Policy Reminder - PAP Devices - Continued Coverage beyond the First Three Months of Therapy - JA DME

A review of recent appeals information has identified denials associated with demonstrating compliance with the PAP Local Coverage Determination (LCD) requirements for continued coverage after the initial three months rental. This article is intended as a review of those criteria.

GENERAL REQUIREMENTS

PAP is covered for beneficiaries with obstructive sleep apnea (OSA). The presence of OSA is documented by clinical evaluation and sleep testing. Refer to the LCD for a discussion of the requirements necessary to establish coverage with a diagnosis of obstructive sleep apnea.

Once the diagnosis of OSA is established, the initial three rental months are covered. But by the end of the first three months, there are additional requirements that must be met in order for equipment rental and supply payments to continue. Compliance with these requirements must be documented in the beneficiary's medical record. When the requirements are not met, coverage for more than the first three months is not possible.

There are two requirements for continued coverage. They are:

1. The treating physician must have an in-person visit with the beneficiary no sooner than the 31st day but no later than the 91st day after initiating therapy, conduct a clinical re-evaluation and document that the beneficiary is benefiting from PAP therapy.
2. There must be objective evidence of the beneficiary's adherence to the use of the PAP device. Adherence to therapy is defined as use of PAP =4 hours per night on 70% of nights during a consecutive thirty (30) day period anytime during the first three (3) months of initial usage. This information must be reviewed by the treating physician and included in the medical record.

FAILURE TO MEET PAYMENT REQUIREMENTS

If the above criteria are not met, continued coverage of a PAP device and related accessories beyond the first three months is not possible. Claims for the fourth month and beyond will be denied as not reasonable and necessary.

If the physician re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the beneficiary is benefiting from PAP therapy as defined in criteria 1 and 2 above, continued coverage of the PAP device will commence with the date of that re-evaluation.

Beneficiaries who fail the initial 12 week trial are eligible to re-qualify for a PAP device but must have both:

1. Face-to-face clinical re-evaluation by the treating physician to determine the etiology of the failure to respond to PAP therapy; and,
2. Repeat sleep test in a facility-based setting (Type 1 study). This may be a repeat diagnostic, titration or split-night study.

CHANGE IN EQUIPMENT

If an E0601 device is tried and found ineffective during the initial facility-based titration or home trial, substitution of an E0470 does not change the length of the trial unless there is less than 30 days remaining in the trial period. If more than 30 days remain in the trial period, the clinical re-evaluation would still occur between the 31st and 91st day following the initiation of an E0601 and objective documentation of adherence on the E0470 would need to occur prior to the 91st day following initiation of the E0601. If less than 30 days remain in the trial period, the clinical re-evaluation and objective documentation of adherence must occur before the 120th day following the initiation of the E0601.

If an E0601 device was used for more than 3 months and the beneficiary was then switched to an E0470, the clinical re-evaluation must occur between the 31st and 91st day following the initiation of the E0470. There would also need to be documentation of adherence to therapy during the 3 month trial with the E0470.

DOCUMENTATION REQUIREMENTS

Both PAP devices (E0601 and E0740) are subject to the Affordable Care Act Section 6407 (ACA) requirements. The ACA requires that there be an in-person encounter with a healthcare provider sometime in the 6 months preceding the prescribing of the item. This visit must address some element of the underlying condition(s) that are the basis for the need for the item. The prescription must be a properly completed Medicare "Detailed Written Order". This document is often referred to as a "Written Order Prior to Delivery (WOPD)". This WOPD and the documentation of the face-to-face visit must be in the supplier's file before delivery of the item can occur.

Suppliers are reminded that all Medicare coverage and documentation requirements for the PAP LCD also apply. There must be sufficient information included in the medical record to demonstrate that all of the applicable coverage criteria are met. This information must be available upon request.

Refer to the Positive Airway Pressure Devices LCD and related policy article for additional information about coverage, coding and documentation.