NDC directory guidance and prior authorization for Firvanq (reconstituted/compounded products)
Customize your policy alerts
Sign up for all kernfamilyhealthcare policy alerts
Know when kernfamilyhealthcare releases new policies or updates existing guidance.
Monitor payer policy activity
Guidance for providers on coverage and prior authorization requirements related to non‑FDA approved reconstituted/compounded oral suspensions and the FDA‑approved product Firvanq; applicable to Kern Family Health Care Medicaid funds and provider prior authorization processes.
No material clinical or coverage changes in this revision.
Coverage Criteria
Coverage stance
Summary coverage positions
Non‑FDA approved reconstituted suspensions (referred to in this document as 'First' reconstituted suspensions) are not FDA‑approved formulations. Medicaid funds may not be spent on these medications. If a member cannot swallow the solid oral product, an appropriate compounded preparation or an alternative formulation (for example, IV vancomycin or intact capsules) must be used instead.
An FDA‑approved oral vancomycin product, Firvanq, has been reviewed and approved by the FDA. Dispensing Firvanq requires prior authorization and it may be approved if medically necessary. Note that assignment of an NDC number does not denote FDA approval; NDCs appear in one of three configurations: 4-4-2, 5-3-2, or 5-4-1.
Coding and Identifiers
| No codes listed |
Provider Actions and Billing Rules
Firvanq requires prior authorization
Firvanq (the FDA‑approved oral vancomycin product) requires prior authorization; coverage may be granted if the medication is determined to be medically necessary.
Provider must request prior authorization for Firvanq
Submit a prior authorization request to the plan when prescribing or dispensing Firvanq; include clinical justification that the FDA‑approved product is medically necessary for the member.
- Include documentation that the member cannot be managed with available alternatives when relevant
- Provide clinical rationale supporting medical necessity to support approval
Prior authorization required to dispense Firvanq
Dispensing Firvanq requires prior authorization and may require submission of medical necessity justification as part of the PA review.
- Do not dispense Firvanq without an approved prior authorization to avoid coverage denial
- Provide clinical notes or prior treatment information if requested during PA review
Medicaid payment may be denied for non‑FDA reconstituted suspensions
Non‑FDA approved 'First' reconstituted suspensions are not FDA‑approved formulations and Medicaid funds may not be spent on these products; use of such non‑FDA reconstituted suspensions is at risk of Medicaid payment denial.
- If a member cannot swallow solid oral products, consider compounded alternatives or FDA‑approved products (e.g., Firvanq) with appropriate PA
- Examples cited include using IV vancomycin or capsules instead of non‑FDA 'First' suspensions
Background
Some patients cannot swallow solid oral products, which can prompt consideration of alternative formulations. When an oral suspension is needed but only a non‑FDA approved reconstituted suspension is available, that product is not eligible for Medicaid payment and a compounded preparation or another FDA‑approved formulation should be used when clinically appropriate. Examples provided include use of IV vancomycin or intact capsules in place of non‑approved reconstituted suspensions.
Definitions
Initial Therapy Criteria
Firvanq initial therapy — authorization requirement for FDA‑approved product
Authorization requirement for FDA‑approved product
Step Therapy / Prior Authorization Details
| Step | Requirement | Coverage status |
|---|---|---|
| 1 | Prior authorization is required for Firvanq (FDA‑approved oral vancomycin). Requests may be approved if medical necessity is demonstrated. | Prior authorization required |
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.