CurrentClover HealthPolicy 4489-A

Jurisdiction Specific Medicare Part B Granix

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This policy governs prior authorization and coverage of Granix under Medicare Part B for specified neutropenia-related uses in Medicare jurisdictions J and M, including clinical criteria, exclusions, authorization durations, and administration requirements.

Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Granix

Policy CodePolicy 4489-A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization for up to six months of coverage when applicable clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsMaximum authorization period

>=20%High-risk regimen threshold

10% to <20%Intermediate-risk regimen threshold

>10 days; <0.1 x 10^9/LProlonged and profound neutropenia

28-42 days

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CurrentClover HealthPolicy 4489-A

Jurisdiction Specific Medicare Part B Granix

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Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Granix

Policy CodePolicy 4489-A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization for up to six months of coverage when applicable clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsMaximum authorization period

>=20%High-risk regimen threshold

10% to <20%Intermediate-risk regimen threshold

>10 days; <0.1 x 10^9/LProlonged and profound neutropenia

28-42 days

No-response exclusion timeframe

OfficeCovered administration setting

Covered Uses and Exclusions

Neutropenia in Cancer Patients Receiving Myelosuppressive Chemotherapy and/or Immunotherapy

Authorization of 6 months may be granted for prevention of febrile neutropenia when the chemotherapeutic agents are covered by Medicare and the applicable criteria below are met.

ONE of the following

Primary prophylaxis: high-risk regimen
- Granix will be used for primary prophylaxis in a member whose risk of febrile neutropenia is 20% or greater based on the chemotherapy regimen.
Primary prophylaxis: intermediate-risk regimen with risk factor
- Granix will be used for primary prophylaxis in a member whose risk of febrile neutropenia is greater than or equal to 10% and less than 20% based on the chemotherapy regimen.
- At least one febrile-neutropenia risk factor is present
  - Age greater than 65 years.
  - Poor performance status.
  - Previous episodes of febrile neutropenia.
  - History of previous chemotherapy or radiation therapy.
  - After completion of combined chemoradiotherapy.
  - Bone marrow involvement by tumor producing cytopenias.
  - Preexisting neutropenia.
  - Poor nutritional status.
  - Poor renal function.
  - Liver dysfunction, such as elevated bilirubin.
  - Presence of open wounds or active infections.
  - Recent surgery within the past 12 weeks.
  - Advanced cancer.
  - Other serious comorbidities.
Secondary prophylaxis
- The member has documented febrile neutropenia from a prior chemotherapy cycle for which primary prophylaxis was not received.
- A reduction in dosage of the chemotherapeutic agent or delay in treatment may compromise disease-free or overall survival or treatment outcome.

Adjunctive Treatment of Neutropenia

Authorization of 6 months may be granted for adjunctive treatment of neutropenia when any of the following conditions is present.

ONE of the following conditions

Expected prolonged (greater than 10 days) and profound (less than 0.1 x 10^9/L) neutropenia.
Age greater than 65 years.
Uncontrolled primary disease.
Pneumonia.
Hypotension and multiorgan dysfunction (sepsis syndrome).
Invasive fungal infection.

Coverage will not be provided for administration of Granix to increase chemotherapy dose intensity, except as otherwise noted.

Coverage will not be provided for continuous use of Granix for myelodysplastic syndromes or Felty's syndrome without infections.

Coverage will not be provided for chemosensitization of myeloid leukemias.

Coverage will not be provided for continued use of Granix if no response is seen within 28–42 days.

Coverage will not be provided for administration of Granix in members with chronic aplastic anemia.

Services performed for excessive frequency are not medically necessary. Frequency is considered excessive when services are performed more frequently than generally accepted by peers and the reason for additional services is not justified by documentation. Granix will be covered when administered under direct supervision in the office setting. When administered by the member or caregiver, the drug will be considered self-administered and not payable.

Clinical Thresholds and Risk Factors

High chemotherapy-regimen risk

Febrile-neutropenia risk20% or greater based on the chemotherapy regimen

Coverage usePrimary prophylaxis with Granix

Authorization period6 months may be granted when the chemotherapeutic agents are covered by Medicare

Intermediate chemotherapy-regimen risk

Febrile-neutropenia riskGreater than or equal to 10% and less than 20% based on the chemotherapy regimen

Additional requirementAt least one risk factor for febrile neutropenia must be present

Coverage use

Authorization, Documentation, and Denial Risks

Prior Authorization

Six-Month Authorization

Authorization of 6 months may be granted for prevention of febrile neutropenia when the chemotherapeutic agents are covered by Medicare and the member meets applicable primary or secondary prophylaxis criteria.

Primary prophylaxis when the chemotherapy regimen carries a febrile neutropenia risk of 20% or greater.
Primary prophylaxis when risk is 10% to less than 20% and at least one qualifying risk factor is present.
Secondary prophylaxis when febrile neutropenia was documented during a prior chemotherapy cycle without primary prophylaxis, and dose reduction or treatment delay could compromise disease-free survival, overall survival, or treatment outcome.

Documentation Required

Supporting Evidence for Other Indications

For indications not listed as covered, submit supporting evidence from Medicare-approved compendia with the request.

Therapy Overview

Granix (tbo-filgrastim) is a granulocyte colony-stimulating factor used to reduce the duration or consequences of neutropenia. This policy addresses its use for prevention of febrile neutropenia in patients receiving myelosuppressive chemotherapy or immunotherapy and for adjunctive treatment of neutropenia in qualifying high-risk clinical situations.

Key Clinical Definitions

Primary prophylaxis

TimingUse before a chemotherapy cycle

PurposePrevent febrile neutropenia

EligibilityRegimen risk is 20% or greater, or 10% to less than 20% with at least one additional febrile-neutropenia risk factor

Secondary prophylaxis

TimingUse after documented febrile neutropenia from a prior chemotherapy cycle

Prior prophylaxisPrimary prophylaxis was not received for the prior cycle

Treatment-impact requirement

Initial Therapy Coverage Pathways

Prevention of Febrile Neutropenia

Authorization of 6 months may be granted for prevention of febrile neutropenia when the chemotherapy agents are covered by Medicare and at least one pathway below is met.

Qualifying prophylaxis pathway

Primary prophylaxis at high regimen risk
- Granix will be used for primary prophylaxis in a member whose chemotherapy regimen has a risk of febrile neutropenia of 20% or greater.>=20%
Primary prophylaxis at intermediate regimen risk
- Granix will be used for primary prophylaxis in a member whose chemotherapy regimen has a risk of febrile neutropenia of at least 10% but less than 20%.>=10% and <20%

Continuation and Response Requirement

Continuation Response Requirement

Continued therapy is excluded when no response is seen within 28–42 days.

Response required for continuation

A response to Granix must be seen within 28–42 days; continued therapy is excluded when no response is seen within this timeframe.Response within 28–42 days

Administration Setting

Billing Rule

Administer Granix in the office

Granix is covered when administered under direct supervision in the office setting. Administration by the member or caregiver is considered self-administered and is not payable.

Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Granix

Policy CodePolicy 4489-A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization for up to six months of coverage when applicable clinical criteria are met.

SourceLink

On This Page

Hospitalization at the time of the development of fever.

Primary prophylaxis with Granix

Age risk factor

Age thresholdGreater than 65 years

Clinical roleRisk factor for febrile neutropenia when regimen risk is at least 10% and less than 20%

Adjunctive treatmentAlso qualifies as a listed condition for adjunctive treatment of neutropenia

Recent surgery risk factor

Surgery timeframeWithin the past 12 weeks

Clinical roleRisk factor for febrile neutropenia

Coverage pathwaySupports primary prophylaxis when chemotherapy-regimen risk is at least 10% and less than 20%

Expected prolonged neutropenia

Expected durationGreater than 10 days

Clinical conditionExpected prolonged neutropenia

Coverage pathwayQualifying condition for adjunctive treatment of neutropenia when profound neutropenia is also present

Profound neutropenia

Absolute neutrophil countLess than 0.1 x 10^9/L

Clinical conditionProfound neutropenia

Coverage pathwayQualifying condition for adjunctive treatment when neutropenia is expected to last greater than 10 days

Documentation Required

Secondary Prophylaxis Documentation

Document the prior chemotherapy-cycle febrile neutropenia and the clinical reason escalation is necessary. Secondary prophylaxis requires that primary prophylaxis was not received and that reducing the chemotherapy dose or delaying treatment may compromise disease-free survival, overall survival, or treatment outcome.

Denial Risk

Frequency Justification

Services performed more frequently than generally accepted by peers are not medically necessary unless the additional frequency is justified by documentation.

Denial Risk

Excluded Clinical Uses

Coverage is excluded for the following clinical uses and circumstances:

Administration to increase chemotherapy dose intensity, except as otherwise specified in the policy.
Continuous use for myelodysplastic syndromes or Felty's syndrome without infections.
Chemosensitization of myeloid leukemias.
Continued use when no response is seen within 28–42 days.
Administration in members with chronic aplastic anemia.

Denial Risk

Excessive Frequency

Excessive frequency is not medically necessary when services are performed more frequently than generally accepted by peers and the reason for the additional services is not justified by documentation.

Billing Rule

Self-Administration

Granix is covered when administered under direct supervision in the office setting. When administered by the member or caregiver, it is considered self-administered and is not payable.

Documentation Required

Unlisted Indications

Indications other than the listed covered uses require individual assessment. Requests must include supporting evidence from Medicare-approved compendia.

Reducing chemotherapy dosage or delaying treatment may compromise disease-free survival, overall survival, or treatment outcome

Expected prolonged and profound neutropenia

Expected durationGreater than 10 days

Absolute neutrophil countLess than 0.1 x 10^9/L

Clinical useQualifying condition for adjunctive treatment of neutropenia

At least one patient risk factor

Age greater than 65 years.
Poor performance status.
Previous episodes of febrile neutropenia.
History of previous chemotherapy or radiation therapy.
Completion of combined chemoradiotherapy.
Bone marrow involvement by tumor producing cytopenias.
Preexisting neutropenia.
Poor nutritional status.
Poor renal function.
Liver dysfunction, such as elevated bilirubin.
Open wounds or active infections.
Recent surgery within the past 12 weeks.
Advanced cancer.
Other serious comorbidities.

Secondary prophylaxis

The member has documented febrile neutropenia from a prior chemotherapy cycle for which primary prophylaxis was not received.
Reducing the chemotherapeutic agent dosage or delaying treatment may compromise disease-free survival, overall survival, or treatment outcome.

Adjunctive Treatment of Neutropenia

Authorization of 6 months may be granted for adjunctive treatment when any one of the following conditions is present.

Qualifying condition

Expected prolonged neutropenia lasting more than 10 days and profound neutropenia below 0.1 x 10^9/L are present.>10 days and <0.1 x 10^9/L
The member is older than 65 years.>65 years
The member has uncontrolled primary disease.
The member has pneumonia.
The member has hypotension and multiorgan dysfunction consistent with sepsis syndrome.
The member has an invasive fungal infection.
The member was hospitalized at the time of the development of fever.