Does E10.641 require prior authorization?

No, E10.641 does not require prior authorization (high confidence). Code is covered without prior authorization.

Verity

`E10.641` — Type 1 diabetes mellitus with hypoglycemia with coma

ICD-10-CM

Prior Authorization

No Prior Auth Required

Code is covered without prior authorization (high confidence)

Documentation Required

CGM devices billed as HCPCS E2103 (and E2102 effective July 1, 2022) must have PDAC coding verification and be listed on the PDAC Product Classification List (PCL) for the respective HCPCS code prior to billing.
For items subject to Final Rule 1713, a face-to-face encounter and a Written Order Prior to Delivery (WOPD) are required for specified HCPCS codes; claims without these will be denied as not reasonable and necessary and items delivered prior to receipt of a WOPD are ineligible for payment.
If beneficiary utilization of BGM testing supplies exceeds usual amounts, the medical record must document an in-person or Medicare-approved telehealth visit evaluating diabetes control, that ordered quantities are reasonable and necessary, and that beneficiary testing frequency corroborates dispensed quantities (narrative or testing log).

Key Coverage Criteria

Medicare may classify adjunctive CGMs as DME (since Feb 28, 2022) when LCD and statutory requirements are met.
Home blood glucose monitors (BGMs) and continuous glucose monitors (CGMs) are covered under the Durable Medical Equipment (DME) benefit when the device and use meet the related LCD reasonable-and-necessary requirements and other Medicare statutory/regulatory requirements.
Therapeutic (non-adjunctive) CGM devices that permit treatment decisions without confirmatory BGM are covered under DME.
A CGM system supply allowance (HCPCS A4238 or A4239) is covered when the beneficiary uses a stand-alone durable CGM receiver or an insulin infusion pump classified as DME to display glucose data, or when a non-DME device is used in conjunction with a durable CGM receiver.
For non-adjunctive CGM systems, the supply allowance (A4239) may include a home BGM and related supplies if clinically necessary.
Beneficiary has diabetes mellitus documented in the medical record.

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Have a follow-up question?

Ask Verity about documentation requirements, denial risks, or coverage in your state.

For the in-person or Medicare-approved telehealth visit required for initial CGM provision, the medical record must document that the beneficiary has diabetes mellitus; the beneficiary or caregiver received appropriate training as shown by a prescription; the CGM is prescribed per FDA indications for use; and the CGM is prescribed to improve glycemic control for an insulin-treated beneficiary or for a beneficiary with a history of problematic hypoglycemia.

For non-insulin-treated beneficiaries with recurrent (more than one) level 2 hypoglycemic events, the treating practitioner must document for each event at least one qualifying item (glucose value for the event, classification of the event as level 2, or incorporation of BGM testing log showing the event) and must document more than one prior medication adjustment or treatment-plan modification before the most recent level 2 event.

For beneficiaries with a history of at least one level 3 hypoglycemic event, the treating practitioner's documentation requirements are specified but details are truncated in this policy text and require review of the full policy/LCD for the complete pathway.

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E10.641 — Type 1 diabetes mellitus with hypoglycemia with coma