Reimbursement resources

Yes, if they meet the following coverage requirements:

1. Sleep test – There must be documentation that the beneficiary had a sleep test, prior to FFS Medicare, which meets the FFS Medicare apnea-hypopnea index (AHI)/respiratory disturbance index (RDI) coverage criteria in effect at the time that your beneficiary seeks a replacement PAP device and/or accessories. As a reminder, those current requirements are:
   • AHI or RDI is greater than or equal to 15 events per hour, with a minimum of 30 events; or
   • AHI or RDI is 5-14 events per hour (minimum of 10 events) with documentation of excessive daytime sleepiness, impaired cognition, mood disorders, insomnia, hypertension, ischemic heart disease, or history of stroke.

   (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.)

2. Clinical Evaluation – Following enrollment in FFS Medicare, the beneficiary must have an in-person evaluation with you to document in their medical record that:
   1. They have a diagnosis of obstructive sleep apnea (OSA); and,
   2. They continue to use and benefit from the PAP device.

https://cgsmedicare.com/pdf/dear_physician_cpap_devices_replacement.pdf

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 second 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.”
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52467&ver=52.

Medicare’s Pricing, Data Analysis and Coding (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.

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 you check with your employer’s benefits administrator to determine if you can use your HSA or FSA funds to purchase Resmed products and accessories.

No. The treating practitioner that does the initial face-to-face exam does not have to be the same practitioner who orders the CPAP. https://med.noridianmedicare.com/web/jadme/article-detail/-/view/2230703/positive-airway-pressure-pap-devices-supplier-frequently-asked-questions-revised-may-2012

No time limit is specified in the policy; however, one would anticipate that these two events occur close together in time, typically within three months.
https://www.cgsmedicare.com/jc/pubs/news/2008/1208/cope8998_5.html

The practitioner may see the beneficiary 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 beneficiary is benefiting from the use of the selected device as evidenced by an in-person 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 beneficiary’s medical record to fulfill the requirement to assess therapy benefit. Consider the following example:

• 11/01/14 – Beneficiary set up with a PAP device
• 12/05/14 – In-person re-evaluation indicates subjective improvement, but objective data is not available
• 1/30/15 – Supplier obtains data demonstrating adherent use; faxes to treating practitioner for review
• 2/01/15 – Add KX modifier to fourth month’s claim

https://www.cgsmedicare.com/jc/pubs/news/2008/1208/cope8998_5.html

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 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.

1. Refer to the “Integrated Devices” fast facts for additional FAQs about billing, non-compliance scenarios, reissuing, etc.

The term treating practitioner encompasses both physicians (defined in section 1861(r)(1) of the Social Security Act) and non-physician practitioners (such as a physician’s assistant [PA], nurse practitioner [NP], and clinical nurse specialist [CNS]; defined in section 1861(aa)(5) of the Social Security Act). In a scenario where the beneficiary visits their primary care provider (PCP) who then refers the beneficiary to a sleep specialist for a polysomnogram and subsequent treatment with PAP and follow-up, both the PCP and the sleep specialist would be considered “treating practitioners” within the context of Medicare regulations. Both practitioners are engaged in diagnosing and treating the beneficiary for sleep disordered breathing. This scenario is quite common in medical practice where the primary medical care for the beneficiary is rendered by the PCP. The subspecialty practitioner consultation is engaged for specific diagnostic and/or therapeutic treatment outside the scope of the PCP’s area of medical expertise.
https://www.cgsmedicare.com/jc/pubs/news/2008/1208/cope8998_5.html

The signed delivery slip or a copy of the itemized sales receipt is sufficient documentation of a request for refill.
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=55426&ver=98&keywordtype=starts&keyword=standard%20documentation&bc=0

Yes, an in-person evaluation by their treating practitioner is required.

For beneficiaries who received a PAP device prior to enrollment in Fee for Service (FFS) Medicare and are seeking Medicare coverage of either rental of the device, a replacement PAP device and/or accessories, both of the following coverage requirements must be met:

1. 1. 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; and,
   2. Clinical Evaluation – Following enrollment in FFS Medicare, the patient must have a face-to-face evaluation by their treating practitioner who documents in the patient’s medical record that:
      1. The beneficiary has a diagnosis of obstructive sleep apnea; and,
      2. The beneficiary continues to use the PAP device.

If criterion 1 or 2 above are not met, the claim will be denied as not reasonable and necessary.

In these situations, there is no requirement for a clinical re-evaluation or for objective documentation of adherence to use of the device.
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33718&ver=43&keywordtype=starts&keyword=positive%20airway&bc=0#:~:text=BENEFICIARIES%20ENTERING%20MEDICARE%3A

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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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 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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

No. All requirements must be met within the 90-day timeframe. 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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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 criterion 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.
   https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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.”
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

The DME MAC Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea Local Coverage Determination (LCD L33718) has an option for repeating the 12-week trial following a face-to-face (F2F) clinical re-evaluation and a Type I polysomnogram (PSG). Because of the restrictions placed by the NCD, there is no mechanism for suppliers to bill for this additional trial until the trial is complete and benefit is demonstrated. Consequently, billing for the KX modifier stops after month 3 if the initial trial fails. Suppliers may only resume billing with the KX modifier when the second 12-week trial is complete, adherence is demonstrated, and a face-to-face clinical re-evaluation has been documented. A timeline example is provided below:

• First 12-week trial
  • Suppliers can use the KX modifier during months 1-3.
  • Continued coverage after 12-week trial – suppliers may bill claims for 4th month and beyond once the in-person assesses benefit and objective evidence of adherence is met (between the 31st and 90th day).
  • If the beneficiary is seen after the 91st day but DOES have a F2F assessment and met adherence during that 31st to 91st day window, suppliers may go back (if they’re holding claims) and append the KX modifier for the 4th month and beyond.
• Second 12-week trial
  • If adherence and benefit is not met during the first 12-week trial, a new in-person is required to determine why adherence and benefit was not achieved AND conduct a new PSG. Only then does a new 12-week trial begin.
  • 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 in-person is conducted to assess benefit and objective evidence of adherence is met may the supplier resume billing the KX modifier (e.g. 4th claim in the 13-month capped rental cycle).

  Suppliers are encouraged to read the entire Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea LCD and LCD-related Policy Articles for additional coverage, coding and coverage requirements.
  https://cgsmedicare.com/jc/pubs/news/2019/05/cope12486.html

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 a 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, they do not meet the policy criteria for continued 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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

No. Since the base PAP device is not (yet) reasonable and necessary (R&N), the essential accessories are not R&N.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

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.
https://www.cgsmedicare.com/jc/pubs/news/2009/0909/cope10618b.html

Suppliers must bill 2-line items for upgraded/excessive DMEPOS items where the beneficiary requests an upgrade. Suppliers must bill both lines on the same claim in the following order:

Line instructions:

Line 1:

Bill the appropriate HCPCS code for the upgraded item the supplier actually provided to the beneficiary with the dollar amount of the upgraded item. If the supplier has a properly obtained ABN on file signed by the beneficiary, use the GA modifier. If the supplier did not properly obtain an ABN signed by the beneficiary, use the GZ modifier.

Line 2:

Bill the appropriate HCPCS code for the reasonable and necessary item with the actual charge for the item. Use the GK modifier.

Suppliers should bill their full submitted charge on the claim line for the upgraded item (Line 1) and the full amount for the reasonable and necessary item (Line 2). If the upgrade is within a code, suppliers still bill 2-line items, using the same code on both lines, but Line 1 would have the higher dollar amount.

Suppliers must bill both lines on the same claim in sequential order. Line 1 and the associated Line 2 should follow each other.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R1142cp.pdf

The Local Coverage Determination (LCD) for Positive Airway Pressure (PAP) devices does state that an E0601 device is covered for beneficiaries with Obstructive Sleep Apnea (OSA) who meet coverage criteria. The JC 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 be denied, and it may be necessary to appeal.

Reference: Starting a New Capped Rental Period, chapter 5. https://www.cgsmedicare.com/jc/pubs/supman/

There must be a standard written order (SWO) for the specific type of mask being used by the beneficiary. If there is a change in the mask used, a new SWO will be required. To return to the previous mask, a new order will be required as that constitutes a change as well.
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=55426&ver=98&keywordtype=starts&keyword=standard%20documentation&bc=0

As of July 1, 2022, Noridian will now be accepting REI as a valid measurement on a PAP sleep study. This does require that respiratory event related arousals (RERA) not be included in the calculation as Medicare does not recognize RERA.
https://med.noridianmedicare.com/web/jddme/education/act/act-qa-080922

If it is changing, yes, a standard written order (SWO) must specify the mask. When a new order is obtained for a change in mask, it replaces the previous order. If there is a need to change back, a new order is required as well.

We understand that many suppliers would prefer explicit, prescribed instructions. The DMDs deliberately did not provide specific guidance as to how a supplier might assess the need for replacement of non-consumable supplies leaving as much flexibility to the supplier’s discretion as possible. The Medicare Program Integrity Manual (PIM) (CMS Pub. 100-08), Chapter 5, §5.2.6 refill requirement requires a determination that the need for the refill is justified. Recognizing that there are differing products and business practices, allowing each supplier to decide how to best assess and document the need for replacement was the most appropriate course.

For purposes of this requirement, non-functional means that the item is no longer able to be used safely or effectively for the purpose for which it was intended. There are numerous reasons that would render durable supplies non-functional. Breakage, wear, or contamination (not all-inclusive) are some common examples. When the item becomes unusable for reasons such as damage, wear, soiling or contamination that is unable to be removed with recommended cleaning, etc., the item can be considered as nonfunctional and may be replaced. All problems with the proper function of an item may not justify replacement (refill) of the item. For example, contrast the above situations with problems with function caused by improper fit or incorrect use such as might occur with a CPAP mask leak. Mask leak may be due to a non-functioning mask OR an ill-fitting or incorrectly worn interface. The latter would not necessitate replacement but rather reassessment of fit and possible adjustment by the practitioner or supplier.
https://cgsmedicare.com/jc/help/faqs/current/refill_requirements.html

According to Medicare, a supplier must not dispense or bill for more than a 3-month quantity of accessories at a time. When billing a 3-month quantity, the supplier must:

1. Bill each individual accessory HCPCS code on a separate line of the claim form.
2. Add a narrative (e.g. “90 days” or “3 months”) to item 19 on the CMS1500 paper claim form (or appropriate NTE segment loop of an electronic claim) indicating that a 3-month supply is billed.
3. Ensure that the “From” and “To” date-of-service fields are the date of delivery (may be shipping date when using a shipping service) and do not span the dates of service.
4. Report the number of units supplied for the 3-month period for each HCPCS code. Ensure that the units don’t exceed the usual maximum allowance.
5. Add the KX modifier if all of the criteria in the “Coverage Indications, Limitations and/or Medical Necessity” section of the related Local Coverage Determination (LCD) have been met.

Verify all billing requirements and beneficiary eligibility with the payer prior to billing.
https://cgsmedicare.com/jc/pubs/news/2019/05/cope12611.html

A new 13-month cap rental starts as Medicare FFS is a separate Insurance plan. The beneficiary may opt for a new machine with 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 beneficiary (or beneficiary’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.

No, an E0601 can be tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting. Ineffective is defined as documented failure to meet therapeutic goals using an E0601 during the titration portion of a facility-based study or during home use despite optimal therapy (i.e. proper mask selection and fitting and appropriate pressure settings). If an E0601 device is tried and found ineffective during the initial facility-based titration or home trial, substitution of an E0470 does not require a new initial in-person clinical evaluation or a new sleep test.
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33718&ver=43&keywordtype=starts&keyword=positive%20airway&bc=0#:~:text=BENEFICIARIES%20ENTERING%20MEDICARE%3A

There are no Medicare documents or links that provide specific guidance on whether equipment owned by the HME and provided to the beneficiary must be refurbished, used, or new. Medicare leaves this decision up to the HME’s discretion. However, when billing for equipment (e.g. A/CPAP, RADs), the supplier must use modifier RR and KX during the 13-month capped rental period.

The E0562 can be billed but will most likely deny due to same/similar system edits since one was previously billed.

Resmed recommends if suppliers bill E0562 claim with the E0470 device, to 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 but 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.

The Local Coverage Determination (LCD) for Positive Airway Pressure (PAP) devices does state that an E0470 device is covered for beneficiaries with obstructive sleep apnea (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 3 months and the beneficiary 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 3-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 durable medical equipment Medicare administrative contractor (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, an 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 beneficiary. 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 be denied, and it may be necessary to appeal.
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33718&ver=43&keywordtype=starts&keyword=positive%20airway&bc=0#:~:text=BENEFICIARIES%20ENTERING%20MEDICARE%3A

Please contact your DME MAC for additional clarification regarding the replacement of an E0601 with an E0470.

CPAP setup definitions and requirements may be regulated by state law and accreditation policies. Therefore, we recommend you check with your state’s various licensing state boards, regulating agencies, accrediting body or a healthcare attorney to ensure you are in compliance with all state and federal laws and regulations.

DMEPOS Licensure information for each state as it pertains to the National Provider Enrollment (NP West)
https://palmettogba.com/palmetto/npewest.nsf/DID/CHEQ4E0825

DMEPOS Licensure information for each state as it pertains to the National Provider Enrollment (NP East)
https://www.novitas-solutions.com/webcenter/portal/DMEPOS/pagebyid?contentId=00269315

All suppliers must be accredited by a Medicare-approved accreditation organization in order to receive and retain a supplier billing number. Accreditation organizations as part of their accrediting process may require services to be available 24 hours a day, 7 days a week as necessary to meet beneficiary needs. These services may or may not require that respiratory services or a licensed clinical professional be on call at all times.

Suppliers should contact their state licensing, accreditation body, healthcare attorney or Medicare for specific guidance.

Yes, we have a RAD qualifying guide document: Respiratory Assist Device (RAD) Guidelines

If the beneficiary 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 beneficiary is on their 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):
  1. The diagnosis of CSA or CompSA; and
  2. Significant improvement of the sleep-associated hypoventilation with the use of an E0470 or E0471 device on the settings that will be prescribed for initial use at home, while breathing the beneficiary’s prescribed FIO2.
• If 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 beneficiaries with documented CSA or CompSA for the first 3 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.”
• https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=33800&ver=26

It is expected that the beneficiary’s medical records reflect this information so that the DME may submit a proper claim.

The RAD 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)

1. The diagnosis of CSA or CompSA; and
2. Significant improvement of the sleep-associated hypoventilation with the use of an E0470 or E0471 device on the settings that will be prescribed for initial use at home, while breathing the beneficiary’s prescribed FIO2.”

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=33800&ver=26

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 ABGs nor VBGs are noted as a required test in Medicare’s 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:
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=33800&ver=26

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 is 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 LCD used to determine coverage for bilevel PAP devices. Each of these disease categories are conditions where the specific presentation of the disease can vary from beneficiary to beneficiary. For conditions such as these, the specific treatment plan for any individual beneficiary will vary as well. Choice of an appropriate treatment plan, including the determination to use a ventilator vs. a bilevel PAP device, is made based upon the specifics of each individual beneficiary’s medical condition. In the event of a claim review, there must be sufficient detailed information in the medical record to justify the treatment selected.
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=33800&ver=26

We recommend reviewing the revised July 2020 Joint DME MAC Correct Coding and Coverage of Ventilators publication or reach out to the payer for guidance.
https://www.dmepdac.com/palmetto/PDACv2.nsf/DIDC/N9L9D6LL9U~Articles%20and%20Publications~Advisory%20Articles

Here is Medicare’s Local Coverage Determination for Oral Appliance for Obstructive Sleep Apnea:
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33611&ver=25&keywordtype=starts&keyword=Oral&bc=0

No. 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.
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52467&ver=52

The routine use of more than one PSG to titrate CPAP therapy would not be considered reasonable and necessary. If more than one CPAP titration PSG is claimed, persuasive medical evidence justifying the medical necessity for the additional tests may be requested.

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.
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36902&ver=12&keywordtype=starts&keyword=polysom&bc=0

For Medicare beneficiaries, make sure that you use the correct scoring of hypopneas when you interpret the HST/PSG. Medicare uses the 4% oxygen desaturation, not the AASM 3% definition. For beneficiaries who may currently be under commercial or non-Medicare insurance coverage, consider scoring beneficiaries using both the 3% and 4% oxygen desaturation metric, and provide a separately scored apnea-hypopnea index (RDI/AHI) based on each metric in your interpretation report. Providing an RDI/AHI scored with both hypopnea definitions, will allow your beneficiary to use the HST/PSG once they are Medicare-eligible.
https://www.cgsmedicare.com/pdf/dear_physician_sleep_test_scoring.pdf

Adding an addendum would also be acceptable, as long as the addendum is added correctly, according to CMS record-keeping principles. The addendum added to the original HST/PSG must be signed and dated by the original interpreting practitioner. In cases where the original interpreting practitioner is no longer available to read the study and score it based upon 4%, it is not acceptable to add an addendum to the original study. In this situation, however, the “new” interpreting practitioner may document the PSG results for 4% in the beneficiary’s medical record, and this will be accepted.
https://www.cgsmedicare.com/jc/pubs/news/2008/1208/cope8998_5.html

It depends. The cardiologist may potentially bill for the professional component, but due to unique contractual relationships between the cardiologist, other qualified healthcare 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 beneficiary situation.

Sometimes a global code is 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)

The physician performing the service must meet one of the following:

1. Be a diplomate of the American Board of Sleep Medicine (ABSM);
   OR
2. Have a Sleep Certification issued by ONE of the following boards:
   1. American Board of Internal Medicine (ABIM),
   2. American Board of Family Medicine (ABFM),
   3. American Board of Pediatrics (ABP),
   4. American Board of Psychiatry and Neurology (ABPN),
   5. American Board of Otolaryngology (ABOto),
   6. American Osteopathic Board of Neurology and Psychiatry (AOBNP),
   7. American Osteopathic Board of Family Medicine, (AOBFP)
   8. American Osteopathic Board of Internal Medicine, (AOBIM)
   9. American Osteopathic Board of Ophthalmology and Otorhinolaryngology (AOBOO);
      OR
3. Be an active physician staff member of a credentialed sleep center or laboratory that has active physician staff members meeting the criteria above in 1 or 2. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36902&ver=12&keywordtype=starts&keyword=polysom&bc=0

It is recommended the provider check with the payer for specific guidance.

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)

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=57049&ver=8

Commercial payer policies may vary. Check with each commercial payer for coverage.

The reduced services modifier, modifier 52, must be used.

If the AHI or RDI is calculated based on less than 2 hours of continuous recorded sleep, the total number of recorded events to calculate the AHI or RDI during sleep testing is at least the number of events that would have been required in a 2-hour period.
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36902&ver=12&keywordtype=starts&keyword=polysom&bc=0

Commercial payer requirements may vary; contact the payer for guidance.

In general, it is best for equipment to be provided within a reasonable timeframe from identification of need. This is usually considered to be 3 months; however, in the case of PAP the only hard deadline is that the sleep study must have been completed within the preceding 12 months of initial setup. This is a requirement of the standard documentation article A5526 regarding continued medical need.
https://med.noridianmedicare.com/web/jddme/dmepos/pap

No. The ApneaLink Air device is indicated for use by healthcare professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult beneficiaries.

In addition, according to the Oxygen and Oxygen Equipment LCD, “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.”
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33797&ver=39&keywordtype=starts&keyword=oxygen&bc=0

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: https://document.resmed.com/documents/articles/10113647r1+HSAT+Reimbursement+Fast+Facts+AMER+Eng.pdf

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.

The American Academy of Sleep Medicine’s (AASM) clinical practice guideline on diagnostic testing for adult OSA recommends a minimum of 2 hours of diagnostic recording.

This requirement may also be specified by the payer, but there is variability from payer to payer.

Medicare’s local coverage determination for polysomnography and other sleep studies states:

• “A positive test for OSA is established if either of the following criteria using the Apnea-Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI) are met:
  • AHI or RDI greater than or equal to 15 events per hour with a minimum of 30 events; or
  • AHI or RDI greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.
• The AHI is equal to the average number of episodes of apnea and hypopnea per hour. The RDI is equal to the average number of respiratory disturbances per hour.
• If the AHI or RDI is calculated based on less than 2 hours of continuous recorded sleep, the total number of recorded events to calculate the AHI or RDI during sleep testing is at least the number of events that would have been required in a 2-hour period.”

Reference: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33718&ver=43&keywordtype=starts&keyword=positive%20airway&bc=0#:~:text=BENEFICIARIES%20ENTERING%20MEDICARE%3A

If a payer’s policy does not specify a required number of hours, determination is at the discretion of the medical director and can be informed by the AASM clinical practice guideline.

Additional services performed during polysomnography (PSG) are usually bundled into the payment of PSG and not separately reimbursed. Check with the payer for proper billing guidance.

Interpretation requirements for HSAT are outlined within insurance policies. Physicians interpreting HSAT tests will typically be required to hold a license in the state where the beneficiary is tested.

Diagnostic testing is covered only if the beneficiary has the symptoms or complaints of one of the conditions listed below. Most of the beneficiaries who undergo the diagnostic testing are not considered inpatients, although they may come to the facility in the evening for testing and then leave after testing is over. The overnight stay is considered an integral part of these tests. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36902&ver=12&keywordtype=starts&keyword=polysom&bc=0

Coverage and Payment rules for diagnostic sleep tests may be found in the CMS National Coverage Determination (NCD) 240.4.1 (CMS Pub.100-03, Chapter 1, Part 4), the applicable A/B MAC LCDs and Billing and Coding articles. The sleep test must be either a polysomnogram performed in a facility-based laboratory (Type I study) or an inpatient hospital-based or home-based sleep test (HST) (Types II, III, IV, Other).

Coverage of a PAP device for the treatment of OSA is limited to claims where the diagnosis of OSA is based upon all of the following:

1. A sleep test (Type I, II, III, IV, Other) that meets the Medicare requirements for a valid sleep test as outlined in NCD 240.4.1 and the applicable A/B MAC LCD and Billing and Coding article; and,
2. A sleep test that is approved by the Food and Drug Administration (FDA) as a diagnostic device; and,
3. The sleep test results meet the coverage criteria in effect for the date of service of the claim for the PAP device; and,
4. The sleep test is ordered by the beneficiary’s treating practitioner; and,
5. The sleep test is conducted by an entity that qualifies as a Medicare provider of sleep tests and is in compliance with all applicable state regulatory requirements.

If the beneficiary’s primary purpose for the visit is to review issues related to 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 beneficiary. Proper code selection is at the discretion of the billing provider, and the code billed must be justified by the service provided and documented.

No. CPT code 99091 services may only be performed by physicians and qualified healthcare practitioners.
https://media.resmed.com/sites/6/20230228002004/1013491r13_Remote_Patient_Monitoring_Guide_Amer_Eng.pdf

https://media.resmed.com/sites/6/20230228002004/1013491r13_Remote_Patient_Monitoring_Guide_Amer_Eng.pdf

The [insert product name] 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 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.

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 an 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 an HCPCS code description as defined by the PDAC after performing an 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.

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.

According to Chapter 3, Section 3 of the Jurisdiction C DME MAC Supplier Manual, the “order date” ideally should reflect the date the order was first communicated to the supplier by the treating practitioner. Therefore, the order date that should be entered on the detailed written order is 06/01/XX.

Visit the following for coding repairs:
https://med.noridianmedicare.com/web/jddme/topics/repairs/repairs

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.

Yes, because after 13 months the order is no longer valid for billing to Medicare. Refer to Continued Medical Need of the Standard Documentation Requirements for All Claims Submitted to DME MACs Local Coverage Article.
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=55426&ver=98&keywordtype=starts&keyword=standard%20documentation&bc=0

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 laws, 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 healthcare 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.”

It is recommended you check with the payer, state licensing boards, regulating agencies, or a healthcare attorney for additional prescription requirement guidance.

The Stark law and regulations restrict the ability of a physician to refer Medicare or Medicaid beneficiaries for DME to a supplier with which the physician has a financial relationship OR to provide DME to his/her own beneficiaries, unless a Stark exception is met. We recommend you seek legal guidance on whether your specific arrangement meets a Stark exception.