Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the Centers of Medicare and Medicaid Services (CMS), is conducting post-payment review of claims for Medicare durable medical equipment (DME) for replacement positive airway pressure (PAP) devices billed with dates of service (DOS) January 1, 2024 through December 31, 2024. 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

Medicare covers positive airway pressure (PAP) device therapy as the first-line of treatment for obstructive sleep apnea (OSA), a sleep-related breathing disorder characterized by repeated upper-airway obstruction during sleep, resulting in intermittent pauses in breathing. Devices that deliver PAP maintain airway patency by preventing reductions or cessation of airflow. Continuous positive airway pressure (CPAP) devices deliver a single, continuous level of air pressure to prevent airway collapse, while bilevel positive airway pressure (BiPAP) devices provide two distinct pressure levels. Medicare coverage for BiPAP devices is limited to cases in which CPAP therapy has been tried and demonstrated to be ineffective based on a therapeutic trial conducted.

In April 2026, the Office of Inspector General (OIG) released a report A-05-21-00036 titled, “Medicare Payments for Positive Airway Pressure Devices Used for the Treatment of Obstructive Sleep Apnea Generally Complied with Medicare Requirements”. The OIG selected a random small sample of claims for PAP devices, used to treat OSA, and found that documentation lacked one or more of the coverage requirements for replacement PAP devices. Based on these findings, the OIG estimated approximately $15.2 million in Medicare payments were made for PAP device claims during the audit period that did not meet applicable billing requirements.

Reason for Review

The SMRC is tasked to perform data analysis and conduct medical record reviews on replacement PAP device claims billed with Healthcare Common Procedure Coding System (HCPCS) codes E0470 and E0601 with dates of service January 1, 2024, through December 31, 2024.

The SMRC will conduct medical record reviews in accordance with applicable 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. 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 for the date of service under review
2. Standard Written Order (SWO) for the replacement PAP device for the date of service under review
3. Proof of Delivery for the replacement PAP device for the date of service under review
4. Medical record documentation to support if the PAP device was replaced during the 5-year reasonable useful lifetime (RUL) because of loss, theft, or irreparable damage due to a specific incident
5. Medical record documentation to support an in-person evaluation was performed by the treating practitioner that supports the beneficiary has obstructive sleep apnea and continues to use and benefit from the PAP device when it was replaced after the 5-year reasonable useful lifetime (RUL)
6. Documentation to support if the beneficiary received the PAP device prior to enrollment to fee-for-service (FFS) Medicare
7. Enrollees new to Medicare seeking coverage for rental of a device or a replacement, require documentation of a prior sleep test supporting OSA and a new in person evaluation
8. If the beneficiary has same or similar equipment, documentation indicating the reason new equipment is necessary
9. Medical record documentation supporting a primary diagnosis of obstructive sleep apnea (OSA)
10. Any other supporting/pertinent documentation
11. Medical record documentation to support national and local requirements
12. Providers and/or suppliers are encouraged to review the documentation prior to submission, to ensure that signature information is available. Please include a signature log or signature attestation for any missing or illegible signature within the medical record
13. If an electronic health record is utilized, include your facility’s process of how the electronic signature is created. Include an example of how the electronic signature, date, and time display once signed by the physician
14. Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC)
15. 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

References

Social Security Act (SSA), Title XVIII

• Section (§)1815(a) Payment to Providers of Services
• §1833(e) Payment of Benefits
• §1834(a) Payment for Durable Medical Equipment
• §1834(a)(7)(C)(i),(ii) and (iii) Replacement of Items
• §1861(s)(6) Medical and Other Health Services
• §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
• §414.210(f)(1) Payment for Replacement of Equipment
• §424.5(a)(6) 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 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), Medicare National Coverage Determination Manual (NCD), Publication (Pub.) 100-03

• Chapter (Ch.) 1 Coverage Determinations, Part 4 Section 240.4, Continuous Positive Airway Pressure (CPAP) Therapy For Obstructive Sleep Apnea (OSA)

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

• Ch. 15 Covered Medical and Other Health Services
• Ch. 16 General Exclusion from Coverage

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

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

• Ch. 3, Verifying Potential Errors and Taking Corrective Actions
• Ch. 5, § 5.2 Rules Concerning DMEPOS Orders Prescriptions
• Ch. 5, § 5.9 Documentation in the Patient’s Medical Record
• Ch. 5, § 5.10 Supplier Documentation
• Ch. 5, § 5.11 Evidence of Medical Necessity
• Ch. 13, §13.5.4 Reasonable and Necessary Provisions in LCDs

Local Coverage Determination (LCD)

• L33718 Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea

Local Coverage Article (LCA)

• A52467 Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea – Policy Article
• A55426 Standard Documentation Requirements for All Claims Submitted to DME MACs

Other

• Office of Inspector General (OIG) April 2026. Medicare Payments for Positive Airway Pressure Devices Used for the Treatment of Obstructive Sleep Apnea Generally Complied With Medicare Requirements. Report Number A-05-21-00036. Retrieved from: https://oig.hhs.gov/documents/audit/11583/A-05-21-00036.pdf

Last Updated Jul 10, 2026