CurrentGeorgia Department of Community HealthPolicy N/A

Georgia Medicaid Fee-for-Service Iron, Parenteral PA Summary

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This policy governs Georgia Medicaid fee-for-service prior authorization and coverage criteria for parenteral iron products used to treat iron deficiency anemia.

Policy Summary

PayerGeorgia Department of Community Health

PolicyGeorgia Medicaid Fee-for-Service Iron, Parenteral PA Summary

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for all parenteral iron agents before requesting coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearLength of authorization

All agentsPrior authorization

4 months+Youngest stated eligible age

18 years+Restricted product age threshold

6 years+Sodium ferric gluconate age threshold

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CurrentGeorgia Department of Community HealthPolicy N/A

Georgia Medicaid Fee-for-Service Iron, Parenteral PA Summary

Customize your policy alerts

Sign up for all Georgia Department of Community Health policy alerts

Know when Georgia Department of Community Health releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy governs Georgia Medicaid fee-for-service prior authorization and coverage criteria for parenteral iron products used to treat iron deficiency anemia.

Policy Summary

PayerGeorgia Department of Community Health

PolicyGeorgia Medicaid Fee-for-Service Iron, Parenteral PA Summary

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for all parenteral iron agents before requesting coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearLength of authorization

All agentsPrior authorization

4 months+Youngest stated eligible age

18 years+Restricted product age threshold

6 years+Sodium ferric gluconate age threshold

Covered Parenteral Iron Products

INFeD

INFeD is approvable when all criteria are met.

INFeD criteria: Member is 4 months of age or older; has iron deficiency anemia; and has experienced intolerance or an unsatisfactory response to oral iron, or has an iron-deficient state not amenable to oral iron therapy.Age >= 4 months

Iron Sucrose Injection Generic

Generic iron sucrose injection is approvable when all criteria are met.

Iron sucrose criteria: Member is 1 year of age or older; has iron deficiency anemia; and has experienced intolerance or an unsatisfactory response to oral iron, or has an iron-deficient state not amenable to oral iron therapy.Age >= 1 year

Ferumoxytol Injection Generic

Generic ferumoxytol is approvable under either of the following pathways.

Ferumoxytol pathways

CKD pathway: Has iron deficiency anemia and chronic kidney disease; and has experienced ineffectiveness, allergies, contraindications, drug-drug interactions, or intolerable side effects to iron dextran (DexFerrum, INFeD) and iron sucrose (Venofer).
Non-CKD pathway: Has iron deficiency anemia in the absence of chronic kidney disease; has experienced intolerance or an unsatisfactory response to oral iron or has an iron-deficient state not amenable to oral iron therapy; and has experienced ineffectiveness, allergies, contraindications, drug-drug interactions, or intolerable side effects to iron dextran (DexFerrum, INFeD) and iron sucrose (Venofer).

Injectafer

Injectafer is approvable under any of the following pathways.

Injectafer pathways

Non-CKD pathway: Member is 1 year of age or older; has iron deficiency anemia in the absence of chronic kidney disease; has experienced intolerance or an unsatisfactory response to oral iron or has an iron-deficient state not amenable to oral iron therapy; and has experienced ineffectiveness, allergies, contraindications, drug-drug interactions, or intolerable side effects to iron dextran (DexFerrum, INFeD) and iron sucrose (Venofer).Age >= 1 year
Non-dialysis CKD pathway: Member is 18 years of age or older; has iron deficiency anemia and chronic kidney disease; is not dependent on dialysis; and has experienced ineffectiveness, allergies, contraindications, drug-drug interactions, or intolerable side effects to iron dextran (DexFerrum, INFeD) and iron sucrose (Venofer).Age >= 18 years; not dialysis-dependent
Heart failure pathway:

Monoferric

Monoferric is approvable under either of the following pathways.

Monoferric pathways

CKD pathway: Member is 18 years of age or older; has iron deficiency anemia and chronic kidney disease; is not dependent on dialysis; and has experienced ineffectiveness, allergies, contraindications, drug-drug interactions, or intolerable side effects to iron dextran (DexFerrum, INFeD) and iron sucrose (Venofer).Age >= 18 years; not dialysis-dependent
Non-CKD pathway: Member is 18 years of age or older; has iron deficiency anemia in the absence of chronic kidney disease; has experienced intolerance or an unsatisfactory response to oral iron or has an iron-deficient state not amenable to oral iron therapy; and has experienced ineffectiveness, allergies, contraindications, drug-drug interactions, or intolerable side effects to iron dextran (DexFerrum, INFeD) and iron sucrose (Venofer).Age >= 18 years

Sodium Ferric Gluconate Complex Injection Generic

Generic sodium ferric gluconate complex is approvable when all criteria are met.

Sodium ferric gluconate criteria: Member is 6 years of age or older; has iron deficiency anemia; is on hemodialysis or chemotherapy; is receiving supplemental epoetin therapy; and has experienced ineffectiveness, allergies, contraindications, drug-drug interactions, or intolerable side effects to iron dextran (DexFerrum, INFeD) and iron sucrose (Venofer).Age >= 6 years

For Injectafer and Monoferric, the chronic kidney disease (CKD) coverage pathway applies only when the member is not dependent on dialysis. This restriction does not apply to their other listed pathways.

Initial Therapy by Product

INFeD — Initial Therapy Criteria

Initial therapy is approvable when all criteria are met.

INFeD: Age 4 months or older; iron deficiency anemia; and intolerance or unsatisfactory response to oral iron, or an iron-deficient state not amenable to oral iron therapy.Age >= 4 months

Iron Sucrose Injection Generic — Initial Therapy Criteria

Initial therapy is approvable when all criteria are met.

Iron sucrose: Age 1 year or older; iron deficiency anemia; and intolerance or unsatisfactory response to oral iron, or an iron-deficient state not amenable to oral iron therapy.Age >= 1 year

Required Prior Therapy

Step	Applicable products	Requirement	Qualifying prior-therapy history
1	Ferumoxytol injection generic; Injectafer; Monoferric; sodium ferric gluconate complex injection generic	Prior use or trial of both iron dextran (DexFerrum or INFeD) and iron sucrose (Venofer).	The prior agents must have been ineffective or associated with an allergy, contraindication, drug-drug interaction, or intolerable side effect.

Step	Applicable products	Requirement	Qualifying oral-iron history
2	INFeD; iron sucrose injection generic; ferumoxytol injection generic; Injectafer; Monoferric	Prior oral iron therapy or documentation that oral iron is unsuitable for the applicable product indication.	Oral iron must have been ineffective or not tolerated, or the member’s iron-deficient state must not be amenable to oral therapy.

Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for all parenteral iron agents. Providers must obtain PA before coverage can be approved.

Applies to all agents listed in this policy.

Prior Authorization

Office and Clinic Administration

For medication administered in a physician’s office or clinic, initiate the coverage request through the Registered User portion of the Georgia Health Partnership website and request coverage from Physician Services. The first dose of INFeD must be administered under the direct supervision of a physician.

Online portal: www.mmis.georgia.gov/portal
Route the request through Physician Services.
Ensure direct physician supervision for the first INFeD dose.

Unsupported block type: prior_auth of the source

Quantity Level Limits

QUANTITY LIMITS

Covered agentsAll parenteral iron agents covered by this policy

Quantity limitsCurrent Quantity Level Limits apply

Where to find limitsGeorgia Medicaid Provider Manual: www.mmis.georgia.gov/portal → Provider Information → Provider Manuals → Pharmacy Services

Administration Site Requirements

Prior Authorization

Request office-administered drug coverage

For medication administered in a physician’s office or clinic, submit the coverage request to Physician Services through the Registered User portion of the Georgia Health Partnership website at www.mmis.georgia.gov/portal.

Billing Rule

Supervise the first INFeD dose

Administer the first dose of iron dextran (INFeD) under the direct supervision of a physician.

Policy Scope

This policy addresses intravenous or parenteral iron treatment for members with iron deficiency anemia when oral iron is ineffective, not tolerated, or unsuitable because the iron-deficient state is not amenable to oral therapy. Coverage is subject to product-specific requirements, which may include criteria related to chronic kidney disease, heart failure, dialysis, chemotherapy, epoetin therapy, and prior experience with other iron agents.

Policy Summary

PayerGeorgia Department of Community Health

PolicyGeorgia Medicaid Fee-for-Service Iron, Parenteral PA Summary

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for all parenteral iron agents before requesting coverage.

SourceLink

On This Page

Member is 18 years of age or older; has iron deficiency anemia and heart failure; and has New York Heart Association Class II or III symptoms.

Age >= 18 years; NYHA Class II/III

Ferumoxytol Injection Generic — Initial Therapy Criteria

Initial therapy is approvable when the member is 18 years of age or older and one of the following pathways is met.

Ferumoxytol pathways

CKD pathway: Iron deficiency anemia and chronic kidney disease plus ineffectiveness, allergy, contraindication, drug-drug interaction, or intolerable side effects to iron dextran (DexFerrum, INFeD) and iron sucrose (Venofer).
Non-CKD pathway: Iron deficiency anemia without chronic kidney disease; oral iron intolerance, unsatisfactory response, or unsuitability; and ineffectiveness, allergy, contraindication, drug-drug interaction, or intolerable side effects to iron dextran (DexFerrum, INFeD) and iron sucrose (Venofer).

Injectafer — Initial Therapy Criteria

Initial therapy is approvable through any of the following pathways.

Injectafer pathways

Non-CKD pathway: Age 1 year or older; iron deficiency anemia without chronic kidney disease; oral iron intolerance, unsatisfactory response, or unsuitability; and prior ineffectiveness, allergy, contraindication, drug-drug interaction, or intolerable side effects with iron dextran and iron sucrose.Age >= 1 year
Non-dialysis CKD pathway: Age 18 years or older; iron deficiency anemia with chronic kidney disease; not dialysis-dependent; and prior ineffectiveness, allergy, contraindication, drug-drug interaction, or intolerable side effects with iron dextran and iron sucrose.Age >= 18 years; not dialysis-dependent
Heart failure pathway: Age 18 years or older; iron deficiency anemia and heart failure; and NYHA Class II or III symptoms.Age >= 18 years; NYHA Class II/III

Monoferric — Initial Therapy Criteria

Initial therapy is approvable through either of the following pathways.

Monoferric pathways

CKD pathway: Age 18 years or older; iron deficiency anemia with chronic kidney disease; not dialysis-dependent; and prior ineffectiveness, allergy, contraindication, drug-drug interaction, or intolerable side effects with iron dextran and iron sucrose.Age >= 18 years; not dialysis-dependent
Non-CKD pathway: Age 18 years or older; iron deficiency anemia without chronic kidney disease; oral iron intolerance, unsatisfactory response, or unsuitability; and prior ineffectiveness, allergy, contraindication, drug-drug interaction, or intolerable side effects with iron dextran and iron sucrose.Age >= 18 years

Sodium Ferric Gluconate Complex Injection Generic — Initial Therapy Criteria

Initial therapy is approvable when all criteria are met.

Sodium ferric gluconate complex: Age 6 years or older; iron deficiency anemia; on hemodialysis or chemotherapy; receiving supplemental epoetin therapy; and prior ineffectiveness, allergy, contraindication, drug-drug interaction, or intolerable side effects with iron dextran and iron sucrose.Age >= 6 years

Step Therapy

Required Prior Parenteral Iron Therapy

Before requesting ferumoxytol, Injectafer, Monoferric, or sodium ferric gluconate complex, document the required prior parenteral iron therapy when the applicable criterion requires it. The required prior agents are iron dextran (DexFerrum or INFeD) and iron sucrose (Venofer), with documented ineffectiveness, allergy, contraindication, drug-drug interaction, or intolerable side effects where specified.

Ferumoxytol: prior iron dextran and iron sucrose failure or intolerance is required in the applicable CKD and non-CKD pathways.
Injectafer: prior iron dextran and iron sucrose failure or intolerance is required for the applicable non-CKD and non-dialysis CKD pathways.
Monoferric: prior iron dextran and iron sucrose failure or intolerance is required for the applicable CKD and non-CKD pathways.
Sodium ferric gluconate complex: prior iron dextran and iron sucrose failure or intolerance is required.

Unsupported block type: step_therapy of the source

Documentation Required

Clinical Documentation Supporting Criteria

Include clinical documentation supporting the requested agent’s applicable coverage pathway. The request should establish the member’s age, IDA diagnosis, relevant comorbidities and treatment status, oral-iron history when required, and outcomes or adverse circumstances associated with prior parenteral iron therapy.

Document iron deficiency anemia and member age.
When applicable, document CKD, dialysis status, heart failure and NYHA class, hemodialysis, chemotherapy, and supplemental epoetin therapy.
Document oral iron ineffectiveness, intolerance, unsatisfactory response, or clinical unsuitability when required.
Document prior iron dextran and iron sucrose use and the applicable ineffectiveness, allergy, contraindication, drug-drug interaction, or intolerable side effect.

Denial Risk

INFeD Eligibility Criteria Not Met

INFeD is not approvable unless the member is at least 4 months old, has iron deficiency anemia, and has either intolerance or an unsatisfactory response to oral iron or an iron-deficient state that is not amenable to oral therapy.

Non-approval risk: member younger than 4 months.
Non-approval risk: no documented IDA diagnosis.
Non-approval risk: no qualifying oral-iron intolerance, unsatisfactory response, or clinical unsuitability.

Denial Risk

Iron Sucrose Eligibility Criteria Not Met

Generic iron sucrose injection is not approvable unless the member is at least 1 year old, has iron deficiency anemia, and has either intolerance or an unsatisfactory response to oral iron or an iron-deficient state that is not amenable to oral therapy.

Non-approval risk: member younger than 1 year.
Non-approval risk: no documented IDA diagnosis.
Non-approval risk: no qualifying oral-iron intolerance, unsatisfactory response, or clinical unsuitability.

Denial Risk

Ferumoxytol Eligibility Criteria Not Met

Ferumoxytol is not approvable when the member does not meet the applicable age, IDA, CKD, oral-iron, and prior parenteral-iron requirements. The CKD pathway requires age 18 or older, IDA with CKD, and ineffectiveness or an applicable adverse circumstance with both iron dextran and iron sucrose; the non-CKD pathway additionally requires the qualifying oral-iron circumstance.

CKD pathway: age 18 or older; IDA and CKD; documented ineffectiveness, allergy, contraindication, drug-drug interaction, or intolerable side effect with iron dextran and iron sucrose.
Non-CKD pathway: age 18 or older; IDA; qualifying oral-iron intolerance or unsatisfactory response, or an iron-deficient state not amenable to oral therapy; and the required prior-agent failure or intolerance.
Non-approval risk: failure to document any required element.

Denial Risk

Brand Parenteral Iron Criteria Not Met

Injectafer and Monoferric are not approvable when the member does not meet the applicable age, IDA, CKD or non-CKD, dialysis, oral-iron, heart-failure, and prior-agent requirements.

Injectafer non-CKD pathway: age 1 year or older, IDA, qualifying oral-iron circumstance, and required failure or intolerance of iron dextran and iron sucrose.
Injectafer CKD pathway: age 18 or older, IDA with CKD, not dependent on dialysis, and required failure or intolerance of iron dextran and iron sucrose.
Injectafer heart-failure pathway: age 18 or older, IDA, and NYHA Class II/III heart failure.
Monoferric CKD pathway: age 18 or older, IDA with CKD, not dependent on dialysis, and required failure or intolerance of iron dextran and iron sucrose.
Monoferric non-CKD pathway: age 18 or older, IDA, qualifying oral-iron circumstance, and required failure or intolerance of iron dextran and iron sucrose.

Denial Risk

Sodium Ferric Gluconate Criteria Not Met

Sodium ferric gluconate complex is not approvable unless the member is at least 6 years old, has IDA, is receiving the required dialysis or chemotherapy and epoetin-related treatment, and has the required failure or intolerance of iron dextran and iron sucrose.

Member must be on hemodialysis or receiving chemotherapy.
Member must be receiving supplemental epoetin therapy.
Document ineffectiveness, allergy, contraindication, drug-drug interaction, or intolerable side effect with iron dextran and iron sucrose.
Non-approval risk: age, diagnosis, treatment-status, or prior-therapy criteria are not met.