Hicon® (Sodium Iodide I-131) (Oral) coverage criteria
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Defines Moda Health's medical necessity, dosing limits, billing codes, and authorization rules for oral Hicon (sodium iodide I-131) for hyperthyroidism and thyroid carcinoma; applies to Moda members and providers submitting claims. Prior authorization criteria do not apply, but pre-payment claims edits and PA validity rules are included.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Approval Criteria
Covered when ALL of the following are met:
Renewal Criteria
Renewal conditions
Before administering oral sodium iodide I-131 for hyperthyroidism, other causes of hyperthyroidism must be ruled out. Examples include thyroid malignancy and TSH-secreting pituitary tumors. This determination should be documented in the medical record as part of the requirement to meet coverage criteria for hyperthyroidism indications.
For purposes of Medicare Part B applicability under this policy, no Medicare Part B covered diagnosis codes are listed (N/A). Providers should refer to Appendix 2 and applicable NCDs/LCDs for Medicare-specific guidance when billing Medicare.
Initial prior authorization validity is provided for a single administration of Hicon. Prior authorization may not be renewed; additional administrations beyond the single authorized administration are not approved under renewal per this policy.
Coding and Dose Limits
| 65174-0880-XX | Hicon NDC for 9,250–37,000 MBq vials (format shown with XX) |
| C73 | Malignant neoplasm of the thyroid gland |
| E05.00 | Thyrotoxicosis with diffuse goiter without thyrotoxic crisis or storm |
| E05.01 | Thyrotoxicosis with diffuse goiter with thyrotoxic crisis or storm |
| E05.10 | Thyrotoxicosis with toxic single thyroid nodule without thyrotoxic crisis or storm |
| E05.11 | Thyrotoxicosis with toxic single thyroid nodule with thyrotoxic crisis or storm |
| E05.20 | Thyrotoxicosis with toxic multinodular goiter without thyrotoxic crisis or storm |
| E05.21 | Thyrotoxicosis with toxic multinodular goiter with thyrotoxic crisis or storm |
| Z85.850 | Personal history of malignant neoplasm of thyroid |
| C73 | Malignant neoplasm of the thyroid gland |
| E05.00 | Thyrotoxicosis with diffuse goiter without thyrotoxic crisis or storm |
| E05.01 | Thyrotoxicosis with diffuse goiter with thyrotoxic crisis or storm |
| E05.10 | Thyrotoxicosis with toxic single thyroid nodule without thyrotoxic crisis or storm |
| E05.11 | Thyrotoxicosis with toxic single thyroid nodule with thyrotoxic crisis or storm |
| E05.20 | Thyrotoxicosis with toxic multinodular goiter without thyrotoxic crisis or storm |
| E05.21 | Thyrotoxicosis with toxic multinodular goiter with thyrotoxic crisis or storm |
| Z85.850 | Personal history of malignant neoplasm of thyroid |
| No codes listed |
Provider Actions & Billing Requirements
Prior authorization valid for a single administration
Prior authorization validity is issued initially for one administration of Hicon and prior authorization may NOT be renewed; additional administrations beyond the single authorization are not approved under renewal.
Verify Medicare coverage, NCDs/LCDs, and local guidance
For Medicare patients, providers should verify Medicare coverage and any applicable NCDs/LCDs or Local Coverage Articles before billing by checking the CMS coverage database and contractor guidance.
- Search for NCD/LCD/LCA documents: https://www.cms.gov/medicare-coveragedatabase/search.aspx
- Follow applicable Medicare Benefit Policy Manual and local contractor rules
Require failure or intolerance to anti‑thyroid medication for hyperthyroidism
For hyperthyroidism indications, the member must have failed anti-thyroid medication therapy or have documented intolerance or a contraindication to anti-thyroid medications before I-131 therapy is approved.
- Failure/intolerance/contraindication applies to Graves disease–related hyperthyroidism per policy language
Confirm prerequisites and provide supporting clinical documentation
Ensure all required pre-treatment prerequisites and documentation are met and provided to support medical necessity and safe administration.
- Confirm other causes of hyperthyroidism are ruled out (e.g., thyroid malignancy, TSH‑secreting pituitary tumors)
- Verify patient is ≥18 years old and females of reproductive potential have a negative pregnancy test prior to treatment
- Confirm adherence to low‑iodide diet and discontinuation of anti‑thyroid medications as specified
Use supported ICD‑10 codes from Appendix 1 to substantiate medical necessity
Use the ICD‑10 diagnosis codes listed in Appendix 1 (e.g., C73; E05.00–E05.21; Z85.850) on claims to support medical necessity for Hicon therapy.
- Appendix 1 diagnoses include C73, E05.00–E05.21, and Z85.850
Claims edits may trigger denial for unmet diagnosis or dosing criteria
Pre‑payment claims edits are applied to diagnosis criteria and to maximum units per dose; claims that do not meet the policy’s diagnosis or dosing edits (including HCPCS unit limits) may be denied.
- Edits include diagnosis matching Appendix 1 and maximum units per administration (see dosing limits)
- Ensure billed units (mCi) align with policy maximums to avoid edit-triggered denials
Follow CMS NCD/LCD requirements for Medicare coverage
Noncompliance with applicable Medicare NCDs or LCDs (where they exist) and related contractor guidance may affect Medicare coverage determinations for Hicon; follow CMS and MAC requirements when treating Medicare beneficiaries.
- Refer to the Medicare Benefit Policy Manual, Chapter 15 §50, and search the CMS coverage database for NCDs/LCDs/LCA using the provided link
Background
Sodium iodide I-131 (oral) is a therapeutic radiopharmaceutical used to treat hyperthyroidism and to ablate or treat differentiated thyroid carcinoma. It is administered orally and dosing is individualized; providers should follow safety and handling precautions and applicable regulatory guidance when using I-131.
Definitions
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