Follow PA Medicaid handbook and InterQual for prior authorization

Prior authorization for CGM and tubeless insulin delivery devices must follow the Pennsylvania Medical Assistance Handbook: Prior Authorization of Pharmaceutical Services; medical necessity for external continuous subcutaneous insulin infusion pumps is evaluated using InterQual criteria (per the policy).

• Applicable HCPCS/CPT/S codes listed in policy should be included with PA submission as appropriate (see coding section).

Follow Pennsylvania DME prior authorization and repairs/replacements policy

Prior authorization requirements, and rules for repairs and replacements, are governed by the Pennsylvania-specific Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements policy; providers must follow that DME prior authorization and repair/replacement process referenced in this policy.

• Refer to the Pennsylvania Durable Medical Equipment policy for detailed repair and replacement coverage and prior authorization steps.

Use FDA labeling and InterQual to establish pump medical necessity

External continuous subcutaneous insulin infusion pumps are considered medically necessary when used according to FDA-labeled indications and when medical necessity criteria per InterQual are met; implantable insulin pumps are listed as unproven and not medically necessary.

• External pumps apply for individuals requiring intensive insulin therapy (insulin-treated ≥3 times/day), including non–type 1/2 causes (e.g., cystic fibrosis–related diabetes, posttransplant, post‑pancreatic surgery).

Refer to DME policy for repair/replacement and step therapy guidance

For coverage of repairs and replacements, refer to the Durable Medical Equipment policy referenced in this document; this policy does not specify a separate step-therapy sequence for pump or CGM replacement.

• No specific step therapy is detailed in this policy—follow the DME policy for repair/replacement criteria and timing.

Ensure complete medical-record documentation to support medical necessity

Patient medical records must fully document medical necessity with relevant history, physical examination findings, and results of pertinent diagnostic tests or procedures; records must be legible, maintained in the chart, and made available upon request.

• Include documentation that supports why intensive insulin therapy (≥3 injections/day) or CGM/pump therapy is clinically indicated.
• Ensure test results and exam findings referenced in the PA/InterQual review are present in the record.

Reference federal, state, and contractual benefit requirements

Before submitting requests, verify and follow applicable federal, state, or contractual benefit requirements (Pennsylvania Code and PA Medicaid handbooks referenced); documentation should demonstrate adherence to those requirements when determining coverage.

• If federal/state/contractual terms conflict with this policy, the federal/state/contractual requirements govern.
• Reference the Pennsylvania Code § 55.1101.31(f) and the PA Medical Assistance handbooks as applicable.

Denial risk: insufficient documentation or OTC CGM requests are out of scope

Requests lacking medical-record documentation that supports medical necessity may be denied or evaluated on a case‑by‑case basis; additionally, requests for coverage of over‑the‑counter CGM systems obtained through retail pharmacies (e.g., Dexcom Stelo, Abbott Lingo, Abbott Libre Rio) are out of scope for this policy and may be denied under mail‑order DME coverage.

• OTC CGM products obtained without prescription are not supported by mail‑order durable medical equipment providers and fall outside this policy's coverage scope.
• Ensure submitted records directly support the InterQual and PA handbook criteria to avoid denial.

OTC CGMs (e.g., Dexcom Stelo, Abbott Lingo, Abbott Libre Rio) are out of scope

Requests for coverage of over‑the‑counter CGM systems (examples cited: Dexcom Stelo, Abbott Lingo, Abbott Libre Rio) are out of scope for this policy and are not supported by mail‑order durable medical equipment providers.

• Do not submit OTC CGM purchases through mail‑order DME benefit requests; such products are obtained through local retail pharmacies and are excluded from this policy.