CurrentClover HealthPolicy 4367-A

Jurisdiction Specific Medicare Part B Bisphosphonate Drug Therapy

Customize your policy alerts

Sign up for clover_health Policy 4367-A alerts

Get alerted when Policy 4367-A changes without checking for updates manually.

Monitor payer policy activity

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

This policy governs coverage and prior authorization for intravenous ibandronate sodium, pamidronate disodium, and zoledronic acid under Medicare Part B. It applies to Clover Health members in the specified Medicare jurisdictions when treatment is requested for listed covered indications and the applicable clinical criteria are met.

Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Bisphosphonate Drug Therapy

Policy CodePolicy 4367-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit supporting evidence from Medicare-approved compendia for indications not listed as covered.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3IV bisphosphonate drugs covered

9Named covered-use categories

12 monthsCommon authorization duration

2 monthsHypercalcemia authorization limit

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentClover HealthPolicy 4367-A

Jurisdiction Specific Medicare Part B Bisphosphonate Drug Therapy

Customize your policy alerts

Sign up for clover_health Policy 4367-A alerts

Get alerted when Policy 4367-A changes without checking for updates manually.

Monitor payer policy activity

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

Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Bisphosphonate Drug Therapy

Policy CodePolicy 4367-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit supporting evidence from Medicare-approved compendia for indications not listed as covered.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3IV bisphosphonate drugs covered

9Named covered-use categories

12 monthsCommon authorization duration

2 monthsHypercalcemia authorization limit

Initial Paget zoledronic acid authorization

6 statesCovered jurisdictions

Covered Indications and Medical Necessity

Treatment of osteoporosis and osteopenia

Covered for 12 months when ANY of the following criteria pathways are met.

Qualifying osteoporosis or osteopenia pathway

Fracture pathway: The patient is a postmenopausal woman or man aged 50 years or older and has had a hip or vertebral fracture, including fragility fracture.
Bone mineral density pathway: The patient is a postmenopausal woman or man aged 50 years or older and has a bone mineral density T-score equal to or worse than -2.5 at the lumbar spine, femoral neck, or total hip.T-score <= -2.5
Osteopenia with additional fracture risk
- Additional fracture-risk factors: History of fracture of the proximal humerus, pelvis, or distal forearm; history of multiple fractures at other sites excluding the face, feet, and hands; FRAX 10-year probability for major osteoporotic fracture of at least 20%; or FRAX 10-year probability for hip fracture of at least 3%.FRAX major osteoporotic fracture >= 20% or hip fracture >= 3%

Hypercalcemia associated with malignancy

Covered for 2 months when the criterion is met.

Malignancy-associated hypercalcemia: The patient has moderate or severe hypercalcemia associated with malignancy, with or without bone metastases, and treatment is provided in conjunction with hydration.

Cancer treatment-induced bone loss

Covered for 12 months when ALL criteria are met.

Cancer treatment-induced bone loss: The patient has breast or prostate cancer; is receiving concurrent adjuvant hormone therapy, an aromatase inhibitor, or a gonadotropin-releasing hormone (GnRH) antagonist or agonist; and the requested drug is pamidronate disodium IV or zoledronic acid IV.

Bone metastases secondary to tumors

Covered for 12 months when the criterion is met.

Bone metastases: The patient has bone metastases secondary to a solid tumor, breast cancer, or prostate cancer.

Multiple myeloma

Covered for 12 months when ALL criteria are met.

Multiple myeloma: The patient has multiple myeloma and the requested drug is pamidronate disodium IV or zoledronic acid IV.

Osteolytic lesions due to metastases

Covered for 12 months when the criterion is met.

Osteolytic metastatic lesions: The patient has osteolytic lesions due to metastases.

Paget's disease of bone

Covered according to the applicable drug-specific pathway.

Paget disease pathway

Pamidronate pathway: The requested drug is pamidronate disodium IV.
Authorization: 1 month; moderate to severe disease is required.
Initial zoledronic acid pathway
- Qualifying clinical condition: Serum alkaline phosphatase is at least two times the upper limit of the age-specific normal reference range; there is risk for complications from Paget's disease; or treatment is intended to induce remission by normalizing serum alkaline phosphatase.Alkaline phosphatase >= 2 times the age-specific upper limit of normal where applicable
Zoledronic acid retreatment pathway:

Osteogenesis imperfecta

Covered for 12 months when ALL criteria are met.

Osteogenesis imperfecta: The patient has osteogenesis imperfecta and the requested drug is pamidronate disodium IV.

Fibrous dysplasia of bone

Covered for 12 months when ALL criteria are met.

Fibrous dysplasia: The patient has fibrous dysplasia of bone, also known as McCune-Albright syndrome, and the requested drug is pamidronate disodium IV.

Discontinuation of denosumab therapy

Covered for 12 months when ALL criteria are met.

Denosumab discontinuation: The patient has discontinued denosumab therapy, including Prolia or Xgeva, and the requested drug is zoledronic acid IV.

Glucocorticoid-induced osteoporosis and transplant-related bone loss

Covered for 12 months when ALL criteria are met.

Glucocorticoid-induced osteoporosis or transplant-related bone loss

Qualifying glucocorticoid-related pathway: The patient is taking glucocorticoids at any dose for an anticipated duration of at least 3 months and will maintain total calcium intake of 1000 to 1200 mg/day and vitamin D intake of 600 to 800 IU/day through diet and/or supplements; the patient is receiving high-dose glucocorticoids and is at moderate, high, or very high risk of fracture; or the patient is receiving high-dose glucocorticoids after a solid-organ transplant and has GFR greater than 35 mL/min, no evidence of chronic kidney disease-mineral and bone disorder, and no evidence of hyperparathyroidism.Glucocorticoid duration >= 3 months; calcium 1000-1200 mg/day; vitamin D 600-800 IU/day; GFR >35 mL/min where applicable

Coverage is available only when all applicable approval criteria are met and the member has no exclusions to the prescribed therapy.

Clinical Thresholds and Qualifying Values

Osteoporosis bone mineral density

Qualifying T-scoreEqual to or worse than -2.5

Osteopenia bone mineral density

Qualifying T-score rangeFrom -1.0 to 2.5

FRAX major osteoporotic fracture probability

10-year probability thresholdMajor osteoporotic fracture probability ≥ 20%

FRAX hip fracture probability

10-year probability threshold

Authorization, Documentation, and Submission Requirements

Prior Authorization

Osteoporosis or Osteopenia Authorization

Prior authorization for osteoporosis or osteopenia may be approved for 12 months when at least one qualifying fracture, bone-density, or fracture-risk pathway is documented.

Postmenopausal woman or man age 50 or older with a hip or vertebral fracture, including a fragility fracture.
Postmenopausal woman or man age 50 or older with osteoporosis-range bone mineral density (T-score ≤ -2.5) at the lumbar spine, femoral neck, or total hip.
Postmenopausal woman or man age 50 or older with a T-score from -1.0 to 2.5 plus a fracture of the proximal humerus, pelvis, or distal forearm, or multiple fractures at other sites excluding the face, feet, and hands.
Osteopenia requiring pharmacologic therapy with a FRAX 10-year major osteoporotic fracture probability ≥ 20% or hip-fracture probability ≥ 3%.

Prior Authorization

Malignancy-Associated Hypercalcemia Authorization

Prior authorization for moderate or severe hypercalcemia associated with malignancy may be approved for 2 months when treatment is provided with hydration, whether or not bone metastases are present.

Policy Background

This policy addresses intravenous bisphosphonate therapy with ibandronate sodium, pamidronate disodium, or zoledronic acid under Medicare Part B. Covered skeletal conditions include osteoporosis and osteopenia, malignancy-associated hypercalcemia, metastatic and osteolytic bone disease, Paget’s disease of bone, multiple myeloma, osteogenesis imperfecta, fibrous dysplasia, cancer treatment-induced bone loss, and glucocorticoid- or transplant-related bone loss. Coverage is indication-specific and depends on the requested drug and the applicable clinical criteria.

Defined Terms

Paget's disease of bone

DefinitionOsteitis deformans, also known as Paget's disease of bone.

Osteoporosis-level bone mineral density

DefinitionBone mineral density at the lumbar spine, femoral neck, or total hip with a T-score of -2.5 or worse.

Cancer treatment-induced bone loss (CTIBL)

DefinitionBone loss caused by cancer treatment in breast or prostate cancer in the setting of concurrent adjuvant hormone therapy, an aromatase inhibitor, or a gonadotropin-releasing hormone (GnRH) antagonist or agonist.

GIOP

Initial Therapy and Drug-Indication Matching

Drug and indication match

Initial therapy is covered only when ALL criteria are met.

Listed indication and drug match: The requested intravenous bisphosphonate is ibandronate sodium, pamidronate disodium, or zoledronic acid, and the diagnosis is one of the corresponding covered uses listed in the policy.

Unlisted indications require individual assessment with supporting evidence from Medicare-approved compendia.

Continuation and Retreatment

Zoledronic acid retreatment for Paget disease

Zoledronic acid retreatment may be authorized for 1 month when ALL criteria are met.

Paget disease retreatment: The member has moderate to severe Paget's disease of bone, relapsed after one year of remission, and retreatment with zoledronic acid is reasonable and necessary because of increased serum alkaline phosphatase, failure to achieve normalization of alkaline phosphatase, or symptom recurrence for which retreatment is dictated by medical practice.

Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Bisphosphonate Drug Therapy

Policy CodePolicy 4367-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit supporting evidence from Medicare-approved compendia for indications not listed as covered.

SourceLink

On This Page

The member relapsed after one year of remission and retreatment with zoledronic acid is reasonable and necessary because of increased serum alkaline phosphatase, failure to achieve normalization of alkaline phosphatase, or symptom recurrence for which retreatment is dictated by medical practice.

Authorization: 1 month.

Hip fracture probability ≥ 3%

Paget disease alkaline phosphatase elevation

Qualifying elevationSerum alkaline phosphatase at least 2 times the upper limit of the age-specific normal reference range

Glucocorticoid duration

Anticipated durationAt least 3 months

Daily calcium intake

Qualifying daily intakeTotal calcium intake of 1000 to 1200 mg/day

Daily vitamin D intake

Qualifying daily intakeVitamin D intake of 600 to 800 international units (IU) per day

Post-transplant renal function

Qualifying GFRGreater than 35 mL/min

Document the malignancy-associated hypercalcemia severity as moderate or severe.
Confirm concurrent hydration and indicate whether bone metastases are present.

Prior Authorization

Disease-Specific Authorization

Disease-specific indications generally support 12 months of authorization when the applicable diagnosis and treatment requirements are documented.

Bone metastases secondary to solid tumors, breast cancer, or prostate cancer: authorization may be granted for 12 months.
Osteolytic lesions due to metastases: authorization may be granted for 12 months.
Multiple myeloma: authorization may be granted for 12 months when the requested drug is pamidronate disodium IV or zoledronic acid IV.
Osteogenesis imperfecta: authorization may be granted for 12 months when the requested drug is pamidronate disodium IV.
Fibrous dysplasia of bone (McCune-Albright syndrome): authorization may be granted for 12 months when the requested drug is pamidronate disodium IV.
After discontinuation of denosumab (Prolia or Xgeva): authorization may be granted for 12 months when the requested drug is zoledronic acid IV.

Prior Authorization

Paget Disease Authorization Durations

Paget disease authorization depends on the drug and treatment phase: pamidronate is authorized for 1 month, initial zoledronic acid for 1 dose, and qualifying zoledronic acid retreatment for 1 month.

Pamidronate disodium IV: 1 month for moderate to severe Paget disease.
Initial zoledronic acid: 1 dose for moderate to severe disease when the request is for a single treatment and at least one qualifying clinical factor is documented.
Initial zoledronic acid factors include alkaline phosphatase at least twice the age-specific upper limit of normal, risk of Paget-related complications, or intent to induce remission through alkaline-phosphatase normalization.
Zoledronic acid retreatment: 1 month when the member relapsed after 1 year of remission and retreatment is reasonable and necessary because of increased alkaline phosphatase, failure to normalize alkaline phosphatase, or symptom recurrence requiring retreatment.

Prior Authorization

Glucocorticoid-Related Bone Loss Authorization

Prior authorization for treatment or prevention of glucocorticoid-induced osteoporosis or glucocorticoid-induced bone loss in transplant recipients may be approved for 12 months when the drug and clinical requirements are met.

Requested treatment must be ibandronate sodium IV or zoledronic acid IV.
The patient is taking glucocorticoids at any dose for an anticipated duration of at least 3 months and will maintain total calcium intake of 1,000–1,200 mg/day and vitamin D intake of 600–800 IU/day through diet and/or supplements; or the patient is receiving high-dose glucocorticoids and is at moderate, high, or very high fracture risk.
For high-dose glucocorticoid use after solid-organ transplant, document GFR >35 mL/min, no chronic kidney disease-mineral and bone disorder, and no hyperparathyroidism.

Denial Risk

Criteria and Exclusion Requirements

Before submitting a request, verify that all applicable approval criteria are satisfied and that the member has no exclusions to the prescribed therapy.

Submit the diagnosis, requested drug and route, duration or dose intent, and supporting clinical findings for every applicable criterion.
Review and address all policy exclusions; failure to meet any applicable approval or exclusion requirement may result in non-approval.

Documentation Required

Compendia Support for Unlisted Indications

Indications not listed in the covered-use criteria are assessed individually. Submit supporting evidence from a Medicare-approved compendium with the authorization request.

Use compendia support for unlisted indications and explain how the evidence supports the requested bisphosphonate therapy.

Documentation Required

Osteoporosis and Osteopenia Clinical Documentation

For osteoporosis or osteopenia requests, provide documentation sufficient to establish the qualifying pathway and fracture risk.

Patient sex, postmenopausal status when applicable, and age (50 years or older).
History and site of hip, vertebral, fragility, proximal humerus, pelvic, distal forearm, or multiple qualifying fractures.
Bone mineral density results, including T-scores and the measured lumbar spine, femoral neck, or total hip region.
FRAX 10-year probability for major osteoporotic fracture and hip fracture when using the osteopenia risk pathway.
Clinical rationale for pharmacologic therapy and the requested treatment.

Documentation Required

CTIBL Documentation

CTIBL requests must document the qualifying cancer, concurrent hormone-related treatment, and an allowed intravenous drug.

Diagnosis of breast cancer or prostate cancer.
Concurrent adjuvant hormone therapy, aromatase-inhibitor therapy, or gonadotropin-releasing hormone (GnRH) antagonist or agonist therapy.
Requested drug is pamidronate disodium IV or zoledronic acid IV.
Clinical documentation linking the bone loss to cancer treatment.

Documentation Required

Paget Disease Documentation

Paget disease requests must establish disease severity, treatment intent, and the laboratory or clinical basis for initial treatment or retreatment.

Document moderate to severe Paget disease and whether the request is for pamidronate, initial zoledronic acid, or zoledronic acid retreatment.
For initial zoledronic acid, document single-dose intent and at least one of: alkaline phosphatase ≥2 times the age-specific upper limit of normal, risk of complications, or intent to induce remission through alkaline-phosphatase normalization.
For retreatment, document relapse after 1 year of remission plus increased alkaline phosphatase, failure to normalize alkaline phosphatase, or symptom recurrence requiring retreatment.

Documentation Required

Glucocorticoid-Related Bone Loss Documentation

Glucocorticoid-related bone-loss requests must document steroid exposure, calcium and vitamin D intake, fracture risk when applicable, and renal or transplant-related findings.

Glucocorticoid dose and anticipated duration; the standard pathway requires use at any dose for at least 3 months.
Total daily calcium intake of 1,000–1,200 mg and vitamin D intake of 600–800 IU through diet and/or supplements.
For high-dose glucocorticoid therapy, moderate, high, or very high fracture-risk classification.
For post-transplant high-dose therapy, GFR >35 mL/min, absence of chronic kidney disease-mineral and bone disorder, and absence of hyperparathyroidism.

Denial Risk

All Criteria and Exclusions Must Be Satisfied

Coverage applies only when all applicable approval criteria are met and the member has no exclusions to the prescribed therapy. Confirm the complete clinical and drug-specific record before submission.

Do not rely on a single qualifying fact when the indication requires multiple criteria.
Document and resolve any exclusion, contraindication, or missing requirement identified during review.

Denial Risk

Unlisted Indications Require Compendia Evidence

Unlisted indications are not automatically covered. They require individual assessment and supporting evidence from Medicare-approved compendia.

Identify the unlisted indication clearly.
Attach relevant Medicare-approved compendia evidence and a clinical explanation supporting medical necessity.

Denial Risk

CTIBL Drug and Diagnosis Restrictions

CTIBL coverage is restricted to qualifying breast or prostate cancer treated with concurrent hormone-related therapy and an allowed IV bisphosphonate.

Qualifying diagnoses: breast cancer or prostate cancer.
Concurrent therapy must be adjuvant hormone therapy, an aromatase inhibitor, or a GnRH antagonist or agonist.
Permitted drugs: pamidronate disodium IV or zoledronic acid IV.

Denial Risk

Indication-Specific Drug Restrictions

For multiple myeloma, osteogenesis imperfecta, and fibrous dysplasia, the requested drug must be pamidronate disodium IV where specified by the indication.

Multiple myeloma: pamidronate disodium IV or zoledronic acid IV is permitted.
Osteogenesis imperfecta: pamidronate disodium IV is required.
Fibrous dysplasia of bone (McCune-Albright syndrome): pamidronate disodium IV is required.

Denial Risk

Denosumab Discontinuation Drug Restriction

After discontinuation of denosumab (Prolia or Xgeva), the requested treatment must be zoledronic acid IV for the 12-month authorization pathway.

Document prior denosumab therapy and its discontinuation.
Do not substitute pamidronate disodium or another drug for this indication.

DefinitionGlucocorticoid-induced osteoporosis or glucocorticoid-induced bone loss in transplant recipients.