HCPCS code E0601: Continuous Positive Airway Pressure (CPAP) device

Read more on how to accurately use and bill for HCPCS code E0601 with the billing and documentation requirements in our short guide.

Use Code

## **What is HCPCS code E0601?** HCPCS Level II code E0601 (maintained by CMS) describes a continuous positive airway pressure (CPAP) device, which falls under the category of durable medical equipment (DME). CPAP therapy is a widely used medical service prescribed mainly for patients with obstructive sleep apnea (OSA). By delivering a constant stream of air, the device helps keep the airway open during sleep, improving oxygenation, reducing apnea events, and supporting better overall health. Although HCPCS Level II codes are managed by CMS rather than the American Medical Association (AMA), providers often use them alongside CPT® codes (maintained by the AMA) when documenting and billing for medical services. Medicare and most other payers treat CPAP devices as capped rental items. This means the supplier bills monthly for up to 13 months. After 13 paid rental months, ownership automatically transfers to the patient, and rental billing stops. CPAP therapy is an effective long-term treatment that can significantly improve sleep quality and reduce related complications.

## **HCPCS code E0601 documentation requirements** To ensure Medicare coverage, the patient's medical record must contain specific documentation to prove medical necessity. This includes: - **Diagnosis of OSA**: A diagnosis confirmed by a sleep test, such as a polysomnogram performed in a sleep lab or a home sleep test. - **Sleep test results**: The test must meet specific criteria for the Apnea-Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI). AHI or RDI ≥ 15 events per hour with a minimum of 30 events. AHI or RDI ≥ 5 and ≤ 14 events per hour with a minimum of 10 events AND documentation of related symptoms like excessive daytime sleepiness, cognitive impairment, or a history of hypertension, ischemic heart disease, or stroke. - **Face-to-face clinical evaluation**: A treating physician must conduct an in-person evaluation before the sleep test to assess the patient for OSA. - **Detailed Written Order (DWO) or Standard Written Order (SWO)**: The treating physician's order must include the patient's name, the order date, a general description of the item (e.g., CPAP device), the practitioner's name and signature, and the date of their signature. - **Proof of delivery**: Documentation proving the device was delivered to the patient. The patient or caregiver must receive instruction from the supplier on proper use and care of the device. This must be obtained prior to device delivery. - **Continued coverage documentation**: For coverage beyond the initial three-month trial, the patient must have a follow-up visit with their physician between the 31st and 91st day of use. Documentation must show that the patient's symptoms have improved and that they are adhering to the therapy. Adherence is typically defined as using the device for at least 4 hours per night on 70% of nights within a consecutive 30-day period.

## **E0601 billing requirements** Billing for E0601 follows a "capped rental" model for Medicare and many private payers. To ensure proper reimbursement for the code, the following requirements must be considered: - **Initial rental period**: The device is rented for a continuous 13-month period. **Months 1-3**: Claims must include a **KX modifier** to indicate that the initial coverage criteria have been met. **Months 4-13**: Claims must continue to use the **KX modifier** to indicate that both initial and continued coverage criteria (adherence) have been met. - **Purchase**: After 13 months of paid rental, the title of ownership of the device transfers from the provider to the patient. - **Accessories**: Accessories and supplies (e.g., masks, tubing, humidifiers) are billed separately. The humidifier (E0562) is often billed separately, even if integrated into the device. You'll use the same serial number for both the CPAP and the humidifier line item, sometimes adding a letter like "H" to differentiate them in billing software.

## **Other relevant codes** - **E0470**: Respiratory assist device, bi-level pressure capability, without backup rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device) - **E0471**: Respiratory assist device, bi-level pressure capability, with back-up rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device) - **E0562**: Humidifier, heated, used with a positive airway pressure device - **A7030**: Full face mask used with positive airway pressure device, each - **A7034**: Nasal interface (mask or cannula) used with a PAP device - **A7035**: Headgear used with a PAP device - **A7037**: Tubing, with or without a swiveling adapter, for use with a PAP device - **A7038**: Disposable filter for a PAP device - **A7039**: Non-disposable filter for a PAP device

Frequently asked questions

Benefit begins if: (1) there’s an in-person evaluation before sleep testing; (2) sleep study shows AHI/RDI ≥ 15 events/hour (or 5–14 with documented symptoms or comorbidities); and (3) patient/caregiver receives usage instruction.

Beginning with month four and thereafter, add KX modifier only if there’s documentation of a re-evaluation between day 31–91, clinical improvement, and PAP therapy adherence. Otherwise, claims should omit KX or be temporarily withheld until documentation is secured.

Medicare classifies E0601 as a capped rental item. After 13 months, the supplier may either provide a replacement PAP device or the supplier may purchase the device (depending on policy), but cannot continue rental billing.