RESPIRATORY 1. The Medicare RAD policy has defined Central sleep apnea (CSA) as: An apnea-hypopnea index (AHI) greater than 5, and Central apneas/hypopneas greater than 50% of the total apneas/hypopneas, and Central apneas or hypopneas 5 times per hour, and Symptoms of either excessive sleepiness or disrupted sleep. It is our understanding that in determining the number of events, that hypopneas must be also defined as central to be included along with the central apneas in the calculation for CSA. Can you please verify if this is correct? If this is correct, we have sleep labs who do not define the hypopnea events as being either obstructive or central. Have the medical directors discussed this issue and is there anything we can do to address this? Response: The LCD stipulates that to qualify under the CSA criterion, central apneas + central hypopneas must be greater than 50% of the total apneas + hypopneas. 2. If we receive a PAP supply only referral where PAP was provided by either another supplier when patient was non-medicare or in the event a CB bid winner is required to take patient from non-bid winner what is required? a. Does new provider have to verify confirm PAP utilization/compliance, and have a new face to face, RX and second face to face? Response: Payment for supplies used with any item of DME is contingent upon the base DME item being reasonable and necessary. DMEPOS suppliers who provide supplies only must ensure that the base item remains reasonable and necessary, including that the beneficiary continues to use the device. In the event of an audit, the supplier may be asked to produce this information to prove that the PAP device is reasonable and necessary. b. What is required for patient owned, capped, rented to purchase, new Medicare eligible, etc. and even non capped where patient wishes to change providers prior to cap being met? Response: Multiple patient scenarios mixed here. New to Medicare see LCD. Change in suppliers prior to CAP must be able to document that reasonable and necessary criteria for PAP device has been met. This is typically done by the new supplier obtaining documentation of initial qualification from the old supplier. 3. What is the current status for physician owned sleep labs providing PAP devices and related supplies for Medicare patients undergoing face to face and testing in their facilities and billing the DME MACs for the equipment under a DME provider number? Is this allowed? There was rumor at the national level that if it is not allowed now, it will be. Can you comment? Response: Physician-owned sleep labs are prohibited from dispensing PAP devices and supplies by Stark laws and regulations. No comment on rumors. 4. Some physician owned satellite labs are telling patients they must go to the central lab for mask fitting which in some cases causes the patient to drive great distances, what is the purpose of this initiative? Can the central lab or the physician bill for the mask fitting if the lab is part of the owned physician s Jurisdiction C Council office complex and the mask, etc. to the DME MAC? Response: How a provider chooses to provide services, in terms of single central site vs. multiple sites is not a DME MAC issue; however, suppliers with multiple sites must comply with the Supplier Standards related to the provision of DMEPOS services. In terms of what the physician can dispense when they own a sleep lab, see Question 3. DOCUMENTATION 1. We have received verbal direction from the DME MACs that we could change the span dates for both of these scenarios but cannot find any written guidance on this. Please confirm that this is acceptable. a. Scenario 1: If the patient was in a SNF for a portion of a date span of an enteral claim, Medicare will pay the claim if we change the From date to the discharge date and by doing so, we will receive payment for the portion of the claim for which the patient was not in an inpatient facility. 2012 Copyright, CGS Administrators, LLC.
Example: Date span 1/1/2011 1/30/2011 Discharge date: 1/6/2011 We can bill date span 1/7/2011 1/30/2011 and not bill the first 6 days (1/1/2011 1/6/2011). Is this acceptable? What about the fact that proof of delivery shows a ship date of 1/1/2011? This also allows us to bill the rental pump and pole provided that for the from date (rental date), the patient was not in an inpatient facility. b. Scenario 2: The patient was discharged from a SNF within 2 days of the original bill date. We can change the beginning date of the span to the discharge date and extend the end date of the span by the same number of days. Example: Date Span 1/1/2011 1/30/2011 Discharge date: 1/2/2011 We can change the date span 1/2/2011 2/1/2011 The only situation a supplier should change their spanned dates is delivering DME prior to discharge: Chapter 6 SM-Date of Service for Pre-Discharge Delivery of DMEPOS: For DMEPOS, the general rule is that the date of service is equal to the date of delivery. However, pre-discharge delivery of items intended for use upon discharge is considered provided on the date of discharge. In this case, the date of service on the claim should be the date of discharge. 2. We continue to see an increasing amount of audits relative to respiratory medications and diabetic supplies from Jurisdiction C. In many cases, the same patients are being audited month after month even though prior month s audited dates of service are paid after prepayment review of documentation that was previously submitted. Why is Jurisdiction C continuing to audit the same patients month after month even after obtaining a favorable decision on prior month s audits? Furthermore, Jurisdiction C has been focused on these product lines and has been auditing very heavily for over a year now despite very favorable results to the claims that have been selected for prepayment review. We are no longer seeing the same volume of prepayment audits for these product lines from other DME MACs and are wondering when we can expect to see the focus on this product line from Jurisdiction C be more in line with what we are seeing from the other DME MACS? Response: CGS has increased the number of audits conducted for various items of DME including diabetic Jurisdiction C Council supplies and nebulizer drugs. Results of the audits dictate that they continue. CGS will investigate the possibility of limiting subsequent month claims when a previous month s claim is paid. 3. These questions arise from the CERT Task Force presentation presented at MedTrade 2011 and at a CERT Task Force Webinar on December 13th. Response: The CERT Task Force is developing a Q&A document and CGS will forward these questions to the CERT Task Force for inclusion in their response. a. In the CERT Task Force presentation the presenter stated verbally that multi page reports (such as a history and physical report, for example) must have all the pages of the report attached, including the signature page. While this seems a logical requirement, it conflicts with two other recent pieces of issued guidance: It violates the HIPAA minimum information necessary clause. If a supplier of enteral therapy only needs the information on page 2 of the 5 page history and physical, and, page 5 of the H&P details the patients past history of mental health issues, it is inadvisable for the creator of the record to release page 5. CMS has indicated in the past it is very concerned with collateral release of unrelated medical data, especially mental health. Recently a Jurisdiction medical director wrote a letter to this supplier asking the supplier to reduce the amount of paper submitted with reconsiderations. It appears the CERT Task Force is rescinding this guidance. Is the CERT Task Force aware that the request to submit all pages of a medical report violates the HIPAA minimum necessary standard, and, inundates the Jurisdiction with an unmanageable amount of paper? b. Slide 33 of the CERT Task Force presentation states that medical record attachments to the CERT audit request must have the physician s signature on each record submitted. This would seem to indicate that weight logs, wound treatment sheets, dietitian assessments, nursing notes, medication administration logs, diabetic testing logs, ICD-9 lists, etc., would not be considered unless a physician had signed each. Upon further questioning of this interpretation during the presentation it was suggested by the presenter that the supporting documentation be attached as 2012 Copyright, CGS Administrators, LLC. Page 2
part of a packet sent along with the Detailed Written Order to the physician. Then, the physician could review and sign/date all the supporting papers along with the Detailed Written Order. Has CMS informed the physician s they will be expected to sign each page of a HME suppliers supporting documentation? What training and education has been provided to the physician community? Why wouldn t the signature of the reports author and/ or the initials of the healthcare professional documenting the medical fact, observation or event be sufficient to support and/or corroborate the medical usage and need of the DME POS item? c. Slide 38 of the CERT Task Force presentation is linking the IOM Pub 100-8, Chapter 3, Section 3.4.1.1 (the correct section is actually 3.3.2.4) as the basis for requiring a physician signature on all medical documentation submitted by a supplier and used to support a claim for payment. This section states: For medical review purposes, Medicare requires that services provided/ordered be authenticated by the author. The method used shall be a handwritten or an electronic signature. Stamp signatures are not acceptable. How does the statement, services provided/ordered be authenticated by the author come to mean that all corroborating documentation from the patient s medical record have the ordering physician s signature placed upon them? In context, doesn t this statement require the Detailed Written Order to contain the signature of the providing/ ordering physician, and, such signature cannot be a stamped signature? How is it that weight logs, wound treatment sheets, dietitian assessments, nursing notes, medication administration logs, diabetic testing logs, ICD-9 lists, etc., are considered the services provided/ ordered and therefore need to be authenticated by the author? d. Slide 40 of the CERT Task Force presentation states the electronic record should state one of the following along with the typed name of the person signing the record: Electronically signed by Electronically verified by Reviewed by Authenticated by Where is the above requirement published as regulation or policy by CMS? Can a claim be denied if the electronic signature on the supporting medical record or the Detailed Written Order doesn t contain one of the prefix statements above? e. Slide 49 of the CERT Task Force presentation states the supplier must submit documentation indicating the patient is still under the supervision of a physician, and, the patient s condition still necessitates the need for the item being requested. Where is this requirement published as a regulation or policy by CMS, or, where has this documentation requirement ever been published in a DMEPOS LCD or Supplier Manual? Is a supplier required to obtain this documentation with each refill? If not, how often must the physician document the condition still necessitate the need for the item? Is the physician required to document this continuous need or would contemporaneous notes made in the medical record by a care-giver or other health care professional be sufficient? f. Slide 49 of the CERT Task Force presentation states the Documentation must be within close proximity to the date of service on the claim and the severity of patient s condition or progression of the disease. Which is the closest correct interpretation of the quotation above? Suppliers should use medical documentation to support their claim from within a past range of time that is most appropriate for the patient. This range of time should consider the pace of change relating to the patient s unique condition; i.e., if the patient s condition is changing rapidly the supporting documentation should be rather current. If the patient s condition has long been stable it may be appropriate to attach supporting medical documentation from a year ago or more. Suppliers are to use medical documentation to support their claim that is within close proximity to the date of service. Additionally, suppliers are expected to include documentation that demonstrates the severity of the disease, and, whether it is worsening or improving in order to justify payment of the claim. 2012 Copyright, CGS Administrators, LLC. Page 3
An accurate understanding of the quotation above is necessary to provide to suppliers. The Jurisdiction Reconsideration/Redetermination departments have requested medical documentation that speaks to the patients clinical course (worsening or improving), and, such documentation is not required by LCD. Secondarily, subjective and unpublished requirements are being used to deny claims because submitted medical records are outside of a reviewer s perception of close proximity. g. Slide 61 of the CERT Task Force presentation highlights the new requirement to proof of delivery method 3 (Delivery to a nursing facility on behalf of a beneficiary). This method now requires suppliers to gather, Documented proof items are to be used by the beneficiary for whom they were delivered. Documented proof implies proof that has already been written. are to be used implies usage that is to occur in the future. How can a supplier document something as fact when it will occur in the future? What is acceptable documented proof that items will be used by a beneficiary for whom they were delivered? h. Slide 65 of the CERT Task Force presentation contains the following bullet point: Ensure records are complete, legible, signed, and contain both sides of each page. Where is the CMS regulation or requirement that records are signed? The only direct discussion in CMS manuals and guidance relating to signatures applies to the execution of the Assignment of Benefits form and the Detailed Written Order. This would seem to directly conflict with IOM 100-8 Chapter 5, section 5.2.2 which states [in summary] that a verbal or preliminary dispensing order must include; a description of the item, the beneficiary s name, the physician s name and the start date of the order. Nowhere in CMS guidance does a preliminary dispensing order require a signature of any type, however, the guidance provided in the CERT Task Force presentation seems to instruct providers that a signature is required. i. The supplier bulletin titled, Reminder for Suppliers of Prosthetics, Orthotics, and Supplies states, Part of a supplier s responsibility when billing Medicare for prosthetics, orthotics, and supplies is to determine if the beneficiary has previously received or used the prescribed item. For what purpose is a supplier to gather this data? Where shall a supplier report the findings of this supplier responsibility? How, for example, will knowledge of past usage of an indwelling foley catheter (a prosthetic) and past usage of a urinary drainage system (a supply) impact the payment, coverage, or utilization of the current patient need? Why are disposable supplies used on a re-occurring, long-term basis for established chronic medical conditions (such as diabetic supplies, surgical supplies, tracheotomy supplies and urological supplies) included in this guidance? ENTERAL/IV 1. When billing for items that are included in a daily kit code, e.g.: Enteral supply kits, and TPN supply kits, and external infusion pump supply kits, we do not necessarily ask the beneficiary to count each one of the ancillary items that are included in the kit but rather determine when we are obtaining current inventory on hand they have adequate supplies to administer their therapy through the end of current usage cycle. For the refill, we would determine, based on therapy protocols and safe administration, what needs to be sent for the next usage cycle. This can vary for each patient depending on what type of IV access they have (flushes), what type of feeding tube they have (extensions, gauze, tape, etc), and what method of administration ( pump sets, bags, cassettes, etc). None of these supplies are billed outside the kit HCPCS code and are reimbursed as a kit per each day of administration. While each ancillary item is listed on the delivery ticket individually, our documentation of contact with beneficiary for refill request would not list individually. We want to know if this is acceptable and meets the requirements for supplies provided on a reoccurring basis. There has been concern in the industry that during audits, it may not be considered as compliant for meeting Quantity of each item that the beneficiary still has remaining. Response: The kit HCPCS code is all-inclusive and billing of individual components is considered unbundling. There is no need to count the number of individual kit components, only the number of kits remaining. 2012 Copyright, CGS Administrators, LLC. Page 4
Second part of this question pertains to written orders and same situation if each ancillary item that is included in the daily administration kit must be listed individually on the detailed written order, or if a statement such as all cassettes/bags and supplies necessary for administration or Enteral gravity/bolus/pump supply kit will be considered detailed? In other words, we are using a description of the HCPCS code vs. itemizing everything that may be included in that HCPCS code. Response: The DWO does not need to list each item in the kit since the items are billed using a kit HCPCS code. Also see article from November 2009 entitled Enteral Nutrition Supply Kits Coverage Reminder. ORTHOTICS/PROSTHETICS 1. There are 4 orthotics product classifications for accreditation: 1 - OR01- Custom fabricated 2 - OR02 Prefabricated Non-Custom 3 - OR03- Off the Shelf 4 - OR04- Penile Pump By reading the product L code description it is easy to understand what would fall within the OR01 (Custom) and OR04 (Penile Pump) categories, but in many other cases OR02 (Prefabricated/Non-Custom) and OR03 (Off the Shelf) are so similar it is difficult to know how to interpret where they would be. This becomes an issue when suppliers who are accredited for the OR03 category think they are providing and billing for an Off the Shelf orthosis but in fact have provided an orthosis from the Prefabricated/Non-Custom category for which they are not accredited and could face repayment procedures down the road during an audit. Please clarify the HCPCS L codes that would be defined in the OR02 and OR03 categories. This is not a DME MAC question. Product classifications for accreditation are established by accrediting agencies, CMS or the National Supplier Clearinghouse. Suggest you contact the applicable organization for the proper interpretation. REHAB 1. If a end-user receives a power wheelchair with a power tilt & seat elevator will the code E2311 be covered or only E2310? Per the LCD it reads: Codes E2310 and E2311 describe the electronic components that allow the patient to control two or more of the following motors from a single interface (e.g., proportional joystick, touchpad, or nonproportional interface): power wheelchair drive, power tilt, power recline, power shear reduction, power leg elevation, power seat elevation, power standing. It is understood that the seat elevator is non-covered, however the manner in which the policy reads, it appears that if a provider were to bill for code E2311 on a power wheelchair with a power tilt & seat elevator it could still be billed and covered (with appropriate medical justification). Please advise. Response: To restate the question: What if a non-covered power wheelchair option such as a power seat elevator or power standing feature necessitates the use of E2311 instead of E2310? Will E2311 be reimbursed? Answer: No. The addition of non-covered options does not justify the additional payment for components that are required by the non-covered option. Since the E2311 will be considered not reasonable and necessary, it may be billed as an upgrade. DME No questions received. EDUCATION No questions received. 2012 Copyright, CGS Administrators, LLC. Page 5