CurrentClover HealthPolicy 5565-A

Jurisdiction Specific Medicare Part B Mircera

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This policy governs Medicare Part B coverage and prior authorization for Mircera in members with specified anemia related to ESRD or CKD, including certain pediatric members converting from another ESA, in Medicare Part B Jurisdictions J and M.

Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Mircera

Policy CodePolicy 5565-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument and correct applicable reversible causes of anemia before initiating or continuing ESA therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization period

<10 g/dL or <30%Adult initiation threshold

<45 mL/min/1.73 m²Nondialysis CKD GFR threshold

10–12 g/dLContinuation hemoglobin target

3 months–17 years

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CurrentClover HealthPolicy 5565-A

Jurisdiction Specific Medicare Part B Mircera

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Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Mircera

Policy CodePolicy 5565-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument and correct applicable reversible causes of anemia before initiating or continuing ESA therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization period

<10 g/dL or <30%Adult initiation threshold

<45 mL/min/1.73 m²Nondialysis CKD GFR threshold

10–12 g/dLContinuation hemoglobin target

3 months–17 years

Pediatric conversion age range

Coverage Criteria

Adult ESRD anemia on dialysis

Authorization of 12 months may be granted when all criteria are met.

Adult ESRD on dialysis

ESRD diagnosis: Member has a diagnosis of end-stage renal disease.
Anemia threshold
- Hemoglobin is less than 10 g/dL at initiation of therapy.Hgb <10 g/dL
- Hematocrit is less than 30% at initiation of therapy.HCT <30%
Recent creatinine: The provider documents the most recent creatinine within the past month prior to initiation or the next dosing of ESA.Within 1 month

Adult CKD anemia without dialysis

Authorization of 12 months may be granted when all criteria are met.

Adult CKD not on dialysis

Anemia threshold
- Hemoglobin is less than 10 g/dL at initiation of therapy.Hgb <10 g/dL
- Hematocrit is less than 30% at initiation of therapy.HCT <30%
GFR requirement: Glomerular filtration rate is less than 45 mL/min/1.73 m².GFR <45 mL/min/1.73 m²

Pediatric CKD anemia conversion

Authorization of 12 months may be granted when the pediatric conversion criteria are met.

Pediatric CKD conversion

Age: Member is 3 months to 17 years of age.3 months–17 years
Conversion from another ESA: Member is converting from another erythropoiesis-stimulating agent.
Prior hemoglobin stabilization: The hemoglobin level was stabilized at 10–12 g/dL with an ESA.Hgb 10–12 g/dL

Continuation therapy

Authorization of 12 months may be granted when both criteria are met.

Stable target: The goal of therapy is to maintain a stable hemoglobin and hematocrit within target ranges of 10–12 g/dL and 30–36%, respectively.Hgb 10–12 g/dL; HCT 30–36%
Recent creatinine: The provider documents the most recent creatinine within the past month prior to the next dosing of ESA.Within 1 month

Clinical Thresholds and Timing

Adult initiation hemoglobin

Adult initiation thresholdHemoglobin less than 10 g/dL

Adult ESRD useApplies to adults on dialysis with anemia related to end-stage renal disease

Adult CKD useApplies to adults with CKD who are not on dialysis

Adult initiation hematocrit

Adult initiation thresholdHematocrit less than 30%

Adult ESRD useApplies to adults on dialysis with anemia related to end-stage renal disease

Adult CKD useApplies to adults with CKD who are not on dialysis

Authorization and Documentation Requirements

Prior Authorization

Adult ESRD Authorization

Prior authorization may be granted for 12 months for anemia of ESRD in an adult member receiving dialysis when all required criteria are met.

Diagnosis of end-stage renal disease.
Hgb <10 g/dL or HCT <30% at initiation of therapy.
Document the most recent creatinine obtained within the month before initiation or the next ESA dose.

Prior Authorization

Adult Nondialysis CKD Authorization

Prior authorization may be granted for 12 months for anemia of CKD in an adult member who is not receiving dialysis when all required criteria are met.

Hgb <10 g/dL or HCT <30% at initiation of therapy.
GFR <45 mL/min/1.73 m².
Document the most recent creatinine obtained within the month before initiation or the next ESA dose.

Policy Background

Mircera (methoxy polyethylene glycol-epoetin beta) is an erythropoiesis-stimulating agent used to treat anemia associated with chronic kidney disease (CKD) and end-stage renal disease (ESRD). Coverage includes adults with ESRD receiving dialysis, adults with advanced CKD who are not receiving dialysis, and pediatric members 3 months through 17 years of age who are converting from another ESA after hemoglobin stabilization. Reversible or alternative causes of anemia should be evaluated, documented, and corrected before ESA therapy is initiated or continued.

Key Terms

Mircera

Brand nameMircera

Generic nameMethoxy polyethylene glycol-epoetin beta

Drug classErythropoiesis-stimulating agent

Chronic kidney disease

Full termChronic kidney disease

Covered adult stagesStages IIIb, IV, and V, including end-stage renal disease

Covered pediatric useCKD-related anemia in members 3 months to 17 years of age who are converting from another ESA after hemoglobin stabilization

Initial Therapy

Adult ESRD initial therapy

Authorization of 12 months may be granted when all criteria are met.

Adult ESRD on dialysis

ESRD diagnosis: Member has a diagnosis of end-stage renal disease.
ONE of
- Hemoglobin is less than 10 g/dL at initiation of therapy.Hgb <10 g/dL
- Hematocrit is less than 30% at initiation of therapy.HCT <30%

Continuation Therapy

Mircera continuation criteria

Authorization of 12 months may be granted when both criteria are met.

Stable target: The goal of therapy is to maintain a stable hemoglobin and hematocrit within target ranges of 10–12 g/dL and 30–36%, respectively.Hgb 10–12 g/dL; HCT 30–36%
Recent creatinine: The provider documents the most recent creatinine within the past month prior to the next dosing of ESA.Within 1 month

Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Mircera

Policy CodePolicy 5565-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument and correct applicable reversible causes of anemia before initiating or continuing ESA therapy.

SourceLink

On This Page

Recent creatinine: The provider documents the most recent creatinine within the past month prior to initiation or the next dosing of ESA.Within 1 month

Adult nondialysis CKD GFR

GFR thresholdLess than 45 mL/min/1.73 m²

PopulationAdults with chronic kidney disease who are not on dialysis

Covered useTreatment of anemia of chronic kidney disease

Hemoglobin stabilization and continuation target

Hemoglobin range10–12 g/dL

Pediatric conversionHemoglobin must have been stabilized at 10–12 g/dL with an ESA before conversion from another ESA

Continuation therapyTherapy should maintain hemoglobin within the 10–12 g/dL target range

Continuation hematocrit target

Continuation targetHematocrit 30–36%

Paired hemoglobin targetMaintain hemoglobin at 10–12 g/dL

Therapy phaseApplies to continuation of ESA therapy for a covered indication

Recent creatinine timing

Required timingWithin the past month

Initial therapyBefore initiation of therapy

Subsequent dosingBefore the next ESA dose

Prior Authorization

Pediatric ESA Conversion Authorization

Prior authorization may be granted for 12 months for anemia of CKD in a pediatric member 3 months through 17 years of age who is converting from another ESA after hemoglobin has been stabilized with ESA therapy.

Document prior treatment with another ESA.
Document a stabilized Hgb level of 10–12 g/dL before conversion.

Unsupported block type: prior_auth

Unsupported block type: documentation

Unsupported block type: billing_rule

End-stage renal disease

Full termEnd-stage renal disease

Covered adult useAnemia related to ESRD in adult members on dialysis

CKD relationshipESRD is included among the covered chronic kidney disease conditions described by the policy

Erythropoiesis-stimulating agent

Full termErythropoiesis-stimulating agent

Use in this policyESA therapy is used for covered anemia related to ESRD or CKD

Creatinine monitoringThe most recent creatinine must be documented within the past month before initiation or the next ESA dose

Recent creatinine: The provider documents the most recent creatinine within the past month prior to initiation or the next dosing of ESA.Within 1 month

Adult nondialysis CKD initial therapy

Authorization of 12 months may be granted when all criteria are met.

Adult CKD without dialysis

ONE of
- Hemoglobin is less than 10 g/dL at initiation of therapy.Hgb <10 g/dL
- Hematocrit is less than 30% at initiation of therapy.HCT <30%
GFR requirement: Glomerular filtration rate is less than 45 mL/min/1.73 m².GFR <45 mL/min/1.73 m²
Recent creatinine: The provider documents the most recent creatinine within the past month prior to initiation or the next dosing of ESA.Within 1 month

Pediatric initial conversion therapy

Authorization of 12 months may be granted for eligible pediatric members.

Age: Member is 3 months to 17 years of age.3 months–17 years
CKD-related anemia: Member is being treated for anemia of chronic kidney disease.
Conversion from another ESA: Member is converting from another erythropoiesis-stimulating agent.
Prior hemoglobin stabilization: The hemoglobin level was stabilized at 10–12 g/dL with an ESA.Hgb 10–12 g/dL