ACT Q and A - May 11, 2022 - JA DME

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.

Questions Received Prior to ACT Meeting

Q: Do you have to be a supplier to bill for custom fitted orthotics when done in a hospital outpatient physical therapy department?
A: To bill Medicare, you must enroll in the Medicare program and apply for a National Provider Identifier (NPI). Additionally, custom fitted orthotics require the expertise of a certified orthotist or an individual with specialized training in the provision of orthosis. For more information, please see the updated Change Request (CR).

Q: All providers are enrolled under a group instead of individually. How do I enroll the group with durable medical equipment (DME)?
A: All suppliers must enroll individually per National Provider Identifier (NPI). Practitioners may be in a group practice and a supplier, but they must enroll per NPI. The National Supplier Clearinghouse (NSC) can help you navigate the enrollment process and answer questions about your application.

Q: Are there any updates to the Public Health Emergency (PHE)?
A: As of April 12, 2022, the Public Health Emergency (PHE) was extended for another 90 days. Please monitor the Emergency and Disaster webpage on the Noridian Medicare website for future PHE updates.

Q: Can you explain how the redeterminations process works?
A: A redetermination is the first level of appeal in which a request is made to review a claim when an original claim determination is unsatisfactory. A redetermination may only be requested if the denial has appeal rights and must be submitted within 120 days of receipt of the initial determination.

Once an initial claim determination is made, providers, participating physicians, and suppliers accepting assignment have the right to appeal. Suppliers that do not accept assignment but are held liable for payment also have appeal rights. Medicare beneficiaries or their authorized representatives, Medicaid state agencies and parties authorized to act on behalf of Medicaid state agencies for the beneficiary may also request an appeal.

There are several reasons a redetermination would be needed such as a change in liability, timely denials, repairs, miscellaneous HCPCS codes, modifier changes or medical necessity denials which require medical record documentation or medical review (not an all-inclusive list). When submitting an appeal, ensure all necessary documentation is included to prove medical necessity for the denied DME. Documentation requirements are defined in the Standard Documentation Requirements (SDR) Article A55426 and detailed in the item specific policy. Redeterminations may be submitted on paper, electronically or via the Noridian Medicare Portal (NMP). For more detailed information, refer to the Redeterminations webpage.

Q: What are the appropriate oxygen diagnosis codes once the Public Health Emergency (PHE) ends?
A: There is no requirement to submit a Certificate of Medical Necessity (CMN) or DME Information Form (DIF) during the PHE for oxygen or external infusion pumps (EIPs). If CMNs or DIFs are not submitted, suppliers must use the CR modifier and COVID-19 narrative for any oxygen or EIP claims submitted during the COVID PHE. CMNs or DIFs are not required regardless of the diagnosis or etiology necessitating the use of the CMN related or DIF related DME. Use of the CR modifier and COVID-19 narrative simply reflects that the claim was submitted during the COVID-PHE.

Q: Are there any updates on the revised oxygen Local Coverage Determination (LCD)?
A: We are aware of changes made to the oxygen National Coverage Determination (NCD) 240.2. However, we are still awaiting guidance from CMS on the updated oxygen LCD. With that, none of the oxygen changes will be going into effect until January 2023.

Q: If a beneficiary is already on home oxygen when they become eligible for Medicare, how does a supplier start billing Medicare?
A: For beneficiaries entering Medicare on oxygen, an initial CMN is required. The beneficiary must also have a qualifying blood gas study obtained within 30 days of the initial date, and a face-to-face (F2F) evaluation with their treating practitioner within 30 of the initial date.

Q: Please clarify use of the recertification CMN 484 when initial claims were billed under the PHE and we want to continue billing without PHE elements?
A: Once you can obtain qualifying documentation, obtain an initial CMN and follow the regular recertification time frames, regardless of whether you have been billing under the PHE waivers and flexibilities. Once you have received your initial CMN, you continue billing where you left off and do not restart at month one.

Q: What do we do if a beneficiary does not resume the use of their positive airway pressure (PAP) device even after their recalled unit was exchanged for a new one? The beneficiary had met compliance prior to the recall.
A: If the beneficiary has stopped using their device, regardless of the recall, you should collect your PAP device and stop billing Medicare. Please see the frequently asked questions in regards to the recall for more information.

Q: For claims, how do we report an EIP that is beneficiary owned because the rentals have capped?
A: Capped rental items where Medicare has paid the full 13 months do not require any additional information to be submitted with the supply claims. If Medicare did not pay for the rental, then a beneficiary owned narrative must be added to the claim for any supplies/accessories. The narrative should indicate beneficiary owned, approximate date of purchase, and who purchased.

Q: Regarding wound care, many of our doctors prescribe daily changes of foam dressings. Do we call the doctor?
A: Foam dressings are covered when used on full thickness wounds (e.g., stage 3 or 4 ulcers) with moderate to heavy exudate. Dressing change for a foam wound cover used as a primary dressing is up to three times per week. If additional foam dressings are prescribed, the medical documentation would have to support the extra dressings and a redetermination would need to be requested to support the overutilization.

Q: Can you please provide information on Medical Doctor (MD) diabetic footwear documentation?
A: Refer to our Therapeutic Shoes Browse by DMEPOS Category page on the Noridian Medicare website for information on the Therapeutic Shoes for Persons with Diabetes policy including the Local Coverage Determination (LCD) and policy article.

Q: Can you provide information on the authorization requirements for orthotics?
A: Refer to our Prior Authorization for orthoses page on the Noridian Medicare website (Medical Review > Pre-Claim Review > Required Prior Authorization Programs) for the requirements and process for Prior Authorization on orthotics.

Q: Would a new Advance Beneficiary Notice of Non-Coverage (ABN) be needed if the beneficiary changes to a portable oxygen system? It is the same reason for the ABN; however, just a different HCPCS code.
A: If there is a change in modality and a change in HCPCS code, then a new ABN would be required. Please see the Advance Beneficiary Notice of Noncoverage (ABN) webpage for more information on ABN requirements.

Q: What modifiers are used when billing high-flow oxygen with a stationary and a portable?
A: The QB modifier is required when prescribed amounts of stationary oxygen for daytime used while at rest and nighttime differ and the average of the two amounts exceeds 4 liters per minute (LPM) and portable oxygen is prescribed. Please see the Oxygen Tips webpage for more modifier information.

Q: For PAP devices, is it a requirement to have a copy of the Epworth Scale in your records outside of the PHE guidelines?
A: This is not a requirement within the PAP policy. The PAP policy addresses the suggested elements for an initial visit to determine need for sleep testing. Not all elements would be required to be evident.

Verbal Questions Asked During ACT

Q: What is the date prior authorization is required for L1832, L1833, and L1851 (knee and back braces)?
A: Prior authorization is being rolled out in stages:

• April 13, 2022: NY, IL, FL, and CA
• July 12, 2022: MD, PA, NJ, MI, OH, KY, TX, NC, GA, MO, AZ, and WA
• October 11, 2022: Nationwide
• Please see the Required Prior Authorization Programs for more information.

Q: We have claims originally submitted with an initial CMN and CR modifier. They later qualified so we removed the CR modifier. Now, claims are denying after a year looking for a recertification?
A: There is no requirement to submit a CMN or DIF during the PHE for oxygen or EIPs. If CMNs or DIFs are not submitted, suppliers must use the CR modifier and COVID-19 narrative for any oxygen or EIP claims submitted during the COVID PHE. CMNs or DIFs are not required regardless of the diagnosis or etiology necessitating the use of the CMN related or DIF related DME. Use of the CR modifier and COVID-19 narrative simply reflects that the claim was submitted during the COVID-PHE.

Written Questions Asked During ACT

Q: We are getting a lot of denials for the ventilator stating that BIPAP therapy was not ruled out. The beneficiaries have a deteriorating neuromuscular disease, and the physician is stating that a BIPAP would not be the proper item. Even with that statement we are still being denied. A BIPAP does not have the capacity to do volume ventilation which is on the orders. Exactly what are they looking since it was already stated that a BIPAP would not meet their needs?
A: The medical record must fully support the device being provided. Information on an order is not considered part of the medical record. If you disagree with a denial, you are encouraged to follow the appeals process. Additionally, if this is an initial claims processing denial, we encourage you to call the provider contact center for assistance. If it is the result of an audit, you may want to contact that auditing entity for guidance.

Q: We have a beneficiary switching from an oral appliance to a PAP device. When the sleep study is done, should it be on or off the oral device?
A: A new sleep study is not required when switching from oral appliance to a PAP device if therapy is continuous. The original qualifying study will be accepted, however there must be a clinical reason documented in the medical record justifying the need for change in therapy. These items are considered same or similar and a second device will deny for that reason. An appeal will be necessary to show the need for change.

Q: Our beneficiary had a sleep study on June 1, 2021. Due to the PAP back-order situation, the machine may not ship for 12 weeks. Will we still be able to ship, or will we have to have a new sleep study as it will be expired since the baseline sleep study has to be within one year?
A: There has been no change to documentation requirements. Medicare documentation requirements indicate that timely documentation is within the preceding 12 months. The sleep study needs to be within one year of the start of therapy. Please see the Standard Documentation Requirements Policy Article for more information.

Q: Is an REI allowed to be used in a home sleep study since it is a surrogate to the apnea hypopnea index (AHI)?
A: REI is not a surrogate for AHI and cannot be used to qualify for Medicare. Only AHI/RDI are acceptable per the PAP LCD.

Q: How specific do continued need notes have to be to support a repair of a piece of equipment?
A: There must be adequate information in the beneficiary’s medical record to support that the item continues to remain reasonable and necessary for continued medical need as indicated in the Standard Documentation Requirements.

Q: For saline (A4216) the physician is ordering 50, 10 m bullets and states that the frequency of use is with every change. Do we need the physician to specify the specific amount use per change?
A: Medicare does not specify the amount to be utilized with each cleaning. Claims will be processed based on what is clinically reasonable and necessary. In the event of a review, the medical record must support the amount of supply utilized.

Q: We have a beneficiary that is coming to us for A4353 (urological supplies) and has been using the closed system for 10 years. We are unable to obtain the original qualifying documentation since it is greater than seven years. How should we proceed?
A: Per the Standard Documentation Requirements Article: “Documentation must be maintained in the supplier's files for seven years from date of service (DOS). 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.” Documentation should be maintained to show when the beneficiary initially started using the supplies to support it has been greater than seven years.

Q: How do we determine what HCPCS codes require Modifier RR for reimbursement?
A: The RR modifier is required for all rental equipment. Those modifiers can be identified on the PDAC website per HCPCS code.

Q: The ostomy pouch liquid deodorant HCPCS A4394 comes in a packet of .27 Fl oz 20 packets equals 5.4 Fl oz. What is the correct quantity to bill? What are the rounding rules?
A: The A4394 is billed one unit per ounce. If you are giving 5.4 ounces, you would round up to six units.

Q: We have a beneficiary that just started PAP therapy prior to going over to Fee-for-Service (FFS). Upon enrollment we noticed the sleep study is invalid and the beneficiary went and had a new one after enrollment in FFS. Can the progress notes prior to FFS be used to support the evaluation prior to the polysomnogram (PSG)?
A: For beneficiaries who received a PAP device prior to enrollment in FFS Medicare and are seeking Medicare coverage of either rental of the device, a replacement PAP device and/or accessories, both of the following coverage requirements must be met:

• 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 an in-person 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.

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

Q: Suppliers are only required to keep documentation for seven years. If a beneficiary had a sleep study 12 years ago and we do not have a copy, because it is greater than seven years, what would we need to have in the documentation to support sleep study coverage criteria was met to provide positive airway pressure (PAP) supplies?
A: If the beneficiary has been on therapy for the last 12 years and Medicare has paid for a device and supplies, a new sleep study would not be required.

Q: We are enrolled as a physician supplier for DME. Is it required to bill for an office visit on the same date when we supply a brace? The LCD that I have on file says the beneficiary must have had a F2F within 30-45 days of supplying the brace. We were recently denied for a knee brace stating, "service or procedure requirement not met". When I called, they stated no office visit was recorded, even though the beneficiary was in the day before for an office visit and came back the next day to receive his brace.
A: For physicians acting as suppliers of certain off-the-shelf orthotics the brace must be provided the same day as an office visit for beneficiaries living in competitive bid areas. If the brace is not provided the same day as the office visit, it will deny.

Q: What is needed to cover a beneficiary for a cluster headache (CH)? Do they still have to do the trial? If the beneficiary wants E-tanks, which are not on the LCD for CH, can we offer an ABN?
A: As of now, a trial for CH is still required. However, this will be changing as of January 2023. If something else is ordered and not covered in the LCD, then an ABN could be issued.

Q: Would CVA with hemiplegia still be a qualifying diagnosis for a Group 3 power wheelchair? The only place we see this clarification on Noridian is from 2009.
A: Group 3 power wheelchairs are covered for beneficiaries with a neurological, myopathy, or congenital skeletal deformity. A CVA with hemiplegia could potentially meet for a neurological condition, it would depend on the documentation submitted.

Q: Can a doctor correlate or cosign a nurses note to meet medical necessity if the F2F has already been completed?
A: The F2F encounter must support payment for the item(s) ordered/prescribed, and be documented in the pertinent portion of the medical record (for example, history, physical examination, diagnostic tests, summary of findings, progress notes, treatment plans or other sources of information that may be appropriate). The supporting documentation must include subjective and objective beneficiary specific information used for diagnosing, treating, or managing a clinical condition for which the DMEPOS is ordered. The F2F encounter should address all coverage criteria, therefore, co-signing a nurse's note will not meet the F2F requirements.

Q: If a beneficiary has been on PAP therapy (under private insurance) but stopped for two years and is now wanting to restart when their PAP device is replaced, is a new sleep study and compliance period required? This beneficiary is now Medicare primary and there is no equipment on file with Medicare.
A: If the beneficiary has not been on any therapy in two years and they are entering Medicare for the first time, they would need a face-to-face encounter with their treating practitioner for evaluation of symptoms, a new sleep study and compliance period. Please see the PAP LCD for more information.

Q: If a beneficiary receives a non-elastic gradient compression device but the specific manufacturer item is not coded on Pricing, Data Analysis and Coding (PDAC) as a A6545, what code should be used to show it is not covered since the specific product line is not PDAC approved?
A: In this situation you would use the A9270 (non-covered item or service) and add a description of the item on the claim.

Q: For the E0483 (high frequency chest wall oscillation system) coverage does the beneficiary need to trial and fail more than one therapy to be considered for coverage?
A: The LCD L33785 states there must be well-documented failure of standard treatments to adequately mobilize retained secretions. It does not state a specific number of tried and failed therapies.

Q: Are CMNs and DIFs no longer needed after January 1, 2023?
A: CMS will discontinue the need for CMNs and DIFs starting with claims with a date of service on or after January 1, 2023.

Q: If the prescription says "authorizing provider and ordering provider" with the prescribing doctor's name and National Provider Identifier (NPI), is that acceptable as an electronic signature?
A: Identification of an electronic signature does not have a required format. You must be able to identify that only the signature could have entered their name. If you are unsure if the signature was signed electronically, you can request the electronic signature protocol from the physician’s office. Keep this information in your file if your claims get audited or if you need to request a redetermination.

Q: A beneficiary was seen by the treating physician who then referred him to see a physical therapist for a consult. Following the physical therapy visit it was it was recommended that the beneficiary needed a U-Step walker, L0147. Can the treating physician amend their notes, contact the beneficiary, and order the device?
A: All medical records can be utilized to substantiate clinical need. The referring physician must have information that indicates the need of the walker and document it in their own clinical records that PT notes were reviewed along with the outcome. At that point, the treating practitioner may order the DME item.