Author: GDIT, (800) 688-6696
The Food and Drug Administration (FDA) previously approved a Risk Evaluation and Mitigation Strategies (REMS) for Mifeprex (mifepristone) to mitigate the risk of serious adverse events. After reviewing the supplemental application, the FDA determined that a REMS is necessary to ensure the safe use of Mifeprex. Under the REMS:
- Mifeprex must be ordered, prescribed and dispensed by or under the supervision of a healthcare provider who prescribes and who meets certain qualifications;
- Healthcare providers who wish to prescribe Mifeprex must complete a Prescriber Agreement Form prior to ordering and dispensing Mifeprex;
- Mifeprex may only be dispensed in clinics, medical offices, and hospitals by or under the supervision of a certified healthcare provider;
- The healthcare provider must obtain a signed Patient Agreement Form before dispensing Mifeprex.
Healthcare providers who prescribe Mifeprex are required under FDA regulations to provide the patient with a copy of the Mifeprex Medication Guide (FDA-approved information for patients).
Providers must follow the guidelines in Clinical Policy 1E-2.
Since the FDA requires Mifeprex to only be dispensed in clinics, medical offices, and hospitals, the North Carolina Medicaid and NC Health Choice programs will add coverage of mifepristone tablets, for oral use (Mifeprex) in the Physician Administered Drug Program effective Feb. 1, 2019 when billed with HCPCS code S0190 - Mifepristone, oral, 200 mg.
Additionally, since Cytotec (misoprostol) 200 mcg is indicated, in a regimen with mifepristone, the Medicaid and NC Health Choice programs will also add coverage of misoprostol tablets, for oral use (Cytotec) for use in the Physician Administered Drug Program when billed with HCPCS code S0191 - Misoprostol, oral, 200 mcg.
Mifeprex is available as tablets containing 200 mg of mifepristone each, supplied as 1 tablet on one blister card. It is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.
Recommended Dose:
• Day 1: Mifeprex 200 mg orally in a single dose
• Day 2 or 3: Misoprostol 800 mcg (four 200 mcg tablets) buccally
• Minimum interval between Mifeprex and misoprostol is 24 hours.
See full prescribing information for further detail.
For Medicaid and NC Health Choice Billing of Mifepristone
- The ICD-10-CM diagnosis code required for billing is: Z33.1 Pregnant State, incidental
- Providers must bill HCPCS code: S0190 - Mifepristone, oral, 200 mg as the primary code in conjunction with HCPCS code: S0191 - Misoprostol, oral, 200 mcg as secondary. S0190 and S0191 should be billed on the same claim form in the order in which they are administered.
- One Medicaid and NC Health Choice unit of coverage is: 200 mg
- The maximum reimbursement rate per unit is: $73.80
- Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDC is: 64875-0001-01
- The NDC units should be reported as "UN1".
- For additional information, refer to the January 2012 Special Bulletin, National Drug Code Implementation Update.
- For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy No. 1B, Attachment A, H.7 on the DHBs website.
- Providers shall bill their usual and customary charge for non-340B drugs.
- PADP reimburses for drugs billed for Medicaid and NC Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the "UD" modifier on the drug detail.
- The fee schedule for the Physician Administered Drug Program is available on the DHB PADP web page.
Misoprostol is available as a 200 mcg tablet and is indicated, in a regimen with mifepristone, for the medical termination of intrauterine pregnancy through 70 days gestation.
Recommended Dose:
- Day 1: Mifeprex (mifepristone) 200 mg orally in a single dose
- Day 2 or 3: Misoprostol 800 mcg (four 200 mcg tablets) buccally
- Minimum interval between Mifeprex and misoprostol is 24 hours.
See full prescribing information for further detail.
For Medicaid and NC Health Choice Billing of Misoprostol
- The ICD-10-CM diagnosis code required for billing is: Z33.1 Pregnant State, incidental
- Providers must bill HCPCS code S0191 Misoprostol, oral, 200 mcg as the secondary code in conjunction with HCPCS code: S0190 - Mifepristone, oral, 200 mg as primary. S0190 and S0191 must be billed on the same claim form in the order in which they are administered.
- One Medicaid and NC Health Choice unit of coverage is: 200 mcg
- The maximum reimbursement rate per unit is: $0.98
- Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDCs are: 00025-1461-31, 00025-1461-34, 00025-1461-60, 63704-0008-01, 59762-5008-01, 59762-5008-02, 43386-0161-01, 43386-0161-06, 68084-0041-01, 68084-0041-11, 00172-4431-49, 00172-4431-60
- The NDC units should be reported as "UN1".
- For additional information, refer to the January 2012 Special Bulletin, National Drug Code Implementation Update.
- For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy No. 1B, Attachment A, H.7 on the DHB website.
- Providers shall bill their usual and customary charge for non-340B drugs.
- PADP reimburses for drugs billed for Medicaid and NC Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the "UD" modifier on the drug detail.
- The fee schedule for the Physician Administered Drug Program is available on the DHB PADP web page.