Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the CMS, is conducting post-payment review of continuous glucose monitor (CGM) and associated supply claims billed to Medicare with dates of service from January 1, 2024, through December 31, 2025. This notification includes the reasons for the review, documentation that will be requested in the Additional Documentation Request (ADR) letter, and resources providers/suppliers may wish to consult when submitting claims.

Background

Continuous glucose monitors enable 24-hour tracking of glucose levels via a sensor placed just beneath the skin, typically on the abdomen or upper arm. The device measures glucose in the interstitial fluid rather than directly from the bloodstream. Real-time data allows for the identification of glucose patterns and trends over time, supporting clinical decision-making. This information can be transmitted to an insulin pump or accessed via a computer or smartphone. A CGM system consists of three components: a senor, transmitter, and receiver. The sensor measures interstitial glucose levels continuously and is replaced every six to 14 days, depending on the brand of sensor and direction of use. A transmitter receives signals from the sensor and relays them to the receiver. The receiver displays glucose readings and trends and is the component covered under the durable medical equipment (DME) benefit.

There are two types of wearable CGM receivers: adjunctive and non-adjunctive. Adjunctive CGMs require beneficiaries to check their blood sugar with a fingerstick before adjusting insulin. Adjunctive CGMs are billed using the Healthcare Common Procedure Coding System (HCPCS) code E2102. Non-adjunctive CGMs support insulin dosing decisions without requiring a fingerstick and are billed with HCPCS E2103. Both types of receivers are covered by CMS. The Food and Drug Administration (FDA) classifies CGMs as either Class II or Class III devices depending on the level of controls to ensure safety, effectiveness, and the risk of the CGM device. Both Class II and Class III devices utilize the same HCPCS codes, however Class III devices and supplies are billed with a KF (item designated by FDA as Class III Devices) modifier. Reimbursement for Class III devices and supplies is greater than Class II devices and supplies.

In November 2025, the Office of Inspector General (OIG) released a report OEI-04-23-00430 titled, “Medicare Payments for Continuous Glucose Monitors and Supplies Exceeded Supplier Costs and Retail Market Prices, Indicating Medicare Can Save At Least Tens of Millions of Dollars in One Year,” which identified a spike in provider reimbursements from $109 million in 2018 to $1.3 billion in 2023. The OIG conducted a study of 1,000 claims across four strata: 250 claims each for Class II CGM devices, Class II supplies, Class III devices, and Class III supplies. The OIG identified a potential vulnerability related to improper coding of CGMs and associated supplies.

Reason for Review

The SMRC is tasked to perform data analysis and conduct medical record reviews on claims billed with HCPCS code E2102, E2103, A4238, and A4239 with dates of service January 1, 2024, through December 31, 2025.

The SMRC will conduct medical record reviews in accordance with applicable waivers/flexibilities/statutory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

Access related project details below.

• Documentation Requirements
• References

Documentation Requirements

Below is a list of specific documentation requirements that will be included in each ADR to obtain the necessary documentation to perform the review.

Providers/suppliers are requested to submit each of the Documentation Requirements outlined below, if and as applicable to the claim on review.

1. Standard Written Order (SWO) for the Continuous Glucose Monitor (CGM) receiver and supplies
2. Proof of Delivery for the CGM receiver and supplies
3. Documentation to support the CGM product name and model number
4. Documentation to support medical necessity for the supplies billed
5. Documentation/prescription to support that the beneficiary/caregiver has sufficient training of CGM device
6. Beneficiary’s medical records (which may include; practitioner medical records, hospital records, nursing home records, home care nursing notes, physical/occupational therapy notes) that support the item(s) provided is/are reasonable and necessary
7. Physician/Non Physician Practitioner (NPP) order or evidence of intent to order
8. Documentation from the prescribing/ordering physician
9. Medical record supporting the beneficiary had a face-to-face or telehealth visit with the treating/ordering practitioner within six months prior to ordering the CGM
10. Medical record documentation to support national and local requirements.
11. Providers/suppliers are encouraged to review the documentation prior to submission, to ensure that signature information is available when authenticity is not conclusively documented. Please include a signature log or signature attestation for any missing or illegible signature within the medical record
12. Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC)
13. Any other supporting/pertinent documentation
14. If medical record documentation is submitted via esMD: Beneficiary identification, date of service, and provider of the service should be clearly identified on each page of the submitted documentation
15. PLEASE NOTE: The supplier or provider is responsible for obtaining all documentation from the ordering/referring provider to ensure medical necessity criteria have been met.

References

Social Security Act (SSA), Title XI

• §1135 Authority to Waive Requirements During National Emergencies

SSA, Title XVIII

• §1815(a) Payment to Providers of Services
• §1833(e) Payment of Benefits
• §1834(a) Payment for Durable Medical Equipment
• §1861(n) Durable Medical Equipment Definition
• §1862(a)(1)(A) Exclusion from Coverage and Medicare as a Secondary Payer
• §1879(a)(1) Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
• §1893(a)(b) Medicare Integrity Program

42 Code of Federal Regulations (CFR)

• §411.15(k)(1) Particular services excluded from coverage
• §414.240 Procedures for making benefit category determinations and payment determinations for new durable medical equipment, prosthetic devices, orthotics and prosthetics, surgical dressings, and therapeutic shoes and inserts
• §424.5(a)(6) Conditions for Medicare Payment-Basic Conditions, Sufficient Information
• §424.57(c)(12) Special Payment Rules for Items Furnished by DMEPOS Suppliers and Issuance of DMEPOS Supplier Billing Privileges

Federal Register

• CMS. Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Final Rule (CMS-1738-F, CMS-1687-F and CMS-5531-F). December 21, 2021. Retrieved from Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Final Rule (CMS-1738-F, CMS-1687-F and CMS-5531-F) | CMS
• CMS. Medicare Program; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues, and Level II of the Healthcare Common Procedure Coding System (HCPCS); DME Interim Pricing in the CARES Act; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas. December 28, 2021. Retrieved from 2021-27763.pdf (govinfo.gov) .

Internet-Only Manual (IOM), Publication (Pub.) 100-02, Medicare Benefit Policy Manual (MBPM)

• Chapter (Ch.)14 Medical Devices
• Ch. 15 Covered Medical and Other Health Services
• Ch. 16 General Exclusion from Coverage

IOM, Pub.100-04, Medicare Claims Processing Manual (MCPM)

• Ch. 1 General Billing Requirements
• Ch. 20 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)
• Ch. 23 §20.9 National Correct Coding Initiative (NCCI)
• Ch. 30, §50 Advance Beneficiary Notice of Non-coverage (ABN)

IOM, Pub. 100-08, Medicare Program Integrity Manual (MPIM)

• Ch 3, Verifying Potential Errors and Taking Corrective Actions
• Ch. 5, § 5.2.1 Standard Written Order/Prescription (SWO)
• Ch. 5, §5.9 Documentation in the Patient’s Medical Record
• Ch. 5, § 5.10 Supplier Documentation
• Ch. 13, §13.5.4 Reasonable and Necessary Provisions in LCDs

CMS Coding Policies

• Pricing Data Analysis and Coding (PDAC) Continuous Glucose Monitors – Correct Coding and Billing – Revised. March 21, 2022. Retrieved from PDAC – Continuous Glucose Monitors – Correct Coding and Billing – Revised (dmepdac.com)

Local Coverage Determination (LCD)

• L33822 Glucose Monitors

Local Coverage Article (LCA)

• A52464 Glucose Monitor-Policy Article
• A55426 Standard Documentation Requirements for All Claims Submitted to DME MACs

Other

• Medicare Learning Network (MLN) MM12654. April Quarterly Update for 2022 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule. Effective April 1, 2022. Retrieved from MM12654 – April Quarterly Update for 2022 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule (cms.gov)
• MLN SE20011. Medicare FFS Response to the PHE on COVID-19. September 8, 2021. Retrieved from SE20011 (cms.gov)
• Office of Inspector General (OIG) November 2025. Medicare Payments for Continuous glucose Monitors and Supplies Exceeded Supplier Costs and Retail Market Prices, Indicating Medicare Can Save At Least Tens of Millions of Dollars in One Year. Report Number OEI-04-23-00430. Retrieved from Medicare payments for continuous glucose monitors and supplies exceeded supplier costs and retail market prices
• Pricing, Data, Analysis, and Coding (PDAC) website. Retrieved from https://dmepdac.com
• U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification website. Retrieved from FDA Website

Last Updated Apr 9, 2026