CurrentUnitedHealthcarePolicy N/A

Growth Hormone for HIV Wasting in Adults (Florida) Prior Authorization Form - Community Planopen_in_new

This prior authorization form and coverage criteria define clinical and documentation requirements for approval of Serostim® (recombinant human growth hormone) for treatment of HIV-associated wasting/cachexia in adult Medicaid recipients in the Community Plan (Florida). It specifies eligibility, required assessments, dosing by weight, approval durations, contraindications, and documentation/submission instructions.

Policy Summary

PayerUnitedHealthcare

PolicyGrowth Hormone for HIV Wasting in Adults (Florida) Prior Authorization Form - Community Planopen_in_new

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionProvider must complete, sign, date the Serostim PA form and submit it (fax to 1-866-940-7328) with official medical records and a six-month weight chronicle; incomplete forms may be returned.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

18+Discrete criteria/fields

90Initial approval period (days)

30Retreatment approval (days)

>=7.5%/>=10%/BMI<20Primary weight-loss/BMI thresholds

Coverage Summary

This prior authorization form and coverage criteria define clinical and documentation requirements for approval of Serostim® (recombinant human growth hormone) for treatment of HIV-associated wasting/cachexia in adult Medicaid recipients in the Community Plan (Florida). Covered with criteria.

Required elements for approval include: completion, signature, and dating of the Serostim PA form by the prescriber; submission of official medical records and a six-month weight chronicle; documentation that the recipient is an adult (18 years or older) with a diagnosis of HIV-associated wasting or cachexia and is on antiretroviral therapy (HAART); documentation of weight-loss or BMI criteria or alternative BCM criteria; evidence of a nutritional assessment and counseling and documentation of prior trials of supportive therapies (appetite stimulants, anabolic steroids, testosterone when hypogonadal) or rationale if not tried; confirmation of absence of active neoplasia (contraindication); and documentation that dosing is within the recommended weight-based guidelines.

Dosing must follow the weight-based schedule and initial approvals are limited to 90 days total with retreatment approvals limited to 30 days at a time. Continuation beyond the initial course is response-based (requires at least a 2% increase in body weight and/or BCM to continue, with monthly reevaluation) and a new PA form is required for additional therapy. Providers must fax the completed form and required records to the PA fax number and retain documentation per instructions.

Quick facts and thresholds

Initial approval period90 days

Retreatment approval period30 days

Primary weight-loss/BMI thresholds>=7.5% in 6 months / >=10% in 12 months / BMI < 20

Positive response threshold>=2% increase in body weight and/or BCM

Number of discrete clinical criteria/fields on PA form18+

Medical-Necessity Criteria

Initial Therapy / Additional Therapy / Retreatment Criteria

Covered when ALL of the following are met:

ALL of the following

Physician has completed, signed, and dated the Serostim PA form
Official medical records submitted to support all questions on the PA form and a six-month weight chronicle indicating the most recent weights
Recipient is 18 years of age or older
Diagnosis of HIV associated wasting or cachexia

Coding

Administrative/contact/billing codes noted on form (fax, phone) - no procedural codes specifiedmixed

No codes listed

Provider Actions / Prior Authorization Requirements

Prior Authorization

Complete and sign Serostim PA form

Complete, sign, and date the Serostim PA form and submit it via fax to 1-866-940-7328 along with official medical records and a six-month weight chronicle. Note that incomplete forms may be returned.

Documentation Required

Submit supporting medical records and lab results

Submit official medical records (e.g., diagnostic evaluations and recent chart notes) and the most recent related laboratory results. Providers must retain copies of all documentation for five years.

Background & Definitions

Serostim® (recombinant growth hormone) is used to treat HIV-associated wasting/cachexia in adults.

The PA form captures a six-month weight history (weights at 6 months, 3 months, current weight and BMI), documentation of HAART regimen, a nutritional assessment and counseling to assure adequate caloric intake and to rule out malabsorption and psychosocial factors, and prior therapies including trials of appetite stimulants (document drug/directions/dates), anabolic steroids (minimum 4 weeks; document drug/directions/dates or provide rationale if not tried), and testosterone replacement in hypogonadal men (minimum 4 weeks).

Patients with active neoplasia are excluded from treatment with Serostim (contraindicated).

Dosing is weight-based and must be documented on the form: >55 kg = 6 mg SC daily; 45–55 kg = 5 mg SC daily; 35–45 kg = 4 mg SC daily; <35 kg = 0.1 mg/kg SC daily. Therapy duration is limited (initial 90 days) and continuation depends on response (≥ 2% increase in body weight and/or BCM to continue, with retreatment approved in 30-day increments and monthly reevaluation).

Term	Definition
BCM
Body Cell Mass — used here as percentage of total body weight; BIA results recommended if applicable.
BIA
Bioelectric Impedance Analysis — series of results may be attached to document BCM.
HAART
Highly Active Anti-Retroviral Therapy (antiretroviral regimen)

Revision History

Policy Summary

PayerUnitedHealthcare

PolicyGrowth Hormone for HIV Wasting in Adults (Florida) Prior Authorization Form - Community Planopen_in_new

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

Recipient is on anti-retroviral therapy (HAART)

ONE of the following weight/BMI/weight-loss criteria

At least a 7.5% unintentional weight loss within the last 6 months>= 7.5% within last 6 months
10% involuntary weight loss in last 12 months>= 10% within last 12 months
Body Mass Index (BMI) < 20 for initial approvalBMI < 20

ALTERNATIVE physiological body composition criteria (one qualifies)

Body Cell Mass (BCM) < 35% (male) of total body weight AND Body Mass Index less than 27BCM < 35% (male) AND BMI < 27
Attach a series of bioelectric impedance analysis (BIA) results if applicable
BCM < 23% (female) of total body weight AND Body Mass Index less than 27BCM < 23% (female) AND BMI < 27
Attach a series of bioelectric impedance analysis (BIA) results if applicable
Greater than or equal to 5% BCM loss over 6 months>= 5% BCM loss over 6 months
Attach BIA results if applicable

A nutritional assessment and counseling have been performed to assure adequate caloric intake, rule out malabsorption, and assess psychosocial factors affecting intake

ONE of supportive prior therapies/assessments

Trial of appetite stimulant if inadequate caloric intake and anorexia (document drug, directions, dates)
Form asks whether trial occurred and to indicate dosage and dates
Trial of anabolic steroid (minimum 4 weeks, e.g., oxandrolone) — documentation of drug/directions and dates OR if no trial, provide rationale
Form asks for documentation or rationale if not tried
Testosterone replacement therapy in hypogonadal men (minimum of 4 weeks) if hypogonadal
Form asks whether recipient is hypogonadal and whether testosterone replacement is/has been administered

No active neoplasia (Serostim is contraindicated in patients with active neoplasia)

Dosing must be within the recommended guidelines for weight (documented on form)

Duration and Response / Retreatment Criteria

Coverage timing and retreatment:

ALL of the following

Initial approval period: total of 90 days90 days
Retreatment approval period: 30 days at a time30 days
Length of therapy is 12 weeks; if positive response occurs (>= 2% increase in body weight and/or BCM) but wasting still evident, treatment may be continued and response reevaluated monthly>= 2% increase in body weight and/or BCM
Physician must submit a new PA form for additional therapy (retreatment)

Dosing by Weight

Dose must be adjusted according to recipient's weight:

ALL of the following

Weight-based dosing (pick the matching weight bracket)
- Greater than 55 kg (121 lb): Dose = 6 mg SC daily>55 kg: 6 mg SC daily
- 45-55 kg (99-121 lb): Dose = 5 mg SC daily45-55 kg: 5 mg SC daily
- 35-45 kg (75-99 lb): Dose = 4 mg SC daily35-45 kg: 4 mg SC daily
- Less than 35 kg (<75 lb): Dose = 0.1 mg/kg SC daily<35 kg: 0.1 mg/kg SC daily

Documentation Required

Document prior trials and rationale

Document the patient's HAART regimen and prior therapy trials: record appetite stimulant use (drug, directions, dates), anabolic steroid use (drug, directions, dates) or provide rationale if no trial, and document testosterone replacement if applicable. Also confirm and document absence of active neoplasia.

Prior Authorization

Dosing documentation

Document that the requested Serostim dosing falls within the recommended weight-based dosing guidelines and provide the dates and doses requested.

Billing Rule

Approval duration limits

Initial approvals are for a total of 90 days. Retreatment approvals are limited to 30 days at a time and require submission of a new PA form for additional therapy.