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PA Bulletin, Doc. No. 21-724

NOTICES

DEPARTMENT OF HUMAN SERVICES

Updates to the Medical Assistance Program Fee Schedule for Administration of SARS-CoV-2 Monoclonal Antibody Therapy

[51 Pa.B. 2603]
[Saturday, May 8, 2021]

 In accordance with 55 Pa. Code § 1150.61(a) (relating to guidelines for fee schedule changes), the Department of Human Services (Department) announces the addition of the following procedure codes to the Medical Assistance (MA) Program Fee Schedule for the administration of monoclonal antibody products for the novel coronavirus (SARS-CoV-2). The effective date and MA Fee for each code is indicated as follows.

Procedure Code Description
Effective Date MA Fee
M0239 Intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring 11/9/20 $247.68
M0243 Intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring 11/21/20 $247.68
M0245 Intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring 2/9/2021 $247.68


 On November 9, 2020, the United States Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the unapproved monoclonal antibody therapy Bamlanivimab 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 or hospitalization, or both.

 On November 21, 2020, the FDA granted an EUA for the unapproved 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 or hospitalization, or both.

 On February 9, 2021, the FDA granted an EUA for the unapproved monoclonal antibody therapy Bamlanivimab and Etesevimab, 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 or hospitalization, or both.

 The MA Program Fee Schedule has been updated with the new Current Procedural Terminology (CPT) codes to allow for payment of the administration of the monoclonal antibody therapies to MA beneficiaries.

 The Department issued MA Bulletins to inform providers enrolled in the MA Program of the addition of the CPT codes for the administration of the monoclonal antibody infusion therapies.

Fiscal Impact

 The estimated fiscal impact of the addition of monoclonal antibody therapy is $0.225 million in total (State and Federal) funds. The estimated fiscal impact of the addition of monoclonal antibody therapy for Fiscal Year 2021-2022 is $0.450 million in total funds.

Public Comment

 Interested persons are invited to submit written comments regarding this notice to the Department of Human Services, Office of Medical Assistance Programs, c/o Regulations Coordinator, Room 515, Health and Welfare Building, Harrisburg, PA 17120. Comments received within 30 days will be reviewed and considered for any subsequent revision to the MA Program Fee Schedule.

 Persons with a disability who require an auxiliary aid or service may submit comments using the Pennsylvania Hamilon Relay Service at (800) 654-5984 (TDD users) or (800) 654-5988 (voice users).

MEG SNEAD, 
Acting Secretary

Fiscal Note: 14-NOT-1438. (1) General Fund; (2) Implementing Year 2020-21 is $75,000; (3) 1st Succeeding Year 2021-22 is $150,000; 2nd Succeeding Year 2022-23 through 5th Succeeding Year 2025-26 are $0; (4) 2019 Program—$344,107,000; 2018-19 Program—$342,544,000; 2017-18 Program—$477,690,000; (7) MA—Fee-for-Service; (8) recommends adoption. Funds have been included in the budget to cover this increase.

[Pa.B. Doc. No. 21-724. Filed for public inspection May 7, 2021, 9:00 a.m.]



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