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Standard Documentation Language for Local Coverage Determinations and Related Policy Articles - Revised

Joint DME MAC Publication

Note: This is a revision to the previous article published in November 2015. This version updates the requirements for orders and face-to-face examinations, in compliance with the ACA Section 6407. While the Standard Documentation language makes reference to “ACA 6407 requirements”, technically these requirements are found in the Social Security Act Section 1843(a)(11)(B) and its implementing regulation at CFR 410.38. The CMS regulation contains the details for the face-to-face examination, written order prior to delivery and the list of items subject to these requirements.

The information in this document supersedes the material currently contained in the LCDs and related PAs. Where there are differences between the policies and this article, this document shall take precedence. This information will be added to future revisions of all LCDs and related PAs.

Many errors reported in DME MAC MR reviews and CERT audits arise from problems associated with submitted documentation; consequently, the DME MACs have created a standardized language for use in LCDs and related PAs. Standardized language first appeared in 2012 and with subsequent changes in CMS and DME MAC program instructions, is being revised with this publication. The updated language will be inserted in the applicable LCDs and related PAs upcoming revisions to these policies.

The standard sections are written in a modular format to allow each policy to contain information relevant to that policy while omitting material that does not apply. As a result, all modules may not be used in every LCD. This article provides a complete listing of all of the documentation requirement modules. For example, the sections would not be included in the DOCUMENTATION REQUIREMENTS section of an LCD for an item that does not require a CMN.

***IMPORTANT***

Many policies contain coverage and documentation requirements that are unique to that specific policy. Such unique information is not included in this article. It is important that suppliers review the actual LCD to be sure to have all of the relevant information necessary applicable to the item(s) provided.

In several places you will see “placeholders” like “XXX” or “###”. Information specific to the policy will be inserted in these spots. Occasionally you may also see “Editor Note” comments. These notes are used to indicate where optional sections may be inserted, when applicable and formatting information.

Standard Language

LCD

COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this local coverage determination, the criteria for “reasonable and necessary”, based on Social Security Act §1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage and/or medical necessity.

Medicare does not automatically assume payment for a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) item that was covered prior to a beneficiary becoming eligible for the Medicare Fee for Service (FFS) program. When a beneficiary receiving a DMEPOS item from another payer (including Medicare Advantage plans) becomes eligible for the Medicare FFS program, Medicare will pay for continued use of the DMEPOS item only if all Medicare coverage, coding and documentation requirements are met. Additional documentation to support that the item is reasonable and necessary, may be required upon request of the DME MAC.

While this Standard Documentation language makes reference to “ACA 6407 requirements”, technically these requirements are found in the Social Security Act Section 1843(a)(11)(B) and its implementing regulation at 42 CFR 410.38. The CMS regulation contains the details for the face-to-face examination, written order prior to delivery and the list of items subject to these requirements.

DWO VERBIAGE

For an item to be covered by Medicare, a detailed written order (DWO) must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed DWO, the item will be denied as not reasonable and necessary.

ACA 5EO or WOPD

For some items in this policy to be covered by Medicare, a written order is required to be in the supplier’s file prior to delivery of the specified item(s). There are two differing order requirements that may apply depending upon the specific item prescribed:

  • The Affordable Care Act Section 6407 (ACA 6407) specifies the five elements that must be contained in this written order. For purposes of this policy, this order is termed the 5-element order (5EO).
  • A written order prior to delivery (WOPD) that meets all of the requirements of a standard detailed written order (DWO).

If the supplier delivers an item addressed in this policy without first receiving the completed order, the item will be denied. Refer to the DOCUMENTATION REQUIREMENTS section of this LCD and/or to the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section of the related Policy Article for information about these prescription requirements and the type of denial that will result from non-compliance.

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized. (CMS Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-8, Chapter 5, Section 5.2.8-9).

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the prescribing practitioner that any changed or atypical utilization is warranted. Regardless of utilization, a supplier must not dispense more than a XX-month quantity at a time.

DOCUMENTATION REQUIREMENTS

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider.”  It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

PRESCRIPTION (ORDER) REQUIREMENTS

GENERAL (PIM 5.2.1)

All items billed to Medicare require a prescription. An order for each item billed must be signed and dated by the prescribing practitioner, kept on file by the supplier, and made available upon request. Items dispensed and/or billed that do not meet these prescription requirements and those below must be submitted with an EY modifier added to each affected HCPCS code.

DISPENSING ORDERS (PIM 5.2.2)

Equipment and supplies that are NOT on the ACA 6407 list or that require a written order prior to delivery (WOPD) may be delivered upon receipt of a dispensing order (prescription). A dispensing order may be verbal or written. The supplier must keep a record of the dispensing order on file. It must contain:

  • Description of the item
  • Beneficiary's name
  • Prescribing practitioner's name
  • Date of the order                                                                                                  
  • Prescribing practitioner's signature (if a written order) or supplier signature (if verbal order)

For the “Date of the order” described above, use the date the supplier is contacted by the prescribing practitioner (for verbal orders) or the date entered by the prescribing practitioner (for written dispensing orders).

In some cases, the prescribing practitioner may specify a future start date for therapy that is different from the date of the order. This start date does not impact the date of the order, date of service (DOS) entered on the claim, Medicare-required forms (e.g., CMN, DIF) or refill/delivery timelines. As long as the supplier has a properly completed dispensing order with a correctly determined prescription date, an item may be shipped or delivered on or after the  date of the dispensing order (except for items that require written orders prior to delivery).

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

The dispensing order must be available upon request.

For items that are provided based on a dispensing order, the supplier must obtain a detailed written order before submitting a claim.

ACA 6407 PRESCRIPTION REQUIREMENTS

ACA 6407 requires a specific written order prior to delivery for the HCPCS codes specified in the table contained in the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section below. This ACA 6407-required prescription has five (5) mandatory elements. For the purposes of this policy, the ACA 6407- required order is referred to as a 5-element order (5EO). The 5EO must meet all of the requirements below:

  • The 5EO must include all of the following elements:
    • Beneficiary’s name
    • Item of DME ordered – this may be general – e.g., “hospital bed”– or may be more specific.
    • Signature of the prescribing practitioner
    • Prescribing practitioner’s National Practitioner Identifier (NPI)
    • The date of the order
  • The 5EO must be completed within six (6) months after the required ACA 6407 face-to-face examination; and,
  • The 5EO must be received by the supplier before delivery of the listed item(s); and,
  • A date stamp or equivalent must be used to document the 5EO receipt date by the supplier.

Note that 5EO for these specified DME items require the National Provider Identifier to be included on the prescription. Prescriptions for other DME items do not have this NPI requirement. Suppliers should pay particular attention to orders that include a mix of items, some of which are subject to these new order requirements. For example, oxygen concentrators (E1390) are often ordered in conjunction with portable oxygen (E0431). Orders for code E0431 require inclusion of the NPI while orders for E1390 do not.

Refer to the related Policy Article NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES section for information about the statutory requirements associated with a 5EO.

For the “Date of the order” described above, use the date the supplier is contacted by the prescribing practitioner (for verbal orders) or the date entered by the prescribing practitioner (for written dispensing orders).

In some cases, the prescribing practitioner may specify a future start date for therapy that is different from the date of the order. This start date does not impact the date of the order, date of service (DOS) entered on the claim, Medicare-required forms (e.g., CMN, DIF) or refill/delivery timelines. As long as the supplier has a properly completed 5EO with a correctly determined prescription date, an item may be shipped or delivered on or after the date of the order.

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

For items that are provided based on a 5EO, the supplier must obtain a detailed written order (see DETAIILED WRITTEN ORDER section below) before submitting a claim for any associated options, accessories and/or supplies that are separately billed.

The 5EO must be available upon request.

DETAILED WRITTEN ORDERS (PIM 5.2.3)

A detailed written order (DWO) is required before billing. Someone other than the prescribing practitioner may produce the DWO. However, the prescribing practitioner must review the content and sign and date the document. It must contain:

  • Beneficiary's name
  • Prescribing practitioner's name
  • Date of the order
  • Detailed description of the item(s)  (see below for specific requirements for selected items)
  • Prescribing practitioner's signature and signature date

For items provided on a periodic basis, including drugs, the written order must include:

  • Item(s) to be dispensed
  • Dosage or concentration, if applicable
  • Route of Administration
  • Frequency of use
  • Duration of infusion, if applicable
  • Quantity to be dispensed
  • Number of refills

For the “Date of the order” described above, use the dispensing order date i.e., the date the supplier was contacted by the prescribing practitioner (for verbal orders) or the date entered by the prescribing practitioner (for written dispensing orders).

Additional order date instructions:

  • If the prescriber creates a complete and compliant DWO, only a single date - the “order date” - is required. This order date may be the date that the prescriber signs the document (either wet signature or electronic signature).
  • If someone other than the prescriber (e.g., DME supplier) creates the DWO then the prescription must be reviewed and, “…personally signed and dated…” by the prescriber. In this scenario, two (2) dates are required:  an “order date” and a prescriber-entered “signature date”.

In some cases, the prescribing practitioner may specify a future start date for therapy that is different from the date of the order. This start date does not impact the date of the order, date of service (DOS) entered on the claim, Medicare-required forms (e.g., CMN, DIF) or refill/delivery timelines. As long as the supplier has a properly completed dispensing order with a correctly determined prescription date, an item may be shipped or delivered on or after the  date of the dispensing order (except for items that require written orders prior to delivery).

Frequency of use information on orders must contain detailed instructions for use and specific amounts to be dispensed. Reimbursement shall be based on the specific utilization amount only. Orders that only state “PRN” or “as needed” utilization estimates for replacement frequency, use, or consumption are not acceptable. (PIM 5.9)

The detailed description in the written order may be either a narrative description or a brand name/model number.

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

The DWO must be available upon request.

A prescription is not considered as part of the medical record. 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. (PIM 5.7) 

WRITTEN ORDERS PRIOR TO DELIVERY (PIM 5.2.4)

A written order prior to delivery (WOPD) is required for XXX. The supplier must have received a WOPD that has been both signed and dated by the prescribing practitioner and meets the requirements above for a DWO before dispensing the item.

For items that require a WOPD, the supplier must obtain a detailed written order before submitting a claim for any associated options, accessories and/or supplies that are separately billed.

NEW ORDER REQUIREMENTS (PIM 5.2.7)

A new prescription is required when:

  • There is a change in the order for the accessory, supply, drug, etc.;
  • On a regular basis (even if there is no change in the order) only if it so specified in the documentation section of a particular medical policy;
  • When an item is replaced; and
  • When there is a change in the supplier.

MEDICAL RECORD INFORMATION

GENERAL (PIM 5.7 -5.9)

The COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY section of this LCD contains numerous reasonable and necessary (R&N) requirements. The NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section of the related Policy Article contains numerous non-reasonable and necessary, benefit category and statutory requirements that must be met in order for payment to be justified. Suppliers are reminded that:

  • Supplier-produced records, even if signed by the prescribing practitioner, and attestation letters (e.g. letters of medical necessity) are deemed not to be part of a medical record for Medicare payment purposes. 
  • Templates and forms, including CMS Certificates of Medical Necessity, are subject to corroboration with information in the medical record.

Information contained directly in the contemporaneous medical record is the source required to justify payment except as noted elsewhere for prescriptions and CMNs. The medical record is not limited to treating practitioner’s 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 the purpose of determining that an item is reasonable and necessary.

CONTINUED MEDICAL NEED

For all Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (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 initial time period. Entries in the beneficiary’s 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 rental 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 beneficiary’s medical record to support that the item continues to be used by the beneficiary and remains 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 by the treating practitioner for refills
  • A recent change in prescription
  • A properly completed CMN or DIF with an appropriate length of need specified
  • Timely documentation in the beneficiary’s 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.

CONTINUED USE

Continued use describes the ongoing utilization of supplies or a rental 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 beneficiary’s 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 to be sufficient to document continued use for the base item, as well.
  • Supplier records documenting beneficiary confirmation of continued use of a rental item.

Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in this policy.

REFILL DOCUMENTATION (PIM 5.2.7-8)

A routine prescription for refills is not needed. Refer to the NEW ORDER REQUIREMENTS section for additional information.

For items that the beneficiary obtains in-person at a retail store, the signed delivery slip or a copy of the itemized sales receipt is sufficient documentation of a request for refill.

For items that are delivered to the beneficiary, documentation of a request for refill must be either a written document received from the beneficiary or a contemporaneous written record of a phone conversation/contact between the supplier and beneficiary. The refill request must occur and be documented before shipment. A retrospective attestation statement by the supplier or beneficiary is not sufficient. The refill record must include:

  • Beneficiary’s name or authorized representative if different than the beneficiary
  • A description of each item that is being requested
  • Date of refill request
  • For consumable supplies i.e., those that are used up (e.g., ostomy or urological supplies, surgical dressings, etc.) the supplier must assess the quantity of each item that the beneficiary still has remaining to document that the amount remaining will be nearly exhausted  on or about the supply anniversary date.
  • For non-consumable supplies i.e., those more durable items that are not used up but may need periodic replacement (e.g., PAP and RAD supplies) the supplier must assess whether the supplies remain functional, providing replacement (a refill) only when the supply item(s) is no longer able to function. The supplier must document the functional condition of the item(s) being refilled in sufficient detail to demonstrate the cause of the dysfunction that necessitates replacement (refill).

This information must be kept on file and be available upon request.

PROOF OF DELIVERY (PIM 4.26, 5.8)

Proof of delivery (POD) is a Supplier Standard. Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers are required to maintain POD documentation in their files. Regardless of the method of delivery, the contractor must be able to determine that the item(s) delivered are the same item(s) submitted for Medicare reimbursement and that the item(s) are received by a specific Medicare beneficiary.

Suppliers, their employees, or anyone else having a financial interest in the delivery of the item are prohibited from signing and accepting an item on behalf of a beneficiary (i.e., acting as a designee on behalf of the beneficiary). The signature and date the beneficiary or designee accepted delivery must be legible.

For the purpose of the delivery methods noted below, designee is defined as any person who can sign and accept the delivery of DMEPOS on behalf of the beneficiary.

Proof of delivery documentation must be available to the Medicare contractor on request. All services that do not have appropriate proof of delivery from the supplier will be denied and overpayments will be requested. Suppliers who consistently fail to provide documentation to support their services may be referred to the Office of Inspector General (OIG) for imposition of Civil Monetary Penalties or other administrative sanctions.

Suppliers are required to maintain POD documentation in their files. There are three methods of delivery:

  • Delivery directly to the beneficiary or authorized representative
  • Delivery via shipping or delivery service
  • Delivery of items to a nursing facility on behalf of the beneficiary

Method 1—Direct Delivery to the Beneficiary by the Supplier

Suppliers may deliver directly to the beneficiary or the designee. In this case, POD to a beneficiary must be a signed and dated delivery document. The POD document must include:

  • Beneficiary’s name
  • Delivery address
  • Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)
  • Quantity delivered
  • Date delivered
  • Beneficiary (or designee) signature

The date delivered on the POD must be the date that the DMEPOS item was received by the beneficiary or designee. The date of delivery may be entered by the beneficiary, designee, or the supplier. When the supplier’s delivery documents have both a supplier-entered date and a beneficiary or beneficiary’s designee signature date on the POD document, the beneficiary or beneficiary’s designee-entered date is the date of service. 

In instances where the supplies are delivered directly by the supplier, the date the beneficiary received the DMEPOS supply must be the date of service on the claim.

Method 2—Delivery via Shipping or Delivery Service Directly to a Beneficiary

If the supplier utilizes a shipping service or mail order, the POD documentation must be a complete record tracking the item(s) from the DMEPOS supplier to the beneficiary. An example of acceptable proof of delivery would include both the supplier’s own detailed shipping invoice and the delivery service’s tracking information. The supplier’s record must be linked to the delivery service record by some clear method like the delivery service’s package identification number or supplier’s invoice number for the package sent to the beneficiary. The POD record must include:

  • Beneficiary’s name
  • Delivery address
  • Delivery service’s package identification number, supplier invoice number or alternative method that links the supplier’s delivery documents with the delivery service’s records
  • Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)
  • Quantity delivered
  • Date delivered
  • Evidence of delivery

If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as the date of service on the claim.

Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary or designee as a POD. This type of POD document must contain the information specified above.

Method 3—Delivery to Nursing Facility on Behalf of a Beneficiary

For items directly delivered by the supplier to a nursing facility or when a delivery service or mail order is used to deliver the item(s) to a nursing facility, the supplier must have:

  1. Documentation demonstrating delivery of the item(s) to the facility by the supplier or delivery entity; and,
  2. Documentation from the nursing facility demonstrating receipt and/or usage of the item(s) by the beneficiary. The quantities delivered and used by the beneficiary must justify the quantity billed.

This information must be available upon request.

CORRECT CODING (PIM 3.3)

Correct coding is a determination that the item(s) provided to the beneficiary are billed using the appropriate HCPCS code for the item. Suppliers are required to correctly code for the items billed. An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, or MAC articles. Information that is sufficiently detailed to unambiguously identify the specific product delivered to the beneficiary and the HCPCS code used to bill for that item must be maintained by the supplier and be available upon request.

For LCDs that use ICD-10 diagnosis codes, correct coding of the ICD-10 code is required. A diagnosis is correctly coded when it meets all the coding guidelines listed in International Classification of Diseases Guidelines (ICD), CMS ICD policy or guideline requirements, LCDs, or MAC articles. Information that is sufficiently detailed to unambiguously justify the ICD-10 code used to bill for DMEPOS items must be contained in the beneficiary’s medical record and be available upon request.

EQUIPMENT RETAINED FROM A PRIOR PAYER

When a beneficiary receiving a DMEPOS item from another payer (including a Medicare Advantage plan) becomes eligible for the Medicare FFS program, the first Medicare claim for that item or service is considered a new initial Medicare claim for the item. Even if there is no change in the beneficiary’s medical condition, the beneficiary must meet all coverage, coding, and documentation requirements for the DMEPOS item in effect on the date of service of the initial Medicare claim.

A POD is required for all items, even those in the beneficiary’s possession provided by another insurer prior to Medicare eligibility. To meet the POD requirements for a beneficiary transitioning to Medicare, the suppler:

  • Must obtain a new POD as described above under “Methods of Delivery” (whichever method is applicable); or,
  • Must obtain a statement, signed and dated by the beneficiary (or beneficiary's designee), attesting that the supplier has examined the DMEPOS item, it is in good working order, and that it 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., date of service)  serves as the start date of the reasonable useful lifetime and period of continuous use. In these cases, the proof of delivery documentation serves as evidence that the beneficiary is already in possession of the item.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

AFFORDABLE CARE ACT (ACA) 6407 REQUIREMENTS

ACA 6407 contains provisions that are applicable to certain specified items in this policy. In this policy the specified items are:

{Insert code table}

These items require an in-person, face-to-face interaction between the beneficiary and their treating practitioner prior to prescribing the item. This face-to-face evaluation must specifically document that the beneficiary was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered. A dispensing order is not sufficient to provide these items. A 5EO (see ACA 5EO section above) must be received prior to delivery. Refer to the related Policy Article NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section for information about these statutory requirements.

The DMEPOS supplier must have documentation of the completed 5EO in their file prior to the delivery of these items.

Suppliers are reminded that all Medicare coverage and documentation requirements for DMEPOS also apply. There must be sufficient information included in the medical record to demonstrate that all of the applicable coverage criteria are met. This information must be available upon request.

GENERAL

CERTIFICATE OF MEDICAL NECESSITY (PIM 5.3) (Editor Note:  Only for items requiring CMN)
A Certificate of Medical Necessity (CMN), which has been completed, signed, and dated by the treating practitioner, must be kept on file by the supplier and made available upon request. The CMN may act as a substitute for the detailed written order if it contains the same information as required in a detailed written order. The CMN for XXX is CMS Form ### (DME form ###). In addition to the order information that the treating practitioner enters in Section B, the supplier can use the space in Section C for a written confirmation of other details of the order or the treating practitioner can enter the other details directly.

A new CMN is not required just because the supplier changes assignment status on the submitted claim.

DME INFORMATION FORM (PIM 5.3)

A DME Information Form (DIF), which has been completed, signed, and dated by the supplier, must be kept on file and made available upon request. The DIF for XXX is CMS Form ### (DME form ###).

REPAIR/REPLACEMENT (BPM Ch. 15, §110.2)

A new Certificate of Medical Necessity (CMN) and/or treating practitioner’s order is not needed for repairs.

In the case of repairs to a beneficiary-owned DMEPOS item, if Medicare paid for the base equipment initially, medical necessity for the base equipment has been established. With respect to Medicare reimbursement for the repair, there are two documentation requirements:

  1. The treating practitioner must document that the DMEPOS item being repaired continues to be reasonable and necessary (see Continued Medical Need section above).; and,
  2. 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.

A treating practitioner’s order and/or new Certificate of Medical Necessity (CMN), when required, is needed to reaffirm the medical necessity of the item for replacement of an item.

REPAIR/REPLACEMENT (BPM Ch. 15, §120)

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 an 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) 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:

  1. 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,
  2. An irreparable change in the condition of the device, or in a part of the device resulting in the need for a replacement; or,
  3. 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.

MISCELLANEOUS

Refer to the Supplier Manual for additional information on documentation requirements. 

APPENDICIES

PIM citations above denote references to CMS Program Integrity Manual, Internet Only Manual 100-8

Utilization Guidelines
Refer to Coverage Indications, Limitations and/or Medical Necessity

POLICY ARTICLE

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”).

BENEFIT CATEGORY

DME is covered under the Durable Medical Equipment benefit (Social Security Act §1861(s)(6)). In order for a beneficiary’s equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.

Or

Prosthetic  devices are covered under the Prosthetic Devices benefit (Social Security Act §1861(s)(8)). In order for a beneficiary’s equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.

STATUTORY PRESCRIPTION (ORDER) REQUIREMENTS

Many DMEPOS items have statutory prescription requirements. Items with statutory order requirements are:

  • All items on the ACA section 6407 product list,
  • Power mobility devices, and
  • Pressure reducing support surfaces.

 If the supplier fails to obtain a prescription or the order fails to comply with the applicable criteria described in the DOCUMENTATION REQUIREMENTS section of the LCD, the item will be denied as statutorily excluded.

AFFORDABLE CARE ACT (ACA) 6407 REQUIREMENTS

ACA 6407 contains provisions that are applicable to specified items in this policy. In this policy the specified items are:

{Select codes from table below}

Face-to-Face Visit Requirements:

As a condition for payment, Section 6407 of the Affordable Care Act (ACA) requires that a practitioner (Medical Doctor (MD), Doctor of Osteopathic Medicine (DO) or Doctor of Podiatric Medicine (DPM), physician assistant (PA), nurse practitioner (NP) or clinical nurse specialist (CNS)) has had a face-to-face examination with a beneficiary within the six (6) months prior to the written order for certain items of DME (Refer to Table A for a list of items).

The treating practitioner must have a face-to-face examination with the beneficiary in the six (6) months prior to the date of the written order for the specified items of DME.

This face-to-face requirement includes examinations conducted via the Centers for Medicare & Medicaid Services (CMS)-approved use of telehealth examinations (as described in Chapter 15 of the Medicare Benefit Policy Manual and Chapter 12 of the Medicare Claims Processing Manual - CMS Internet-Only Manuals, Publ. 100-02 and 100-04, respectively).

For the treating practitioner prescribing a specified DME item:

  • The face-to-face examination with the beneficiary must be conducted within the six (6) months prior to the date of the prescription.
  • The face-to-face examination must document that the beneficiary was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered.
  • Remember that all Medicare coverage and documentation requirements for DMEPOS also apply. There must be sufficient medical information included in the medical record to demonstrate that the 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.

The treating practitioner that conducted the face-to-face examination does not need to be the prescriber for the DME item; however, the prescriber must:

  • Verify that the qualifying in-person visit occurred within the 6-months prior to the date of their prescription; and,
  • Have documentation of the qualifying face-to-face examination that was conducted.

The prescriber must provide a copy of the 5EO for the item(s) to the DMEPOS supplier before the item can be delivered.

A new face-to-face examination is required each time a new prescription for one of the specified items is ordered. A new prescription is required by Medicare:

  • For all claims for purchases or initial rentals. 
  • When there is a change in the original prescription for the accessory, supply, drug, etc.
  • On a regular basis (even if there is no change in the original order) 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

The first bullet, “For all claims for purchases or initial rentals”, includes all claims for payment of purchases and initial rentals for items not originally covered (reimbursed) by Medicare Part B. Claims for items obtained outside of Medicare Part B, e.g. from another payer prior to Medicare participation (including Medicare Advantage plans), are considered to be new initial claims for Medicare payment purposes.

ACA 6407 Prescription Requirements:

ACA 6407 requires a written order prior to delivery for the HCPCS codes specified in the table above. This ACA 6407-required prescription has five (5) mandatory elements. For the purposes of this policy, the ACA 6407- required order is referred to as a 5-element order (5EO). The 5EO must meet all of the requirements below:

  • The 5EO must include all of the following elements:
    • Beneficiary’s name
    • Item of DME ordered - this may be general – e.g., “hospital bed”– or may be more specific.
    • Signature of the prescribing practitioner
    • Prescribing practitioner’s National Practitioner Identifier (NPI)
    • The date of the order
  • The 5EO must be completed within six (6) months after the required ACA 6047 face-to-face examination; and,
  • The 5EO must be received by the supplier before delivery of the specified item(s); and,
  • A date stamp or equivalent must be used to document the 5EO receipt date by the supplier.

Refer to the related Local Coverage Determination DOCUMENTATION REQUIREMENTS section for information associated with a 5EO.

Suppliers should pay particular attention to orders that include a mix of items to which ACA 6407 does and does not apply to assure that these ACA order requirements are met.

The treating practitioner that conducted the face-to-face examination does not need to be the prescriber for the DME item(s); however, the prescriber must:

  • Verify that the in-person visit occurred within the 6-months prior to the date of their prescription; and,
  • Have documentation of the face-to-face examination that was conducted.

Date and Timing Requirements

There are specific date and timing requirements:

  • The date of the face-to-face examination must be on or before the date of 5EO and may be no older than 6 months prior to the prescription date.
  • The date of the face-to-face examination must be on or before the date of delivery for the item(s) prescribed.
  • The date of the 5EO must be on or before the date of delivery.
  • The DMEPOS supplier must have the completed 5EO in their file prior to the delivery of these items.

All other date and timing requirements specified in the CMS Program Integrity Manual regarding specific items or services remain unchanged.

Upon request by the contractor, all DMEPOS suppliers must provide documentation from the treating practitioner face-to-face examination and the completed 5EO.

A date stamp (or equivalent) is required which clearly indicates the supplier’s date of receipt of the 5EO.

Claim Denial

Claims for the specified items subject to ACA 6407 that do not meet the requirements specified above will be denied as statutorily noncovered – failed to meet statutory requirements.

If the supplier delivers the item prior to receipt of the 5EO, it will be denied as statutorily noncovered. If the 5EO is not obtained prior to delivery, payment will not be made for that item even if a written order is subsequently obtained. If a similar item is subsequently provided by an unrelated supplier who has obtained a written order prior to delivery, it will be eligible for coverage.

CODING GUIDELINES

(Editor Note: Only use first paragraph when items require PDAC review)

The only products that may be billed using codes XXX are those for which a written Coding Verification Review has been made by the Pricing, Data Analysis, and Coding (PDAC) Contractor and subsequently published on the appropriate Product Classification List.

Suppliers should contact the Pricing, Data Analysis, and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Revised 4/28/2016
Revised 11/5/2015
Revised 10/30/2014
Retracted 10/2/2014
Revised 9/25/2014
Posted 3/2/2012

Standard Documentation Language for Local Coverage Determinations and Related Policy Articles – Revised
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