CurrentFlorida BluePolicy 10-008

Unclassified Drugs

Governs billing and reimbursement requirements for drugs without specific HCPCS/CPT codes (including compounded drugs and convenience kits) for Florida Blue members and providers across all lines of business.

Policy Summary

PayerFlorida Blue

PolicyUnclassified Drugs

Policy CodePolicy 10-008

Change TypeNo material changes

Effective DateMay 14, 2010

Next Review Date

Key ActionSubmit each NDC on a separate claim line with required 11-digit NDC details per provider manual to avoid denials.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

80% AWPreimbursement basis for drugs without established ASP

2pricing updates/year

6+compound criteria

Highdenial risk for incorrect HCPCS

Compound and Unclassified Drug Coverage Criteria

Compound and unclassified drug coverage criteria

Policy Summary

PayerFlorida Blue

PolicyUnclassified Drugs

Policy CodePolicy 10-008

Change TypeNo material changes

Effective DateMay 14, 2010

Next Review Date

Key ActionSubmit each NDC on a separate claim line with required 11-digit NDC details per provider manual to avoid denials.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

ALL of the following

There must be a valid prescription order from a physician with at least one FDA-approved ingredient that has a recognized NDC number.
There is no commercially available product comparable to the compound product.
There is good evidence in the medical literature to support the use of all active ingredients.
ALL active ingredients are prescribed for the specific diagnosis.
The intended route of administration for the compounded prescription is supported by medical and scientific evidence.
None of the active ingredients are addressed in another medical coverage guideline with coverage limitations disallowing it to be considered a medical necessity.
Exceptions
- Bulk powders with a valid NDC used in compounding drugs for treatment of severe spasticity of cerebral or spinal cord origin and severe, chronic, intractable pain for use in infusion pumps meet medical necessity per published Medical Coverage Guideline.
- Bulk powders with a valid NDC used in compounding alpha hydroxyprogesterone caproate injection and progesterone vaginal suppositories meet medical necessity per published Medical Coverage Guideline.
Exclusions
- Substances primarily utilized as stabilizing agents, inert ingredients, or diluents used in the compounded drug are incidental to the preparation and NOT eligible for reimbursement.
- Non-prescription preparations are NOT eligible for reimbursement.
Claim/billing requirement
- Additional reimbursement for specific compounded medications must be accompanied by an entry on the claim in an additional line (see examples).

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Provider Billing, Documentation, and Denial Risks

Denial Risk

Claim submission requirements and denial risk

Submit each NDC on a separate claim line and include all required NDC details per the provider manual. Do not use an unclassified HCPCS code when a specific HCPCS code exists for the drug; claims using an unspecified HCPCS when a specific code is available will be denied. Claims missing required information will be denied and returned for correction.

Submit each NDC on a separate claim line.
Include 11-digit NDC, NDC description, NDC quantity (with AWPU), and assigned unit of measure.
Do not use unclassified HCPCS when a specific HCPCS code exists for the drug (denial risk).

Billing Rule

Convenience kit billing restriction

Point-of-use convenience kits that contain non-drug components (e.g., alcohol prep pads, cotton balls, band aids, gloves, swabs, gauze) will not be reimbursed as kits. Non-drug components are considered included in the practice expense for drug administration. Bill the appropriate HCPCS for the medication only; claim lines with NDCs representing these kits will be denied.

Convenience kits containing non-drug components will be denied.
Report the appropriate HCPCS code for the medication(s) contained in the kit for reimbursement.
Refer to the periodically updated Convenience Kit Example Listing for examples (not exhaustive).

Documentation Required

Compound drug documentation and criteria

Compound drugs require a valid prescription and full claim-level documentation. Reimbursement is allowed only when all compound criteria are met and supporting NDC information is submitted as specified.

A valid prescription order from a physician with at least one FDA‑approved ingredient that has a recognized 11‑digit NDC.
No commercially available product comparable to the compound product.
Good evidence in the medical literature supporting use of all active ingredients.
All active ingredients are prescribed for the specific diagnosis.
Intended route of administration is supported by medical/scientific evidence.
None of the active ingredients are excluded by other coverage guidelines with disallowing limitations.
Submit for each active ingredient: 11‑digit NDC, NDC description, NDC quantity (with AWPU), and assigned unit of measure.
Substances that are inert/stabilizers/diluents or non‑prescription preparations are not eligible for reimbursement.
Additional compound fees must be submitted on a separate claim line (example: compounding fee J3490 with associated NDC and quantities).
Exceptions: Certain bulk powders with valid NDCs used for specific indications (e.g., severe spasticity infusion pumps; alpha hydroxyprogesterone caproate injection and progesterone vaginal suppositories) may meet medical necessity per published Medical Coverage Guideline.

J3490	Unclassified drugs
J3590	Unclassified biologic
J9999	NOC antineoplastic drug
A9699	Radiopharmaceutical, therapeutic, NOC
Q0181	Unspecified oral dosage form

OpenPayer

Unclassified Drugs

Compound and Unclassified Drug Coverage Criteria

Coding and Reimbursement Basis

Provider Billing, Documentation, and Denial Risks

Definitions