CurrentCignaPolicy N/A

Growth Hormone (somatropin) prior authorization — coverage criteria and form requirements

Cigna prior authorization form and requirements for prescription of somatropin products for pediatric and adult indications; governs providers requesting coverage through Cigna and affects prescribing clinicians and pharmacies processing PA for Cigna members.

Policy Summary

PayerCigna

PolicyGrowth Hormone (somatropin) prior authorization — coverage criteria and form requirements

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the Cigna growth hormone prior authorization form with required documentation (stim test results, BMI when applicable, prior product trial records, diagnosis, and prescriber attestation).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7named products listed

2age groups

2stimulation thresholds ref

1NDC required

Coverage Criteria for Somatropin (Growth Hormone)

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Illustrative condition-specific documentation and test criteria (form-based)

Coverage requires submission of indication-specific diagnostic and objective data. Examples of condition-specific requirements follow (as presented on the form):

Pediatric indications listed: Form lists multiple pediatric indications (GHD, Turner, Noonan, Prader-Willi, SGA/IUGR including Silver-Russell Syndrome, Short Stature Homeobox deficiency, Idiopathic Short Stature, CKD, corticosteroid-induced short stature, congenital adrenal hyperplasia, HIV-related lipodystrophy, and others). Provider must select the applicable diagnosis on the form and attach supportive documentation.

See chunks 6 and 9

Pediatric GHD with defined CNS pathology or tumor resection: If patient has defined CNS pathology or has undergone tumor resection: document either deficiency in at least one other pituitary hormone OR confirm GH deficiency by stimulation testing. If stimulation testing is provided, include stimulus agent, test dates, and numeric results. The form defines a positive stim test as peak GH <10 ng/mL.GH peak <10 ng/mL

See chunks 9-11

Pediatric GHD without other pituitary hormone deficiency: If no other pituitary hormone deficiency is present, provide documentation that GHD was confirmed by stimulation testing. If confirmed, submit two stimulation test reports (agent, dates, results). Approval requires two stimulation test results each showing peak GH <10 ng/mL.Two stim tests with peak <10 ng/mL

See chunks 10-12

Pediatric GHD — additional evaluation items: For patients without perinatal insults or congenital/genetic defects, submit pretreatment IGF‑1 with date and lab reference range; report whether IGF‑1 is below lab-specific lower limit and document exclusion of other causes of low IGF‑1 (malnutrition, uncontrolled diabetes, hypothyroidism, hepatic insufficiency, oral estrogen).IGF‑1 below lab reference range when applicable

See chunk 11

Noonan syndrome or Short Stature Homeobox (SHOX) deficiency: Requires documentation of open epiphyses, pretreatment height and growth velocity, and meeting specified pretreatment growth thresholds (examples include baseline height <5th percentile, one‑year velocity >2 SD below mean, or sustained 1.5 SD below mean over two years). Medication should be prescribed by or in consultation with an endocrinologist for listed diagnoses.varies by selection (see form)

See chunks 13 and 9

SGA/IUGR (including Silver‑Russell Syndrome): Provide birth weight and length, heights at ages 2–4 (or indicate <2 years), and document either birth weight or length ≤ -2 SD for gestational age OR baseline height <5th percentile for age/gender. Include endocrinology consultation when indicated.birth weight/length ≤ -2 SD OR baseline height <5th percentile

See chunk 9

Idiopathic Short Stature (Non‑GHD) in pediatric patients: Require assessment for constitutional delay of growth and puberty, confirmation of open epiphyses, predicted adult height thresholds (males <160 cm; females <150 cm), baseline height ≤1.2 percentile or SDS ≤ -2.25, and documented growth velocity data (examples: <4 cm/year or <10th percentile). Prescriber should be endocrinologist or consult an endocrinologist.predicted adult height and SDS criteria as specified

See chunk 13

Pediatric CKD‑related short stature: Requires documentation of renal function and CKD stage, endocrinology or nephrology involvement, pretreatment height and growth velocity, and meeting the pre‑treatment height/velocity thresholds described on the form (for example baseline height <5th percentile or specified velocity criteria).GFR <60 mL/min/1.73 m2 or CKD stage ≥2 (as applicable)

See chunk 6

Continuation of pediatric therapy: If request is for continuation, attach evidence of clinical benefit: increase in height of at least 2 cm in the most recent year (or other form‑specified benefit metrics) and supporting chart documentation.≥2 cm/year height increase for continuation

See chunk 6

Adult Somatropin Coverage Criteria

Covered when ALL of the following are met

Adult GHD diagnostic criteria and attestations: 1) Patient is age 18 years or older; 2) Demonstrated GH deficiency on standard stimulation testing: peak GH <5 ng/mL by polyclonal antibody (RIA) OR peak GH <2.5 ng/mL by monoclonal antibody (IRMA) to a standard GH stimulation test (insulin, levodopa, clonidine, arginine, or glucagon); 3) If standard RIA/IRMA testing was not diagnostic and macimorelin was used, macimorelin testing must show maximum serum GH <2.8 ng/mL across the 4 blood draws; 4) If macimorelin was used, patient BMI must be ≤40 kg/m2; 5) For GHD of defined etiology or Prader‑Willi Syndrome, therapy is prescribed by or in consultation with an endocrinologist; 6) Prescriber documents diagnosis on the form and signs the certification attesting that somatropin is not being prescribed for anti‑aging, cosmetic, or athletic performance enhancement and that the medication is medically necessary.RIA <5 ng/mL; IRMA <2.5 ng/mL; macimorelin <2.8 ng/mL; BMI ≤40 kg/m2

See chunks 18-19

Testing Thresholds, BMI, and Billing Codes

NDC requirementNDC

NDC	NDC number required on medical claims to confirm claim is payable for the drug Genotropin

inv-08: GH stimulation test response thresholds — adults RIA/IRMA and macimorelin details

Adult RIA thresholdPeak GH < 5 ng/mL when measured by polyclonal antibody (RIA)

Adult IRMA thresholdPeak GH < 2.5 ng/mL when measured by monoclonal antibody (IRMA)

Macimorelin testingMaximum serum GH < 2.8 ng/mL across the 4 blood draws (macimorelin stimulation)

Macimorelin BMI considerationWhen macimorelin peak GH <2.8 ng/mL, document patient BMI ≤ 40 kg/m2

inv-09: Pediatric growth response / criteria — examples for continuation and initiation criteria

Continuation growth responseFor continuation, document beneficial response and height increase ≥2 cm/year in the most recent year

Pediatric stim-test confirmationGHD confirmation by two stimulation tests with peak GH < 10 ng/mL each (provide stimulus, dates, and results)

Pre‑treatment height/velocity criteriaExamples for initiation include baseline height ≤2 SD below mean, 1‑year height velocity >2 SD below mean, or sustained velocity ≥1.5 SD below mean over two years

inv-10: GH stimulation test cutoffs — RIA, IRMA, macimorelin numeric cutoffs

RIA numeric cutoffPeak GH < 5 ng/mL (polyclonal RIA)

IRMA numeric cutoffPeak GH < 2.5 ng/mL (monoclonal IRMA)

Macimorelin numeric cutoffMaximum serum GH < 2.8 ng/mL across 4 blood draws (macimorelin)

inv-11: BMI — BMI ≤ 40 kg/m2 consideration for testing/eligibility

BMI threshold for macimorelinDocument BMI ≤ 40 kg/m2 when macimorelin stimulation is used and peak GH < 2.8 ng/mL

Adult assessmentBMI query appears only after macimorelin result is <2.8 ng/mL (checks eligibility), not applied to RIA/IRMA cutoffs

Form instruction contextQuestion asks: 'Does the patient have a body mass index (BMI) of less than or equal to 40 kg/m2?' following macimorelin result

Provider Requirements, Documentation, and Risks

Prior Authorization

Prior authorization form completion and submission

Complete and submit Cigna's Growth Hormone prior authorization form with all required patient and provider details. The form must include patient identifiers (Cigna ID, DOB, address), prescriber information (DEA, NPI or TIN, specialty), medication requested and dosing, and where the medication will be obtained. Incomplete or missing form fields can delay review.

Patient identifiers (Cigna ID, DOB, address) must be completed.
Prescriber identifiers (DEA, NPI or TIN, specialty) required.
Specify medication, strength, dose, frequency, and source (specialty pharmacy, retail, office stock, etc.).

Prior Authorization

Prior authorization questionnaire and prescriber attestation

Answer and attach the appropriate prior authorization questionnaire for pediatric or adult patients. For adults, include stimulation test results (RIA/IRMA or macimorelin results), BMI when applicable, and documentation of prior benefit or response for continuation requests. The attestation section must be completed and signed by the prescriber.

Adult questionnaire: include growth hormone stimulation test results (RIA <5 ng/mL or IRMA <2.5 ng/mL), or macimorelin max <2.8 ng/mL when performed, and BMI ≤40 kg/m2 if applicable.
Continuation requests: attach documentation of beneficial response (chart notes, claims, receipts).
Complete prescriber attestation and signature certifying accuracy.

Step Therapy

Preferred-product trial requirement

The PA form asks whether the patient has tried BOTH Genotropin and Omnitrope and requires supporting documentation when indicated. If you indicate prior trial(s), attach medical records or prescription evidence. If claiming inability to use both products due to formulation differences, include documentation explaining the allergy or serious adverse reaction risk.

Question asks: Has patient tried BOTH Genotropin and Omnitrope? Answer required.
If yes, attach documentation such as chart notes, prescription claims, or receipts.
If unable to use both due to inactive ingredient differences, provide specific clinical documentation.

Denial Risk

Illicit use / non‑FDA purpose and dispensing risk

Human growth hormone is FDA-approved only for specified indications. Federal law prohibits dispensing GH for anti-aging, longevity, cosmetic, or performance enhancement purposes. Pharmacies may refuse to dispense if they believe the prescription is for non‑FDA uses, and failure to comply with law carries criminal penalties. Prescribers must document diagnoses and complete the certification that the drug is not prescribed for anti‑aging, cosmetic, or athletic performance.

Physician must document the diagnosis on the form and sign the prescriber certification.
Pharmacies may decline to dispense GH for suspected non‑approved uses (anti‑aging, cosmetic, performance enhancement).
Federal law prohibits dispensing GH for non‑approved purposes and noncompliance can result in criminal penalties.

Documentation Required

Required supporting documentation

Attach all required supporting documentation to avoid denial. Acceptable documentation includes chart notes, lab and test results, stimulation test reports, prescription claims records, prescription receipts, genetic testing (when requested), and other relevant medical records. Requests lacking documentation to verify prior therapy, indication, or response may be denied.

Attach chart notes, lab/test results, and stimulation test reports.
Include prescription claims records or receipts to document prior product trials or continued benefit.
Provide genetic testing results when diagnosis (e.g., Prader‑Willi or Turner) requires confirmation.

Documentation Required

Prescriber attestation and diagnosis documentation

Prescriber must document the patient diagnosis on the form and sign required attestations. The form includes a prescriber certification that the medication is not being prescribed for anti‑aging, cosmetic, or athletic performance and an attestation that the information provided is true and accurate; both must be signed and dated.

Document the diagnosis in the space provided on the form.
Prescriber Certification: sign to confirm medication is not for anti‑aging, cosmetic, or athletic purposes.
Attestation: prescriber signature and date acknowledging accuracy and consent to potential audits.

Billing Rule

NDC required on claims

Include the NDC on medical claims for Genotropin to confirm payment. The NDC is on the drug packaging; providers may reference Cigna's Crosswalk of HCPCS Codes Requiring NDC on Claims on the Cigna for Health Care Professionals website for guidance.

NDC number is required on medical claims for Genotropin.
Refer to Cigna's crosswalk of HCPCS codes requiring NDC on the Cigna for HCP website for additional billing guidance.

Test Thresholds and BMI Definitions

inv-23: GH stimulation test thresholds — adult thresholds by assay and macimorelin specifics

Adult RIA threshold (definitions)GH peak <5 ng/mL by polyclonal RIA

Adult IRMA threshold (definitions)GH peak <2.5 ng/mL by monoclonal IRMA

Macimorelin specificsMacimorelin considered if RIA/IRMA not diagnostic; max GH <2.8 ng/mL across 4 draws; BMI ≤40 kg/m2 is queried

inv-24: Growth hormone stimulation test thresholds (duplicate phrasing) — numeric cutoffs for RIA/IRMA and macimorelin

RIA cutoffPeak GH < 5 ng/mL (polyclonal antibody, RIA)

IRMA cutoffPeak GH < 2.5 ng/mL (monoclonal antibody, IRMA)

Macimorelin cutoffMaximum serum GH < 2.8 ng/mL for the 4 blood draws when macimorelin used

inv-25: BMI consideration — macimorelin threshold context with BMI ≤40 kg/m2

Macimorelin BMI contextAfter macimorelin shows max GH <2.8 ng/mL, the form asks whether patient BMI is ≤ 40 kg/m2 to assess eligibility

BMI applicabilityBMI requirement is specific to macimorelin testing pathway and not tied to RIA/IRMA cutoffs

DocumentationForm question: 'Does the patient have a body mass index (BMI) of less than or equal to 40 kg/m2?' must be answered when macimorelin result meets cutoff

OpenPayer

Growth Hormone (somatropin) prior authorization — coverage criteria and form requirements

Coverage Criteria for Somatropin (Growth Hormone)

Testing Thresholds, BMI, and Billing Codes

Provider Requirements, Documentation, and Risks

Background on Somatropin Use

Test Thresholds and BMI Definitions