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CENTERS FOR MEDICARE &
MEDICAID SERVICES (CMS)
Special
Edition – Thursday, December 3, 2020
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COVID-19
Antibody Treatment and Enforcement Discretion Reminder
CMS
Takes Further Steps to Ensure Medicare Beneficiaries Have Wide Access to
COVID-19 Antibody Treatment
The U.S. Food and Drug Administration issued
an Emergency Use Authorization (EUA) for the investigational monoclonal
antibody therapy, casirivimab and imdevimab, administered together, for the
treatment of mild-to-moderate COVID-19 in adults and pediatric patients with
positive COVID-19 test results who are at high risk for progressing to severe
COVID-19 and/or hospitalization. Casirivimab and imdevimab, administered
together, may only be administered in settings in which health care providers
have immediate access to medications to treat a severe infusion reaction,
such as anaphylaxis, and the ability to activate the Emergency Medical System
(EMS), as necessary. Review the Fact Sheet for Health Care Providers EUA of Casirivimab
and Imdevimab regarding the limitations of authorized use
when administered together. During the COVID-19 Public Health Emergency
(PHE), Medicare will cover and pay for these infusions the same way it covers
and pays for COVID-19 vaccines (when furnished consistent with the EUA). CMS identified specific code(s) for the
monoclonal antibody product and specific administration code(s) for Medicare
payment: Regeneron’s Antibody Casirivimab and Imdevimab
(REGN-COV2) , EUA effective November 21, 2020. Q0243: Long descriptor: Injection, casirivimab and
imdevimab, 2400 mg Short descriptor: casirivimab and imdevimab M0243: Long Descriptor: intravenous infusion,
casirivimab and imdevimab includes infusion and post administration
monitoring Short Descriptor: casirivi and imdevi
infusion Additional Resources:
COVID-19
Vaccines and Monoclonal Antibody Infusion: Enforcement Discretion Relating to
SNF Consolidated Billing
To facilitate the efficient administration of
COVID-19 vaccines to Skilled Nursing Facility (SNF) residents, CMS is
exercising enforcement discretion with respect to
statutory provisions requiring consolidated billing by SNFs as well as any
associated statutory references and implementing regulations, including as
interpreted in pertinent guidance. Through the exercise of this discretion,
we will allow Medicare-enrolled immunizers working within their scope of
practice and subject to applicable state law, including, but not limited to,
pharmacies working with the United States, as well as infusion centers, and
home health agencies, to bill directly and receive direct reimbursement from
the Medicare program for vaccinating Medicare Part A SNF residents. This
enforcement discretion, and accordingly the ability for entities other than
the SNF to submit claims for these monoclonal antibody products and their
administration furnished to Medicare Part A SNF residents, is limited to the
period described in the above-cited enforcement discretion notice. Like our newsletter? Have
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