CurrentColorado Rocky Mountain Health PlansPolicy N/A

Growth Hormone Therapy Prior Authorization Form Coverage Criteria

This document is a prior authorization / beneficiary request form used by Colorado Rocky Mountain Health Plans for evaluating coverage of growth hormone (GH) products (including Zorbitive and Increlex) for qualifying patients; it affects prescribing providers and beneficiaries requesting GH therapy coverage.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGrowth Hormone Therapy Prior Authorization Form Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization form with required clinical data including diagnosis, drug details, IGF-1/IGFBP-3 and stimulation test results, growth metrics, epiphyseal status, and prescriber signature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5document chunks provided

2drug-specific callouts

Authorization and Medical Necessity Criteria

Authorization / medical necessity criteria

Coverage consideration requires documentation that ALL of the following relevant items are provided and met, as applicable to the diagnosis and product:

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGrowth Hormone Therapy Prior Authorization Form Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Main documentation and diagnostic criteria: Completed beneficiary and prescriber information; drug name/strength/quantity/length; diagnosis; prescriber signature

Required for all requests

Acceptable indications/history items (any): History items include Turner syndrome; Prader-Willi syndrome; craniopharyngioma in the last 2 years; panhypopituitarism or cranial irradiation in the last 2 years; MRI evidence of hypopituitarism; hypopituitarism; chronic renal insufficiency in the last 2 years; SGA with IUGR; history of growth hormone deficiency (GHD) in the last 2 years; other documented relevant history.

At least one relevant indication/history item should be selected where applicable

Growth and laboratory criteria: Documented growth metrics and testing: height and percentile, height velocity (including if <25th percentile for bone age), bone age, IGF-1 and IGFBP-3 levels with results, and GH stimulation testing (agents used and peak ng/ml) where applicable.

Required to support diagnosis of GHD or other growth indications

Anthropometric and velocity thresholds (when applicable): Patient's height < 3rd percentile for chronological age OR birth weight/length >2 SD below mean for gestational age with no catch-up by age 2 OR unexplained short stature with height >2.25 SD below mean and bone age >2 SD below mean; height velocity <25th percentile for bone age.

Apply these thresholds when relevant to the indication

Product-specific requirements: For Zorbitive: documentation of short bowel syndrome in the last 2 years. For Increlex: documentation of GH resistance (e.g., GH receptor or post-receptor pathway mutation), IGF-1 gene defects, prior GH product exposure with neutralizing antibodies, or severe short stature with IGF-1 criteria (height <3 SD and IGF-1 <3 SD) and normal/elevated GH levels.

Complete product-specific fields as applicable

Step therapy for non-preferred drugs: If the requested drug is non-preferred, document failure of two preferred drugs or provide a reason the patient cannot try two preferred drugs.

Failure documentation required for non-preferred agents

Epiphyseal status: Document whether the epiphysis is open (required if patient > 9 years old).

Required to determine appropriateness of growth-promoting therapy

The form does not list any explicit exclusions. There is no separate section labeled “Exclusions” or checked boxes that identify conditions automatically excluded from coverage on the prior authorization form.

The form does not specify explicit "not medically necessary" scenarios. Operationally, this means requests are evaluated against the form’s documentation and criteria: absence of required information or failure to meet the documented clinical criteria (for example missing IGF‑1/IGFBP‑3 results, stimulation test data, growth metrics, or indication selection) may lead to denial rather than a predefined written list of not‑medically‑necessary conditions.

Clinical Thresholds and Measurements

Height percentile / SDS thresholds

Height percentilePatient's height < 3rd percentile for chronological age

Standard deviation (short stature)Height > 2.25 standard deviations below mean for age (unexplained short stature criteria)

Birth metricsBirth weight and/or length > 2 SD below mean for gestational age with no catch-up by age 2

Severe short stature for IncrelexPatient height < 3 SD below mean with IGF-1 level < 3 SD below mean (Increlex-specific)

Height velocity

Height velocity thresholdHeight velocity < 25th percentile for bone age

Documentation fieldForm requests recording of Height Velocity value and marking if < 25th percentile for bone age

Relation to bone ageVelocity assessed relative to bone age rather than chronological age

What Providers Must Submit

Prior Authorization

Prior authorization form completion — required fields

Prior authorization requests must be submitted using the payer's Prior Authorization form and include all required fields. Incomplete forms or missing required fields may delay processing or result in denial.

Include beneficiary demographics: full name, beneficiary ID, date of birth, and gender.
Include prescriber details: prescribing provider name, NPI, requester contact name, phone number and extension.
Complete drug information: drug name, strength, quantity per 30 days, and requested length of therapy (select duration).
Provider signature and date are required on the form.

Step Therapy

Step therapy / preferred drug trials

For non-preferred drugs, the request must document prior step therapy trials or provide a clinical rationale why trials are not appropriate.

Document failure of two preferred drugs: list the preferred agents, dates of therapy, and reason for failure (inefficacy, intolerance, adverse event).
If trials are not appropriate, provide specific medical reasons why the patient cannot try preferred alternatives (e.g., contraindication, allergy, prior adverse reaction).
For biologics or specialty agents, include any prior authorization/coverage determinations for the preferred drugs attempted.

Documentation Required

Required documentation

Providers must submit supporting clinical documentation along with the prior authorization form to demonstrate medical necessity.

Relevant diagnostic information and clinical history (diagnosis, onset, and previous therapies).
Objective data as applicable: lab results (e.g., IGF-1, IGFBP-3), stimulation testing results (agents used, peak values), imaging reports (MRI) and growth/height velocity metrics.
Current treatment status and growth rate over the prior year; if previously treated, include dates and response.
For product-specific indications (e.g., Zorbitive, Increlex), include condition-specific documentation such as history of short bowel syndrome or GH receptor mutation testing.

Denial Risk

Potential denial triggers

Common denial triggers — ensure these areas are completed and supported to avoid denials.

Failure to document prior preferred drug trials or to provide a valid medical reason for not attempting them.
Missing diagnostic or stimulation testing results (e.g., absent IGF-1/IGFBP-3 levels, missing peak GH from stimulation testing).
Incomplete prescriber or beneficiary demographics, or missing prescriber signature/date on the form.
Lack of objective growth data or other condition-specific documentation required for the requested therapy.

Biomarkers and Clinical Status Definitions

IGF-1 / IGFBP-3

IGF-1Insulin-like Growth Factor-1 (serum biomarker); low levels are used as part of the clinical assessment for growth hormone deficiency and indications for IGF-1 therapy

IGFBP-3Insulin-like Growth Factor Binding Protein-3 (serum biomarker) that modulates IGF-1 availability; measured alongside IGF-1 to support diagnosis

Clinical roleLow IGF-1 and IGFBP-3 levels are requested on the form to support diagnosis of GHD, GH resistance, or criteria for products like Increlex

Epiphyseal status

Epiphyseal status requirementForm asks whether epiphysis (growth plate) is open for patients > 9 years old; documentation is required

Yes/No recordingThe form provides a checkbox to indicate whether the epiphysis is open (Yes/No)

PurposeOpen growth plates must be documented for older children to determine appropriateness of growth‑promoting therapy

Policy Background and Purpose

This prior authorization form collects the clinical data used to assess indications for growth hormone and related therapies across pediatric and certain adult presentations. It requires the requester to supply diagnosis, relevant history (for example Turner syndrome, Prader‑Willi, craniopharyngioma, panhypopituitarism, chronic renal insufficiency, SGA/IUGR, or prior growth hormone deficiency), growth metrics (height, percentile, height velocity and bone age), laboratory results (including IGF‑1 and IGFBP‑3 levels), and GH stimulation testing (agents and peak ng/ml where applicable). The form also captures product‑specific items (e.g., short bowel syndrome for Zorbitive) and asks about epiphyseal status for patients older than 9 years to determine appropriateness of growth‑promoting therapy.