1. General Information

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. The criteria “reasonable and necessary” is based on Social Security Act §1862 (a)(1)(A) provisions.

Before submitting a claim to the DME MAC, you must have on file a dispensing order, the written order, the Certificate of Medical Necessity (CMN) (if applicable), the DME MAC Information Form (DIF) (if applicable), information from the treating practitioner concerning the patient’s diagnosis1, and any information required for the use of specific modifiers or attestation statements as defined in certain Local Coverage Determinations (LCDs) (see Chapter 9 of this manual for information about LCDs). You should also obtain as much documentation from the patient’s medical record as you determine you need to assure that coverage criterion for an item has been met. If the information in the beneficiary’s medical record does not adequately support the medical necessity for the item, you are liable for the dollar amount involved unless a properly executed advance beneficiary notice (ABN) (see Section 8 below) of possible denial has been obtained.

Documentation must be maintained in the supplier’s files for seven (7) years from the 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.

2. Definition of Physician

Physician means any of the following entities legally authorized to practice by a state in which he/she performs this function. The services performed by a physician within these definitions are subject to any limitations posed by the State on the scope of practice.

  • Doctor of medicine
  • Doctor of osteopathy (including osteopathic practitioner) – must be licensed to practice medicine and surgery
  • Doctor of dental surgery or dental medicine
  • Chiropractor (see below)
  • Doctor of podiatry (see below) or surgical chiropody
  • Doctor of optometry

The following practitioners may document the medical necessity of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) items, including completing orders and Certificates of Medical Necessity (CMNs), in place of a physician provided that they meet the practitioner requirements defined in Chapter 15 of the Benefit Policy Manual (Publication 100-02), the services performed are within their scope of practice as defined by their state, and they are treating the beneficiary for the condition for which the item is needed.

  • Physician Assistant
  • Nurse Practitioner
  • Clinical Nurse Specialist

The term physician does not include such practitioners as Christian Science practitioner or naturopath. There is no Medicare benefit for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items ordered by these entities.

Medicare coverage for all items and services furnished or ordered by chiropractors is statutorily excluded, with the exception of treatment by means of manual manipulation of the spine to correct a subluxation. Therefore, all DMEPOS items ordered by chiropractors are denied.

Medicare coverage for all items and services furnished or ordered by podiatrists is limited by state statutes governing the scope of practice for podiatry. You should be familiar with the limitations imposed by the statutes of the state(s) in which you operate and dispense DMEPOS items. Claims submitted to the DME MAC, when furnished or ordered by podiatrists practicing outside the limits of their licensure, will be denied as statutorily non-covered. Podiatrists are excluded by statute from ordering a power operated vehicle (POV) or power wheelchair.

3. Prescription (Order) Requirements

All items billed to Medicare require a prescription. For each item billed, you must have a signed and dated order from the treating practitioner. You must keep the order on file and make 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

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. You must keep a record of the dispensing order on file. It must contain:

  • The description of the item
  • The beneficiary’s name
  • The prescribing practitioner’s name
  • The date of the order
  • The prescribing practitioner’s signature (if a written order) or your signature (if verbal order)

For the “Date of the order” described above, use the date you were 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. You must have a properly completed dispensing order with a correctly determined prescription date before shipping or delivering an item (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, you must obtain a detailed written order before submitting a claim.

DETAILED WRITTEN ORDERS

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:

  • The beneficiary’s name.
  • The prescribing practitioner’s name.
  • The date of the order.
  • All items, options or additional features that are separately billed or require an upgraded code. The description can be either a narrative description (e.g., lightweight wheelchair base), a HCPCS code, a HCPCS code narrative, or a brand name/model number.
  • The prescribing practitioner’s signature
  • Signature date, if applicable (see below)

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

  • The item(s) to be dispensed
  • The dosage or concentration, if applicable
  • The route of administration, if applicable
  • The frequency of use
  • The duration of infusion, if applicable
  • The quantity to be dispensed
  • The number of refills

For the “date of the order” described above, use the dispensing order date i.e., the date you were 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 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 viewed 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. You must have a properly completed dispensing order with a correctly determined prescription date before shipping or delivering an item (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 (CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 5, §5.9).

The detailed description in the written order may be either a narrative description (e.g., lightweight wheelchair base), a HCPCS code, a HCPCS code narrative, or a brand name/model number.

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements. Refer to the “Signature Requirements” section in this chapter.
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)

NEW ORDER REQUIREMENTS

A new prescription is required when:

  • For all claims for purchases or initial rentals;
  • 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;
  • An item is replaced (see explanation below); or
  • There is a change in the supplier, and the new supplier is unable to obtain a copy of a valid order and documentation from the original supplier.

A new order is required when an item is being replaced because the item is worn or the patient’s condition has changed. Your records should also include beneficiary-specific information regarding the need for the replacement item. This information should be maintained in your files and be available to the DME MACs or UPICs upon request. Failure to provide the appropriate documentation or providing documentation that contains broad, nonspecific explanations will result in claim(s) denial.

A new order is required before replacing lost, stolen, or irreparably damaged items to reaffirm the medical necessity of the item. Proof of loss or damage through documentation such as a police report, picture, or corroborating statement should be submitted with the claim.

WRITTEN ORDER PRIOR TO DELIVERY (WOPD)

There are two categories of DMEPOS items that require a WOPD:

  • As a condition of payment pursuant to 42 CFR 410.38(c), Power Mobility Devices (PMDs) require a 7 Element Order (7EO). A separate Detailed Product Description (DPD) is also required for any associated options and accessories. Please review the PMD policy for additional information.
  • As a condition of payment pursuant to 42 CFR 410.(g), certain specified covered items of DME require a written order prior to delivery of the item (5 Element Order of 5EO).

POWER MOBILITY DEVICES WOPD (7 ELEMENT ORDER)

42 CFR 410.38(c) requires a specific WOPD of PMDs for the HCPCS codes specified in the table contained in the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section of the LCD related Policy Article. The required prescription has seven (7) mandatory elements. For the purposes of this document, the 42 CFR 410.38(c) required order is referred to as a 7EO.

The 7EO must be received by the supplier within 45 days after the completion of the face-to-face examination.

The 7EO must meet all of the requirements below:

  • Beneficiary’s name
  • Description of the item that is ordered. This may be general – e.g., “power operated vehicle”, “power wheelchair”, or “power mobility device”– or may be more specific.
  • Date of the face-to-face examination
  • Pertinent diagnoses/conditions that relate to the need for the POV or power wheelchair
  • Length of need
  • Prescribing physician’s signature
  • Date of prescribing physician’s signature

The supplier may provide a template order listing the seven required elements but is prohibited from completing any part of it. The treating physician completing the face-to-face requirements must write the 7EO. The 7EO may only be written after the completion of the face-to-face exam requirements.

The DMEPOS supplier shall have on file the 7EO prior to the delivery of these items. A date stamp or equivalent must be used by the supplier to document receipt date.

AFFORDABLE CARE ACT (ACA 6407) 5-ELEMENT ORDER (5EO)

Affordable Care Act Section 6407 (ACA 6407) requirements are found in the Social Security Act Section 1843(a)(11)(B) and its implementing regulation at 42 CFR 410.38(g). 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.

42 CFR 410.38(g) requires a specific written order prior to delivery for specified HCPCS codes. The required prescription has five (5) mandatory elements. For the purposes of this document, the 42 CFR 410.38(g) required order is referred to as a 5EO. The 5-Element Order (5EO) must meet all of the requirements below.

1.The 5EO must include all of the following elements:

  • The beneficiary’s name
  • The item of DME ordered — this may be general e.g “hospital bed”, pr may be more specific
  • The signature of the prescribing practitioner
  • The prescribing practitioner’s National Practitioner Identifier (NPI)
  • The date of the order

2. The 5EO must be completed within six (6) months after the required ACA 6407 face-to-face examination; and,

3. The date of the written order shall be on or before the date of delivery or date shipped if the shipping date is used as the DOS.

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. You should pay particular attention to orders that include a mix of items, some of which are subject to these 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 Standard Documentation Requirements for All Claims Submitted to DME MACs Policy Article (PA) (A55426) for information associated with a 5EO and statutory requirements.

For the “Date of the order” described above, use the date you were 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 you have 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, you must obtain a detailed written order (see the Detailed Written Order section) before submitting a claim for any associated options, accessories and/or supplies that are separately billed.

The 5EO must be available upon request.

If you deliver an item without first receiving the completed order, the item will be denied.

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