BiPAP

INITIAL COVERAGE:

In this policy, the term PAP (positive airway pressure) device will refer to both a single-level continuous positive airway pressure device (E0601) and a bi-level respiratory assist device without back-up rate (E0470) when it is used in the treatment of obstructive sleep apnea.

I. An E0601 device device is covered for the treatment of obstructive sleep apnea (OSA) if criteria A - C are met:

A. The patient has a face-to-face clinical evaluation by the treating physician prior to the sleep test to assess the patient for obstructive sleep apnea.

B. The patient has sleep test that meets either of the following criteria (1 or 2):

1. The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per hour with a minimum of 30 events; or,

2. The AHI or RDI is greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and documentation of:

a. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,

b. Hypertension, ischemic heart disease, or history of stroke.

C. The patient and/or their caregiver has received instruction from the supplier of the device in the proper use and care of the equipment.

If a claim for an E0601 is submitted and all of the criteria above have not been met, it will be denied as not reasonable and necessary.

II. An E0470 device is covered for those patients with OSA who meet criteria A-C above, in addition to criterion D:

D. An E0601 has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting.

Ineffective is defined as documented failure to meet therapeutic goals using an E0601 during the titration portion of a facility-based study or during home use despite optimal therapy (i.e., proper mask selection and fitting and appropriate pressure settings).

If E0470 is billed for a patient with OSA and criteria A-D are not met, it will be denied as not reasonable and necessary.

A bi-level positive airway pressure device with back-up rate (E0471) is not reasonable and necessary if the primary diagnosis is OSA. If an E0471 is billed with a diagnosis of OSA, it will be denied as not reasonable and necessary. If an E0601 device is tried and found ineffective during the initial facility-based titration or home trial, substitution of an

E0470 does not require a new initial face-to-face clinical evaluation or a new sleep test.

If an E0601 device has been used for more than 3 months and the patient is switched to an E0470, a new initial face-to face clinical evaluation is required, but a new sleep test is not required. A new 3 month trial would begin for use of the E0470. Coverage, coding and documentation requirements for the use of E0470 and E0471 for diagnoses other than OSA are addressed in the Respiratory Assist Devices (RAD) Local Coverage Determination (LCD) and Policy Article (PA).

Sleep Tests

Coverage and Payment rules for sleep tests may be found in the local coverage determinations (LCDs) for the applicable Medicare Part A or Part B contractor. There may be differences between those LCDs and the DME MAC LCD. For the purposes of coverage of PAP therapy, the DME MAC coverage, coding and payment rules take precedence.

Coverage of a PAP device for the treatment of OSA is limited to claims where the diagnosis of OSA is based upon a sleep test (Type I, II, III, IV, Other) that meets the Medicare coverage criteria in effect for the date of service of the claim for the PAP device. The sleep test must be either a polysomnogram performed in a facility-based laboratory (Type I study) or a home sleep test (HST) (Types II, III, IV, Other). The test must be ordered by the beneficiary’s treating physician and conducted by an entity that qualifies as a Medicare provider of sleep tests and is in compliance with all applicable state regulatory requirements.

A Type I sleep test is the continuous and simultaneous monitoring and recording of various physiological and pathophysiological parameters of sleep with physician review, interpretation, and report. It is facility-based and must include sleep staging, which is defined to include a 1-4 lead electroencephalogram (EEG), electro-oculogram (EOG),

submental electromyogram (EMG) and electrocardiogram (ECG). It must also include at least the following additional parameters of sleep: airflow, respiratory effort, and oxygen saturation by oximetry. It may be performed as either a whole

night study for diagnosis only or as a split night study to diagnose and initially evaluate treatment.

An HST is performed unattended in the beneficiary’s home using a portable monitoring device. A portable monitoring device for conducting an HST must meet one of the following criteria:

A. Type II device - Monitors and records a minimum of seven (7) channels: EEG, EOG, EMG, ECG/heart rate, airflow, respiratory movement/effort and oxygen saturation; or,

B. Type III device - Monitors and records a minimum of four (4) channels: respiratory movement/effort, airflow, ECG/heart rate and oxygen saturation; or,

C. Type IV device - Monitors and records a minimum of three (3) channels, one of which is airflow; or,

D. Other - Devices that monitor and record a minimum of three (3) channels that include actigraphy, oximetry and peripheral arterial tone and for which there is substantive clinical evidence in the published peer-reviewed medical literature that demonstrates that the results accurately and reliably correspond to an AHI or RDI as defined above. This determination will be made on a device by device basis (See Appendix B for list of approved devices in this category).

For PAP devices with initial dates of service on or after November 1, 2008, all beneficiaries who undergo an HST must, prior to having the test, receive instruction on how to properly apply a portable sleep monitoring device. This instruction must be provided by the entity conducting the HST and may not be performed by a DME supplier. Patient instruction may be accomplished by either:

1. Face-to-face demonstration of the portable sleep monitoring device’s application and use; or,

2. Video or telephonic instruction, with 24 hour availability of qualified personnel to answer questions or troubleshoot issues with the device.

For PAP devices with initial dates of service on or after November 1, 2008, all HSTs (Type II, III, IV, Other) must be interpreted by a physician who holds either:

1. Current certification in Sleep Medicine by the American Board of Sleep Medicine (ABSM); or,

2. Current subspecialty certification in Sleep Medicine by a member board of the American Board of Medical

Specialties (ABMS); or,

3. Completed residency or fellowship training by an ABMS member board and has completed all the requirements for subspecialty certification in sleep medicine except the examination itself and only until the time of reporting of the first examination for which the physician is eligible; or,

4. Active staff membership of a sleep center or laboratory accredited by the American Academy of Sleep Medicine (AASM) or The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations - JCAHO).

For PAP devices with coverage based on a facility-based polysomnogram (Type I) performed on or after January 1,

2010, the interpreting physician must meet one of the requirements listed above (1-4) for credentialing.

CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:

Continued coverage of a PAP device (E0470 or E0601) beyond the first three months of therapy requires that, no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating physician must conduct a clinical reevaluation and document that the beneficiary is benefiting from PAP therapy.

For PAP devices with initial dates of service on or after November 1, 2008, documentation of clinical benefit is demonstrated by:

1. Face-to-face clinical re-evaluation by the treating physician with documentation that symptoms of obstructive sleep apnea are improved; and,

2. Objective evidence of adherence to use of the PAP device, reviewed by the treating physician.

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.

If the above criteria are not met, continued coverage of a PAP device and related accessories 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 patient 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 requalify 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.

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 that 3 months and the patient was then switched to an E0470, the clinical reevaluation 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.

If there is discontinuation of usage of a PAP device at any time, the supplier is expected to ascertain this and stop billing for the equipment and related accessories and supplies.

For a PAP device dispensed prior to November 1, 2008, if the initial coverage criteria in effect at the time were met and the criteria for coverage after the first 3 months that were in effect at the time were met, the device will continue to be covered for PAP devices with initial dates of service on or after November 1, 2008 as long as the patient continues to compliantly use the device.

REPLACEMENT:

This section applies to PAP devices initially provided and covered while the beneficiary was in Medicare fee-for-service (FFS). If a PAP device is replaced during the 5 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 5 year RUL, there must be a face-to-face evaluation by their treating physician 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.

BENEFICIARIES ENTERING MEDICARE

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:

1. 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,

2. Clinical Evaluation – Following enrollment in FFS Medicare, the beneficiary must have a face-to-face evaluation by their treating physician who documents in the beneficiary’s medical record that:

a. The beneficiary has a diagnosis of obstructive sleep apnea; and,

b. The beneficiary continues to use the PAP device.

If either criteria 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 to use of the device.

ACCESSORIES:

Accessories used with a PAP device are covered when the coverage criteria for the device are met. If the coverage criteria are not met, the accessories will be denied as not reasonable and necessary.

The following table represents the usual maximum amount of accessories expected to be reasonable and necessary:

A4604 - 1 per 3 months

A7027 - 1 per 3 months

A7028 - 2 per 1 month

A7029 - 2 per 1 month

A7030 - 1 per 3 months

A7031 - 1 per 1 month

A7032 - 2 per 1 month

A7033 - 2 per 1 month

A7034 - 1 per 3 months

A7035 - 1 per 6 months

A7036 - 1 per 6 months

A7037 - 1 per 3 months

A7038 - 2 per 1 month

A7039 - 1 per 6 months

A7046 - 1 per 6 months


Quantities of supplies greater than those described in the policy as the usual maximum amounts will be denied as not reasonable and necessary.

A supplier must not dispense more than a 3-month quantity of PAP accessories at a time.

Suppliers should stay attuned to atypical utilization patterns of their clients. A beneficiary or their caregiver must specifically request refills of PAP accessories before they are dispensed. The supplier must not automatically dispense a quantity of supplies on a predetermined regular basis, even if the beneficiary has "authorized" this in advance. As referenced in the Program Integrity Manual (Internet-Only Manual, CMS Pub. 100-8, Chapter 4.26.1) “Contact with the beneficiary or designee regarding refills should take place no sooner than approximately 7 days prior to the delivery/shipping date. For subsequent deliveries of refills, the supplier should deliver the DMEPOS product no sooner than approximately 5 days prior to the end of usage for the current product.”

Either a non-heated (E0561) or heated (E0562) humidifier is covered when ordered by the treating physician for use with a covered PAP (E0470 or E0601) device.