Multi-ingredient Compound Policy
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Administrative pharmacy policy governing coverage and prior authorization criteria for multi-ingredient compounded medications for CareSource Georgia Marketplace plan members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Multi-Ingredient Compounds
Non-pain multi-ingredient compound criteria
Coverage for non-topical-pain multi-ingredient compounds
ALL of the following
- The primary active ingredients in the compound are approved by the FDA for the indication, age, or route of administration; OR if any active ingredient is not FDA approved for the requested indication/age/route, there must be evidence from TWO published studies from major peer-reviewed scientific or medical journals supporting use as safe and effective.
- The active ingredients are prescribed in therapeutic amounts based on FDA approved indications.
- The compound contains only one active ingredient per any specific therapeutic drug class as defined by First Data Bank.
- If the compound is similar to a commercially available product but differs in dosage, dosage form, or inert ingredient (e.g., flavoring, dye, preservative), prescriber chart notes documenting the medical need for the compound (e.g., inability to swallow, allergy to inactive ingredients) are required.
- If any ingredient in the compound (active or inactive) otherwise requires prior authorization, the member must meet that ingredient's established medical necessity criteria.
- The member has tried and failed at least 3 preferred medications (if available) that can be used to treat the member's condition; trial dates must be included with the prior authorization request.
- The compound will NOT be covered when any of the following apply: it is used for an excluded benefit (e.g., cosmetic, obesity, sexual dysfunction, infertility), contains ingredients withdrawn for safety, is for a commercially available product, or is for convenience only.
Topical pain compound criteria
Coverage for topical pain multi-ingredient compounds
ALL of the following
- Member has a diagnosis of chronic moderate to severe pain associated with neuropathic or nociceptive pain.
- Member must have tried at least 3 listed drugs from different groups for at least 30 days each: non-opioid oral medications (or documented contraindication), diclofenac 1% or OTC Voltaren gel, topical lidocaine (e.g., lidocaine cream 3%–4% or lidocaine patch 4%), and topical capsaicin.
- The compound contains no more than one active ingredient per any specific drug class as defined by First Data Bank.
- The compound contains no more than 3 drug classes for active ingredients.
- The compound does NOT contain any controlled substances.
- Active ingredients must be FDA approved or compendia supported for topical use and for the pain indication.
Coding and Code Limits
Authorization, Documentation, and Provider Requirements
Prior authorization, initial approval, and reauthorization requirements
Prior authorization is required for all multi-ingredient compounded medications. Initial approval will be for 3 months (or the prescriber’s requested shorter length of therapy). Reauthorization, when requested, is granted for 12 months and requires documentation of effectiveness: for pain compounds, improvement of at least 3 points on a 0–10 pain scale; for other compounds, chart documentation showing effectiveness and safety.
- Initial approval: 3 months or prescriber-requested shorter length (chunk 10).
- Reauthorization: 12 months (chunk 10).
- Reauthorization requirements: pain—≥3 point improvement on 0–10 pain scale; other compounds—chart-documented effectiveness and safety (chunk 7).
Clinical eligibility and evidence requirements for coverage
Coverage of multi-ingredient compounds is conditional on meeting clinical eligibility criteria: primary active ingredients must be FDA‑approved for the indication/age/route or, if not FDA‑approved for the requested use, supported by two published peer‑reviewed studies; active ingredients must be prescribed in therapeutic amounts; only one active ingredient per therapeutic drug class; and members must have tried and failed required prior therapies (three preferred meds for non‑pain compounds; three different drug‑group trials ≥30 days each for topical pain).
- If any active ingredient is not FDA‑approved for the requested indication/age/route, two published studies from major peer‑reviewed journals are required (chunk 5).
- Active ingredients must be prescribed in therapeutic amounts and limited to one active per therapeutic class as defined by First Data Bank (chunk 5).
- Non‑pain compounds: member must have tried and failed at least 3 preferred medications; trial dates must be included with the prior authorization request (chunk 5).
- Topical pain compounds: member must have tried ≥3 drugs from different groups for at least 30 days each (non‑opioid oral meds or documented contraindication; diclofenac 1%/OTC Voltaren; topical lidocaine; topical capsaicin); no more than 1 active per drug class and no more than 3 drug classes; compounds must not contain controlled substances; active ingredients must be FDA‑approved or compendia supported for topical use and the pain indication (chunk 6).
Definitions
Initial Therapy and Trial Requirements
Initial therapy trials
Initial therapy and trial requirements
ALL of the following
- Non-pain compounds: Member must have tried and failed at least 3 preferred medications (if available) that can be used to treat the condition; trial dates must be included with the prior authorization request.
- Topical pain compounds: Member must have tried at least 3 agents from different groups for ≥30 days each (non-opioid oral agents or documented contraindication; diclofenac 1%/OTC Voltaren gel; topical lidocaine; topical capsaicin).
- Initial authorization period: up to 3 months, or a prescriber's requested shorter length of therapy.
Reauthorization and Continuation Criteria
Reauthorization
Reauthorization requirements
ALL of the following
- Pain compounds: Reauthorization requires documented improvement of at least 3 points on a 0–10 pain scale, supported by chart notes.
- All other compounds: Reauthorization requires chart documentation demonstrating evidence of effectiveness and safety for continuation of approval.
- Reauthorization period: up to 12 months for continued approval (per authorization rules).
Step Therapy Requirements
| Step | Requirement | Notes |
|---|---|---|
| 1 | Member must try specified preferred or listed alternatives before compound approval | Non-pain compounds: member must have tried and failed at least 3 preferred medications (trial dates included in prior authorization). Topical pain compounds: member must have tried at least 3 listed drugs from different groups for ≥30 days each (non-opioid oral meds or documented contraindication; diclofenac 1%/OTC Voltaren gel; topical lidocaine; topical capsaicin). |
Quantity and Reimbursement Limits
Site of Care and Special Considerations
Drug‑shortage requests handled case‑by‑case
If a request is due to a drug shortage (infusion center setting), the request will be evaluated on a case‑by‑case basis.
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