CurrentCignaPolicy N/A

Diabetes - twiist Products Drug Quantity Management Policy - Per Days

Defines drug quantity management limits and exception criteria for twiist Starter and Refill Kits for Cigna-administered health benefit plans and describes coverage review process when quantity limits are exceeded.

Policy Summary

PayerCigna

PolicyDiabetes - twiist Products Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateMar 25, 2026

Key ActionSubmit prior authorization when quantity limits at point of service are exceeded and provide documentation supporting need for more frequent cassette changes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10cassettes per Refill Kit

1 kitRetail max / 30 days

3 kitsHome delivery max / 90 days

1 / 720 daysStarter Kit max

72 hrscassette change interval

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inv-01: twiist Refill Kit - Exception Criteria

Exceptions to stated quantity limits are covered as medically necessary only when the specific criteria below are met.

twiist Refill Kit exception: If a patient requires the cassette to be changed more frequently than every 3 days, approve the requested quantity for a 30-day supply at retail and a 90-day supply at home delivery.change more frequently than every 72 hours

All other exceptions are considered not medically necessary.

inv-02: twiist Starter Kit - Exception Criteria

twiist Starter Kit: No overrides recommended for the Starter Kit.n/a

Starter Kit quantity limits remain as stated.

Exceptions to the stated quantity limits for twiist products are covered as medically necessary only when they meet the specific criteria listed in this policy. If a request does not meet those criteria, the exception is considered not medically necessary and coverage is not provided.

When requesting an exception to the quantity limits, providers should document why the patient requires deviation from the standard supply calculation (for example, clinical justification that the cassette must be changed more frequently than every 72 hours (3 days)). Requests that do not demonstrate the specific need described in the criteria (such as documentation that supports more frequent cassette changes) will be considered not medically necessary.

Coding, Supply Calculations, and Kit Limits

Coding guidance (no explicit codes listed)mixed

affected codes

Policy references that claims must be accompanied by covered diagnosis and/or procedure code(s); specific billing codes not listed in this policy.

Cassette change interval / supply calculation

Cassette change intervalChange cassette every 72 hours (3 days) or when empty

Cassettes per Refill Kit10 cassettes per kit

Retail supply calculation1 Refill Kit (10 cassettes) sufficient per 30 days (provides a new cassette every 72 hours)

Home delivery supply calculation3 Refill Kits (30 cassettes) per 90 days

Maximum insulin per cassetteEach 3 mL cassette holds 100 to 300 units of rapid‑acting insulin (100 units/mL)

Provider Actions, Prior Authorization, and Denial Risk

Prior Authorization

Quantity limit prior authorization requirement

Quantity limits apply at point of sale. If the Drug Quantity Management rule is not met for the requested twiist product at the point of service, approval will be determined by the medical necessity criteria in this policy. All approvals are provided for 1 year unless otherwise noted.

twiist Refill Kit retail limit: 1 kit per 30 days
twiist Refill Kit home delivery limit: 3 kits per 90 days
twiist Starter Kit retail/home delivery limit: 1 kit per 720 days

Documentation Required

Documentation and review expectations

Providers must submit coverage requests and supporting documentation in accordance with the applicable benefit plan terms and using the most appropriate diagnosis and procedure/drug codes as of the date of submission. Coverage requests that do not meet the Drug Quantity Management rule at point of service will be reviewed against the exception criteria; claims for services not accompanied by covered codes will be denied.

Submit requests with relevant clinical rationale when requesting an exception to the quantity limits
Include frequency of cassette changes or other clinical details to support need for quantities beyond stated limits

Step Therapy

Step therapy

There are no step therapy requirements described for twiist products in this program; the program focuses on quantity management and exceptions to quantity limits are handled via documentation and review of medical necessity.

Step therapy: none required for twiist; manage via quantity exception criteria

Background and Clinical Context

The twiist Automated Insulin Delivery (AID) system is a subcutaneous device intended to deliver rapid-acting insulin for management of diabetes mellitus in patients aged ≥ 6 years. The system interfaces with compatible digitally connected devices to execute dosing commands and is used with specified rapid-acting insulins and single‑use cassettes designed to be changed every 72 hours (3 days) or when empty.

Definitions

twiist AID system — definition

Device typeAutomated insulin delivery (AID) system for subcutaneous delivery of insulin

IndicationManagement of diabetes mellitus in patients ≥ 6 years of age who require insulin

ConnectivityInterfaces with compatible digitally connected devices to receive and execute dosing commands

Insulin compatibilityDesigned to work with tested rapid‑acting insulins (see dosing guidance)

twiist cassette — definition

Cassette designSingle‑use 3 mL cassette in sterile packaging

Insulin capacityFilled with at least 100 units up to a maximum of 300 units of rapid‑acting insulin (100 units/mL)

Recommended change intervalChange every 72 hours (3 days) or when empty

Validated insulinsHumalog (insulin lispro 100 units/mL) and NovoLog (insulin aspart 100 units/mL) tested for use with the system