ACT Questions and Answers - May 16, 2019

Questions Received Prior to ACT Meeting

Q1. How should suppliers handle the addition of a non-qualifying function when a beneficiary is already on a multi-function ventilator with qualifying criteria (i.e., oxygen added for pneumonia)?
A1. The most important aspect to remember with the multi-function ventilator is that each function used must meet the Medicare coverage criteria. If the beneficiary already meets the requirements for two or more functionalities, there is no prohibition from activating another function even if the coverage criteria for the third is not met. The reimbursement will remain the same and the reasonable useful lifetime will be applied as well.

Q2. Which files should be used to find the correct price for items subject to the Competitive Bidding Program (CBP) that were provided to patients in a Competitive Bidding Area (CBA) for dates of service in 2018? The Single Payment Amount (SPA) files on the Competitive Bidding Implementation Contractor (CBIC) website or the CMS DMEPOS Fee Schedule files?
A2. Use the CMS DMEPOS Fee Schedule files for pricing during the competitive bid gap period.

Q3. Should the KL modifier only be appended to diabetic supplies on the former CBA National Mail-Order Fee Schedule file?
A3. The KL modifier should be used for diabetic supplies that have been shipped. This will allow the proper fee schedule to be used.

Q4. What are the criteria to qualify a beneficiary for a positive airway pressure (PAP) device when the beneficiary fails with an oral appliance? Will there be a same or similar denial?
A4. If the oral appliance for obstructive sleep apnea (OSA) has not reached the five-year reasonable useful lifetime (RUL), a PAP device will deny as same and similar. Clinical documentation is required in appeals to show a change in medical condition necessitating the change to PAP.

Q5. How can an oxygen claim be submitted when there is no oxygen testing and the beneficiary chooses option 1 on the Advance Beneficiary Notice of Non-coverage (ABN)?
A5. For the claim to be processed, there must be a Certificate of Medical Necessity (CMN) submitted with the claim.

Q6. Are electronic signatures acceptable on the Detailed Written Order (DWO)?
A6. Yes.

Q7. What occurs when a beneficiary is released from a skilled facility when equipment was being rented prior to admission?
A7. Billing can be resumed at the next rental month upon discharge if the beneficiary still qualifies for the equipment.

Q8. Can we bill the daily allowance for the enteral supply kit regardless of how many supplies were given to patient?
A8. Per the Enteral Nutrition Local Coverage Determination (LCD). HCPCS codes B4034-B4036 describe a daily supply fee rather than a specifically defined "kit." The use of individual items may differ from beneficiary to beneficiary and from day to day. Items included in these codes are not limited to pre-packaged "kits" bundled by manufacturers or distributors. These supply allowances include, but are not limited to, a catheter/tube anchoring device, feeding bag/container, flushing solution bag/container, administration set tubing, extension tubing, feeding/flushing syringes, gastrostomy tube holder, dressings (any type) used for gastrostomy tube site, tape (to secure tube or dressings), Y connector, adapter, gastric pressure relief valve, declogging device, etc. These items must not be separately billed using the miscellaneous code (B9998) or using a specific code for any individual item, should a unique HCPCS code for item exist (for examples dressing, tape, etc.).

Q9. Please explain the appropriate use of G codes.
A9. Refer to the Medical Director Article titled Frequently Asked Questions – Temporary Transitional Payment for Home Infusion Therapy Services for CY 2019 and 2020 (CR10836).

Q10. Under the coverage criteria for hospital beds, is "pillow and wedges must have been considered and ruled out" still part of the criteria?
A10. No. That portion was removed with the August 1, 2013 revision.

Q11. Is an ABN form required when Medicare is secondary?
A11. Yes, if the Medicare coverage criteria is not met.

Q12. Are home sleep studies required to be scored at the same 4% as baseline and split night sleep studies?
A12. Yes. The scoring criteria is the same for both home sleep testing (HST) and facility-based testing.

Q13. Where can a copy of the HCPCS codes affected by the Affordable Care Act (ACA) be located?
A13. See this listing on the ACA: Face-to-Face and Detailed Written Order webpage.

Q14. What happens if an ABN is completed when one is not required?
A14. ABNs are mandatory when an item is expected to deny as "not reasonable and necessary.." ABNs are voluntary when the item is statutorily non-covered. The use of blanket ABNs is not an acceptable practice. Suppliers must give beneficiaries enough information to decide whether to obtain the item/service.

Q15. Is an infusion pump ever covered for enteral therapy when the physician orders pump at times and gravity at other times?
A15. There may be cases where a beneficiary is moved back and forth from a pump to another method; however, a new DME Information Form (DIF) is required.

Q16. A lifetime order is on file for PAP supplies, such as HCPCS A7034. Will this order ever expire?
A16. Unless there is a change in the order, a lifetime order for PAP supplies will not expire. When a change occurs, a new order is required; however, all state requirements must be met as well.

Q17. Is medical documentation from the ordering physician required when providing repair and replacement of orthotics and prosthetics?
A17. There is not a requirement for clinical records specifically for the repair or replacement, however the coverage criteria must be met for all DMEPOS items for repair and replacement to be covered. Additionally, there is a requirement for continued medical need. Medicare will not pay for repair on an orthosis (or any other DMEPOS item) if the item itself is no longer medically necessary, therefore, medical records must exist from the treating physician documenting that the item continues to be medically necessary for that beneficiary. This documentation must be dated within the previous 12 months from the date of service (DOS) under review.

Q18. Are suppliers able to bill for adjustments made to a custom item within the 90-day warranty time frame due to the volume of the change?
A18. No. Medicare will not cover repair charges within a warranty period.

Q19. How can suppliers bill a claim as a 90-day supply order and have the claim adjudicated/paid on the first pass without having to re-open the claim?
A19. Once a three-month supply schedule has been established, it should not be a problem; however, due to claims editing, when a change from one month to three-month supply occurs a narrative should be added to the claim and a reopening may be required to change the schedule.

Q20. Can Noridian provide further clarification on the purpose of the modifiers that reference DMEPOS Competitive Bidding Program numbers? Why were they created? What happens when they are used? Some are listed in the fee schedules and some are not.
A21. Modifiers can be for informational purposes or pricing purposes or both. With the implementation of competitive bid, special modifiers were created to assist suppliers and contractors in recognizing these claims. Depending on the product category and the contract period or "round," different modifiers were used to define competitive bid circumstances. Competitive bid modifiers are used in addition to policy modifiers.

Q21. Are modifiers KK and KW appropriate for billing in 2019? They are not included in the 2019 former CBA fee schedule files.
A22. The KK modifier is still in use; however, the KW modifier is not. The KK modifier identifies the same supply or accessory HCPCS code that is furnished in multiple competitive bidding product categories or when the same code can be used to describe both competitively and non-competitively bid items.

Q22. Are the face-to-face (F2F) and written order for PAP resupply required to come from the same physician?
A23. Beneficiaries may have more than one treating physician which allows for F2F and orders to come from different physicians; however, the ordering physician must have access to the F2F information.

Q23. Is the HCPCS E0467 multi-function ventilator covered for two units/month?
A24. Due to the small size of this new ventilator, two ventilators are not needed. One ventilator can be used bedside and on a wheelchair. Noridian is currently reviewing all publications for updates addressing coverage of a second ventilator.

Verbal Questions Received During ACT Meeting

Q1. According to an update made in September 2005, suppliers cannot use the RA modifier on a brace within five years if it has been lost, stolen, or irreparably damaged. It states the only time it is appropriate to use this modifier is for orthotics, when there was a natural disaster. Is this correct?
A1. The RA modifier may be used in the case of lost, stolen, or irreparably damaged equipment from specific events (e.g. fire, flood, lost by movers). We also suggest adding a narrative to the claim to indicate what occurred. Ensure documentation is in the medical record to support the RA modifier.

Follow-up Question. We were told in the Live Chat that the only time we can use the RA is in the case of a natural disaster.
Answer. The RA can be used on orthotics within five years if the item is lost, stolen or irreparably damaged. The RA cannot be used if the item is worn out from regular use.

Follow-up Question. If the item is worn out within five years, will it deny as patient responsibility?
Answer. The item will deny as same or similar and the only time it can be appealed is if a supplier has documentation to substantiate a change in medical condition. It must be a specific incident that occurs with irreparable damage.

Follow-up Question. A beneficiary has an articulating Ankle/Foot Orthosis (AFO) and a joint breaks. Does that qualify for the use of the RA modifier because that's irreparable damage?
Answer
. To use the RA modifier, a specific incident must occur. An example is if the beneficiary falls and the joint breaks. An AFO is expected to last five years. Noridian recommends obtaining an ABN.

Q2. We had many appeals deny as they did not have our address and phone number printed on the ABN. I'm looking at a podiatry journal and it does not state this information is required. Why is this specific information not requested on the form?
A2. The correct CMS ABN must be used and all elements must be completed. The CMS ABN instructions state these are required items. Since the ABN is a CMS form, Medicare Administrative Contractors (MACs) are unable to make changes to it.

Q3. We are a home infusion pharmacy and have a patient who received Parenteral Nutrition therapy. For the first part of the therapy, the patient did not meet Medicare criteria. We billed the claim with the GA modifier for denial but Medicare paid it. We submitted a Redetermination request to have the claim reprocessed with the proper denial but are receiving letters stating that no additional payment will be made and that we need to go to the next step in the appeals process. We don't know what to do at this point.
A3. A voluntary refund may be submitted as there may be a previous valid DME Information Form (DIF) on file and the system doesn't know that it shouldn't be paying, even with the GA modifier appended.

Follow-up Question. Can the beneficiary be billed even though we don't have a patient responsibility (PR)denial from Medicare?
Answer. Yes. You'll have evidence of refund, qualifying documentation, and the ABN. You'll also want to have a conversation with the beneficiary to ensure he/she understands.

Q4. We are an orthotics and prosthetics firm. We've been told that repairs are covered for the lifetime of the device. The problem occurs when we need to replace straps, which aren't listed on the original prescription. If the original doctor is no longer in practice, we must get a detailed written order with notes from another doctor who doesn't always make notes on amputees. Who do we bill on the claim?
A4. If you're getting an order because the straps are being replaced as part of the repair, the current treating physician is listed on the claim.

Follow-up Question. If the physician is an endocrinologist, he/she doesn't put anything in his/her notes regarding the patient's brace or orthotic. We're allowed to bill for repairs, the original ordering doctor is not in practice anymore and the current doctor does not document anything regarding a brace. 
Answer. According to our Medical Review staff, the original order is fine for the repair because the straps are part of the original device. The real issue here is that there needs to be documented medical need. If the repair is ever reviewed, it will deny because there's no evidence of ongoing medical need. Noridian recommends that suppliers tell their beneficiaries that regardless of who they see, talk about the ongoing need for their DMEPOS item.

Q5. Are there plans for an in-person meeting in New York soon?
A5. We don't have one scheduled currently, but we do get to the New York area periodically so watch the listserv for notification.

Q6. Regarding Pre-Submitted Question 11, we understand that we can't do a blanket ABN for every service, to allow the claim to be processed by a secondary insurance, but if we know a code is never covered, such as the codes for an antibiotic with an IV push, can we choose to complete an ABN?
A6. When a code is listed as non-covered, Noridian considers this good business practice and good care because you're making it clear to the beneficiary before he/she receives the antibiotic that Medicare will not pay. This would be a voluntary ABN and a service to those beneficiaries. If the policy indicates that a code will deny as not reasonable and necessary, a mandatory ABN would be required.

Q7. Currently, we have our standard Consent to Treat form which does have a clause about the patient accepting financial responsibility for service not covered by insurance. We also have a second form called a Medicare Beneficiary Authorization form that we have Medicare patients sign when they are receiving a therapy covered by Medicare. We were hoping to be more efficient with our forms. Is there specific language required on a Consent to Treat form?
A7. It is required that the beneficiary authorizes suppliers to bill the Medicare program on his/her behalf, but it is not a requirement that it is on a separate form nor does it have specific language requirement; however, be advised that in your Consent to Treat that you somehow make it evident that it is also being used as the Beneficiary Authorization to bill. When our review staff look at requested documentation, it can sometimes be difficult to find the authorization.

Q8. We have a patient who was renting an infusion pump. The pump did not meet purchase price and the patient transferred to another supplier. The patient did sign a pump responsibility form. Can we bill the patient for that unreturned pump? We've tried to get it back but she's not responding to us.
A8. The only time the patient can be billed is if an ABN was issued in advance of providing the pump. The other option is to get local law enforcement involved because he/she does have equipment that belongs to you. See specific language regarding supplier's rights to recover resalable items in the CMS Internet Only Manual (IOM), Publication 100-04, Medicare Claims Processing Manual, Chapter 30, Section 50.13.4.

Q9. We have a request for refill (RFR) and all the criteria for the J code and HCPCS A4222 (Infusion supplies for external drug infusion pump) are met. The pharmacy tech did not obtain the documentation needed for the HCPCS A4221 (Supplies for maintenance of non-insulin drug infusion catheter). Can we bill for the drug and the HCPCS A4222?
A9. If there is no evidence of contact with the beneficiary related to that item, it cannot be billed for; however, the two codes there is documentation for may be billed.

Q10. If we send a beneficiary any part of an enteral nutrition supply kit, can we bill for the kit?
A10. If any part of the kit is provided, for example, gauze, tape, extensions, saline, the daily allowance for the kit may be billed.

Follow-up Question. Because of Medicare's reduced rates, we lose money when we just provide the formula. Are we allowed to tell the patient that we cannot supply their formula until he/she take all their items?
Answer. It is not appropriate to withhold provision of formula until additional supplies are needed.

Q11. Under prosthetics, there is no five-year ruling. If we supply a prosthetic within the five-year period, should the RA modifier be appended?
A11. There is no RUL for prosthetics but if any DMEPOS item is being replaced due to loss, stolen, or irreparable damage, the RA modifier can be used. It is never used due to wear.

Q12. We have drug shortages right now with both Subcutaneous and Intravenous immunoglobulin (IVIG). Physicians are aware of these shortages and are writing a Detailed Written Order, for example, Gammagard but in the event of shortages, Gamimune or Gamunex could be used. Can all three be put on the DIF for the pump and only bill for the pump and applicable drug?
A12. The LCD states the exact drug being used must be on the DIF. In the instance of a shortage, it is recommended that a new DIF be obtained; however, if timing is an issue, an amendment can be done. Suppliers and physicians must follow the guidelines outlined in the CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.3.2.5 regarding appropriate and acceptable amendments to a document.

Q13. Are the slides for this ACT going to be sent out?
A13. No. The Questions & Answers are posted to the website within 30 days.

Q14. We dispense specialty formula. The LCD states suppliers must show medical necessity for the specialty formula and the Medicare Claims Processing Manual goes into detail about showing how the patient failed to tolerate a standard formula. We ask physicians to provide the results of the trial of standard formula. The physicians will not trial the beneficiary on the standard formula because it is, for example, too dangerous. The reasons they give usually don't specify ‘patient cannot tolerate trial of standard formula due to the following reasons…'. They usually indicate, ‘patient needs this formula and it's justified due to the following reasons….'. Is this acceptable during an audit?
A14. Noridian does not want to see the LCD, IOM, or National Coverage Determination language quoted in the medical records. In addition, medical records cannot be pre-approved. We look for a full description of why the patient needs the specialty formula.

Q15. On the Respiratory Assist Device (RAD) calculation to determine if the central hypopneas are half of the total apnea and hypopneas, should the mixed or just the strictly centrals be included? We're having problems with labs not splitting the hypopneas out, so the math doesn't work without these broken out.
A15. The mixed are part of the total, not part of the total central hypopneas. It's been several years since the medical directors specified that the central hypopneas must be scored. When labs are not scoring the central hypopneas, they must be made aware of this requirement for their Medicare beneficiaries.

Q16. If the chart notes just say the beneficiary is having sleep disturbances in the discussion section but the list of ongoing diagnoses indicates insomnia, fatigue, and snoring, is this enough for a F2F prior to a sleep study?
A16. Yes, they discussed the sleep disturbances and those are indicated in the diagnosis listing

Written Questions Received During ACT Meeting

Q1. A beneficiary has been using HCPCS A4353 (Intermittent urinary catheter) for a long period of time, prior to our date of service. What is the best practice to obtain valid medical records that state why the patient needs these supplies?
A1. The intake process may include reaching out to the beneficiary's care provider/prescribing physician to gather applicable medical records; however, per the Standard Documentation Requirements, "If the Medicare qualifying supplier documentation is older than seven years, proof of continued medical necessity of the item or necessity of the repair can be used as the supporting Medicare qualifying documentation."

Q2. The patient's zip code determines pricing in most situations but there are no columns in the DMEPOS or DMEPEN fee schedules for Guam, the Northern Mariana Islands, or American Samoa. How are DME claims from those areas priced and where is this documented?
A2. These areas use the Hawaii fee schedule. See the PDAC website.

Q3. There is a table in the CMS Medicare Learning Network (MLN) Matters (MM)8181 that indicates the KE modifier is appropriate for claims for patients who permanently reside in a CBA (now former CBA) when appended to an accessory for use with wheelchair HCPCS K0005, K0009, or K0898. MM10707 has verbiage that seems to indicate that KE is only appropriate for patients in rural and non-contiguous areas. Please clarify.
A3. Beginning June 1, 2018, in cases where accessories included in the 2008 CBP are furnished for use with base equipment that was not included in the 2008 CBP (for example, manual wheelchairs, canes and aspirators), for beneficiaries residing in rural or non-contiguous, non-competitive bid areas, suppliers should append the KE modifier to the HCPCS code for the accessory. Suppliers should not use the KE modifier with accessories that were included in the 2008 CBP and furnished for use with base equipment that was not included in the 2008 CBP area when these accessories are furnished to beneficiaries residing in non-rural, non-competitive bid areas.

Q4. Why is the KY modifier not included in the fee schedule files and can it be added?
A4. The DME MACs do not control the fee schedule. They are set by CMS.

Q5. Does the KK modifier affect pricing? There is separate pricing for the KG modifier in the former CBA fee schedule file, but there is not for the KK modifier. Is it an informational modifier now?
A5. The KK will still affect pricing based on zip code.

Q6. How do we bill when a beneficiary has an overstock of syringes from previous month(s)? Can a supplier bill for a daily allowance of B4034-B4036 (Enteral feeding supply kit) when a beneficiary has enough for the next 30 days and we're only sending formula?
A6. Since the kits are not being provided, only the formula would be billed.

Q7. Can a supplier bill B4087-B4088 (Gastro/jejuno tube) with a different date of service other than the shipping date?
A7. When an item is shipped using a shipping service (FedEx/UPS, etc.), the date of service can be the date the item was shipped, when the shipping label was created, or it can be the date of actual delivery. If the beneficiary or their designee picks the item up in your storefront, or you use your company van, etc., to deliver to the beneficiary, the date of service is the date the beneficiary received the item.

Q8. Can a supplier use the same DWO from previous order, if the order switched back within a couple of weeks? Example: Prescription was at 1400 calories, switched to 1600, and switched back to 1400 a week later. Will I need to get a new DWO signed or can I use the DWO from the previous prescription?
A8. A new order must be obtained. Per the Standard Documentation Requirements Policy Article. "A new prescription is required if there is a change in the order for the accessory, supply, drug, etc."

Q9. A patient's last G-tube was billed on February 22, 2019. We are supplying the beneficiary's refill for May on May 14, 2019. They are requesting their G-tube. If we send it with their regular tube feeding order, can we also send the G-tube and be paid? If not, can we tell the beneficiary it is too soon, and he/she needs to wait until the June refill or do we need to send it on May 22 and incur an extra delivery fee?
A9. You can educate that only one G-tube (either B4087 or B4088) is allowed every three months and inform the beneficiary when it can be sent to meet reasonable and necessary guidelines. A 10-day overlap prior to their expected utilization period is acceptable.

Q10. Is modifier RA used for a replacement prosthetic within five years?
A10. Prosthetics do not have a five-year RUL. The RA modifier should be used if the item is lost, stolen, or irreparably damaged regardless of RUL.

Q11. Is Noridian going to request CMS to update the ABN to add the address and telephone number in the notifier area? Will they add more space under Section H where the verbiage for not accepting assignment must be written? How do we contact CMS directly?
A11. CMS can be reached at BNImailbox@cms.hhs.gov for any CMS ABN questions.

Q12. Why aren't the new Medicare Beneficiary Identifier (MBI) numbers noted on the Noridian website? If we have the old Medicare number, Noridian should let us see the new MBI.
A12. The MBIs are specific to each beneficiary. Each beneficiary should have a new Medicare card with the new MBI. Noridian offers the Medicare Beneficiary Identifier webpage that provides more information. There is also look-up tool, within Noridian Medicare Portal (NMP), in which users can look up a beneficiary MBI if he/she has not received their new card. If the beneficiary has not received their card, he/she may want to contact Social Security Administration to ensure that their address is correct.

Q13. What if the notification of Medicare capped or sale items form was not signed at the time of set up? Can it be in the file before billing or does it need to be the same date as the delivery?
A13. This should be reviewed and signed by the beneficiary prior to their receipt of the item.

Follow-Up. If the delivery was made, we need to do a pick up and redeliver, correct? If it was a sale item, there isn't anything we can do?
Answer. That is correct.

Q14. Can a telephone order for a concentrator be used as a verbal order?
A14. Yes, a telephone order can be considered a dispensing order for the concentrator if it meets all requirements of a dispensing order. Other oxygen modalities require the five-element order per the Affordable Care Act (ACA).

Q15. A patient failed compliance with another company and there has been a qualifying break in service. He/she now comes to our provider with a new F2F that documents qualifying sleep symptoms and has repeated the sleep study. Can we start a new 13-month rental period?
A15. Yes. With an appropriate break in need, a new rental period will start.

Q16. Regarding pre-submitted question 4, is it enough to document that the oral appliance does not reduce the apnea-hypopnea index (AHI) and/or the patient is intolerant?
A16. There should be sufficient documentation to show the intolerance. Noridian is unable to advise on chart notes prior to claim submission. It is the supplier's responsibility to determine if the coverage criteria have been met.

Q17. Does the break in service have to include a change in condition?
A17. A break in service may be due to a break in billing, such as a Part A stay. Stopping the use of the device for 60 days plus the days remaining in the rental month where usage stopped would be considered a break in need. See the New Capped Rental Period webpage for more information.

Q18. If we have Blincyto therapy and the diagnosis is on the order, is this acceptable? If the order states the medical records corroborates the stated diagnosis, is this acceptable? If the medical records do not clearly state 'refractory/relapsed' verbiage but for instance state ‘not having achieved remission' or ‘failed remission', are these acceptable as well?
A18. Any information on the order cannot alone be used to meet coverage criteria. The information must be corroborated in the medical records. Medical records may not include that specific verbiage, rather must support the criteria; therefore, other words used to support that criteria are acceptable.

Q19. The Parenteral Nutrition LCD states that regarding small bowel obstructions, we need a surgical statement. What if the patient has obstruction outside the small bowel (large bowel obstruction, esophageal obstruction, pancreatic obstruction, etc.)? I assume the surgical statement is not required because it does not specifically state this in the LCD. Is this correct?
A19. The other types of obstructions listed as examples (which are not small bowel obstructions) are not conditions that are listed in any scenarios within any of the coverage criteria; therefore, coverage will not be met. For example, an esophageal obstruction may result in a swallowing disorder of which those conditions are noncovered.

Follow-up. I have asked these types of questions before, particularly regarding esophageal anatomical issues where the patient can swallow fine, but the bolus of nutrition gets stuck. I was told if we can show why the beneficiary cannot use a feeding tube (via G or J tube), we can accept this as a condition. Gastric obstruction was acceptable as well, per previous Ask the Contractor teleconferences. To clarify, all conditions outside the small bowel and gastric motility will not be covered?
Answer. If it is not specifically a swallowing disorder, they may have, per the LCD "disease of the stomach and/or intestine which is a motility disorder and impairs the ability of nutrients to be transported through the GI system." However, they must also meet criteria 1 and 2 as well as one of criteria A-F or G and H. Without looking at specific records, it is difficult to speak to what condition may qualify. The only obstruction covered per the LCD is documented under Criterion D. "The beneficiary has complete mechanical small bowel obstruction where surgery is not an option."

Follow-up. Are Medicare auditor/appeals staff trained to ask for surgical statements overall? If there is an anatomical obstruction/tumor within the GI (esophageal anatomical, gastric obstruction, pancreatic obstruction) will they automatically ask to address why surgical intervention was not appropriate?
Answer. Reviewers are bound to follow the LCD/Policy Article (PA) requirements. Whatever the level of review, the conditions allowed/denied is the same. The records are reviewed to determine if surgical intervention was addressed or not or why it's contraindicated.

Q20. Are the Physical Therapist (PT)/Occupational Therapist (OT) in the specialty evaluation required to medically justify the electronics for a single or multiple power option wheelchair? For example, a Group 3 Single power option (tilt) with power center mount leg rest is justified in the specialty evaluation because the beneficiary does not have a functional weight shift and is at high risk for pressure ulcers. Does the PT/OT now need to medically justify the HCPCS E2311 (Electronic connection between wheelchair controller and two or more power seating system motors) and the batteries? There is no mention in the LCD regarding any medical criteria for electronics/batteries or in the Power Wheelchair Electronics Clarification sheet updated August 14, 2018. It would be listed as required on the Detailed Product Description.
A20. Documentation must support any item that is being provided and billed to Medicare. The PA states "The specialty evaluation that is required for beneficiaries who receive a Group 2 Single Power Option or Multiple Power Options Power Wheelchair (PWC), any Group 3 PWC, or a push-rim activated power assist device is in addition to the requirement for the face-to-face examination. The specialty evaluation provides detailed information explaining why each specific option or accessory – i.e., power seating system, alternate drive control interface, or push-rim activated power assist –is needed to address the beneficiary's mobility limitation. There must be a written report of this evaluation available on request." This is not an all-inclusive list so make sure the records support the needs for every item billed and provided.

Follow-up. What is the medical justification requirement for the electronics/batteries? Isn't the fact a patient meets criteria for the Group 3 with tilt provide justification for the electronics that are used to control those power features? A power chair can't operate without batteries.
Answer. All information must be included in the medical records, including the electronics for the batteries. Batteries for Power Mobility Devices (PMDs) must be billed separately from the base so they need to be justified.

Q21. If a beneficiary was on the HCPCS E0467 (Multi-function ventilator) and decides a few months later that he/she does not want the equipment and wants to go back to each individual item, i.e., ventilator and suction, can the he/she do so? Will a letter from the beneficiary suffice to change back or do we need him/her to go back to the physician and get medical documentation to support the change? What documents are acceptable for changing the beneficiary back or is that never an option?
A21. Letters of medical necessity must always be corroborated by the medical record. Additionally, a new order will be required for the stand-alone items. RUL guidelines apply as well, so all individual items will deny same/similar and require appeal for coverage consideration. There must be a clinical reason documented in the medical record for the need to change.

Follow-up. For a beneficiary to change to the HCPCS E0467, is it correct that a beneficiary must go back to the physician for a F2F? Can the physician order one if there was a F2F within the past six months?
Answer. To qualify in this scenario, the F2F documentation (medical record) must indicate that the physician is ordering the multi-function ventilator, the medical need, etc. The HCPCS E0467, however, does not appear on the ACA list for the 5EO which specifies a F2F within six months of any new order.

Q22. Is there an issue with same or similar in NMP? When checking, results vary depending on the date of service (DOS) that is entered. Same/similar does not always show up. When we ask our level 2 representative, he can see same/similar on his end.
A22. We are not aware of an issue with this functionality currently. Using option 1 does go by the DOS entered and a single code. It will provide five-eight years of information, depending on the item. It might be more beneficial to use option 2 where a range of codes may be checked.

Q23. A beneficiary is noncompliant, and the PAP is picked up. The beneficiary goes through the testing over again and the equipment is redelivered and is compliant at the end of three months. What DOS do we bill? Do we bill the date we redelivered, or do we bill the date the beneficiary became compliant? Is there somewhere I can find this information in writing?
A23. The date of service is the redelivery after testing. The delivery/date of service information is outlined in the Standard Documentation Requirements.

Q24. At the time of service, our beneficiary did not have Part B, only Part A; however, their eligibility was retro-activated. An ABN was not completed at the time of service but now that the patient is Part B eligible for the DOS. What do we do as we expect this service will not be covered? The patient wants us to submit a claim to Medicare but the diagnosis is not in the LCD.
A24. Without the specific claim information or related policy, we can suggest is that you submit the claim and review the remittance advice when received. If you receive a denial, the Denial Code Resolution section of our website will assist with the next steps. Additionally, if the beneficiary had Medicaid who facilitated retro-active enrollment in Medicare, you may need to work with that Medicaid program.

Q25. If a dispensing order states ‘oxygen concentrator,' is it also required to state portable system, if that is needed?
A25. Yes. An order for each separately billable item is necessary. The portable requires the five-element order (5EO) prior to delivery.

Q26. Is it required for a beneficiary to be seen yearly to document continued need for oxygen and PAP supplies?
A26. For ongoing supplies and rented DME items, in addition to information that justifies the initial provision of the item(s) and/or supplies, there must be information in the beneficiary's medical record to support that the item continues to remain reasonable and necessary. Information used to justify continued medical need must be timely for the DOS under review. Any of the following may serve as documentation justifying continued medical need.

  • A recent order by treating physician/practitioner for refills
  • A recent change in prescription
  • A properly completed CMN or DIF with an appropriate length of need specified
  • Timely documentation in beneficiary's medical record showing usage of item

Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in the policy.

Q27. Is the doctor required to state the beneficiary is expected to improve with oxygen? Is it sufficient that he/she states the patient requires oxygen at 2 LPM within the plan?
A27. The medical records supporting on-going medical need should be clear that there is improvement. Examples include, but are not limited to, through testing with and without oxygen, resolution of symptoms, etc.

Q28. Does the progress note for wheelchairs need to state that the beneficiary is not unwilling to use the wheelchair in their home? Is it assumed that the patient needs it in his/her home unless otherwise stated (i.e., needs w/c for community needs)?
A28. Documentation must show that the beneficiary will be using the wheelchair in his/her home and has not expressed unwillingness to do so.

Q29. Does the detailed order for a nebulizer need to state the medication being ordered? If so, is the prescribing practitioner required to describe the dosage, frequency, concentration of drug, volume, and solution? Which of these is needed?
A29. The Standard Documentation Requirements lists all elements that are required for orders. A detailed written order must include the following elements. Beneficiary's name, date of the order, a description of all items, options, accessories, or additional features that are separately billed or require an upgraded code. The description can be either a general description (e.g., wheelchair or hospital bed), a HCPCS code, a HCPCS code narrative, or a brand name/model number. For drugs used as a supply for a DME item, the written order must include the beneficiary name, the name of the drug, dosage, or concentration (if applicable), frequency of administration (if applicable), quantity to be dispensed, number of refills, date of the order, and the physician/practitioner's signature.

Q30. Is a F2F required on the 12th month rental? Are we required to get a new order for nebulizers?
A30. A new prescription meets the need for continued medical need; however, the beneficiary's medical record must continue to support criteria for the medications and supplies.

Q31. Sometimes progress notes are sent over from a prescribing practitioner and the status says ‘pending.' Is this satisfactory with Medicare? Does the status need to be ‘complete'?
A31. They are not complete until they have been signed and dated. Records indicating "pending" would not be acceptable for a review.

Q32. For sales items, such as knee braces, crutches, wound care supplies, does the progress note need to describe the beneficiary's condition?  Is the order sufficient as to the item being ordered or does the note need to state as a result of the condition that a knee brace is needed or wound care supplies, etc.?
A32. Because there are different treatment modalities for conditions, there needs to be documentation in the record of the item being provided. A prescription is not considered part of the medical record and justification of the item needs to be within the medical record.

Q33. The prescribing practitioner wants the beneficiary to have Coude tip catheters. The notes state ‘patient instructed to use the 16fr Coude tip catheter.' Does this meet justification for specialty catheters? Is the doctor required to state why it is needed?
A33. When a Coude tip catheter is used (either male or female beneficiaries), there must be documentation in the beneficiary's medical record of the medical necessity for that catheter. An example is the inability to catheterize with a straight tip catheter. This documentation must be available upon request. If documentation is requested and does not substantiate medical necessity, claims will be denied as not reasonable and necessary.

Q34. Is it necessary for us to be cautious about when a beneficiary has had pneumonia (beneficiary was recently hospitalized)? The new progress note states that the beneficiary is now at baseline. Does Medicare look to see if the beneficiary is still on a medication for pneumonia, potentially disqualifying the him/her for coverage?
A34. To meet coverage criteria, reviewers will want to see the antibiotics and/or steroid taper completed. If the expectation is that once the beneficiary has completed their medication course, oxygen is no longer needed. Medicare coverage criteria would not be met.

Q35. Does the note need to state there is no alternative to oxygen therapy? Is it sufficient for the note to state the beneficiary requires oxygen at 2 LPM for Chronic Obstructive Pulmonary Disease (COPD)?
A35. The oxygen LCD states "Alternative treatment measures have been tried or considered and deemed clinically ineffective." If they haven't been tried, the medical records must show they were considered and deemed ineffective.

Q36. Can a dealer bill labor for a repair of equipment when the part only is under warranty? For example, a beneficiary needs a replacement motor of a wheelchair and the motor is covered under warranty, but the labor is not under warranty. Can a dealer bill HCPCS K0739 for the labor?
A36. When labor is not covered by the warranty, it may be billed and considered for payment by Medicare.

Q37. Is the Prior Approval form for support surfaces available yet? If yes, where can it be found?
A37. At the time of the ACT there was no prior approval form for Pressure Reducing Support Surfaces (PRSS). Suppliers were instructed to see the CMS website on prior authorization for further information; however, following this ACT call and prior to publication of the Q & A document, CMS provided instruction to the DME MACs on education for expansion of the Condition of Payment Prior Authorization program to include Group 2 Pressure Reducing Support Surfaces. This program will launch July 2019 for California (JD) and New Jersey (JA), then move to nationwide in October. See Required Prior Authorization Programs.

Q38. We have a beneficiary who qualified for PAP with a diagnostic polysomnogram (PSG), failed the trial period, started on Bipap, and did well but was unable to meet compliance usage within 90 days. The beneficiary had new F2F, new facility-based diagnostic PSG only (without titration). The doctor states this qualifies the patient to begin a new Bipap trial and meets LCD PAP criteria. He also states the LCD refers to PAP for both HCPCS E0601 and HCPCS E0470 and the beneficiary had a F2F and facility-based diagnostic study. Does the diagnostic study requalify for another trial of HCPCS E0470?
A38. Rental will not begin again; however, a second trial period will be allowed. The follow-up visit must state the etiology of the failure and the beneficiary must have the facility-based study. That study can be diagnostic, titration or split night. The fourth month of rental cannot be billed until compliance has been achieved.

Q39. Is there clarification on the second trial period about PAP devices? Is just the download required to continue to bill with the KX modifier? Do we have to have the compliance download and the follow-up F2F in hand before billing? Is the second trial adherence period still just the 90 days or is it unlimited until the patient meets the 70%?
A39. All the initial compliance criteria apply to the second attempt to qualify for use/reimbursement of the PAP.

Follow-up. A policy update was to come out today regarding the billing of the second trial, is this to come soon? When do we release with the KX modifier?
Answer. The KX modifier is to be used when compliance has been met. The Correct Billing - Continued Coverage for Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea article was published on May 16, 2019.

Q40. When providing a PRSS (Group 1 or 2), do we need to make sure the beneficiary qualifies for the bed at the time he/she is getting the PRSS? This is for cases where the beneficiary doesn't have a hospital bed, or the bed was paid for by a previous payer.
A40. If there is a denied hospital bed on file, the Group 1 or 2 PRSS mattress will also deny; however, if they are using their own bed or it is a patient-owned hospital bed (that was paid completely by Medicare), they must follow the criteria listed in the LCD.

Q41. The beneficiary did not have testing done for oxygen. We did obtain an ABN. How do we send the CMN since there is no testing?
A41. Without a completed CMN, the claim will be rejected. A CMN must be provided for the ordered oxygen even if the testing is non-qualifying. We suggest working with the beneficiary and physician to have all requirements completed to ensure proper therapy and allow billing.

Q42. The initial order for oxygen states 24 hours. The F2F is done and the doctor changes this to nighttime only. Is new testing required? OSA is not the diagnosis on this but if the patient has OSA, what needs to be done?
A42. If the original testing qualified for 24 hours there is no need for retesting to be changed to nocturnal oxygen only; however, if portability had been prescribed an order for nocturnal only use eliminates the need for the portable. The response is the same if the beneficiary had OSA because the initial need was established at rest.

Q43. A patient is getting a custom tracheostomy tube. The allowable is $54.16 and this does not cover our cost of $500. What can we do to recover our cost?
A43. The only way to collect more than the Medicare allowable is if you are a non-participating supplier and bill non-assigned. There are some items that require mandatory assignment.

Q44. For HCPCS A6197 (wound cover), is a venous ulcer with full thickness covered and what diagnosis code is required to bill Medicare?
A44. The alginate dressing A6197 is covered for a moderately to highly exudative full thickness wound. The medical record must support this as well as the criteria documented in the PA. Coverage is not diagnosis driven.

Follow-up. Does a physician order require a diagnosis code?
Answer. There are different types of orders depending on the LCD. All order requirements are listed in the Standard Documentation Requirements (Policy Article A55426). The only order that requires a diagnosis is a 7 Element Order (7EO) for PMDs.

Follow-up. Are vascular wounds covered under surgical dressings?
Answer. Yes. Vascular wounds could be covered under surgical dressings if they meet coverage criteria listed in the surgical dressing LCD.

Q45. A beneficiary had a sleep study, F2F, then a titration but no F2F prior to the first sleep study to assess for OSA. Is a new F2F to assess for OSA required, then a repeat sleep study?
A45. The PAP LCD requires a F2F prior to the diagnostic sleep study to assess for OSA. There is not an established timeframe for this F2F to occur; however, due to ACA requirements, if a F2F occurs greater than six months prior to the order, a new F2F is required. Presumably there was some contact to initiate the order for the study. The supplier should determine what prompted the initiation of the order.

Q46. Medicare previously paid for a machine and the beneficiary wants a replacement machine. We do not have a copy of the qualifying sleep study on file and it is over seven years old. Does the beneficiary need a new diagnostic sleep study?
A46. The PAP LCD states the following for replacement machines. "This section applies to PAP devices initially provided and covered while the beneficiary was in Medicare fee-for-service (FFS). If a PAP device is replaced during the five-year reasonable useful lifetime (RUL) because of loss, theft, or irreparable damage due to a specific incident, there is no requirement for a new clinical evaluation, sleep test, or trial period.
If a PAP device is replaced following the 5-year RUL, there must be a face-to-face evaluation by their treating practitioner that documents that the beneficiary continues to use and benefit from the PAP device. There is no requirement for a new sleep test or trial period."

Q47. A beneficiary is on a Respiratory Assist Device (RAD), HCPCS E0471, along with oxygen and only wears oxygen at night with the machine. Do we need a new titration to requalify for oxygen? Can we just do an overnight oximetry?
A47. The RAD LCD does not specify that the testing must be completed during polysomnography; however, there must be evidence that the beneficiary is in their chronic stable state at the time of testing.

Q48. Are home sleep studies required to be scored at 4% criteria?
A48. Yes. The scoring criteria is the same for both home sleep tests (HST) and facility-based testing.

Q49. Medicare did not pay for a hospital bed. A beneficiary is now on Medicare and would like a replacement Group 1 support surface. Are we required to show that the beneficiary qualifies for a hospital bed under Medicare guidelines? Can we just show that the beneficiary qualifies for the support surface? 
A49. When a beneficiary receiving a DMEPOS item from another payer (including a Medicare Advantage plan) becomes eligible for the Medicare Fee-For-Service (FFS) program, the first Medicare claim for that item or service is considered a new initial Medicare claim. Medicare does not automatically continue coverage for any item obtained from another payer when a beneficiary transitions to Medicare coverage.

For Medicare to provide payment, the beneficiary must meet all Medicare coverage, coding, and documentation requirements for the DMEPOS items in effect on the DOS of the initial Medicare claim.

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August 21, 2019

Last Updated Feb 06, 2020