RETIRED - ACA 6407 - Supplier FAQ - JA DME
RETIRED - Affordable Care Act 6407 - Supplier Frequently Asked Questions - Revised
DME MAC Joint Publication
Originally published July 15, 2015
This FAQ is revised to update the criteria associated with the written order prior to delivery 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 1834(a)(11)(B) and it's 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.
Question: What is ACA 6407?
Answer: "ACA" refers to the Affordable Care Act of 2012 and "6407" is the specific section of the Affordable Care Act which requires a face-to-face (F2F) encounter with a physician and a valid written order prior to delivery. Suppliers should review the DME MAC Joint Publication titled "Face-to-Face Examination and Prescription Requirements Prior to the Delivery of Certain DME Items Specified in the Affordable Care Act - Revised" for a complete list of affected HCPCS codes.
Question: When will CMS enforce the Face-to-Face requirements and five element order (5EO)?
Answer: Section 6407 of the ACA was implemented on July 1, 2013, and the DME MAC contractors began enforcement of the 5EO and NPI requirements for dates of services on or after January 1, 2014. Enforcement of the F2F requirements by the DME MACs has been postponed by CMS until a future date.
Question: What is the difference between "implementation" and "enforcement" regarding ACA 6407?
Answer: Implementation is the date that the provisions of ACA 6407 became effective (July 1, 2013). Enforcement is when DME MACs begin auditing claims to determine that suppliers are following the provisions of ACA 6407.
Question: Is the Comprehensive Error Rate Testing (CERT) contractor following the DME MAC delay in enforcement of the F2F requirements?
Answer: No. CERT has been instructed by CMS not to delay the enforcement of the F2F requirements. The CERT contractor operates under the rules of the Improper Payments Elimination and Recovery Act (IPERA) and must enforce all coverage and payment rules mandated by CMS regulations. Consequently, claims reviewed by the CERT contractor that are not compliant with the F2F requirements may result in denial or recoupment. If the CERT contractor denies for this reason, suppliers may submit a request for a redetermination.
Question: Do suppliers need to obtain a new F2F encounter every six months?
Answer: No, there is no requirement under ACA 6407 that a supplier obtain documentation of a new F2F encounter on a periodic basis. A F2F encounter within six months prior to the 5EO date is required for any order obtained on or after July 1, 2013.
Question: What if the policy has a requirement for a F2F encounter within 30-days for an item that is also on the ACA list? Must the F2F encounter be performed within the 30-days or within six months?
Answer: There is no 30-day F2F requirement. There are existing LCD requirements that require a physician encounter that must be performed for certification. The ACA F2F requirement does not replace any existing patient/physician encounters. Suppliers must meet both the ACA requirements and any certification requirements outlined in the applicable Local Coverage Determination (LCD). By meeting the LCD requirement, the ACA requirement is automatically met.
Question: Does the ACA F2F requirement apply to orthotics and prosthetics?
Answer: Not at this time. ACA 6407 (SSA Section 1834(a)(11)(B)) and the implementing regulation at 42 CFR 410.38 gives the Secretary the authority to specify to which HCPCS codes the face-to-face requirement and written order prior to delivery apply. CMS did not include orthotics or prosthetic codes on the list of applicable HCPCS codes. Suppliers should review the DME MAC Joint Publication titled "Face-to-Face Examination and Prescription Requirements Prior to the Delivery of Certain DME Items Specified in the Affordable Care Act - Revised" for a complete list of affected HCPCS codes.
Question: Must the F2F encounter specifically mention the DME item being ordered?
Answer: No. However, in order for the ACA requirements to be met, the F2F encounter must address a medical condition that supports the item ordered.
Question: Does the F2F encounter with the treating 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)) need to specifically state the beneficiary was there for a F2F encounter for the specific DME item, or can the beneficiary have a visit and the physician's notes show physical limitations that justify the specific DME item?
Answer: In contrast to power mobility devices, items subject to the ACA 6407 requirements do not require that the F2F encounter specify that the visit was expressly for the purpose of documenting the need for the specific item of DME. However, as noted above, there must be sufficient documentation in the medical records to support the need for the item ordered.
Question: Can the F2F documentation be electronically signed by the treating practitioner?
Answer: CMS has published instructions to contractors allowing electronic signatures (see CMS Program Integrity Manual, Chapter 3, Section 188.8.131.52). CMS has not provided detailed guidance defining the format or contents of an electronic signature. CMS does allow contractors to authenticate electronic signatures. We recommend that when suppliers obtain electronic records that the electronic signatures are clearly identifiable as electronic and meet the same date and credential standards as outlined in Chapter 3, Section 184.108.40.206 that are also required for a non-electronic signature for the same document type. Refer to each LCD and the Supplier Manual for additional information regarding signatures.
Five-Element Written Orders Prior to Delivery (5EO)/Face-to-Face
Question: What elements must be included on the 5EO for items associated with ACA 6407 HCPCS code list?
Answer: ACA 6407 requires five specific elements that must be included on the order:
- 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
A date stamp or equivalent must be used to document the 5EO receipt date by the supplier.
Question: What date should be used for the "date of the order" on the 5EO?
Answer: Use the date the supplier is contacted by the treating practitioner (for verbal orders) or the date entered by the treating practitioner (for written dispensing orders).
Question: What if the treating practitioner wants to specify additional elements on the 5EO?
Answer: Nothing prohibits the treating practitioner (or the supplier) from including additional elements on the 5EO. The five elements listed above are the minimum elements required.
Question: Some treating practitioners indicate a future date on which to start therapy. How is this handled?
Answer: In some cases, the treating 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.
Question: May the treating practitioner use a signature or date stamp on the 5EO?
Answer: Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 220.127.116.11.
Question: The ACA 6407 does not apply to all DMEPOS and does not apply to various supplies and accessories. How should suppliers handle those items?
Answer: For non-ACA items and items that do not require a written order prior to delivery, a standard dispensing order and detailed written order are sufficient. For ACA 6407 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. Suppliers should review the DME MAC Joint Publication titled "Face-to-Face Examination and Prescription Requirements Prior to the Delivery of Certain DME Items Specified in the Affordable Care Act - Revised" for a complete list of affected HCPCS codes.
Question: Can the 5EO and the F2F encounter be on the same document as long as it is in the medical record?
Answer: No. The F2F encounter and 5EO must be two separate documents. The face-to-face encounter must be documented in the pertinent portion of the medical record (for example, history, physical examination, diagnostic tests, summary of findings, diagnoses, treatment plans or other information as it may be appropriate).
Question: If the beneficiary is in the hospital, can the attending physician conduct the F2F encounter and the beneficiary's primary care physician complete the 5EO?
Answer: Yes. 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.
Question: Can the F2F encounter, 5EO and the delivery of the DME item all be completed in the same day?
Answer: Yes. However, the date stamp (or equivalent) indicating the date of receipt must clearly reflect that the 5EO was received prior to delivery of the item.
Documenting a Receipt Date
Question: Must the 5EO be date stamped by the supplier upon receipt?
Answer: A date stamp (or equivalent) is required which clearly indicates the supplier's date of receipt of the completed 5EO.
Question: What methods are acceptable for documenting a receipt date?
Answer: The DME MACs do not specify what method may be used to indicate date of receipt; however, there must be some indicator or notation on the documents that they were received by the supplier within the required time period. Some commonly accepted methods are:
- Hardcopy date stamps
- Hand-written dates
- Facsimile headers and electronic receipt dates (see question 22 for additional information)
Regardless of the method used, it must be clear to contractor staff reviewing the claim that the date received meets the requirements in the applicable LCD.
Question: Can a fax header be used to document receipt of the 5EO prior to delivery, or must we use a date stamp?
Answer: We highly recommend the use of a date stamp to document receipt of the 5EO. If a fax date or equivalent is used, the information must be legible, it must be clear that the supplier is the one that received the 5EO on the date listed. Possible ways to document this would be to also submit a copy of the fax cover sheet or the header listing the "to" and "from" sender names.
5EO - Corrections to Document
Question: What happens if there is an error on the 5EO document and it is not noticed until after the equipment is delivered to the beneficiary?
Answer: Written order prior to delivery (WOPD) is a long-standing statutory requirement for certain items of DME. The list of items subject to WOPD (termed a 5EO for ACA 6407 items) was expanded by the Affordable Care Act Section 6407. Medicare policy stipulates that a 5EO that is missing an element is not "curable" by a provider (i.e., a provider cannot make corrections to a 5EO) except as outlined below:
- If errors in the 5EO are found prior to delivery, the supplier has two options:
- The 5EO may be properly amended following the guidance in the Medicare Program Integrity Manual (Internet-Only Manual, Publication 100-08), Chapter 3, Section 18.104.22.168; or,
- A new 5EO may be created and sent to the physician for signature and date.
- If errors in the 5EO are found after delivery of the item, the supplier has two options:
- If the error is discovered prior to claim submission, the original supplier may recover the delivered item(s), obtain a compliant, complete 5EO and then may redeliver the item(s) to the beneficiary; or,
- If the error is discovered after submitting a claim, the original supplier can recover their items and a new supplier must complete the transaction after complying with all requirements.
Because 5EO is a statutory requirement, claims denied because of a defective 5EO result in a beneficiary liability determination. Suppliers are strongly encouraged to review their 5EO documentation carefully prior to delivery to ensure that all the requirement elements are present on the document.
Question: Does Medicare consider a different location (with a different NPI or PTAN) another supplier?
Answer: Yes. A different location of the same company is considered a "new" supplier as that location operates and bills the Medicare program under a separate NPI/PTAN.
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 Tue, 04 Dec 2018 13:14:57 +0000