MedicaidCoverageMedium impact
Newly Approved FDA Drug Therapies & Vaccines
Maryland Medicaid·MD·Managed Care Organizations
Effective date
Jun 12, 2000
We identified it
Jun 20, 2026
Summary
Maryland Medicaid managed care organizations must expand their formularies to include all newly FDA-approved drugs, vaccines, and immunizations. MCOs must also cover approved drugs prescribed for off-label uses when supported by official drug compendia and have procedures for non-formulary drug requests.
Action Required
Immediately: Billing teams should verify that newly FDA-approved drugs and vaccines are covered by Maryland Medicaid MCOs without prior authorization denials. For formulary drugs requiring preauthorization, ensure requests are processed within 72 hours. Establish procedures to document medical necessity for non-formulary drug requests and off-label uses supported by official drug compendia.