CurrentIndependent HealthPolicy M20200508035

Hicon® (Sodium Iodide I-131) therapy coverage

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Defines medical necessity criteria and coverage limits for a single administration of Hicon® (sodium iodide I-131) for hyperthyroidism and differentiated thyroid carcinoma across Independent Health lines of business and products.

Policy Summary

PayerIndependent Health

PolicyHicon® (Sodium Iodide I-131) therapy coverage

Policy CodePolicy M20200508035

Change TypeNo material change

Effective DateJul 1, 2020

Last ReviewJun 1, 2026

Next Review Date

Key ActionProvide one administration of Hicon only when all clinical, preparatory and safety criteria are met (including diagnostic confirmation, pregnancy testing when applicable, low-iodide diet, and discontinuation of anti-thyroid medications).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1maximum covered administrations

≤10 unitsmax dose — hyperthyroidism

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CurrentIndependent HealthPolicy M20200508035

Hicon® (Sodium Iodide I-131) therapy coverage

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Policy Summary

PayerIndependent Health

PolicyHicon® (Sodium Iodide I-131) therapy coverage

Policy CodePolicy M20200508035

Change TypeNo material change

Effective DateJul 1, 2020

Last ReviewJun 1, 2026

Next Review Date

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1maximum covered administrations

≤10 unitsmax dose — hyperthyroidism

≥18minimum age for DTC

Coverage Criteria for Hicon® (Sodium Iodide I-131)

Initial and indication-specific coverage criteria

Covered when ALL of the following are met:

Overall coverage prerequisites

Indication
- Hyperthyroidism indication
  - Exclusion of other causes: Other causes of hyperthyroidism have been ruled out (e.g., thyroid malignancy, TSH-secreting pituitary tumors)
  - Hyperthyroidism subcriteria: Member has a confirmed diagnosis of hyperthyroidism related to Graves' disease with failure/intolerance/contraindication to anti-thyroid medication OR member has a confirmed diagnosis related to toxic nodular/multinodular goiter or toxic adenoma
- Differentiated thyroid carcinoma indication
  - Diagnosis: Member has a diagnosis of follicular or papillary thyroid carcinoma
  - Radioiodine uptake: Member has proven or suspected radio-iodine uptake of the thyroid bed or tumor
  - Use cases: Therapy will be used for adjuvant (post-surgical) RAI ablation OR treatment of locoregional, metastatic, or recurrent DTC

Initial approval procedural and safety criteria

Initial approval additional criteria (apply to DTC treatment scenarios):

Initial approval criteria

Age: Member is 18 years or older
Pregnancy testing: If of childbearing age, negative pregnancy test prior to treatment
Breastfeeding: If lactating or breastfeeding, discontinue breastfeeding at least 6 weeks prior to administration
Low-iodide diet: Member has adhered to a low-iodide diet for at least two weeks prior to therapy

Coverage is limited to a single administration of Hicon® (sodium iodide I-131). Per policy, coverage will be provided for one administration of Hicon® and cannot be renewed. Providers should plan treatment accordingly and document that the requested administration is the one-time therapeutic dose.

Use of Hicon® outside the policy’s specified indications, dosing limits, or without meeting the required preparatory and safety conditions is not covered. This includes doses exceeding the stated per-administration limits (hyperthyroidism up to 10 billable units (370 mBq; 10 mCi) and differentiated thyroid carcinoma up to 200 billable units (7400 mBq; 200 mCi)), treatment for diagnoses other than the listed indications, or administration when required steps have not been completed.

Required preparatory and safety conditions include ruling out other causes of hyperthyroidism, adherence to a low-iodide diet for at least two weeks, discontinuation of anti-thyroid medications at least three days prior, discontinuation of breastfeeding, and a negative pregnancy test for females of childbearing potential. Failure to meet these criteria may result in non-coverage.

Dosing Units, Age Limits, and Codes

Hyperthyroidism dosing unitsmixedCovered

billable units up to 10

370 mBq; 10 mCi per administration for hyperthyroidism

Differentiated thyroid carcinoma dosing unitsmixedCovered

billable units up to 200

7400 mBq; 200 mCi per administration for differentiated thyroid carcinoma

Minimum age for certain DTC criteria

Minimum ageMember is 18 years or older

ApplicabilityApplies to initial approval criteria for treatment of locoregional, metastatic, or recurrent differentiated thyroid carcinoma (DTC)

Related requirementsNegative pregnancy test if of childbearing potential; discontinue breastfeeding ≥6 weeks prior to administration

Provider Actions, Documentation, and Billing Notes

Prior Authorization

No pre-authorization required

Pre-authorization is not required for Hicon® (sodium iodide I-131) per this policy.

Step Therapy

Step therapy — failure/intolerance to anti-thyroid meds

For hyperthyroidism due to Graves' disease, the member must have failed anti-thyroid medication therapy or have documented intolerance or a contraindication to those medications before Hicon is covered.

Applies to confirmed Graves' disease presenting as the cause of hyperthyroidism
This requirement is part of the hyperthyroidism indication bundle (coverage up to 10 billable units per administration)

Background

Sodium iodide I-131 is a radioactive isotope of iodine that, when administered orally in a single dose (liquid or capsule), is absorbed in the gastrointestinal tract, concentrated by the thyroid gland, and destroys thyroid cells through radiation. It is commonly used to treat hyperthyroidism (most frequently for Graves’ disease, toxic multinodular goiter, or toxic adenoma) and as adjunctive therapy for differentiated thyroid carcinoma (papillary or follicular).

Most patients develop hypothyroidism within months after radioactive iodine ablation and require thyroid hormone replacement. Standard preparatory steps before administration include a low-iodide diet for at least two weeks, stopping anti-thyroid drugs three days prior, discontinuing breastfeeding, and ensuring a negative pregnancy test for women of childbearing potential. These measures optimize radioiodine uptake and reduce risks to the patient and others.

Definitions

Hicon® (Sodium Iodide I-131) — Agent definition and indications

AgentHicon® (Sodium Iodide I-131)

ClassRadioactive therapeutic agent (I-131)

IndicationsTreatment of hyperthyroidism and selected cases of carcinoma of the thyroid

Administration limitPolicy provides coverage for one (1) administration only

Hyperthyroidism — Definition of the condition

DefinitionHyperthyroidism (overactive thyroid): occurs when the thyroid gland produces too much of the hormone thyroxine

Common effects

Policy Summary

PayerIndependent Health

PolicyHicon® (Sodium Iodide I-131) therapy coverage

Policy CodePolicy M20200508035

Change TypeNo material change

Effective DateJul 1, 2020

Last ReviewJun 1, 2026

Next Review Date

SourceLink

On This Page

Anti-thyroid meds: Discontinue all anti-thyroid medication for at least three days prior to therapy (examples: methimazole, propylthiouracil, triiodothyronine, thyroxine)

Contraception counseling: Members with reproductive potential counseled to use effective contraception during treatment and for at least six months after last dose

GI symptoms: Member is not currently experiencing vomiting and/or diarrhea

Documentation Required

Required clinical documentation and preparatory steps

Clinical documentation must confirm the diagnosis and relevant preparatory and safety steps were completed prior to administration.

Diagnosis: Graves' disease, toxic nodular/multinodular goiter, toxic adenoma, or papillary/follicular thyroid carcinoma
Prior treatments and failures or documented contraindications to anti-thyroid medications when applicable
Pregnancy test result if of childbearing potential (must be negative prior to treatment)
Adherence to a low-iodide diet for at least two weeks prior to therapy
Discontinuation of all anti-thyroid medications for at least three days prior to therapy
Counseling on effective contraception for members with reproductive potential (during treatment and for at least six months after last dose)
If lactating, documentation that breastfeeding was discontinued at least 6 weeks prior to administration
Document absence of current vomiting and/or diarrhea

Denial Risk

Denial risk triggers — single administration and unmet preparatory/clinical conditions

Coverage is limited to a single administration and will be denied if required clinical or preparatory conditions are not met.

Only one administration of Hicon® is covered; the policy explicitly states it cannot be renewed
Denial risk if other causes of hyperthyroidism have not been ruled out (e.g., thyroid malignancy, TSH‑secreting pituitary tumors)
Denial risk for failure to obtain a negative pregnancy test when required, for incomplete low-iodide diet adherence, failure to stop anti-thyroid meds, ongoing breastfeeding without required discontinuation, or presence of vomiting/diarrhea at time of therapy

Increased metabolism, unintentional weight loss, and arrhythmias

Clinical relevanceIndication for radioiodine (I-131) therapy such as Hicon® when consistent with coverage criteria