Medical/Specialty Pharmacy Drugs Requiring Prior Authorization
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Defines Florida Blue prior authorization requirements, submission routing, and product-specific handling for medical benefit–processed specialty (Rx) drugs and identifies drugs/HCPCS/CPT codes listed for prior auth review.
No material clinical or coverage changes in this revision.
Coverage criteria and listing
Member's products and coverage vary based upon the policy type and benefits. All services must meet the definition of medical necessity as outlined in the Member's benefit contract. Select benefit types enforce prior authorization to ensure the services align with the medical necessity criteria before the services are rendered, while other benefits verify the medical necessity criteria through post-service or concurrent review.
For products that require a prior authorization, failure to obtain an authorization prior to the service being rendered may result in the services (and supportive services) being denied which may apply financial liability to the member and/or provider depending upon contract arrangements.
Below are the standard product types that require a prior authorization for the Medical/Specialty Pharmacy (Rx) Drugs:
- BlueCare HMO
- My Blue*
- Medicare Advantage HMO*
- BlueOptions ACA Plans (Group & Individual plans)
- BlueChoice Group ACA Plans (effective 4/1/2016)
- Medicare Advantage PPO
- SimplyBlue Group
- Prior Authorization required in addition to referral when applicable
NOTE: Products that do not require authorization for the listed drugs are eligible for a Voluntary Predetermination of Select Services.
The Medical/Specialty Pharmacy (Rx) Drug List does NOT identify the following:
- Medical Specialty Pharmacy (Rx) Drugs listed do NOT guarantee coverage is available through the member's medical benefit. Eligibility and benefits (E&B) must be verified prior to providing services.
- The list does NOT identify prior authorization requirements for drugs processed and covered through the member's Pharmacy Benefit.
- The list should NOT be used as reference for BlueCard out-of-area members. Contact BlueCard Eligibility for out-of-area eligibility and coverage.
The HCPCS/CPT drug listing below is a catalog mapping HCPCS/J-codes to drug names, generic alternatives, internal flags (PADP, CEI, SAD) and relevant dates. Entries may indicate special handling such as “Drug not separately allowed, bundled within.” Presence on this list does NOT by itself indicate coverage; benefits vary by plan and prior authorization may still be required.
Representative entries (not exhaustive):
- C9399 — TYMLOS (ABALOPARATIDE) — SAD**L 08/02/2019
- C9399 — UKONIQ (UMBRALISIB) — SAD**L 05/01/2017
- C9399 — VANFLYTA (QUIZARTINIB) — SAD**L 02/05/2021
- C9399 — VARITHENA (POLIDOCANOL INJECTABLE FOAM) — SAD**L 07/28/2023 — COMMENTS: Drug not separately allowed, bundled within.
- J1559 — HIZENTRA (HUMAN IMMUNE GLOBULIN) — DRUG DATE 04/01/2010
- J1561 — GAMMAKED / GAMUNEX / GAMUNEX-C (HUMAN IMMUNE GLOBULIN) — various SAD flags and dates
- J1562 — VIVAGLOBIN — DRUG DATE 03/01/2006 — COMMENTS: product discontinued
- J1599 — YIMMUGO / Unclassified IVIG — DRUG DATE 06/13/2024
- J1930 — SOMATULINE DEPOT (LANREOTIDE) — PADP X — DRUG DATE 04/15/2010
- J2323 — TYSABRI (NATALIZUMAB) — PADP X — DRUG DATE 03/15/2008
- J2326 — SPINRAZA (NUSINERSEN) — DRUG DATE 12/28/2016
- J2506 — NEULASTA (PEGFILGRASTIM) — SAD flags — DRUG DATE 04/01/2002
- J2778 — LUCENTIS (RANIBIZUMAB) — DRUG DATE 10/15/2007
- J2820 — LEUKINE (SARGRAMOSTIM) — SAD flags — DRUG DATE 11/14/2016
- J2941 — GENOTROPIN / HUMATROPE / NORDITROPIN (SOMATROPIN) — SAD** flags
- J3490 / J3590 — Unclassified or miscellaneous drug codes (e.g., TOSYMRA, TRYNGOLZA, TYMLOS, VARITHENA, NEMLUVIO, NGENLA, NYPOZI) — various PADP/CEL/SAD flags and dates — some entries include: COMMENTS: Drug not separately allowed, bundled within.
Notes:
- Self-administered drugs may have limited benefits when billed through the medical benefit.
- New drugs approved by the FDA may not be listed immediately but could be subject to prior authorization.
- Drugs listed may not be covered by the member's benefits; verify eligibility and benefits before providing services.
- When new codes are assigned to drugs, search by HCPCS/CPT code and/or drug brand name to confirm processing and coverage.
The provided catalog does not include explicit coverage exclusions or determinations of “not medically necessary.” It functions as a mapping of codes to drug entries and internal flags. Any coverage determinations (including exclusions or medical necessity denials) are made based on the member's benefit plan, medical necessity criteria, and any applicable prior authorization or utilization management policies.
Additional provider guidance:
- Verify member eligibility and benefits prior to service.
- Confirm whether the member's plan requires prior authorization for the specific drug and administration route.
- Check if the drug is processed under the pharmacy benefit versus the medical benefit; prior authorization processes differ by benefit type.
Where entries indicate “Drug not separately allowed, bundled within,” the drug is considered part of another procedure or service for billing purposes and is not eligible for separate reimbursement. Providers should:
- Review the applicable procedure or bundle billing guidance before submitting claims.
- Confirm with the payer if separate reimbursement is appropriate in exceptional circumstances and obtain prior authorization when required.
This section contains only code-to-drug mappings and administrative flags. It does not itself establish clinical coverage rules or exclusions. Coverage is determined by the applicable benefit contract and utilization management policies.
Drugs included in the HCPCS/J-code catalog may be subject to plan-specific coverage limitations. Prior to providing services or submitting claims, verify:
- Member eligibility and plan benefits via Eligibility & Benefits (E&B) systems.
- Whether the drug is covered under the medical benefit or the pharmacy benefit.
- Any prior authorization, step therapy, quantity limits, or other utilization management requirements.
This segment is informational and lists HCPCS/CPT codes with associated drug names and administrative flags. It does not provide clinical criteria or medical necessity rules. For clinical coverage criteria, refer to the payer's utilization management and medical necessity policy documents.
The provided content does not include determinations of procedures or drugs being 'not medically necessary.' Coverage decisions of that nature are handled through separate clinical policy documents and prior authorization determinations.
This document section is a catalog-style listing used for reference mapping of HCPCS/CPT codes to drug brand names, generic equivalents, and internal administrative flags (PADP, CEI, SAD) along with effective or listed dates. It is maintained to support coding, billing, and prior authorization workflows. Updates to codes and new drug approvals may be reflected periodically; always confirm current coding and coverage status before billing.
HCPCS/CPT/Q-code listings and mappings
| 90281 | GamaSTAN SID / IMMUNE GLOBULIN |
| 90283 | CARIMUNE NF / FLEBOGAMMA / GAMMAGARD / GAMMAGARD SD / GAMMAKED / GAMMAPLEX / GAMUNEX / GAMUNEX-C / OCTAGAM / PRIVIGEN (IMMUNE GLOBULIN variants) |
| 90284 | CUVITRU / GAMMAGARD LIQUID / GAMMAKED / GAMUNEX-C / HIZENTRA / HYQVIA (IMMUNE GLOBULIN variants) |
| 90378 | SYNAGIS / PALIVIZUMAB |
| 90399- | Unlisted IVIG (IMMUNE GLOBULIN) |
| A9156* | ORAL MUCOADHESIVE, ANY TYPE (A9156*) |
| A9513 | LUTATHERA / LUTETIUM LU 177 |
| A9543 | ZEVALIN / IBRITUMOMAB TIUXETAN |
| A9590 | AZEDRA / IODINE I-131 IOBENGUANE |
| A9600 | METASTRON / STRONTIUM SR-89 CHLORIDE |
| C9399 | Unclassified drugs — multiple drug name entries listed under C9399 |
| 69399 | New HCPCS, Q5141 effective 01/01/2025 (note in document) |
| G0138 | OPFOLDA & POMBILITI ADM (documented) |
| J0129 | ORENCIA IV / ABATACEPT |
| J0139 | HUMIRA / ADALIMUMAB |
| J0172 | ADUHELM / ADUCANUMAB-AVWA |
| J0174 | LEQEMBI / LECANEMAB-IRMB |
| J0175 | KISUNLA / DONANEMAB-AZBT |
| J0177 | EYLEA HD / AFLIBERCEPT |
| J0178 | EYLEA / AFLIBERCEPT |
| J0179 | BEOVU / BROLUCIZUMAB-DBLL |
| J0180 | FABRAZYME / AGALSIDASE BETA |
| J1299 | SOLIRIS (ECULIZUMAB) |
| J4300 | SOLIRIS (ECULIZUMAB) - new HCPCS |
| J3398 | DRUG NAME = LUXTURNA (VORETIGENE NEPARVOVEC‑RZYL) |
| J3399 | DRUG NAME = ZOLGENSMA (ONASEMNOGENE ABEPARVOVEC‑XIOI) |
| J3401 | DRUG NAME = VYJUVEK (BEREMAGENE GEPERPAVEC‑SVDT) |
| J3420 | DRUG NAME = B+ (GYANOCOBALAMIN) |
| J3489 | DRUG NAME = (ZOLEDRONIG AGID) [text fragmented] |
| J3490 | DRUG NAME = AIMOVIG (ERENUMAB‑AOOE) and many additional drugs listed under J3490 placeholder |
| J3490 | Unclassified drugs / miscellaneous injectable drug code |
| J3590 | Unclassified biologic or other drug code (miscellaneous) |
| Q5150 | New HCPCS (noted effective 04/01/2025) — referenced in document |
| J1414 | New HCPCS referenced (effective 01/01/2025) |
| Q5139 | New HCPCS referenced (effective 01/01/2025) |
| J3392 | New HCPCS referenced (effective 01/01/2025) |
| Q5143 | New HCPCS referenced (effective 01/01/2025) |
| Q5149 | New HCPCS referenced (effective 04/01/2025) |
| Q5151 | New HCPCS referenced (effective 04/01/2025) |
| Q5140 | New HCPCS referenced (effective 01/01/2025) |
| J3590 | Unclassified drugs / placeholder HCPCS referenced for many newly added drugs |
| J7170 | HEMLIBRA (emicizumab-kxwh) |
| J7171 | ADZYNMA (adamts13, recombinant-krhn) |
| J7175 | COAGADEX (factor X) |
| J7177 | FIBRYGA (human fibrinogen concentrate) |
| J7178 | RIASTAP (human fibrinogen concentrate) |
| J7179 | VONVENDI (von Willebrand factor) |
| J7180 | CORIFACT (factor XIII concentrate) |
| J7181 | TRETTEN (factor XIII A-subunit) |
| J7182 | NOVOEIGHT (factor VIII) |
| J7193 | DRUG = nla |
| J7194 | PROFILNINE SD (FACTOR IX) |
| J7195 | BENEFIX (FACTOR IX) |
| J7198 | FEIBA (ANTI-INHIBITOR COAGUALTION) |
| J7199* | Unclassified FACTOR (HEMOPHILIA CLOTTING FACTOR, NOT) |
| J7200 | RIXUBIS (FACTOR IX) |
| J7201 | ALPROLIX (FACTOR IX) |
| J7202 | IDELVION (FACTOR IX) |
| J7203 | REBINYN (FACTOR IX, GLYCOPEGYLATED) |
| J7204 | ESPEROCT (FACTOR VIII, GLYCOPEGYLATED-EXEI) |
| J7318 | DUROLANE (HYALURONAN DERIVATIVE) |
| J7320 | GENVISC 850 (HYALURONAN/DERIVATIVE) |
| J7321 | HYALGAN / SUPARTZ / VISCO-3 (SODIUM HYALURONATE) |
| J7324 | ORTHOVISC (HIGH MOLECULAR WEIGHT) |
| J7325 | SYNVISC / SYNVISC ONE (HYLAN G-F 20) |
| J7326 | GEL-ONE (CROSS-LINKED HYALURONATE) |
| J7327 | MONOVISC (HIGH MOLECULAR WEIGHT) |
| J7328 | GEL-SYN (HYALURONAN DERIVATIVE) |
| J7329 | TRIVISC (HYALURONAN DERIVATIVE) |
| J7330 | MACI (AUTOLOGOUS CULTURED) |
| J8611 | JYLAMVO (METHOTREXATE) |
| J8612 | XATMEP (METHOTREXATE) |
| J8655 | AKYNZEO (NETUPITANT and PALONOSETRON) |
| J8700 | TEMODAR (TEMOZOLOMIDE) |
| J8705 | HYCAMTIN ORAL (TOPOTECAN) |
| J8999 | Oral Chemo (ORAL CHEMO PRESCRIPTION DRUG) |
| J9019 | ERWINAZE (ASPARAGINASE) - PADP = X |
| J9021 | RYLAZE (ASPARAGINASE ERWINIA) - PADP = X |
| J9022 | TECENTRIQ (ATEZOLIZUMAB) - PADP = X |
| J9023 | BAVENCIO (AVELUMAB) - PADP = X |
| J9056 | VIVIMUSTA / BENDAMUSTINE HYDROCHLORIDE |
| J9057 | ALIQOPA / COPANLISIB |
| J9058 | BENDAMUSTINE |
| J9063 | ELAHERE / MIRVETUXIMAB-SORAVTANSINE-GYNX |
| J9064 | CABAZITAXEL |
| J9118 | ASPARLAS / CALASPARGASE PAGOL-MKNL |
| J9119 | LIBTAYO / CEMIPLIMAB-RWIC |
| J9144 | DARZALEX FASPRO / DARATUMUMAB & HYALURONIDASE-FIHJ |
| J9145 | DARZALEX / DARATUMUMAB |
| J9153 | VYXEOS / DAUNORUBICIN and CYTARABINE |
| J9999 | AMTAGVI / multiple unclassified or newly added specialty drugs (placeholder) |
| Q2041 | YESCARTA (axicabtagene ciloleucel) |
| Q2042 | KYMRIAH (tisagenlecleucel) |
| Q2043 | PROVENGE (sipuleucel-T autologous CD54+) |
| Q2049 | LIPODOX (doxorubicin liposomal) |
| Q2050 | DOXIL (doxorubicin liposomal) |
| Q2053 | TECARTUS (brexucabtagene autoleucel) |
| Q2054 | BREYANZI CD4 (lisocabtagene maraleucel) |
| Q2055 | ABECMA (idecabtagene vicleucel) |
| Q2056 | CARVYKTI (ciltacabtagene autoleucel) |
| Q2057 | TECELRA (afamitresgene autoleucel) |
| Q3028 | REBIF / VENTAVIS / interferon beta-1a entries |
| Q4082* | Unclassified Rx* |
| Q5101 | ZARXIO (filgrastim-sndz) |
| Q5103 | INFLECTRA (infliximab-dyyb) |
| Q5104 | INFLECTRA / RENFLEXIS entries |
| Q5106 | RETACRIT (epoetin alfa) / PADP = X |
| Q5107 | MVASI (bevacizumab-awwb) |
| Q5108 | FULPHILA (pegfilgrastim-jmdb) |
| Q5109 | IXIFI (infliximab-qbtx) |
| Q5110 | NIVESTYM (filgrastim-aafi) |
| Q5106 | RETACRIT / EPOETIN ALFA |
| Q5107 | MVASI / BEVACIZUMAB-AWWB |
| Q5108 | FULPHILA / PEGFILGRASTIM-JMDB |
| Q5109 | IXIFI / INFLIXIMAB-QBTX |
| Q5110 | NIVESTYM / FILGRASTIM-AAFI |
| Q5111 | UDENYCA / PEGFILGRASTIM-CBQV (including ONBODY 01/23/2024) |
| Q5112 | ONTRUZANT / TRASTUZUMAB-DTTB |
| Q5113 | HERZUMA / TRASTUZUMAB-PKRB |
| Q5114 | OGIVRI / TRASTUZUMAB-DKST |
| Q5115 | TRUXIMA / RITUXIMAB-ABBS |
Prior authorization, billing, and submission guidance
Prior Authorization Required
Prior authorization is required or implied for many listed specialty drugs and HCPCS/J-code billed drugs. Providers must verify member benefits and submit prior authorization requests to the appropriate Florida Blue vendor or PBM based on place of service, billing entity, and member product type before administering or billing the drug. Failure to obtain prior authorization when required may result in denial and financial liability.
- Prior authorization implied for listed specialty drugs and PADP‑managed drugs.
- Prior authorization applies to the HCPCS and J‑code drug listings in this section (see code groups for specific codes).
- Newly FDA‑approved or newly coded drugs may be subject to prior authorization even if not yet listed — verify benefits.
Where to Submit Prior Authorization
Submit medical/specialty pharmacy prior authorization requests to the Florida Blue vendor or PBM responsible for the member’s product and the drug’s routing: Caremark/OptumRx for pharmacy‑benefit managed drugs; Prime Therapeutics (MRxM) for PADP/Prime specialty pharmacy managed drugs; CareCentrix for home infusion/home health/AIS network services; Availity, Blue Express, or Florida Blue provider portals/phone lines for other medical benefit submissions. Use the entity billing drug and place of service to determine routing.
- Prime Therapeutics provider self‑service: https://gatewaypa.com (physician tab) or (800) 424‑4947.
- CareCentrix Phone: (877) 561‑9910 Fax: (877) 627‑6688.
- Prime Therapeutics (Part D/MedAdv/other lines): phone/fax numbers listed in vendor guidance.
Billing and HCPCS/J‑code Guidance
J‑codes, miscellaneous J‑codes (J3490/J3590/J9999) and unclassified HCPCS entries are included in the catalog as mapping records; presence in the list often triggers prior authorization tracking or PADP management. Providers must bill using the assigned specific HCPCS/Q/J code when available — using a miscellaneous/unlisted J‑code when a specific HCPCS exists can affect adjudication and PA processing.
- Use the assigned HCPCS/Q/J code when billed; avoid J3490/J3590/J9999 if a specific code exists.
- Unclassified Rx/Forgotten mapping entries are present (e.g., J3490 entries for infertility and other drugs) — review code mapping before billing.
- New HCPCS assignments with effective dates are noted; ensure claim dates align with HCPCS effective dates.
PADP / Program Management Flags
PADP (Prime/ MRxM) managed drugs and PADP‑marked codes may require prior authorization and/or program enrollment. PADP flags and CEL/SAD annotations identify program management level, required enrollment, and historical effective dates for codes; verify the PADP/CEL/SAD indicators and follow enrollment requirements where marked.
- PADP = X indicates PADP management; review and submit to Prime/ MRxM when indicated.
- CEL/SAD flags denote additional program flags or historical notes — reference the PADP/CEL/SAD fields for operational requirements.
- PADP‑marked drugs may require provider enrollment in specialty programs or specific vendor routing.
Documentation and Claim Submission Requirements
Document drug name, generic/alternate name, applicable HCPCS/Q/J code and the date of service on authorization and claim submissions. For newly assigned HCPCS/Q codes, include the drug brand name and confirm the HCPCS effective date to avoid billing code/date mismatch denials.
- Required claim and drug mapping details: drug name, generic alternate, HCPCS/Q/J code, effective date.
- Billing code/date mismatch risk — ensure the HCPCS effective date matches claim DOS.
- If a new HCPCS/Q code exists for a drug, do not submit under miscellaneous J‑codes; document the specific code on the authorization and claim.
Scope and Limitations of This Listing
This section is primarily a registry/catalog of HCPCS/J codes mapped to drug names and management flags; it does not enumerate detailed authorization criteria, step‑therapy sequences, or explicit denial rules. Providers must verify benefit coverage and follow the specific prior authorization program rules for each drug as indicated by PADP/CEL/SAD flags or by contacting the applicable vendor.
- No explicit authorization/denial rules or step‑therapy algorithms are provided in this excerpt — refer to the vendor/PBM policy for criteria.
- Benefit verification is required prior to service: confirm member benefits and medical necessity.
- When criteria are required, follow the vendor/PBM prior authorization checklist for supporting documentation.
Provider Actions and Denial Risks
Provider actions to reduce denial risk: verify member benefits and product coverage before service; use specific HCPCS/Q/J codes when available; route prior authorization to the correct vendor; and include complete clinical documentation with PA requests. Be alert for HCPCS effective date mismatches and for bundled billing situations where drug supply may be included in another payment.
- Benefit verification required — check eligibility and benefits prior to providing services.
- Bundled billing: some drugs may be bundled with procedures — review billing guidelines to avoid denials.
- Provider must bill using the listed HCPCS/J‑code corresponding to the drug administered.
Terms and internal flags
Step therapy and PBM-managed prior authorization notes
| Coverage item | Detail |
|---|---|
| Some products require prior approval via a PBM or Prime Therapeutics | |
| Refer to Caremark or OptumRx for pharmacy benefit prior approvals; Prime Therapeutics (formerly MRxM) handles many medical‑benefit specialty drug requests (provider self‑service gatewaypa.com or phone) — submission routing depends on entity billing and place of service | |
| Step therapy specifics and required trial/failure sequences are not provided in this excerpt |
| Step therapy observation | Source note |
|---|---|
| No explicit step therapy rules provided in these chunks | |
| Entries include PADP and CEL flags indicating some drugs are managed under payer programs; program-managed drugs may have separate prior‑authorization or step requirements not listed here |
| Observation | Implication for providers |
|---|---|
| No step therapy sequences are specified in this excerpt; many products are listed under miscellaneous J‑codes (e.g., J3490) or placeholders requiring provider mapping to the specific drug | |
| When a drug is billed under a miscellaneous code (J3490/J3590) providers must map the administered product to the appropriate HCPCS/Q code and follow PADP/CEL/SAD flags; specific step‑therapy enforcement is determined by the program managing the drug and is not described here |
Place of service and routing
Route PA by Place of Service and rendering entity
Place of Service and Rendering Entity Participation Status influence which vendor handles the prior authorization; home infusion/home health and AIS routes may require CareCentrix coordination when participating in the CCX network.
- For home infusion/home health/AIS participating in CCX: route reviews coordinated with CareCentrix (phone/fax as provided).
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