Blue Cross MA Interferon Coverage & Prior Auth

Coverage Criteria

Covered Indications

Covered when medical necessity and applicable FDA or mandated off‑label criteria are met.

Interferon product coverage: Coverage applies for FDA‑approved indications listed in the policy (examples include genital warts, chronic hepatitis B, Kaposi's sarcoma, acute/chronic hepatitis C, and malignant melanoma for interferon alpha; Chronic Granulomatous Disease and other FDA‑approved uses for interferon gamma).

Prior authorization required for listed products

Sylatron (peginterferon alfa‑2b) specific: Sylatron is covered as adjuvant treatment of melanoma with microscopic or gross nodal involvement when initiated within 84 days of definitive surgical resection including complete lymphadenectomy.within 84 days

Off‑label and state‑mandated uses: Certain off‑label uses listed in the United States Pharmacopeia (USP) may be covered per Massachusetts mandate; however, for some cancers evidence indicates interferon may not improve health and may worsen quality of life — these uses require Individual Consideration.

Individual Consideration available for requests not meeting clinical criteria

Conditions not specifically listed for interferon gamma (Actimmune) are not covered because the policy states there is insufficient scientific data to demonstrate improved health outcomes for other conditions.

Endnotes reference inclusion of certain off-label uses from the United States Pharmacopeia and note alignment with CMS/local Medicare regulations, but these endnotes do not present explicit additional exclusions beyond those stated in the policy text.

The policy notes that for several cancer indications historically considered for interferon therapy, evidence indicates interferon may not improve health outcomes and can worsen quality of life; such oncology uses are therefore not supported by the evidence cited in these sections and would not be routinely covered absent compelling justification or Individual Consideration.

The referenced endnotes and citations document clinical trials, guideline reviews, and historical policy revisions but do not include explicit standalone statements using the phrase 'not medically necessary' in the cited chunks.

Coding

HCPCS CodesHCPCS

J9212	Injection,interferon Alfacon-1 recombinant, mcg_(Infergen).
J9214	million units_(Intron A; Rebetron Kit).
J9215	(Alferon N).
J9216	(Actimmune_).

ICD-10 Diagnosis Codes (selected examples)ICD-10

A63.0	Anogenital (venereal) warts.
B18.2	Chronic viral hepatitis C.
B17.10	Acute viral hepatitis C without further specification (as listed).
B18.1	Chronic viral hepatitis B without delta-agent.
B18.0	Chronic viral hepatitis B with delta-agent.
B19.20	Unspecified viral hepatitis C without hepatic coma.
C43.*	Malignant melanoma codes (multiple C43.x entries listed).

ICD-10 Diagnosis Codes (eyelid/skin)ICD-10

C44.1391	Sebaceous cell carcinoma of skin of left upper eyelid,including canthus.
C44.1392	Sebaceous cell carcinoma of skin f left lower eyelid,including canthus.
C44.191	Other specified malignant neoplasm of skin of unspecified eyelid,including canthus_.
C44.1922	(listed with no description in source).

ICD-10 Diagnosis Codes (ear/face/neck/trunk/limbs)ICD-10

C44.1991	(listed with no description in source).
C44.1992	(listed with no description in source).
C44.201	Unspecified malignant neoplasm of skin of unspecified ear and external auricular canal.
C44.202	Unspecified malignant neoplasm of skin of right ear and external auricular canal.
C44.209	Unspecified malignant neoplasm of skin of left ear and external auricular canal.
C44.211	Basal cell carcinoma of skin of unspecified ear and external auricular canal.
C44.219	Basal cell carcinoma of skin of left ear and external auricular canal.
C44.221	Squamous cell carcinoma of skin of unspecified ear and external auricular canal_.
C44.301	Unspecified malignant neoplasm of skin of nose.
C44.310	Basal cell carcinoma of skin of unspecified parts of face.

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ICD-10 Diagnosis Codes (continued skin sites)ICD-10

C44.321	Squamous cell carcinoma of skin of nose.
C44.329	Squamous cell carcinoma of skin of other parts of face.
C44.390	Other specified malignant neoplasm of skin of unspecified parts of face.
C44.40	Unspecified malignant neoplasm of skin of scalp and neck.
C44.41	Basal cell carcinoma of skin f scalp and neck_.
C44.510	Basal cell carcinoma of anal skin.
C44.511	Basal cell carcinoma of skin of breast.
C44.520	Squamous cell carcinoma of anal skin.
C44.521	Squamous cell carcinoma of skin of breast_.
C44.521	(duplicate entry in source with no additional description).

ICD-10 Diagnosis Codes (various malignancies and Kaposi's)ICD-10

C44.90	Unspecified malignant neoplasm of skin,unspecified.
C44.91	Basal cell carcinoma of skin,unspecified.
C44.92	Squamous cell carcinoma of skin,_unspecified_.
C46.0	Kaposi's sarcoma of skin.
C46.1	Kaposi's sarcoma of soft tissue.
C53.0	Malignant neoplasm of endocervix.
C56.1	Malignant neoplasm of_right ovary _.
C64.1	Malignant neoplasm of right kidney_except renal pelvis.
C71.0	Malignant neoplasm of cerebrum,except lobes and ventricles.

ICD-10 Diagnosis Codes (lymphomas, leukemias, myeloma)ICD-10

C82.50	Diffuse_follicle center Iymphoma,_unspecified site.
C83.10	Mantle cell Iymphoma,unspecified site.
C83.70	Burkitt lymphoma,unspecified site_.
C84.00	Mycosis fungoides,Iymph nodes of head,face,and neck.
C86.0	Extranodal NKIT-cell lymphoma,nasal type.
C90.00	Multiple_myeloma not having achieved remission.
C91.10	Chronic lymphocytic_ leukemia of B-cell type_not having achieved remission.
C92.10	Chronic myeloid leukemia,BCRIABL-positive,_not having achieved remission.

ICD-10 Diagnosis Codes (melanoma in situ and other miscellaneous codes)ICD-10

D03.10	(listed with no description in source).
D03.111	Melanoma in situ of right upper eyelid,_including canthus.
D03.112	Melanoma in situ of right lower eyelid,including canthus.
D03.121	Melanoma in situ of left upper eyelid,_including canthus_.
D03.122	Melanoma in situ of left lower eyelid,_including canthus.
D14.1	Benign neoplasm of larynx_.
D45	Polycythemia vera.
D71	Functional disorders of polymorphonuclear neutrophils.
E34.0	Carcinoid syndrome_.
G60.3	Idiopathic progressive neuropathy.

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Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required — PA is required for the interferon products listed on the formulary (e.g., Actimmune, Alferon‑N, Infergen, Intron‑A, Sylatron). Requests for outpatient retail pharmacy prior authorization or formulary exception must use the BCBSMA Prior Authorization/Formulary Exception form or be submitted via Pharmacy Operations by phone or fax.

Affected products: Actimmune (interferon gamma‑1b); Alferon‑N (interferon alfa‑n3); Infergen (interferon alfacon‑1); Intron‑A (interferon alfa‑2b); Sylatron (peg‑interferon alfa‑2b)
Pharmacy Operations: Tel: 1‑800‑366‑7778; Fax: 1‑800‑583‑6289
Submit via BCBSMA Prior Authorization/Formulary Exception form or call/fax Pharmacy Operations

Step Therapy

Step Therapy / Quality Care Dosing — No Specific Rules Specified

Step therapy / Quality Care Dosing are referenced by the policy as part of formulary management, but no specific step therapy rules or sequences are specified in this section. Manage step therapy and dosing rules according to current formulary and Pharmacy Operations guidance.

Definitions & Key Products

Sylatron (peginterferon alfa-2b) coverage

DrugSylatron (peginterferon alfa-2b)

Covered indicationAdjuvant treatment of melanoma with microscopic or gross nodal involvement

Initiation timing requirementTreatment must be started within 84 days of definitive surgical resection including complete lymphadenectomy

Coverage contingent on medical necessityCoverage applies when medical necessity is met and prior authorization requirements are satisfied

Interferon gamma (Actimmune) coverage

DrugInterferon gamma (Actimmune)

Covered uses

Initial Therapy Criteria

Sylatron Initial Therapy

Covered when ALL of the following are met:

Sylatron initiation: Adjuvant treatment is for patients with malignant melanoma with microscopic or gross nodal involvement following definitive surgical resection including complete lymphadenectomy.

Timing of initiation: Therapy must be started within 84 days of definitive surgical resection (including complete lymphadenectomy).within 84 days

threshold":"","note":"Requests that do not meet clinical criteria may be submitted for Individual Consideration","children":[]}

Step Therapy

Policy element	Details
Step therapy / Quality Care Dosing reference
Policy references Prior Authorization Step Therapy and Quality Care Dosing; specific step edits and sequencing are managed via formulary and BCBSMA Pharmacy Operations. (Formulary status for listed interferon products = PA required)

Site of Care Requirements

Billing Rule

Retail specialty pharmacy requirement for most members

Members (except certain Medicare-related plans) are required to fill prescriptions for the listed medications at a provider in BCBSMA's retail specialty pharmacy network.

This retail specialty pharmacy requirement applies to BCBSMA members other than Medex, Blue MedicareRx, and Medicare Advantage plans that include prescription drug coverage.
See the BCBSMA Specialty Pharmacy List link referenced in the policy for network providers.

Background

Interferon alpha and interferon gamma are used for a mix of FDA-approved and some off-label oncology, viral, and immunologic indications. Examples cited include genital warts, chronic hepatitis B, Kaposi's sarcoma, acute and chronic hepatitis C, and malignant melanoma for interferon alpha; Chronic Granulomatous Disease and specific pediatric indications for interferon gamma. The policy also highlights Sylatron (peginterferon alfa-2b) as covered for adjuvant treatment of malignant melanoma with microscopic or gross nodal involvement when started within 84 days of definitive surgical resection (including complete lymphadenectomy). Endnotes reference USP-listed off-label uses and prior clinical trials and guideline analyses that inform coverage decisions.

OpenPayer

Interferon and Peginterferon Medications (Pharmacy Benefit) — Coverage Criteria

Coverage Criteria

Coding

Provider Actions & Authorization

Definitions & Key Products

Initial Therapy Criteria

Step Therapy

Site of Care Requirements

Background