Medical Necessity Letter (Growth Hormone Therapy)

From: [Clinician name], [Credentials]; [Specialty]; [Practice/Institution name]; [Address]; Phone: [Phone]; Fax: [Fax]; NPI: [NPI]

Date: [Date]

To: [Health plan name], [Prior Authorization / Appeals Department], Attn: [Medical Director name]; [Fax/Address]

Re: [Patient full name], DOB: [DOB], Member ID: [Member ID], [Prior authorization or claim reference number]; Request Type: [Prior Authorization Request / Appeal of Denial]; Medication: Somatropin ([Brand name]) via [Route], Requested Duration: [Duration]
(For appeals, include: Denial Ref#: [Denial number], Denial Date: [Denial date])

Executive Summary

[Explicit request statement for approval or continuation of GH product and regimen] for [Primary indication: pediatric GH deficiency / Turner syndrome / small for gestational age without catch-up / Prader-Willi syndrome / idiopathic short stature / chronic kidney disease-related growth failure / adult GH deficiency]. Objective data demonstrate [Brief summary: height SDS/percentile, pre-treatment or on-treatment growth velocity, GH stimulation test peak with threshold if performed, epiphyseal status], and alternative causes for impaired growth have been evaluated and addressed. [For continuation requests: brief response summary documenting benefit and rationale for ongoing therapy.]

(For appeals, include the following denial response section)

• Denial reason 1: [Quoted or paraphrased reason]. Response: [Concise evidence-based response referencing data and attachments].
• Denial reason 2: [Quoted or paraphrased reason]. Response: [Concise evidence-based response].

Diagnoses

• Primary diagnosis: [Diagnosis name], ICD-10: [Code]
• Relevant comorbidities: [Conditions affecting growth, dosing, monitoring, or safety such as hypothyroidism, scoliosis, OSA risk, diabetes risk, prior malignancy, pituitary disease context] (Include only if applicable)
• Treatment response to date: [Change in height SDS, growth velocity, IGF-1 trends, functional outcomes for adults] and rationale for ongoing therapy [continued growth potential, IGF-1 within target, clinical benefit] (For continuation requests only)

Objective Growth Data

(Include at least three time points. Note pre-treatment vs on-treatment status. Do not fabricate values; if SDS/percentiles unavailable, include raw values and reference attached growth chart.)

Date	Chronological Age	Height (cm) [Percentile; SDS; Reference]	Weight (kg); BMI [Percentile]	Annualized Growth Velocity (cm/yr)	Pubertal Stage	Status
[Date 1]	[Age]	[Height; Percentile; SDS; CDC / WHO]	[Weight; BMI; Percentile]	—	[Stage]	[Pre-treatment / On-treatment]
[Date 2]	[Age]	[Height; Percentile; SDS; Reference]	[Weight; BMI; Percentile]	[Velocity]	[Stage]	[Pre-treatment / On-treatment]
[Date 3]	[Age]	[Height; Percentile; SDS; Reference]	[Weight; BMI; Percentile]	[Velocity]	[Stage]	[Pre-treatment / On-treatment]

Interpretation: [Brief narrative summarizing growth pattern and clinical significance]. Mid-parental target height: [Value and calculation]. Bone age: [Reading, method, date]. Predicted adult height: [Value/method]. (Include each element only if available; reference attachments, e.g., "See Attachment A: Growth chart.")

Diagnostic Evaluation

• Endocrine testing:
  • IGF-1: [Value, SDS, lab reference range, date] (Attachment: [Letter])
  • IGFBP-3: [Value, range, date] (If obtained)
  • GH stimulation testing: [Agents used, peak GH values, assay, interpretation threshold, date] (Attachment: [Letter])
  • Thyroid function: [TSH, Free T4, date] (Attachment: [Letter])
  • Other pituitary axes: [ACTH/cortisol, gonadotropins, prolactin, dates] (For adult GHD)
  • (If test pending) [Test name] ordered on [date], pending.
  • (If payer-required test not clinically appropriate) [Test name] not indicated because [reason]. Alternative evidence: [Description, e.g., structural lesion with multiple pituitary hormone deficiencies].
• Imaging:
  • Bone age radiograph: [Date, reading, method, epiphyseal status: open / closed] (Attachment: [Letter])
  • Pituitary MRI: [Date, key findings] (Attachment: [Letter]) (If performed)
• Indication-specific testing: (Include only sections relevant to patient's indication)
  • Birth history (SGA): [Gestational age, birth weight/length SDS, documentation of inadequate catch-up growth]
  • Genetic confirmation (Turner/PWS): [Karyotype or genetic method, date]
  • Sleep/respiratory evaluation (PWS): [Findings, date]
  • CKD parameters: [Stage, eGFR, metabolic labs, date]
  • Exclusion of alternative causes (ISS): [Summary of evaluation]

Medical Necessity Justification

Standard referenced: [Payer medical policy name and ID / FDA-labeled indication / Clinical guideline with citation]

Criterion (policy/guideline)	Patient Evidence (dated findings; attachments)
Growth failure severity threshold [Height ≤ specified SDS/percentile]	[Height SDS/percentile, date, reference standard, attachment]
Pre-treatment growth velocity below threshold	[Velocity value, interval dates, attachment]
Confirmatory testing completed	[Test type, peak GH values, lab/assay, dates, attachment]
Growth potential documented [open epiphyses / delayed bone age]	[Bone age, epiphyseal status, date, attachment]
Exclusion of alternative causes of poor growth	[Summary of evaluations with dates and attachments]
Specialist involvement and follow-up	[Treating specialist credentials, planned follow-up intervals]
Confirmed adult GH deficiency per guideline (For adult GHD)	[Stimulation test, peak GH, pituitary disease context, attachment]

Requested Therapy

• Medication: Somatropin ([Brand name])
• Dose and calculation: [mg/kg/day or mg/day] based on weight [current weight, date] = [calculated dose]
• Frequency/Route: [Nightly / specified frequency]; subcutaneous
• Planned start/continuation date: [Date]
• Duration requested: [Months]
• Supplies: [Pen device / syringes, pen needles, alcohol swabs, sharps container] (If bundled by payer)
• Product switch rationale: [Formulary preference / shortage / tolerability / adherence / device preference] (If applicable)

Evidence-Based Rationale

[Concise synthesis of why GH is indicated for this patient's diagnosis, referencing guideline and/or FDA labeling. For pediatrics: expected benefits include improved growth velocity and favorable height SDS trajectory, reducing risk of persistent severe short stature. For adults: expected benefits include improvements in body composition, bone and metabolic parameters, exercise capacity, and quality-of-life measures.] (Do not promise specific adult height; frame outcomes appropriately.)

Alternatives addressed: [Nutritional optimization completed / other endocrine deficiencies corrected / observation has not resulted in adequate growth / other therapies not indicated or inferior].

Safety and Monitoring Plan

• Contraindication screening: [No active malignancy], [no acute critical illness], [epiphyses open for growth promotion], [PWS respiratory risk assessment completed] (Include elements relevant to indication)
• Risk mitigation: [Sleep evaluation plan, glucose monitoring, thyroid surveillance, scoliosis monitoring, IIH symptom counseling] (Include as applicable)
• Monitoring intervals: Follow-up every [3-6 months for pediatrics / more frequent during adult titration, then every 6-12 months]; height/weight each visit; growth velocity calculated every [6-12] months; IGF-1 every [3-6] months with target [within age- and sex-specific normal range]; additional labs [glucose, thyroid] as indicated
• Continuation criteria: [Payer-defined response threshold if applicable; adherence and tolerability documented]
• Discontinuation criteria: [Epiphyseal closure or minimal remaining growth potential / lack of meaningful response despite adherence / serious adverse events / transition to adult care]

Attachments

1. Growth chart with percentile/SDS curves
2. Bone age report
3. Lab reports (IGF-1, IGFBP-3, GH stimulation, thyroid)
4. Pituitary MRI report (If applicable)
5. Genetic testing confirmation (If applicable)
6. Denial letter (For appeals)
7. [Additional supporting documentation]

Closing

Please [approve this request for / overturn the denial and authorize] [medication name and regimen] for [patient name] based on the evidence and medical policy alignment detailed above. I am available for peer-to-peer discussion if helpful.

Sincerely,
[Clinician name], [Credentials]
[Title/Role], [Practice/Institution]
Direct phone: [Phone] | Fax: [Fax] | Email: [Email]