DME MAC A will be initiating a widespread prepayment probe review of claims for Positive Airway Pressure (PAP) Device (E0601). The review is being initiated due to a high volume of claim errors found by the Comprehensive Error Rate Testing (CERT) Contractor.

Suppliers will be sent a documentation request for information listed below. The requested documentation must be returned within 30 days from the date of the letter to avoid claim denials. According to the announcement from NHIC Corp, documentation should include the following per LCD (L11528):

For initial coverage, the ordering physician is responsible for the following documentation:

A. A detailed order that includes the following:
a. Patient name
b. The description of item(s) to be dispensed
c. The ordering physician’s legible signature
d. The date of the ordering physician’s signature

NOTE: In addition, orders for continuing supplies should include appropriate information on the quantity used, frequency of change, and duration of need. Refer to PIM 5.2.3 for details.

B. A face-to-face clinical evaluation by the treating physician prior to the sleep study test to assess the patient for obstructive sleep apnea,

C. A Medicare-covered sleep test that meets either of the following criteria:
    1. The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events with a minimum of 30 events; or

2. The AHI or RDI is greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and documentation of:
    • Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or
    • Hypertension, ischemic heart disease, or history of stroke

D. The patient and/or their caregiver have received instruction from the supplier of the PAP device and accessories in the proper use and care of the equipment.

Continued coverage beyond the first 3 months of therapy requires that, no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating physician must conduct a clinical re-evaluation and document that the beneficiary is benefiting from PAP therapy.

The ordering physician is responsible for the following documentation:

A. A face-to-face clinical re-evaluation by the treating physician with documentation that symptoms of obstructive sleep apnea are improved; and

B. Objective evidence of adherence to use of the PAP device, reviewed by the treating physician.

NOTE: Documentation of adherence to PAP therapy shall be accomplished through direct download or visual inspection of usage data with documentation provided in a written report format to be reviewed by the treating physician and included in the beneficiary’s medical record.
Beneficiaries who fail the initial 12-week trial are eligible to requalify for a PAP device but must have both:

A. A face-to-face clinical evaluation by the treating physician to determine the etiology of the failure to respond to PAP therapy; and
B. A repeat test in a facility-based setting (Type 1 study).

For detailed descriptions of the five types of covered sleep studies and/or complete coverage information, you may access the Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (LCD) L11528 at the following Web site: [removed] [/removed]

Additional information about PAP devices may also be found at the following Web site link:
[removed] [/removed]

A common problem in these reviews is missing or incomplete records. Please ensure when submitting documentation requests that all requested documentation is included with your file and respond in a timely manner.