Effective with date of service Feb. 24, 2020, the Medicaid and NC Health Choice programs cover cefiderocol for injection, for intravenous use (Fetroja®) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3490 - Unclassified drugs.
Strength/Package Size: For injection: 1 gram of cefiderocol as a lyophilized powder for reconstitution in single-dose vials.
Indicated in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible Gram-negative microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Recommended Dose (see full prescribing information for details):
- Administer 2 grams of Fetroja® for injection every 8 hours by intravenous (IV) infusion over 3 hours in patients with creatinine clearance (CLcr) 60 to 119 mL/min.
- Dose adjustments are required for patients with CLcr less than 60 mL/min. See Table 1 in the Package Insert for recommended dosages.
- For patients with CLcr greater than or equal to 120 mL/min, Fetroja® 2 grams administered every 6 hours by IV infusion over 3 hours is recommended.
- The recommended duration of treatment with Fetroja® is 7 to 14 days. The duration of therapy should be guided by the severity of infection and the patient’s clinical status for up to 14 days.
For Medicaid and NC Health Choice Billing
- The ICD-10-CM diagnosis codes required for billing are: N10 - Acute pyelonephritis; N11.0 - Nonobstructive reflux-associated chronic pyelonephritis; N11.1 - Chronic obstructive pyelonephritis; N11.8 - Other chronic tubulo-interstitial nephritis; N11.9 - Chronic tubulo-interstitial nephritis, unspecified; N12 - Tubulo-interstitial nephritis, not specified as acute or chronic; N13.6 - Pyonephrosis; N16 - Renal tubulo-interstitial disorders in diseases classified elsewhere; N30.00 - Acute cystitis without hematuria; N30.01 - Acute cystitis with hematuria; N30.20 - Other chronic cystitis without hematuria; N30.21 - Other chronic cystitis with hematuria; N30.80 - Other cystitis without hematuria; N30.81 - Other cystitis with hematuria; N30.90 - Cystitis, unspecified without hematuria; N30.91 - Cystitis, unspecified with hematuria; N34.1 - Nonspecific urethritis; N34.2 - Other urethritis; N39.0 - Urinary tract infection, site not specified.
Additional codes, to identify infectious agent: B96.1 - Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere; B96.20 - Unspecified Escherichia coli [E. coli] as the cause of diseases classified elsewhere; B96.21 - Shiga toxin-producing Escherichia coli [E. coli] (STEC) O157 as the cause of diseases classified elsewhere; B96.22 - Other specified Shiga toxin-producing Escherichia coli [E. coli] (STEC) as the cause of diseases classified elsewhere; B96.23 - Unspecified Shiga toxin-producing Escherichia coli [E. coli] (STEC) as the cause of diseases classified elsewhere; B96.29 - Other Escherichia coli [E. coli] as the cause of diseases classified elsewhere; diseases classified elsewhere; B96.4 - Proteus mirabilis (morganii) as the cause of diseases classified elsewhere; B96.5 - Pseudomonas (aeruginosa) (mallei) (pseudomallei) as the cause of diseases classified elsewhere
- Providers must bill with HCPCS code: J3490 - Unclassified drugs
- One Medicaid and NC Health Choice unit of coverage is: 1 gram (1 vial)
- The maximum reimbursement rate per unit is: $198.00
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 59630-0266-01, 59630-0266-10
- 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 1B, Attachment A, H.7 on Medicaid's 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 PADP is available on Medicaid's PADP web page.
Contact
NCTracks Contact Center: 800-688-6696