Oral and Enteral Formula
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Defines medical necessity criteria, coding guidance, and coverage rules for oral and enteral nutrition products (standard, specialized, elemental/semi-elemental, metabolic, and specialty infant) for Meridian members; applies to Medicaid line of business.
No material clinical or coverage changes in this revision.
Coverage Criteria for Oral and Enteral Nutrition
inv-01: Initial Approval — Standard Products
Covered when ALL of the following are met:
inv-02: Continued Approval — Standard Products
Covered when ALL of the following are met:
inv-03: Other diagnoses/indications
For diagnoses/uses not listed in the policy sections:
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety consistent with the plan’s off‑label use policy (CP.PMN.53) or other applicable evidence‑of‑coverage documents.
Non‑FDA approved indications that lack adequate supporting documentation per the plan’s off‑label use requirements are considered not authorized. Requests for such off‑label use must meet the documentation standards in CP.PMN.53 to be considered for coverage.
Coding, Codes and Limits
| NDC: 43900-0186-29 | Boost Breeze |
| NDC: 70074-0565-01 | Ensure Clear |
| NDC: 70074-0624-81 | Ensure Clear |
| NDC: 70074-0649-01 | Ensure Clear |
| NDC: 70074-0648-99 | Ensure Clear |
Provider Actions and Authorization Requirements
Prior authorization — product-specific and coding requirements
Requests for Boost Breeze (NDC 43900-0186-29) or Ensure Clear (NDCs 70074-0565-01, 70074-0624-81, 70074-0649-01, 70074-0648-99) require submission of documentation demonstrating that the approval criteria are met; use HCPCS codes B4102 or B4103 for enteral formula billing as applicable.
- Specify product NDC on the request.
- Include member’s route of administration and daily caloric amount to verify it does not exceed policy limits.
Step therapy — no explicit sequence; documentation required
No formal step therapy sequence is specified in the policy; however, initial approval requires documentation that the requested standard product and clinical-necessity criteria are met before coverage is authorized.
- Do not assume prior trials substitute for required documentation—submit clinical evidence of need per initial approval criteria.
Required clinical documentation to support requests
Provider must submit clinical documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria when requesting formula.
- Documentation should demonstrate the specific indication (e.g., cancer of mouth/throat/esophagus; head/neck injury, surgery, radiation; chronic neurological disorder; severe craniofacial anomaly; or transition from tube/parenteral feeding).
- Include documentation of route (tube vs oral), member age, and daily caloric needs to confirm policy thresholds are not exceeded.
Denial risk — missing supporting documentation
Failure to submit supporting documentation (office notes, lab results, or other clinical information) that the member meets the policy’s approval criteria may result in denial of the request.
- Absence of documentation linking the member’s condition to one of the listed indications or missing caloric/administration details are common reasons for denial.
Medical Necessity Criteria
inv-16: Standard product medical necessity
Covered when ALL criteria below are met:
Documentation Submission Requirements
Submit supporting clinical documentation with requests
Include relevant clinical records with all prior authorization requests—office notes and lab results are examples—to demonstrate the member meets the policy’s approval criteria for the requested formula.
- If requesting Boost Breeze or Ensure Clear, include documentation that the product requested and daily caloric limits meet the policy criteria
- Show evidence of severe swallowing/chewing difficulty due to one of the listed conditions when applicable
Not Covered
Coverage is not provided for non‑FDA approved indications when there is insufficient evidence of efficacy and safety as required by the off‑label use policy (CP.PMN.53) or the member’s evidence‑of‑coverage documents. Such requests will be denied unless adequate supporting documentation is submitted.
Definitions
Background
Enteral nutrition is feeding delivered through the gastrointestinal tract via a tube, catheter, or stoma, or administered orally when a patient cannot meet nutritional needs with regular food. These products are intended to provide necessary nutrients when oral intake is inadequate and may be medically necessary to prevent serious disability or death in members whose conditions preclude full use of regular food.
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