Standard Documentation Requirements for All Claims Submitted to DME MACs

Revision Effective Date: 01/01/2024
EQUIPMENT RETAINED FROM A PRIOR PAYER:
Added: “Unless otherwise specified in an LCD or NCD, the original documentation (including but not limited to an original order and practitioner records) completed prior to the beneficiary entering FFS Medicare may be used to support that all Medicare requirements are met (such as the SWO, WOPD, and face-to-face encounter requirements). As a reminder, for items on the Required Face-to-Face Encounter and Written Order Prior to Delivery List, documentation used to satisfy the face-to-face encounter requirements must have been conducted within six months prior to the date on the WOPD.” as clarification


07/02/2026: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
PROOF OF DELIVERY (POD):
Revised: “National Supplier Clearinghouse” to “National Provider Enrollment Contractors”
FACE-TO-FACE ENCOUNTER:
Revised: “The exception to this requirement is for items replaced with an identical item (same HCPCS code) following the expiration of the five-year RUL.” to “The exception to this requirement is for items replaced with an identical item (same HCPCS code) following the expiration of the RUL of the item.” as clarification


05/28/2026: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
FACE-TO-FACE ENCOUNTER:
Added: “
The exception to this requirement is for items replaced with an identical item (same HCPCS code) following the expiration of the five-year RUL
.” as clarification
04/30/2026: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
ARTICLE TEXT:
Revised: “Note: The information in this document supersedes the material currently contained in all LCDs and related policy articles. Where there are differences between the policies and this article, this document shall take precedence.” to “Note: The information in the LCDs and/or related policy articles supersede this document. Where there are differences between the policies and this article, the LCDs and/or related policy articles shall take precedence.” as clarification
PROOF OF DELIVERY (POD):
Added: “unless otherwise specified in an LCD and/or LCD-related policy article.” as clarification to statement regarding date of service and date of delivery


05/29/2025: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
MEDICAL RECORD DOCUMENTATION:
Added: Reference to the Social Security Act section 1834(h)(5) regarding documentation created by orthotists and prosthetists shall be considered part of the individual’s medical record to support documentation created by the treating practitioner as clarification


04/17/2025: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
REPLACEMENT
Added: "oxygen equipment" to the statement regarding items Medicare will replace in cases of loss or irreparable damage
Removed: “oxygen equipment” from the statement regarding
replacement items Medicare does not cover


11/07/2024: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
MEDICAL RECORD DOCUMENTATION:
Removed: "A prescription is not considered to be part of the medical record, except in the case of documenting medical necessity for replacement prosthetic limbs."


09/26/2024: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
DOCUMENTATION REQUIREMENTS:
Removed: "a CMN (if applicable), a DIF (if applicable)"
MEDICAL RECORD DOCUMENTATION:
Removed: "and CMNs (for DOS prior to 01/01/2023)
"
Removed: "
including CMS CMNs prior to DOS 01/01/2023
"
CONTINUED MEDICAL NEED:
Removed: "A properly completed CMN or DIF obtained prior to DOS 01/01/2023, with an appropriate length of need specified"
CERTIFICATE OF MEDICAL NECESSITY (CMN) & DME INFORMATION FORM (DIF):
Removed: Section header and entire section
REPAIRS/REPLACEMENTS:
Removed: "CMN and/or
"
Removed: "and/or new CMN (prior to DOS 01/01/2023)"


02/08/2023: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
MEDICAL RECORD DOCUMENTATION:
Revised: Supplier produced records by replacing “Supplier-produced records, even if signed by the treating practitioner, and attestation letters (e.g. letters of medical necessity) are deemed not to be part of a medical record for Medicare payment purposes.” with “Supplier prepared statements and physician attestations by themselves do not provide sufficient documentation of medical necessity, even if signed by the ordering physician.” as clarification
REFILL DOCUMENTATION REQUIREMENTS:
Removed: “either a written document received from the beneficiary or a contemporaneous written record of a phone conversation/contact between the supplier and beneficiary”
Added: “individualized to the beneficiary (i.e., the beneficiary or their caregiver/designee affirms the need for refill) and documented in the record. Medicare does not prescribe the mode of communication used to gather the information. For example, the refill request communication may be performed via automated text messaging or email as long as each required aspect of the refill request is captured.” as clarification
Added: “Documentation of affirmative response indicating a need for refill” based on CMS Final Rule CMS-1780-F
Removed: “For consumable supplies i.e., those that are used up (e.g., ostomy or urological supplies, surgical dressings, etc.) the supplier must assess the quantity of each item that the beneficiary still has remaining to document that the amount remaining will be nearly exhausted on or about the supply anniversary date.” based on CMS Final Rule CMS-1780-F
Removed: “For non-consumable supplies i.e., those more durable items that are not used up but may need periodic replacement (e.g., PAP and RAD supplies) the supplier must assess whether the supplies remain functional, providing replacement (a refill) only when the supply item(s) is no longer able to function. The supplier must document the functional condition of the item(s) being refilled in sufficient detail to demonstrate the cause of the dysfunction that necessitates replacement (refill).” based on CMS Final Rule CMS-1780-F


12/14/2023: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2023
ORDERS:
Revised: Reference to “1861(r)(1)” which refers to physicians by removing “(1)” to reflect the full statutory definition of treating practitioner
WRITTEN ORDERS PRIOR TO DELIVERY (WOPD)
:
Added: Statutory definition of treating practitioner for PMDs
FACE-TO-FACE ENCOUNTER:
Removed: “For example, the National Coverage Determination § 240.2 “Home use of Oxygen” requires a face-to-face examination within a month of starting home oxygen therapy.” (effective 09/27/2021)


06/15/2023: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2023
MEDICAL RECORD DOCUMENTATION:
Added: “(for DOS prior to 01/01/2023)" after “CMN”
Added: “prior to DOS 01/01/2023” in the second reminder bullet after “CMN”
CONTINUED MEDICAL NEED:
Added: "of supplies" to the end of the first bullet after "refills"
Added: Bullet justifying continued medical need to include an order/prescription for repairs
Added: “obtained prior to DOS 01/01/2023,” in the fourth bullet of items that justify continued need after “CMN or DIF”
CERTIFICATE OF MEDICAL NECESSITY (CMN) & DME INFORMATION FORM (DIF):
Added: Billing information relevant to CMNs and DIFs, for DOS affected by the CMN and DIF elimination
REPLACEMENT:
Added: “(prior to DOS 01/01/2023)” after "CMN"


11/24/2022: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 04/06/2020
WRITTEN ORDERS PRIOR TO DELIVERY (WOPD):
Added:

“The current required Face-to-Face Encounter and Written Order Prior to Delivery List is available here.” with a hyperlink to the list


04/14/2022: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 04/06/2020
MEDICAL RECORD DOCUMENTATION:
Added: Statement regarding content of beneficiary’s medical record
02/03/2022: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination. This revision is non-substantive.

Revision Effective Date: 04/06/2020
DOCUMENTATION REQUIREMENTS:
Added: Statement regarding exceptions to ongoing justification for continued medical need


12/30/2021: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination. This revision is non-substantive.

Revision Effective Date: 04/06/2020
STANDARD WRITTEN ORDER (SWO):
Revised: Reference to the Medicare Program Integrity Manual from 'Internet only manual' to 'CMS Pub.'
DOCUMENTATION REQUIREMENTS:
Revised: “DME MAC supplier” to “DMEPOS supplier” in second paragraph
CORRECT CODING:
Revised: Reference to the Medicare Program Integrity Manual from 'Internet only manual' to 'CMS Pub.'
Added: “45 CFR” in front of 162.1002 reference in first paragraph
Revised: ‘Durable Medical Equipment Coding System’ reference to ‘DMECS’ to match the PDAC website
REPAIRS/REPLACEMENT:
Revised: References to the Medicare Benefit Policy Manual from 'Internet only manual' to 'CMS Pub.'
SIGNATURE REQUIREMENTS:
Revised: Reference to the Medicare Program Integrity Manual from 'Internet only manual' to 'CMS Pub.'


03/11/2021: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 04/06/2020
REFILL DOCUMENTATION:
Added: "REQUIREMENTS" to title

PROOF OF DELIVERY (POD):
 Added: Prohibition for billing prior to discharge date


04/02/2020: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2020

 PRESCRIPTION (ORDER) REQUIREMENTS:
 Revised: Title to ORDERS
 Revised: Language based on Final Rule 1713-F
 NEW ORDER REQUIREMENTS:
 Revised: Language based on Final Rule 1713-F
 DISPENSING ORDERS:
 Deleted: Entire section based on Final Rule 1713-F
 DETAILED WRITTEN ORDER:
 Revised: Title to STANDARD WRITTEN ORDER (SWO) based on Final Rule 1713-F
 Revised: Language based on Final Rule 1713-F
 WRITTEN ORDERS PRIOR TO DELIVERY (WOPD):
 Revised: Language based on Final Rule 1713-F
 POWER MOBILITY DEVICES WOPD (7 ELEMENT ORDER):
Deleted: Entire section based on Final Rule 1713-F
POWER MOBILITY DEVICES DETAILED PRODUCT DESCRIPTION:
 Deleted: Entire section based on Final Rule 1713-F
 WOPD FOR SPECIFIED DMEPOS ITEMS (5 ELEMENT ORDER):
 Deleted: Entire section based on Final Rule 1713-F
DOCUMENTATION REQUIREMENTS:
 Revised: Language based on Final Rule 1713-F
 FACE-TO-FACE EXAMINATION FOR SPECIFIED DMEPOS ITEMS:
 Revised: Title to FACE-TO-FACE ENCOUNTER
R
evised: Language based on Final Rule 1713-F
FACE-TO-FACE REQUIREMENTS:
Deleted: Title of section
 CERTIFICATE OF MEDICAL NECESSITY (CMN) & DME INFORMATION FORM (DIF):
 Revised: Language based on Final Rule 1713-F


01/02/2020: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2019
DOCUMENTATION REQUIREMENTS:
Added: Narrative section to clarify longstanding claims processing instructions
Added: Date Span section to clarify longstanding claims processing instructions


08/08/2019: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2019
ARTICLE TEXT:
Removed: Last updated date
POWER MOBILITY DEVICES WOPD (7 ELEMENT ORDER):
Revised: 42 CFR 410.38(c) paragraph to remove the reference to HCPCS table
PROOF OF DELIVERY (POD):
 Added: Postage paid delivery invoice option for POD documentation


04/04/2019: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2019
 DETAILED WRITTEN ORDERS (DWO):
 Added: Exception to DWO when the prescribing practitioner is also the supplier
 PROOF OF DELIVERY (POD):
 Removed: Postage paid delivery invoice option from POD documentation
CORRECT CODING:
 Removed: Link to PDAC Contact Form


01/31/2019: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article and not a local coverage determination.

Revision Effective Date: 08/28/2018
PRESCRIPTION (ORDER) REQUIREMENTS
Removed: Future start date language
Revised: Elements of the DWO
Removed: Prescribing physician's name from the DWO
Removed: Additional order date instructions
Added: Specific references to WOPD requirements
Added: Practitioner to all physician references
DOCUMENTATION REQUIREMENTS
Clarified: Supplier documentation as it relates to specific products provided to beneficiary


08/23/2018: At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 05/07/2018
PRESCRIPTION (ORDER) REQUIREMENTS
Correction: Corrected "nurse physician" to "nurse practitioner"
WOPD FOR SPECIFIED DMEPOS ITEMS (5 ELEMENT ORDER)
Correction: Corrected typo "SPECIFICIED" to "SPECIFIED"
Clarified: Date of written order before date of delivery to include or shipped date
PROOF OF DELIVERY (POD)
Added: General Medicare DOS rule
Added: Two options for DOS utilizing a shipping service
REPLACEMENT
Correction: Changed "cases" to "case"
05/03/2018: At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 12/21/2017
PROOF OF DELIVERY:
 Revised: Description of item being delivered


12/21/2017: At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 11/20/2017
DETAILED WRITTEN ORDERS:
Revised: Description of all items ordered
 GENERAL:
 Added: Seven (7) year documentation retention direction
 PROOF OF DELIVERY:
 Revised: POD shipping date definition for Method 2
 PROOF OF DELIVERY REQUIREMENTS FOR RECENTLY ELIGIBLE MEDICARE FFS:
 Revised: Supplier record information to an “and” from an “or”
 REPLACEMENT:
 Revised: updated word “entire” to “entirely”


11/16/2017:
At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 06/01/2017
REFILL REQUIREMENTS:
Revised: Deleted refill requirements that are policy specific and are currently located in the applicable LCDs

Revision Effective Date: 06/01/2017
PROOF OF DELIVERY:
Revised: Corrects clerical error introduced with 01/01/2017 version. Language reverts to original three methods of delivery found in 04/28/16 version of SDL article.

Revision Effective Date: 05/25/17
WRITTEN ORDERS PRIOR TO DELIVERY (WOPD)
Removed: Requirement for “Standard WOPD” for specific items identified by CMS or DME MACs such as Negative Pressure Wound Therapy (NPWT)

Revision Effective Date: 04/20/17
NEW ORDER REQUIREMENTS
Revised: Change in supplier direction
PROOF OF DELIVERY
Revised: Proof of Delivery requirements and use of long description of the HCPCS code
Previous Revisions 10/31/14; 11/05/15; 04/28/16; 01/01/17
Originally published 02/17/12