Peanut (Arachis hypogaea) Allergen Powder-dnfp Powder for Oral Administration (Palforzia™) HCPCS Code J3590: Billing Guidelines

Tuesday, May 19, 2020

Effective with date of service April 2, 2020, the Medicaid and NC Health Choice programs cover peanut (Arachis hypogaea) allergen powder-dnfp powder for oral administration (Palforzia™) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3590 - Unclassified biologics.

Strength/Package Sizes: Powder for oral administration supplied in 0.5 mg, 1 mg, 10 mg, 20 mg and 100 mg capsules or 300 mg sachets.

Indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.

Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

Recommended Dose: Treatment with Palforzia™ is administered in 3 sequential phases: Initial Dose Escalation, Up-Dosing and Maintenance. 

Phase 1. Initial Dose Escalation:

  • Initial Dose Escalation is administered on a single day under the supervision of a health care professional in a health care setting with the ability to manage potentially severe allergic reactions, including anaphylaxis.
  • Initial Dose Escalation is administered in sequential order on a single day beginning at Level A (5 Levels A - E, 0.5 mg - 6 mg). Each dose should be separated by an observation period of 20 to 30 minutes.
  • Dosing Configuration for Initial Dose Escalation (Single Day Dose Escalation):- Dose Level A: One 0.5 mg capsule (0.5 mg total) 
    • Dose Level B: One 1 mg capsule (1 mg total) 
    • Dose Level C: One 0.5 mg capsule; one 1 mg capsule (1.5 mg total) 
    • Dose Level D: Three 1 mg capsules (3 mg total) 
    • Dose Level E: Six 1 mg capsules (6 mg total) 

Phase 2. Up-Dosing: 

  • Up-Dosing consists of 11 dose levels and is initiated at a 3 mg dose (Level 1).
  • The first dose of each new Up-Dosing level is administered under the supervision of a health care professional in a health care setting with the ability to manage potentially severe allergic reactions, including anaphylaxis.
  • Observe patients after administering the first dose of a new Up-Dosing level for at least 60 minutes until suitable for discharge.
  • If the patient tolerates the first dose of the increased dose level, the patient may continue that dose level at home. Each dose should be consumed daily with a meal at approximately the same time each day, preferably in the evening.
  • Administer all the dose levels in sequential order at 2-week intervals if tolerated.
  • Daily Dosing Configuration for Up-Dosing:
    • Dose Level 1: Three 1 mg capsules (3 mg total daily dose)
    • Dose Level 2: Six 1 mg capsules (6 mg total daily dose)
    • Dose Level 3: Two 1 mg capsules; one 10 mg capsule (12 mg total daily dose)
    • Dose Level 4: One 20 mg capsule (20 mg total daily dose)
    • Dose Level 5: Two 20 mg capsules (40 mg total daily dose)
    • Dose Level 6: Four 20 mg capsules (80 mg total daily dose)
    • Dose Level 7: One 20 mg capsule; one 100 mg capsule (120 mg total daily dose)
    • Dose Level 8: Three 20 mg capsules; one 100 mg capsule (160 mg total daily dose)
    • Dose Level 9: Two 100 mg capsules (200 mg total daily dose)
    • Dose Level 10: Two 20 mg capsules; two 100 mg capsules (240 mg total daily dose)
    • Dose Level 11: One 300 mg sachet (300 mg total daily dose)

Phase 3. Maintenance: 

  • Complete all dose levels of Up-Dosing before starting Maintenance.
  • The Maintenance dose of Palforzia™ is 300 mg daily.
  • Daily Dosing Configuration for Maintenance:
    • Dose Level 11: One 300 mg sachet

See Package Insert for detailed information regarding dose modification, management of consecutive missed doses and discontinuation of Palforzia™.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code(s) required for billing are: T78.01XA - Anaphylactic reaction due to peanuts, initial encounter; T78.01XD - Anaphylactic reaction due to peanuts, subsequent encounter; T78.01XS - Anaphylactic reaction due to peanuts, sequela; Z91.010 - Allergy to peanuts
  • Providers must bill with HCPCS code: J3590 - Unclassified biologics
  • One Medicaid and Health Choice unit of coverage is: per daily dose 
  • The maximum reimbursement rate per unit is: $32.04
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 71881-0113-13, 71881-0101-45, 71881-0102-90, 71881-0103-45, 71881-0104-15, 71881-0105-30, 71881-0106-60, 71881-0107-30, 71881-0108-60, 71881-0109-30, 71881-0110-60, 71881-0111-15 and 71881-0111-30
  • 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 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