Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsClover Health Prolia Coverage Prior Auth | OpenPay…
    Ask Trek AI about this page
    CurrentClover HealthPolicy 3835-A

    Jurisdiction Specific Medicare Part B Prolia and Biosimilars

    Customize your policy alerts

    Sign up for clover_health Policy 3835-A alerts

    Get alerted when Policy 3835-A changes without checking for updates manually.

    Monitor payer policy activity

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

    Prior authorization and coverage criteria for Prolia and listed denosumab biosimilars administered under Medicare Part B in Clover Health jurisdictions 6 and K.

    Policy Summary
    PayerClover Health
    PolicyJurisdiction Specific Medicare Part B Prolia and Biosimilars
    Policy CodePolicy 3835-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionEnsure hypocalcemia is corrected prior to initiation of the requested drug, when applicable.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsStandard authorization duration
    1,000 mg dailyRequired supplemental calcium
    ≥400 IU dailyRequired supplemental vitamin D
    5Listed covered-use categories
    10Listed states

    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.

    Covered Indications

    Postmenopausal osteoporosis

    Covered when all of the following are met:

    • Required supportive treatment: The member will receive supplemental calcium and vitamin D.Calcium 1,000 mg daily and at least 400 IU vitamin D daily
    • Calcium status: Hypocalcemia will be corrected prior to initiation of the requested drug, if applicable.

    • Clinical qualification

      • High fracture risk: The member is at high risk for fracture.
      • Failed other therapy: The member has failed treatment with other available osteoporosis therapies.
      • Intolerant to other therapy: The member is intolerant to treatment with other available osteoporosis therapies.

    Osteoporosis in men

    Covered when all of the following are met:

    • Required supportive treatment: The member will receive supplemental calcium and vitamin D.Calcium 1,000 mg daily and at least 400 IU vitamin D daily
    • Calcium status: Hypocalcemia will be corrected prior to initiation of the requested drug, if applicable.

    • Clinical qualification

      • High fracture risk: The member is at high risk for fracture.
      • Failed other therapy:

    Glucocorticoid-induced osteoporosis

    Covered when all of the following are met:

    • Required supportive treatment: The member will receive supplemental calcium and vitamin D.Calcium 1,000 mg daily and at least 400 IU vitamin D daily
    • Calcium status: Hypocalcemia will be corrected prior to initiation of the requested drug, if applicable.

    • Clinical qualification

      • High fracture risk: The member is at high risk for fracture.
      • Failed other therapy:

    Bone loss during androgen deprivation therapy

    Covered when both of the following are met:

    • Qualifying indication: The member is receiving androgen deprivation therapy for prostate cancer and requires treatment of bone loss.
    • Required supportive treatment: The member will receive supplemental calcium and vitamin D.Calcium 1,000 mg daily and at least 400 IU vitamin D daily
    • Calcium status: Hypocalcemia will be corrected prior to initiation of the requested drug, if applicable.

    Bone loss during adjuvant aromatase inhibitor therapy

    Covered when both of the following are met:

    • Qualifying indication: The member is a woman receiving adjuvant aromatase inhibitor therapy for breast cancer and requires treatment of bone loss.
    • Required supportive treatment: The member will receive supplemental calcium and vitamin D.Calcium 1,000 mg daily and at least 400 IU vitamin D daily
    • Calcium status: Hypocalcemia will be corrected prior to initiation of the requested drug, if applicable.

    All other approvable indications

    Covered when the indication is approvable under the specified local coverage article.

    Other approvable indications: The requested treatment is for an approvable indication listed in local coverage article A52399.

    Authorization may be granted for 12 months.

    Supplementation Requirements

    Supplemental calcium
    Required daily amount1,000 mg of supplemental calcium daily
    Required with vitamin DThe member will receive supplemental calcium and vitamin D
    Applies toCovered osteoporosis and cancer-therapy-associated bone-loss indications described in the policy
    Supplemental vitamin D
    Required minimum daily amountAt least 400 IU of supplemental vitamin D daily
    Required with calciumThe member will receive supplemental calcium and vitamin D
    Applies to

    Authorization and Coverage Actions

    Prior Authorization

    Authorization may be granted for 12 months

    Authorization may be granted for 12 months when the member meets the criteria for the applicable indication. For other approvable indications, authorization is based on the criteria in local coverage article A52399.

    Denial Risk

    Meet all applicable clinical criteria

    Coverage authorization requires the applicable clinical criteria to be met. This includes supplemental calcium and vitamin D, with hypocalcemia corrected before initiation of the requested drug when applicable.

    • Supplemental calcium: 1000 mg daily.
    • Supplemental vitamin D: at least 400 IU daily.
    • For osteoporosis indications, the member must also be at high risk for fracture, have failed other available osteoporosis therapies, or be intolerant to those therapies.

    Policy Background

    Prolia (denosumab) and the listed denosumab biosimilars are covered under Medicare Part B for osteoporosis-related fracture-risk reduction and selected cancer-therapy-associated bone loss indications. Covered uses include postmenopausal osteoporosis, osteoporosis in men, glucocorticoid-induced osteoporosis, bone loss in men receiving androgen deprivation therapy for prostate cancer, and bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer.

    Coverage generally requires calcium supplementation of 1,000 mg daily and vitamin D supplementation of at least 400 IU daily; hypocalcemia must be corrected before treatment when applicable. Osteoporosis indications also require high fracture risk, failure of other available osteoporosis therapies, or intolerance to those therapies. Other approvable indications are assessed individually under local coverage article A52399.

    Initial Authorization Criteria

    Initial osteoporosis therapy

    Initial authorization may be granted for 12 months when all listed requirements are met.

    • Qualifying osteoporosis indication: The member has postmenopausal osteoporosis, osteoporosis in men, or glucocorticoid-induced osteoporosis.
    • Calcium and vitamin D supplementation: The member will receive supplemental calcium and vitamin D.Calcium 1,000 mg daily and at least 400 IU vitamin D daily
    • Correction of hypocalcemia: Hypocalcemia will be corrected prior to initiation if applicable.
    Policy Summary
    PayerClover Health
    PolicyJurisdiction Specific Medicare Part B Prolia and Biosimilars
    Policy CodePolicy 3835-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionEnsure hypocalcemia is corrected prior to initiation of the requested drug, when applicable.
    SourceLink
    On This Page
    Covered IndicationsSupplementation RequirementsAuthorization and Coverage ActionsPolicy BackgroundInitial Authorization Criteria
    The member has failed treatment with other available osteoporosis therapies.
  1. Intolerant to other therapy: The member is intolerant to treatment with other available osteoporosis therapies.
    2. The member has failed treatment with other available osteoporosis therapies.
  2. Intolerant to other therapy: The member is intolerant to treatment with other available osteoporosis therapies.
    3. Covered osteoporosis and cancer-therapy-associated bone-loss indications described in the policy
    Prior Authorization

    Obtain LCA review for other indications

    Indications outside the specifically listed uses require assessment under local coverage article A52399. Submit the request for review according to the criteria for the applicable indication in that article.

    Clinical qualification:
    The member meets at least one of the following: high risk for fracture, failure of other available osteoporosis therapies, or intolerance to other available osteoporosis therapies.

    Initial cancer-therapy-associated bone loss treatment

    Initial authorization may be granted for 12 months when both listed requirements are met.

    • Qualifying cancer-therapy-associated bone loss: The member has bone loss associated with androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer.Androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer
    • Calcium and vitamin D supplementation: The member will receive supplemental calcium and vitamin D.Calcium 1,000 mg daily and at least 400 IU vitamin D daily
    • Correction of hypocalcemia: Hypocalcemia will be corrected prior to initiation if applicable.