CurrentCignaPolicy IP0299

IP0299_Ursodiol_Coverage_Policy

Defines medical necessity criteria, authorization duration, and reauthorization requirements for ursodiol capsules (Reltone and generic ursodiol 200 mg/400 mg capsules) including required failure/intolerance to ursodiol tablets prior to coverage.

Policy Summary

PayerCigna

PolicyIP0299_Ursodiol_Coverage_Policy

Policy CodePolicy IP0299

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must document failure, contraindication, or intolerance to ONE of the listed generic ursodiol tablet products (ursodiol 250 mg tablet or ursodiol 500 mg tablet) for initial coverage of ursodiol capsules.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes.

2Required prior products to fail/contraindicated/intolerant to

12 monthsInitial authorization duration

12 monthsReauthorization duration

Coverage Summary

This policy covers with criteria ursodiol capsules (Reltone and generic ursodiol 200 mg/400 mg capsules) and defines medical necessity requirements, authorization duration, and reauthorization rules. The policy supports medical necessity review for Reltone (ursodiol) 200 mg or 400 mg capsules and generic ursodiol 200 mg or 400 mg capsules, requiring documentation of failure, contraindication, or intolerance to listed ursodiol tablet products for initial coverage and documentation of beneficial response for continuation. Ursodiol is indicated for treatment of radiolucent, noncalcified gallbladder stones <20 mm in patients who are poor surgical candidates or refuse surgery and for prevention of gallstone formation in obese patients with rapid weight loss.

Initial Therapy / Medical Necessity Criteria

Initial Therapy / Medical Necessity

Covered when ALL of the following are met:

ALL of the following

Request is for Reltone (ursodiol) 200 mg or 400 mg capsules or generic ursodiol 200 mg or 400 mg capsules
ALL of the following
- ONE of
  - (generic) ursodiol 250 mg tablet
  - (generic) ursodiol 500 mg tablet

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Reauthorization / Continuation Therapy Criteria

Reauthorization / Continuation Therapy

Continuation is covered when ALL of the following are met:

ALL of the following

Original medical necessity criteria are met (as above)
There is documentation of beneficial response to ursodiol capsules
Beneficial response = Clinical evidence or documentation by provider indicating the patient is deriving therapeutic benefit from ursodiol therapy (as required for reauthorization).

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Provider Actions & Authorization Rules

Prior Authorization

Documentation of prior failure/contraindication/intolerance required

Providers must document failure, contraindication, or intolerance to ONE of the listed generic ursodiol tablet products (ursodiol 250 mg tablet or ursodiol 500 mg tablet) for initial coverage of ursodiol capsules.

ursodiol 250 mg tablet
ursodiol 500 mg tablet

Prior Authorization

Reauthorization documentation

For reauthorization, providers must document beneficial response to ursodiol capsules to continue coverage.

Documentation Required

Samples not acceptable

Receipt of sample product does not satisfy any criteria requirements for coverage.

Billing Rule

Authorization duration

Initial and reauthorization approval durations are up to 12 months.

Clinical Evidence

Evidence/citation: Reltone (ursodiol) prescribing information; Intra-Sana Laboratories LLC; November 2022.

Policy background: Ursodiol (ursodesoxycholic acid) is indicated for radiolucent, noncalcified gallbladder stones <20 mm in patients who are poor surgical candidates or refuse surgery and for prevention of gallstone formation in obese patients experiencing rapid weight loss.

Policy scope: The policy supports medical necessity review for Reltone (ursodiol 200 mg, 400 mg capsules) and generic ursodiol 200 mg, 400 mg capsules and requires documentation of failure, contraindication, or intolerance to one of the listed ursodiol tablet products for initial coverage; reauthorization requires documentation of beneficial response.

Definitions

Defined term — Beneficial responseClinical evidence or documentation by provider indicating the patient is deriving therapeutic benefit from ursodiol therapy (as required for reauthorization).

Background

Ursodiol (ursodesoxycholic acid) is a naturally occurring bile acid found in small quantities in human bile. It is indicated to dissolve radiolucent, noncalcified gallbladder stones <20 mm in greatest diameter in patients who are poor surgical candidates or who refuse surgery, and to prevent gallstone formation in obese patients with rapid weight loss.

The policy specifically lists coverage and medical necessity review for capsule products including Reltone (ursodiol 200 mg, 400 mg capsules) and generic ursodiol 200 mg, 400 mg capsules. For initial therapy, the policy requires documentation of failure, contraindication, or intolerance to ONE of the following ursodiol tablet products: generic ursodiol 250 mg tablet or generic ursodiol 500 mg tablet.

Continuation (reauthorization) is considered medically necessary when the original medical necessity criteria are met and there is documentation of a beneficial response to ursodiol capsules; initial and reauthorization approval durations are up to 12 months.