CurrentHighmark PennsylvaniaPolicy N/A

Insulin pump Certificate of Medical Necessity (Medicare Advantage) coverage criteria

Form and documentation requirements for Medicare Advantage coverage consideration of an insulin pump for beneficiaries; governs what clinical information providers must submit to Highmark Pennsylvania for a CMN.

Policy Summary

PayerHighmark Pennsylvania

PolicyInsulin pump Certificate of Medical Necessity (Medicare Advantage) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionComplete the CMN with typed office note, required lab values (including fasting C-peptide and fasting blood sugar), physician signature, and documentation of diabetes education, MDI history, and self-testing frequency.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6required clinical data elements

>=3minimum MDI injections

4x/dayrequired self-tests/day

>7%HgbA1c threshold

Coverage Criteria for Insulin Pump CMN

Initial coverage criteria

Covered when ALL of the following are met:

Documentation: Typed office note and copies of laboratory tests including fasting C-peptide, fasting blood sugar (mg/dL), actual or calculated creatinine clearance, and laboratory lower limit of normal for fasting C-peptide must be provided.

Physician signature required on CMN (stamps not acceptable).

Education and prior therapy: Patient has completed comprehensive diabetes education and has been on multiple daily injections (>=3 injections/day) with frequent self-adjustments for at least 6 months prior to pump initiation.>=6 months

Document average glucose self-testing >=4 times/day during the 2 months prior to initiation.

Clinical indications (at least one): Patient meets one or more of: HgbA1c >7%; history of recurring hypoglycemia; wide pre-meal glucose fluctuations; dawn phenomenon with fasting blood sugars frequently >200 mg/dL; history of severe glycemic excursions.

Policy Summary

PayerHighmark Pennsylvania

PolicyInsulin pump Certificate of Medical Necessity (Medicare Advantage) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

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Key Clinical Thresholds and Coding-Adjacent Metrics

HgbA1c threshold

HgbA1c threshold> 7%

PurposeOne of the clinical indications required on the CMN; must meet at least one listed criterion for pump consideration.

Location on formItem 3 (clinical criteria) — option a: Glycosylated hemoglobin level (HgbA1c) greater than 7%.

Self-monitoring frequency

Required frequency>= 4 times/day

Measurement periodAverage of at least 4 blood glucose self-tests per day during the 2 months prior to pump initiation (or during the month prior to Medicare enrollment for prior pump users).

Form referenceDocumented in Item 3 (education/prior therapy) and Item 4 for prior pump users on the CMN.

MDI duration

Minimum duration>= 6 months

DefinitionPatient must have been on multiple daily injections (at least 3 injections per day) with frequent self-adjustments of insulin dose for at least 6 months prior to pump initiation.

Form referenceStated in Item 3 (education and prior therapy) on the CMN.

Provider Actions, Documentation & Authorization

Prior Authorization

Prior Authorization & CMN Required

Prior authorization requires completion of the Certificate of Medical Necessity (CMN) for Insulin Pump. The CMN must be fully completed and submitted with the authorization request; physician signature is required on the CMN (stamps are not acceptable). Provide a contact name and phone number on the form.

Complete and submit the CMN with the prior authorization request
Physician signature required on CMN (no stamps)
Include contact name and phone number on CMN

Denial Risk

Documentation & Denial Risk

Authorization requests must include all required clinical documentation. Missing or incomplete documentation may result in denial or delay of the authorization.

Typed office note with pertinent clinical information
Copies of relevant laboratory tests
Failure to provide all required fields or documents can lead to denial of authorization

Documentation Required

Required Clinical Documentation

Submit the following required clinical documentation with the CMN: a typed office note with pertinent information and copies of laboratory tests including fasting C‑peptide level, fasting blood sugar (mg/dL), actual or calculated creatinine clearance (mL/min), laboratories' lower limit of normal for fasting C‑peptide, HgbA1c, and beta cell autoantibody status (positive/negative).

Typed office note with pertinent information
Laboratory results: fasting C‑peptide, fasting blood sugar (mg/dL), creatinine clearance (mL/min), lab lower limit of normal for fasting C‑peptide, HgbA1c
Beta autoantibody test result (Y/N)

Step Therapy

Conservative Therapy & Self‑Monitoring Prerequisites

Prior to consideration for an insulin pump, patients must have completed conservative therapy and documented self‑monitoring: completion of a comprehensive diabetes education program, and treatment with multiple daily injections (≥3 injections/day) with frequent self‑adjustment of insulin doses for at least 6 months prior to initiation. Documented frequency of glucose self‑testing averaging at least 4 times per day during the 2 months prior to pump initiation is required. Additionally, patient must meet one or more clinical criteria (HgbA1c >7%, history of recurring hypoglycemia, wide premeal glucose fluctuation, dawn phenomenon with fasting sugars frequently >200 mg/dL, or history of severe glycemic excursions).

Completion of comprehensive diabetes education program
Multiple daily injections ≥3/day with frequent self‑adjustment for ≥6 months prior to pump initiation
Documented self‑monitoring: average ≥4 glucose checks/day for the 2 months prior to initiation
Must meet one or more: HgbA1c >7%, recurring hypoglycemia, wide premeal glucose fluctuations, dawn phenomenon (fasting sugars frequently >200 mg/dL), or severe glycemic excursions

Background

Insulin pump therapy is considered when patients with diabetes have not achieved adequate control or have problematic glycemic variability despite conservative measures. The CMN requires documentation of completion of a comprehensive diabetes education program and a history of multiple daily injections (at least 3 injections/day) with frequent self-adjustments for at least 6 months, plus documented average self-monitoring of blood glucose of >= 4 times/day during the specified pre-initiation period. The form also collects objective laboratory data (including fasting C‑peptide, fasting blood sugar, creatinine clearance and antibody status) and asks providers to indicate clinical indications such as HgbA1c > 7%, recurrent hypoglycemia, wide glucose fluctuations, dawn phenomenon or severe glycemic excursions to justify pump initiation.

Definitions

Multiple daily injections (MDI)

DefinitionMultiple daily injections (MDI) = a regimen of at least 3 insulin injections per day with frequent self-adjustment of insulin doses for at least 6 months prior to pump initiation.

Minimum injections>= 3 injections/day

Required documentationDocumented in Item 3 of the CMN as part of education and prior therapy requirements.

Frequent self-testing

DefinitionFrequent self-testing = documented average of at least 4 blood glucose self-tests per day.

Required periodTypically documented during the 2 months prior to pump initiation (or the month prior to Medicare enrollment for prior pump users).

Form referenceSpecified in Item 3 (education/prior therapy) and Item 4 for prior pump users on the CMN.