HMSA SCIG/IVIG Prior Auth Guidance

Coverage Criteria for Immune Globulin

Form submission

Covered when ALL of the following administrative steps are met

submission: Provider completes the prior authorization form including patient demographics, requested product, ICD-10 diagnosis code and site of administration; and faxes the completed form to CVS Caremark Specialty Programs at 1-866-237-5512.

Contact numbers for prior authorization questions and specialty customer care are provided on the form.

Home administration requirement

Criteria specific to home administration

home_admin: If the requested product will be administered in the patient's home, the treating practitioner must determine and attest on the form that home administration is medically necessary and appropriate.

The form routes to subsequent questions based on the home-administration response.

Primary immune deficiency indications

Covered when ALL of the following are met for PID indications

pid_icd: Diagnosis corresponds to one of the listed primary immunodeficiency ICD-10 codes on the form (examples include D80.x, D81.x, D82.0, D83.x, or G11.3).

Selection of a listed PID code on the form often directs to 'No Further Questions' for that branch.

CIDP initial and continuation

CIDP coverage

cidp: Patient has a diagnosis of chronic inflammatory demyelinating polyneuropathy (ICD-10 G61.81) and the request is for an appropriate immune globulin product listed on the form (e.g., Hizentra, HyQvia, etc.).

For continuation requests the form asks whether the patient has demonstrated significant improvement in disability and maintenance of improvement since starting IG therapy.

MMN criteria

MMN initial coverage criteria

mmn_initial: Progressive, multifocal, asymmetrical motor weakness without objective sensory loss affecting two or more nerves for at least one month AND electrodiagnostic testing (EMG/NCS) performed to confirm the diagnosis with documentation available upon request.

If standard first-line (corticosteroids) and second-line (immunosuppressants) treatments were tried and unsuccessful, documentation is required per the form.

Dermatomyositis / Polymyositis

DM/PM initial coverage criteria

dm_pm: Patient exhibits at least four of the listed clinical features (examples include proximal muscle weakness, elevated CK or aldolase, myogenic EMG changes, compatible muscle pathology, positive anti-synthetase antibodies, non-destructive arthritis/arthralgias, systemic inflammatory signs).

Documentation (e.g., labs, EMG, pathology) may be requested to support criteria.

Autoimmune blistering disorders

Autoimmune blistering diseases

pemphigus_bullous: Diagnosis of an autoimmune blistering disorder (e.g., pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, epidermolysis bullosa acquisita) with biopsy confirmation encouraged; conventional therapy has failed or is contraindicated; and IG is intended for short-term control rather than routine maintenance unless otherwise specified.

The form asks whether IG will be given with conventional treatment and whether use is short-term; documentation may be requested.

ITP criteria

Immune thrombocytopenic purpura

itp_coverage_paths: Coverage pathways include: pregnant patients (special pathway); adults with refractory ITP post-splenectomy with pre-treatment platelet count <30,000/mcL; newly diagnosed children/adults or patients at high risk for bleeding or with significant bleeding requiring rapid platelet increase; and chronic/persistent ITP where platelet thresholds and prior response/intolerance to corticosteroids or anti-D therapy are considered.Platelet count thresholds specified on the form (e.g., <30,000/mcL; 30,000 to <50,000/mcL; >=50,000/mcL).

Documentation of platelet counts and bleeding-risk factors must be submitted upon request.

CLL-related prophylaxis

B-cell chronic lymphocytic leukemia

cll_prophylaxis: IG prescribed for prophylaxis of bacterial infections in patients with a history of recurrent sinopulmonary infections and low pre-treatment IgG level; the form requests the pre-treatment IgG value and documents thresholds (e.g., <500 mg/dL in one section; <400 mg/dL in another section where documentation must be provided upon request).Pre-treatment IgG thresholds specified on the form (examples include <500 mg/dL and <400 mg/dL).

Laboratory evidence (copy of IgG result) must be provided upon request to support the threshold.

LEMS and immune checkpoint inhibitor toxicities

LEMS and immune checkpoint toxicities

lems: LEMS diagnosis confirmed by neurophysiology studies (e.g., EMG) or a positive anti-P/Q type voltage-gated calcium channel antibody test; trials of symptomatic agents (anticholinesterase such as pyridostigmine and amifampridine) should be attempted and documented as unsuccessful or not tolerated prior to IG unless severe weakness is present.

If severe weakness is present or plasmapheresis/venous access issues exist, the form allows direct approval; documentation must be available upon request.

ici_toxicities: For moderate or severe immune-related adverse events from PD-1/PD-L1 inhibitors, IG may be considered when the offending drug is held or discontinued and one of the listed serious adverse events is present (examples: pneumonitis, myocarditis, GBS, myositis, Stevens-Johnson), per the form selections.

Form questions require selection of the specific adverse event and that the drug has been held or discontinued; documentation should be submitted if requested.

General coverage and indication-specific criteria

Covered when the form documents indication-specific criteria and required prior trials/diagnostic confirmations are met and documentation is available upon request.

Indication-specific branching: The form contains multiple indication branches (for example: LEMS, immune checkpoint inhibitor-related toxicities, GBS, ADEM, autoimmune hemolytic anemia, autoimmune neutropenia, multiple myeloma, toxic shock syndrome, SLE, TEN/SJS, measles postexposure, tetanus/varicella prophylaxis) that use yes/no gating questions to determine whether criteria are met for coverage.

See the numbered question sequence on the form for each indication.

LEMS specific: Diagnosis confirmed by neurophysiology or positive anti-P/Q antibody AND trials of anticholinesterase and amifampridine attempted or documented intolerance; presence of severe weakness permits approval without those trials.

Refer to form questions 530-535.

ICI toxicities specific: Patient experienced a moderate or severe PD-1/PD-L1 adverse event, the offending agent is held or discontinued, and one of the listed severe immune-related adverse events is present as selected on the form.

Many diagnosis branches on the form include an Other option that immediately routes the request to a terminal “No Further Questions” node when no additional criteria are specified. This means that selecting Other often ends the indication-specific questionnaire on the form and no further clinical fields are requested for that branch.

The form does not list broad, blanket exclusions. Instead, eligibility is determined by a series of indication-specific gating questions; absent the required answers (for example a listed ICD code, documentation of prior therapy failure, or fulfillment of timing thresholds), the branch will typically resolve to a No Further Questions terminal node and the request will not meet the criteria.

For continuation or renewal requests the form specifically asks the clinician to attest that the patient is deriving benefit from therapy (for example, reduction in infections, improvement in disability, or stabilization of condition). Continued coverage is contingent on documentation or attestation of clinical benefit.

The questionnaire contains multiple terminal nodes labeled “No Further Questions.” These occur when required qualifying criteria are absent (for example: selection of an unlisted diagnosis without supporting criteria, lack of required prior therapy failure, missing diagnostic confirmation, or timing outside specified windows). When a branch reaches such a terminal node the implied outcome is that the request does not meet the indication-specific criteria.

Relevant Diagnosis and Clinical Threshold Codes & Values

Primary immune deficiency and CIDP ICD-10 codesICD-10

D80.0	hereditary hypogammaglobulinemia
D80.2	selective deficiency of immunoglobulin A [IgA]
D80.3	selective deficiency of immunoglobulin G [IgG] subclasses
D80.4	selective deficiency of immunoglobulin M
D80.5	immunodeficiency with increased immunoglobulin M [IgM]
D80.6	antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia
D80.7	transient hypogammaglobulinemia of infancy
D81.0	severe combined immunodeficiency [SCID] with reticular dysgenesis
D81.1	severe combined immunodeficiency [SCID] with low T- and B-cell numbers
D81.2	severe combined immunodeficiency [SCID] with low or normal B-cell numbers

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Other covered diagnoses (form selections)ICD-10

Various ICD-10 codes

The form lists many additional ICD-10 diagnoses for which immune globulin may be requested (examples include multifocal motor neuropathy, pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, epidermolysis bullosa acquisita, acquired hypogammaglobulinemia secondary to malignancy or CAR-T therapy, antiphospholipid syndrome, asthma, Kawasaki syndrome in pediatrics, idiopathic thrombocytopenic purpura, B-cell chronic lymphocytic leukemia, multifocal motor neuropathy, dermatomyositis, polymyositis, Lambert-Eaton myasthenic syndrome, immune checkpoint inhibitor-related toxicities, Guillain-Barre syndrome, and transplant-related indications)

Pre-treatment IgG level (CLL)

Pre-treatment IgG threshold (CLL section 503)Less than 500 mg/dL (documentation such as a copy of the laboratory report must be submitted upon request)

Pre-treatment IgG threshold (CLL section 528)Less than 400 mg/dL (documentation such as a copy of the laboratory report must be submitted upon request)

If IgG ≥ thresholdForm allows selection of 'Greater than or equal to' with 'No Further Questions' in the CLL branch

Platelet count thresholds (ITP)

Severe thrombocytopeniaPre-treatment platelet count < 30,000/mcL (30 x 10^9/L)

Moderate thrombocytopenia

Provider Submission, Documentation, and Prior Therapy Requirements

Prior Authorization

Complete and fax prior authorization form

Prior authorization must be requested by completing and faxing the CVS Caremark Specialty Programs prior authorization form to 1-866-237-5512. Failure to submit the completed form via fax may result in denial or processing delay. For questions about the prior authorization process, contact CVS Caremark at 1-808-254-4414; for Specialty Customer Care (eligibility, copay, delivery) call CaremarkConnect® at 1-800-237-2767.

Send completed form to: CVS Caremark Specialty Programs — Fax: 1-866-237-5512
CVS Caremark questions: 1-808-254-4414; Specialty Customer Care: 1-800-237-2767

Note

Submission and initial triage

All requests are submitted to CVS Caremark Specialty Programs (Fax: 1-866-237-5512). The form includes screening questions about whether the patient is currently receiving immune globulin therapy and routes the request through initial triage based on the indication and responses.

Requests must be sent to CVS Caremark Specialty Programs — Fax: 1-866-237-5512

Definitions and Requested Product Details

Requested product

Available SCIG products (selectable)Cutaquig, Cuvitru, Hizentra, HyQvia, Xembify

Other product optionForm provides a free-text 'Other' field to specify a different product

Home administration

Home administration questionForm asks: 'Will the requested product be administered in the patient’s home?' (Yes/No)

Medical necessity attestationIf yes, the practitioner must determine and attest that home administration is medically necessary and appropriate

Form routingResponses route the form to subsequent questions based on the answer

Background

Immune globulin (SCIG/IVIG) is utilized across immunologic, hematologic, neurologic, and autoimmune conditions. This prior authorization form collects the requested product, ICD-10 diagnosis selection, site of administration (including home administration questions), relevant objective data (e.g., pre-treatment IgG, platelet counts, EMG/NCS or biopsy results), and prior-treatment history to determine medical necessity for coverage decisions.

OpenPayer

Prior authorization criteria for subcutaneous and intravenous immune globulin (SCIG/IVIG)

Coverage Criteria for Immune Globulin

Relevant Diagnosis and Clinical Threshold Codes & Values

Provider Submission, Documentation, and Prior Therapy Requirements

Definitions and Requested Product Details

Background