Common Topics and Questions Regarding Medicare Guidelines
Common Topics and Questions About Medicare Guidelines
The Patient Failed the PAP Therapy Compliance Period. What Do I Do Next?
Beneficiaries who fail the initial 12-week trial are eligible to requalify for a PAP device, but must have both:
- In-person clinical re-evaluation by the treating practitioner to determine the etiology of the failure to respond to PAP therapy; and
- A repeat sleep test in a facility-based setting (Type 1 study). This may be a repeat diagnostic, titration, or split-night study.
Replacement PAP Device
If a PAP device is replaced during the five-year reasonable useful lifetime (RUL) because of loss, theft, or irreparable damage due to a specific incident, there is no requirement for a new clinical evaluation, sleep test, or trial period.
If a PAP device is replaced following the five-year RUL, there must be an in-person evaluation by their treating practitioner that documents that the beneficiary continues to use and benefit from the PAP device. There is no requirement for a new sleep test or trial period.
New Patient Entering Medicare Benefit Program
For beneficiaries who received a PAP device prior to enrollment in fee for service (FFS) Medicare and are seeking Medicare coverage of either rental of the device, a replacement PAP device and/or accessories, both of the following coverage requirements must be met:
- Sleep test. There must be documentation that the beneficiary had a sleep test, prior to FFS Medicare enrollment, that meets the Medicare AHI/RDI coverage criteria in effect at the time that the beneficiary seeks Medicare coverage of a replacement PAP device and/or accessories; and
- Clinical evaluation. Following enrollment in FFS Medicare, the beneficiary must have an in-person evaluation by their treating practitioner who documents in the beneficiary’s medical record that the beneficiary:
a. Has a diagnosis of obstructive sleep apnea; and
b. Continues to use the PAP device.
If criterion 1 or 2 above are not met, the claim will be denied as not reasonable and necessary.
In these situations, there is no requirement for a clinical re-evaluation or for objective documentation of adherence.
Respiratory Assist Devices: Severe COPD Medical Criteria
An E0470 device is covered if criteria 1-3 are met:
- An arterial blood gas PaCO2, done while awake and breathing the beneficiary’s prescribed FIO2, is greater than or equal to 52mm Hg.
- Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for greater than or equal to a cumulative 5 minutes of nocturnal recording time (minimum recording time of 2 hours), done while breathing oxygen at 2 LPM or the beneficiary’s prescribed FIO2 (whichever is higher).
- Prior to initiating therapy, sleep apnea and treatment with a continuous positive airway pressure device (CPAP) has been considered and ruled out. Note: Formal sleep testing is not required if there is sufficient information in the medical record to demonstrate that the beneficiary does not suffer from some form of sleep apnea (obstructive sleep apnea (OSA), CSA and/or CompSA) as the predominant cause of awake hypercapnia or nocturnal arterial oxygen desaturation.
If all of the above criteria for beneficiaries with COPD are met, an E0470 device will be covered for the first three months of therapy.
If all of the above criteria are not met, E0470 and related accessories will be denied as not reasonable and necessary.
An E0471 device will be covered for a beneficiary with COPD in either of the two situations below, depending on the testing performed to demonstrate the need.
Situation 1. For severe COPD beneficiaries who qualified for an E0470 device, an E0471 started any time after a period of initial use of an E0470 device is covered if both criteria 1 and 2 are met.
- An arterial blood gas PaCO2, done while awake and breathing the beneficiary’s prescribed FIO2, shows that the beneficiary’s PaCO2 worsens greater than or equal to 7mm Hg compared to the original result from criterion 1 (above).
- A facility-based PSG demonstrates oxygen saturation less than or equal to 88% for greater than or equal to a cumulative 5 minutes of nocturnal recording time (minimum recording time of 2 hours) while using an E0470 device that is not caused by obstructive upper airway events – i.e., AHI less than 5. (Refer to the positive airway pressure (PAP) devices for the treatment of obstructive sleep apnea LCD for information about E0470 coverage for obstructive sleep apnea.)
Situation 2. For severe COPD beneficiaries who qualified for an E0470 device, an E0471 device will be covered if, at a time no sooner than 61 days after initial issue of the E0470 device, both of the following criteria 1 and 2 are met:
- An arterial blood gas PaCO2 is done while awake and breathing and the beneficiary’s prescribed FIO2 still remains greater than or equal to 52mm Hg.
- Sleep oximetry while breathing with the E0470 device demonstrates oxygen saturation less than or equal to 88% for greater than or equal to a cumulative 5 minutes of nocturnal recording time (minimum recording time of 2 hours), done while breathing oxygen at 2 LPM or the beneficiary’s prescribed FIO2 (whichever is higher).
If E0471 is billed but the criteria described in either situation 1 or 2 are not met, it will be denied as not reasonable and necessary.
Respiratory Assist Devices: Central Sleep Apnea or Complex Sleep Apnea Medical Criteria
An E0470 or E0471 device is covered when, prior to initiating therapy, a complete facility-based, attended PSG is performed documenting the following (1 and 2):
- The diagnosis of CSA or CompSA; and
- Significant improvement of the sleep-associated hypoventilation with the use of an E0470 or E0471 device on the settings that will be prescribed for initial use at home, while breathing the beneficiary’s prescribed FIO2.
If both of the above criteria are met, either an E0470 or an E0471 device (based on the judgment of the treating practitioner) will be covered for beneficiaries with documented CSA or CompSA for the first three months of therapy.
If both of the above criteria are not met, then E0470 or E0471 and related accessories will be denied as not reasonable and necessary.
Continued Coverage Criteria for Respiratory Assist Devices E0470 and E0471 Beyond the First Three Months of Therapy
Beneficiaries covered for the first three months of an E0470 or an E0471 device must be re-evaluated to establish the medical necessity of continued coverage by Medicare beyond the first three months. While the beneficiary may certainly need to be evaluated at earlier intervals after this therapy is initiated, the re-evaluation upon which Medicare will base a decision to continue coverage beyond this time must occur no sooner than 61 days after initiating therapy by the treating practitioner. Medicare will not continue coverage for the fourth and succeeding months of therapy until this re-evaluation has been completed.
There must be documentation in the beneficiary’s medical record about the progress of relevant symptoms and beneficiary usage of the device up to that time. Failure of the beneficiary to be consistently using the E0470 or E0471 device for an average of 4 hours per 24-hour period by the time of the re-evaluation (on or after 61 days after initiation of therapy) would represent noncompliant utilization for the intended purposes and expectations of benefit of this therapy. This would constitute reason for Medicare to deny continued coverage as not reasonable and necessary.
A signed and dated statement completed by the treating practitioner no sooner than 61 days after initiating use of the device, declaring that the beneficiary is compliantly using the device (an average of 4 hours per 24-hour period) and that the beneficiary is benefiting from its use, must be obtained by the supplier of the device for continued coverage beyond three months.
If the above criteria are not met, continued coverage of an E0470 or an E0471 device and related accessories will be denied as not reasonable and necessary.
Respiratory Assist Devices: Beneficiaries Entering Medicare
For beneficiaries who received an E0470 or E0471 device prior to enrollment in fee-for-service (FFS) Medicare and are seeking Medicare reimbursement for a rental, either to continue using the existing device or for a replacement device, coverage transition is not automatic. These claims are considered to be new, initial rentals for Medicare. Therefore, all current coverage and documentation requirements set out in this policy must be met with the exceptions noted below.
Qualification testing. Use of testing performed prior to Medicare eligibility is allowed. There must be documentation that the beneficiary had the testing required by the applicable scenario, e.g., oximetry, sleep testing, or spirometry, prior to FFS Medicare enrollment, that meets the current coverage criteria in effect at the time that the beneficiary seeks Medicare coverage of a replacement device and/or accessories; and
Clinical evaluation. Following enrollment in FFS Medicare, the beneficiary must have an in-person evaluation by their treating practitioner who documents all of the following in the beneficiary’s medical record:
- The beneficiary has the qualifying medical condition for the applicable scenario; and
- The testing performed, date of the testing used for qualification and results; and
- The beneficiary continues to use the device; and
- The beneficiary is benefiting from the treatment.
Medicare Non-Invasive Ventilators Medical Criteria
The Centers for Medicare & Medicaid Services (CMS) National Coverage Determinations Manual (CMS Pub. 100-03) in Chapter 1, Part 4, Section 280.1, stipulates that ventilators (E0465, E0466, and E0467) are covered for the following conditions:
Neuromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure consequent to chronic obstructive pulmonary disease.
Each of these disease categories are comprised of conditions that can vary from severe and life-threatening to less serious forms. These ventilator-related disease groups overlap conditions described in this respiratory assist devices medical policy criteria used to determine coverage for bi-level PAP devices. Each of these disease categories are conditions where the specific presentation of the disease can vary from beneficiary to beneficiary. For conditions such as these, the specific treatment plan for any individual beneficiary will vary as well. Choice of an appropriate treatment plan, including the determination to use a ventilator vs. a bi-level PAP device, is made based upon the specifics of each individual beneficiary’s medical condition. In the event of a claim review, there must be sufficient detailed information in the medical record to justify the treatment selected.
Additional Suggested Documentation for Non-Invasive Ventilator Admission
- History of hospital readmission.
- Clinical evidence of why bi-level therapy is not appropriate.
- Documentation validating non-invasive ventilation settings improve patient’s medical condition.
- Test results documenting disease severity:
- PaCo2 greater or equal to 52mmHGPulmonary function test: FEV less than 50% predicted or maximal inspiratory pressure less than 60cm H2OEnd tidal CO2 monitoring
- X-rays, ultrasound, MRI, CT scan
- Clinical progress notes demonstrating tolerance and improvement on the prescribed non-invasive ventilator setting.