ModifiedPremera BluecrossPolicy N/A

Pharmacologic Treatment of Osteoporosis

Defines medical necessity, site-of-service review, and coverage criteria for specified pharmacologic agents used to treat osteoporosis for Premera members; affects providers requesting medical or pharmacy benefit coverage for listed osteoporosis drugs.

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of Osteoporosis

Policy CodePolicy N/A

Change TypeCoverage criteria updatedmaterial additions and removals

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document trial and failure of two generic bisphosphonates (or contraindication) when requesting anabolic agents; trial of generic teriparatide is required before branded teriparatide coverage.

SourceLink

POLICY UPDATE CHANGES

Added site of service review for Evenity (romosozumab-aqqg).

Clarified that Site of Service Medical Necessity criteria can apply to injection drugs.

Added coverage for calcitonin salmon nasal spray and generic and brand calcitonin salmon injections for specified indications.

Updated Bonsity, brand Teriparatide, and Forteo coverage criteria to require trial and failure with generic teriparatide.

Removed brand teriparatide coverage criteria as the product has been withdrawn from the market.

12 monthsmaximum total duration approved for Evenity

13+age threshold for site-of-service review

3 codesHCPCS codes listed

Added

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generic teriparatide

Addedcalcitonin formulations covered

Coverage Criteria for Osteoporosis Drugs

inv-01: Evenity (romosozumab-aqqg) Initial Therapy

Covered when ALL of the following are met:

Evenity initial criteria: The individual is a postmenopausal female AND has tried and failed or had intolerance to two generic bisphosphonates (either two oral medications or one oral and one IV) unless bisphosphonates are contraindicated AND the dose is limited to 210 mg once every month AND total duration of therapy is 12 months or lessduration <= 12 months

Generic bisphosphonates listed: alendronate, ibandronate, risedronate, zoledronic acid.

inv-02: Teriparatide (Bonsity/Forteo/generic teriparatide) Initial Therapy

Covered when ALL of the following are met:

Teriparatide criteria: The individual tried and failed or had intolerance to two generic bisphosphonates (either two oral medications or one oral and one IV) unless bisphosphonates are contraindicated AND the dose is limited to 20 mcg per day (once daily)20 mcg/day

Generic bisphosphonates defined as alendronate, ibandronate, risedronate, zoledronic acid.

inv-03: Calcitonin salmon indications

Covered when specified conditions are met:

Calcitonin nasal spray criteria: Assigned female at birth AND diagnosed with postmenopausal osteoporosis AND >5 years postmenopause AND tried and failed or had intolerance to two generic bisphosphonates (either two oral medications or one oral and one IV)

Nasal spray is managed through pharmacy benefit.

Calcitonin injection criteria: Diagnosed with hypercalcemia (documented calcium >= 14 mg/dL) OR diagnosed with Paget's disease of bone with baseline radiographic osteolytic lesions and alternatives unsuitable OR diagnosed with postmenopausal osteoporosis when injection formulation is appropriate; prior trial of two generic bisphosphonates required unless contraindicatedcalcium >= 14 mg/dL

Injection may be self-administered or provider-administered; managed through medical and pharmacy benefits.

inv-04: Tymlos (abaloparatide) Initial Therapy

Covered when ALL of the following are met:

Tymlos criteria: The individual is male or postmenopausal female AND has tried and failed or had intolerance to two generic bisphosphonates (either two oral medications or one oral and one IV) unless bisphosphonates are contraindicated AND the dose is limited to 80 mcg per day (once daily)80 mcg/day

Generic bisphosphonates include alendronate, ibandronate, risedronate, zoledronic acid. AACE/ACE guidance limits abaloparatide duration to 2 years.

inv-05: Policy coverage updates

Summary of recent policy-level changes affecting coverage:

generic teriparatide requirement: Coverage criteria for Bonsity (teriparatide), Forteo (teriparatide), and brand teriparatide were updated to require trial and failure with generic teriparatide prior to coverage of branded teriparatide products (brand later withdrawn).

Effective with 2024 update; brand later removed per 2025-12/01 history.

calcitonin coverage addition: Calcitonin salmon nasal spray and calcitonin salmon injections (Miacalcin and generic) were added as covered indications for postmenopausal osteoporosis; injections also added for Paget's disease of bone and hypercalcemia.

Some changes effective October 3, 2025 after provider notification.

site of service review added: Site of service review was added for Evenity (romosozumab-aqqg); Site of Service Medical Necessity criteria may apply to injectable drugs and may restrict allowable administration settings.

Clarified in 2025 updates.

All uses of Bonsity (teriparatide), calcitonin salmon nasal spray, Evenity (romosozumab-aqqg), Forteo (teriparatide), generic calcitonin salmon injection, Miacalcin injection, generic teriparatide, and Tymlos (abaloparatide) that are not specifically listed as covered in this policy are considered investigational. Requests for these agents must meet the drug-specific coverage criteria described in the policy (including prior bisphosphonate trial requirements and dose limits) to be considered medically necessary. Prior authorization is required for the agents addressed in this policy; initial approvals for Evenity may be granted for up to 12 months, and other approval durations follow the agent-specific criteria and continuation rules in the policy.

Oral bisphosphonates are considered contraindicated in individuals with esophageal disorders (for example, achalasia, esophageal stricture, Barrett's esophagus, or esophageal varices). When oral bisphosphonates are contraindicated, the policy requires only an IV zoledronic acid trial as the bisphosphonate step where applicable.

This medical policy does not apply to Medicare Advantage plans. Coverage determinations for Medicare Advantage members are governed by the member's plan benefits and not by this policy.

The hospital outpatient site (and other higher-acuity settings) for infusion or injectable therapy is considered not medically necessary when the policy's site-of-service criteria are not met. Site-of-service review criteria define when outpatient infusion, infusion center, physician office, or home administration is preferred; if those criteria are unmet, hospital outpatient administration will not be considered medically necessary.

Historically, agents and uses not meeting the specified criteria in this policy were classified as investigational or not medically necessary. The policy record shows prior additions and clarifications over time (for example, initial policy creation in 2019, dose limits and contraindication notes added in 2020, and coding and indication updates in subsequent years). These historical entries document that agents outside the outlined indications and requirements were not approved for coverage.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J0630	Injection, calcitonin salmon, up to 400 units (use to report: Miacalcin and generic calcitonin salmon)
J3110	Injection, teriparatide, (Bonsity, Forteo, and generic teriparatide) 10 mcg
J3111	Injection, romosozumab-aqqg (Evenity), 1 mg

HCPCS codes referenced/updatedHCPCS

J3110	HCPCS code added for Forteo
J3111	HCPCS code referenced earlier for teriparatide
J0630	HCPCS code added for Miacalcin and generic calcitonin salmon injection
J0897	HCPCS code referenced in relation to Xgeva/prior auth history

Provider Actions, Authorization, and Documentation

Denial Risk

Age-based site-of-service denial risk

Site-of-service review may deny administration in hospital-based outpatient settings for pediatric individuals under age 13. For the purpose of site-of-service medical necessity, the policy applies only to individuals aged 13 years and older; pediatric physiology, dosing, equipment, and staffing considerations drive this limitation.

Site-of-service applies to hospital outpatient, infusion centers, physician office, or home administration.
Pediatric age cutoff: <13 years — site-of-service review limited; may be denied if administered in higher-acuity hospital outpatient setting for those under 13.

Documentation Required

Required medical record documentation

Medical records submitted for review must document that the medical necessity criteria are met. Include office visit notes with the diagnosis and a complete medication history showing prior therapies, trials, dates, and reasons for discontinuation or intolerance.

Background and Scope

Osteoporosis is a pathological condition of reduced bone mass and structural deterioration of bone that increases fracture risk. Bone remodeling becomes imbalanced with age, leading to fragility fractures that are associated with substantial morbidity, mortality, and healthcare costs—hip fractures in particular carry high morbidity and mortality. Pharmacologic treatment aims to reduce fracture risk by either inhibiting bone resorption (antiresorptives such as bisphosphonates and denosumab) or stimulating bone formation (anabolic agents such as teriparatide and abaloparatide) and, in the case of romosozumab (Evenity), transiently increasing bone formation via sclerostin inhibition.

Definitions

Osteoporosis definition — low bone mass and fracture risk

DefinitionOsteoporosis: a pathological condition of reduced bone mass and increased fracture risk due to imbalance in bone remodeling; low bone mass is defined as T-score <-1.0.

Clinical consequenceThin, fragile bones are at high risk of fracture, with hip fractures linked to high morbidity and mortality.

EpidemiologyApproximately 10.2 million Americans ≥50 years estimated to have osteoporosis; an additional 43.4 million have low bone mass (NOF 2014).

Site of service definition — locations where drug administered and review applicability

DefinitionSite of service: the location where the drug is administered (hospital-based outpatient setting, infusion center, physician's office, or at home).

Age applicability

Initial Therapy Criteria and Recommendations

inv-32: Initial therapy requirements — prior bisphosphonate trials and dosing limits

Initial therapy requirements for listed agents:

General anabolic/osteoporosis agent requirement: Most anabolic and specified osteoporosis agents require prior trial and failure or intolerance to two generic bisphosphonates (either two oral medications or one oral and one IV) unless bisphosphonates are contraindicated

Applies across teriparatide, abaloparatide, Evenity, and calcitonin nasal spray where specified; oral bisphosphonates considered contraindicated in esophageal disorders.

Dose limits are based on FDA-approved prescribing information: teriparatide (20 mcg/day) and abaloparatide (80 mcg/day); romosozumab limited to 210 mg monthly; follow product labeling for administration and durationsee individual agent thresholds

Dose limits added to drug-specific sections per 2020/2024 updates.

inv-33: Initial therapy recommendations — guideline-based first-line agents and duration

Re-authorization and Continuation Criteria

inv-35: Re-authorization / Continuation — agent-specific reauth rules

Re-authorization and continuation rules vary by agent:

Evenity re-authorization: Future re-authorization of Evenity beyond 12 months is considered investigational and not approved

Initial approvals up to 12 months only; requests exceeding this risk denial.

Teriparatide and abaloparatide re-authorization: Non-formulary exception reviews for teriparatide (Bonsity, Forteo, generic) and abaloparatide (Tymlos) may be approved up to 12 months when documentation shows ongoing high fracture risk; other reauthorizations may be approved up to 2 years when condition has stabilized and no serious side effects

Applies to Bonsity, generic teriparatide, Forteo, Tymlos, and calcitonin injections per policy text.

inv-36: Continuation / re-authorization notes from history

Notes from policy history and re-authorization guidance:

Step Therapy Requirements

Requirement	Details
Required prior step before most anabolic agents and calcitonin nasal spray
Trial and failure or intolerance to two generic bisphosphonates (either two oral medications or one oral and one IV) unless bisphosphonates are contraindicated

Requirement	Details
Mandatory prior trial of generic teriparatide
Policy updated to require trial and failure with generic teriparatide prior to coverage of branded teriparatide products; generic teriparatide listed as medically necessary when other bisphosphonate trials failed

Coverage condition	Policy detail
Generic teriparatide must be tried and failed before Bonsity/Forteo/brand teriparatide are covered
Bonsity and Forteo coverage criteria require trial and failure of generic teriparatide in addition to prior failure or intolerance to two generic bisphosphonates (two oral or one oral + one IV), and dose limit for teriparatide is 20 mcg/day

Site-of-Service Medical Necessity Review

Note

Site‑of‑service review applies to infusion, office, home, hospital outpatient

Site‑of‑service review applies to IV infusion and injectable drug administration settings and identifies physician office, infusion center, home infusion, and hospital outpatient as medically necessary sites when criteria are met.

Preferred medically necessary sites include physician office, infusion center, and home infusion; hospital outpatient may be medically necessary for initial 90 days or certain high‑risk conditions [[4]].
Site‑of‑service review applies to IV and injectable drugs per the policy Coverage Criteria section [[3]].

Note

Site‑of‑service review applies to administration locations for ages ≥13

Site‑of‑service review is applied to administration locations (physician office, infusion center, hospital outpatient, home) for individuals aged 13 and older; age criterion for site‑of‑service review is ≥13 years.

Policy explicitly states age 13+ is the threshold for site‑of‑service medical necessity review [[18],[3]].
Allowed administration locations include infusion center, physician office, hospital outpatient, and home when medically necessary [[4]].

Policy Revision History

2019-05-01policy_created

New policy approved April 9, 2019 and made effective August 2, 2019; initial coverage included Forteo, Tymlos, and Prolia where criteria are met.

2019-06-01interim_update

Added criteria for Evenity (romosozumab-aqqg) and updated Tymlos criteria; HCPCS J3111 added and J3590 removed in subsequent update.

2020-08-01annual_review

Added Bonsity (teriparatide) and brand Teriparatide to coverage criteria and added dose limits based on FDA-approved dosing; clarified oral bisphosphonate contraindications for esophageal disorders.

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of Osteoporosis

Policy CodePolicy N/A

Change TypeCoverage criteria updatedmaterial additions and removals

Effective DateJun 1, 2026

Next Review DateN/A

SourceLink

On This Page

Submit office visit notes that contain the diagnosis and medication history.
Include documentation of trials/failures or contraindications to prior bisphosphonates and teriparatide (generic) when required.

Note

Prescribing information and dose limits

All drugs listed in this policy are subject to the FDA-approved dosing and administration in the product prescribing information. Dose limits in the policy reflect FDA-approved dosing: e.g., teriparatide (including generic) limited to 20 mcg once daily; abaloparatide limited to 80 mcg once daily; romosozumab limited to 210 mg monthly. Site-of-service review criteria may also apply to injectable products.

Follow each product's FDA dosing and administration in the prescribing information.
Teriparatide (Bonsity/Forteo/generic): dose limit 20 mcg once daily.
Abaloparatide (Tymlos): dose limit 80 mcg once daily.
Evenity (romosozumab-aqqg): 210 mg once monthly; total duration limited to 12 months.

Note

Prescribing information and site of service

Site-of-service review applies to injectable and infused drugs in this policy. When evaluating medical necessity for site of service, reviewers will consider the administration location (e.g., hospital outpatient infusion department) and whether the administration in that setting is justified based on age and clinical need.

Site-of-service review covers hospital-based outpatient, outpatient hospital IV infusion department, physician office, infusion center, or home.
Evenity (romosozumab-aqqg) is specifically subject to site-of-service review.

Step Therapy

Step requirement before anabolic agents

Prior to approval of anabolic osteoporosis agents (teriparatide, abaloparatide, romosozumab in appropriate settings), the individual must have trialed and failed or been intolerant to two generic bisphosphonates (either two oral agents or one oral and one IV) unless bisphosphonates are contraindicated. For oral bisphosphonate contraindications, esophageal disorders (e.g., achalasia, stricture, Barrett's esophagus, varices) are considered contraindications.

Generic bisphosphonates include: alendronate (oral), ibandronate (oral), risedronate (oral), zoledronic acid (IV).
Oral bisphosphonates are contraindicated in patients with esophageal disorders; if contraindicated, different trial requirements may apply.

Step Therapy

Teriparatide generic-first requirement

Brand teriparatide products (Bonsity, Forteo) and darivatives require trial and failure of generic teriparatide before coverage of the branded products will be considered. The policy was updated to require a generic teriparatide trial and failure prior to coverage of branded teriparatide formulations.

Generic teriparatide must be tried and failed or documented intolerance before approving Bonsity or Forteo.
Dose limit for teriparatide (all formulations): 20 mcg once daily.

Site-of-service medical necessity review applies for individuals age 13 years and older.

Review scopeSOS criteria apply only to medical benefit reviews; site-of-service review can restrict allowable administration settings for injectable/IV drugs (e.g., Evenity).

Low bone mass / osteoporosis clinical threshold note

Low bone mass thresholdLow bone mass is defined as T-score <-1.0 at the femoral neck or lumbar spine.

Clinical significanceLow bone mass and osteoporosis increase fracture risk and are common in older adults; decisions guided by fracture risk assessment and guidelines.

Guideline contextAACE/ACE and NOF recommendations inform initial therapy choices and treatment duration considerations for individuals at high fracture risk.

Sclerostin definition — target of romosozumab

DefinitionSclerostin: a protein primarily produced by osteocytes that inhibits Wnt pathway signaling and bone formation.

Therapeutic relevanceSclerostin is the pharmacologic target of romosozumab (Evenity), an anti‑sclerostin monoclonal antibody that increases bone formation and reduces resorption.

Mechanism summaryBy inhibiting sclerostin, romosozumab transiently increases bone formation and reduces bone resorption to increase bone mass.

Osteoporosis drug classes covered by policy

Anabolic agentsTeriparatide (Bonsity, Forteo, generic teriparatide) and abaloparatide (Tymlos); increase bone formation.

AntiresorptivesBisphosphonates (alendronate, risedronate, ibandronate, zoledronic acid), denosumab (Prolia), raloxifene; reduce bone resorption.

Sclerostin inhibitorRomosozumab (Evenity) — anti‑sclerostin monoclonal antibody with dual action to increase formation and decrease resorption.

CalcitoninCalcitonin salmon formulations (nasal spray, injection, Miacalcin) — listed as covered for specific indications (postmenopausal osteoporosis, hypercalcemia, Paget's disease).

Guideline-based recommendations to consider when selecting initial therapy:

Initial therapy choices: Alendronate, risedronate, zoledronic acid, or denosumab are appropriate as initial therapy for most individuals at high fracture risk; abaloparatide, denosumab, romosozumab, teriparatide, and zoledronate may be considered for individuals unable to use oral therapy or at very high fracture risk

Recommendations based on AACE/ACE clinical practice guideline.

Recommended durations: Limit romosozumab treatment to 1 year and limit abaloparatide and teriparatide to 2 years; follow with a long-term agent such as a bisphosphonate or denosumab as recommended by guidelinesromosozumab <= 1 year; abaloparatide/teriparatide <= 2 years

Per AACE/ACE guideline recommendations.

inv-34: Initial therapy — requirements noted in updates

Initial therapy requirements noted in recent updates:

teriparatide generic-first update: Coverage for branded teriparatide products was updated to require trial and failure of generic teriparatide prior to coverage (generic teriparatide added to criteria).

Noted in 2024 update; brand teriparatide later withdrawn.

Historical duration changes: Re-authorization duration for some agents has been updated historically (e.g., Prolia to 2 years in 2021); teriparatide and abaloparatide re-authorization language modified in the past to reflect prescribing information allowing use beyond 2 years in select high-risk patients

See main policy history for dates and rationale.

Non-formulary exception duration clarification: Non-formulary exception review authorizations for drugs in this policy may be approved up to 12 months (clarified in 2025 updates)<= 12 months

Applies across listed agents where non-formulary exception is used.

Note

Site‑of‑Service Medical Necessity review may restrict administration sites for Evenity and injectables

Site of Service Medical Necessity review may apply to Evenity and other injectable drugs; administrators may review and restrict allowable sites of administration based on the policy.

2025 updates added site‑of‑service review for Evenity and clarified SOS criteria can apply to injection drugs [[37],[46]].
The policy defines allowable medically necessary sites and circumstances when hospital outpatient care may be required [[4]].

2021-05-01interim_update

Updated Prolia (denosumab) initial and re-authorization duration to 2 years and removed the 2-year treatment duration limit for Bonsity, brand Teriparatide, Forteo, and Tymlos per revised prescribing information.

2023-03-01interim_update

Added coverage for Tymlos (abaloparatide) for the treatment of men with osteoporosis.

2023-05-09coding_update

Coding updates including changes to HCPCS prior authorization statements (J0897/Xgeva) were made in May 2023.

2024-02-01annual_review

Added generic teriparatide to coverage criteria; updated Bonsity, brand Teriparatide, and Forteo criteria to require trial and failure with generic teriparatide; added HCPCS code J3110 for Forteo.

2025-03-01annual_review

Clarified that non-formulary exception review authorizations for all drugs listed may be approved up to 12 months and affirmed that listed medications are subject to FDA dosing and administration information.

2025-07-01interim_update

Added coverage for calcitonin salmon nasal spray (postmenopausal osteoporosis) and, effective October 3, 2025 after provider notification, added coverage for generic calcitonin salmon injection and Miacalcin injection for postmenopausal osteoporosis, Paget's disease, and hypercalcemia; added HCPCS J0630; added site-of-service review for Evenity and clarified Site of Service criteria can apply to injection drugs.

2025-11-01interim_update

Moved Prolia (denosumab) and HCPCS code J0897 to a separate denosumab policy (effective November 1, 2025 per approval October 13, 2025).

2025-12-01interim_update

Removed brand teriparatide coverage criteria after the product was withdrawn from the market.

2026-06-01annual_reviewLatest

Annual review completed May 25, 2026 with policy statements unchanged.