DraftUnitedHealthcarePolicy N/A

Teduglutide (Gattex) prior authorization — short bowel syndrome

Forms and criteria governing prior authorization and reauthorization requests for teduglutide (Gattex) for beneficiaries with short bowel syndrome receiving parenteral nutrition; intended for providers submitting authorization requests to UnitedHealthcare.

Policy Summary

PayerUnitedHealthcare

PolicyTeduglutide (Gattex) prior authorization — short bowel syndrome

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form including beneficiary identifiers, prescriber NPI, drug details, documentation of SBS diagnosis and PN dependence (>=12 months for initial; ongoing PN for reauthorization), plus prescriber signature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

initial & reauthorizationrequest types present on form

age/diagnosis/PN durationminimum data elements

length selectionstherapy duration options

NPI requiredprescriber info

Coverage Criteria

inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Therapy: 1) Beneficiary meets the required minimum age as indicated on the form (provider answered 'Yes' to 'Is the beneficiary age or older?'); 2) Beneficiary has a diagnosis of short bowel syndrome (SBS) (provider answered 'Yes'); 3) Beneficiary has been dependent on parenteral nutrition for at least 12 months (provider answered 'Yes' to PN dependence); 4) Prescriber completes required beneficiary and drug information on the form and signs the attestation.>= 12 months

Fields and checkboxes on the form must be completed and prescriber attestation provided.

inv-02: Continuation/Reauthorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Continuation/Reauthorization: 1) Beneficiary is continuing to receive parenteral nutrition while taking Gattex (provider answered 'Yes'); 2) Prescriber confirms ongoing therapy details and provides signature and date on the form.

Policy Summary

PayerUnitedHealthcare

PolicyTeduglutide (Gattex) prior authorization — short bowel syndrome

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Prescriber signature is mandatory for reauthorization.

No explicit exclusion conditions are listed on the prior authorization form for teduglutide (Gattex). The form’s coverage sections present required affirmative clinical criteria for initial and reauthorization requests but do not enumerate specific diagnoses, comorbidities, or other circumstances that would be stated as exclusions.

The form does not list discrete "not medically necessary" scenarios, but approval is contingent on submission of required clinical details. Failure to document key items — for initial requests: beneficiary age, a diagnosis of short bowel syndrome (SBS), and confirmation of dependence on parenteral nutrition for at least 12 months; and for reauthorization: confirmation that the beneficiary is continuing to receive parenteral nutrition while on Gattex — creates an implicit risk of denial because the form requires those responses to determine eligibility.

Initial Therapy

inv-13: Initial Therapy — Initial authorization questions

Initial authorization questions

Initial Therapy - Authorization Questions: Provider must answer: (1) Is the beneficiary age or older? (Yes/No); (2) Does the beneficiary have a diagnosis of short bowel syndrome (SBS)? (Yes/No); (3) Has the beneficiary been dependent on parenteral nutrition for at least 12 months? (Yes/No); (4) Complete required beneficiary and drug information and obtain prescriber attestation/signature.>= 12 months

All items must be documented on the initial authorization form.

Continuation / Reauthorization

inv-14: Reauthorization — Reauthorization checks

Reauthorization checks

Reauthorization - Verification Checks: Provider must confirm: (1) Is the beneficiary continuing to receive parenteral nutrition while taking Gattex? (Yes/No); (2) Prescriber must sign and date the form certifying the accuracy and completeness of the information.

Prescriber signature is mandatory for reauthorization and required for processing.

Provider Actions & Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required using the benefit-specific prior authorization form. The form must capture beneficiary, prescriber, and drug information and indicate whether this is an initial authorization or a reauthorization request.

Use the payer's prior authorization form that includes beneficiary name, ID, date of birth, and gender
Include prescriber name and NPI, requester contact name and phone
Provide drug name, strength, quantity per 30 days, and requested length of therapy
Indicate whether the request is Initial or Reauthorization

Step Therapy

No step therapy requirements are specified on this form.

Documentation Required

Required Form Fields and Clinical Documentation

The form must include required clinical fields and documentation to support medical necessity: beneficiary demographics, prescriber details, medication details, and clinical evidence addressing diagnosis and PN dependence. Failure to include required clinical details may result in denial or incomplete review.

Beneficiary: last name, first name, beneficiary ID, date of birth, gender
Prescriber: provider NPI, requester contact name and phone
Drug: name, strength, quantity per 30 days, length of therapy
Clinical evidence: documentation of age, diagnosis of short bowel syndrome (SBS), and duration of parenteral nutrition dependence

Denial Risk

Missing Required Clinical Details

Missing required clinical details — such as beneficiary age, a documented SBS diagnosis, or documentation that the beneficiary has been dependent on parenteral nutrition for >= 12 months — may lead to denial or an incomplete review.

Denial Risk

Missing Reauthorization Documentation

For reauthorization requests, the form must document that the beneficiary continues to receive parenteral nutrition while receiving therapy (e.g., Gattex). Absence of this documentation may lead to denial.

Coding & Key Clinical Fields

Parenteral nutrition duration — minimum

Minimum PN duration for initial authorization>= 12 months (form asks: 'Has the beneficiary been dependent on parenteral nutrition for at least 12 months?')

Context of requirementRequired for initial authorization of teduglutide for SBS as documented on the form

Consequence of missing documentationFailure to document PN dependence >= 12 months may trigger denial of an initial authorization request

Quantity & Therapy Duration

Gattex (teduglutide) — quantity

Quantity per 30 daysUser-entered on form (Drug Information field: 'Quantity Per 30 Days')

Associated fieldsDrug name and strength are collected alongside quantity per 30 days on the drug information section of the form

Use in authorizationProvider must specify the monthly quantity when submitting prior authorization for Gattex (teduglutide)

Gattex (teduglutide) — length of therapy

Length of therapy optionsSelectable on form: up to 30, 60, 90, 120, or 365 days

Field locationCaptured in Drug Information as 'Length of Therapy (in days)'

PurposeUsed to indicate planned duration of a course when requesting initial authorization or reauthorization

Definitions

Parenteral nutrition dependence — definition

DefinitionProvider-confirmed reliance on parenteral nutrition (PN) to maintain nutrition; form asks whether the beneficiary has been dependent on PN for at least 12 months

Form question'Has the beneficiary been dependent on parenteral nutrition for at least 12 months?' (Yes/No)

Role in authorizationRequired documentation for initial authorization of teduglutide for short bowel syndrome

Background

Teduglutide (Gattex) is indicated on the form for use in adult patients with short bowel syndrome (SBS) who require parenteral support. The prior authorization form captures the clinical elements used to establish coverage: for initial authorization it asks whether the beneficiary meets the minimum age requirement, has a diagnosis of SBS, and has been dependent on parenteral nutrition for at least 12 months; for reauthorization it asks whether the beneficiary is continuing to receive parenteral nutrition while taking Gattex and requires the prescriber’s signature and date to attest to the information provided.