ACT Questions and Answers - Respiratory Policies - May 14, 2020

The following questions and answers (Q&As) are cumulative from the DMEPOS Ask the Contractor Teleconference (ACT) – Respiratory Policy Focus. Some questions have been edited for clarity and answers may have been expanded to provide further details. Similar questions were combined to eliminate redundancies. If a question was specific just for one supplier, Noridian addressed directly with the supplier. This session included Medicare program updates, pre-submitted questions, and questions posed during the event.

As many questions pertained to the Coronavirus (COVID-19) Public Health Emergency (PHE) please note that during the COVID-19 PHE, clinical criteria are not being enforced for specified policies. The DME MACs will look to CMS for direction on what would need to occur for these policies once the PHE has ended and enforcement of clinical criteria is reinstated.

Questions Received Prior to ACT


Q1. Due to the COVID-19 PHE do we still need oxygen testing?
A1. The Oxygen National Coverage Determination (NCD), Local Coverage Determination (LCD) and Policy Article (PA) requirements are not being enforced for the duration of the Coronavirus (COVID-19) PHE. As such, oxygen testing would not be required. Please note however, that there must be medical records supporting that oxygen in “reasonable and necessary”.

Q2. How do we submit oxygen claims without a Certificate of Medical Necessity (CMN) during the PHE?
A2: For DME MAC processing purposes, these claims are submitted with the CR modifier and a narrative indicating “COVID-19”. Suppliers may need to review processes for releasing claims with their individual software vendors.

Q3. During this time of PHE, will there be a timeline for a beneficiary that fails Positive Airway Pressure (PAP) therapy and needs to go back for facility titration?
A3. The PAP NCD, LCD, and PA requirements will not be enforced for the duration of the PHE. Following the PHE, the DME MACs will return to enforcement.

Q4. What are the guidelines for DME dispensing amounts, in excess of 30 days, due to COVID-19?
A4. All Part B drugs whose policies indicate a limitation of a 30-day supply are eligible to have a 90-day supply provided during the COVID-19 PHE.

Q5. Are there updates as to if competitive bid will be postponed?
A5. Updates on Round 2021 of the  Competitive Bidding Program can be found on the Competitive Bidding Implementation Contractor (CBIC) website.

Q6. If a beneficiary is receiving a virtual setup and equipment is shipped to their house, is the date of service (DOS) the ship date or the visit date?
A6. Suppliers should reference the Standard Documentation Article which indicates that when method 2 is used for POD, the DOS may be either the ship date or the date the beneficiary receives the item(s).


Q7. Is a replacement PAP unit automatically replaceable after five years even if the unit is not broken or repairs cost less than replace?
A7. A PAP device may be replaced at the end of the five-year reasonable useful lifetime if ordered by the treating practitioner.

Q8. Will a claim deny for an expired DME Information Form (DIF)?
A8. Suppliers are expected to utilize the current DIF form with all claim submissions. Links to the most current DIF forms can be found on the Noridian website under the Forms tab for Jurisdiction A or Jurisdiction D.

Q9. Our beneficiary qualified for Adaptive Servo Ventilation (ASV) and it is recommended on titration, but the beneficiary wants to try BiPAP because it is cheaper. Can they?
A9. Therapeutic treatment is the determination of the prescribing practitioner and they will need to work with their beneficiary.

Q10. A PAP beneficiary failed the 12-week trial and there has been a break in therapy for more than 60 days, is the beneficiary expected to restart?
A10. An end to medical necessity occurs when the beneficiary stops using the device for 60 days, plus the days remaining in the rental month in which usage stops. Medical necessity must now be re-established.

Q11. We see a lot of hypoxia for a diagnosis with qualifying labs but no obvious underlying condition. Is this OK?
A11. When hypoxia-related symptoms that may be expected to improve with oxygen therapy are noted, there should be some indication in the medical record as to what is suspected of causing those symptoms.

Q12. What are the face-to-face (F2F)/verbal prescription requirements for nebulizer medications dispensed by pharmacy without a nebulizer?
A12. Coverage of the nebulizer itself is dependent on the qualification for the inhalation medication. It is not a requirement for the pharmacy to also provide the nebulizer. Medicare requires that there be a Standard Written Order (SWO) prior to billing. State requirements may be stricter however, so please be sure to follow those as well.

Q13. Is a sleep study required to be obtained/submitted if it was completed over seven years ago? How would Noridian determine that it met criteria?
A13. When a beneficiary enters Medicare on PAP therapy, one of the requirements is that there be a sleep study that meets the coverage criteria in effect at the time the beneficiary enters Medicare. If that sleep study is not available, a new study would be required. Evidence of a qualifying study must be available upon request.

Written Questions Asked During ACT

COVID-19-Related – Clinical Indications

Q14. Are chronic stable state reasonable and necessary or clinical indications not being enforced?
A14. Clinical indications are not being enforced for specified policies during the duration of the PHE, however, there must be information in the medical record to show that the oxygen is reasonable and necessary. Please visit the CMS webpage for all Coronavirus Waivers and Flexibilities.

Q15. Is the NCD for ventilators under the Interim Final Rule (IFR)?
A15. The treating practitioner’s notes need to document why the equipment is being prescribed. Additionally, CMS has published information on multi-function ventilators following the ACT. See MLN Matters Number SE20012 Revised.

Q16. Is testing for oxygen required for non-COVID beneficiaries?
A16. As noted in CMS-5531-IFC, clinical indications for specified policies are not being enforced for the duration of the COVID-19 PHE. Testing is considered a clinical indication of the oxygen policy. Suppliers should ensure that the medical indication for prescribing the oxygen is within the medical record as all items provided must be “reasonable and necessary”.

Q17. If PAP compliance failed, due to the PHE, can we continue to bill after the third month and for supplies until the beneficiary is able to have a follow-up appointment and new facility-based sleep study?
A17. PAP NCD, LCD, and PA requirements are listed with the specified policies that will not have clinical indications for coverage enforced for the duration of the PHE. Following the PHE, the DME MACs will return to enforcement.

Q18. We have a beneficiary who was originally ordered oxygen for the diagnosis of COVID-19. The diagnosis has improved; however, the physician would like the beneficiary to continue coverage due to chronic obstructive pulmonary disease (COPD). Is a revised CMN required to document the new diagnosis, in addition to documentation in the medical record?
A18. The CMN is not being required during the PHE per CMS guidance in CMS-5531-IFC. Therefore, a revised CMN will not be needed for the change in condition, at this time. However, the medical record must reflect the “reasonable and necessary” information.

Q19. For beneficiaries heading into month 13 of oxygen, is the F2F recertification visit still required during the PHE, or can we bill until the PHE is lifted?
A19. Policies requiring F2F encounters are not being enforced for the duration of the COVID-19 PHE. However, there must be information in the medical record to show that the oxygen remains “reasonable and necessary”.

Q20. Can you confirm that a F2F is considered a clinical indicator?
A20. Yes, the F2F is considered a clinical indicator.

Q21. If you can't get an initial CMN signed and the initial date is prior to March 1, what option does a supplier have?
A21. The requirement for submission of a CMN is not being enforced during the COVID19 PHE. Suppliers, however, must make sure the medical record is updated with the reasonable and necessary information.

Q22. If an existing Medicare beneficiary needs to have a new baseline sleep study because their old one was scored using the 3% criterion to define a hypopnea, will they require a F2F documenting why the physician is ordering a new study?
A22. For beneficiaries entering Medicare on PAP therapy the requirements include a sleep study that meets the criteria in effect at the time that the beneficiary enters Medicare and a F2F visit with their treating practitioner confirming an obstructive sleep apnea (OSA) diagnosis and use of the PAP device. The F2F is a requirement of the policy and not specific to the order for the new sleep study.

Q23. Do the F2F guidelines apply to inhalation medications dispensed to beneficiaries only, and not nebulizers?
A23. The waiver of F2F requirements apply to all DMEPOS policies during the COVID-19 PHE.

Q24. If a beneficiary needs to replace their PAP supplies and their baseline study is scored using the 3% criterion, can we dispense supplies during the PHE with that study on file?
A24. Since the clinical indications are not being enforced during the COVID-19 PHE, you can continue to dispense supplies. However, know that updated testing/scoring may be required after the PHE has ended.

Q25. When enforced, do new F2F encounters have to happen every six months or once we get one set of records is that good or need new ones every year?
A25. Under the prior guidance, the F2F is needed within six months of any new order. At this time, the DME MACs are awaiting direction from CMS for those items that will be on the new “required list”. Also, note that your state may have guidelines that require F2F visits at different intervals and you would need to adhere to those as well.

Q26. To clarify, we don’t need a F2F for other DME like wheelchairs, beds, lifts, etc.?
A26. That is correct per CMS-5531-IFC, any policy requiring a F2F visit will not have that requirement enforced for the duration of the COVID-19 PHE.

Q27. On the DME MAC site, it states DME MACs, Zone Program Integrity Contractors (ZPICs) and Recovery Audit Contractors (RACs) are not enforcing F2F, only Comprehensive Error Rate Testing (CERT). Has this has now changed to include all are enforcing? I’m asking specifically for nebulizers.
A27. No Medicare contractors will be enforcing the F2F documentation criteria during the PHE. That is subject to change after the PHE has ended.

COVID-19-Related – Telehealth

Q28. We are attempting to obtain telehealth visits as much as possible for PAP, oxygen, etc., for non-COVID-19 and COVID-19 beneficiaries. Should we be obtaining video and audio in order to use the telehealth visits as F2F? I realize they are not required but if the beneficiary is able to participate, we are requesting the visit.
A28. If the beneficiary can have the audio and video visit, this meets the relaxed telehealth criteria, and this is recommended. If the beneficiary is not able to, you should be confirming that the medical records contain the reasonable and necessary information, including the documented telehealth visit that took place. These medical records must be available to Medicare on request.

Q29. If the beneficiary fails the 90-day trial period for the PAP and can get a telehealth F2F but cannot get into a sleep lab for an in-lab re-titration, can we use the CR modifier to bill month four?
A29. The PAP policy is included in the policies where the clinical criteria are not being enforced for the duration of the COVID-19 PHE. When the policy clinical coverage indications cannot be met, all affected claims must be billed with the CR modifier and the narrative “COVID-19”. Following the PHE, the DME MACs will return to enforcement.

Q30. What if the beneficiary is in a rural area and does not have access to video for a telephone visit?
A30. Regardless of where the beneficiary is located, for the duration of the COVID-19 PHE, F2F visits are not required per CMS-5531-IFC except for Power Mobility Devices (PMD). However, in order to qualify as a F2F visit for DMEPOS under the “relaxed” telehealth rules for the COVID-19 PHE, there must be both audio and visual interaction between the beneficiary and the prescribing practitioner.

Follow-up Question: We can still bill off and accept an order off a telephone only visit but the dilemma is what happens after the PHE?
Answer: At this time, the DME MACs have not been provided direction by CMS for what will be required following the COVID-19 PHE.

Q31. If we have documentation as to why video was not possible, no smart phone etc.., and due to age, they could not come in the office, would the audio only work for F2F with documentation as to why audio only?
A31. As the F2F requirements are not being enforced during the COVID-19 PHE, the phone interaction is acceptable for the practitioner to determine what will be prescribed.  The medical record must support that the item(s) are “reasonable and necessary”.

Q32. We are having a sleep lab that sometimes uses telephone-only to do compliance follow-ups when beneficiaries cannot do an audio/video visit. Is this acceptable?
A32. Because the F2F requirements are not being enforced during the COVID-19 PHE, audio only will be accepted during the emergency, however audio only does not meet the DMEPOS telehealth requirements for a true F2F. As such, suppliers will need to follow instructions for actions to be taken when the PHE ends once they are provided.

COVID-19-Related – CR Modifier

Q33. When would you use the CR modifier and the COVID-19 narrative? Would you only use this for beneficiaries that have been diagnosed with COVID-19 or suspected of COVID-19? Or would you also use it when you do not have all of documentation you normally would obtain but cannot due to the pandemic?
A33. The CR modifier and COVID-19 narrative are used when submitting a claim to the DME MAC if documentation was impacted in any way by the COVID-19 PHE. This applies to both diagnosed COVID-19 and non-COVID-19 beneficiaries.

Follow-up Question: If we can obtain all the documentation and follow the regular requirements, would we not include the CR modifier and the COVID-19 narrative, correct?
Answer: Yes, that is correct.

Q34. If the PAP rental needs to continue billing month four with KX CR modifiers and the narrative of COVID-19, would all supply orders also need the CR modifier and narrative?
A34. Yes, that is correct.

Q35. Would the CR modifier and COVID-19 narrative need to be added to month four only for PAP if no F2F was able to be obtained?
A35. All subsequent claims affected by the COVID-19 PHE will require the CR modifier, along with the KX modifier, if applicable. Please note that there is a joint article on the Noridian website entitled “Correct Use of the KX Modifier During the COVID-19 PHE” addressing the proper use of the KX modifier and CMS has published a revision to MLN SE20011 providing direction on use of the CR modifier.

COVID-19-Related – Miscellaneous

Q36. In an Online Special Edition MLN Connects dated Friday, April 3, 2020, it stated that “Effective immediately, CMS is suspending claims editing for multi-function ventilators when there are claims for separate devices in history that have not met their reasonable useful lifetime.” Will this change be effective post the COVID-19 Public Health Emergency (PHE)? Also, when do the DME MACs anticipate updating/revising the “Correct Coding and Coverage of Ventilators” Joint DME MAC Publication?
A36. CMS has advised the DME MACs following this Ask the Contractor Teleconference (ACT) that this change will be permanent. This information was published on June 1 by Noridian and can be found in MLN Number SE20012.

Q37. You mentioned that enteral nutrition now can be dispensed in a 90-day supply during the PHE. Where is this information located?
A37. This information is located on the Noridian website under Policies > Medicare Director Articles > Billing of Part B Drugs and Enteral Nutrition to DME MACs During COVID-19 Pandemic – Dispensing Amounts – Revised.

Non COVID-19-Related

Q38. I have no way of telling if that sleep study was scored using the 3% or 4% criterion. If a sleep study states that RULE VII.4A (3%) and VII.4B (4%) are used to define a hypopnea, is that acceptable? There is no way of telling if it's 3%, 4% or both.
A38. Upon review, the documentation needs to be clear as to how it was scored. There will need to be evidence that RULE VII.4B is defined as 4%.

Q39. The recent Master List of HCPCS Potentially Subject to F2F shows only nebulizer, large volume E0575. On the other hand, the LCD/ND and MACs are showing in their Required List all nebulizers, despite the HCPCS. Which is correct?
A39. The only policy requiring the F2F during the COVID-19 PHE is Power Mobility Devices because it's a statutory requirement. CMS will publish a required list which will be a subset of the Master List sometime soon. Additionally, Noridian maintains the Affordable Care Act (ACA) impacted items on our website for claims with dates of service prior to January 1, 2020.

Q40. Does the reasonable useful lifetime (RUL) date go by how many months paid or by the initial date on file?
A40. The RUL starts with the initial date on file.

Q41. If a beneficiary is on a Bi-pap S and they need a new baseline study because their old one was scored at 3%, will they be required to start over and prove that PAP has been tried and failed?
A41. For beneficiaries entering Medicare on therapy, there is not a requirement for a trial. The requirements are for a F2F visit with the treating practitioner confirming OSA and benefit from the device being utilized as well as a sleep study meeting the Medicare diagnostic requirements at the time, they enter Medicare.

Q43. If a sleep study was scored at 3% and you can take the hypopneas (required to be scored at 3%) and the beneficiary still meets the index with apneas only, is that acceptable?
A43. Yes, if apneas-only meet coverage criteria, that is acceptable.

Q44. Does the supplier’s order still need both the start and the signature date? Previously, it did, and the physician’s order could have just one date.
A44. The only date needed on the Standard Written Order (SWO) is the date the treating practitioner communicated the need for the item to the supplier.

Verbal Questions Asked During ACT

Q45. Can you clarify, we are not required to use the COVID-19 diagnosis code in order to use the CR modifier?
A45. If claims are impacted by the COVID-19 PHE, the CR modifier is required with the narrative of “COVID-19”. The only time the COVID-19 diagnosis code is used, in addition to the other diagnosis (e.g. pneumonia or bronchitis), is if the beneficiary was diagnosed with COVID-19.

Q46. Is the KX modifier used when it is typical to be put on a claim, even if the beneficiary is not compliant?
A46. Yes, if all other policy criteria not impacted by COVID-19 PHE waivers and flexibilities are met.

Q47. The beneficiary has met compliance, but he/she isn’t able to have the F2F (they were able to have a phone call with the physician). I understand we can still bill for month four right now. When the pandemic is over, will the beneficiary have to go back for the F2F, or will that phone call suffice?
A47. You are correct that because the F2F is being waived during the COVID19 PHE, you can continue to bill month four. However, we don’t know what CMS will direct the Medicare Administrative Contractors (MACs) to tell suppliers when the PHE has ended. We will share the direction as soon as we receive it from CMS.

Follow-up Question: We are in a rural area so a visual and audio conference would be sufficient for a F2F, but what about audio-only?
Answer: If you just have an audio call, then that would be allowed as the F2F is not required during the PHE, however you will want to watch for direction on how to manage these cases when the PHE has ended. If it was audio and video and the beneficiary was compliant during the first 90 days, then all the criteria would have been met.

Follow-up Question: In this scenario, the beneficiary did not meet compliance in the 90 days. Normally, we would have the beneficiary return the device or go back to the sleep lab. With the PHE, the doctor still wants the beneficiary to use the PAP device. Do we continue to bill and hope the beneficiary becomes compliant by month five, for example, or do we stop billing until he/she becomes compliant?
Answer: If the beneficiary is unable to obtain a F2F or return to a sleep lab as a result of the COVID-19 PHE, there are waivers and flexibilities in place to allow non-enforcement of the standard clinical indications for coverage and not require the F2F. Suppliers must ensure the medical records show that the equipment is medically reasonable and necessary.

Q48. We have an oxygen CMN with the initial date of February 7, 2020, and we have all that we need for documentation, except the CMN signature of the physician. Can we submit the March DOS before the February DOS?
A48. Claims can be billed out of order and if the reason that the signature cannot be obtained is a result of the COVID-19 PHE, then the claims beginning in March could be billed with the CR modifier and the COVID-19 narrative until the signature can be obtained. 

Q49. If we get a telehealth visit and it contains all the information we need, do we know whether the beneficiary will need to go back for a subsequent F2F?
A49. A telehealth visit with both audio and video components will meet the requirements of a F2F visit for DMEPOS.

Q50. We received a PAP order that has the full-face mask checked and, on the bottom, the physician wrote ‘fit to patient, nasal mask can be used in place of full-face mask’ but they don’t have nasal cushion checked off. Can a physician check all the masks and cushion options at once or would that be denied as a blanket order?
A50. A physician could check all the options and you could dispense from that initial order, but that order can’t be utilized for billing because that would be considered blanket. There must be a SWO that has only the items that were dispensed listed; unless the physician specified in the medical records which specific accessories were to be utilized with the PAP setup.

Follow-up Question: If we get a prescription for the full-face mask and the beneficiary tries it for a week but doesn’t like it and wants to switch to a nasal mask, do we have to go back and get another prescription? The provider doesn’t know which supplies the beneficiary will settle with when writing the order.
Answer: A new prescription is needed as it is a change in the type of supply being utilized.

Follow-up Question: Is there a way to open it up and allow the beneficiary to choose during their setup?
Answer: If a full mask is provided because the supplier received an order stating ‘CPAP and supplies’ or ‘CPAP and beneficiary choice of supply’, for example, that will be acceptable for dispensing, however you must have an SWO prior to billing recording the supplies actually provided. If the beneficiary subsequently changes their mind, a new order is required to bill the different supplies the next time.


Last Updated Tue, 23 Jun 2020 19:19:24 +0000