Article - Standard Documentation Requirements for All Claims Submitted to DME MACs (A55426)

CMS National Coverage PolicyN/AArticle TextMany errors reported in Medicare audits are due to claims submitted with incomplete or missing requisite documentation. Consequently, the Durable Medical Equipment Medicare Administrative Contracts (DME MACs) have created guidance to assist Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) suppliers in understanding the information necessary to justify payment.The documentation requirements are compiled from Statutes, Code of Federal Regulations, Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations (NCDs), CMS rulings and sub-regulatory guidance (CMS manuals), and DME MAC publications. This article sets out the general requirements that are applicable to all DMEPOS claims submitted to the DME MACs.Documentation must be maintained in the supplier's files for seven (7) years from date of service (DOS).***IMPORTANT***All Policy Specific Documentation Requirements are located in the LCD-related Policy Article, which is linked to the applicable LCD.It is important that suppliers review the actual LCD, the related Policy Article, and the Standard Documentation Requirements (SDR) article to be sure to have all of the relevant information necessary and applicable to the item(s) provided.Note: The information in this document supersedes the material currently contained in all LCDs and related policy articles. Where there are differences between the policies and this article, this document shall take precedence.ORDERSGENERALAll claims for items billed to Medicare require a written order/prescription from the treating practitioner as a condition for payment.This written order/prescription is referred to as the Standard Written Order (SWO) (see below).All claims refers to all claims submitted for payment of purchases or rentals to Medicare Part B.The term treating practitioner is used throughout this document and except where specifically noted, refers to physician, as defined in section 1861(r) of the Social Security Act, or physician assistant (PA), nurse practitioner (NP), or clinical nurse specialist (CNS), as those terms are defined in section 1861(aa)(5) of the Social Security Act.The name and National Provider Identifier (NPI) of the treating practitioner on the order/prescription for the item or service shall be used on the claim submitted to the DME MAC. The order/prescription shall be kept on file and made available upon request.Items dispensed and/or billed that do not meet these order/prescription requirements and those below must be submitted with an EY modifier added to each affected HCPCS code.Certain items require an order based on statute (e.g., therapeutic shoes for diabetics, oral anticancer drugs, and oral antiemetic drugs which are a replacement for intravenous antiemetic drugs). In such instances, if statutory requirements related to the order are not met, the claim will be denied as not meeting the benefit category.For DMEPOS items other than PMDs, someone other than the treating practitioner may complete certain required elements of the SWO; however, the SWO must be signed by the treating practitioner.Prescribing of DMEPOS is limited by Medicare regulations and by the treating practitioners respective scope of practice as determined by the state wherein they practice. Chiropractors are not permitted to prescribe DMEPOS items.NEW ORDER REQUIREMENTSA new order/prescription is required:For all claims for purchases or initial rentals;If there is a change in the DMEPOS order/prescription (e.g., quantity);On a regular basis (even if there is no change in the order/prescription) only if it is so specified in the documentation section of a particular medical policy;When an item is replaced;When there is a change in the supplier, and the new supplier is unable to obtain a copy of a valid order/prescription for the DMEPOS item from the transferring supplier.STANDARD WRITTEN ORDER (SWO)A SWO must be communicated to the supplier prior to claim submission. For certain items of DMEPOS, a written order is required prior to delivery (WOPD) of the item(s) to the beneficiary (see below).A SWO must contain all of the following elements:Beneficiary's name or Medicare Beneficiary Identifier (MBI)Order DateGeneral description of the itemThe 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 numberFor equipment - In addition to the description of the base item, the SWO may include all concurrently ordered options, accessories or additional features that are separately billed or require an upgraded code (List each separately).For supplies  In addition to the description of the base item, the DMEPOS order/prescription may include all concurrently ordered supplies that are separately billed (List each separately)Quantity to be dispensed, if applicableTreating Practitioner Name or NPITreating practitioner's signatureSignatures must comply with the CMS signature requirements outlined in the Medicare Program Integrity Manual (CMS Pub.100-08), Chapter 3, Section 3.3.2.4. Signature and date stamps are not allowed.Upon request by a contractor, DMEPOS suppliers must provide documentation of the completed SWO.In those limited instances in which the treating practitioner is also the supplier and is permitted to furnish specific items of DMEPOS and fulfill the role of the supplier in accordance with any applicable laws and policies, a SWO is not required. However, the medical record must still contain all of the required SWO elements.WRITTEN ORDERS PRIOR TO DELIVERY (WOPD)A WOPD is a completed SWO that is communicated to the DMEPOS supplier before delivery of the item(s).Pursuant to Final Rule 1713 (84 Fed. Reg Vol 217), CMS may select DMEPOS items appearing on the Master List of DMEPOS Items potentially subject to a Face-to-Face Encounter and WOPD requirement and include them on a Required List.The Required List will be comprised of:Statutorily required DMEPOS items such as Power Mobility Devices (PMDs); andAdditional DMEPOS items selected by CMS appearing on the Required List.Items appearing on the Required List are subject to the face-to-face encounter and WOPD requirements.CMS and the DME MACs will post on their websites the Required List of the selected HCPCS codes, once published through the Federal Register Notice, and the Required List will be periodically updated. The current required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Note that the face-to-face encounter and WOPD requirements are statutorily required for PMDs, and in accordance with this statutory obligation, both will continue to be required, and will be included in any future publications of the Required List.The date of the WOPD shall be on or before the date of delivery.A WOPD must be completed within six (6) months after the required face-to-face encounter.For PMDs, following the face-to-face encounter, the treating practitioner must complete the WOPD of the item pursuant to 1834(a)(1)(E)(iv). The term treating practitioner for PMDs is defined as both physicians (defined in section 1861(r)(1) of the Social Security Act) and non-physician practitioners (i.e., PA, NP, and CNS); defined in section 1861(aa)(5) of the Social Security Act.Upon request by a contractor, DMEPOS suppliers must provide documentation of the completed WOPD.DOCUMENTATION REQUIREMENTSGENERALThere are numerous CMS manual requirements, reasonable and necessary (R&N) requirements, benefit category, and other statutory and regulatory requirements that must be met in order for payment to be justified. In the event of a claim review, a DMEPOS supplier must provide sufficient information to demonstrate that the applicable criteria have been met thus justifying payment.Before submitting a claim to Medicare, the DMEPOS supplier must have on file anSWO,a WOPD (if applicable), information from the treating practitioner concerning the patient's diagnosis, and any information required for the use of specific modifiers or attestation statements as defined in certain DME MAC policies. The supplier should also obtain as much documentation from the patient's medical record in order to assure themselves that coverage criteria for an item have been met. If the information in the patient's medical record does not adequately support the medical necessity for the item, the supplier is liable for the dollar amount involved unless a properly executed Advance Beneficiary Notice of Noncoverage (ABN) of possible denial has been obtained.CMS requires that in the event of an audit, the MACs, CERT, SMRC, Recovery Auditors, and UPICs shall determine that an item/service is correctly coded. The supplier must have on file a description of items provided to the beneficiary in sufficient detail to determine the accuracy of claims coding including a description of the items(s) delivered. The description can be either a narrative description (e.g., lightweight wheelchair base), a HCPCS code, the long description of a HCPCS code, or a brand name/model number.Reimbursement shall be based on the specific utilization amount that is supported by contemporaneous medical records.Documentation must be maintained in the supplier's files for seven (7) years from DOS.If the Medicare qualifying supplier documentation is older than 7 years, proof of continuedmedical necessity of the item or necessity of the repaircan be used as the supporting Medicare qualifying documentation.REASONABLE AND NECESSARY CRITERIA (R&N)CMS National Coverage Determinations (NCDs) and contractor Local Coverage Determinations (LCDs) describe the requirements that must be met for an item to be considered R&N. These R&N criteria are often referred to as medical necessity.MEDICAL RECORD DOCUMENTATIONIn the event of a claim review, information contained directly in the contemporaneous medical record is the source required to justify payment except as noted elsewhere for prescriptions. The medical record is not limited to treating practitioners office records but may include records from hospitals, nursing facilities, home health agencies, other healthcare professionals, etc. (not all-inclusive). Records from suppliers or healthcare professionals with a financial interest in the claim outcome are not considered sufficient by themselves for determining that an item is reasonable and necessary. DMEPOS suppliers are reminded that:Supplier prepared statements and physician attestations by themselves do not provide sufficient documentation of medical necessity, even if signed by the ordering physician.Templates and forms are subject to corroboration with information in the medical record.A prescription is not considered to be part of the medical record, except in the case of documenting medical necessity for replacement prosthetic limbs. Medical information intended to demonstrate compliance with coverage criteria may be included on the prescription but must be corroborated by information contained in the medical record.The beneficiarys medical record must contain sufficient documentation of the beneficiarys medical condition to substantiate the necessity for the type and quantity of items ordered and for the frequency of use or replacement (if applicable). The information should include the beneficiarys diagnosis and other pertinent information including, but not limited to, duration of the beneficiarys condition, clinical course (worsening or improvement), prognosis, nature and extent of functional limitations, other therapeutic interventions and results, past experience with related items, etc.In addition to the general requirements discussed above, certain DMEPOS items may have specific documentation requirements. Details regarding these policy specific requirements are contained in the applicable LCD-related Policy Article.CONTINUED MEDICAL NEEDFor all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered; therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription. For purchased items, initial months of a rental item or for initial months of ongoing supplies or drugs, information justifying reimbursement will come from this timeframe. Entries in the beneficiarys medical record must have been created prior to, or at the time of, the initial DOS to establish whether the initial reimbursement was justified based upon the applicable coverage policy.For ongoing supplies and rented DME items, in addition to information described above that justifies the initial provision of the item(s) and/or supplies, there must be information in the beneficiarys 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/prescription by the treating practitioner for refills of supplies;A recent order/prescription by the treating practitioner for repairs;A recent change in an order/prescription;Timely documentation in the beneficiarys medical record showing usage of the item.Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in the policy.For some items, the initial justification for medical need establishes that the condition necessitating the item is permanent. As a result, once the benefit category is met (or continues to be met), ongoing documentation of medical need is not required. Refer to the LCD-related Policy Articles for clarification regarding exceptions to ongoing justification for continued medical need.CONTINUED USEContinued use describes the ongoing utilization of supplies or a rented item by a beneficiary.Suppliers are responsible for monitoring utilization of DMEPOS rental items and supplies. No monitoring of purchased items or capped rental items that have converted to a purchase is required. Suppliers must discontinue billing Medicare when rental items or ongoing supply items are no longer being used by the beneficiary.Beneficiary medical records or supplier records may be used to confirm that a DMEPOS item continues to be used by the beneficiary. Any of the following may serve as documentation that an item submitted for reimbursement continues to be used by the beneficiary:Timely documentation in the beneficiarys medical record showing usage of the item, related option/accessories and supplies;Supplier records documenting the request for refill/replacement of supplies in compliance with the REFILL DOCUMENTATION REQUIREMENTS section. This is deemed sufficient to document continued use for the base item, as well;Supplier records documenting beneficiary confirmation of continued use of a rental item.