CurrentBlue Cross Blue Shield - MassachusettsPolicy 332

External insulin pumps and supplies — coverage criteria

Defines medical necessity, coverage, prior authorization, coding, and replacement rules for external insulin infusion pumps and related supplies for Blue Cross Blue Shield Massachusetts members.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyExternal insulin pumps and supplies — coverage criteria

Policy CodePolicy 332

Change TypeClarified codingpharmacy-only note for select disposable pumps

Effective Date

Next Review Date

Key ActionObtain precertification for inpatient services and ensure documentation of prior trial of multiple daily injections with frequent self-testing when requesting pump coverage.

SourceLink

POLICY UPDATE CHANGES

Clarified coding information.

Note that Omnipod DASH and Omnipod 5 can only be obtained through the pharmacy benefit.

Medicare information removed; see MP #132 for determinations.

1/4 yrspump replacement frequency

15u/30dreservoir limit (A9274)

MDI + ≥4/dayMDI + testing requirement

30+references

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Coverage Criteria for External Insulin Pumps and Supplies

Initial coverage criteria

Covered when ALL of the following are met:

Primary coverage criteria: Individual is prescribed an external insulin pump by a diabetologist familiar with insulin pump management and has completed a comprehensive diabetes education program within the past two years.

Eligibility group 1

MDI and testing: Follows a program of multiple daily injections of insulin; AND documents average self-testing at least 4 times per day during the past month; AND has performed frequent self-adjustments of insulin doses for the past 6 months.>= 4 tests/day (average)
Clinical findings on MDI
- Brittle diabetes with recurrent episodes of diabetic ketoacidosis, hypoglycemia, or both, resulting in recurrent and/or prolonged hospitalization.
- Elevated HbA1c: Glycosylated hemoglobin (HbA1c) greater than 7.0 percent.> 7.0%
- Recurring hypoglycemia: History of recurring hypoglycemia or severe glycemic excursions.
- Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL.> 200 mg/dL fasting
- Wide premeal fluctuations: Wide fluctuations in blood glucose before mealtime.

Eligibility group 2: Individuals with diabetes mellitus successfully using a continuous insulin infusion pump prior to enrollment and who have documented average glucose self-testing of at least 4 times per day during the month prior to enrollment.>= 4 tests/day (average)

Pre-existing pump users eligible.

Covered alternatives, refills, and replacements

Additional covered/clarifying provisions:

Disposable pumps: Disposable external insulin pumps with wireless communication to a handheld control unit (e.g., OmniPod) are an acceptable alternative when the main criteria are met. Note: Omnipod DASH and Omnipod 5 can only be obtained through the pharmacy benefit.

Refills and replacements: Refills for medically necessary disposable external insulin pumps are medically necessary. Replacement pumps are medically necessary if out of warranty, malfunctioning, and not refurbishable. Purchase of one insulin pump is allowed every 4 years.1 pump per 4 years

For pediatric individuals requiring a larger reservoir, provide current reservoir volume, current insulin needs, and current insulin change-out frequency for consideration on a case-by-case basis.

Not covered / not medically necessary: Replacement of currently functional and warranted insulin pumps for the sole purpose of receiving the most recent pump technology (upgrades) is considered not medically necessary. Equipment upgrades or accessories whose sole purpose is to integrate an insulin pump and interstitial glucose monitor via wireless communication are considered not medically necessary.

Exclusions and scope: Jet pressure infusion devices are considered not medically necessary. Surgically implanted insulin infusion systems and chronic intermittent intravenous insulin therapy (CIIIT) and pulsatile IV insulin therapy (PIVIT) are considered investigational. The policy also states that intensive diabetes management, including pump therapy, is contraindicated for individuals (or caregivers of children) who are unwilling or unable to participate in intensive glucose management and to acquire the necessary cognitive and technical skills.

Massachusetts statutory reference: this policy notes the Massachusetts mandate cited as Massachusetts General Laws Part Title XXII Chapter 175 Section 4ZN. The policy references the state mandate in the context of coverage determinations (for example, insulin injection pens determined medically necessary in accordance with the Massachusetts mandate).

Replacement for upgrade-only: the policy specifies that replacement of currently functional and warranted insulin pumps solely to obtain the latest technology (an "upgrade") is considered not medically necessary and may be denied. Similarly, equipment upgrades or accessories whose sole purpose is to integrate pump and interstitial glucose monitor via wireless communication are considered not medically necessary.

Billing and Coding

HCPCS CodesHCPCSCovered

A4210	Needle-free injection device, each.
A4226	Supplies for maintenance of insulin infusion pump with dosage rate adjustment using therapeutic continuous glucose sensing per week.
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.
A9274	External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories. (Omnipod).
E0784	External ambulatory infusion pump, insulin.
S9145	Insulin pump initiation, instruction in initial use of pump (pump not included).
S5560
S5561	Insulin delivery device, reusable pen; 3 ml size.

1–10 of 12

1/2

CPT Codes (investigational note)CPTExperimental

0740T	Remote autonomous algorithm-based recommendation system for insulin dose calculation and titration; initial set-up and patient education.
0741T	Remote autonomous algorithm-based recommendation system for insulin dose calculation and titration; provision of software, data collection, transmission, and storage each 30 days.

inv-08: Frequency of glucose self-testing — average of at least 4 times per day

Required average self-testing frequencyDocumentation of an average of at least 4 times per day of glucose self-testing during the past month

Context within eligibilityOne of the subcriteria for individuals on multiple daily injections to qualify for an external insulin pump

Pre-enrollment for existing pump usersExisting continuous insulin infusion pump users must have documented average self-testing of at least 4 times per day during the month prior to enrollment

inv-09: HbA1c threshold — greater than 7.0 percent

HbA1c criterionGlycosylated hemoglobin (HbA1c) greater than 7.0 percent is listed as one qualifying condition while on multiple daily injections

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Precertification/preauthorization is required for inpatient services described in this policy. For outpatient services, prior authorization is not required for Commercial PPO and Indemnity products; consult plan-specific rules for other product types.

Inpatient services: precertification/preauthorization IS REQUIRED.
Outpatient Commercial PPO and Indemnity: prior authorization is not required.

Documentation Required

Education and Provider Documentation

Documentation must include evidence of diabetes education and specialist management. Members should have completed a comprehensive diabetes education program within the past two years, and the pump must be prescribed by a diabetologist familiar with insulin pump management.

Completed comprehensive diabetes education within the past 2 years.

Background and Scope

Background — external insulin infusion pumps: an external insulin pump provides continuous subcutaneous insulin infusion to deliver both basal and bolus insulin according to a programmable regimen. Use of these devices requires patient (and caregiver, when relevant) ability and willingness to participate in intensive diabetes management, including education and technical skill acquisition; the policy therefore requires evidence of comprehensive diabetes education and ongoing specialist management for coverage.

Key Definitions

inv-21: External insulin infusion pump — device definition

DefinitionAn external insulin infusion pump is a programmable, battery-powered mechanical syringe/reservoir device controlled by a micro-computer to provide continuous subcutaneous insulin infusion (CSII)

ComponentsTypically includes a syringe/reservoir (2–3 day capacity) and an infusion set with a small needle or cannula inserted into subcutaneous tissue

FunctionProgrammed to deliver a steady basal amount of insulin and to release bolus doses at meals or programmed intervals

inv-22: Basal and bolus — definition of terms

Basal (definition)A steady background insulin delivery programmed by the pump to meet basal metabolic needs

Bolus (definition)An additional insulin dose delivered at mealtimes or at programmed intervals to cover carbohydrate intake or correct hyperglycemia

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyExternal insulin pumps and supplies — coverage criteria

Policy CodePolicy 332

Change TypeClarified codingpharmacy-only note for select disposable pumps

Effective Date

Next Review Date

Key ActionObtain precertification for inpatient services and ensure documentation of prior trial of multiple daily injections with frequent self-testing when requesting pump coverage.

SourceLink

On This Page

Use of external insulin pumps for indications other than those listed in the policy is considered not medically necessary.

HbA1c >7.0% is one of several possible indications (e.g., brittle diabetes, recurrent hypoglycemia) that may justify pump coverage when other criteria are met

Measurement contextAppears as documentation requirement while the member is on a multiple daily injection regimen

Prescription by a diabetologist familiar with pump management.

Step Therapy

Step Requirement: MDI Before Pump

Members must have trialed and documented multiple daily injections (MDI) prior to initiating pump therapy unless already using a continuous insulin infusion pump. Documentation of MDI regimen and related clinical findings is required.

Requirement: Trial of multiple daily injections (MDI) prior to pump coverage, unless already on a continuous infusion pump.
Document frequency of glucose self-testing (average ≥4 times/day) and history of self-adjustments of insulin doses.

Documentation Required

Replacement Pump Documentation

Replacement pump requests require documentation of current insulin pump reservoir volume, current insulin needs, and insulin change-out frequency. Replacement is considered medically necessary for pumps out of warranty, malfunctioning, or not refurbishable. Purchases are allowed once every 4 years unless medically justified.

Required when requesting replacement: current reservoir volume; current insulin needs; current insulin change-out frequency.
Replacement covered if pump is out of warranty, malfunctioning, and cannot be refurbished.
Limit: one pump purchase every 4 years (exceptions may be considered).

Denial Risk

Upgrade-Only Replacement Denied

Replacement of a currently functional and warranted insulin pump solely for the purpose of receiving newer technology (an "upgrade") is considered not medically necessary.

Upgrades for technology only (no clinical need) are NOT MEDICALLY NECESSARY.
Accessories or integrations solely to enable wireless communication between pump and glucose monitor are NOT MEDICALLY NECESSARY.

Note

Not Present in This Section — See References

Some content referenced in this section (for example, bibliographic references and additional provider actions) is not present here and appears only in the policy reference list.

See References section for cited studies and guideline statements not reproduced here.

Note

No Other Step Therapy or Authorization/Documentation Requirements Stated

No step therapy (beyond the MDI requirement described) or additional authorization/documentation requirements are specified in these provider-action highlights.

Aside from the specified MDI trial requirement, no other step therapy rules are stated in these chunks.
Outpatient prior authorization not required for certain commercial products as noted.

PurposeBasal and bolus programming together allow fine-tuning of insulin delivery to achieve intensive glucose control and reduce glycemic complications

inv-23: CSII / Insulin pump — continuous subcutaneous insulin infusion definition and references

TermContinuous subcutaneous insulin infusion (CSII), commonly called insulin pump therapy

DescriptionTherapy in which an external programmable pump provides continuous basal insulin with user-programmed bolus doses to manage diabetes mellitus

Evidence and guidanceCSII and insulin pump therapy are discussed and supported in multiple cited studies and guidelines (see reference list) for improving glycemic control in appropriate patients