RETIRED - Face-to-Face Examination and Prescription Requirements Prior to the Delivery of Certain DME Items Specified in the ACA - Revised - JA DME

DME MAC Joint Publication

This revision adds information clarifying who may perform the in-person visit and the responsibilities of the ordering physician.

As a condition for payment, Section 6407 of the Affordable Care Act (ACA) requires that a physician (MD, DO or 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). 

A 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 prescription for the accessory, supply, drug, etc.
• If a local coverage determination (LCD) requires periodic prescription renewal (i.e., policy requires a new prescription on a scheduled or periodic basis)
• When an item is replaced
• When there is a change in the supplier
• When required by state law

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.

These Affordable Care Act requirements are effective for claims for all of the specified items that require a new order (prescription) on or after July 1, 2013. Enforcement of these rules related to the face-to-face examination requirement and face-to-face documentation is delayed until a date to be announced by CMS in Calendar Year 2014. This delay in enforcement does not apply to the prescription requirements for a Written Order Prior to Delivery or to the requirement to include the prescriber's NPI on the prescription.

ACA 6407 also contains provisions requiring that a physician verify that a face-to-face examination performed by a PA, NP or CNS was done within the 6 months prior to the creation of a prescription for the specified item(s). This article does not address these provisions in detail. Additional information addressing physician verification will be forthcoming.

Face-To-Face Examination Requirements

The physician 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).

The DMEPOS supplier must have documentation of both the face-to-face visit and completed written order prior to delivery (WOPD) in their file prior to the delivery of these items.   

For the physician 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 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.
• The prescriber must provide a copy of the face-to-face examination and the prescription for the item(s) to the DMEPOS supplier before the item can be delivered.

Prescription (order) Requirements

These specified items require a written order that must be obtained prior to delivery (WOPD). A WOPD is a standard Medicare detailed written order, which must be completed and in the DMEPOS supplier's possession BEFORE the item is delivered. The prescription (order) for the DME must include all of the items below:

• Beneficiary's name,
• Physician's Name
• Date of the order and the start date, if start date is different from the date of the order
• Detailed description of the item
• The prescribing practitioner's National Provider Identifier (NPI),
• The signature of the ordering practitioner
• Signature date

For any of the specified 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, if applicable
• Frequency of use
• Duration of infusion, if applicable
• Quantity to be dispensed
• Number of refills, if applicable

For any of the specified items affected by this face-to-face requirement to be covered by Medicare, a written, signed and dated order 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 prescriptions 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.

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 written order (prescription) 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 written order must be on or before the date of delivery.
• The DMEPOS supplier must have documentation of both the face-to-face visit and the completed WOPD in their file prior to the delivery of these items.

A date stamp (or similar) is required which clearly indicates the supplier's date of receipt of both the face-to-face record and the completed WOPD with the prescribing physician's signature and signature date. It is recommended that both documents be separately date-stamped to avoid any confusion regarding the receipt date of these documents.

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 In-exsufflation Devices
• Manual Wheelchairs
• 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 Nerve Stimulators (TENS)
• Wheelchair options and Accessories

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 WOPD requirements.

TABLE A:  DME List of Specified Covered Items

The DME list of Specified Covered Items is as follows.  The original list was at 77 FR 44798.  This original list contains some codes (codes marked with an "*") that have been deleted or that were made not valid for Medicare while other codes (codes marked with an "**") have had narrative changes.  Updates to the list will be made as CMS releases revisions. 

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

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