Non‑Covered Product Examples — FDA‑Unapproved Drugs
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Describes HealthChoice of Oklahoma's position to exclude certain FDA‑unapproved drugs from the pharmacy benefit, who may be grandfathered, and examples of affected product classes and specific non‑covered products affecting members and prescribing providers.
No material clinical or coverage changes in this revision.
Coverage Criteria for FDA-Unapproved Drugs
Coverage stance and grandfathering
Coverage stance and grandfathering
Decision informed by PBM contracting and clinical reviews; not all unapproved drugs are excluded.
New prescriptions for these drugs will be notified as not covered and may be denied.
Non-covered product examples
Examples of excluded product classes and recommended alternatives
List is illustrative, not exhaustive, and is subject to change; consult the EGID Unapproved Drug List and CMS data file for the full current list.
HealthChoice excludes certain drugs that are legally marketed in the U.S. but lack formal FDA approval. As stated in the policy, FDA‑unapproved drugs will be excluded from the HealthChoice pharmacy benefit unless specifically identified as covered or grandfathered, a determination informed by PBM contracting and clinical review. Members who were already receiving these unapproved drugs at the time the policy took effect will be grandfathered through calendar year 2022, while new prescriptions for these products may be denied.
This section provides representative examples of non‑covered products and therapeutic classes to illustrate the scope of exclusions; it is not an exhaustive coding table. For a complete and authoritative list of medications and COD status codes, providers should consult the CMS Medicaid Drug Rebate Program data file referenced in the policy.
The policy lists multiple specific product examples that are presented as non‑covered/unapproved. Representative named products include Prevident 5000 (and variants such as Prevident 5000 Plus and Prevident Enamel Pro), Dentagel, and Ferrex 150 Forte. These products are shown among repeated entries in the document’s Unapproved Drug List‑EGID and are provided as illustrative examples of items subject to exclusion.
Providers should note these named examples occur within larger category lists (dental products, emollient/keratolytic agents, hematopoietic mixtures, topical antifungals, salicylates, rectal combinations, urinary analgesics, etc.) and that documentation or prescribing for the listed brand‑name products may be treated as requests for non‑covered items.
The document enumerates representative therapeutic classes shown as examples of non‑covered items. These include ANTIFUNGALS - TOPICAL, ANTISPASMODICS, KERATOLYTIC/ANTIMITOTIC AGENTS, ANTISEBORRHEIC PRODUCTS, EMOLLIENT/KERATOLYTIC AGENTS, ESTROGEN COMBINATIONS, RECTAL COMBINATIONS/RECTAL STEROIDS, URINARY ANALGESICS, HYDROCORTISONE/IODOQUINOL, SALICYLIC ACID WART REMOVAL, and HEMATOPOIETIC MIXTURES.
The policy lists these classes to illustrate product groups subject to exclusion; individual entries within each class (for example, topical corticosteroids, salicylic acid formulations, or hematopoietic/iron mixtures) are repeated across the Unapproved Drug List‑EGID examples.
Within the section labeled Unapproved Drug List‑EGID, the policy provides additional example entries and product classes designated as unapproved or non‑covered. Examples called out in this segment include antiseborrihic products, sodium bicarbonate and other bicarbonates, Anusol‑HC (rectal steroid), and multiple hematopoietic mixtures such as Ferrex 150 Forte Plus and Ferrocite.
These entries illustrate the range of products included on the EGID example list — spanning topical agents, antiseptics, keratolytic agents, iron/hematopoietic preparations, and rectal steroid formulations — and are presented as non‑covered examples under the payer’s unapproved product framework.
Additional representative therapeutic classes and branded examples appear repeatedly in the Unapproved Drug List‑EGID. Notable mentions include topical corticosteroids (e.g., hydrocortisone acetate/PR), branded acne cleansers such as Plexion cleanser and Avar cleanser, Dakins solution and other chlorine antiseptics, and iron products including FerraLet 90 and ferrous sulfate.
These repeated listings reflect the document’s role as an illustrative collection of non‑covered products and therapeutic classes; each listed product or class is presented as an example that may lead to claim denial if submitted as a non‑FDA approved item.
The Unapproved Drug List‑EGID section also enumerates several additional branded products and mapped class relationships. Example named entries include DEBACTEROL, DAKINS SOLUTION (various strengths), FERREX 28, HEMATOGEN FORTE, HEMMOREX‑HC, and PRAMOSONE — each shown alongside an associated therapeutic class (for instance, DEBACTEROL mapped to ANTISEPTICS - MOUTH/THROAT).
These mappings indicate how certain brand‑name entries are classified in the document and are provided as examples of products that the payer treats as unapproved and therefore non‑covered for pharmacy benefit purposes.
The products and therapeutic classes shown in this section are intended as examples rather than an exhaustive or definitive list. As the policy states, the Unapproved Drug List‑EGID entries are illustrative and claims for the listed products may be considered not medically necessary / non‑covered under the payer’s unapproved drug policy.
Providers should use the examples to identify likely non‑covered items and consult the full CMS Medicaid Drug Rebate Program data file or the payer’s maintained EGID list for authoritative coverage status and COD codes.
This section identifies the listed items as unapproved/non‑covered products by example; the document presents these entries to demonstrate categories and brand names that the payer regards as unapproved. The policy excerpts do not contain formal NMN decision‑tree language within these chunks, but do make clear that claims for the listed products would be treated as non‑covered under the unapproved product framework.
Where a complete determination is required, providers should reference the CMS data file and the payer’s EGID list for COD status codes and definitive coverage classifications.
Coding and Identification
| 11 | COD status code indicating unapproved drug (per Medicaid Drug Rebate Program data file) |
| 12 | COD status code indicating unapproved drug (per Medicaid Drug Rebate Program data file) |
| 13 | COD status code indicating unapproved drug (per Medicaid Drug Rebate Program data file) |
Provider Actions, Prior Authorization, and Denial Risk
Exceptions, appeals and grandfathering
Members currently on listed FDA‑unapproved drugs are grandfathered through calendar year 2022; members with new prescriptions will be notified that these drugs are not covered and may apply for an exception or appeal.
- Members currently on unapproved drugs retain coverage through 2022 (grandfathered).
- Members with new prescriptions for these drugs will be notified that the drugs are not covered.
- Members may apply for an exception or appeal for coverage of certain non‑FDA approved drugs.
Prior authorization — examples only
This section provides example product names and therapeutic classes but does not identify specific CPT/HCPCS/NDC codes or a required prior authorization pathway for those examples.
- Examples shown are illustrative and not an exhaustive coding list.
- No specific billing codes are listed in this section as requiring prior authorization.
Unapproved / non‑covered product examples (no PA pathway specified)
The document lists multiple products as examples of unapproved/non‑covered items (the Unapproved Drug List‑EGID); these are presented as excluded products with no PA pathway described for them.
- Example non‑covered products and classes are enumerated in the Unapproved Drug List‑EGID (e.g., dental products, hematopoietic mixtures, topical agents).
- The policy text presents these as non‑covered examples rather than as items eligible for prior authorization.
Prior authorization not applicable to listed unapproved products
Products listed as examples on the Unapproved Drug List‑EGID are considered non‑covered and prior authorization is not supported for these unapproved products as a coverage pathway.
- Entries shown in the Unapproved Drug List‑EGID are treated as exclusions from the pharmacy benefit.
- The policy states prior authorization is not supported for these unapproved examples.
Prior authorization — not specified for non‑covered examples
The document does not specify prior authorization requirements for the listed non‑covered examples; providers should not assume a PA pathway exists for these items.
- Listed items are presented as non‑covered examples and the text does not specify affected billing codes or PA requirements.
- Providers should refer to the EGID Unapproved Drug List and CMS data for definitive coding guidance.
Non‑covered examples — prior authorization implications
Requests for products listed as unapproved/non‑covered examples should be expected to be excluded from coverage; prior authorization is not a guaranteed route to obtain coverage for these items.
- Providers should expect exclusion and potential denial for requests of listed products.
- If considering alternatives, follow standard PA processes for FDA‑approved alternatives where applicable.
Use FDA‑approved alternatives when available
When possible, prescribe FDA‑approved alternatives (Rx or OTC) listed as class alternatives instead of the unapproved products identified in the Unapproved Drug List‑EGID.
- The non‑covered examples list provides FDA‑approved Rx and/or OTC alternatives by therapeutic class (e.g., FDA‑approved estradiol/conjugated estrogens for estrogens; OTC iron for hematopoietic products).
- Consult the EGID list and CMS drug rebate data for approved alternatives and coding.
Step therapy — none provided in section
No step therapy rules are provided in this section; the policy directs providers to use FDA‑approved alternatives for new prescriptions where applicable but does not define step failures or required trials.
- The document explicitly contains no step therapy rules in this excerpt.
- Providers should follow usual formulary/PA rules for FDA‑approved alternatives when applicable.
Reference lists and COD status codes
Consult the EGID Unapproved Drug List and the CMS Medicaid Drug Rebate Program data file for the authoritative list of non‑FDA approved drugs and the COD status codes (11, 12, 13) used to identify unapproved drugs.
- The CMS Medicaid Drug Rebate Program data file contains Covered Outpatient Drug (COD) status codes; unapproved drugs have codes 11, 12 or 13.
- See the EGID Unapproved Drug List for the current full list — it may change over time.
Documentation note — no PA instructions provided
This section contains example product names and therapeutic classes but provides no specific documentation or prior authorization instructions; avoid submitting documentation assuming coverage for the listed non‑covered examples.
- The document lists product names (e.g., ANALPRAM HC, ANUSOL‑HC, FERREX 150 FORTE PLUS) and therapeutic classes as examples of non‑covered items.
- No PA submission requirements or documentation templates are provided in these chunks.
Use product‑class mappings for coverage classification
Product‑to‑therapeutic‑class mappings shown in the document (for example, DEBACTEROL = ANTISEPTICS - MOUTH/THROAT) should be used to guide coverage classification and claims processing.
- The Unapproved Drug List‑EGID maps specific product names to therapeutic class codes used for coverage decisions (sample mappings provided in the document).
Denial risk for new prescriptions of unapproved drugs
Providers should expect that new prescriptions for FDA‑unapproved drugs will not be covered under the HealthChoice pharmacy benefit and may be denied.
- New prescriptions for unapproved drugs are subject to exclusion and potential denial.
- Consult with patients and prescribe covered FDA‑approved alternatives where appropriate.
Denial risk for listed unapproved products
Requests or claims for products included on the Unapproved Drug List‑EGID may be denied as non‑covered; examples listed in the document (e.g., Ferrex 150 Forte Plus, Ferrocite, Anusol‑HC, Plexion cleanser, Dakins solution) are at risk of denial.
- The Unapproved Drug List‑EGID entries are presented as non‑covered examples and subject to non‑coverage.
- Named examples in the list have been identified as at risk for denial when billed to the HealthChoice pharmacy benefit.
Non‑covered product listing — do not submit without confirmation
Claims for items on the HealthChoice 'Unapproved Drug List‑EGID' are presented as non‑covered product examples; providers should not submit coverage requests for these products without confirming exception/appeal eligibility.
- The policy identifies many therapeutic classes and brand examples as non‑covered under the Unapproved Drug List‑EGID.
- Members may apply for exceptions or appeals; grandfathering applies only through 2022 for current users.
Background and Rationale
Background: HealthChoice has adopted a policy to exclude certain legally marketed drugs that lack FDA approval from the pharmacy benefit. This position was developed in conjunction with the HealthChoice contracted PBM and informed by clinical reviews, and it clarifies that while some unapproved drugs will be excluded, members who were already receiving these products were grandfathered through calendar year 2022.
The section advises providers to consult for alternate FDA‑approved therapies when managing affected patients and directs readers to the CMS Medicaid Drug Rebate Program data file for a complete list of non‑covered medications and for COD status codes used to identify unapproved drugs.
Definitions and Lists
Initial Therapy Guidance
Initial therapy guidance — recommended action for initial prescriptions
Recommended action for initial prescriptions
New prescriptions for unapproved drugs are subject to exclusion; consult plan resources for covered alternatives.
Continuation (Grandfathered) Therapy
Continuation (grandfathered) therapy
Grandfathering for existing users
After that period, coverage status may change; members may apply for exceptions or appeals per plan processes.
Step Therapy and Preferred Sequencing
| Step | Requirement | Provider action |
|---|---|---|
| 1 | Prescribe FDA-approved alternatives (Rx or OTC) where available before using listed unapproved products. | When initiating therapy for conditions represented in the non-covered examples, select an FDA‑approved prescription or over‑the‑counter alternative from the appropriate therapeutic class (for example: use FDA‑approved Rx or OTC anorectal hydrocortisone/phenylephrine/pramoxine products instead of HC Pramoxine 2.5‑1% cream; use OTC iron products instead of Ferrex 150 Forte; use FDA‑approved triptans or butalbital products for migraine instead of Isometh/APAP dichlor capsules). |
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