Medicare Program Integrity Manual 
Chapter 5  Durable Medical Equipment, Prosthetics, 
Orthotics, and Supplies (DMEPOS) Items and Services 
Having Special DME Review Considerations 
 
Table of Contents  
(Rev. 11431, 05-26-22) 
 
Transmittals for Chapter 5 
 
5.1  Home Use of DME, Prosthetics, Orthotics, and Supplies 
5.2  Rules Concerning DMEPOS Orders Prescriptions 
5.2.1  Standard Written Order/ Prescription (SWO) 
5.2.2  Required Elements of a SWO  
5.2.3  Who can complete a SWO  
5.2.4  Timing of the Order/Prescription  
5.2.5 - When a New Order/Prescription is Required  
5.2.6 - Refills of DMEPOS Items Provided on a Recurring Basis  
5.3  Master List of DMEPOS Items Potentially Subject to a Face- to- Face Encounter  
         and WOPD and/or Prior Authorization Requirements 
5.3.1  Notification of DMEPOS Item(s) Selected and Included on the Required 
Face-to-Face Encounter and Written Order Prior To Delivery List  
5.4  Face-to-Face Encounter Definition  
5.4.1  Timing of the Face-to-Face Encounter 
5.4.2  Documentation from the Face-to-Face Encounter 
5.4.3  Suspension of Face-to-Face Encounter and WOPD Requirements 
5.5  Certificates of Medical Necessity (CMNs) and DME Information Forms (DIFs) 
5.5.1  Completing a CMN or DIF 
5.5.2  Cover Letters for CMNs 
5.5.3 - Reserved for Future Use 
5.6  DME MACs and UPICs Authority to Initiate an Overpayment and/or Civil        
Monetary Penalty  (CMP) When Invalid CMNs or DIFs Are Identified 
5.7 - Nurse Practitioner or Clinical Nurse Specialist Rules Concerning Orders and       
        CMNs 
5.8 - Physician Assistant Rules Concerning Orders and CMNs  
5.9 - Documentation in the Patients Medical Record  
5.10 - Supplier Documentation  
           5.10.1 - Suppliers Documentation for DMEPOS Repair Claims            5.10.2 - Suppliers Documentation for Claims for Replacement of Essential     
                       Accessories for Beneficiary-Owned Continuous Positive Airway Pressure    
                      (CPAP) and Respiratory Assist Devices (RADs)  
5.11 - Evidence of Medical Necessity  
5.11.1 - Evidence of Medical Necessity for the Oxygen Claims  
5.11.2 - Evidence of Medical Necessity: Wheelchair and Power Operated Vehicle 
(POV) Claims 
5.12 - Period of Medical Necessity - Home Dialysis Equipment  
5.13 - Safeguards in Making Monthly Payments  
          5.13.1 - Reserved for Future Use 
5.14 - Pick-up Slips  
5.15 - Incurred Expenses for DMEPOS  
5.16 - Reserved for Future Use  
5.17 - Definitions of  Customized DMEPOS 
5.18 - Advance Determination of Medical Coverage (ADMC) of Customized DMEPOS 
5.18.1 - Items Eligible for ADMC 
5.18.2 - Instructions for Submitting ADMC Requests 
5.18.3 - Instructions for Processing ADMC Requests 
5.18.4 - Affirmative ADMC Decisions 
5.18.5 - Negative ADMC Decisions 
5.19 - DME MAC Tracking 
  5.1  Home Use of DME, Prosthetics, Orthotics, and Supplies 
(DMEPOS) 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
The Social Security Act (the Act) defines those items and services covered by Medicare 
and identifies certain conditions for payment. In Section 1834(a)(11) of the Act, Congress 
sets forth prescription and face-to-face encounter requirements for certain items. We note 
that Section 1834(h)(3) of the Act requires that section 1834(a)(11) of the Act apply to 
orthotics and prosthetics in the same manner as it applies to items of DME. 
 
See Pub. 100-04, chapter 20, section 10 for more information related to home use of 
DME. 
 
5.2  Rules Concerning DMEPOS Orders/Prescriptions 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
A written order/prescription is a written communication from a treating practitioner that 
documents the need for a beneficiary to be provided an item of DMEPOS. As used 
throughout this chapter, treating practitioner means a physician, as defined in section 
1861(r)(1) of the Act, or physician assistant, nurse practitioner, or clinical nurse 
specialist, as those terms are defined in section 1861(aa)(5) of the Act.   
 
All DMEPOS items require a written order/prescription from the treating practitioner for 
Medicare payment as a condition of payment.  
 
Certain items require an order/prescription based on statute. In such instances, if the 
statutory requirements related to the order are not met, the claim will be denied as not 
meeting the benefit category. If the error cannot be cured, or can be cured but it is not 
cured within the prescribed timeframe, there may be financial implications for the 
beneficiary (see Pub. 100-04, Chapter 30, for more information on limitation on liability).   
 
A supplier must maintain the written order/prescription and the supporting documentation 
provided by the treating practitioner and make them available to CMS and its contractors 
upon request. 
 
In those limited instances in which the treating practitioner is also the supplier and is 
permitted to furnish specific items of DMEPOS and fulfill the role of the supplier in 
accordance with any applicable laws and policies, a separate SWO is not required. 
However, the medical record must still contain all of the required SWO elements. 
 
5.2.1 - Standard Written Order/Prescription (SWO) 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
  All claims for DMEPOS items billed to Medicare require a written order/prescription 
from the treating practitioner as a condition for payment. The required elements of a 
DMEPOS order/prescription have been codified at 42 CFR 410.38(d)(1) and are listed 
below.  
 
5.2.2 - Required Elements of a SWO 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
A SWO must contain all of the following elements:  
 
  Beneficiary name or Medicare Beneficiary Identifier (MBI); 
  General description of the item.  
  The description can be either a general description (e.g., wheelchair or 
o
hospital bed), a brand name/model number, a HCPCS code, or a 
HCPCS code narrative; 
  For equipment  In addition to the description of the base item, the 
o
SWO may include all concurrently ordered options, accessories, or 
additional features that are separately billed or require an upgraded 
code (List each separately); 
  For supplies  In addition to the description of the base item, the SWO 
o
may include all concurrently ordered supplies that are separately billed  
Note: If such items are not concurrently ordered, they nonetheless 
require an order for payment purposes 
  Quantity to be dispensed, if applicable; 
  Order Date; 
  Treating Practitioner Name or National Provider Identifier (NPI); and 
  Treating Practitioner Signature.  
 
The elements of the SWO will be evaluated in accordance with Ch. 3, Section 3.3.2.1, 
which discusses using the totality of the record to verify compliance with required 
elements.  
 
Note also that while the SWO has a limited number of required order elements, 
suppliers/providers are permitted to add elements that may provide clarity for issues such 
as length of need (LON), frequency of use, dosage form/strength, refills frequency, etc.  
This additional information shall be corroborated by information in the medical record. 
 
Suppliers may also wish to consult state law or regulation since some states may have 
additional requirements for the elements of an order/prescription (e.g., refill frequency). 
 
5.2.3 Who can complete a SWO 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020)   
\Statute requires that the treating practitioner who conducts the qualifying face-to-face 
encounter for Power Mobility Devices (PMDs) also prepare the SWO for the PMD 
base.  For items other than PMDs appearing on the Required Face-to-Face and Written 
Order Prior to Delivery List, the treating practitioner who conducts the face-to-face 
encounter does not need to be the prescriber of the DMEPOS items so long as the 
prescribing practitioner has knowledge of, and documentation to support (e.g., face-to-
face), the condition that requires his or her writing an order/prescription.  
 
For non-PMD items, and PMD separately billed accessories, certain elements of the 
order/prescription may be completed by someone other than the treating practitioner, so 
long as the treating practitioner identified in the order, via their name or national provider 
identifier (NPI), signs the document.  
 
5.2.4  Timing of the Order/Prescription 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
Written Order Prior to Delivery (WOPD) 
 
For PMDs and other DMEPOS items selected for inclusion on the Required Face-to-Face 
Encounter and Written Order Prior to Delivery List (See section 5.3.1 below), the SWO 
must be communicated to the supplier prior to delivery. For items requiring a WOPD, the 
contractors shall verify that the date of the written order is on or before the date of 
delivery or on or before the date shipped, the shipping date is used as the date of service.  
For additional information, see Chapter 4, section 26.1. 
 
Written Orders Prior to Claim Submission: 
 
For DMEPOS items that are not PMDs or otherwise included on the Required Face-to-
Face Encounter and Written Order Prior to Delivery List, the SWO must be 
communicated to the supplier prior to claim submission. 
 
5.2.5 - When a New Order/Prescription is Required 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
A new order/prescription is required:  
 
 For all claims for purchases or initial rentals;  
 If there is a change in the DMEPOS order/prescription (e.g., quantity);  
 On a regular basis (even if there is no change in the order/prescription) only if it is so 
specified in the documentation section of a particular medical policy;  
 When an item is replaced; and  
 When there is a change in the supplier, and the new supplier is unable to obtain a copy 
of a valid order/prescription for the DMEPOS item from the transferring supplier.   
5.2.6 - Refills of DMEPOS Items Provided on a Recurring Basis 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
For DMEPOS products that are supplied as refills to the original order/prescription, 
suppliers must contact the beneficiary prior to dispensing the refill and not 
automatically ship on a pre-determined basis, even if authorized by the beneficiary.  
This shall be done to ensure that the refilled item remains reasonable and necessary, 
existing supplies are approaching exhaustion, and to confirm any 
changes/modifications to the SWO. Contact with the beneficiary or designee regarding 
refills must take place no sooner than 14 calendar days prior to the delivery/shipping 
date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner 
than 10 calendar days prior to the end of usage for the current product. This is 
regardless of which delivery method is utilized. DME MACs shall allow for the 
processing of claims for refills delivered/shipped prior to the beneficiary exhausting 
his/her supply. 
 
5.3 - Master List of DMEPOS Items Potentially Subject to a Face- to- 
Face Encounter and WOPD and/or Prior Authorization Requirements  
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
42 CFR 410.38 and Final Rule 1713 (84 Fed. Reg Vol 217) creates a Master List of 
DMEPOS Items Potentially Subject to Face-To-Face Encounter and Written Order Prior 
to Delivery and/or Prior Authorization Requirements.  The Master List shall serve as a 
library of DMEPOS items from which items may be selected for inclusion on either the:  
 
  Required Face-to-Face Encounter and Written Order Prior to Delivery List; or 
  Required Prior Authorization List. 
 
Items included in either Required List are subject to the face-to-face encounter and 
WOPD or prior authorization requirements, respectively, as a condition of payment.  
 
See Chapter 3 for instructions regarding the requirements for items selected and included 
on the Required Prior Authorization List.  
 
The following instructions are limited to those items selected and included on the 
Required Face-to-Face Encounter and Written Order Prior to Delivery List. 
5.3.1  Notification of DMEPOS Item(s) Selected and Included on the 
Required Face-to-Face Encounter and Written Order Prior To Delivery 
List  (Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
Items selected and included in the Required Face-To-Face Encounter and Written Order 
Prior to Delivery List are published in the Federal Register with no less than 60 days 
notice and posted on CMS and its contractors websites.  Contractors shall include the 
effective date on their websites.  Contractors shall apply the face-to-face encounter and 
WOPD requirement as a condition of payment for any item appearing on the Required 
Face-To-Face Encounter and Written Order Prior to Delivery List beginning on the 
published effective date.   
5.4  Face-to-Face Encounter Definition  
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
A face-to-face encounter means an in-person or telehealth encounter between the treating 
practitioner and the beneficiary. The face-to-face encounter must be used for the purpose 
of gathering subjective and objective information associated with diagnosing, treating, or 
managing a clinical condition for which the DMEPOS is ordered. Telehealth encounters 
used to satisfy the face-to-face requirement must meet the requirements of 42 CFR  
410.78 and 414.65 for purposes of DMEPOS coverage.  
 
5.4.1  Timing of the Face-to-Face Encounter  
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
For DMEPOS items appearing on the Required Face-to-Face and Written Order Prior to 
Delivery List, the treating practitioner must document and communicate to the DMEPOS 
supplier that the treating practitioner has had a face-to-face encounter with 
the beneficiary within the 6 months preceding the date of the written order/prescription.  
 
A qualifying face-to-face encounter is required each time there is a new 
order/prescription for a DMEPOS items on the Required Face-to-Face and Written Order 
Prior to Delivery List. A single face-to-face encounter may document the clinical 
conditions necessitating multiple DMEPOS items. In this situation, regardless of whether 
the DMEPOS items are prescribed on different dates, the single face-to-face encounter 
may be utilized in support of the multiple items, so long as the encounter date is within 6 
months prior to the date of the orders. As always, the supplier is responsible for 
submitting documentation to support each claim upon request. 
 
The face-to-face requirement codified at 42 CFR 410.38 does not supplant other CMS 
coverage policies. For example, the National Coverage Determination  240.2 Home use 
of Oxygen requires a physician examination within a month of starting home oxygen 
therapy. 
  5.4.2  Documentation from the Face-to-Face Encounter  
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
A supplier must maintain the SWO and the supporting documentation provided by the 
treating practitioner and make them available to CMS and its contractors upon request. A 
supplier must submit additional documentation to CMS or its contractors, upon request, 
to support and/or substantiate the medical necessity for the DMEPOS.  
 
The face-to-face encounter must support payment and be documented in the pertinent 
portion of the medical record (for example, history, physical examination, diagnostic 
tests, summary of findings, progress notes, treatment plans or other sources of 
information that may be appropriate).  The supporting documentation must include 
subjective and objective beneficiary specific information used for diagnosing, treating, or 
managing a clinical condition for which the DMEPOS is ordered. 
 
Section 1834(h)(5) of the Act states that for purposes of determining the reasonableness 
and medical necessity of orthotics and prosthetics, documentation created by orthotists 
and prosthetists shall be considered part of the individuals medical record to support 
documentation created by eligible professionals as described in section 1848(k)(3)(B) of 
the Social Security Act. Documentation from a face-to-face encounter conducted by a 
treating practitioner, as well as documentation created by an orthotist or prosthetist, 
becomes part of the medical records. If the orthotist or prosthetist notes support the 
documentation created by eligible professionals described in section 1848(k)(3)(B), they 
can be used together to support medical necessity of an ordered DMEPOS item. In the 
event the orthotist or prosthetist documentation does not support the documentation 
created by the eligible professional, payment may be denied. 
 
If a supplier bills for an item listed on the Required Face-to-Face Encounter and Written 
Order Prior to Delivery List and does not possess documentation of the face-to-face 
encounter and/or the WOPD, the item will be denied.  
 
5.4.3  Suspension of Face-to-Face Encounter and WOPD Requirements  
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
CMS may suspend the face-to-face encounter and WOPD requirements generally or for a 
particular item or items at any time and without undertaking rulemaking, except those 
items for which inclusion on the Required Face-to-Face Encounter and Written Order 
Prior to Delivery List was statutorily imposed or codified in prior rule making, such as 
power mobility devices. CMS will post notification of the suspension on the CMS 
website. Upon direction from CMS, contractors shall post notification of the suspension 
on their websites and may utilize other communication tools to alert suppliers of the 
suspension.  5.5  Certificates of Medical Necessity (CMNs) and DME Information 
Forms (DIFs) 
(Rev. 11431; Issued: 05-26-22; Effective: 06-28-22; Implementation: 06-28-22) 
 
The CMS seeks to reduce burden and modernize processes to ensure a reduction in 
improper payments and an increase in customer satisfaction.  The CMN form and DIF 
were originally required to help document the medical necessity and other coverage 
criteria for selected Durable Medical Equipment, Prosthetics, Orthotics, and Supplies 
(DMEPOS) items.  In the past, a supplier received a signed CMN from the treating 
physician or created and signed a DIF to submit with the claim. Due to improvements in 
claims processing and medical records management, the information found on CMNs or 
DIFs is available either on the claim or in the medical record and is 
redundant.  Therefore, to reduce burden and increase customer satisfaction, providers 
and suppliers no longer need to submit these forms for services rendered after January 1, 
2023. 
 
  For claims with dates of service on or after January 1, 2023  providers and 
suppliers no longer need to submit CMNs or DIFs with claims.  Due to electronic 
filing requirements, claims received with these forms attached will be rejected 
and returned to the provider or supplier.   
  For claims with dates of service prior to January 1, 2023  processes will not 
change and if the CMN or DIF is required, it will still need to be submitted with 
the claim, or be on file with a previous claim.   
This statement applies throughout the Program Integrity Manual wherever CMNs and 
DIFs are mentioned.  
 
A CMN or a DIF is a form required to help document the medical necessity and other 
coverage criteria for selected DMEPOS items. CMNs contain Sections A through D. 
Sections A and C are completed by the supplier and Sections B and D are completed by 
the physician. A DIF is completed and signed by the supplier. It does not require a narrative 
description of equipment and cost or a physician signature. 
 
The following forms below have been approved by the Office of Management and Budget 
(OMB). For the CMS. For the CMS forms 484, 846, 847, 848, 849, 854, 10125 and 10126, 
the OMB# is 0938-0679. 
 
  CMN CMS-484  Oxygen 
  CMN CMS-846  Pneumatic Compression Devices 
  CMN CMS-847 -- Osteogenesis Stimulators 
  CMN CMS-848  Transcutaneous Electrical Nerve Stimulators 
  CMN CMS-849  Seat Lift Mechanisms 
  CMN CMS-854  Section C Continuation Form 
  DME Information Form CMS-10125  External Infusion Pumps 
  DME Information Form CMS-10126  Enteral & Parenteral Nutrition 
  The TENS CMN is for purchases only. A TENS CMN will no longer be necessary for 
rentals. 
 
For certain items or services billed to a DME MAC, the supplier must receive a signed 
CMN from the treating physician or a signed DIF from the supplier. For these items, a 
supplier must have a signed original, faxed, photocopied, or electronic CMN or DIF in 
their records when submitting a claim for payment to Medicare. 
 
A signed original, faxed, photocopied, or electronic CMN or DIF must be maintained by 
the supplier and be available to the DME MACs, UPICs, SMRC, and DME RACs on 
request. When hardcopy CMNs or DIFs are submitted to the DME MACs, UPICs, SMRC 
and DME RACs, the supplier must include a copy of only the front side. When CMNs are 
submitted electronically to the DME MAC, information from sections A and B are 
required. 
 
It is in the suppliers interest to maintain a copy of what they faxed to the physician. 
Suppliers must maintain a copy of the completed CMN or DIF in their records. However, 
if the physician only faxes the front of the completed CMN then the supplier is only 
required to maintain the front portion of the CMN. 
 
However, when the CMN or DIF is submitted electronically and the supplier chooses to 
maintain a hard copy CMN or DIF, the font may be modified as follows: 
 
  Pitch may vary from 10 characters per inch (cpi) to 17.7 cpi; 
o
 
  Line spacing must be 6 lines per inch 
o
 
  Each form must have a minimum 1/4 inch margin on all four sides. 
o
 
Without  exception,  these  modified  hard  copy  forms  must  contain  identical 
questions/wording to the CMS forms, in the same sequence, with the same pagination, and 
identical instructions/definitions printed on the back; and CMN question sets may not be 
combined. 
 
The CMN can serve as the physician's detailed written order if the narrative description in 
section C is sufficiently detailed. This would include quantities needed and frequency of 
replacement for accessories and supplies. For items requiring both a CMN and a written 
order prior to delivery (e.g., seat lift mechanisms) suppliers may utilize a completed and 
physician-signed CMN for this purpose. Otherwise, a separate order in addition to a 
subsequently completed and signed CMN is necessary. 
 
The supplier may not complete the information in section B of the CMN. A supplier who 
knowingly and willfully completes section B of the form is subject to a civil monetary 
penalty up to $1,000 for each form or document so distributed. Any supplier who remains 
in non-compliance after repeated attempts by the contractor to get the supplier into  compliance, refer to your RO (for UPICs refer the supplier to the primary GTL or associate 
GTL and SME) as a potential civil monetary penalty case. 
 
The fee schedule amount, narrative description of the items furnished and the supplier's 
charge for the medical equipment or supplies being furnished must be completed on a 
CMN  by  the  supplier  prior  to  it  being  furnished  to  the  physician.  A  supplier  who 
knowingly and willfully fails to include this information may be subject to a civil monetary 
penalty up to $1,000 for each form or document so distributed. Any supplier who remains 
in non-compliance, after repeated attempts by the contractor to get the supplier into 
compliance, refer to your RO (for UPICs, refer the supplier to the primary GTL or 
associate GTL and SME) as a potential civil monetary penalty case. 
 
The CMS will not accept any other certifications of medical necessity by other insurers or 
government agencies. 
 
Suppliers and physician may choose to utilize electronic CMNs (e-CMNs) or electronic 
DIFs (e-DIFs). E-CMNs or e-DIFS must adhere to all privacy, security, and electronic 
signature rules and regulations promulgated by CMS and DHHS. Additionally, e-CMNs 
or e-DIFs must contain identical questions/wording to the CMS forms, in the same 
sequence, with the same pagination, and identical instructions/definitions as printed on the 
back of the hardcopy form. 
If an item requires a CMN or a DIF and the supplier does not have a faxed, photocopied, 
original hardcopy, or an electronic signed CMN or DIF in their records when they submit 
a claim to Medicare, the claim will be denied. 
 
In cases where two or more suppliers merge, the resultant supplier should make all 
reasonable attempts to secure copies of all active CMNs or DIFs from the supplier(s) 
purchased. This document should be kept on file by the resultant supplier for future 
presentation to the DME MACs, and UPICs. 
 
When reviewing claims where the medical record contains a copied, faxed or electronically 
maintained CMN or DIF (any CMN or DIF created, modified, and stored via electronic 
means such as commercially available software packages and servers), the DME MACs, 
or  UPICs  must  accept  the  copied,  faxed  or  electronic  document  as  fulfilling  the 
requirements for these documents. 
 
When a UPIC is investigating potentially fraudulent behavior by a supplier, it will be the 
supplier's  responsibility  to  prove  the  authenticity/validity  of  the  claim(s)  under 
investigation. UPICs may require the supplier to prove the authenticity/validity of the 
signature on the CMN, DIF, order, or any other questionable portion of the claim(s) under 
investigation. 
 
Upon request by the DME MACs, UPICs, SMRC or DME RACs, suppliers must provide 
the CMN or DIF, in a format that the DME MACs, UPICs, SMRC, and DME RACs can 
accept, in a timely manner. Upon medical review, the DME MACs, UPICs, SMRC, and 
DME RACs should not deny claims solely because the CMN or DIF is faxed, copied, or  electronic. The DME MACs, UPICs, SMRC, and DME RACs may request the supplier to 
download and print a hard copy of an electronic order, CMN or DIF if the DME MACs, 
UPICs, SMRC, and DME RACs cannot access it electronically. 
 
For items that require a CMN, and for accessories, supplies, and drugs related to an item 
requiring a CMN, the CMN may serve as the written order if the narrative description in 
Section C is sufficiently detailed (as described above). This applies to both hard copy and 
electronic orders or CMNs. A DIF does not contain a section for a narrative description 
and is not applicable. 
 
A supplier must have a hard copied, faxed or electronic order, CMN or DIF in their records 
when they can submit a claim for payment to Medicare. Suppliers must ensure the security 
and integrity of electronically maintained CMNs or DIFs are in accordance with any 
regulations published by CMS. 
 
The DME MACs or UPICs need not make any shared system changes to electronically 
accept e-CMNs or e-DIFS as CMS views e-CMNs or e-DIFs as a transaction between the 
physician and suppliers. Suppliers must continue to use current systems for transmitting 
claim information to the DME MAC or UPICs. 
 
5.5.1  Completing a CMN or DIF 
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21) 
 
The "Initial Date" found in Section A of the CMN, should be either the specific date that 
the physician gives as the start of the medical necessity or, if the physician does not give 
a specific start date, the "Initial Date" would be the date of the order. 
 
The "Signature Date" is the date the physician signed and dated Section D of the CMN. 
This date might not be the same as the "Initial Date", since the "Signature Date" must 
indicate when the physician signed Section D of the CMN. Medicare requires a legible 
identifier for services provided/ordered. The method used shall be handwritten or an 
electronic signature in accordance with chapter 3, section 3.4.1.1 to sign an order or other 
medical record documentation for medical review purposes. Signature and date stamps are 
not acceptable for use on CMNs and DIFs. 
 
The "Delivery Date/Date of Service" on the claim must not precede the "Initial Date" on 
the CMN or DIF or the start date on the written order. To ensure that an item is still 
medically necessary, the delivery date/date of service must be within 3 months from the 
"Initial Date" of the CMN or DIF or 3 months from the date of the physician's signature. 
 
The DME MACs and UPICs have the authority to request to verify the information on a 
CMN or DIF at any time. If the information contained either in the suppliers records or in 
the patients medical record maintained by the ordering physician fails to substantiate the 
CMN or DIF, or if it appears that the CMN or DIF has been altered, the DME MACs and 
UPICs should deny the service and initiate the appropriate administrative or corrective 
actions.   
In the event of a post pay audit, the supplier must be able to produce the CMN or DIF and, 
if requested by the DME MACs or UPICs DME produce information to substantiate the 
information on the CMN or DIF. If the supplier cannot produce this information, the DME 
MACs and UPICs should deny the service and initiate the appropriate administrative or 
corrective actions. 
 
If there is a change made to any section of the CMN after the physician has signed the 
CMN, the physician must line through the error, initial and date the correction; or the 
supplier may choose to have the physician complete a new CMN. 
 
5.5.2  Cover Letters for CMNs 
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21) 
 
Cover letters can be used by a supplier as a method of communication between the supplier 
and the physician. It is not CMS's intent to restrict necessary communication between the 
supplier and the physician. CMS does not require nor regulate the cover letter. The DME 
MACs and UPICs should not take adverse action against suppliers that solely involve 
cover letters. 
 
The DME MACs should regularly publish an article in their bulletins asking suppliers to 
remind physicians and suppliers of their responsibility in completing and signing the CMN 
or DIF. It is the physicians and suppliers responsibility to determine both the medical 
need for, and the utilization of, all health care services. The physician and supplier should 
ensure that information relating to the beneficiarys condition is correct. The DME MAC 
and UPICs should encourage suppliers to include language in their cover letters to remind 
physicians of their responsibilities. 
 
5.5.3  Reserved for Future Use 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
5.6  DME MACs and UPICs Authority to Initiate an Overpayment 
and/or Civil Monetary Penalty (CMP) When Invalid CMNs or DIFs Are 
Identified 
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21) 
 
Section 1862(a)(1)(A) of the Act prohibits Medicare payment for services that are not 
reasonable and necessary. Section 1833(e) of the Act requires that Medicare be furnished 
by providers and suppliers "such information as may be necessary in order to determine 
the amount due...." These sections provide support that a failure to have a valid CMN or 
DIF on file or to submit a valid CMN or DIF to the DME MACs or UPICs makes the 
underlying claim improper because Medicare does not have sufficient information to 
determine whether the claim is reasonable and necessary. A valid CMN is one in which 
the treating physician has attested to and signed supporting the medical need for the item,  and the appropriate individuals have completed the medical portion of the CMN. A valid 
DIF is one in which the supplier has attested to and signed supporting the medical need for 
the item. When the DME MACs and UPICs identify a claim for which a CMN or DIF is 
not valid, they may deny the claim and/or initiate overpayment action. 
 
If a DME MAC or UPIC identifies a supplier that has a pattern of improperly completing 
the CMN or DIF, the DME MAC or UPIC may choose to initiate a potential Civil 
Monetary Penalty (CMP) case against the supplier. The authority for such action is found 
in 1834(j)(2)(A)(iii) of the Act which states that "any supplier of medical equipment and 
supplies who knowingly and willfully distributes a CMN in violation of clause (I) or fails 
to provide the information required under clause (ii) is subject to a civil money penalty in 
an  amount  not  to  exceed  $1,000  for  each  such  certificate  of  medical  necessity  so 
distributed." The provisions of 1128A of the Act (other than subsections (a) and (b) shall 
apply to CMPs penalties under this subparagraph in the same manner as they apply to a 
penalty or proceeding under 1128(A)(a)) of the Act. 
 
5.7  Nurse Practitioner or Clinical Nurse Specialist Rules Concerning 
Orders and CMNs 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
A nurse practitioner or clinical nurse specialist may give the dispensing order and sign 
the detailed written order in the following situations: 
 
  They are treating the beneficiary for the condition for which the item is needed; 
 
  They are practicing independently of a physician; 
 
  They bill Medicare for other covered services using their own provider number; 
and  
 
  They are permitted to do all of the above in the State in which the services are 
rendered. 
 
A nurse practitioner or clinical nurse specialist may complete Section B and sign Section 
D of a CMN if they meet all the criteria described above for signing orders. 
 
5.8  Physician Assistant Rules Concerning Orders and CMNs 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
Physician assistants may provide the dispensing order and write and sign the detailed 
written order if they satisfy all the following requirements: 
 
  They meet the definition of physician assistant found in 1861(aa)(5)(A) of the 
Act;   
  They are treating the beneficiary for the condition for which the item is needed; 
 
  They are practicing under the supervision of a Doctor of Medicine or Doctor of 
Osteopathy; 
 
  They have their own NPI; and  
 
  They are permitted to perform services in accordance with State law. 
 
Physician assistants may complete section b and sign section D of a CMN if they meet all 
the criteria described above for signing orders. 
 
5.9  Documentation in the Patients Medical Record 
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21) 
 
For any DMEPOS item to be covered by Medicare, the patients medical record must 
contain sufficient documentation of the patients medical condition to substantiate the 
necessity for the type and quantity of items ordered and for the frequency of use or 
replacement (if applicable). The information should include the patients diagnosis and 
other  pertinent  information  including,  but  not  limited  to,  duration  of  the  patients 
condition, clinical course (worsening or improvement), prognosis, nature and extent of 
functional limitations, other therapeutic interventions and results, past experience with 
related items, etc. If an item requires a CMN or DIF, it is recommended that a copy of the 
completed CMN or DIF be kept in the patients record. However, neither a physicians 
order nor a CMN nor a DIF nor a supplier prepared statement nor a physician attestation 
by itself provides sufficient documentation of medical necessity, even though it is signed 
by the treating physician or supplier. There must be information in the patients medical 
record that supports the medical necessity for the item and substantiates the answers on 
the CMN (if applicable) or DIF (if applicable) or information on a supplier prepared 
statement or physician attestation (if applicable). When a CMN or DIF and a medical 
record contain conflicting information due to a minor error or omission within the CMN 
or DIF, but all coverage, coding and payment criteria are substantiated through the medical 
record, the reviewer shall rely upon the content of the medical record (absent suspicion of 
abuse or gaming) and shall not issue a denial. 
 
See  PIM,  chapter  3,  section  3.4.1.1,  for  additional  instructions  regarding  review  of 
documentation during pre- and post-payment review. 
 
The patients medical record is not limited to the physicians office records. It may include 
hospital, nursing home, or HHA records and records from other health care professionals. 
 
The documentation in the patients medical record does not have to be routinely sent to 
the supplier or to the DME MACs or UPICs. However, the DME MACs or UPICs may 
request this information in selected cases. If the DME MACs or UPICs do not receive the 
information when requested or if the information in the patients medical record does not  adequately support the medical necessity for the item, then on assigned claims the supplier 
is liable for the dollar amount involved unless a properly executed advance beneficiary 
notice (ABN) of possible denial has been obtained. 
 
5.10 - Supplier Documentation 
(Rev. 11032; Issued: 09-30-21; Effective: 10-12-21; Implementation: 11-10-21) 
 
A. General 
 
Before submitting a claim to the DME MAC (or before dispensing the item  see section 
5.2.4), the supplier must have on file a standard written order, the CMN (if applicable), 
the DIF (if applicable), information from the treating practitioner concerning the patient's 
diagnosis, and any information required for the use of specific modifiers or attestation 
statements as defined in certain DME MAC policies. The supplier should also obtain as 
much documentation from the patient's medical record as they determine they need to 
assure themselves that coverage criteria for an item have been met. If the information in 
the patient's medical record does not adequately support the medical necessity for the 
item, the supplier is liable for the dollar amount involved unless a properly executed 
ABN of possible denial has been obtained. 
 
Documentation must be maintained in the supplier's files for seven (7) years from date of 
service. If the provider responds, in writing, that the Medicare qualifying supplier 
documentation is older than 7 years, and provides proof of continued medical necessity of 
the item or necessity of the repair, the contractors shall not deny the claim based solely on 
missing the supporting Medicare qualifying documentation that is over 7 years old. 
 
B. Proof of Delivery 
 
Section 424.57(c)(12) requires suppliers, as part of their standards to be met for 
enrollment and participation, to maintain proof of delivery documentation in their files. In 
certain instances, compliance with proof of delivery may be required as a condition of 
payment, and must be available to the DME MAC, RAC, SMRC, CERT, and UPIC on 
request. For such items, if the supplier does not have appropriate proof of delivery 
documentation within the prescribed timeframes, associated claims will be denied and 
overpayments recouped. We note that non-compliance with supplier standards may also 
result in revocation from the Medicare program. Suppliers who consistently do not 
provide documentation to support their services may be referred to the OIG or NSC for 
investigation and/or imposition of sanctions. If the beneficiary is newly eligible to the 
Medicare program, the proof of delivery standards require the supplier to obtain a 
statement, signed and dated by the beneficiary (or beneficiary's designee), that the 
supplier has examined the item. 
 
Please refer to IOM 100-08. Ch. 4, Section 4.7.3.1 for additional information regarding 
all proof of delivery requirements. 
 
5.10.1 - Suppliers Documentation for DMEPOS Repair Claims  (Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
When reviewing DMEPOS claims for repairs, the contractor shall review for continued 
medical necessity of the item and necessity of the repair. Contractors are not required to 
determine that the requirements for provision of the DMEPOS item as when it was 
originally ordered were met.  For example, even though a face-to-face encounter is 
required for the initial provision of certain wheelchairs, it is not needed for the repair of a 
wheelchair already covered and paid for by Medicare.  However, documentation from the 
treating practitioner that indicates the wheelchair being repaired continues to be 
medically necessary is required.  For this purpose, documentation is considered timely 
when it is on record in the preceding 12 months, unless otherwise specified in relevant 
Medicare policy. 
 
In addition, the contractor shall ensure that the suppliers record includes the nature of the 
repair required and work performed to restore the item to its functionality to meet the 
Medicare beneficiarys medical need. 
 
These instructions do not replace or alter other longstanding instructions related to 
coverage and payment for reasonable and necessary repairs and maintenance and 
servicing of DMEPOS items.  Contractors shall continue to adhere to these program 
policies and procedures.  Examples include, but are not limited to, Chapter 15, section 
110.2 of the Benefit Policy Manual and Chapter 20, sections 10.2 and 40 of the Claims 
Processing Manual.  Contractors are also reminded that parts and labor covered under a 
manufacturer or supplier warranty are not to be considered reasonable and necessary 
under regulation; therefore, contractors shall determine for each claim whether billed 
parts and labor are covered under a warranty.  For reasonable and necessary parts, 
payment is made on a lump sum basis based on the contractors individual consideration 
of a reasonable payment amount for the part.  For reasonable and necessary labor, 
payment is based on a reasonable fee established by the contractor for labor associated 
with repairing the item. 
 
5.10.2 - Suppliers Documentation for Claims for Replacement of 
Essential Accessories for Beneficiary-Owned Continuous Positive 
Airway Pressure (CPAP) and Respiratory Assist Devices (RADs) 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
When reviewing claims for replacement of essential accessories for beneficiary-owned 
CPAP and RADs, the contractor shall review for continued medical necessity of the 
DME and necessity of the replacement accessory.  Contractors are not required to 
determine that the requirements for provision of the CPAP and RAD as when it was 
originally ordered were met.  For example, even though a face-to-face encounter is 
required for the initial provision of the CPAP device, it is not needed for replacement of a 
CPAP mask for a patient-owned CPAP device covered by Medicare in the past.  
However, documentation from the treating practitioner that indicates the CPAP or RAD  which requires replacement accessories continues to be medically necessary is required.  
For this purpose, documentation is considered timely when it is on record in the 
preceding 12 months, unless otherwise specified in relevant Medicare policy. 
 
In addition, the contractor shall ensure that the suppliers record includes the reason why 
the accessory(s) need to be replaced to meet the Medicare beneficiarys medical need.  
The contractor shall also ensure that the suppliers record includes the reason why any 
new accessories (e.g., heated humidifier or heated tubing) need to be furnished to meet 
the Medicare beneficiarys medical need.  These instructions do not replace or alter other 
longstanding instructions related to coverage and payment for reasonable and necessary 
accessories for patient-owned DME.  Contractors shall continue to adhere to these 
program policies and procedures. 
 
5.11 - Evidence of Medical Necessity 
(Rev. 10538; Issued: 12-30-20; Effective: 01-01-20; Implementation: 12-29-20) 
 
If replacement supplies are needed for the therapeutic use of purchased DMEPOS, the 
treating practitioner must specify on the standard written order, or on the CMN, the type 
of supplies needed, in such a manner that the supplier may calculate the necessary 
disbursement and assess the continued need for refill with the beneficiary. DME 
MACs, UPICs, and other contractors evaluate supply utilization information as part of 
their medical necessity and coverage determinations for DMEPOS.  
 
Absent a State law to the contrary or a supply utilization problem, the standard written 
order or CMN submitted for the DMEPOS may also serve as medical evidence for supply 
replacement claims. However, when a standard written order for DMEPOS is renewed or 
revised, supply utilization information must be specified or updated by the treating 
practitioner on the CMN.  DME MACs, UPICs, and other contractors assess the 
continuing medical necessity. 
 
The DME MACs, UPICs, and other contractors must establish procedures for monitoring 
the utilization of replacement supplies. Suppliers must have documentation to support the 
medical necessity of changes in the equipment, device, or supply utilization requirements.  
Absent such notification, DME MACs, UPICs, and other contractors do not allow claims 
for unexplained increases in supply utilization above the usage level they previously 
determined as medically necessary.  Suppliers shall make this information available to 
the DME MACs, UPICs, and other contractors on request. 
 
If necessary or appropriate for a medical necessity determination, the DME MAC, UPIC, 
or other contractor must ask the supplier to obtain documentation from the treating 
practitioner, establishing the severity of the patient's condition and the immediate and 
long term need for the equipment and the therapeutic benefits the patient is expected to 
realize from its use. A claim of therapeutic effectiveness or benefit based on speculation 
or theory alone cannot be accepted. When restoration of function is cited as a reason for 
use of DMEPOS, the exact nature of the deformity or medical problem should be clear 
from the medical evidence submitted. Also, the manner in which the equipment or device  will restore or improve the bodily function should be explained by the treating 
practitioner. 
 
If the DME MAC, UPIC, or other contractor is unsuccessful in obtaining medical 
information from the supplier for non-assigned claims, it gives the beneficiary the 
opportunity to obtain the desired information from the supplier. If, after obtaining the 
requested information, a question of medical necessity remains, the DME MAC, UPIC, 
or other contractor must resolve the issue. 
 
5.11.1  Evidence of Medical Necessity for the Oxygen Claims 
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21) 
 
If DME MACs, CERT, UPICs, Recovery Auditors or the SMRC learn that the physician 
of record is no longer the treating physician, the supplier shall obtain from the physician 
currently responsible for the patient's pulmonary condition a current fully-completed 
oxygen CMN. After review of this oxygen CMN, DME MACs continue monthly payments 
if the evidence establishes medical necessity. Their records must be updated to identify the 
new treating physician. 
 
For an initial claim, the physician must submit a signed certification of medical necessity 
that includes an oxygen/blood gas lab result. This certification must be corroborated with 
information in the medical record. A physician signature on the oxygen lab test result is 
not necessary to corroborate the certification. Instead, the reviewer should consider all 
submitted records from all of the beneficiarys healthcare professionals. 
 
Therefore, contractors shall not deny an oxygen or oxygen equipment claim solely because 
the claim lacks a physician signature on the oxygen lab test result. 
 
5.11.2 - Evidence of Medical Necessity: Wheelchair and Power Operated 
Vehicle (POV) Claims 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
The physician or treating practitioner (a physician assistant, nurse practitioner or clinical 
nurse specialist) must conduct a face-to-face encounter of the beneficiary and write a 
written order for the power mobility device (PMD). The face-to-face examination and the 
written order must comply with the instructions found under Required Elements of a 
SWO, Written Order Prior to Deliver, Face-to-Face Encounter Definitions and Timing of 
the Face-to-Face Encounter. 
 
The face-to-face examination requirement does not apply when only accessories for 
power mobility devices are being ordered, nor does it apply for the ordering of 
replacement PMDs. A replacement PMD would be the same device as previously 
ordered. However, if a beneficiary has a POV but would like to replace the POV with a 
power wheelchair, then a face-to-face examination would need to be conducted.   
  Prior to dispensing a PMD, the DMEPOS supplier must obtain from the physician or 
treating practitioner who performed the face-to-face examination the written order 
accompanied by supporting documentation of the beneficiarys need for the PMD in the 
home. Pertinent parts from the documentation of the beneficiarys PMD evaluation may 
include the history, physical examination, diagnostic tests, summary of findings, 
diagnoses, and treatment plans. The physician or treating practitioner should select only 
those parts of the medical record that clearly demonstrate medically necessity for the 
PMD. The parts of the medical record selected should be sufficient to delineate the 
history of events that led to the request for the PMD; identify the mobility deficits to be 
corrected by the PMD; and document that other treatments do not obviate the need for the 
PMD, that the beneficiary lives in an environment that supports the use of the PMD and 
that the beneficiary or caregiver is capable of operating the PMD. In most cases, the 
information recorded at the face-to-face examination will be sufficient. However, there 
may be some cases where the physician or treating practitioner has treated a patient for an 
extended period of time and the information recorded at the face-to-face examination 
refers to previous notes in the medical record. In this instance, those previous notes 
would also be needed. The physician, treating practitioner or supplier that is a HIPAA 
covered entity should make sure to remove or edit any materials that may be contained 
within the medical record that are not necessary to support the order.  For example, a 
gynecologic report would not be needed in the records submitted for a beneficiary whose 
clinical need for a PMD is based solely on disability secondary to a stroke. 
 
As defined in the PIM, chapter 3, if data analysis indicates potentially aberrant billing, 
contractors shall continue to follow the general guidance for performing medical review 
on claims. 
 
5.12  Period of Medical Necessity - Home Dialysis Equipment 
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21) 
 
Situations may occur causing temporary non-use of equipment: 
 
  Beneficiary requires in-facility treatment for re-stabilization or as a result 
of some acute condition. The beneficiary is expected to return to home 
dialysis; 
 
  Beneficiary is temporarily without a suitable home dialysis assistant; 
 
  Beneficiary is away from home but expects to return; or 
 
  Beneficiary is a transplant candidate and is taken off home dialysis preparatory 
to transplant. (If the transplant cannot occur, or if the transplant is not successful, 
the patient will very likely resume home dialysis and an evaluation can be made 
whether it will be within the immediate or foreseeable future.) 
 
Under such circumstances, DME MACs or UPICs determine that medical necessity exists 
and pay for a period of up to 3 months after the month home dialysis equipment was last  used. This does not eliminate the necessity for periodic reevaluation of medical necessity. 
It provides a tolerance to avoid frequent reevaluation in renal dialysis situations and 
provides for continuity of payments where economically advantageous. 
 
5.13 - Safeguards in Making Monthly Payments 
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21) 
 
The DME MACs and UPICs shall establish appropriate safeguards to assure that payments 
are not made beyond the last month of medical necessity. They must develop appropriate 
safeguards to identify and investigate the following: 
 
  Multiple claims for rental of the same or similar equipment from the same 
supplier within the same rental month (e.g., rental claims with different start 
dates  but  within  the  same  rental  period);  Pub.  100-04,  chapter 20,  30.5 
specifically forbids payments for multiple claims for rental of the same or similar 
equipment from either the same or a different supplier during the same rental 
month. 
 
  Contraindicated items of rented or purchased equipment; 
 
  Incompatible claims information (e.g., liquid oxygen contents billed for 
a purchased gas delivery system); 
 
  Medical equipment rentals or purchases after a beneficiary's death; 
 
  Rental start dates on or after the purchase of the same or comparable equipment 
(absent evidence that the beneficiary has disposed of purchased equipment); 
 
  Rental claims for the same or similar equipment from different suppliers for 
the same or overlapping rental months; and 
 
  Equipment rental start dates within periods of confinement in an institution 
that cannot be considered a patient's home. 
 
The  DME  MACs  and  UPICs  shall  resolve  these  situations  on  a  prepayment  basis. 
Development, if necessary, may be via written or telephone contact per Pub. 100-08 
subject to any other documentation or development guidelines specified in Pub. 100-02, 
chapter 15, 100-01, Pub. 100-04, chapter 20, 10.1.1 and Pub. 100-04, chapter 20, 
100.2.3. 
 
To the extent possible, DME MACs and UPICs give beneficiaries and supplier- assignees 
advance notice of the date and reason that payments are scheduled to stop. (See Pub. 100-
04, chapter 21 for EOMB language.) 
 
5.13.1  Reserved for Future Use  (Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
5.14  Pick-up Slips 
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21) 
 
For purposes of this section, a pick-up slip is written confirmation, provided by a supplier, 
that the supplier has removed an item of DME from the beneficiarys home. 
 
When making determinations, DME MACs and UPICs must ascertain not only whether 
equipment is present in the home, but must determine which equipment is actually being 
used by the patient. Therefore, it is inappropriate to determine, solely based on lack of a 
pick up slip that a piece of equipment may still be in use. Likewise, it is inappropriate for 
DME MACs and UPICs to deny claims solely based on lack of a pick-up slip. DME MACs 
and  UPICs  should  develop  these  claims  to  determine  which  piece  of  equipment  is 
medically necessary. 
 
5.15  Incurred Expenses for DMEPOS 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
The first month's expense for rental is incurred on the date of delivery of the equipment.  
Expenses for subsequent months are incurred on the same date of the month. Where 
equipment is purchased, benefits are payable on the same basis. Suppliers may submit 
claims as of the date expenses are incurred. If the date of delivery is not specified on the 
claim, reviewers assume, in the absence of evidence to the contrary, that the date of 
purchase or rental was the date of delivery. 
 
Generally, for all DMEPOS, the suppliers date of service (DOS) is the date of delivery 
to a beneficiarys home. For DMEPOS provided to a beneficiary immediately following a 
hospital inpatient stay and/or DME immediately following a nursing home stay, the DOS 
is the date of final discharge to the beneficiarys home. For mail order DMEPOS 
provided immediately subsequent to a hospital inpatient stay and/or DME immediately 
following a nursing home stay, the DOS is the later of the actual delivery date or the date 
of the discharge. Under no circumstances can the DOS be earlier than the date of 
delivery. 
 
No payment may be made for rental for any month throughout which the patient is in an 
institution that does not qualify as his or her home (see Pub. 100-02, chapter 15, 110.3) 
or is outside the U.S. (See Pub. 100-02, chapter 16, 60.) If the patient is at home as of 
the first day of a rental month and, for part of the same rental month, is in an institution 
which cannot qualify as his or her home, or is outside the U.S., payment may be made for 
the entire rental month. Similarly, if an item of rental equipment is returned to the 
supplier before the end of a payment month because the beneficiary died in that rental 
month or because the equipment became unnecessary in that month, payment may be 
made for the entire rental month. However, if the supplier charges for only part of a  month, or the DME MAC is aware that the supplier customarily follows such a practice, 
it pays on a prorated basis. If the individual is outside the U.S. for more than 30 days and 
returns to the U.S. (before resuming payments), it determines medical necessity as in an 
initial case. 
 
Note that in the case of purchased equipment, Pub. 100-02, chapter 16, 60 requires that 
the beneficiary must have been in the United States when the item was delivered, and 
Pub. 100-01, chapter 2, 40.1 requires that the individual must have had Supplementary 
Medical Insurance (SMI) coverage at the time the item was delivered. Therefore, where a 
purchased item of equipment was delivered to an individual outside the United States or 
before his/her coverage period began (i.e., the effective date of his/her enrollment), the 
entire expense of the item is excluded from coverage whether it was paid for in its 
entirety at purchase or on a deferred or installment basis. Payment cannot be made in 
such cases even though the individual uses the item inside the United States or after 
his/her coverage begins. 
 
Contractor systems must maintain the outcome (e.g., audit trail) of prepayment decisions 
such as approved, denied, or partially denied. 
 
5.16  Reserved for Future Use 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
5.17 - Definition of Customized DMEPOS 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
42 CFR 414.224 defines customized DME as being items of DME which have been 
uniquely constructed or substantially modified for a specific beneficiary according to the 
description and orders of the beneficiary's treating physician.  See Pub. 100-04, Chapter 
20, Section 30.3 for information on customized DME. 
 
5.18  Advance Determination of Medicare Coverage (ADMC) of 
Customized DMEPOS 
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21) 
 
Section 1834(a)(15)(C) of the Act provides that carriers shall, at the request of a supplier 
or beneficiary, determine in advance of delivery of an item whether payment for the item 
may not be made because the item is not covered if: 
 
  The item is a customized item, 
 
  The patient to whom the item is to be furnished, or the supplier, requests that such 
advance determination be made, and 
 
  The item is not an inexpensive item as specified by the Secretary.   
This section provides for direction in implementing 1834 (a)(15)(C) of the Act. 
It is important to note that ADMCs are not initial determinations as defined at 42 CFR 
405.801(a), because no request for payment is being made. As such, an ADMC cannot be 
appealed. 
 
This is a voluntary program. Beneficiaries and suppliers are not required to submit ADMC 
requests in order to submit claims for items. Additionally, UPICs may not require an 
ADMC request as a prerequisite for submitting a claim. 
 
5.18.1  Items Eligible for ADMCs 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
The DME MACs shall publish examples of the types of items for which ADMCs are 
available. These examples shall be published yearly in the DME MACs Supplier Manual 
or yearly in the DME MACs Supplier Bulletin.  Examples will be published in the form 
of HCPCS codes eligible for this program. Because HCPCS codes describe general 
categories" of equipment, this list is not a list of specific items, but rather a general list 
of the categories of types of items eligible for this program. 
 
5.18.2  Instructions for Submitting ADMC Requests 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
Suppliers or beneficiaries may submit, in hard copy, requests for ADMC. Requests must 
contain adequate information from the patient's medical record to identify the patient for 
whom the item is intended, the intended use of the item, and the medical condition of the 
patient that necessitates the use of a customized item. Each DME MAC shall publish the 
mailing address to which requests should be sent. 
 
5.18.3  Instructions for Processing ADMC Requests 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
Once a request is received, the DME MAC shall determine if there is sufficient medical 
documentation that supports whether the item is reasonable and necessary. In addition, a 
review of the beneficiarys claims history should be conducted in order to determine 
whether any other reason exists to cause the claim to be denied, e.g., whether the same or 
similar equipment has already been provided. 
 
Upon receipt of a request, the DME MAC shall render an advance determination of 
Medicare coverage within 30 calendar days. DME MACs shall provide the requestor with 
their decision, be it affirmative or negative, in writing. 
  If requests are received for the wrong item(s), the request will be rejected. Rejected 
requests should not be counted as workload. 
 
Requests for appropriate items received without documentation to support coverage will 
be denied as not meeting the medical necessity requirements Medicare has established for 
the item. 
 
5.18.4  Affirmative ADMC Decisions 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
When making an ADMC, the DME MAC should review the information submitted with 
the request to determine; 1) if a benefit category exists, 2) if a statutory exclusion exists, 
and 3) if the item is reasonable and necessary. 
 
An affirmative ADMC decision will provide the supplier and the beneficiary assurance 
that the beneficiary, based on the information submitted with the request, will meet the 
medical necessity requirements Medicare has established for the item. An affirmative 
ADMC decision does not provide assurance that the beneficiary meets Medicare 
eligibility requirements nor does it assure that any other Medicare requirements (MSP, 
etc.) have been met. Only upon submission of a complete claim, can the DME MAC 
make a full and complete determination. 
 
An affirmative ADMC decision does not extend to the price that Medicare will pay for 
the item. 
 
An affirmative ADMC decision is valid for a period of 6 months from the date the 
decision is rendered. Oftentimes, beneficiaries who require customized DME are subject 
to rapid changes in medical condition. These changes may obviate the need for a 
particular item, either because the beneficiary's condition improved or deteriorated. For 
this reason, the date the item was provided to the beneficiary cannot be more than 6 
months after the date the ADMC decision was made. 
 
The DME MACs reserve the right to review claims on a pre- or post-payment basis and, 
notwithstanding the requirements of this section, may deny claims and take appropriate 
remedy if they determine that an affirmative ADMC decision was made based on 
incorrect information. 
 
5.18.5  Negative ADMC Decisions 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
A negative ADMC decision communicates to the supplier and the beneficiary that, based 
on the information submitted with the request, the beneficiary does not meet the medical 
necessity requirements Medicare has established for the item. The negative ADMC 
decision should indicate why the request was denied.   
A beneficiary or a supplier can resubmit an ADMC request if additional medical 
documentation is obtained that could affect the prior negative ADMC decision. However, 
requests may only be submitted once during a 6-month period. 
 
5.19 - DME MAC Tracking 
(Rev. 10190; Issued: 06-19-2020; Effective: 01-01-2020; Implementation: 07-01-
2020) 
 
The DME MACs shall develop the capability to track ADMC requests in order to assure 
that decisions are rendered in a timely and appropriate fashion. DME MACs shall also 
develop the capability to ensure that: 1) items for which an affirmative ADMC decision 
was made are not denied as not meeting the medical necessary requirements of the 
policy, and 2) claims for item that received a negative ADMC decision are denied as not 
covered, unless additional medical documentation submitted with the claims supports 
coverage. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Transmittals Issued for this Chapter 
  Rev #  Issue Date  Subject  Impl Date  CR# 
R11431PI 05/26/2022  Publication (Pub.) 100-08, Chapter 5 Update  06/28/2022 12726 
- Planned Elimination of Certificates of 
Medical Necessity (CMN) and Durable 
Medical Equipment Information (DIF) Forms 
R11032PI 09/30/2021  Updates to Chapters 1, 3, 4, 5, 8 and 9 of  11/10/2021 12375 
Publication (Pub.) 100-08 
R10984PI 09/09/2021  Updates to Chapters 1, 3, 4, 5, 8 and 9 of  11/10/2021 12375 
Publication (Pub.) 100-08  Rescinded and 
replaced by transmittal 11032 
R10749PI 05/11/2021  Updates to Chapter 4 and Chapter 5 of  06/11/2021 12257 
Publication (Pub.) 100-08 
R10538PI 12/30/2020  Clarifying The Use of As-Needed/PRN  12/29/2020 11997 
Orders for Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies 
(DMEPOS) 
R10492PI 11/25/2020  Clarifying The Use of As-Needed/PRN  12/29/2020 11997 
Orders for Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies 
(DMEPOS) 
R10190PI 06/19/2020  Revising Chapters 3 and 5 of Publication  07/01/2020 11599 
(Pub.) 100-08, to Reflect the Recent Final 
Rule CMS-1713-F 
R834PI  10/12/2018  Order Requirements When Prescribing  11/13/2018 10984 
Practitioner is Also the Supplier and is 
Permitted to Furnish Specific Items of 
Durable Medical Equipment, Prosthetics, 
Orthotics, and Supplies (DMEPOS) 
R812PI  07/27/2018  Clarify Detailed Written Orders For Durable  08/28/2018 10345 
Medical Equipment, Prosthetics, Orthotics, 
And Supplies (DMEPOS) 
R806PI  07/06/2018  Clarify Detailed Written Orders For Durable  08/07/2018 10345 
Medical Equipment, Prosthetics, Orthotics, 
And Supplies (DMEPOS)  Rescinded and 
replaced by Transmittal 812 
R750PI  10/20/2017  Proof of Delivery Documentation  11/20/2017 10324 
Requirements 
R753PI  10/27/2017  Certificates of Medical Necessity (CMN) and 11/28/2017 10244 
Durable Medical Equipment (DME) 
Information Forms (DIF) 
R733PI  07/27/2017  Clarification of Certificate of Medical  08/28/2017 10148 
Necessity (CMN) and Durable Medical  Rev #  Issue Date  Subject  Impl Date  CR# 
Equipment Information Forms (DIFs) 
R722PI  05/26/2017  Clarifying Date and Timing Requirements  06/27/2017 10106 
for Certain Durable Medical Equipment 
Prosthetics Orthotics and Supplies 
(DMEPOS) 
R705PI  03/24/2017  Durable Medical Equipment, Prosthetics,  04/24/2017 9886 
Orthotics, and Supplies (DMEPOS) Order 
Requirements for Changing Suppliers 
R693PI  12/30/2016  Clarification of Appeal Rights for Denials  01/31/2017 9910 
Stemming from Statutory Requirements 
R672PI  08/19/2016  Documentation for Durable Medical  11/23/2016 9741 
Equipment Prosthetics, Orthotics and 
Supplies (DMEPOS) Claims for 
Replacement of Essential Accessories for 
Beneficiary-Owned Continuous Positive 
Airway Pressure (CPAP) Devices and 
Respiratory Assist Devices (RADs) 
R662PI  07/01/2016  Date and Timing Requirements  08/01/2016 9679 
R641PI  02/19/2016  Proof of Delivery in Nursing Facilities  03/19/2016 9524 
R623PI  11/03/2015  Written Orders Prior to Delivery (WOPD)  10/10/2015 9364 
R618PI  10/09/2015  Written Orders Prior to Delivery (WOPD)   10/10/2015 9364 
Rescinded and replaced by Transmittal 623 
R612PI  09/10/2015  Changes to Supplier Documentation and  09/29/2015 9063 
Evidence of Medical Necessity for Oxygen 
Claims 
R611PI  08/28/2015  Changes to Supplier Documentation and  09/29/2015 9063 
Evidence of Medical Necessity for Oxygen 
Claims  Rescinded and replaced by 
Transmittal 612 
R608PI  08/14/2015  Update to Pub. 100-08 to Provide Language- 09/14/2015 8747 
Only Changes for Updating ICD-10 and ASC 
X12 
R598PI  06/12/2015  Proof and Date of Delivery  07/13/2015 9194 
R546PI  10/17/2014  Documentation for Durable Medical  11/04/2014 8952 
Equipment Prosthetics, Orthotics and 
Supplies (DMEPOS) Repair Claims. This CR 
rescinds and fully replaces CR 8843. 
R533PI  08/01/2014  Documentation for Durable Medical  11/04/2014 8843 
Equipment Prosthetics, Orthotics and 
Supplies (DMEPOS) Repair Claims   Rev #  Issue Date  Subject  Impl Date  CR# 
Rescinded and replaced by CR 8952, 
Transmittal 546 
R528PI  07/03/2014  Proof of Delivery  08/05/2014 8643 
R468PI  05/31/2013  Detailed Written Orders and Face-to-Face  07/01/2013 8304 
Encounters 
R460PI  04/19/2013  Clarify the Definition of Customized Durable 07/19/2013 8194 
Medical Equipment (DME) Items 
R378PI  07/01/2011  Prospective Billing for Refills of DMEPOS  08/02/2011 7452 
Items Provided on a Recurring Basis 
R281PI  12/31/2008  Signature and Date Stamps for DME  02/02/2009 6261 
Supplies-CMNs and DIFs 
R242PI  02/22/2008  Items and Special Services Having Special  03/01/2008 5909 
DME Review Considerations 
R168PI  10/31/2006  DMEPOS Transcutaneous Electrical Nerve  01/02/2007 5107 
Stimulators (TENS) Certificate of Medical 
Necessity (CMN) for Purchases:  Form 
CMS-848 
R167PI  10/27/2006  New DMEPOS Certificates of Medical  10/01/2006 4296 
Necessity (CMNs) and DME Information 
Forms (DIFS) for Claims Processing 
R166PI  10/06/2006  DMEPOS Transcutaneous Electrical Nerve  01/02/2007 5107 
Stimulators (TENS) Certificate of Medical 
Necessity (CMN) for Purchases:  Form 
CMS-848  Replaced by Transmittal 168 
R159PI  09/22/2006  New DMEPOS Certificates of Medical  10/02/2006 4296 
Necessity (CMNs) and DME Information 
Forms (DIFS) for Claims Processing  
Replaced by Transmittal 167 
R157PI  08/25/2006  Evidence of Medical Necessity: Wheelchair  10/16/2006 5128 
and Power-Operated Vehicle (POV) Claims 
(Clarification of CR 3952, Transmittal 128, 
Dated October 28, 2005) 
R156PI  08/18/2006  Evidence of Medical Necessity: Wheelchair  09/18/2006 5128 
and Power-Operated Vehicle (POV) Claims 
(Clarification of CR 3952, Transmittal 128, 
Dated October 28, 2005)- Replaced by 
Transmittal R157 
R142PI  03/02/2006  New DMEPOS Certificates of Medical  10/02/2006 4296 
Necessity (CMNs) and DME MAC 
Information Forms (DIFS) for Claims  Rev #  Issue Date  Subject  Impl Date  CR# 
Processing - Replaced by Transmittal 159 
R138PI  02/10/2006  New DMEPOS Certificates of Medical  10/02/2006 4296 
Necessity (CMNs) and DME MAC 
Information Forms (DIFS) for Claims 
Processing - Replaced by Transmittal 142 
R128PI  10/28/2005  Evidence of Medical Necessity: Wheelchair  10/25/2005 3952 
and Power Operated Vehicle (POV) Claims 
R124PI  09/23/2005  Evidence of Medical Necessity: Wheelchair  10/25/2005 3952 
and Power Operated Vehicle (POV) Claims - 
Replaced by Transmittal 128 
R121PI  09/14/2005  Evidence of Medical Necessity: Wheelchair  10/17/2005 3952 
and Power Operated Vehicle (POV) Claims - 
Replaced by Transmittal 124 
R100PI  01/21/2005  Review of Documentation During Medical  02/22/2005 3644 
Review 
R071PI  04/09/2004  Rewrite of Program Integrity Manual (except  05/10/2004 3030 
Chapter 10) to Apply to PSCs 
R061PI  01/02/2004  Clarification of Proof of Delivery  02/02/2004 2903 
Requirements 
R059PI  11/28/2003  Written Orders  01/05/2004 2937 
R050PI  09/26/2003  Advance Determination of Medicare  10/10/2003 2866 
Coverage (ADMC) Requests 
R048PIM 09/12/2003  Items Denied as not Meeting Benefit  10/01/2003 2872 
Category 
R037PI  01/17/2003  Written Orders  02/01/2003 2471 
R030PI  09/27/2002  Written Orders  10/15/2002 2202 
R016PIM 11/28/2001  Adds Various Program Memoranda for BI  11/28/2001 1732 
Requests for Information, Organizational 
Requirements, Unsolicited Voluntary Refund 
Checks, Anti-Kickback Statute Implications 
R011PIM 09/18/2001  Completing a CMN  09/24/2001 1773 
R005PIM 02/26/2001  Advance Determination of Medicare  07/2001  1187 
Coverage (ADMC) of Customized Durable 
Medical Equipment (DME) 
R004PIM 01/31/2001  Physician Assistant Rules Concerning Orders 01/31/2001 1471 
and CMNs 
R003PIM 11/22/2000  Complete Replacement of PIM Revision 1.  NA  1292 
R001PIM 06/2000  Initial Release of Manual  NA  931  Back to top of chapter