Positive Airway Pressure (PAP) Devices - JD DME

• 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 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 manufacturer or 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 reporting method. Engage beneficiary in his/her care and emphasize importance of monitoring his/her therapy, including potential loss of Medicare reimbursement for PAP device due to failure to meet adherence requirements. Supplier should instruct beneficiary to monitor his/her device after initial 30 days of use and report back to supplier the point at which he/she meets adherence metric
• Suppliers are not required to continue to document adherence after initial three month period. Following initial three month trial and documentation of meeting coverage criteria, suppliers should document continued use of device which may be accomplished via documentation of attestation by beneficiary
• Continued coverage of PAP therapy cannot be extended to beneficiaries who come close to meeting adherence metric requirements but don't quite achieve all of them in the 90 day timeframe. All requirements must be met within the 90 day time frame

For beneficiaries new to Medicare who are already on PAP therapy, there must be documentation of the most recent sleep study meeting Medicare's current criteria, as well as a clinical evaluation on or after Medicare enrollment documenting a diagnosis of obstructive sleep apnea (OSA) and continued use. A new Standard Written Order (SWO) is required to begin billing Medicare FFS. If the PAP device was previously billed to Medicare FFS and the beneficiary switches to a Medicare health maintenance organization (HMO), billing would resume where it left off once the beneficiary switches back to Medicare FFS. In that case, documentation should be available to support continued use and continued medical need.

The order must list the PAP device and related supplies. The description may be general or have multiple options listed, for example:

• CPAP Mask
• Mask of Choice
• Mask - Fit to Comfort
• Mask - One per three months

This applies to the mask and other related accessories such as tubing, cushions, pillows, and headgear.

Suppliers must ensure that the beneficiary information is on file with Medicare Fee for Service (FFS) to avoid denials. Claims for supplies and accessories used with beneficiary owned equipment must include all three pieces of information listed below. Claims lacking any one of these elements will be denied for missing information. Narrative added to each claim line, item 19 of the 1500 claim form or the 2400/NTE segment of an electronic claim until base item is on file:

• HCPCS code of base equipment; and
• A notation equipment is beneficiary-owned; and,
• Date beneficiary obtained equipment (approximate)
  • i.e., Beneficiary owned HCPCS; purchased month and year

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 results of studies conducted by hospitals certified to do such tests.

While a few months delay in obtaining a CPAP could be understandable, over a year would be harder to justify. A new evaluation by the treating practitioner would be needed to explain the delay and, because a lot of things can change medically/physically for the beneficiary in that year, a new sleep test or titration study may be appropriate.

• 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 beneficiary visits his/her primary care provider (PCP) who then refers him/her to a sleep specialist for a polysomnogram and subsequent treatment with PAP and follow-up, both PCP and sleep specialist are considered a "treating physician" within 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 primary medical care for patient is rendered by PCP and subspecialty physician consultation is engaged for specific diagnostic and/or therapeutic treatment outside the scope of PCP's area of medical expertise.
• Nurse practitioners, clinical nurse specialists and physician assistants are allowed to conduct initial clinical evaluation and/or follow-up evaluation. Social Security Act §1861(s) addresses provision of Medical and Other Services.
• Treating physician who performs initial face-to-face exam does not have to be same physician that orders CPAP.

• If beneficiary is admitted to an inpatient hospital or skilled nursing facility (SNF), during his/her 12 week trial period, trial period is suspended. The 12 week trial period applies to PAP use in home setting. The trial period, including requirement for adherence monitoring and timing of face-to-face re-evaluation (i.e., between 31st and 91st day) resumes when beneficiary returns home.
• Beginning on Day 61 of trial period, if supplier has knowledge that 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. Beneficiary should choose an option box, and sign and date ABN when a mandatory ABN is issued. ABN should advise beneficiary that if, by 90th day of therapy, he/she does not meet 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 beneficiary will be liable for payment.
• If compliance is not documented in first 90 days and 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 underlying condition that necessitates PAP therapy.

How to handle reporting test results and determining coverage when the values are not whole numbers. This most often occurs for oxygen saturation results (either arterial blood gas or pulse oximetry) and sleep tests, where the apnea/hypopnea index (AHI) or respiratory disturbance index (RDI) results are expressed with a decimal place. In both instances, standard numerical rounding rules apply. For example, consider a sleep test where the AHI is reported as below:

• If the value is 12.01 to 12.49, round down to 12
• If the value is 12.50 to 12.99, round up to 13