RETIRED - Face-to-Face Examination and Prescription Requirements Prior to the Delivery - JA DME
RETIRED - Face-to-Face Examination and Prescription Requirements Prior to the Delivery of Certain DME Items Specified in the Affordable Care Act - Revised
This article was retired on August 17, 2017. Please review the Standard Documentation Requirements for All Claims Submitted to DME MACs (A55426) for current information.
DME MAC Joint Publication
Revised April 28, 2016
Revised October 01, 2015
Revised May 29, 2014
Posted February 20, 2014
This FAQ is 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 NPI 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.
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
- Osteogenesis Stimulators
- 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
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.
|E0185||Gel or gel-like pressure mattress pad|
|E0188||Synthetic sheepskin pad|
|E0189||Lamb's wool sheepskin pad|
|E0194||Air fluidized bed|
|E0197||Air pressure pad for mattress standard length and width|
|E0198||Water pressure pad for mattress standard length and width|
|E0199||Dry pressure pad for mattress standard length and width|
|E0250||Hospital bed fixed height with any type of side rails, mattress|
|E0251||Hospital bed fixed height with any type side rails without mattress|
|E0255||Hospital bed variable height with any type side rails with mattress|
|E0256||Hospital bed variable height with any type side rails without mattress|
|E0260||Hospital bed semi-electric (Head and foot adjustment) with any type side rails with mattress|
|E0261||Hospital bed semi-electric (head and foot adjustment) with any type side rails without mattress|
|E0265||Hospital bed total electric (head, foot and height adjustments) with any type side rails with mattress|
|E0266||Hospital bed total electric (head, foot and height adjustments) with any type side rails without mattress|
|E0290||Hospital bed fixed height without rails with mattress|
|E0291||Hospital bed fixed height without rail without mattress|
|E0292||Hospital bed variable height without rail without mattress|
|E0293||Hospital bed variable height without rail with mattress|
|E0294||Hospital bed semi-electric (head and foot adjustment) without rail with mattress|
|E0295||Hospital bed semi-electric (head and foot adjustment) without rail without mattress|
|E0296||Hospital bed total electric (head, foot and height adjustments) without rail with mattress|
|E0297||Hospital bed total electric (head, foot and height adjustments) without rail without mattress|
|E0300||Pediatric crib, hospital grade, fully enclosed|
|E0301||Hospital bed Heavy Duty extra wide, with weight capacity 350-600 lbs with any type of rail, without mattress|
|E0302||Hospital bed Heavy Duty extra wide, with weight capacity greater than 600 lbs with any type of rail, without mattress|
|E0303||Hospital bed Heavy Duty extra wide, with weight capacity 350-600 lbs with any type of rail, with mattress|
|E0304||Hospital bed Heavy Duty extra wide, with weight capacity greater than 600 lbs with any type of rail, with mattress|
|E0424||Stationary compressed gas Oxygen System rental; includes contents, regulator, nebulizer, cannula or mask and tubing|
|E0431||Portable gaseous oxygen system rental includes portable container, regulator, flowmeter, humidifier, cannula or mask, and tubing|
|E0433||Portable liquid oxygen system|
|E0434||Portable liquid oxygen system, rental; includes portable container, supply reservoir, humidifier, flowmeter, refill adaptor, content gauge, cannula or mask, and tubing|
|E0439||Stationary liquid oxygen system rental, includes container, contents, regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing|
|E0441||Oxygen contents, gaseous (1 months supply)|
|E0442||Oxygen contents, liquid (1 months supply)|
|E0443||Portable Oxygen contents, gas (1 months supply)|
|E0444||Portable oxygen contents, liquid (1 months supply)|
|E0450*||Volume control ventilator without pressure support used with invasive interface|
|E0460*||Negative pressure ventilator portable or stationary|
|E0461*||Volume control ventilator without pressure support node for a noninvasive interface|
|E0462||Rocking bed with or without side rail|
|E0463*||Pressure support ventilator with volume control mode used for invasive surfaces|
|E0464*||Pressure support vent with volume control mode used for noninvasive surfaces|
|E0470||Respiratory Assist Device, bi-level pressure capability, without backup rate used non-invasive interface|
|E0471||Respiratory Assist Device, bi-level pressure capability, with backup rate for a non-invasive interface|
|E0472||Respiratory Assist Device, bi-level pressure capability, with backup rate for invasive interface|
|E0480||Percussor electric/pneumatic home model|
|E0482||Cough stimulating device, alternating positive and negative airway pressure|
|E0483||High Frequency chest wall oscillation air pulse generator system|
|E0484||Oscillatory positive expiratory device, non-electric|
|E0570||Nebulizer with compressor|
|E0575||Nebulizer, ultrasonic, large volume|
|E0580||Nebulizer, durable, glass or autoclavable plastic, bottle type for use with regulator or flowmeter|
|E0585||Nebulizer with compressor & heater|
|E0601||Continuous airway pressure device|
|E0607||Home blood glucose monitor|
|E0627||Seat lift mechanism incorporated lift-chair|
|E0628||Separate Seat lift mechanism for patient owned furniture electric|
|E0629||Separate seat lift mechanism for patient owned furniture non-electric|
|E0636||Multi positional patient support system, with integrated lift, patient accessible controls|
|E0650||Pneumatic compressor non-segmental home model|
|E0651||Pneumatic compressor segmental home model without calibrated gradient pressure|
|E0652||Pneumatic compressor segmental home model with calibrated gradient pressure|
|E0655||Non- segmental pneumatic appliance for use with pneumatic compressor on half arm|
|E0656||Non- segmental pneumatic appliance for use with pneumatic compressor on trunk|
|E0657||Non- segmental pneumatic appliance for use with pneumatic compressor chest|
|E0660||Non- segmental pneumatic appliance for use with pneumatic compressor on full leg|
|E0665||Non- segmental pneumatic appliance for use with pneumatic compressor on full arm|
|E0666||Non- segmental pneumatic appliance for use with pneumatic compressor on half leg|
|E0667||Segmental pneumatic appliance for use with pneumatic compressor on full-leg|
|E0668||Segmental pneumatic appliance for use with pneumatic compressor on full arm|
|E0669||Segmental pneumatic appliance for use with pneumatic compressor on half leg|
|E0671||Segmental gradient pressure pneumatic appliance full leg|
|E0672||Segmental gradient pressure pneumatic appliance full arm|
|E0673||Segmental gradient pressure pneumatic appliance half leg|
|E0675||Pneumatic compression device, high pressure, rapid inflation/deflation cycle, for arterial insufficiency|
|E0692||Ultraviolet light therapy system panel treatment 4 foot panel|
|E0693||Ultraviolet light therapy system panel treatment 6 foot panel|
|E0694||Ultraviolet multidirectional light therapy system in 6 foot cabinet|
|E0720||Transcutaneous electrical nerve stimulation, two lead, local stimulation|
|E0730||Transcutaneous electrical nerve stimulation, four or more leads, for multiple nerve stimulation|
|E0731||Form fitting conductive garment for delivery of TENS or NMES|
|E0740||Incontinence treatment system, Pelvic floor stimulator, monitor, sensor, and/or trainer|
|E0744||Neuromuscular stimulator for scoliosis|
|E0745||Neuromuscular stimulator electric shock unit|
|E0747||Osteogenesis stimulator, electrical, non-invasive, other than spine application.|
|E0748||Osteogenesis stimulator, electrical, non-invasive, spinal application|
|E0749||Osteogenesis stimulator, electrical, surgically implanted|
|E0760||Osteogenesis stimulator, low intensity ultrasound, non-invasive|
|E0762||Transcutaneous electrical joint stimulation system including all accessories|
|E0764||Functional neuromuscular stimulator, transcutaneous stimulations of muscles of ambulation with computer controls|
|E0765||FDA approved nerve stimulator for treatment of nausea & vomiting|
|E0782||Infusion pumps, implantable, Non-programmable|
|E0783||Infusion pump, implantable, Programmable|
|E0784||External ambulatory infusion pump|
|E0786||Implantable programmable infusion pump, replacement|
|E0840||Tract frame attach to headboard, cervical traction|
|E0849||Traction equipment cervical, free-standing stand/frame, pneumatic, applying traction force to other than mandible|
|E0850||Traction stand, free standing, cervical traction|
|E0855||Cervical traction equipment not requiring additional stand or frame|
|E0856||Cervical traction device, cervical collar with inflatable air bladder|
|E0958**||Manual wheelchair accessory, one-arm drive attachment|
|E0959**||Manual wheelchair accessory-adapter for Amputee|
|E0960**||Manual wheelchair accessory, shoulder harness/strap|
|E0961**||Manual wheelchair accessory wheel lock brake extension handle|
|E0966**||Manual wheelchair accessory, headrest extension|
|E0967**||Manual wheelchair accessory, hand rim with projections|
|E0968*||Commode seat, wheelchair|
|E0969*||Narrowing device wheelchair|
|E0971**||Manual wheelchair accessory anti-tipping device|
|E0973**||Manual wheelchair accessory, adjustable height, detachable armrest|
|E0974**||Manual wheelchair accessory anti-rollback device|
|E0978*||Manual wheelchair accessory positioning belt/safety belt/ pelvic strap|
|E0980*||Manual wheelchair accessory safety vest|
|E0981**||Manual wheelchair accessory Seat upholstery, replacement only|
|E0982**||Manual wheelchair accessory, back upholstery, replacement only|
|E0983**||Manual wheelchair accessory power add on to convert manual wheelchair to motorized wheelchair, joystick control|
|E0984**||Manual wheelchair accessory power add on to convert manual wheelchair to motorized wheelchair, Tiller control|
|E0985||Wheelchair accessory, seat lift mechanism|
|E0986**||Manual wheelchair accessory, push activated power assist|
|E0990**||Manual wheelchair accessory, elevating leg rest|
|E0992**||Manual wheelchair accessory, elevating leg rest solid seat insert|
|E1014||Reclining back, addition to pediatric size wheelchair|
|E1015||Shock absorber for manual wheelchair|
|E1020||Residual limb support system for wheelchair|
|E1028**||Wheelchair accessory, manual swing away, retractable or removable mounting hardware for joystick, other control interface or positioning accessory|
|E1029**||Wheelchair accessory, ventilator tray|
|E1030**||Wheelchair accessory, ventilator tray, gimbaled|
|E1031||Rollabout chair, any and all types with castors 5" or greater|
|E1035**||Multi-positional patient transfer system with integrated seat operated by care giver|
|E1036**||Patient transfer system|
|E1037||Transport chair, pediatric size|
|E1038**||Transport chair, adult size up to 300lb|
|E1039**||Transport chair, adult size heavy duty >300lb|
|E1161||Manual Adult size wheelchair includes tilt in space|
|E1227*||Special height arm for wheelchair|
|E1228*||Special back height for wheelchair|
|E1232||Wheelchair, pediatric size, tilt-in-space, folding, adjustable with seating system|
|E1233**||Wheelchair, pediatric size, tilt-in-space, folding, adjustable without seating system|
|E1234||Wheelchair, pediatric size, tilt-in-space, folding, adjustable without seating system|
|E1235||Wheelchair, pediatric size, rigid, adjustable, with seating system|
|E1236||Wheelchair, pediatric size, folding, adjustable, with seating system|
|E1237||Wheelchair, pediatric size, rigid, adjustable, without seating system|
|E1238||Wheelchair, pediatric size, folding, adjustable, without seating system|
|E1296*||Special sized wheelchair seat height|
|E1297*||Special sized wheelchair seat depth by upholstery|
|E1298*||Special sized wheelchair seat depth and/or width by construction|
|E2502**||Speech Generating Devices prerecord messages between 8 and 20 Minutes|
|E2506**||Speech Generating Devices prerecord messages over 40 minutes|
|E2508**||Speech Generating Devices message through spelling, manual type|
|E2510**||Speech Generating Devices synthesized with multiple message methods|
|E2227**||Rigid pediatric wheelchair adjustable|
|K0002||Standard hemi (low seat) wheelchair|
|K0004||High strength ltwt wheelchair|
|K0005||Ultra Lightweight wheelchair|
|K0006||Heavy duty wheelchair|
|K0007||Extra heavy duty wheelchair|
|K0009||Other manual wheelchair/base|
|K0606**||AED garment with electronic analysis|
|K0730||Controlled dose inhalation drug delivery system|
Last Updated Thu, 10 Jan 2019 13:06:45 +0000