The reimbursement information is being provided on an “as is” basis with no express or implied warranty of any kind and should be used solely for your internal informational purposes. The information does not constitute professional or legal advice on reimbursement and should be used at your sole liability and discretion. All coding, coverage policies and reimbursement information are subject to change without notice. ResMed does not represent or warrant that any of the information being provided is true or correct and you agree to hold ResMed harmless in the event of any loss, damage, liabilities or claims arising from the use of the reimbursement information provided to you. Before filing any claims, it is the provider’s sole responsibility to verify current requirements and policies with the applicable payer.
1. Will Medicare pay for a replacement CPAP device if the patient has had it less than 5 years but received it prior to joining fee-for-service (FFS) Medicare?
Yes, if they meet the following coverage requirements:
(Note: For purposes of this policy, the calculation of the AHI or RDI includes only apneas and hypopneas. Respiratory effort-related arousals [RERAs] must not be used in the calculation of the AHI or RDI. In addition, Medicare defines hypopnea 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.)
Note that the ordering practitioner must conduct the clinical evaluation face-to-face with the patient within six (6) months prior to the date of the order for the PAP device and the supplier must receive the written order prior to delivering the device to the patient. https://cgsmedicare.com/pdf/dpl_cpap_devices_replacement.pdf
2. May a supplier bill Medicare for the AirMini or its accessories?
The AirMini may be billed to Medicare if it's considered medically necessary and ALL Medicare coverage requirements are met. However, Medicare does not pay for a 2nd PAP within the 5-year reasonable useful lifetime.
The AirMini and its accessories have not been code-verified by Medicare’s Pricing, Data Analysis and Coding (PDAC) contractor so we are unable to offer any specific coding guidance.
To bill for AirMini accessories, Medicare guidelines state:
"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."
Read full guidelines.
Medicare's PDAC contractor is responsible for verifying the Healthcare Common Procedure Coding System (HCPCS) code(s) used to describe a DME item for the purpose of billing Medicare. Obtaining PDAC HCPCS code verification for most DME items is voluntary.
As a service to our customers, ResMed requests and receives PDAC HCPCS code verifications for numerous products; however, not all products or model numbers publicly listed by PDAC are launched into the market and only HCPCS codes reported by PDAC should be used when billing.
Coding is limited to each individual product’s model number, so the coding of one product’s model number does not apply to the coding of another model number.
When a particular product and/or model number reported by PDAC has not received a HCPCS code, it is the supplier’s responsibility to determine whether additional HCPCS code(s) fall within an existing HCPCS definition, and if so, use the associated HCPCS code when submitting claims.
To search for HCPCS codes based on a description of an item or assigned to a product's model number, PDAC's DME Coding System (DMECS) Information tool may be queried or the supplier may contact the PDAC contractor directly.
Commercial payer requirements vary and DME suppliers should directly contact their payers for billing guidance.
3. Can patients use their Health Savings Account (HSA) or Flexible Spending Account (FSA) for costs associated with AirMini and/or its accessories?
The Internal Revenue Service states the following in their Publication 969 (dated Mar. 04, 2019): “Qualified medical expenses are those expenses that would generally qualify for the medical and dental expenses deduction.” These are explained in Publication 502 (dated Jan 09, 2019). We recommend your patients check with their employers' benefits administrator to determine whether or not they can use their HSA or FSA funds to purchase ResMed products and accessories.
4. Must the same treating practitioner that did the initial face-to-face exam also order the PAP equipment?
No. The treating practitioner that does the initial face to face exam does not have to be the same practitioner that orders the CPAP. https://med.noridianmedicare.com/documents/2230703/17635061/PAP+Devices+FAQs
5. Is there a time limit from initial face-to-face evaluation to the sleep study?
No time limit is specified in the policy; however, one would anticipate that these two events occur reasonably close together in time, typically within 3 months.
6. Must the treating practitioner review the adherence (compliance) report during the re-evaluation between the 31-91 day?
The practitioner may see the patient and conduct the follow-up evaluation between the 31st and 91st day. Continued coverage of a PAP device requires that a determination be made by the treating practitioner that the patient is benefiting from the use of the selected device as evidenced by a face-to-face clinical follow-up evaluation and adherence to therapy. While the documentation of adherence may occur following the treating practitioner’s follow-up evaluation, the adherence report must be provided to the treating practitioner for inclusion in the patient's medical record in order to fulfill the requirement to assess therapy benefit.
7. I have a question on the CPT number 94660 for ongoing CPAP management. Can that be used for non-invasive ventilation (NIV) Astral patients when they are looking at the reports?
No, CPT 94660 is not the most appropriate code when reviewing Astral reports. CPT 94660 is related to the face-to-face service addressing the use of CPAP while CPT 94002 is related to the face-to-face service addressing the use of ventilators. CPT 94002 description states, "Ventilation assist and management, initiation of pressure or volume preset ventilators for assisted or controlled breathing; hospital inpatient/observation, initial day" (CPT 2018 Professional Edition).
However, your question seems to be primarily referring to reviewing the proper codes associated with reviewing reports and not the face-to-face.
If addressing other issues not related to sleep disorders during the same visit, submitting an E/M code (99211-99215) may be a more appropriate option. CPT code 94660 should not be billed in addition to an E/M code for the same patient visit. In addition, CPT code 99091 separately pays physicians or other qualified healthcare professionals for Remote Patient Monitoring (RPM). CPT code 99091 is not specific to sleep-related data, but may allow qualified practitioners to bill for the time spent collecting, reviewing and/or interpreting physiologic data (e.g. AHI, FiO2, etc.) retrieved from ResMed connected health solutions. See the connected health services quick reference guide for more information.
8. Can we bill for a heated humidifier (E0562) even when it is integrated with the device?
Yes, a heated (E0562) humidifier is covered when ordered by the treating practitioner for use with a covered (E0601, E0470, E0471) device. According to a joint Durable Medical Equipment Medicare Administrative Contractor (DME MAC) correct coding for integrated respiratory products publication dated 12/29/2014, the correct codes for the integrated product are code E0601 for the base CPAP device and code E0562 for the integrated humidification. The same principle applies to respiratory assist devices with integrated humidification. The correct codes for the integrated RAD products are code E0470 or E0471 for the base RAD device and code E0562 for the integrated humidification.
a) Refer to the "Integrated Devices" fast fact for additional FAQs about billing, non-compliance scenarios, reissuing, etc.
9. Who can conduct initial face-to-face and/or follow-up clinical evaluations for certain Durable Medical Equipment (DME)?
Pursuant to 42 CFR 410.38(g), certain specified covered items of DME require an in-person, face-to-face examination with the treating practitioner (medical doctor [MD], doctor of osteopathic medicine [DO] or doctor of podiatric medicine [DPM], physician assistant [PA], nurse practitioner [NP] or clinical nurse specialist [CNS]).
A registered nurse (RN) may not conduct the face-to-face evaluation.
10. What is sufficient documentation of a request for refill of items that the patient obtains in-person at a retail store?
The signed delivery slip or a copy of the itemized sales receipt is sufficient documentation of a request for refill.
Standard documentation requirements for all claims submitted to DME MACs (A55426)
11. I have a patient who purchased a CPAP prior to joining FFS Medicare. Is the patient required to have a face-to-face visit with their treating practitioner prior to getting CPAP accessories?
Yes, a face-to-face visit is required.
For patients who received a PAP device prior to enrollment in 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:
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.
Read full guidelines.
We recommend that you review the local coverage determination (LCD) Coverage, indication and limitation information. If you have any further questions that are not outlined in the LCD, we recommend that you contact Medicare directly for further clarification.
12. If a patient is put on a respiratory assist device (RAD) device (E0470) with less than 30 day left in the initial 91-day period, the LCD indicates that the patient will be given up to 120 days after the initiation of PAP therapy to document adherence. If the patient had a face-to-face exam in the 31 to 91-day period while on a CPAP device, must they have another face-to-face exam after they are on RAD? Certainly if they did not have a face-to-face exam in the 31 to 90 days we understand that one would need to be done before the 120th day?
Yes, the patient would need to have a follow-up evaluation before the 120th day to determine benefit from the RAD (E0470) device. This answer is based on the assumption that the reason the patient changed from a CPAP to RAD is the failure to show clinical benefit with the CPAP device. According to the national coverage determination (NCD), continued coverage requires demonstration of therapy benefit within the first 90 days. The LCD recognizes that some patients 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.
13. 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 patient via telephone and ask them to read values from their device (i.e. phone-in compliance) or the supplier or physician may read the values during a home/office visit. The values must document that the patient is using the device for 4 or more hours per night for 70% of the nights in a consecutive 30-day period.
14. 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 patient and she states that as of 12/01/14, there are a total of 650 hours on her 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 (3) months of initial usage.
15. Several manufacturers have devices that report "sessions" of use. Are these types of devices acceptable to meet the LCD requirement for adherence?
Possibly, depending on the definition of "session," which can vary based on the manufacturer or the session definition if a user-defined option. 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 session in conjunction with total days of use over a 30-day period and determine whether or not the patient met the adherence requirement.
16. 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 patient 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 patient 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.
17. Must suppliers continue to document 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 period of 30 consecutive days, suppliers should document continued use of the device. This may be accomplished via documentation of attestation by the patient.
18. A patient 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 face-to-face follow-up evaluation?
The 12-week trial period applies to PAP use in the home setting. If a patient 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 face-to-face re-evaluation (i.e. between the 31st and 91st day) resumes when the patient returns home.
19. Can continued coverage of PAP therapy be extended to patients who come close to meeting the adherence metric requirements but don't quite achieve all of them in the 90-day timeframe?
No. All of the requirements must be met within the 90-day time frame. CMS' national coverage determination contained specific language that benefits 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 physician. Even if that takes 4-6 weeks, there is still adequate time to achieve the liberal local coverage determination metric of ≥ 4 hours per night on 70% of the nights in a 30-day period.
20. A patient received a CPAP device paid for by FFS Medicare in 1998 and now needs to replace their device. Do they have to get a face-to-face evaluation, a new sleep study and meet the other requirements in the new LCD?
According to the LCD:
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 patient continues to use and benefit from the PAP device. There is no requirement for a new sleep test or trial period.
21. A patient was diagnosed with obstructive sleep apnea and received a PAP device paid for by private insurance. The patient is now enrolled in FFS Medicare and needs a replacement PAP device and/or accessories. What is required for coverage?
For patients 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:
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 patient's enrollment in FFS Medicare.
22. DME company ABC conducts home sleep tests and then refers patients to DME company XYZ for PAP therapy after the physician 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."
23. If compliance is not documented in the first 90 days with use of an E0601 and the patient then has a new facility-based Type 1 sleep test (diagnostic, titration or split-night) and face-to-face evaluation with a physician and a new trial period on an E0601 begins, 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.
A new 12-week trial may begin, however, suppliers may not bill the KX modifier during this new 12-week trial. Only after the new 12-week trial is completed and a new face-to-face is conducted to assess benefit and objective evidence of adherence is met may the supplier resume billing the KX modifier (i.e. 4th claim in the 13 month capped rental cycle).
For more info, click here for Medicare's Joint DME MAC Article published May 16, 2019
However, starting a new 3-month trial and capped rental for use of an E0470 may be an alternative therapy option if during the repeat Type 1 sleep test it is determined that an E0601 was tried and proven ineffective and all other E0601 coverage criteria are met per the PAP LCD.
24. Would it be considered use of a blanket Advance Patient Notice of Noncoverage (ABN) to have all new PAP patients sign an ABN at the beginning of therapy stating that if they do not get a face-to-face evaluation or refuse to get the follow-up re-examination by their treating physician between the 31st and 91st day that 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 patient. However, the supplier may issue a voluntary ABN at the start of therapy, or at any time during therapy, to forewarn the patient of the potential for Medicare non-coverage if certain clinical requirements are not met during the trial period. The patient does not select an option box or sign a voluntary ABN, and the voluntary ABN does not transfer liability to the patient.
Beginning on Day 61 of the trial period, if the supplier has knowledge that the patient 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. The patient should choose an option box, and sign and date the ABN when a mandatory ABN is issued.
This ABN should advise the patient that if, by the 90th day of therapy, they do not meet the 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 the patient will be liable for payment.
Additional information regarding issuance of voluntary and mandatory ABNs can be found in the Internet Only Manual (IOM) 100-04, Medicare Claims Processing Manual, Chapter 30, Section 50.
25. What can a supplier do if the patient does not get in to see the treating physician within the 31st-91st day?
If the patient received the re-evaluation at a later date and it was documented that the patient 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.
26. What can be done in a situation where an order is received for PAP therapy but the patient never had a face-to-face evaluation? Can the face-to-face 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 patient has a clinical evaluation and sleep test. There is a sound clinical rationale for this specific sequence of events; therefore, a face-to-face 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 patient that the PAP device will not be covered since the coverage requirements were not met.
For more information, please refer to the LCD.
27. What is needed to obtain a CPAP if there is a long period of time between the original face-to-face and sleep test/polysomnogram and when the patient actually obtains and starts on the CPAP? For example, what if the patient goes for a face-to-face to assess for 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 physician would need to be provided to explain the delay and, because a lot of things can change medically/physically for the patient in that year, a new sleep test or titration study may be appropriate.
28. Why did Medical Review deny my claim stating the sleep test did not document the patient 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 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.
29. When submitting a claim for supplies for patient-owed equipment such as a CPAP, nebulizer, etc., is it necessary to include a claim narrative indicating the patient-owned information even when Medicare paid 13 months of rental for the item?
When Medicare FFS originally pays the 13-month cap for DME, it is not necessary to include a narrative on the claim for the replacement of related supplies and accessories. If the supply or accessory has additional and/or separate criteria, these must also be met in order for coverage to be considered.
30. If a patient is requesting more supplies than what is allowed and reimbursed by Medicare, how is the claim submitted? The patient is willing to sign an ABN, choosing option 1, and will pay for the extra supplies that he/she wants. For example, for HCPCS code A7031 (face mask interface), the order is for 2 per month. Medicare's maximum allowable is 1 per month. When the supplier submits the claim, how should the claim be submitted?
Suppliers must bill 2 line items for upgraded/excessive DMEPOS items where the patient requests an upgrade. Suppliers must bill both lines on the same claim in the following order:
Bill the appropriate HCPCS code for the upgraded item the supplier actually provided to the patient with the total charge of the upgraded item(s). If the supplier has a properly obtained ABN on file signed by the patient, use the GA modifier. If the supplier did not properly obtain an ABN signed by the patient, use the GZ modifier.
Bill the appropriate HCPCS code for the reasonable and necessary item with the total charge for the item(s). Use the GK modifier.
Suppliers should bill their full charge on the claim line for the upgraded item(s) (Line 1) and the full charge for the reasonable and necessary item(s) (Line 2). If the upgrade is within a HCPCS code, suppliers still bill 2 line items, using the same code on both lines.
Suppliers must bill both lines on the same claim in sequential order. Line 1 and the associated line 2 should follow each other.
31. My patient has been using a RAD (E0470) for the treatment of OSA. The patient qualifies for a new device under the Reasonable Useful Lifetime (RUL) rule but recently had a sleep test and the physician is ordering a CPAP (E0601) device since E0470 is no longer considered effective therapy for the patient. Will Medicare cover the E0601 even though the patient is using an E0470 device?
The LCD for PAP devices does state that an E0601 device is covered for patients with OSA who meet coverage criteria. The JB MAC Supplier Manual states that if equipment is changed to different but similar equipment due to a change in medical condition, a new 13-month rental period would begin. In the instance provided, the E0470 was not effective in treating the OSA. Because their medical condition would support the change, a new 13-month rental may begin. In these situations, suppliers may need to provide documentation showing that the original equipment was not effective in treating the patient. If a supplier bills a claim for the replacement equipment and it denies with a same and similar denial, it may be necessary to appeal the denial. Suppliers would then have the opportunity to provide the documentation that shows the E0470 was ineffective along with documentation supporting the medical necessity for the E0601. Suppliers may bill their first claim for the E0601 with a narrative stating the E0470 was ineffective; however, the claim may still deny and it may be necessary to appeal.
32. The policy states that the data that the physician evaluates must be for a period of 30 consecutive days. The policy is silent on a time frame in which the physician must see the patient in relationship to the data.
The physician may see the patient and conduct the follow-up evaluation between the 31st and 91st day. Continued coverage of a PAP device requires that a determination be made by the treating physician that the patient is benefiting from the use of the selected device as evidenced by a face-to-face clinical follow-up evaluation and adherence to therapy. While the documentation of adherence may occur following the treating physician's follow-up evaluation, the adherence report must be provided to the treating physician for inclusion in the patient's medical record in order to fulfill the requirement to assess therapy benefit. Consider the following example:
33. Full face masks bill under HCPCS A7030, nasal masks bill under HCPCS A7034. If a patient switches type of mask is a new order required from the physician? If the patient then switches back to original type of mask later, would another order be required from the physician?
There must be a detailed written order (DWO) for the specific type of mask being used by the beneficiary. If there is a change in the mask used, a new DWO will be required. To return to the previous mask, a new order will be required as that constitutes a change as well.
34. For initial coverage of CPAP, will Medicare allow a sleep study that includes an REI (respiratory event index)? The AASM is advocating this index for use with some home sleep studies.
The current NCD 240.4 and LCD do not allow for the REI measurement regardless of the AASM guidelines. Until the NCD is updated by Medicare, Noridian and the other contractor cannot accept an REI measurement to meet coverage criteria.
The supplier may ask the physician to re-score the test using AHI or RDI criteria to meet Medicare guidelines.
35. A patient comes in and is fitted for a mask after 30 days. The supplier changes the mask to a different size or type, is a new order required?
If it is changing, yes, a detailed written order (DWO) must specify the mask. When a new order is obtained for change in mask, it replaces the previous order. If there is a need to change back, a new order is required as well.
36. In assessing functional condition of supplies, can documentation occur on the signed delivery order?
The functional condition is part of the refill requirement and therefore must be verified prior to delivery of the item. This may occur in a contemporaneous conversation with the patient that is recorded by the supplier. Tubing cracked...mask not maintaining seal... are examples of this type of documentation.
37. When supplies are dispensed, how should they bill and should a narrative be added?
When a three-month order is dispensed, suppliers should report the total quantity supplied for that date of service. This quantity reflects the amount to last three months. Add a narrative, in Item 19 of the CMS-1500 claim form or the NTE segment of the appropriate loop on an electronic claim, indicating a three-month supply is billed.
38. A patient started his/her PAP therapy a few months before having Medicare. Will Medicare pay for the remainder of a rental or does a new machine need to be re-delivered?
A new 13-month cap rental starts as Medicare FFS is a separate Insurance plan. The patient may opt for a new machine with a proof of delivery or retain the machine they received a few months ago. If the previous device is retained, the supplier must obtain a statement, signed and dated by the patient (or patient's designee), attesting that the supplier has examined the DMEPOS item, it is in good working order and that it meets Medicare requirements. The item is still required to last five years.
39. Must a patient go back to the lab to document ineffective therapy on E0601 prior to switching to an E0470?
No, an E0601 can be tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting.
For beneficiaries changing from an E0601 to E0470 due to ineffective therapy while on E0601 (either during a facility-based titration or in the home setting), the treating practitioner must document that both of the following issues were addressed prior to changing to an E0470 device:
The re-evaluation must take place within the first 3 months of treatment; however, formal assessment of improvement cannot be documented before the 31st day. The re-evaluation must document both improvement in subjective symptoms of OSA and objective data related to adherence to PAP therapy.
40. Is it true that an HME supplier can put out a refurbished device for a Medicare patient with a modifier on the billing?
Medicare doesn’t provide specific guidance on whether equipment owned by the HME and provided to the patient must be refurbished, used, or new and leaves this up to the HME’s discretion. However, when billing for equipment (e.g. A/CPAP, RADs), the supplier must use modifier RR during the 13-month capped rental period.
41. If a patient upgrades from an E0601 to E0470, can a new humidifier (E0562 NU) be billed with the E0470 even though an E0562 NU was initially billed with the E0601?
Yes, suppliers may bill the subsequent E0562 claim with the E0470 and should include a narrative in item 19 of the CMS-1500 claim form or the appropriate NTE segment on an electronic claim stating that the E0562 is to be used with the new E0470. However, the claim may still deny with a same and similar denial since the E0562 is on file with the E0601. Suppliers would then have the opportunity to appeal to provide documentation that supports the change in medical necessity for the E0470 as well as provide an explanation of the reason that the initial humidifier billed with the E0601 cannot be used with the E0470. Please contact your DME MAC for additional guidance.
42. Will a new capped rental begin if a patient switches from an E0601 device to an E0470 device?
The LCD for PAP devices does state that an E0470 device is covered for beneficiaries with OSA who meet coverage criteria in addition to the E0601 having been tried and proven ineffective. It goes on to state that if the E0601 device has been used for more than three months and the patient then switches to an E0470, a new initial face-to-face clinical evaluation is required, but a new sleep test is not. Then a new three-month trial would begin for the E0470. If the E0601 was found to be ineffective during the home trial, the substitution of an E0470 does not require a new initial face-to-face clinical evaluation or a new sleep test.
The DME MAC manuals state that if equipment is changed to different but similar equipment due to a change in medical condition, a new 13-month rental period would begin. In the instance provided, the E0601 was not effective in treating the OSA. Because their medical condition would support the change, a new 13-month rental would begin. Please keep in mind that in these situations, suppliers may need to provide documentation showing that the original equipment was not effective in treating the patient. If a supplier bills a claim for the replacement equipment and it denies with a same and similar denial, it may be necessary to appeal the denial. Suppliers would then have the opportunity to provide the documentation that shows the E0601 was ineffective along with documentation supporting the medical necessity for the E0470. Suppliers may bill their first claim for the E0470 with a narrative stating the E0601 was ineffective; however, the claim may still deny and it may be necessary to appeal.
Please contact your DME MAC for additional clarification regarding the replacement of an E0601 with an E0470.
1. Does ResMed have a fast facts reimbursement sheet for adaptive servo-ventilation (ASV) that covers specifics for E0471?
Yes, we have a fast fact and a RAD qualifying guide. Below are the links:
2. Can you please clarify and provide documentation that placing the patient on oxygen during a titration isn’t necessary? I met with a key customer that has a referral for a complex sleep apnea (CompSA) patient. They are scripting a patient with an Air Curve ST-A in IVAPs mode.
If the patient has compSA and is being prescribed the AirCurve ST-A for the treatment of compSA, then according to the Medicare RAD policy, the polysomnography (PSG) must occur while the patient is on his/her prescribed oxygen.
"An E0470 or E0471 device is covered when, prior to initiating therapy, a complete facility-based, attended PSG is performed documenting the following (A and B):
If all of the above criteria are met, either an E0470 or an E0471 device (based upon the judgment of the treating physician) will be covered for patients with documented CSA or CompSA for the first three months of therapy.
If all of the above criteria are not met, then E0470 or E0471 and related accessories will be denied as not reasonable and necessary."
CMS RAD LCD
It is expected that the patient's medical records reflect this information so that the DME may submit a proper claim.
3. If a patient is diagnosed with CSA or CompSA, can the improvement of sleep-associated hypoventilation be documented with the use of an E0470 or E0471 device be done at home or must it be documented during the attended PSG?
No. The RAD local coverage determination (LCD) states that, "An E0470 or E0471 device is covered when, prior to initiating therapy, a complete facility-based, attended PSG is performed documenting the following (A and B): A. The diagnosis of CSA or CompSA; and B. 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 patient's prescribed FIO2."
4. Can a venous blood gas (VBG) test be used to qualify a patient for a RAD with or without a backup rate (E0470 or E0471)?
VBGs are not currently listed in Medicare's RAD policy as a covered test so it would not be considered valid for purposes of covering an E0470 or E0471. A ventilator may be another therapy option since arterial blood gas (ABGs) nor VBGs are noted as a required test in Medicare's national coverage determination (NCD) coverage for ventilators. However, choice of an appropriate treatment plan, including the determination to use a ventilator vs. a bilevel device, is made based upon the specifics of each individual beneficiary's medical condition. In the event of a claim review, there must be sufficiently detailed information in the medical record to support the treatment selected. Review the ventilator fast fact for coverage details
1. Will Medicare cover an Astral™ (E0466) device for patient with a restrictive disease due to obesity?
The Centers for Medicare & Medicaid Services (CMS) National Coverage Determinations Manual (Internet-Only Manual, Publ. 100-03) in Chapter 1, Part 4, Section 280.1 stipulates that ventilators (E0465, E0466) are covered for the following conditions:
"[N]euromuscular 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 (RADs) local coverage determination (LCD) used to determine coverage for bilevel positive airway pressure (PAP) devices. Each of these disease categories are conditions where the specific presentation of the disease can vary from patient to patient. For conditions such as these, the specific treatment plan for any individual patient will vary as well. Choice of an appropriate treatment plan, including the determination to use a ventilator vs. a bilevel PAP device, is made based upon the specifics of each individual patient'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.
We recommend reviewing the revised January 2019 Joint Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Correct Coding and Coverage of Ventilators publication or reach out to the payer for guidance. https://cgsmedicare.com/jc/pubs/news/2019/04/cope11985.html
1. Will Medicare pay durable medical equipment (DME) suppliers for home sleep tests (HSTs) studies?
No, Medicare will not pay DME suppliers for HST studies when billing Medicare as a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) supplier. No aspect of a home sleep test, including but not limited to receiving instruction on how to proper apply a HST nor delivery and/or pickup of the device, may be performed by a DME supplier.
2. Does Medicare pay for a 2nd polysomnography (PSG) to determine if a patient has central sleep apnea (CSA) if the initial PSG was used to qualify an obstructive sleep apnea (OSA) patient for positive airway pressure (PAP) therapy?
More than one PSG or HST per year would not be expected.
Medicare states that "More than one HST per year interval would not be expected. If more than one HST session is performed for suspected OSA, persuasive medical evidence justifying the medical necessity for the additional tests will be required. Similarly, more than two PSG per year interval would not be expected. If more than two PSG sessions are performed for the diagnosis or adjustment of treatment of sleep, pervasive medical evidence justifying the medical necessity for the additional tests will be required upon request. When services are performed in excess of established parameters, they may be subject to review for medical necessity."
Noridian Healthcare Solutions, LLC, Mac Part B (California) LCD (#L36861) titled Polysomnography and Other Sleep Studies which was last updated on 08/24/2017 with effective dates 10/01/2017.
Please contact Medicare directly for further clarification on coverage for a second PSG.
3. If a sleep lab conducts an HST and the patient scores a 3% desaturation based on commercial payer parameters and now the patient is a Medicare patient which needs 4% desaturation scoring, can the sleep lab re-score the same study or do they need to start from scratch?
The lab though may choose to re-score the study using the 4% criterion but should save both original and re-scored test results in the patient's file in case the apnea–hypopnea index (AHI)/respiratory disturbance index (RDI) is challenged by an auditor.
However, Medicare's PAP local coverage determination (LCD) policy requires that the AHI/RDI coverage criteria are met when the patient seeks replacement of a PAP device and or accessories. It doesn't speak to the 3% or 4% scoring. Medicare uses 4% when scoring hypopneas, so there may be a possibility that the AHI/RDI was derived from only apneas and no hypopneas were reported so the test may or may not need re-scoring.
"For patients 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 patient had a sleep test, prior to FFS Medicare enrollment, that meets the Medicare AHI/RDI coverage criteria in effect at the time that the patient seeks Medicare coverage of a replacement PAP device and/or accessories."
4. Can a cardiologist charge Medicare for only the HST professional component?
It depends. The cardiologist may potentially bill for the professional component, but due to unique contractual relationships between the cardiologist, other qualified health care professionals who may be involved in the interpretation of the HST, and place of service, we can’t provide definitive guidance and recommend that the cardiologist verify with Medicare if they are qualified to bill the professional component in a particular patient situation.
Sometimes a global code is being used to bill both professional and technical components. Reimbursement will be allowed for the professional and technical components or for the global procedure but not for both, so it also depends on how the service is being billed.
When billing for the professional component, modifier 26 should be appended to the usual HST procedure code. (AMA CPT 2018 professional codebook)
5. Who is allowed to interpret home sleep tests?
If a home sleep study is performed after November 1, 2008, it must be interpreted by a clinician who holds either:
Clinicians interpreting facility-based polysomnographies will be required to meet this requirement for coverage of PAP devices provided after January 1, 2010.
If there are differences between the durable medical equipment medicare administrative contractor (DME MAC) and Medicare Part A or B LCDs, the DME MAC coverage criteria takes precedence for the purposes of coverage of a PAP device.
6. May incomplete HST studies (due to patient error) be billed?
It is recommended the provider check with the payer for specific guidance.
7. Do you have a list of covered ICD-10 codes for home sleep testing?
Medicare's Polysomnography and Other Sleep Studies local coverage policy provides a list of ICD-10 codes for HST. This list is not all-inclusive; check with the local coverage policy for approved ICD-10 codes.
G47.10 - Hypersomnia, unspecified
G47.13 - Recurrent hypersomnia
G47.14 - Hypersomnia due to medical condition
G47.19 - Other hypersomnia
G47.30 - Sleep apnea, unspecified
G47.33 - Obstructive sleep apnea (adult) (pediatric)
CPT codes 95800, 95801 and 95806 are generally allowed when performed in a facility for the indications listed above. CPT codes G0398, G0399, or G0400 are generally allowed when performed in the home for the indications listed above. Source: Local Coverage Determination (LCD): Polysomnography and Other Sleep Studies (L36902) -
Commercial payer policies may vary. Check with each commercial payer for coverage.
8. What modifier may be used to bill for an incomplete home sleep test (e.g. patient discontinues, less than 6 hours, etc.)?
For Medicare, include modifier 52, "Partially reduced or eliminated services" when billing for incomplete home sleep tests. Include the statement, "reduced services" in Item 19 in CMS-1500 claim form (or electronic equivalent) along with a brief reason to explain why the test was incomplete. The provider should maintain documentation in the patient's medical record that includes reason. To determine charge amount, reduce normal fee by percentage of service not provided (e.g. if 75% of normal service provided, reduce amount billed by 25%). Medicare claims processing system reimburses lower of actual charge or fee schedule allowance.
Commercial payer requirements may vary; contact the payer for guidance.
9. When do sleep studies expire?
Sleep studies do not expire; however, studies used to qualify a patient under Medicare, must meet Medicare guidelines as outlined in the PAP LCD at the time the patient enters Medicare. In the case of an initial study performed for the purposes of diagnosis after Medicare eligibility, it is preferred that therapy be initiated within three months of the study, but in no case, would longer than 12 months be considered. Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in the LCD.
10. Is an additional face-to-face required if the original one prior to the sleep study is greater than six months before the order?
Yes, to meet the face-to-face requirements per the CMS Medicare Learning Network (MLN) Matters (MM)8304, in which the physician has had a face-to-face examination with a patient within the six (6) months before the written order. If the original face-to-face was greater than 6 months prior to the written order being obtained, the patient must have a second face-to-face after the PSG.
11. Can the ApneaLink™ be used to qualify Medicare patients for home oxygen services?
No. The ApneaLink Air device is indicated for use by health care professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients.
In addition, according to the Oxygen and Oxygen Equipment LCD, "Home overnight oximetry is limited solely to stand-alone overnight pulse oximetry performed in the beneficiary's home under the conditions specified below. Overnight oximetry performed as part of home sleep testing or as part of any other home testing is not considered to be eligible under this provision to be used for qualification for reimbursement of home oxygen and oxygen equipment even if the testing was performed in compliance with the requirements of this section."
U.S. Centers for Medicare & Medicaid Services. Local Coverage Determination (LCD): Oxygen and Oxygen Equipment (L33797), eff 01Jan2019. Retrieved Mar 22, 2019 from https://www.cms.gov/medicare-coverage-database/license/cpt-license.aspx?from=~/overview-and-quick-search.aspx&npage=/medicare-coverage-database/details/lcd-details.aspx&LCDId=33797&%3bver=23&%3bCoverageSelection=Local&%3bArticleType=All&%3bPolicyType=Final&%3bs=All&%3bCptHcpcsCode+=E1392&%3bbc=gAAAACAAAAAA&
12. May we bill CPT code 95800 for the ApneaLink Air home sleep testing device?
The recording of sleep time is required to bill 95800. See the American Medical Association’s (AMA) CPT code description below.
The ApneaLink Air does not record sleep time and therefore does not meet the requirements of CPT code 95800. The ApneaLink Air is considered a Type III home sleep test (HST) and meets the code description of CPT code 95806 or HCPCS code G0399.
Please consult the following link for additional ApneaLink Air billing details:
Different insurers accept different codes for HSTs. Some insurers accept the G0399 code, while others accept the 95806 CPT code for the ApneaLink Air. Still other insurers accept both the G code and the CPT code. An HST provider will need to contact each insurer they work with to identify which codes can be reported.
AMA CPT 95800 Code Description - Sleep study, unattended, simultaneous recording heart rate, oxygen saturation, respiratory analysis (e.g. by airflow or peripheral arterial tone), and sleep time.
1. What medical billing code(s) can a healthcare practitioner use for face-to-face continuous positive airway pressure (CPAP) follow-up visits with patients?
If the patient's primary purpose for the visit is to review issues related to positive airway pressure (PAP) therapy, then the practitioner may bill CPT code 94660. CPT code 94660 is specific to the initial education and long-term management of CPAP therapy. Alternatively, practitioners may consider using E/M codes 99211-99215 to bill for the time spent with the patient. Proper code selection is at the discretion of the billing provider, and the code billed must be justified by the service provided and documented.
2. Can clinical staff (e.g. nurse practitioners or physician assistants) perform and bill for CPT code 99091 services?
Clinical staff members' ability to perform some or all of the work under CPT code 99091 and/or bill for it may vary based on the practitioner's state's scope of practice rules, as well as the payer's rules. Billing practitioners should check with the payer or healthcare attorney to determine if and when clinical staff may perform and/or bill for CPT code 99091 services.
1. Can an HME supplier bill for both stationary (E1390) and Portable Oxygen (E1392) codes when dispensing the Mobi™ portable oxygen concentrator (POC)?
Mobi's FDA-cleared indications for use state that the device may be used continuously for patients requiring supplemental oxygen. It is up to the patient's physician to determine appropriate use of the device based on their specific condition. Mobi can be billed for both E1390 & E1392 Pricing, Data Analysis and Coding (PDAC) codes.
2. Please clarify the date of service to be used when billing maintenance and service for oxygen. Does the date of service have to be the actual date of the visit? For example: The patient has oxygen stationary equipment that "capped out" on 12/01/08 which would make the first allowable maintenance and service billable on 07/01/09. However, the equipment has been serviced on 06/15/09. May a supplier bill for the 06/15/09 M&S visit on 07/01/09 or do they have to wait until maintenance is required again?
The 2009 6-month maintenance and servicing payment for oxygen concentrators and transfilling equipment only applies when the supplier physically makes an in-home visit to inspect the equipment and the date of the visit falls on or after the 6-month anniversary date. In the example provided, the supplier would not be able to bill for an M&S payment on 7/1/09 for a service visit that occurred on 6/15/09. In this particular case, if the supplier physically makes another in-home visit to inspect the equipment between 7/1/09 and 12/31/09, they would be eligible to bill for the 6-month M&S payment. The date of service on the claim would be the date of the actual visit. https://www.cgsmedicare.com/jc/help/faqs/oxygen_faqs.html#
3. If a patient is past the 36-month rental period for oxygen equipment (i.e. payment for the equipment has capped) and the patient has a stationary concentrator, stationary liquid tank and portable liquid cylinders in the home, what code(s) may be billed?
Per the Oxygen Policy Article: If the patient has a stationary concentrator, portable liquid equipment, and a stationary liquid tank to fill the portable cylinders, when payment for contents begins, payment will only be made for portable liquid contents. The only code that may be billed is E0444 (portable liquid contents). Code E0442 (stationary liquid contents) must not be billed in this situation because the stationary tank is just used to fill the portable cylinders.
4. If the required physician re-evaluation is not performed within 90 days prior to recertification but is performed at a later date, what should be entered as the Recertification Date on the Oxygen CMN?
In that situation, the date of the last physician visit should be entered as the Recertification Date on the CMN. For more information, please refer to the Oxygen and Oxygen Equipment LCD and https://cgsmedicare.com/jc/help/faqs/oxygen_faqs.html
5. Is hypoxia a good diagnosis for ordering oxygen?
The NCD for oxygen does not have an approved diagnosis list for oxygen coverage. However, there has to be a specific disease that affects the lungs and/or oxygen levels in the blood. Hypoxia is the result of a disease but is not an actual diagnosis. The national coverage determination (NCD) for oxygen lists examples of what would be considered acceptable for "hypoxia-related symptoms or findings that might be expected to improve with oxygen therapy". The examples provided include pulmonary hypertension, recurring congestive heart failure due to chronic cor pulmonale, erythrocytosis, impairment of the cognitive process, nocturnal restlessness and morning headaches. https://cgsmedicare.com/jc/help/faqs/oxygen_faqs.html
6. What is required to show that alternate treatments have been tried and failed in order to qualify for oxygen?
Oxygen is rarely the first-line treatment for lung conditions. Therefore, per the NCD, the medical records must document that "other forms of treatment (e.g. medical and physical therapy directed at secretions, bronchospasm and infection) have been tried, have not been sufficiently successful, and oxygen therapy is still required."
7. Can you explain the two scenarios for qualifying for oxygen?
The patient may qualify for oxygen either during an inpatient hospital stay or as an outpatient but who also is in a chronic stable state. If the patient qualifies during an inpatient hospital stay, the O2 saturation should be within two days of discharge and the most recent one obtained at that particular qualifying condition. If the patient qualifies as an outpatient, they must be in a chronic stable state, meaning the O2 saturation cannot be obtained during an acute exacerbation of the lung condition or during an acute respiratory condition/infection. https://cgsmedicare.com/jc/help/faqs/oxygen_faqs.html
8. A patient has a diagnosis of obstructive sleep apnea (OSA) and does not meet any of the Oxygen LCD Group I or Group II criteria, yet their physician has prescribed home oxygen therapy. In this instance, would the home oxygen be covered?
No, home oxygen would not be covered. In order for home oxygen to be reimbursed the payment rules described in the oxygen policy must be met. https://www.cgsmedicare.com/jc/pubs/news/2013/1113/cope23913.html
9. A patient has a diagnosis of OSA and demonstrated oxygen desaturation during a titration polysomnogram(PSG) as described in the oxygen LCD. Following diagnosis and optimal treatment of the OSA during the titration PSG, it is discovered that the patient is not using the PAP device as prescribed (refused the device, is non-compliant, etc.) but the physician has prescribed oxygen for use during sleep. In this instance, would the home oxygen be covered?
Yes, home oxygen is covered. For patients with OSA, the titration PSG is used to:
Patient compliance with treatment after testing is not a factor in determining eligibility for payment of home oxygen. Note: This answer assumes that OSA is the only other concurrent condition that could affect blood oxygen levels and that the underlying lung disease is adequately treated and stable as required by the Oxygen LCD.
10. A patient has a diagnosis of OSA and demonstrated oxygen desaturation during a titration polysomnogram(PSG) as described in the oxygen LCD; however, the patient is unable to tolerate PAP therapy during the titration PSG. The physician does not prescribe PAP but rather prescribes oxygen therapy. In this instance, would the home oxygen be covered?
No, home oxygen is not covered. Oxygen is not the primary treatment for OSA. The Oxygen LCD requires that the patient is optimally treated with respect to their OSA thus satisfying the Oxygen LCD "chronic stable state" requirement.
11. A patient has a diagnosis of OSA and has been diagnosed with a chronic, severe lung disease (i.e. COPD, emphysema). The patient has tried PAP, other treatment options, such as an oral appliance, weight loss and surgery. All treatments have been determined by their physician to be unsuccessful. With no active OSA treatment, the patient continues to desaturate at night (< 88% for 5 total minutes or more), as evidenced by overnight oximetry testing. The physician has prescribed home oxygen for use at night. In this instance, would the home oxygen be covered?
This question actually has insufficient information to determine whether home oxygen might be eligible for payment. What is missing is information about the type of testing done. A titration PSG must have been performed. During the titration phase, optimal treatment with the PAP device must have been achieved. Only after optimal treatment with a PAP device can an assessment of the remaining hypoxia (if any) be done. For the patients remaining hypoxic while receiving optimal PAP therapy, home oxygen may be covered if the oxygen testing reaches the levels required by the oxygen LCD. Compliance with treatment for OSA is not a determining factor for qualification of home oxygen.
12. A patient has a diagnosis of OSA and has been diagnosed with a chronic, severe lung disease (i.e. COPD, emphysema). During a titration PSG that lasted more than 2 hours, the patient was titrated with PAP to anAHI/RDI of <10 events per hour, yet continued to desaturate below 88% for more than five total minutes. The physician has prescribed oxygen for use in conjunction with the PAP. In this instance, would the home oxygen be covered?
Yes, home oxygen would be covered. The question restates the titration PSG requirements described in the LCDs. A titration PSG meeting these requirements can be used for qualification of home oxygen.
13. A patient has a diagnosis of OSA and has been diagnosed with a chronic, severe lung disease (i.e. COPD, emphysema). The patient was prescribed a PAP and the physician has ordered a home overnight oximetry test that was performed on room air without the patient using their PAP device. The patient desaturated below 88% for more than five total minutes. In this instance, would the home oxygen be covered?
No, home oxygen would not be covered. Patients with diagnosed but untreated OSA are not in a "chronic, stable state." Therefore, they do not meet the Oxygen LCD Group I or Group II criteria. Only testing with a titration PSG may be used to qualify a patient with OSA for concurrent payment of home oxygen.
14. A patient has diagnoses of OSA and chronic, severe lung disease (i.e. COPD, emphysema). The patient has an oximetry testing performed during the day, while at rest. The patient's resting SpO2 is < 88% and the patient's physician has prescribed home oxygen therapy. In this instance, would home oxygen be covered?
Yes, home oxygen would be covered. This patient meets the Oxygen LCD Group I criteria. Oximetry testing while the patient is awake may be used for qualification of home oxygen. While awake OSA does not affect blood oxygen levels.
15. A patient has diagnoses of OSA and chronic, severe lung disease (i.e. COPD, emphysema). The patient has pulse oximetry testing performed during the day, while exercising. The patient's baseline SpO2 is 92% and their SpO2 < 88% during exercise. The patient is tested during exercise while on oxygen and their SpO2 is 92%. The physician prescribes home oxygen therapy for use during activity/exercise. In this instance, would home oxygen be covered?
Yes, home oxygen would be covered. This patient meets the Oxygen LCD Group I criteria. As discussed in Q8, oximetry testing while awake continues to be acceptable for the qualification of home oxygen. OSA does not affect the blood oxygen levels of an awake patient.
16. When oxygen qualification testing is obtained from a titration polysomnogram, is portable oxygen covered?
No, as with overnight oximetry, only stationary oxygen is justified based on titration polysomnography.
17. For a patient now eligible for Medicare who is already on PAP and O2, are both therapies eligible for reimbursement?
Each therapy has separate and independent coverage criteria that must be met in order to be eligible for Medicare reimbursement. Items reimbursed by other payers prior to Medicare eligibility are not a determinant for Medicare program payment. Claims submitted to Medicare for items previously paid outside of Medicare are considered new, initial Medicare claims. All applicable coverage and documentation requirements in effect at the initial Medicare date of service (DOS) must be met. There are two limited exceptions:
18. As the supplier, we obtain all documentation. A week later, a prescription is provided by the ordering physician asking to test the beneficiary for a POC and beneficiary qualifies. Are we required to get a revised certificate of medically necessity (CMN) for that once we get the prescription for the POC?
If the beneficiary qualified for the original portable with rest or exercise testing, a new test is not required for a portable oxygen concentrator. There is a requirement for a new order for the change in modality; however, a revised CMN is not required.
1. What Healthcare Common Procedure Coding System (HCPCS) code can I use to bill for a product it isn’t assigned a HCPCS code?
The product has not been code-verified by Medicare's Pricing, Data Analysis and Coding (PDAC) contractor.
Medicare's Pricing Data Analysis and Coding (PDAC) contractor is responsible for verifying the HCPCS code(s) used to describe a durable medical equipment (DME) item for the purpose of billing Medicare. Obtaining PDAC HCPCS code verification for most DME items is voluntary.
As a service to our customers, ResMed requests and receives PDAC HCPCS code verifications for numerous products; however, not all products or model numbers publicly listed by PDAC are launched into the market.
Coding is limited to each individual product's model number, so the coding of one product's model number does not apply to the coding of another model number.
When a particular product and/or model number reported by PDAC has not received a HCPCS code, it is the supplier's responsibility to determine whether HCPCS code(s) fall within an existing HCPCS definition, and if so, use the associated HCPCS code when submitting claims.
To search for HCPCS codes based on a description of an item or assigned to a product's model number, PDAC's DME Coding System (DMECS) Information tool may be queried or the supplier may contact the PDAC contractor directly.
However, if an item does not meet a HCPCS code description as defined by the PDAC after performing a HCPCS search, filing a claim using HCPCS code E1399 (miscellaneous Durable Medical Equipment) and/or executing a Medicare Advance Patient Notice of Noncoverage (ABN) may be an appropriate alternative solution.
It is recommended that you check with commercial payers for specific coding and coverage requirements prior to filing a claim for the item because requirements may vary between payers.
2. What is the billing code for the Gecko Pads?
The Gecko pads HCPCS billing code is A9270. Medicare considers this code non-covered. Collecting cash may be an option and commercial payers may provide payment for A9270.
3. Based on the following example, what is the correct order date to enter on the detailed written order?
Example: On 06/01/XX we receive a written dispensing order for an item of DME that does not require a written order prior to delivery. We deliver the equipment on 06/02/XX and also prepare a detailed written order for the prescribing practitioner's review and signature. Is the order date the date we received the dispensing order or is it the date we prepared the detailed order for the prescribing practitioner's review and signature?
According to Chapter 3, Section 3 of the Jurisdiction C DME MAC Supplier Manual, the "date of the order" is the date the supplier was contacted by the prescribing practitioner (for verbal orders) or the date entered by the prescribing practitioner (for written dispensing orders). Therefore, the order date that should be entered on the detailed written order is 06/01/XX.
A start date is not a required element of either a dispensing or detailed written order.
4. How do you code for a continuous positive airway pressure (CPAP) repair?
Repairs to items which a patient owns are covered when necessary to make the items serviceable. Any Medicare-enrolled supplier can perform repairs on patient-owned equipment. Repairs (parts and labor) of DMEPOS items are performed on the base item. The replacement of parts or components that make up the base item is considered to be a repair.
For Medicare, the supplier may use E1399 and include an RB modifier to bill for a CPAP/respiratory assist device (RAD) repair and will want to include a narrative in item 19 of the CMS-1500 claim form or the appropriate NTE segment on an electronic claim which includes a description of the repair as well as the manufacturer’s name, product name, model number, amount of the repair, and the justification of the repair.
The supplier may also bill for labor using K0739 with the number of units of service for the repair time where 1 unit of service = 15 minutes. Medicare allows 2 units of service for CPAP repairs.
If the supplier is loaning a device, the supplier may bill using K0462 equal to 1-month rental. Medicare will deny claims for this code beyond 1-month rental.
The supplier may choose to execute an ABN with the patient and collect cash upfront if the supplier has reason to expect that Medicare will not pay for the repair.
How to use modifier RB: https://med.noridianmedicare.com/web/jddme/article-detail/-/view/2230715/how-to-use-modifier-rb
Temporary loaner: https://med.noridianmedicare.com/web/jadme/topics/repairs/replacement
5. What documentation is required as evidence of parts cost in the completion of a repair? Is a detailed repair invoice required?
It will be necessary to have something, though Medicare doesn't specify a format, to show the parts and their cost that were a part of the repair.
6. Does labor have to be broken down in minutes for each part? The manufacturer is issuing a flat fee that includes parts and labor.
Labor must be billed in 15-minute increments. The supplier must know the minutes involved. Only the entity completing the repair will be able to provide this information.
7. If you use a detailed written order (DWO) as both your dispensing order and your DWO and that DWO has a LON of less than 99, does the dispensing order expire when your DWO expires (i.e. DWO is for CPAP and CPAP supplies and the LON is for 13 months will a new dispensing order be required for any resupply orders places after month 13?)
Yes, because after 13 months the order is no longer valid for billing to Medicare.
8. Do accessories for PAP & RAD devices require a prescription when purchased individually?
For Medicare, all claims for items billed to Medicare require a prescription. However, a routine prescription for refills is not needed. Due to the various state prescription law, ResMed issues the following prescription statement.
ResMed's Prescription Requirement Position Statement:
"This information is intended as general guidance and is not legal advice. Due to the variety of applicable US laws on this topic, the entity dispensing medical products is responsible for complying with all applicable laws and regulations.
Flow generator systems, including patient interfaces and humidifiers, are Class II medical devices that require a prescription before they may be dispensed to a patient. The accessories that accompany Class II medical devices also require a prescription, according to federal law (21 U.S.C. § 321(h)). The prescription for purchase must be from a licensed US physician or medical practitioner.
While federal law may not explicitly require a separate prescription for dispensing a replacement part, for example a replacement cushion used with a patient interface, some states require a prescription before a replacement part may be dispensed.
Reimbursement issues also affect whether a prescription may be required in a particular instance. For example, many state health care insurers require a prescription for a replacement part to be eligible for reimbursement. Private insurers often have their own requirements before a system—or a replacement part—will be eligible for reimbursement.
In light of the varying requirements of federal and state law, ResMed may include the prescription requirement on its devices, patient interfaces, accessories, and replacement parts."
Suppliers should check with their payers or a health care attorney for additional prescription requirement guidance.
9. When there has been a change in medical condition, would the RA modifier be used for a change in equipment within the 5-year reasonable useful lifetime (RUL)?
No. The RA modifier is only appended when there is replacement due to lost, stolen or irreparably damaged equipment and when oxygen is replaced after 5 years. Noridian recommends a narrative on the change in condition. If there is same/similar equipment on file, the claim will most likely deny and the supplier will need to appeal with the medical documentation to justify the change. It is encouraged to indicate a change in condition on the Redetermination Request Form when appealing the same/similar denial.
10. What are the U.S. indications for use for each device?
|Product name||Model numbers (may not be all-inclusive list)||Indication|
|Astral™||27001, 27003||• The Astral 100/150 provides continuous or intermittent ventilatory support
for patients weighing more than 11 lb (5 kg) who require mechanical ventilation
• The iVAPS mode with optional AutoEPAP is intended for patients weighing more than 66 lb (30 kg)
• The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation
|Stellar™||24157, 24140||• The Stellar is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb/13 kg
and above) with respiratory insufficiency, or respiratory failure,
with or without obstructive sleep apnea
• The device is for noninvasive use, or invasive use (with the use of
the ResMed Leak Valve)
• Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage
|AirCurve™ ST-A||28210, 28211, 28219||• The AirCurve 10 ST-A is indicated to provide non-invasive
ventilation for patients weighing more than 30 lb (13 kg) with respiratory insufficiency or obstructive sleep apnea (OSA)
• The iVAPS mode is indicated for patients weighing more than 66 lb (30 kg)
• The AirCurve 10 ST-A is intended for home and hospital use
• The humidifier is intended for single patient use in the home environment
and re-use in a hospital/institutional environment
|AirCurve 10: S, VAuto, ST||37213, 37214, 37211, 37212, 37306, 37307||• Indicated for the treatment of obstructive sleep apnea (OSA) in
patients weighing more than 66 lb (30 kg)
• It is intended for home and hospital use
• The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment
|AirMini™||38113||• The AirMini self-adjusting system is indicated for the treatment of
obstructive sleep apnea (OSA) in patients (female patients with mild to
moderate OSA when using AutoSet for Her treatment mode)
weighing more than 66 lb (30 kg)
• It is intended for home and hospital use
|AirSense™ 10: AutoSet™, AutoSet for Her, CPAP, Elite||37207, 37208, 37209, 37210, 37203, 37204, 37205, 37206||• Indicated for the treatment of obstructive sleep apnea (OSA) in
patients weighing more than 66 lb (30 kg)
• It is intended for home and hospital use
• The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment
|AirCurve 10 ASV*||37215, 37216||• The AirCurve 10 ASV device is indicated for the treatment of patients
weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing
• It is intended for home and hospital use
• The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment
|Mobi™||35001||• The ResMed Mobi is used on a prescriptive basis by adult patients
who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration
oxygen to these patients
• It is not life-supporting or life-sustaining
• It may be used continuously in a home, institution or travel environment
• The Mobi is also portable
|ApneaLink™ Air||22354||• The ApneaLink Air device is indicated for use by health care
professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients
• ApneaLink Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep
• The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation
• The device is intended for home and hospital use under the direction of a HCP
* ASV therapy is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF <- 45%) and moderate to severe predominant central sleep apnea
|Revision History Date||Revision History Number||Revision History Explanation|
|20 May 2019||11.0||– Added ‘Revision History’ section
– Numbered sections and questions for quick find and to simplify history revisions.
– Updated question 3, sec. I
– Deleted question 4, sec. I
– Updated question 8, sec. I
– Updated question 24, sec. I
– Added question 42, sec. I
– Added question 43, sec. I
– Added question 4, sec. II
– Updated question 12, sec. V
– Updated question 1, sec. VII