RETIRED - ACA 6407 - Supplier FAQ - JA DME

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.

ACA 6407

1. 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.
2. 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.
3. 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.
4. 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.

Face-to-Face Encounter

5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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 3.3.2.4). 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 3.3.2.4 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

11. 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:
12. Beneficiary's name
13. Item of DME ordered - this may be general – e.g., "hospital bed"– or may be more specific.
14. Signature of the prescribing practitioner
15. Prescribing practitioner's National Practitioner Identifier (NPI)
16. The date of the order

A date stamp or equivalent must be used to document the 5EO receipt date by the supplier.

12. 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).
13. 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.
14. 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.
15. 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 3.3.2.4.
16. 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.
17. 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).
18. 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:
19. Verify that the in-person visit occurred within the 6-months prior to the date of their prescription; and,
20. Have documentation of the face-to-face examination that was conducted.
19. 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

20. 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.
21. 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:
22. Hardcopy date stamps
23. Hand-written dates
24. 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.

22. 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

23. 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:

1. If errors in the 5EO are found prior to delivery, the supplier has two options:
2. The 5EO may be properly amended following the guidance in the Medicare Program Integrity Manual (Internet-Only Manual, Publication 100-08), Chapter 3, Section 3.3.2.5; or,
3. A new 5EO may be created and sent to the physician for signature and date.

2. If errors in the 5EO are found after delivery of the item, the supplier has two options:
3. 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,
4. 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.

24. 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.