Positive Airway Pressure (PAP) Devices
| Review Type || Description |
| Medical Review || View notifications and findings of pre and post claim reviews completed by Noridian Medical Review Staff |
| Topic || Reminder |
| Adherence || |
- The LCD was revised to include allowance for visual inspection based on comments that not all suppliers use devices that allow downloading of adherence information. Visual inspection means determining adherence by looking at information on the PAP device's display screen and documenting the values in a written report. The supplier may contact the beneficiary via telephone and ask them to read values from their device (i.e., phone-in compliance) or the supplier or physician may read the values during a home/office visit.
- Devices with an hour meter that simply reports "device on" time or "blower on" time will not provide enough information, for documenting adherence, to determine that the PAP device was used according to coverage criteria.
- Several manufacturers have devices that report "sessions" of use. These types of devices are possibly acceptable to meet LCD requirements for adherence. It depends on the definition of "session" which can vary based on the manufacturer or the session definition if a user-defined option.
- Devices that report information on a rolling 30 day interval can be problematic if using visual inspection as the reporting method. Engage the beneficiary in their care and emphasize the importance of monitoring their therapy, including the potential loss of Medicare reimbursement for their PAP device due to failure to meet the adherence requirements. The supplier should instruct the beneficiary to monitor their device after the initial 30 days of use and report back to the supplier the point at which they meet the adherence metric.
- Suppliers do not need to continue to document adherence after the initial three month period. Following the initial three month trial and documentation of meeting coverage criteria, suppliers should document continued use of the device. This may be accomplished via documentation of attestation by the beneficiary.
- Continued coverage of PAP therapy cannot be extended to beneficiaries who come close to meeting the adherence metric requirements but don't quite achieve all of them in the 90 day timeframe. All of the requirements must be met within the 90 day time frame.
| Change in Therapy || |
- If the beneficiary had a face-to-face exam in the 31 to 91 day period while on a CPAP device, another face-to-face exam is required if RAD is initiated during this time. The LCD recognizes that some beneficiaries may require a change in therapy to a RAD device and this transition may happen late in the first 90 day period such that an extension to 120 days is necessary.
| Sleep Test || |
- A DME supplier is not a qualified provider of laboratory services. No aspect of an HST [home sleep test], including but not limited to delivery and/or pickup of the device, may be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.
| Time Limit || |
- There is no time limit from the initial face-to-face evaluation to the sleep study; however, one would anticipate that these two events occur reasonably close together in time, typically within three months.
| Treating Physician || |
- Medicare statute defines treating physician as one "…who furnishes a consultation or treats the beneficiary for a specific medical problem and who uses the [diagnostic x-ray tests, diagnostic laboratory tests and other diagnostic tests] results in the management of the beneficiary's specific medical problem." In a scenario where the beneficiary visits their primary care provider (PCP) who then refers the beneficiary to a sleep specialist for a polysomnogram and subsequent treatment with PAP and follow-up, both the PCP and the sleep specialist would be considered a "treating physician" within the context of Medicare regulations. Both physicians are engaged in diagnosing and treating the beneficiary for sleep disordered breathing. This scenario is quite common in medical practice where the primary medical care for the patient is rendered by the PCP and subspecialty physician consultation is engaged for specific diagnostic and/or therapeutic treatment outside the scope of the PCP's area of medical expertise.
- Nurse practitioners, clinical nurse specialists and physician assistants are allowed to conduct the initial clinical evaluation and/or follow-up evaluation. The Social Security Act §1861(s) addresses the provision of Medical and Other Services.
- The treating physician that does the initial face-to-face exam does not have to be the same physician that orders the CPAP.
| Trial Period || |
- If a beneficiary is admitted to an inpatient hospital or skilled nursing facility (SNF), during their 12 week trial period, the trial period is suspended. The 12 week trial period applies to PAP use in the home setting. The trial period, including the requirement for adherence monitoring and the timing of the face-to-face re-evaluation (i.e., between the 31st and 91st day) resumes when the beneficiary returns home.
- Beginning on Day 61 of the trial period, if the supplier has knowledge that the beneficiary is not making efforts to meet policy criteria for continued coverage or there is other reason to anticipate that continued coverage will be denied, a mandatory ABN may be issued. The beneficiary should choose an option box, and sign and date the ABN when a mandatory ABN is issued. This ABN should advise the beneficiary that if, by the 90th day of therapy, s/he does not meet the policy criteria for continue coverage (e.g., adherent to therapy and obtain a follow-up face-to-face evaluation), Medicare may deny subsequent claim(s) and the beneficiary will be liable for payment.
- If compliance is not documented in the first 90 days and the beneficiary then has a new facility-based polysomnogram and face-to-face evaluation with a physician and a new trial period is begun, a new capped rental period does not begin. Standard break-in-need rules apply because there has been no change in the underlying condition that necessitates the PAP therapy.
Last Updated Oct 18, 2017