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

Description of the item or serviceManufacturer nameProduct name and numberSupplier Price List (PL) amountHCPCS code of related item (if applicable)Miscellaneous HCPCS codes billed without this information will be rejected and will need to be resubmitted with the missing information included.If you have questions, please contact the PDAC HCPCS Helpline at (877) 735-1326 during the hours of 9:30 a.m. to 5:00 p.m. ET, Monday through Friday. You may also visit the PDACwebsiteto chat with a representative or select the Contact Us button at the top of the page for email inquiry, FAX or postal mail information.EQUIPMENT RETAINED FROM A PRIOR PAYERWhen 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.A POD is required for all items, even those in the beneficiarys possession provided by another insurer prior to Medicare eligibility.PROOF OF DELIVERY REQUIREMENTS FOR RECENTLY ELIGIBLE MEDICARE FFSThe supplier record must document:A statement, signed and dated by the beneficiary (or beneficiary's designee), that the supplier has examined the item, meets the POD requirements; andA supplier attestation that the item meets Medicare requirements.For the purposes of reasonable useful lifetime and calculation of continuous use, the first day of the first rental month in which Medicare payments are made for the item (i.e., DOS) serves as the start date of the reasonable useful lifetime and period of continuous use. In these cases, the POD documentation serves as evidence that the beneficiary is already in possession of the item.FACE-TO-FACE ENCOUNTERAs a condition for payment, 42 CFR 410.38 and Final Rule 1713 (84 Fed. Reg Vol 217) require that a treating practitioner have a face-to-face encounter with a beneficiary within the six (6) months prior to prescribing items that appear on the Required List.The face-to-face 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.This face-to-face requirement also includes examinations conducted via the CMS-approved use of telehealth examinations, which must meet the requirements of 42 CFR  410.78 and 414.65 for purposes of DMEPOS coverage.A WOPD must be completed within six (6) months after the required face-to-face encounter.Refer to the applicable LCD-related Policy Article NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section for more information regarding documentation requirements.The 6-month timing requirement does not supplant other coverage or documentation requirements.There must be sufficient medical information included in the medical record to demonstrate that all other applicable coverage criteria are met. Refer to the applicable Local Coverage Determination for information about the medical necessity criteria for the item(s) being ordered.For items other than PMDs that appear on the Required List, thetreating practitioner that conducted the face-to-face encounter does not need to be the prescriber for the DMEPOS item; however, the prescriber must:Verify that a qualifying face-to-face encounter occurred within the 6-months prior to the date of their prescription; and,Have documentation of the qualifying face-to-face encounter that was conducted.A qualifying face-to-face encounter is required each time a new order/prescription for one of the specified items on the Required List is ordered.CMS and the DME MACs will post on their websites the Required List of selected HCPCS codes, which will be published through the Federal Register Notice, and periodically updated.Upon request by a contractor, all DMEPOS suppliers must provide documentation of the face-to-face encounter.REPAIRS/REPLACEMENTGENERALFor the purposes of Medicare reimbursement, repairs are not synonymous with replacements. Repairs (parts and labor) of DMEPOS items are performed on the base item. The replacement of parts or components that make up the base item is considered to be a repair. Conversely, the furnishing of new separately payable accessories that were not part of the initial base item is considered to be replacement, which is addressed in the section below.Replacement of a beneficiary owned DMEPOS item typically involves providing an identical or nearly identical item.REPAIRSThe definition of a repair is found in the Medicare Benefit Policy Manual (CMS Pub. 100-02), Chapter 15, Section 110.2.A. That section generally defines repair as to fix or mend and to put the item back in good condition after damage or wear.Repairs to items which a beneficiary owns are covered when necessary to make the items serviceable. However, routine periodic maintenance, such as testing, cleaning, regulating, and checking is not covered.Medicare does not separately reimburse for repairs of:Items in the frequent and substantial servicing payment category; or,Oxygen equipment; or,Items in the capped rental payment category during the capped rental period; or,Items covered under a manufacturers or suppliers warranty; or,Previously denied items.A new treating practitioners order is not needed for repairs.In the case of repairs to a beneficiary-owned DMEPOS item, if Medicare paid for the base item initially, medical necessity for the base item has been established. With respect to Medicare reimbursement for the repair, there are two documentation requirements:The treating practitioner must document that the DMEPOS item being repaired continues to be reasonable and necessary (see Continued Medical Need section above); and,Either the treating practitioner or the supplier must document that the repair itself is reasonable and necessary.The supplier must maintain detailed records describing the need for and nature of all repairs including a detailed explanation of the justification for any component or part replaced as well as the labor time to restore the item to its functionality.REPLACEMENTThe definition of replacement is found in the Medicare Benefit Policy Manual (CMS Pub. 100-02), Chapter 15, Section 110.2.C. That section generally defines replacement as the provision of an entirely identical or nearly identical item when it is lost, stolen or irreparably damaged.Beneficiary owned items or a capped rental item may be replaced in cases of loss or irreparable damage. Irreparable damage may be due to a specific accident or to a natural disaster (e.g., fire, flood). Contractors may request documentation confirming details of the incident (e.g., police report, insurance claim report).Replacement of items due to irreparable wear takes into consideration the Reasonable Useful Lifetime (RUL) of the item. The RUL of DME is determined through program instructions. In the absence of program instructions, carriers may determine the RUL, but in no case can it be less than 5 years. If the item has been in continuous use by the beneficiary on either rental or purchase basis for its RUL, the beneficiary may elect to obtain a replacement.Medicare does not cover replacement for items in the frequent and substantial servicing payment category, oxygen equipment, or inexpensive or routinely purchased rental items.A treating practitioners order, when required, is needed to reaffirm the medical necessity for replacement of an item.There are special rules for the replacement of artificial arms, legs and eyes.Adjustments and repairs of prostheses and prosthetic components are covered under the original order for the prosthetic device.Medicare payment may be made for the replacement of prosthetic devices, which are artificial limbs, or for the replacement of any part of such devices, without regard to continuous use or useful lifetime restrictions if a treating practitioner determines that the replacement device, or replacement part of such a device, is necessary.Claims involving the replacement of a prosthesis or major component (foot, ankle, knee, socket etc.) must be supported by a new treating practitioner's order and documentation supporting the reason for the replacement. The reason for replacement must be documented by the treating practitioner, either on the order or in the medical record, and must fall under one of the following:A change in the physiological condition of the patient resulting in the need for a replacement. Examples include but are not limited to, changes in beneficiary weight, changes in the residual limb, beneficiary functional need changes; or,An irreparable change in the condition of the device, or in a part of the device resulting in the need for a replacement; or,The condition of the device, or the part of the device, requires repairs and the cost of such repairs would be more than 60 percent of the cost of a replacement device, or, as the case may be, of the part being replaced.The prosthetist must retain documentation of the prosthesis or prosthetic component replaced, the reason for replacement, and a description of the labor involved irrespective of the time since the prosthesis was provided to the beneficiary. This information must be available upon request. It is recognized that there are situations where the reason for replacement includes but is not limited to changes in the residual limb; functional need changes; or irreparable damage or wear/tear due to excessive beneficiary weight or prosthetic demands of very active amputees.SIGNATURE REQUIREMENTSAll signatures 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.