Positive Airway Pressure (PAP) – Supplier

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Adherence Monitoring

1. Help us understand the term "visual inspection" as it relates to adherence monitoring. What does this mean, and how can it be documented?

   • The Policy Article (PA) for PAP includes 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 (phone-in compliance), or the supplier or practitioner may read the values during a home/office visit. The values must document that the beneficiary is using the device for 4 or more hours per night for 70% of the nights in a consecutive 30-day period.

     Originally published: 11.15.13
     Reviewed: 12.06.23

2. Can we report hours used, for example, with information from a device with an hour meter, and meet the requirement for documenting adherence? For example, "Spoke to beneficiary, and she states that as of 12/01/14, there are a total of 650 hours on her continuous positive airway pressure (CPAP) machine. She states that she uses the CPAP every night, and it is very beneficial. On 11/01/14, the beginning reading was 500 hours. This calculates to 5 hours per night for 30 days."

   • No. Devices that simply report "device on" time or "blower on" time will not provide enough information to determine that the PAP device was used ≥ 4 hours per night on 70% of nights during a consecutive thirty (30) day period anytime during the first three months of initial usage.

     Originally published: 11.15.13
     Reviewed: 12.06.23

3. Several manufacturers have devices that report "sessions" of use. Are these types of devices acceptable to meet the local coverage determination (LCD) requirement for adherence?

   • Possibly, depending on the definition of "session," which can vary based on the manufacturer or user-defined options (when available). For example, consider a device that measures a "session" as use greater than X hours and also reports number of days used. Assuming that a session was set up to measure use ≥ 4 hours, one could use the number of sessions in conjunction with total days of use over a 30-day period and determine whether or not the beneficiary met the adherence requirement.

     Originally published: 11.15.13
     Reviewed: 12.06.23

4. We use devices from a manufacturer that reports adherence information on a rolling 30 day basis. Information is displayed in a window on the device; however, adherence may vary depending on which 30 day period is examined. How can we use this device and still meet the adherence requirement?

   • Devices that report information on a rolling 30 day interval can be problematic if using visual inspection as the reporting method. One solution is to 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. In the scenario with this specific piece of equipment, 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.

     Note that most devices that allow one to potentially determine adherence through visual inspection are designed to report adherence information in much greater detail via download. Suppliers are strongly encouraged to discuss the capabilities of devices being considered for purchase with each manufacturer to determine the capacity for reporting adherence as defined in the LCD.

     Originally published: 11.15.13
     Reviewed: 12.06.23

5. Are suppliers required to continue documenting adherence as defined in the LCD after the initial 3 month period?

   • No. Following the initial 3 month trial and documentation of use ≥ 4 hrs. per night on 70% of nights in a 30 consecutive day period, suppliers should document continued use of the device. This may be accomplished via documentation of attestation by the beneficiary.

     Originally published: 11.15.13
     Reviewed: 12.06.23

6. The PAP LCD states, "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." Can you please clarify whether the ≥ 4 hours per night is continuous use or cumulative use in a 24-hour period? Would a beneficiary who uses the device for 4 hours a night, but has a break in usage of 45 minutes still satisfy the requirements of the LCD?

   • The ≥ 4 hours per night is based on continuous use, with allowances for short breaks (such as toileting).

     Originally published: 11.15.13
     Reviewed: 12.06.23

7. A beneficiary was placed on PAP therapy, and during the course of their 12 week trial period, they were hospitalized for two weeks. How does this impact the requirement for adherence monitoring and timing of the in-person follow-up evaluation?

   • The 12 week trial period applies to PAP use in the home setting. If a beneficiary is admitted to an inpatient hospital or skilled nursing facility (SNF), the trial period is suspended. The trial period, including the requirement for adherence monitoring and the timing of the in-person re-evaluation (between the 31st and 91st day) resumes when the beneficiary returns home.

     Originally published: 11.15.13
     Reviewed: 12.06.23

8. Can continued coverage of PAP therapy 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?

   • No. All requirements must be met within the 90-day time frame. CMS's national coverage determination (NCD) specifies that benefit from PAP therapy must be demonstrated in the first 12 weeks in order to provide continued coverage beyond that time. Compliance is a major issue with PAP; failure of therapy is often related to mask fit, humidification, ramp time, etc. Most of these issues arise in the first few days of treatment and must be aggressively addressed by the supplier and/or treating practitioner. Even if that takes 4-6 weeks, there is still adequate time to achieve the liberal LCD metric of ≥ 4 hours per night on 70% of the nights in a 30-day period.

     Originally published: 11.15.13
     Reviewed: 12.06.23

9. Is another in-person encounter required at the end of the second trial period?

   • Yes. Just like with the initial trial that failed, there must be an in-person visit to document benefit from the use of the PAP device.

     Originally published: 06.28.19
     Reviewed: 12.06.23

Reimbursement Issues

1. A beneficiary received a CPAP device paid for by Fee-for-Service (FFS) Medicare in 1998 and now needs to replace their device. Do they have to get an in-person evaluation, a new sleep study, and meet the other requirements in the new LCD?

   • According to the LCD, if a CPAP device is replaced following the 5-year reasonable useful lifetime (RUL), there must be an in-person evaluation by their treating practitioner that documents that the beneficiary continues to use and benefit from the CPAP device. There is no requirement for a new sleep test or trial period.

     Originally published: 11.15.13
     Reviewed: 12.06.23

2. A beneficiary was diagnosed with obstructive sleep apnea and received a PAP device paid for by private insurance. The beneficiary is now enrolled in FFS Medicare and needs a replacement PAP device and/or accessories. What is required for coverage?

   • For beneficiaries who received a PAP device prior to enrollment in FFS Medicare and are now seeking Medicare coverage of either 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, that meets the FFS Medicare apnea-hypopnea index (AHI)/respiratory disturbance index (RDI) coverage criteria in effect at the time that the beneficiary seeks a replacement PAP device and/or accessories.
     2. 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 both
        1. Has a diagnosis of obstructive sleep apnea
        2. Continues to use the PAP device

     If either criteria 1 or 2 above are not met, the claim will be denied as not medically necessary. The supplier may hold claims, pending confirmation that the above requirements are met, and then submit claims with the KX modifier beginning with the date of the beneficiary's enrollment in FFS Medicare.

     Originally published: 11.15.13
     Reviewed: 12.06.23

3. DME company ABC conducts home sleep tests and then refers beneficiaries to DME company XYZ for PAP therapy after the practitioner makes the diagnosis of obstructive sleep apnea. Since the two companies are not related and DME company XYZ did not conduct the home sleep test, is DME company XYZ allowed to dispense the PAP device based on this test?

   • No, a DME supplier is not a qualified provider of laboratory services; therefore, this is not a valid test for Medicare purposes. According to the PAP Policy Article, "No aspect of a 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 or to tests conducted in facility-based sleep laboratories."

     Originally published: 11.15.13
     Reviewed: 12.06.23

4. If a beneficiary is put on a respiratory assist device (RAD) with less than 30 days left in the initial 91 day period, the LCD indicates that the beneficiary will be given up to 120 days after the initiation of PAP therapy to document adherence. If the beneficiary had an in-person exam in the 31 to 91 day period while on a CPAP device, must they have another in-person exam after they are on RAD? Certainly, if they did not have an in-person exam in the 31 to 90 days, we understand that one would need to be done before the 120th day.

   • Yes, the beneficiary would need to have a follow-up evaluation before the 120th day to determine benefit from the RAD device. This answer is based on the assumption that the reason the beneficiary changed from a CPAP to RAD is the failure to show clinical benefit with the CPAP device. According to the NCD, continued coverage requires demonstration of therapy benefit within the first 90 days. 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.

     Originally published: 11.15.13
     Reviewed: 12.06.23

5. If compliance is not documented in the first 90 days and the beneficiary then has a new facility-based polysomnogram, in-person evaluation with a practitioner, and a new trial period is begun, does a new capped rental period start?

   • No. Standard break-in-service rules apply because there has been no change in the underlying condition that necessitates the PAP therapy. Consequently, a new capped rental period does not begin.

     Originally published: 11.15.13
     Reviewed: 12.06.23

6. Would it be considered use of a blanket advance beneficiary notice (ABN) to have all new PAP beneficiaries sign an ABN at the beginning of therapy stating that if they do not get an in-person evaluation or refuse to get the follow-up re-examination by their treating practitioner between the 31st and 91st day, Medicare will deny the claim?

   • Yes, it would be considered a "blanket" ABN if the notice was presented at the beginning of therapy for the purpose of transferring financial liability to the beneficiary. However, the supplier may issue a voluntary ABN at the start of therapy, or at any time during therapy, to forewarn the beneficiary of the potential for Medicare non-coverage if certain clinical requirements are not met during the trial period. The beneficiary does not select an option box or sign a voluntary ABN, and the voluntary ABN does not transfer liability to the beneficiary.

     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 if 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, she/he does not meet the policy criteria for continue coverage (e.g., adherent to therapy and obtain a follow-up in-person evaluation), Medicare may deny subsequent claim(s) and the beneficiary will be liable for payment.

     Additional information regarding issuance of voluntary and mandatory ABNs is available in the Internet Only Manual (IOM) 100-04, Medicare Claims Processing Manual, Chapter 30, Section 50.

     Originally published: 11.15.13
     Reviewed: 12.06.23

7. What can a supplier do if the beneficiary does not get in to see the treating practitioner within the 31st-91st day?

   • If the beneficiary received the re-evaluation at a later date and it was documented that the beneficiary was benefiting from the use of the PAP device, the supplier may begin submitting claims with the KX modifier from the date of that re-evaluation. Claims for services in the interim between the 91st day and the date of the re-evaluation must be submitted with the KX omitted.

     Originally published: 11.15.13
     Reviewed: 12.06.23

8. What can be done in a situation where an order is received for PAP therapy but the beneficiary never had an in-person evaluation? Can the in-person evaluation be done after the sleep test or after initiation of PAP therapy, and will that meet our documentation requirements?

   • The NCD and LCD require that, prior to initiating PAP therapy, the beneficiary has a clinical evaluation and sleep test. There is a sound clinical rationale for this specific sequence of events; therefore, an in-person evaluation performed after the sleep test or after the initiation of PAP therapy would not meet the coverage requirements, and a KX modifier must not be added to the claim. Suppliers may obtain an ABN to inform the beneficiary that the PAP device will not be covered since the coverage requirements were not met.

     For more information, please refer to the Local Coverage Determination.

     Originally published: 11.15.13
     Reviewed: 12.06.23

9. What is needed to obtain a CPAP if there is a long period of time between the original in-person and sleep test/polysomnogram and when the beneficiary actually obtains and starts on the CPAP? For example, what if the beneficiary goes for an in-person visit to assess for obstructive sleep apnea (OSA) in March of 2016 and has a qualifying sleep test in April of 2016, but didn’t obtain and start using the CPAP until May of 2017?

   • 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 need to be provided 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.

     Originally published: 06.27.17
     Reviewed: 12.06.23

10. Why did Medical Review deny my claim stating the sleep test did not document the beneficiary meets coverage criteria for a PAP device when the RDI was 25?

    • Without knowing the specifics of the sleep test, it could be for a few different reasons. The LCD requirements state that hypopneas are defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% decrease in oxygen saturation. So, if the sleep test based hypopneas on a 3% decrease in oxygen saturation, then the hypopneas cannot be used to score the test. Another reason could be that respiratory effort related arousals (RERAs) were used in determining the RDI. RERAs cannot be used to calculate either the AHI or the RDI. Only apneas and hypopneas (based on the 4% decrease in oxygen saturation) can be used to determine the AHI and RDI. Another reason could be if the test was based on less than 2 hours of sleep, then the total number of events would need to be at least the number of events required in a 2-hour recording.

      Originally published: 06.27.17
      Reviewed: 12.06.23

11. Can suppliers bill Medicare for related accessories during the second trial period?

    • No. Since the base PAP device is not (yet) reasonable and necessary (R&N), the essential accessories are not R&N.

      Originally published: 06.28.19
      Reviewed: 12.06.23

12. Can suppliers resume billing the 4th rental month once the beneficiary becomes compliant? For example: January 1 is the initial set-up, and they are not compliant by the end of March (the 12-week trial). In April, they are able to schedule a re-evaluation and sleep test. In mid-May, their download show adherence to therapy per LCD guidelines. Can the supplier resume billing month four in mid-May, since they have reached compliance?

    • Yes. The documentation must show that the beneficiary has met compliance no sooner than the 31st day of the second 12-week trial. (In this example it was completed in April.) Once compliance has been met, the supplier may resume billing the 4th rental month and append the KX modifier. In the given example, billing would resume in May.

      Originally published: 06.28.19
      Reviewed: 12.06.23

Additional Resources

• Correct Billing – Continued Coverage for Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea
• Dear Physician Letter – PAP: Initial Qualification
• Dear Physician Letter – PAP: Replacement
• Internet Only Manual (IOM) 100-04, Medicare Claims Processing Manual
• Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea LCD
• Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea PA