01-155 CGMs After the PHE Notification of Medical Review

Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the CMS, is conducting post-payment review of claims for Medicare DME billed on dates of service from November 12, 2023 through September 22, 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 (CGMs) 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 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. The receiver is the component covered under the durable medical equipment (DME) benefit.

There are two types of wearable CGM receivers. Adjunctive CGMs require beneficiaries to check their blood sugar with a fingerstick before adjusting insulin. Non-adjunctive CGMs support insulin dosing decisions without requiring a fingerstick. Both types of receivers are covered by CMS. Following the conclusion of the Public Health Emergency (PHE), a revision to Local Coverage Determination (LCD) L33822, Glucose Monitors, effective April 16, 2023, updated the CGM eligibility criteria. The revised policy now supports coverage for beneficiaries who are insulin-treated and removes the previous requirement of administering insulin three or more times daily or using a continuous, subcutaneous insulin infusion pump.

Reason for Review

The SMRC is tasked to perform data analysis and conduct medical record reviews on claims billed with HCPCS code E2103 with dates of service November 12, 2023, through September 22, 2025.

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

Claim Sample Detail

HCPCS Code Description
E2103 Non-adjunctive, non-implanted continuous glucose monitor or receiver

Access related project details below.

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)
  2. Proof of Delivery
  3. Documentation to support the Continuous Glucose Monitor (CGM) product name and model number
  4. Documentation/prescription to support that the beneficiary/caregiver has sufficient training of CGM device
  5. 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
  6. Physician/Non Physician Practitioner (NPP) order or evidence of intent to order
  7. Documentation from the prescribing/ordering physician
  8. Medical record supporting the beneficiary had a face-to-face or telehealth visit with the treating/ordering practitioner
  9. Medical record documentation to support national and local requirements.
  10. 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
  11. Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC)
  12. Any other supporting/pertinent documentation
  13. 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
  14. PLEASE NOTE: It is the responsibility of the supplier or provider to obtain 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

Social Security Act (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

  • Final Rule, Volume 86, Number 246. 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. Effective December 28, 2021. Retrieved from 2021-27763.pdf (govinfo.gov) external link icon.

CMS Rulings

Internet Only Manual (IOM), Publication (Pub.) 100-03, Medicare National Coverage Determination Manual (NCD)

  • NCD 40.2 Home Blood Glucose Monitors
  • NCD 280.1 Durable Medical Equipment

IOM, 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. 4, § 4.7.3.1 Supplier Proof of Delivery Documentation Requirements
  • Ch. 5, § 5.2.1 Physician Orders
  • 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) external link icon

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

Last Updated Jan 16, 2026