Face-to-Face Examination and Prescription Requirements Prior to the Delivery of Certain DME Items Specified in the Affordable Care Act - Revised - DME MAC Joint Publication

This article has been revised to update the criteria associated with the five-element written order prior to delivery (5EO) and face-to-face examination. While this document 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.

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).

These ACA 6407 requirements are effective for claims for all of the specified items that require a new order on or after July 1, 2013. DME MAC enforcement of these rules related to the face-to-face examination requirement and face-to-face documentation is delayed until further notice from CMS. This face-to-face examination enforcement delay does not apply to the Comprehensive Error Rate Testing (CERT) program contractor. In addition, this delay in enforcement does not apply to the prescription requirements for a Written Order Prior to Delivery/5EO or to the requirement to include the prescriber's NPI on the prescription.

ACA 6407 also contained a provision requiring that an MD or DO co-sign the face-to-face examination performed by a PA, NP or CNS. This requirement was eliminated by the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.

Prescription (order) Requirements

A face-to-face examination is required each time a new prescription (i.e., written order) for one of the specified items in Table A 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 above, 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. This means that all Medicare payment requirements must be met, the same as any other item initially covered by Medicare.

ACA 6407 requires a specific written order prior to delivery for the HCPCS codes specified in Table A below. This ACA 6407-required prescription has five (5) mandatory elements. 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 listed item(s); and,
• A date stamp or equivalent must be use 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.

For items that are provided based on a 5EO, the supplier must obtain a detailed written order before submitting a claim for any associated options, accessories and/or supplies that are separately billed and not listed on the table below.

The 5EO must be available upon request.

For any of the specified items affected by the ACA 6407 requirements to be covered by Medicare, a written, signed and dated order (5EO) must be received by the supplier prior to delivery of the item. If the supplier delivers the item prior to receipt of a written order, it will be denied as statutorily noncovered. If the written order 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.

Note that the 5EO for these specified DME items require the National Provider Identifier (NPI) of the prescribing practitioner. 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.

Face-To-Face Examination Requirements

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 treat 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.

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 the 5EO and may be no older than 6 months prior to the 5EO 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 documentation of 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 qualifying 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 completed 5EO.

Claim Denial

Claims for the specified items subject to these face-to-face requirements and prescription requirements that do not meet the requirements specified above will be denied as statutorily noncovered - failed to meet statutory requirements.

Local Coverage Determinations (LCD)

LCDs that contain items subject to these requirements are:

• Automatic External Defibrillators
• Cervical Traction Devices
• External Infusion Pumps
• High-frequency Chest Wall Oscillation Devices
• Home Glucose Monitors
• Hospital Beds
• Manual Wheelchairs
• Mechanical In-exsufflation Devices
• Nebulizers
• Osteogenesis Stimulators
• Oxygen
• Patient Lifts
• Pneumatic Compression Devices
• Positive Airway Pressure Devices
• Pressure Reducing Support Surfaces
• Respiratory Assist Devices
• Seat Lift Mechanisms
• Speech Generating Devices
• Transcutaneous Electrical Joint Stimulation Devices
• Transcutaneous Electrical Nerve Stimulators (TENS)
• Wheelchair options and Accessories
• Wheelchair Seating

These LCDs will be updated to include the requirements at a future date.

Numerous items are not included in a specific LCD. Some have coverage criteria described by National Coverage Determinations. Others have coverage determined on a case-by-case or individual-claim basis. This article and the associated CMS publications will constitute notice of these requirements for all of the applicable codes.

Refer to the applicable LCD, NCD and/or the Supplier Manual for additional information about 5EO requirements.

TABLE A: DME List of Specified Covered Items

For the full DME List of Specified Covered Items visit:
http://www.medicarenhic.com/viewdoc.aspx?id=2580 

Refer to the Pricing, Data Analysis and Coding Contractor web site for information on coding at: http://www.dmepdac.com