ModifiedPremera BluecrossPolicy N/A

Pharmacologic Treatment to Reduce Serum Phosphorus

Criteria and coverage rules for oral phosphate‑reducing medications (phosphate binders and tenapanor) used to treat hyperphosphatemia and Auryxia for iron‑deficiency anemia in people with chronic kidney disease; applies to medications managed under the pharmacy benefit.

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment to Reduce Serum Phosphorus

Policy CodePolicy N/A

Change TypeMaterial update — added Xphozahproduct removal and clarifications

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization through the pharmacy benefit demonstrating required trial of comparator agents and documentation of continued clinical response for re‑authorization.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for Xphozah (tenapanor).

Removed Phoslyra (calcium acetate solution) due to product discontinuation.

Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months.

Medications listed in this policy are subject to the product's FDA dosage and administration prescribing information.

up to 12 monthsmax approval duration

47%Xphozah diarrhea rate

37%prevalence on dialysis

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Auryxia (ferric citrate) — hyperphosphatemia

Covered when ALL of the following are met

Auryxia for hyperphosphatemia: The individual has hyperphosphatemia and has tried and had an inadequate response or intolerance to sevelamer HCl or sevelamer carbonate.

From policy coverage criteria for Auryxia (ferric citrate).

Auryxia (ferric citrate) — iron deficiency anemia

Covered when ALL of the following are met

Auryxia for iron deficiency anemia: The individual has iron deficiency anemia and has tried and had an inadequate response or intolerance to both oral iron (e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate) and IV iron (e.g., iron dextran, iron sucrose, sodium ferric gluconate complex).

From policy coverage criteria for Auryxia (ferric citrate).

Fosrenol, Renagel, Renvela, Velphoro — hyperphosphatemia

Covered when ALL of the following are met

Non-Auryxia phosphate binders: Fosrenol (lanthanum carbonate), Renagel (sevelamer HCl), Renvela (sevelamer carbonate), and Velphoro (sucroferric oxyhydroxide) may be considered medically necessary for the treatment of hyperphosphatemia when the individual has tried and had an inadequate response or intolerance to sevelamer HCl or sevelamer carbonate.

Policy groups these agents with the same prerequisite trial requirement.

Xphozah (tenapanor) — dialysis patients

Covered when ALL of the following are met

Xphozah for serum phosphorus reduction: The individual has chronic kidney disease AND is currently receiving dialysis AND Xphozah (tenapanor) will be used as add-on therapy to reduce serum phosphorus AND the individual has tried and had an inadequate response or intolerance to phosphate binder therapy (e.g., calcium acetate; sevelamer; lanthanum).

From policy coverage criteria for Xphozah; coverage criteria for Xphozah were added in 2024.

General coverage and administrative criteria

Policy covers specified phosphate binders and Xphozah (tenapanor) when criteria are met; non-formulary exceptions may be granted up to 12 months and coverage follows FDA dosing.

General coverage conditions: Medications listed in this policy are subject to the product's FDA dosage and administration prescribing information; non-formulary exception authorizations may be approved for up to 12 months.

Document notes additions/removals of specific products (Xphozah added; Phoslyra removed).

Requests for uses of Auryxia (ferric citrate), Fosrenol (lanthanum carbonate), Renagel (sevelamer HCl), Renvela (sevelamer carbonate), Velphoro (sucroferric oxyhydroxide), and Xphozah (tenapanor) that are for conditions not specified in this policy are considered investigational. Such requests are not covered under the medical necessity criteria in this policy and may be denied.

Phoslyra (calcium acetate solution) has been removed from the list of covered products because the manufacturer discontinued the product. As a result, Phoslyra is not available for coverage

Historically, agents included in this policy were designated investigational when the documented coverage criteria were not met. Specific not-medically‑necessary conditions and examples are not present in this excerpt; in practice, requests that fall outside the policy’s stated indications or required prior‑therapy trials are treated as investigational and may be denied.

Initial Therapy Criteria

Initial Therapy — Initial approval considerations

Initial approval considerations

Initial approval duration: Initial authorization may be approved up to 12 months for listed agents when medical necessity criteria are met.

From Length of Approval / Initial Therapy criteria.

Initial therapy (summary) — Xphozah (tenapanor) coverage criteria were added

Xphozah (tenapanor) coverage criteria were added; details of initial therapy criteria are in the full policy.

Initial therapy note: Coverage for specific initial therapy regimens and agent selection is governed by criteria elsewhere in the policy; Xphozah was added to the policy in 2024.

Refer to full policy for full initial therapy details.

Continuation / Re-authorization Criteria

Re-authorization — continuation criteria

Re-authorization

Re-authorization conditions: May be approved up to 12 months in duration when there is documentation of continued clinical response and that ongoing treatment is required.

From Length of Approval / Re-authorization criteria.

Continuation therapy duration — Non-formulary exception review authorizations

Continuation of therapy is subject to non-formulary exception duration (may be approved up to 12 months) and adherence to the product's FDA prescribing information.

Clarified in 2025 update.

Step Therapy Requirements

Step	Requirement	Failure criteria / required trial	Notes
1	Trial of specified alternative agents required prior to coverage	Individual must have tried and had an inadequate response or intolerance to listed comparators (e.g., for phosphate binders: sevelamer HCl or sevelamer carbonate; for Auryxia iron‑deficiency indication: both oral iron and IV iron).	Applies to Auryxia and other phosphate binders per policy coverage criteria.

Step	Requirement	Failure criteria / required trial	Notes
0	No specific step therapy sequence present in this excerpt	Refer to full policy for any step edits or detailed sequencing requirements	History and interim reviews note additions/removals to the policy; step edits not detailed in this excerpt.

Coding

No codes in this excerptmixed

No codes listed

Coding

Coding availabilityNo procedure, diagnosis, or billing codes are listed in this policy excerpt.

ThresholdsNone specified in the excerpt.

ActionConsult the member benefit booklet or contact customer service to determine specific coverage and billing requirements.

Provider Actions and Prior Authorization

Prior Authorization
Pharmacy benefit management
The phosphate-reducing oral drugs covered by this policy are managed under the pharmacy benefit and require prior authorization per the plan's prescription drug policies. Prescribers should submit authorization requests to the pharmacy benefit manager following the payer's standard prior authorization process.
Pharmacy benefit: oral phosphate binders and tenapanor are processed through the pharmacy benefit.
Prior authorization: required per the prescription drug policy and medical necessity criteria.

Documentation Required
Documentation and approval duration
Authorization decisions are subject to adherence with the product's FDA-approved dosing and administration, and approvals for non‑formulary exception requests may be granted for up to 12 months. Re‑authorization (continuation) requests require documentation of continued clinical response and that ongoing treatment is necessary; such re‑authorizations may be approved for up to 12 months when adequate documentation is provided.

Background

Hyperphosphatemia commonly occurs in people with chronic kidney disease and is associated with vascular calcification, cardiovascular events, and increased morbidity and mortality. It is frequently observed in individuals receiving dialysis and contributes to mineral and bone disorder management decisions; treatment is directed at lowering serum phosphate using dietary measures and pharmacologic phosphate‑reducing agents when indicated.

Definitions

Hyperphosphatemia

DefinitionHyperphosphatemia: elevated serum phosphate commonly seen in chronic kidney disease and associated with vascular calcification, cardiovascular events, and increased mortality.

PrevalenceOccurs in approximately 37% of individuals on dialysis.

Clinical significanceTreated because of association with adverse outcomes despite lack of randomized trial data directly linking phosphate lowering to improved hard outcomes.

Evidence basisManagement is guided by epidemiologic evidence, observational studies, and guideline recommendations (e.g., KDIGO).

Clinical practice guideline

Guideline referencedKDIGO (Kidney Disease: Improving Global Outcomes) clinical practice guideline for CKD-MBD.

Quantity Limits

Quantity limits and dosing

Quantity limits ruleAll listed medications: quantity/usage limited per the product's FDA dosing and administration.

Drugs covered under this ruleIncludes lanthanum carbonate, sevelamer (carbonate and HCl), ferric citrate (Auryxia), sucroferric oxyhydroxide (Velphoro), and tenapanor (Xphozah).

ApplicationAuthorization decisions and continuation are subject to adherence with FDA prescribing information.

Site of Care

Billing Rule
Pharmacy benefit — home administration
Oral phosphate‑reducing agents in this policy are managed through the pharmacy benefit; no site‑of‑care restriction for administration is specified in this excerpt.
Agents include oral formulations intended for home use; site‑of‑care limitations are not specified here.

Note