DraftUnitedHealthcarePolicy N/A

Vowst (fecal microbiota product) coverage for recurrent Clostridioides difficile infection

Defines clinical and administrative requirements for coverage of Vowst in beneficiaries (adult patients) with recurrent CDI; applies to providers requesting prior authorization from UnitedHealthcare.

Policy Summary

PayerUnitedHealthcare

PolicyVowst (fecal microbiota product) coverage for recurrent Clostridioides difficile infection

Policy CodePolicy N/A

Change TypeNo material change (draft)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization confirming beneficiary is ≥18, has ≥3 CDI episodes in 12 months, completed antibiotics 2–4 days prior, will take required bowel prep, and has ANC >500; prescriber signature is mandatory.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum beneficiary age

≥3/12moRequired CDI episodes

>500Minimum ANC

2–4 daysAntibiotic timing

Coverage Criteria for Vowst

Initial therapy eligibility

Covered when ALL of the following are met:

Age: Beneficiary is ≥ 18 years of age

Diagnosis: Confirmed recurrent Clostridioides difficile infection (CDI) with a total of ≥3 episodes of CDI within 12 months≥3 episodes in 12 months

Antibiotic timing: Antibiotic treatment for recurrent CDI will be completed 2 to 4 days prior to initiation of Vowst therapy2–4 days before

Policy Summary

PayerUnitedHealthcare

PolicyVowst (fecal microbiota product) coverage for recurrent Clostridioides difficile infection

Policy CodePolicy N/A

Change TypeNo material change (draft)

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Vowst is considered not medically necessary when the beneficiary does not meet the required eligibility elements. These include: being under 18 years of age; not having a confirmed diagnosis of recurrent CDI defined as ≥ 3 episodes within 12 months; failing to complete antibiotic treatment 2 to 4 days prior to planned Vowst initiation; not agreeing to the specified bowel preparation (10 oz magnesium citrate or 250 mL PEG electrolyte solution for impaired kidney function); or having an absolute neutrophil count (ANC) ≤ 500 cells/mm3. Active toxic megacolon or small bowel ileus also render therapy not medically necessary.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Requirements

Prior Authorization Required: Prior authorization is required for Vowst. Confirm beneficiary age (≥ 18 years), recurrent CDI episode count, timing of antibiotic completion, ANC, and absence of exclusionary conditions. Ensure prescriber signature and NPI are provided and that requester contact information is complete.

Beneficiary ≥ 18 years of age
≥3 CDI episodes within 12 months
Antibiotic therapy completed 2–4 days before Vowst
ANC > 500 cells/mm3
No toxic megacolon
No small bowel ileus
Prescriber signature mandatory; include Prescribing Provider NPI # and requester contact (name, phone, ext.)

Step Therapy

Step Therapy: No explicit step therapy sequence is specified for Vowst. Do not substitute a required prior-treatment sequence beyond the documented requirement that the beneficiary has recurrent CDI (≥3 episodes) and that antibiotic treatment is completed 2–4 days prior to initiation.

No step-therapy agents or ordered trials required

Documentation Required

Required Documentation

Required Documentation: Provide beneficiary identifiers (name, ID #, DOB, gender), clinical documentation confirming recurrent CDI and episode count, documentation of antibiotic completion date relative to planned Vowst administration, ANC value, and absence of exclusionary conditions (toxic megacolon, small bowel ileus). Include prescriber signature (mandatory) and prescriber NPI, and requester contact information (name, phone, extension).

Beneficiary identifiers: last name, first name, ID #, DOB, gender
Clinical notes confirming ≥3 CDI episodes in 12 months
Date antibiotic course completed (must be 2–4 days before Vowst)
Recent ANC value (>500 cells/mm3)
Statement/notes excluding toxic megacolon and small bowel ileus
Prescriber signature (mandatory) and Prescribing Provider NPI #
Requester contact: name, phone number, extension

Denial Risk

Potential Denial Triggers

Potential Denial Triggers: Requests may be denied for missing or incomplete documentation, patient age <18 years, fewer than 3 CDI episodes in 12 months, antibiotic therapy not completed 2–4 days prior to planned administration, ANC ≤ 500 cells/mm3, or presence of exclusionary conditions (toxic megacolon, small bowel ileus).

Missing/incomplete documentation (beneficiary or clinical)
Beneficiary < 18 years of age
< 3 CDI episodes within 12 months
Antibiotics not completed 2–4 days before Vowst initiation
ANC ≤ 500 cells/mm3
Toxic megacolon or small bowel ileus present

Background

This policy addresses coverage of Vowst (a fecal microbiota–based product) for treatment of recurrent Clostridioides difficile infection (CDI). Clinical eligibility checks required for prior authorization include confirmation that the beneficiary is ≥18 years old, has a documented history consistent with recurrent CDI (≥ 3 episodes within 12 months), will complete antibiotic therapy 2–4 days before initiation, will perform the specified bowel preparation the evening before dosing (10 oz magnesium citrate or 250 mL PEG electrolyte solution for those with impaired renal function), and has an ANC > 500 cells/mm3. The assessment also screens for contraindications such as toxic megacolon and small bowel ileus.

OpenPayer

Vowst (fecal microbiota product) coverage for recurrent Clostridioides difficile infection

Coverage Criteria for Vowst

Key Clinical Thresholds and Codes

Provider Requirements and Prior Authorization

Background

Definitions