing a historic, first-of-its-kind policy that drastically expands access to COVID-19 monoclonal antibodies to beneficiaries without cost-sharing," said CMS Administrator Seema Verma. "Our timely approach means beneficiaries can receive these potentially life-saving therapies in a range of settings – such as in a doctor's office, nursing home, infusion centers, as long as safety precautions can be met. This aggressive action and innovative approach will undoubtedly save lives."
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