ACT Q and A - October 6, 2021

The following questions and answers (Q&As) are cumulative from the mini Ask the Contractor Teleconference (ACT) on respiratory services. 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.

Q1. If the beneficiary signs the wrong date on the day the drug is delivered do you use the delivery date or the incorrect signed date?
A1. The date entered on the delivery documentation must be the actual date of delivery, however if the beneficiary utilizes a date with their signature, that will become the date for delivery purposes. Please see the Standard Documentation Requirements Article for more information on proof of delivery.

Q2. A beneficiary with a nebulizer rental is no longer using it and refuses to return the machine, can the remaining rental months be billed to the beneficiary?
A2. If the criteria for coverage indication, limitations, and/or medical necessity have not been met (the beneficiary is not using the equipment) an Advance Beneficiary Notice of Noncoverage (ABN) may be completed. Suppliers could contact law enforcement in the case that the beneficiary does not wish to assume financial responsibility. Reference the Internet Only Manual (IOM) Chapter 30. Chapter 30 provides information on how to deal with beneficiaries refusing to sign an ABN and not returning equipment. It also discusses the supplier's right to recover resalable items.

Q3. Where are updated Durable Medical Equipment (DME) billing guidelines / requirements located?
A3. When seeking updated billing guidelines and requirements, visit the Noridian website to explore our many educational opportunities including, webinars, DME on Demand tutorials, checklists, and much more.

Q4. How do we work with Medicare subscribers unwilling to assist in obtaining required face-to-face (F2F) documentation and testing to meet Medicare requirements?
A4. When suppliers encounter a beneficiary, who will not complete the required on-going actions to meet coverage requirements, the supplier may offer an Advance Beneficiary Notice of Noncoverage (ABN). The supplier must be specific in the reason that Medicare won’t pay due to the lack of action needed to meet coverage requirements. Suppliers should document attempts for signature thoroughly and after multiple, varied attempts the beneficiary may be billed with a copy of the unsigned ABN. See our ABN webpage for more information.

Q5. When a beneficiary travels overseas for months Medicare does not cover, but secondary does, how do we bill for denial and is an ABN needed?
A5. Medicare beneficiaries who receive their equipment in the United States may take it out of the country, however, supplies and medications for use with devices cannot be provided overseas. If providing supplies more than the allowed amount per utilization period prior to travel, an ABN may be utilized for the excess supplies and the beneficiary or their secondary would have to cover those.

Q6. Please provide information on the future state of Certificate of Medical Necessity (CMN) 484 and Recertification CMNs.
A6. Noridian does not have any information regarding the future state of CMN 484 and Recertification CMNs currently. Education material will be created to address this question when changes are implemented. Please see the decision memo on our website for the latest information.

Q7. What will be the obstructive sleep apnea (OSA) requirements and testing rules in the updated Oxygen Local Coverage Determination (LCD)?
A7. There have not been any updates made to the OSA coverage criteria or testing section of the LCD currently. Education material will be created to address this question if changes are implemented. Please visit the most current Oxygen LCD for more information.

Q8. How are CMNs affected with COVID–19?
A8. If the beneficiary is unable to be seen by their treating physician or be tested due to COVID-19 related issues, a CMN is not required. However, there must be records that show medical necessity for the oxygen equipment that is being provided. In these cases, the claims should be billed with the CR modifier and COVID-19 narrative.

Q9. Is an infusion pump required when billing for supplies for home infusion therapy (A4221, IV tubing, catheters, etc.)? What are the required modifiers?
A9. Per the LCD for external pumps, supplies are covered for a covered infusion pump. This means the beneficiary must own, either Medicare paid or purchased elsewhere, a pump that meets medical necessity of the policy. The modifiers associated with the policy are listed below. They must bill with a modifier to receive payment. If no modifier is present the claim will reject for missing a modifier.


EY – No physician or other licensed health care provider order for this item or service

GA – Waiver of liability statement issued as required by payer policy, individual case

GY - Item or service statutorily excluded or does not meet the definition of any Medicare benefit

GZ – Item or service expected to be denied as not reasonable and necessary

JB - Administered Subcutaneously

JW - Drug amount discarded/not administered to any patient

KX - Requirements specified in the medical policy have been met

Q10. Can information regarding the upcoming changes in the oxygen national coverage determination (NCD) be provided?
A10. Noridian is aware of the update communicated in the Centers for Medicare & Medicaid Services (CMS) decision memo and more direction will be coming soon. See the decision memo on our website.

Q11. For Oxygen recertification under the COVID-19 19 public health emergency (PHE), do we still need to re-certify the beneficiary or can we continue to bill after 12 months?
A11. Per the Oxygen LCD, a Recertification CMN is required “12 months after Initial Certification, (i.e., with the thirteenth month’s claim) for Group I” beneficiaries. If the recertification cannot be completed due to COVID-19 and the PHE, note that suppliers may append the CR modifier and continue billing past month 12. Clinical indications for oxygen coverage will not be enforced during the COVID-19 PHE; however, there must be evidence of medical necessity for the home oxygen.

Verbal Questions

Q1. During the PHE, if we use the high liter flow (HLF) modifier along with the CR modifier, will Noridian reimburse at that rate?
A1. If the HLF modifier is utilized, suppliers will be reimbursed at that HLF rate. Keep in mind that there must be documentation to support the need for HLF during the COVID-19 PHE when coverage criteria are not being enforced. See the Oxygen LCD for more information.

Q2. Regarding Positive Airway Pressure (PAP) therapy compliance, if compliance is not met in the first 90 days is a new F2F and a new titration needed? Does the 90-day trial period start over?
A2. If compliance is not achieved in the first 90 days of PAP usage, that is considered a failed trial. The beneficiary must have a new F2F to determine reasons for failure and a new in lab sleep study. That study may be a diagnostic, titration, or split night. A new trial period will begin, and the supplier may not bill month four, until compliance has been achieved.

Written Questions

Q1. If we change from a portable gaseous system (E0431) to a portable oxygen concentrator (E1392) and it has been a while, are we required to get current chart notes for the change in modality?
A1. Any change in oxygen modality requires a new order. Chart notes do not need to be submitted to Medicare but should be kept on file by the supplier in case they are requested by Medicare.

Q2. Is there any time frame on the Oxygen NCD response?
A2. Noridian is aware of the update and more direction will be coming soon. When LCD changes are implemented, Noridian will begin providing education based on the new guidelines.

Q3. Can we bill a non-invasive ventilator (E0466) with the CR modifier during the PHE?
A3. If suppliers are unable to get the appropriate documentation due to the PHE for provision of a non-invasive ventilator, the CR modifier can be billed with COVID-19 on the narrative. The medical records must still show the item is medically necessary for the beneficiary. See the MLN Matters SE20011 Revised for information on the proper use of the CR modifier.

Q4. Can we use the pressure settings prescribed by the physician for the bilevel positive airway pressure (BiPAP) and ASV even though it doesn't appear on the pressure distribution in the titration sleep study?
A4. The pressure settings prescribed can be different than the pressure setting used in the study because the treating practitioner must assess the optimal treatment based on the sleep study information.

Q5. Which documentation do we need to collect if a beneficiary is not compliant for a PAP machine, but they still have the PAP device and the sleep study was done within the year?
A5. When the beneficiary fails the PAP trial, there must be a F2F to evaluate the reasons for failure and a repeat sleep study. During the PHE those requirements are not being enforced. See the PAP LCD for more information on a failed trial period.

Q6. Since there is no update yet if the PHE will be extended (the current PHE is scheduled to expire on October 18, 2021), will Medicare follow the same rule, or will they resume the normal guideline?
A6. Following this ACT, the COVID-19 PHE was extended another 90 days. See the COVID-19 webpage for all the most up to date PHE information.

Q7. Is there a way to avoid having a denial for CO176 or N592 if we attempt to bill oxygen from the PHE billing to normal criteria? I was told the system only accepts one initial date and that we'd have to do a redetermination.
A7. When an initial CMN is obtained, the supplier may submit that CMN and stop using the CR modifier. Rental will continue from the original date that the claim was submitted with the CR modifier, not from the date of the initial CMN (that was submitted subsequently.) If this initial CMN is getting denied, then the claim should be appealed.

Q8. We have a beneficiary who struggles with hypoventilation. What documentation do we need since they can't have a sleep study?
A8. If the reason that the sleep study cannot be completed is due to COVID-19, you may bill with the CR modifier and COVID-19 narrative. Otherwise, a diagnostic sleep study is required to determine whether the beneficiary would meet coverage criteria.

Q9. We have a Standard Written Order (SWO) signed by Dr. X that is not Provider Enrollment Chain and Ownership System (PECOS)-enrolled; however, there is a supervising provider Dr. Y that is PECOS-enrolled. Will the SWO be valid?
A9. The provider signing the order must be enrolled in PECOS.

Q10. In the event of a claim review for replacement oxygen equipment due to the end of reasonable useful lifetime (RUL), in addition to a new initial CMN, what other medical documentation is required?
A10. A new initial CMN is required and can fulfill the evidence of on-going medical need requirement. A F2F is not required by Medicare. This can be found in the Oxygen LCD on the Noridian website. Please see the Oxygen LCD for more information on replacement.

Q11. We have a DME ABN form CMS-R-131 signed November 2, 2020. ABNs are good for a year. Are we required to execute a new ABN after January 1, 2021? Due to COVID-19, CMS extended the deadline for using the renewed ABN until January 1, 2021.
A11. The annual renewal requirement has been removed. Per MLN Matters 12242, an ABN remains effective after valid delivery so long as there has been no change in care, health status, or Medicare coverage guidelines. See MLN Matters 12242 for information regarding the removal of the one-year renewal guidelines.

Q12. We have an oxygen setup with an ABN option one. With the ABN update not having an expiration date unless there is a change, are we still required to get recert chart notes and a recertification CMN?
A12. The recertification CMN is different from the ABN. To continue therapy, the beneficiary must qualify under the coverage criteria so a recertification CMN and physician visit would be necessary. Furthermore, If the ABN on file is not expiring until after October 14, 2021, then unless there is a change in condition, care, or treatment, it is valid for an indefinite amount of time. See MLN Matters 12242 for the most recent ABN guidelines.

Q13. Where can I locate the MLN Matters 12242 regarding an ABN remaining effective after valid delivery so long as there has been no change in care, health status, or Medicare coverage guidelines?
A13. MLN Matters 12242 can be found on the CMS website.

Q14. How long is the CR modifier and CMN going to be effective?
A14. Currently there has been no information regarding the length of the PHE waivers or the use of modifiers. Once any information has been released, the education team will start to educate on it.

Q15. When portable oxygen is added after stationary, then a revised CMN is necessary. In this case do both items, the stationary and portable, need to be listed on the CMN?
A15. All items being billed to Medicare need to be listed on the CMN.

Q16. Regarding billing month four once compliance is met with a PAP device, if at month eight they become compliant, does that date become the month four date or does month four stay at the original month four date?
A16. The date compliance has been met is when month four begins. See the PAP LCD for more information on billing the fourth month once compliance has been reached.

Q17. I have a beneficiary who had an E1390 with an initial date of July 12, 2017, that capped. The beneficiary then got an E1392. Which certification type is needed for the E1392?
A17. A revised CMN would be necessary when a portable oxygen system is added after stationary system.

Q18. Scenario: Initial and recertification CMNs are on file, 13 payments were made, and last billed/paid by Medicare on October 28, 2020. The beneficiary then purchased their own equipment, returned the provider’s, and has continued to use the oxygen, which has been documented in the records. Now in September 2021, the beneficiary is getting oxygen from us, (different provider). Should we get a new initial and use the break in billing (BIB) narrative since there hasn’t been a change in medical condition?
A18. Since there was no change in condition and the beneficiary continued to need the equipment, then it would be acceptable to treat this as a “break in billing” situation. A new initial CMN is not necessary. A narrative needs to be added to the claim explaining why there was a break in billing. If the claim denies, submit an appeal with all documentation supporting medical need. See the break in billing webpage for more information.

Q19. How much time is considered for break in service (BIS) if a beneficiary stopped using their PAP three years ago and now gets qualified? Should this be a new cap (only four months were previously paid)?
A19. If there is more than 60 days plus the days remaining in the month when usage stopped with change in medical condition, a new rental item can be provided. For more information, see our Break in Need or Service and Break in Billing webpage.

Q20. Is it acceptable for a beneficiary or representative to send in an e-mail to re-order supplies if it contains all the required refill information or do we need to follow up with them verbally before shipping?
A20. Per the Standard Documentation Requirements article: For items that are delivered to the beneficiary, documentation of a request for refill must be either a written document received from the beneficiary or a contemporaneous written record of a phone conversation/contact between the supplier and beneficiary. The refill request must occur and be documented before shipment.

Q21. If the wrong item is sent to the beneficiary, how many days do we have to do the exchange (same HCPCS) before we must do the refund to Medicare and bill for a new date of service?
A21. It would be beneficial to complete the exchange as soon as possible, as there can be a lapse in time due to processing. The refund for the incorrect item should be initiated as soon as it has been identified.

Q22. The company I work for (Company A) bought another company (Company B) and we have active rentals of CPAPs, BIPAPs and Oxygen that were set up with Company B. Does Company A need a new Assignment of Benefits (AOB) signed by the beneficiary with Company A's name on it to continue the billing of the active rental?
A22. A new assignment of benefits (beneficiary authorization) signed by the beneficiary with Company A's name on it would be necessary.

Q23. While a beneficiary is renting PAP and oxygen, the beneficiary becomes eligible for Medicare. What is required to continue the oxygen coverage, as testing was done seven months prior to becoming eligible?
A23. A beneficiary entering Medicare on oxygen requires qualifying testing to determine Medicare coverage. A F2F visit with their treating practitioner and a qualifying test within 30 days of the initial date on the CMN must be completed. In the case of OSA, testing has to occur in a titration polysomnography while the beneficiary is at optimal PAP settings.

Q24. If equipment was purchased for a beneficiary prior to the beneficiary becoming Medicare, is it required to obtain serial numbers for that equipment?
A24. For Medicare it would not be a requirement, but any information that a supplier has on the equipment may be beneficial to have on record.

Q25. We are trying to qualify a beneficiary for a Respiratory Assist Device (RAD) (E0471). They do not have testing on file. Can the physician then request to place the beneficiary on a ventilator so they can qualify without testing or is that testing still required?
A25. The beneficiary must be on the device appropriate to their condition. During the COVID-19 PHE coverage criteria are not being enforced for respiratory equipment; however, there must be evidence of medical necessity. It would not be appropriate to provide and bill a ventilator when the RAD device could be utilized.

Q26. If a beneficiary starts on oxygen because of COVID and now wants to continue with it due to underlying conditions, do we need a revised CMN with a new diagnosis and do we need to requalify the beneficiary? The physician has indicated that their COVID has resolved but the oxygen is needed due to post COVID symptoms?
A26. Oxygen can be billed if the medical records support medical necessity for the items billed. Oxygen is not a diagnosis driven policy so a COVID diagnosis would not be necessary.

Q27. What do we need to do when the diagnosis changes from COVID to another respiratory diagnosis? The beneficiary was initially qualified under COVID.
A27. The PHE remains in effect for now and once the PHE ends we will provide further education. As long as the oxygen remains medically necessary it will be covered during the PHE with or without a COVID diagnosis. Suppliers should continue to append the CR modifier and COVID-19 narrative. If the coverage criteria are met for the device being billed, treat as normal with an appropriate SWO or CMN.


Last Updated Mon, 15 Nov 2021 20:59:23 +0000