| Adherence |
- 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 PAP device's display screen and documenting values in a written report. Supplier may contact beneficiary via telephone and ask them to read values from his/her device (i.e., phone-in compliance) or supplier or physician may read 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 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
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| Change in Therapy |
- If beneficiary had a face-to-face exam in 31 to 91 day period while on a CPAP device, another face-to-face exam is required if RAD is initiated during this time. LCD recognizes that some beneficiaries may require a change in therapy to a RAD device and this transition may happen late in first 90 day period such that an extension to 120 days is necessary
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| Non-consumables |
- Non-consumable supplies may be replaced when they are non-functional. Usual maximums listed in LCD should not be construed as a routine or automatic replacement schedule or amount. If an item is still working and in good condition, there is no need to replace it. Suppliers are required to confirm and document amount and condition of supplies before sending out replacements
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| PAP supplies |
- One common reason for denial of PAP supplies is due to lack of verification that the patient owns or rents PAP device. If patient has received a PAP device prior to Medicare eligibility, claim for supplies must include HCPCS, indication of beneficiary ownership, and date of purchase of PAP device. This information must be entered in Item 19 on CMS-1500 paper claim form or NTE2300 or NTE2400 loops of an electronic claim
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| Phillips Respironics Recall |
Review the Medical Directors article regarding the Frequently Asked Questions on Philips Respironics Respiratory Products Recall |
| Sleep Test |
- 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
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| Time Limit |
- There is no time limit from initial face-to-face evaluation to sleep study; however, one would anticipate that these two events occur reasonably close together in time, typically within three months
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| 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 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
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| Trial Period |
- 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
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