ACT Questions and Answers - November 14, 2019
The following questions and answers (Q&As) are cumulative from the DMEPOS Ask the Contractor Teleconference (ACT). 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. Does the sleep study for beneficiaries on a Respiratory Assist Device (RAD) need to be scored at 4%?
A1. The scoring for RAD is based on the number of apneas and hypopneas. Keeping in mind that according to the Local Coverage Determination (LCD), a hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline and with at least a 4% decrease in oxygen saturation.
Q2. The beneficiary received a Positive Airway Pressure (PAP) device prior to Medicare but the sleep study does not meet Medicare qualifications. What type of sleep study should be done?
A2. For Medicare qualification purposes, a diagnostic study would be required. Sleep tests can be facility- or home-based that meets either one of the following criteria:
- Apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) > 15 events per hour with a minimum of 30 events; or
- AHI or RDI > 5 - 14 events per hour with a minimum of 10 events and documentation of:
- Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or
- Hypertension, ischemic heart disease, or history of stroke
Q3. What are the policies and regulations for cash pay of a covered item and where can these policies be found on the website?
A3. If accepting assignment, Medicare needs to be billed first. If billing non-assigned, the beneficiary can be charged.National Supplier Clearinghouse
Q4. For face-to-face (F2F) items, does the delivery date have to take place within six months of the F2F visit?
A4. There is no requirement for when delivery should take place following the F2F, however a reasonable amount of time would be the general expectation. Reasonable is usually defined as three months though not a specific requirement.
Q5. If a Proof of Delivery (POD) was not signed, what modifier is added to the claim at time of submission?
A5. There is no specific modifier to append when the POD is not signed. However, since a signature is required for POD option 1 (in-store pick up or supplier-direct delivery, not shipping service), do not append the KX modifier if directed to when all documentation requirements are met, based on the specific LCD in question.
Q6. We need to know the current standards related to clinical records/eMRs that may appear to be in letter format, "Dear Dr. xxxx".
A6. It is acceptable and common practice for a physician to write a letter to another physician following a referral. These letters are considered part of the patient's medical record. However, when reviewer's see the blanket "to whom it may concern" letters that appear to be written just to meeting coverage criteria, these must be backed up in the patient's medical record.
Q7. Is the GZ or GA mandatory on DME claims? Does one or the other have to be submitted?
A7. Most policies require the KX, GZ or GA modifier to indicate the documentation requirements have been met or a valid Advance Beneficiary Notice of Noncoverage (ABN) was obtained etc. Please check the applicable Local Coverage Determination (LCD) to determine the modifiers required.
Q8. Who is able to sign the detailed written order?
A8. The detailed written order (DWO) should be the treating physician/practitioner which can be any of the following within their scope of practice:
- Doctor of Medicine (MD)
- Doctor of Osteopathy (DO)
- Doctor of Optometry (OD)
- Doctor of Medical Dentistry (DMD)
- Doctor of Dental Surgery (DDS)
- Doctor of Podiatric Medicine (DPM)
- Physician Assistant (PA)
- Nurse Practitioner (NP)
- Clinical Nurse Specialists (CNS)
Q9. Can you clarify the requirement for a beneficiary that fails their CPAP trial but refuses to be retested, then have a F2F and good usage?
A9. A repeat sleep study is a required element when a beneficiary fails the initial trail regardless of subsequent usage. That study must be an in-lab type 1 study:
Q10. Can you replace a device within the five-year reasonable useful lifetime (RUL) if it is due to significant volumetric changes that cannot be adjusted for?
A10. Equipment can be replaced within the RUL if there is a change in clinical condition that is well documented within the medical record.
Q11. The beneficiary wants to transfer from her current DME provider to our company. Is she required to get a new F2F and detailed written order (DWO)?
A11. New documentation is not needed unless it cannot be transferred from the prior supplier.
Q12. A beneficiary received an E0601 (PAP device) October 2016 and now would like an E0470 (RAD), will Medicare pay?
A12. If there is a change in medical condition that is well documented, Medicare may pay.
Q13. Is there any population group that will be excluded from the Health Insurance Claim Number (HICN) to Medicare Beneficiary Identifier (MBI) crosswalk or that will not be issued an MBI (who have Medicare coverage)?
A13. There will be no exclusions for issuing MBIs to Medicare beneficiaries and no one is exempt from the crosswalk.
Q14. Are the number of refills required on the DWO?
A14. Yes, however only in the case of drugs used as a supply for a DME item. Please review Standard Documentation Requirements Policy Article.
Questions Asked During ACT
Q1. We receive a lot of orders from physicians and we generate a DWO. Does the physician who signs the DWO have to be the same physician who prescribes it? Does there have to be a reference in the medical record for the beneficiary's original prescribing physician?
A1. The physician signing the order may be different however the signing physician must have access to the original medical records.
Q2. If a beneficiary initiated PAP therapy seven years ago and failed compliance and now wants to reinitiate PAP therapy, would it be considered a brand new setup with a new F2F visit, sleep study and prescription for billing month one or would you bill month four after the patient has had a repeat sleep study and has met compliance?
A2. The beneficiary would be considered new which would require a new F2F and sleep study. Billing would start at month one.
Q3. Medicare is no longer crossing over our Medicaid/qualified beneficiaries. Do we have to bill them manually as secondary payer?
A3. Medicaid is responsible to set up these automatic crossovers. If you've contacted them and they won't update their files, then yes, you'll have to submit a manual claim as secondary.
Q4. Regarding an oral appliance to PAP, can an original diagnostic sleep study be used in conjunction with a current F2F verifying that even with the oral appliance, the patient is still experiencing Obstructive Sleep Apnea (OSA) symptoms. Are we able to use the diagnostic sleep study that was used to qualify the patient for the oral appliance?
A4. The original sleep study can be used to qualify for the PAP if a beneficiary has been on oral appliance therapy, however the medical record will need to clearly detail the need to change to PAP therapy.
Q5. We have a 2011 sleep study for a Medicare-paid E0471 (RAD) that does not have the central hypopneas broken out or the central apnea-central hypopnea index (CAHI). Would this study qualify for a replacement PAP? The CAHI did not come into effect until December 1, 2014, and the criteria was updated to have the central apneas and central hypopneas broken out. This is a replacement after five years.
A5. If a RAD device is replaced following the five-year reasonable useful lifetime (RUL), there must be a F2F by their treating physician that documents the beneficiary continues to use and benefit from the device. A new prescription is required. There is no requirement for new testing.
Q6. Is a diagnosis required on a detailed written order (DWO)? If it is not required and there is a diagnosis listed, however we bill with a different diagnosis that is documented in the physician records, would that cause claim review denial issues?
A6. Per the Standard Documentation Article, a DWO is required before billing and it must contain:
- Beneficiary's name
- Date of the order
- 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 supplies, list all supplies that are separately billable, and for each include the frequency of use (if applicable), and the quantity dispensed;
- Prescribing physician/practitioner's signature (and date if applicable - see above).
The DWO does not require a diagnosis code. The reviewer will be looking at the medical record for the appropriate diagnosis code.
Q7. A patient owns an E0601 (PAP device) with a date of purchase of November 28, 2018, prior to their Medicare effective date of June 1, 2019. We have a qualifying sleep study after the Medicare effective date of August 25, 2019, with a F2F after the Medicare effective date verifying OSA and continued use dated July 16, 2019. Can we bill for PAP supplies with the patient-owned E0601 from November 28, 2018, and qualifying sleep study of June 1, 2019, and if we can, are we required to meet compliance?
A7. For beneficiaries entering Medicare on PAP therapy, no compliance trial period is required. Suppliers should follow the "Beneficiaries Entering Medicare" portion of the Positive Airway Pressure Device LCD. Beneficiaries must have a F2F visit and a sleep study that meets the Medicare requirements at the time they enter Medicare.
Q8. Can we accept an oxygen Certificate of Medical Necessity (CMN) that has a number span listed in the length of need (LON) and if so, do we take the lowest number for the LON?
A8. A range is not acceptable on the CMN, however you can accept for the lowest number. It would be a good business practice to get a new CMN when all requirements are not met.
Q9. Can we use the F2F for a wheelchair when a beneficiary was covered by the private payer or does Medicare need a new F2F when they went to Medicare?
A9. The Wheelchair LCD does not specify additional F2F requirements beyond those of the Affordable Care Act requirement of a F2F within six months of any order.
Q10. Question 23 from the May 16, 2019, ACT gives conflicting guidance as to which date of service (DOS) to bill. There is a noncompliant beneficiary and the PAP is picked up. The beneficiary goes through testing again, the equipment is redelivered, and the patient is compliant at the end of the three months. The instruction was the redelivery date is billed as the DOS. At an event in September, we were told the date the patient became compliant after the retrial should be billed as the DOS.
A10. The 4th month billing will resume with a DOS after the beneficiary becomes complaint and a F2F that confirms their compliance has been completed. There was a clarification by the medical directors following the May 2019 ACT. Noridian will pursue publishing a correction to the May ACT document.
Q11. If a Type 1 diagnostic sleep study is done in lab, can we go by the AHI or RDI or only the AHI?
A11. Medicare fee-for-service accepts either AHI or RDI as qualifying for PAP therapy, however do note that Medicare does not recognize RERA in the calculation.
Q12. If Medicare covers A7032 and A7034 (Cushion for nasal mask interface and nasal interface mask or cannula) and A7031 (face mask interface), they cannot be both billed at setup. When they are an ongoing patient, will Medicare cover these items if dispensed at the same time, basically for the rebill?
A12. A nasal mask interface and a full face mask interface may not be billed at the same time. Additionally, the DWO must be specific to the interface being provided.
Q14. A sleep study was covered during private pay, would this be covered for Medicare?
A14. When a beneficiary enters Medicare on therapy the requirement is that there be a sleep study that meets the criteria in effect at the time the beneficiary enters Medicare. If the previous study meets this requirement coverage can continue. If not, a new study would be required.
Q15. We are under the impression there is never a circumstance for a recertification on a DME Information Form (DIF); for example, parenteral (TPN) or enteral nutrition, is this correct?
A15. Yes, a supplier would submit a revised DIF and not a recertifying DIF.
Q16. For parenteral and enteral DIFs, if someone goes from bolis to a pump administration, it is our understanding they would need the initial DIF for changing. Is this correct?
A16. The supplier would submit a revised DIF for the nutrition change and an initial DIF for the pump change.
Q17. For beneficiaries that have Small Bowel Obstruction (SBO)/obstructions/strictures, etc., if we see there are defendable points that the beneficiary cannot have surgery to remove the obstruction, such as peritoneal metastasis, history of previous resections, metastasizing cancers, etc., can suppliers override asking for providers to address why surgery is contraindicated?
A17. If the medical records support other reasons why surgery is not an option, requirements are not being overridden.
Q18. The same or similar tool on the website shows E0601 (PAP device) is same or similar to the oral appliance. Is the oral appliance same or similar to the E0601?
A18. Yes, the are considered same or similar to each other.
Q19. Within the five-year period, Medicare pays for E0601, either all 13 or at least 12 payments. Now the doctor wants to order E0470 (RAD) under OSA. Will this deny as same or similar or will Medicare allow the new E0470 rental? What documentation is needed with the new F2F and order?
A19. The E0470 is likely to deny for same or similar based on the chart on our website and due to the fact they are being utilized to treat the same medical condition. If there is a clinical need for the change in therapy, it must be well documented in the medical record and suppliers may file an appeal to show the reason for change and the request for a new rental period.
Q20. For PAP supplies, while the beneficiary is in a second trial period (first trial failed), we billed with no KX modifier and a GA modifier because we did get an ABN saying supplies are not covered. Why would Noridian pay the supplies when there was no KX modifier on the claim?
A20. Medicare should not be paying for supplies while the beneficiary is in the second trial. Please reach out to the Contact Center for the appropriate jurisdiction for assistance with this specific claim.
Q21. A beneficiary has been renting a PAP for the past four months with an Advantage plan but will be enrolled in Fee-for-Service (FFS) Medicare for December. Do we need a new F2F and order?
A21. The PAP policy specifically lists the requirements for beneficiaries entering Medicare. But in short, they will need the following:
- Sleep test - There must be documentation that the beneficiary had a sleep test, prior to FFS Medicare enrollment, that meets the Medicare AHI/RDI coverage criteria in effect at the time that the beneficiary seeks Medicare coverage of a replacement PAP device and/or accessories; and,
- Clinical Evaluation - Following enrollment in FFS Medicare, the beneficiary must have a F2F evaluation by their treating practitioner who documents in the beneficiary's medical record that:
- The beneficiary has a diagnosis of obstructive sleep apnea; and,
- The beneficiary continues to use the PAP device
Q22. We had an instance where a beneficiary entered a Part A stay and wanted to continue using their external infusion pump and medication. The hospital refused to contract, so the beneficiary wanted to pay for a week's worth of their medication. The ABN stated they wanted to pay but wanted Medicare billed but I cannot get a patient responsibility (PR) denial on the claim because the patient was on a Part A stay, even after a redetermination. Are we supposed to deny the request outright and make them wait, regardless of what the beneficiary wants and is willing to pay for?
A22. If a claim for drugs is billed during an inpatient stay, the claim will deny based upon consolidated billing rules. This is not considered a reasonable and necessary denial so the ABN would not be valid.
Q23. If a beneficiary becomes deceased prior to the collection of the diabetic paperwork that Medicare requires, are we allowed to salvage bill for the custom inserts or shoes even though all the paperwork was completed prior to the patient passing?
A23. CMS IOM, Publication 100-02, Medicare Benefit Policy Manual Chapter 15, Section 20.3 - Artificial Limbs, Braces, and Other Custom Made Items Ordered But Not Furnished: Date of Incurred Expense
"If a custom-made item was ordered but not furnished to a beneficiary because the individual died or because the order was canceled by the beneficiary or because the beneficiary's condition changed and the item was no longer reasonable and necessary or appropriate, payment can be made based on the supplier's expenses. (See subsection B for determination of the allowed amount.) In such cases, the expense is considered incurred on the date the beneficiary died or the date the supplier learned of the cancellation or that the item was no longer reasonable and necessary or appropriate for the beneficiary's condition. If the beneficiary died or the beneficiary's condition changed and the item was no longer reasonable and necessary or appropriate, payment can be made on either an assigned or unassigned claim."
Q24. A beneficiary is seen on October 1, 2019, for an oxygen follow-up for their chronic obstructive pulmonary disease (COPD); however, testing is not documented in the visit. The patient returns to the physician's office for testing and this visit is indicated as a nurse visit for oxygen testing. The nurse and the physician sign the visit. Is this valid? My concern is verifying chronic stable state. If the patient had been seen on October 1, 2019, for COPD exacerbation and given antibiotic and a steroid taper then returned on October 15, 2019, for the purpose of testing only after taking the antibiotic and taper, would this be valid testing?
A24. The testing would be valid; however, there should be some statement saying acute issues have resolved.
Q25. For Medically Unlikely Edits (MUEs), such as >350 grams per week lipids, if suppliers have a written reason why a beneficiary needs greater than these amounts or if the medical records state supporting documentation on greater than the MUE, would Medicare cover over this amount?
A25. For parenteral nutrition liquids, the medical records must support the need for lipids greater than 1500 grams per month. With the example provided of 350gm/week, a four-week supply would be 1400 grams and therefore, would not need additional rationale.
Q26. Regarding the ankle braces Local Coverage Determination (LCD), it is not clear if weakness must be documented as part of the objective examination by the provider or if weakness can't be the beneficiary's subjective complaint.
A26. The beneficiary's medical record should include detailed documentation in the treating practitioner's records to support medical necessity of the item billed. Focused history and examination of an impacted body part is critical to establishing medical necessity.
Q27. What is the time frame a sleep study can be amended or rescored if the hypopneas were not scored at the 4% decrease in oxygen saturation? Our sleep study is dated October 18, 2016, the addendum is dated October 23, 2019. Would the addendum be acceptable?
A27. As long as the data is present from the original study, the rescoring on October 23, 2019, would be a clarification of that data and would be valid.
Q28. What if a beneficiary does not get in to see the treating clinician for a re-evaluation between the 31st and 91st day of PAP treatment and saw the doctor after the 91st day, will Medicare still pay?
A28. Billing may resume after the F2F occurs and compliance has been confirmed, even if it is after the 91st day.
Q29. Would this example be valid testing?
- At rest on room air 90%
- At exercise on room air qualifying result 87%
- At rest with 2 LPM result 98%
- At exercise on 2 LPM result 98%
A29. This example meets the requirement for the three elements of exercise testing. In fact, the resting on 2LPM would not be required.
Q30. What would need to be provided to show the data is present from the original sleep study to have an October 18, 2016, sleep study rescored with the hypopneas at the 4% decrease in oxygen saturation, other than the addendum?
A30. The raw data from 2016 that allowed the rescoring would support the addendum.
Q31. For beneficiaries with OSA, the nocturnal oximetry conducted during the titration demonstrates an oxygen saturation = 88% for five minutes total (which need not be continuous). Does the five-minute desaturation need to be at the optimal pressure? For example, the doctor ordered CPAP 15 CWP 2 LPM but the titration study recommended a titration on BIPAP/ASV. Would the optimal pressure be considered 15CWP that the doctor ordered? Would the saturation = 88% for five minutes be counted from desaturationon 15CWP thru CWP to total the five minutes or does the titration study need to document the optimal pressure?
A31. Optimal therapy occurs when the AHI/RDI is reduced to less than or equal to an average of 10 events per hour or if the initial AHI/RDI was less than an average of 10 events per hour, the titration demonstrates further reduction in the AHI/RDI. As a result, if at 15 CWP the AHI is reduced to less than 10, that would be acceptable.
Q32. If a beneficiary only has a phone call with the physician prior to a sleep study, does that take the place of a F2F? The physician has "phone call notes" that he signed.
A32. No, the definition of a F2F is that the beneficiary is seen in person by the treating practitioner. A phone conversation is not a F2F.
Q33. If a beneficiary has a PAP provided by another supplier more than five years ago and the beneficiary comes to our company for their replacement PAP, are we required to obtain a copy of the original sleep study or do we only need the F2F and written order prior to delivery (WOPD) to be able to deliver?
A33. If Medicare paid for the full 13 months of rental, the coverage criteria is considered to have been met and the sleep study would not be necessary. The beneficiary would need a new F2F showing the continued need for the equipment.
Q34. For external infusion pump (EIP) Blincyto, the usual dose is 28 mcg per day per policy. How should suppliers handle cases where the beneficiary is on a dose outside of this? Less or even greater, if the physician documents the reason, would this be covered under EIP?
A34. For dosages less than the 28 mcg, it would need to follow the manufacturer's guidance and the medical records would need to support the claim. For claims billing over the policy, per the LCD, claims for more than 875 units of service (UOS) or 25 vials will be denied as not reasonable and necessary.
Q35. Regarding immunoglobulin G (IGG) therapy under the EIP policy, we have a primary diagnosis that is not covered and a secondary that is. If the physician documents that IGG is the primary diagnosis but does not state the secondary diagnosis is explicitly excluded to treat the patient for IGG therapy, does the primary diagnosis negate the secondary diagnosis?
A35. If the medical records support a diagnosis requiring IGG, it should be billed with that diagnosis and payment will be considered.
Q36. Some knee braces require positive findings on examination. Is this the same for ankle weakness? I know it is based on presenting problem and history but must there be a positive finding on examination to meet LCD guidelines?
A36. For ankle/foot orthoses, the exam finding of ankle weakness is essentially a positive finding. The records must support either the presence of weakness or deformity of the foot and ankle, must require stabilization and will benefit functionally.
Q37. If a beneficiary was receiving enteral nutrition for dysphagia and is now on total parenteral nutrition (TPN) because of a leaking ENT feeding tube, technically this would not be a TPN/dysphagia diagnosis which is clearly noncovered. The condition driving the need for TPN is the leaking Gtube/Jtube, a fistula of sorts. What is Medicare's take on this type of condition? Would records specifically have to state some sort of fistula?
A37. If the Gtube/Jtube is leaking, in the absence of any qualifying condition, such as an enterocutaneous fistula, criteria will not be met. In this case, if it's an issue of the tube leaking, and no other physician findings, then the test of permanence is not met. However, if the leaking is due to a fistula, per the Policy Article, to meet Criterion C, the records would need to clearly document the presence of an enterocutaneous fistula as well as documentation to support the beneficiary requires 20-35 cal/kg/day.
Q38. We have some PAP beneficiaries who come to us from other providers and need repair of their device and we need to provide a loaner and then possibly bill for the repair. If we cannot get the original order from the initial provider, do we need to seek a new one since repair does not specifically require an order?
A38. Though repair does not require an order, a supplier in this instance would want to obtain an order for the device itself to show that it was prescribed for the beneficiary.
Q39. A beneficiary had a F2F four months ago for a PAP device and we billed their Medicare Advantage plan. The patient now has FFS Medicare. Why does he need a new F2F if the previous was less than six months ago?
A39. Medicare Advantage is also known as Medicare Part C. It is technically still a part of Medicare, but it is not sold or managed by the federal government. So, the beneficiary would need the new F2F per LCD to meet requirements for Medicare fee-for-service showing the patient is benefitting from the equipment.
Q40. If a supplier appends a GY modifier on a claim for routine foot care, will this process as PR or deny as a provider write off?
A40. There is not a HCPCS code for routine foot care billable to the DME MAC. This question should be addressed with the Part B MAC.
Q41. If the prescribing doctor orders one K level prosthesis for a beneficiary but the supplier feels the beneficiary does not meet the coverage criteria for the ordered K level, can the supplier downgrade?
A41. The functional level is based on the evaluation of the treating practitioner and the prosthetist. Noridian recommends having a conversation with the treating practitioner to have documentation showing a consistent functional level.
Q42. Can a telephone note showing the patient called and spoke with a nurse about their medication be used to qualify for medical criteria to submit claims?
A42. This appears to be a Part B physician service question and not directly related to DMEPOS. However, an office visit cannot be billed based on a conversation between a nurse and a patient regarding their prescription.
Q43. HCPCS code K0739 (Repair), along with other items, is billed for denial with the GA modifier on all lines with a narrative. Medicare previously gave the PR denial, but now I'm seeing CO107 denial (related/qualifying claim/service not identified). It is there, Customer Service can see it, why are they now denying with this code?
A43. The GA modifier doesn't guarantee a PR denial. Suppliers will want to appeal these claims with documentation if the expected denial is not received (CO vs PR).
Q44. If a beneficiary has a F2F visit and an order is written however it contains errors, does a new F2F need to take place before the new/corrected order will be accepted if it is past the 180-day time frame or will the corrected order be ok for delivery?
A44. The corrected order would be acceptable as long as it is supported by the medical record and is dated/signed prior to delivery for the affordable care act items.
Q45. In the past, oxygen billed for denial would pay. Now CMS has updated the edit and the correct denial is received. Have you heard if they are considering the same process for rehab?
A45. We are not aware of any updates at this time. If you feel editing isn't set up correctly, please reach out to the Supplier Contact Center let them know.
Q46. If an item is statutorily not covered and the beneficiary signs a waiver, which order are the modifiers placed on the claim? (GX then GY or GY then GX)
A46. There is no required order for the modifiers that are appended.
Q47. Can preparatory prostheses be coded as any K level? Additionally, is only the socket portion replaceable?
A47. When an initial prosthesis or a preparatory below-knee prosthesis is provided, prosthetic substitutions and/or additions of procedures and components are covered in accordance with the functional level assessment. The preparatory base code itself doesn't require the functional level but certain components do. For a preparatory prosthesis, generally it's only the socket that would be replaceable. There could be instances were other things need replacing and documentation would be needed to support the need for replacement. Hopefully, the beneficiary's stump would be healed enough for a definitive prosthesis at the time replacement parts are needed.
Q48. If a F2F does not document what is needed, can the physician do an amendment to the F2F if it is before the patient receives the equipment?
A48. The physician cannot do an amendment to add information omitted from the original dictation. Amendments may only provide clarity to the original record. If new information needs to be added, a repeat F2F should be completed to assess for that criteria.
Last Updated Feb 10, 2020