ModifiednorthwoodPolicy N/A

Insulin Infusion Pump and Supplies Coverage Criteria

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Clinical policy governing medical necessity and coverage of external insulin infusion pumps and associated supplies for members with diabetes mellitus or other conditions causing insulinopenia; applies to providers ordering and managing pump therapy under Northwood plans.

Policy Summary

Payernorthwood

PolicyInsulin Infusion Pump and Supplies Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial revisions to criteria, coding, and supply limits

Effective DateMar 15, 2021

Last ReviewJan 1, 2025

Next Review DateJan 1, 2024

Key ActionSubmit prior authorization with documentation of prior MDI trial (≥3 injections/day), glucose testing frequency, and clinical indication to support pump coverage.

SourceLink

POLICY UPDATE CHANGES

Added OmniPod (A9274) coverage and plan-specific coding instructions for WellSense and MassHealth plans.

Revised HCPCS code guidance: For SCO members use A4224/A4225 instead of A4230/A4231/A4232; For WellSense MH/MHCP/ACO, use A4230/A4231/A4232 with allowed quantity 20 per month.

Removed requirement for frequent self-adjustments of insulin dose for at least six months and completion of a comprehensive diabetes education program as pump initiation prerequisites; added prior MDI trials and other non-diabetes insulinopenic diagnoses as qualifying considerations.

Updated supply quantity guidance to reflect supplies 2 boxes/month (10 per box).

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ModifiednorthwoodPolicy N/A

Insulin Infusion Pump and Supplies Coverage Criteria

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Policy Summary

Payernorthwood

PolicyInsulin Infusion Pump and Supplies Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial revisions to criteria, coding, and supply limits

Effective DateMar 15, 2021

Last ReviewJan 1, 2025

Next Review DateJan 1, 2024

Key ActionSubmit prior authorization with documentation of prior MDI trial (≥3 injections/day), glucose testing frequency, and clinical indication to support pump coverage.

SourceLink

POLICY UPDATE CHANGES

Added OmniPod (A9274) coverage and plan-specific coding instructions for WellSense and MassHealth plans.

Revised HCPCS code guidance: For SCO members use A4224/A4225 instead of A4230/A4231/A4232; For WellSense MH/MHCP/ACO, use A4230/A4231/A4232 with allowed quantity 20 per month.

Updated supply quantity guidance to reflect supplies 2 boxes/month (10 per box).

≥3minimum prior multiple daily injection frequency required

20/moinfusion sets quantity (A4230/A4231)

A9274OmniPod HCPCS referenced in policy

2 boxes/mosupply quantity update

Coverage Criteria for Insulin Infusion Pumps and Supplies

Initial therapy criteria

Covered when ALL of the following are met:

Ordering and diagnosis: Must be ordered by the member's treating practitioner and for members with diabetes mellitus or another non-diabetes condition causing insulinopenia

Prior therapy: Member has been performing multiple daily injections (MDIs) consisting of at least three injections per day>=3 injections/day

Prior MDI treatments were tried and were not effective in managing blood sugar and/or medical symptoms

Monitoring frequency: Member's current treatment plan involves testing blood glucose at least four times per day>=4 tests/day

This testing requirement does not apply to members currently using Continuous Glucose Monitoring (CGM)

Clinical indication: At least one of the following while on a multiple daily injection regimen: (i) HbA1c > 7.0% OR (ii) history of recurring hypoglycemia OR (iii) fluctuations >100 mg/dL in pre-meal blood glucose OR (iv) dawn phenomenon with fasting blood sugars frequently >200 mg/dL OR (v) history of severe glycemic excursionsHbA1c >7.0% or listed clinical features

Continuation therapy criteria

Continued coverage when ALL of the following are met:

Follow-up: Member is seen and evaluated by the treating practitioner at least every 3 monthsevery 3 months

Clinical response: There is clinical evidence demonstrating stabilization or improvement of the initial indication for the devicedocumented stabilization or improvement

Provider qualifications: Pump must be ordered and follow-up provided by a practitioner who manages multiple members on continuous subcutaneous insulin infusion (CSII) therapy and works closely with a team (nurses, diabetic educators, dieticians) experienced in CSIIexperienced practitioner and team involvement

Initial Therapy/Qualification

Policy criteria updated (high-level):

Initial qualifying considerations: Prior treatments with multiple daily injections (MDIs) were tried and were not effective in managing blood sugars and/or medical symptoms; diagnosis may include Type 1 diabetes or another non-diabetes condition causing insulinopenia.

Replaced earlier requirement for frequent self-adjustments of insulin dose for at least six months and completion of a comprehensive diabetes education program; added non-diabetes insulinopenic diagnoses as qualifying considerations.

The policy lists specific items that are not reasonable and necessary and therefore not covered. These include: easy fill filling aids, remote controllers, computer software/adapters/upload kits, pump covers or cases (including shower bags), infusion set insertion devices (e.g., Sof-serter, Quick-serter, Silserter), and routine antiseptic supplies such as alcohol, betadine, iodine, PhisoHex solutions, swabs, or wipes when they are not required for pump function. The policy further states that a disposable external ambulatory insulin delivery system and all non-standard supplies and accessories are considered not reasonable and necessary except where a specific plan exclusion does not apply (see WellSense plan exceptions).

Repair is limited to restoration to serviceable condition and replacement is covered only when repair costs exceed purchase price or the device is irreparably damaged (not due to misuse); however, the listed non-covered accessories and supplies remain excluded from reimbursement under these rules.

HCPCS code A9274 (OmniPod) is referenced in the policy and has historically been treated differently across payers. The document records that A9274 was added to the policy and, at times, categorized as not reasonable and necessary because it was not considered standard and basic; plan-specific guidance was established in subsequent updates.

Special Coverage Information notes plan-level variation: some plans (for example, WellSense MH/MHCP/ACO and WellSense SCO) may permit coverage of the OmniPod (A9274) when pump criteria are met, while Medicare coverage of A9274 is not guaranteed. Providers must therefore follow the plan-specific coding instructions and prior authorization requirements for A9274 to determine coverage.

The policy describes a disposable external ambulatory insulin delivery system as an external ambulatory insulin delivery system that is disposable and whose associated supplies and accessories are generally considered non-standard and not reasonable and necessary under the policy. When listed as not reasonable and necessary, these items include the disposable pump itself and all related non-basic supplies and accessories.

Certain supplies associated with external insulin infusion systems are itemized elsewhere in the policy (for example, replacement batteries and transparent film dressings) and some supplies are assigned HCPCS codes for prior authorization and quantity limits; however, the disposable external ambulatory systems and their non-standard accessories remain excluded from coverage except where a plan specifically states otherwise.

Historically, the policy explicitly categorized some disposable external ambulatory insulin delivery systems, including HCPCS A9274, as not reasonable and necessary on the basis that they were not standard and basic. Policy revision history documents the addition of A9274 and subsequent decisions to list disposable systems among non-covered items in prior versions of the policy.

Over time the policy was updated to reflect plan-specific exceptions and coding guidance; these historical classifications remain important for understanding current plan variations and the need to verify coverage for devices like the OmniPod on a per-plan basis.

HCPCS and Supply Coding

HCPCS Level II Codes and descriptionsHCPCS

A4224	Supplies for maintenance of insulin infusion catheter, per week.
A4225	Supplies for external insulin infusion pump, syringe type cartridge, sterile each.
A4230	Infusion set for external insulin pump; non-needle cannula type.
A4231	Infusion set for external insulin pump; needle type.
A4232	Syringe with needle for external insulin pump, sterile 3cc.
A4244	Alcohol or peroxide, per pint.
A4245	Alcohol wipes, per box.
A4246	Betadine or pHisoHex solution, per pint.
A4247	Betadine or iodine swabs, per box.
A4649	Surgical supply, miscellaneous (use for batteries, piston rod, adapter).

1–10 of 17

1/2

HCPCS codes referencedHCPCS

A9274	OmniPod (external ambulatory insulin delivery system).
A4230	Infusion pump component/supplies (per policy context).
A4231	Infusion pump component/supplies (per policy context).
A4232	Infusion pump component/supplies (per policy context).
A4224	Alternate HCPCS code for SCO members (used instead of A4230/A4231/A4232).
A4225	Alternate HCPCS code for SCO members (used instead of A4230/A4231/A4232).

Historical supply HCPCS referencedHCPCS

A6257	Previously revised transparent film dressing/supply (allowed revisions noted historically).
A6258	Supply code noted historically as not reasonable and necessary.
A6259	Supply code noted historically as not reasonable and necessary.

MDI injections per day

MDI injections per day>= 3 injections/day

Source contextMultiple daily injections (MDIs) consisting of at least three injections per day required as prior therapy

DocumentationMedical record must show member has been performing MDIs (>=3/day)

Blood glucose testing frequency

Blood glucose testing frequency>= 4 times per day (requirement waived if using CGM)

ExceptionDoes not apply to members currently utilizing Continuous Glucose Monitoring (CGM)

Provider Requirements, Prior Auth, and Documentation

Prior Authorization

Prior authorization and supply limits

External insulin pumps and the specified supplies listed in the policy require an order from the member's treating practitioner and prior authorization consistent with the coverage criteria; supplies are limited to the HCPCS codes and quantities listed in the policy.

Order must be by the member's treating practitioner.
Supplies are limited to the quantities listed (see HCPCS codes and quantities).
Prior authorization required per plan rules.

Prior Authorization

Submit correct HCPCS codes and supporting documentation

When submitting a request, include the correct HCPCS codes for the pump and supplies and attach supporting clinical documentation that demonstrates the member meets the policy criteria; plan-specific coding guidance (e.g., WellSense, SCO) must be followed.

Include HCPCS codes for device and supplies listed in policy (e.g., A4230/A4231/A4232, A4224/A4225, A9274 where applicable).

Background

An insulin infusion pump is a battery-operated device used to deliver continuous subcutaneous insulin for management of diabetes mellitus and other insulinopenic conditions. Pump therapy provides programmable basal insulin delivery with bolus dosing capability and is considered when multiple daily injections (MDIs) have not achieved adequate glycemic control.

This policy requires that pumps be ordered by the treating practitioner and that members have prior therapy with MDIs (a regimen of at least three injections per day). Initial eligibility typically requires documented blood glucose monitoring (≥ 4 times per day unless the member uses a continuous glucose monitor) and clinical indications such as HbA1c > 7.0%, recurrent hypoglycemia, large pre-meal glucose fluctuations, or severe glycemic excursions. Continued coverage requires follow-up evaluations by the treating practitioner at least every 3 months with documentation of stabilization or improvement and management by a practitioner experienced in continuous subcutaneous insulin infusion (CSII) working with an interdisciplinary diabetes care team.

Definitions

Insulin infusion pump — definition

DefinitionInsulin infusion pump — a battery-operated device delivering insulin at a controlled rate via a needle placed under the skin (subcutaneous)

FunctionDelivers continuous subcutaneous insulin for management of diabetes mellitus or other insulinopenic conditions

Device characteristicOperates on battery power to provide controlled insulin delivery

Multiple daily injections (MDIs) — definition

DefinitionMultiple daily injections (MDIs) — a regimen consisting of at least three insulin injections per day

Role in policyRequired prior therapy before considering pump coverage

Policy Summary

Payernorthwood

PolicyInsulin Infusion Pump and Supplies Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial revisions to criteria, coding, and supply limits

Effective DateMar 15, 2021

Last ReviewJan 1, 2025

Next Review DateJan 1, 2024

Key ActionSubmit prior authorization with documentation of prior MDI trial (≥3 injections/day), glucose testing frequency, and clinical indication to support pump coverage.

SourceLink

On This Page

Documentation requirementMedical record must show current treatment plan involves testing blood glucose at least 4x/day unless CGM used

HbA1c threshold

HbA1c threshold> 7.0 percent

Clinical alternativesOr at least one qualifying clinical indication such as recurring hypoglycemia or severe glycemic excursions

ContextListed as one qualifying criterion while on an MDI regimen

Allowed quantity for WellSense HCPCS A4230/A4231/A4232

Allowed quantity (WellSense)20 per month for HCPCS A4230/A4231/A4232

Plan noteApplies to WellSense MH/MHCP/ACO members per Special Coverage Information

Coding implicationEnsure correct HCPCS codes and quantities are submitted for WellSense plans

Supply box frequency

Supply box frequency2 boxes per month (10 per box)

Operational updateQuantity box updated to reflect supplies 2 boxes/month (10 per box)

DocumentationFollow plan-specific supply limits when ordering supplies

Attach clinical documentation showing how the member meets each coverage criterion.

Step Therapy

Prior multiple daily injection therapy required

Prior to approval for pump therapy, the medical record must document that the member performed multiple daily injections (MDIs) of at least three injections per day and that MDIs were tried and were not effective in managing blood sugars and/or medical symptoms.

MDI regimen must be at least three injections per day.
Documentation must indicate MDIs were tried and found ineffective.

Step Therapy

Document prior MDI trial and ineffectiveness

Document prior treatment with MDIs and that they were tried and not effective; this prior MDI trial is a qualifying consideration for initiation of pump therapy.

Record dates, regimen (≥3 injections/day), and clinical response to prior MDI therapy.

Documentation Required

Required order, documentation and follow-up

The order must be from the treating practitioner and the medical record must include documentation of the prior MDI regimen (≥3 injections/day), blood glucose testing frequency (≥4 times/day unless using CGM), at least one qualifying clinical criterion, and regular follow-up evaluations.

Order signed by treating practitioner.
Document prior MDI regimen (frequency and dates).
Document blood glucose testing frequency or CGM use.
Document at least one qualifying clinical criterion (e.g., HbA1c > 7.0%, recurrent hypoglycemia).
For continued coverage, document evaluation by practitioner at least every 3 months with evidence of stabilization or improvement and multidisciplinary team involvement.

Billing Rule

Use plan-specific HCPCS codes and quantities

Plan-specific documentation must use the HCPCS codes and quantities required by the member's plan (examples: WellSense MH/MHCP/ACO uses A4230/A4231/A4232 with quantity 20/month; WellSense SCO requires A4224/A4225 instead of A4230/A4231/A4232).

Verify plan-specific code and quantity rules before submission (e.g., WellSense vs SCO).
Reference NCD/LCD verbiage and the policy's Special Coverage Information Per Plan when applicable.

Denial Risk

Denial risk for incomplete prior trials or testing frequency

Coverage may be denied if the medical record does not document required prior trials (MDIs), the required blood glucose testing frequency (unless CGM), or the specified clinical indications described in the coverage criteria.

Missing documentation of ≥3 injections/day MDI regimen or that MDIs were ineffective.
Missing documentation of ≥4 daily blood glucose tests (unless on CGM).
Missing documentation of at least one qualifying clinical indication (e.g., HbA1c > 7.0%, recurrent hypoglycemia).

Denial Risk

Risk of denial from coding/coverage mismatches (A9274 and supply codes)

Using HCPCS A9274 (OmniPod) or incorrect supply codes can lead to denials—A9274 is not Medicare-covered in some contexts and certain plans require alternate codes (for example, SCO members must use A4224/A4225 rather than A4230/A4231/A4232).

Confirm A9274 coverage for the member's plan before billing (OmniPod may be approvable for some WellSense plans).
Use alternate HCPCS codes required by plan (e.g., A4224/A4225 for SCO) to avoid coding/coverage mismatches.

Medical record must demonstrate member performed MDIs (>=3/day)

OmniPod (A9274) — definition and coverage note

DefinitionOmniPod (A9274) — disposable external ambulatory insulin delivery system referenced in the policy and subject to plan-specific coverage

Plan guidanceOmniPod (A9274) may be approved for WellSense MH/MHCP/ACO when policy criteria are met; Medicare coverage may vary

Historical noteA9274 has been previously noted as not reasonable and necessary for some plans; confirm plan-specific coverage