Standard Documentation Requirements for All Claims Submitted to DME MACs

Many errors reported in Medicare audits are due to claims submitted with
incomplete or missing requisite documentation. Consequently, the Durable
Medical Equipment Medicare Administrative Contracts (DME MACs) have created
guidance to assist Durable Medical Equipment, Prosthetics, Orthotics and
Supplies (DMEPOS) suppliers in understanding the information necessary to
justify payment.

The documentation requirements are compiled from Statutes, Code of Federal
Regulations, Centers for Medicare and Medicaid Services (CMS) National
Coverage Determinations (NCDs), CMS rulings and sub-regulatory guidance (CMS
manuals), and DME MAC publications. This article sets out the general
requirements that are applicable to all DMEPOS claims submitted to the DME
MACs.

Documentation must be maintained in the supplier's files for seven (7) years
from date of service (DOS).

*****IMPORTANT*****

**All Policy Specific Documentation Requirements are located in the LCD-
related Policy Article, which is linked to the applicable LCD.**

**It is important that suppliers review the actual LCD, the related Policy
Article, and the Standard Documentation Requirements (SDR) article to be sure
to have all of the relevant information necessary and applicable to the
item(s) provided.**

_**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.**_

**ORDERS**

GENERAL

All claims for items billed to Medicare require a written order/prescription
from the treating practitioner as a condition for payment.

This written order/prescription is referred to as the Standard Written Order
(SWO) (see below).

"All claims" refers to all claims submitted for payment of purchases or
rentals to Medicare Part B.

The term "treating practitioner" is used throughout this document and except
where specifically noted, refers to physician, as defined in section 1861(r)
of the Social Security Act, or physician assistant (PA), nurse practitioner
(NP), or clinical nurse specialist (CNS), as those terms are defined in
section 1861(aa)(5) of the Social Security Act _._

The name and National Provider Identifier (NPI) of the treating practitioner
on the order/prescription for the item or service shall be used on the claim
submitted to the DME MAC. The order/prescription shall be kept on file and
made available upon request.

Items dispensed and/or billed that do not meet these order/prescription
requirements and those below must be submitted with an EY modifier added to
each affected HCPCS code.

Certain items require an order based on statute (e.g., therapeutic shoes for
diabetics, oral anticancer drugs, and oral antiemetic drugs which are a
replacement for intravenous antiemetic drugs). In such instances, if statutory
requirements related to the order are not met, the claim will be denied as not
meeting the benefit category.

For DMEPOS items other than PMDs, someone other than the treating practitioner
may complete certain required elements of the SWO; however, the SWO must be
signed by the treating practitioner.

Prescribing of DMEPOS is limited by Medicare regulations and by the treating
practitioner's respective scope of practice as determined by the state wherein
they practice. Chiropractors are not permitted to prescribe DMEPOS items.

NEW ORDER REQUIREMENTS

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;
  * 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.

STANDARD WRITTEN ORDER (SWO)

A SWO must be communicated to the supplier prior to claim submission. For
certain items of DMEPOS, a written order is required prior to delivery (WOPD)
of the item(s) to the beneficiary (see below).

A SWO must contain all of the following elements:

  * Beneficiary's name or Medicare Beneficiary Identifier (MBI)
  * Order Date
  * General description of the item
    * The description can be either a general description (e.g., wheelchair or hospital bed), a HCPCS code, a HCPCS code narrative, or a brand name/model number
    * For equipment - In addition to the description of the base item, the 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 DMEPOS order/prescription may include all concurrently ordered supplies that are separately billed (List each separately)
  * Quantity to be dispensed, if applicable
  * Treating Practitioner Name or NPI
  * Treating practitioner's signature

Signatures must comply with the CMS signature requirements outlined in the
Medicare Program Integrity Manual (CMS Pub.100-08), Chapter 3, Section
3.3.2.4. Signature and date stamps are not allowed.

Upon request by a contractor, DMEPOS suppliers must provide documentation of
the completed SWO.

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
SWO is not required. However, the medical record must still contain all of the
required SWO elements.

WRITTEN ORDERS PRIOR TO DELIVERY (WOPD)

A WOPD is a completed SWO that is communicated to the DMEPOS supplier before
delivery of the item(s).

Pursuant to Final Rule 1713 (84 Fed. Reg Vol 217), CMS may select DMEPOS items
appearing on the Master List of DMEPOS Items potentially subject to a Face-to-
Face Encounter and WOPD requirement and include them on a Required List.

The Required List will be comprised of:

  * Statutorily required DMEPOS items such as Power Mobility Devices (PMDs); and
  * Additional DMEPOS items selected by CMS appearing on the Required List.

Items appearing on the Required List are subject to the face-to-face encounter
and WOPD requirements.

CMS and the DME MACs will post on their websites the Required List of the
selected HCPCS codes, once published through the Federal Register Notice, and
the Required List will be periodically updated. The current required Face-to-
Face Encounter and Written Order Prior to Delivery List is available
[here](https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-
Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).

Note that the face-to-face encounter and WOPD requirements are statutorily
required for PMDs, and in accordance with this statutory obligation, both will
continue to be required, and will be included in any future publications of
the Required List.

The date of the WOPD shall be on or before the date of delivery.

A WOPD must be completed within six (6) months after the required face-to-face
encounter.

For PMDs, following the face-to-face encounter, the treating practitioner must
complete the WOPD of the item pursuant to 1834(a)(1)(E)(iv). The term
"treating practitioner" for PMDs is defined as both physicians (defined in
section 1861(r)(1) of the Social Security Act) and non-physician practitioners
(i.e., PA, NP, and CNS); defined in section 1861(aa)(5) of the Social Security
Act.

Upon request by a contractor, DMEPOS suppliers must provide documentation of
the completed WOPD.

**DOCUMENTATION REQUIREMENTS**

GENERAL

There are numerous CMS manual requirements, reasonable and necessary (R&N)
requirements, benefit category, and other statutory and regulatory
requirements that must be met in order for payment to be justified. In the
event of a claim review, a DMEPOS supplier must provide sufficient information
to demonstrate that the applicable criteria have been met thus justifying
payment.

Before submitting a claim to Medicare, the DMEPOS supplier must have on file
SWO,  a WOPD (if applicable), a CMN (if applicable), a 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 in order 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 Advance Beneficiary Notice of Noncoverage
(ABN) of possible denial has been obtained.

CMS requires that in the event of an audit, the MACs, CERT, SMRC, Recovery
Auditors, and UPICs shall determine that an item/service is correctly coded.
The supplier must have on file a description of items provided to the
beneficiary in sufficient detail to determine the accuracy of claims coding
including a description of the items(s) delivered. The description can be
either a narrative description (e.g., lightweight wheelchair base), a HCPCS
code, the long description of a HCPCS code, or a brand name/model number.

Reimbursement shall be based on the specific utilization amount that is
supported by contemporaneous medical records.

Documentation must be maintained in the supplier's files for seven (7) years
from DOS.

If the Medicare qualifying supplier documentation is older than 7 years, proof
of continued _medical necessity of the item or necessity of the repair_ can be
used as the supporting Medicare qualifying documentation.

REASONABLE AND NECESSARY CRITERIA (R&N)

CMS National Coverage Determinations (NCDs) and contractor Local Coverage
Determinations (LCDs) describe the requirements that must be met for an item
to be considered R&N. These R&N criteria are often referred to as medical
necessity.

MEDICAL RECORD DOCUMENTATION

In the event of a claim review, information contained directly in the
contemporaneous medical record is the source required to justify payment
except as noted elsewhere for prescriptions and CMNs (for DOS prior to
01/01/2023). The medical record is not limited to treating practitioner's
office records but may include records from hospitals, nursing facilities,
home health agencies, other healthcare professionals, etc. (not all-
inclusive). Records from suppliers or healthcare professionals with a
financial interest in the claim outcome are not considered sufficient by
themselves for determining that an item is reasonable and necessary. DMEPOS
suppliers are reminded that:

  * Supplier prepared statements and physician attestations by themselves do not provide sufficient documentation of medical necessity, even if signed by the ordering physician.
  * Templates and forms, including CMS CMNs prior to DOS 01/01/2023, are subject to corroboration with information in the medical record.
  * A prescription is not considered to be part of the medical record, except in the case of documenting medical necessity for replacement prosthetic limbs. Medical information intended to demonstrate compliance with coverage criteria may be included on the prescription but must be corroborated by information contained in the medical record.
  * The beneficiary's medical record must contain sufficient documentation of the beneficiary's 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 beneficiary's diagnosis and other pertinent information including, but not limited to, duration of the beneficiary's condition, clinical course (worsening or improvement), prognosis, nature and extent of functional limitations, other therapeutic interventions and results, past experience with related items, etc.

In addition to the general requirements discussed above, certain DMEPOS items
may have specific documentation requirements. Details regarding these policy
specific requirements are contained in the applicable LCD-related Policy
Article.

CONTINUED MEDICAL NEED

For all DMEPOS items, the initial justification for medical need is
established at the time the item(s) is first ordered; therefore, beneficiary
medical records demonstrating that the item is reasonable and necessary are
created just prior to, or at the time of, the creation of the initial
prescription. For purchased items, initial months of a rental item or for
initial months of ongoing supplies or drugs, information justifying
reimbursement will come from this timeframe. Entries in the beneficiary's
medical record must have been created prior to, or at the time of, the initial
DOS to establish whether the initial reimbursement was justified based upon
the applicable coverage policy.

For ongoing supplies and rented DME items, in addition to information
described above that justifies the initial provision of the item(s) and/or
supplies, there must be information in the beneficiary's medical record to
support that the item continues to remain reasonable and necessary.
Information used to justify continued medical need must be timely for the DOS
under review. Any of the following may serve as documentation justifying
continued medical need:

  * A recent order/prescription by the treating practitioner for refills of supplies;
  * A recent order/prescription by the treating practitioner for repairs;
  * A recent change in an order/prescription;
  * A properly completed CMN or DIF obtained prior to DOS 01/01/2023, with an appropriate length of need specified;
  * Timely documentation in the beneficiary's medical record showing usage of the item.

Timely documentation is defined as a record in the preceding 12 months unless
otherwise specified elsewhere in the policy.

For some items, the initial justification for medical need establishes that
the condition necessitating the item is permanent. As a result, once the
benefit category is met (or continues to be met), ongoing documentation of
medical need is not required. Refer to the LCD-related Policy Articles for
clarification regarding exceptions to ongoing justification for continued
medical need.

CONTINUED USE

Continued use describes the ongoing utilization of supplies or a rented item
by a beneficiary.

Suppliers are responsible for monitoring utilization of DMEPOS rental items
and supplies. No monitoring of purchased items or capped rental items that
have converted to a purchase is required. Suppliers must discontinue billing
Medicare when rental items or ongoing supply items are no longer being used by
the beneficiary.

Beneficiary medical records or supplier records may be used to confirm that a
DMEPOS item continues to be used by the beneficiary. Any of the following may
serve as documentation that an item submitted for reimbursement continues to
be used by the beneficiary:

  * Timely documentation in the beneficiary's medical record showing usage of the item, related option/accessories and supplies;
  * Supplier records documenting the request for refill/replacement of supplies in compliance with the REFILL DOCUMENTATION REQUIREMENTS section. This is deemed sufficient to document continued use for the base item, as well;
  * Supplier records documenting beneficiary confirmation of continued use of a rental item.

Timely documentation is defined as a record in the preceding 12 months unless
otherwise specified elsewhere in this policy.

CLAIM NARRATIVES

Most DMEPOS accessory/supply items provided on a recurring basis can be
dispensed with a three-month supply. Please review the REFILL REQUIREMENTS
section of each individual LCD for further details. When billing more than one
month's supply of these items, include a narrative in the NTE segment of the
electronic claim indicating the number of months you are billing. For example,
if you bill a three-month supply of PAP accessories (i.e., mask, tubing,
cushions), you must add "90-day supply" or "three-month supply". This
additional information is required so that the DME MACs can correctly process
the claim.

DATE SPANS ON CLAIMS

The following DMEPOS items require a date span on all claims submitted to the
DME MACs:

  * Diabetic testing supplies (i.e., test strips, lancets)
  * Continuous passive motion devices (CPM)
  * Parenteral and enteral nutrition
  * Parenteral and enteral administration kits
  * External infusion pump supplies (Recommended)

Suppliers must span the dates of service using "From" and "To" dates on any
electronic or paper claim for the items listed above. The "From" date is when
the items were provided to the Medicare beneficiary. The "To" date is the last
date the supplies are expected to be used. For example, if you are providing a
three-month supply (January - March 2019) of diabetic testing supplies for a
beneficiary, the "From" date on the claim would be "01/01/2019" and the "To"
date would be "03/31/2019". This additional information is required so that
the DME MACs can correctly process the claim.

REFILL DOCUMENTATION REQUIREMENTS

This section contains general refill requirements that pertain to all
policies. Refer to the applicable LCD for policy specific refill requirements.

A routine prescription for refills is not needed.

For items that the beneficiary obtains in-person at a retail store, the signed
delivery slip or a copy of the itemized sales receipt is sufficient
documentation of a request for refill.

For items that are delivered to the beneficiary, documentation of a request
for refill must be 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. The refill request must occur and be
documented before shipment. A retrospective attestation statement by the
supplier or beneficiary is not sufficient.

The refill record must include:

  * Beneficiary's name or authorized representative if different from the beneficiary
  * A description of each item that is being requested
  * Documentation of affirmative response indicating a need for refill
  * Date of refill request

This information must be kept on file and be available upon request.

PROOF OF DELIVERY (POD)

42 CFR 424.57(c)(12) requires suppliers to maintain POD documentation in their
files.

POD documentation, as well as claims documentation, must be maintained in the
supplier's files for 7 years (starting from the DOS).

No billing may be made for any DMEPOS to the DME MAC prior to the date of
discharge from an inpatient facility. A supplier may deliver a DME,
prosthetics, or orthotics item (but not supplies) to a beneficiary in an
inpatient facility that does not qualify as the beneficiary's home, for the
purpose of fitting or training the beneficiary in the proper use of the item.
This delivery may be done up to two (2) days prior to the beneficiary's
anticipated discharge to their home. The supplier must bill the date of
service on the claim as the date of discharge and the supplier must ensure
that the beneficiary takes the item home, or the supplier picks up the item at
the facility and delivers it to the beneficiary's home on the date of
discharge. Any attempt by the supplier and/or facility to substitute an item
that is payable to the supplier for an item that, under statute, should be
provided by the facility, may be considered fraudulent.

Suppliers, their employees, or anyone else having a financial interest in the
delivery of the item(s) are prohibited from signing and accepting an item on
behalf of a beneficiary (i.e., acting as a designee on behalf of the
beneficiary). The relationship of the designee to the beneficiary should be
noted on the delivery slip obtained by the supplier (i.e., spouse, neighbor).
The signature of the designee should be legible. If the signature of the
designee is not legible, the supplier/shipping service should note the name of
the designee on the delivery slip.

For the purpose of the delivery methods noted below, designee is defined as
any person who can sign and accept the delivery of DMEPOS on behalf of the
beneficiary.

The supplier should also have on file any documentation containing a
description of the item delivered to the beneficiary to determine the accuracy
of claims coding including, but not limited to, a voucher, invoice or
statement in the supplier records. A description of the items(s) delivered
must be noted on the POD. The description can be either a narrative
description (e.g., lightweight wheelchair base), a HCPCS code, the long
description of a HCPCS code, or a brand name/model number.

POD documentation must be available to the Medicare contractor on request. All
services that do not have appropriate POD from the supplier will be denied and
overpayments will be requested. Suppliers who consistently fail to provide
documentation to support their services may be referred to the Office of
Inspector General (OIG) or the National Supplier Clearinghouse for
investigation and/or imposition of sanctions. As a general Medicare rule, the
date of service shall be the date of delivery. There are three methods of
delivery. Regardless of the method of delivery, the contractor must be able to
determine that the item(s) delivered are the same item(s) submitted for
Medicare reimbursement and that the item(s) were received by a specific
beneficiary:

  * Delivery directly to the beneficiary or authorized representative
  * Delivery via shipping or delivery service
  * Delivery of items to a nursing facility on behalf of the beneficiary

Method 1--Direct Delivery to the Beneficiary by the Supplier

Suppliers may deliver directly to the beneficiary or the designee. In this
case, POD to a beneficiary must be a signed and dated delivery document. The
POD document must include:

  * Beneficiary's name
  * Delivery address
  * A description of the item(s) being delivered. The description can be either a narrative description (e.g., lightweight wheelchair base), a HCPCS code, the long description of a HCPCS code, or a brand name/model number
  * Quantity delivered
  * Date delivered
  * Beneficiary (or designee) signature

The date delivered on the POD must be the date that the DMEPOS item was
received by the beneficiary or designee. The date of delivery may be entered
by the beneficiary, designee, or the supplier. When the supplier's delivery
documents have both a supplier-entered date and a beneficiary or beneficiary's
designee signature date on the POD document, the beneficiary (or designee)
entered date is the DOS.

In instances where the supplies are delivered directly by the supplier, the
date the beneficiary received the DMEPOS supply must be the DOS on the claim.

Method 2--Delivery via Shipping or Delivery Service Directly to a Beneficiary

If the supplier utilizes a shipping service or mail order, the POD
documentation must be a complete record tracking the item(s) from the DMEPOS
supplier to the beneficiary. An example of acceptable POD would include both
the supplier's own detailed shipping invoice and the delivery service's
tracking information. The supplier's record must be linked to the delivery
service record by some clear method like the delivery service's package
identification number or supplier's invoice number for the package sent to the
beneficiary. The POD document must include:

  * Beneficiary's name
  * Delivery address
  * Delivery service's package identification number, supplier invoice number, or alternative method that links the supplier's delivery documents with the delivery service's records
  * A description of the item(s) being delivered. The description can be either a narrative description (e.g., lightweight wheelchair base), a HCPCS code, the long description of a HCPCS code, or a brand name/model number
  * Quantity delivered
  * Date delivered
  * Evidence of delivery

If a supplier utilizes a shipping service or mail order, suppliers have two
options for the DOS to use on the claim:

  1. Suppliers may use the shipping date as the DOS. The shipping date is defined as the date the delivery/shipping service label is created or the date the item is retrieved by the shipping service for delivery. However, such dates should not demonstrate significant variation.
  2. Suppliers may use the date of delivery as the DOS on the claim. 

Suppliers may also utilize a return postage-paid delivery invoice from the
beneficiary or designee as POD. This type of POD document must contain the
information specified above.

Method 3--Delivery to Nursing Facility on Behalf of a Beneficiary

For items directly delivered by the supplier to a nursing facility or when a
delivery service or mail order is used to deliver the item(s) to a nursing
facility, the supplier must have:

  * Documentation demonstrating delivery of the item(s) to the facility by the supplier or delivery entity; and,
  * Documentation from the nursing facility demonstrating receipt and/or usage of the item(s) by the beneficiary. The quantities delivered and used by the beneficiary must justify the quantity billed.

**CORRECT CODING**

Healthcare Common Procedure Coding System (HCPCS) CODING

The Medicare Program Integrity Manual (CMS Pub. 100-08), Chapter 3, Sections
3.3.B and 3.6.2.4 specify that for Medicare claims, only CMS and the Durable
Medical Equipment Medicare Administrative Contractors (DME MACs) have the
authority to establish HCPCS Level II Coding Guidelines. Pursuant to 42 CFR 
414.40 and 45 CFR  162.1002, CMS has the authority to assign and manage HCPCS
codes (create, delete, change code narrative etc.). The DME MACs have the
authority to evaluate products to make benefit category and coding
determinations for any DME item that does not logically fall into any of the
generic categories listed in NCD 280.1.

Correct HCPCS coding is a determination that the item provided to a
beneficiary is billed using the appropriate HCPCS code for that item.
Suppliers are required to correctly code for the item billed. An item/service
is correctly coded when it meets all the coding guidelines listed in CMS HCPCS
guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles.

The Pricing, Data Analysis, and Coding (PDAC) contractor maintains product
listings for many HCPCS codes on their [website](https://www.dmepdac.com/)
(Select, DMECS to search for HCPCS codes and associated product lists). Not
every HCPCS code has a product classification list; but reviewed products are
added to the listings for each code as coding determinations are completed.
For Medicare claim purposes, this product classification listing is accepted
as evidence of correct coding.

Each supplier is ultimately responsible for the HCPCS code they select to bill
for the item provided. Resources such as LCDs, LCD-related Policy Articles,
DME MAC articles, code determinations letters and DMECS are useful; but many
products currently on the market have not been reviewed. For these un-reviewed
products, each supplier must use their best judgment in selecting HCPCS codes
for billing and are encouraged to check with The PDAC Contact Center, which
can provide information that will assist in correct code selection.

_**Information that is sufficiently detailed to unambiguously identify the
specific product delivered to the beneficiary and the HCPCS code used to bill
for that item must be maintained by the supplier and be available upon
request.**_

Not Otherwise Classified (NOC) BILLING INFORMATION

Items billed with any HCPCS code with a narrative description that indicates
miscellaneous, NOC, unlisted, or non-specified, must also include the
following information in loop 2400 (line note), segment NTE02 (NTE01=ADD) of
the ANSI X12N, version 5010A1 professional electronic claim format or on Item
19 of the paper claim form:

  * Description of the item or service
  * Manufacturer name
  * Product name and number
  * Supplier Price List (PL) amount
  * HCPCS code of related item (if applicable)

Miscellaneous HCPCS codes billed without this information will be rejected and
will need to be resubmitted with the missing information included.

If you have questions, please contact the PDAC HCPCS Helpline at (877)
735-1326 during the hours of 9:30 a.m. to 5:00 p.m. ET, Monday through Friday.
You may also visit the PDAC [website](https://www.dmepdac.com/) to chat with a
representative or select the Contact Us button at the top of the page for
email inquiry, FAX or postal mail information.

EQUIPMENT RETAINED FROM A PRIOR PAYER

When a beneficiary receiving a DMEPOS item from another payer (including a
Medicare Advantage plan) becomes eligible for the Medicare Fee For Service
(FFS) program, the first Medicare claim for that item or service is considered
a new initial Medicare claim. Medicare does not automatically continue
coverage for any item obtained from another payer when a beneficiary
transitions to Medicare coverage.

For Medicare to provide payment, the beneficiary must meet all Medicare
coverage, coding, and documentation requirements for the DMEPOS items in
effect on the DOS of the initial Medicare claim.

A POD is required for all items, even those in the beneficiary's possession
provided by another insurer prior to Medicare eligibility.

PROOF OF DELIVERY REQUIREMENTS FOR RECENTLY ELIGIBLE MEDICARE FFS

The supplier record must document:

  * A statement, signed and dated by the beneficiary (or beneficiary's designee), that the supplier has examined the item, meets the POD requirements; and
  * A supplier attestation that the item meets Medicare requirements.

For the purposes of reasonable useful lifetime and calculation of continuous
use, the first day of the first rental month in which Medicare payments are
made for the item (i.e., DOS) serves as the start date of the reasonable
useful lifetime and period of continuous use. In these cases, the POD
documentation serves as evidence that the beneficiary is already in possession
of the item.

FACE-TO-FACE ENCOUNTER

As a condition for payment, 42 CFR 410.38 and Final Rule 1713 (84 Fed. Reg Vol
217) require that a treating practitioner have a face-to-face encounter with a
beneficiary within the six (6) months prior to prescribing items that appear
on the Required List.

The face-to-face encounter must support payment for the item(s)
ordered/prescribed, 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.

This face-to-face requirement also includes examinations conducted via the
CMS-approved use of telehealth examinations, which must meet the requirements
of 42 CFR  410.78 and 414.65 for purposes of DMEPOS coverage.

A WOPD must be completed within six (6) months after the required face-to-face
encounter.

Refer to the applicable LCD-related Policy Article NON-MEDICAL NECESSITY
COVERAGE AND PAYMENT RULES section for more information regarding
documentation requirements.

The 6-month timing requirement does not supplant other coverage or
documentation requirements.

There must be sufficient medical information included in the medical record to
demonstrate that all other applicable coverage criteria are met. Refer to the
applicable Local Coverage Determination for information about the medical
necessity criteria for the item(s) being ordered.

For items other than PMDs that appear on the Required List, the treating
practitioner that conducted the face-to-face encounter does not need to be the
prescriber for the DMEPOS item; however, the prescriber must:

  * Verify that a qualifying face-to-face encounter occurred within the 6-months prior to the date of their prescription; and,
  * Have documentation of the qualifying face-to-face encounter that was conducted.

A qualifying face-to-face encounter is required each time a new
order/prescription for one of the specified items on the Required List is
ordered.

CMS and the DME MACs will post on their websites the Required List of selected
HCPCS codes, which will be published through the Federal Register Notice, and
periodically updated.

Upon request by a contractor, all DMEPOS suppliers must provide documentation
of the face-to-face encounter.

**CERTIFICATE OF MEDICAL NECESSITY (CMN) & DME INFORMATION FORM (DIF)**

Providers and suppliers no longer need to submit Certificate of Medical
Necessity (CMN) or DME Information Form (DIF) for services rendered on or
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 - If the CMN or DIF is required, it must be submitted with the claim, or be on file with a previous claim.

For dates of service for which a CMN is required, a CMN, which has been
completed, signed, and dated by the treating practitioner, must be kept on
file by the supplier and made available upon request. The CMN for XXX is CMS
Form ### (DME form ###). In addition to the order information that the
treating practitioner enters in Section B, the supplier can use the space in
Section C for a written confirmation of other details of the order or the
treating practitioner can enter the other details directly.

The CMN may act as a substitute for a SWO if it contains all the required
elements.

For items requiring both a CMN and a WOPD (e.g., items on the Required Face-
to-Face and WOPD List) suppliers may utilize a completed and treating
practitioner signed CMN for this purpose. Otherwise, a separate WOPD in
addition to a subsequently completed and signed CMN is necessary.

A new CMN is not required just because the supplier changes assignment status
on the submitted claim.

For certain items or services billed to a DME MAC, the supplier must receive a
signed CMN from the treating practitioner. For these items, a supplier must
have a signed original, faxed, photocopied, or electronic CMN in their records
when submitting a claim for payment to Medicare.

DME INFORMATION FORM

For dates of service for which a DIF is required, a DIF, which has been
completed, signed, and dated by the supplier, must be kept on file and made
available upon request. The DIF for XXX is CMS Form ### (DME form ###).

The supplier must have a signed and dated DIF in their records when submitting
a claim for payment to Medicare.

**REPAIRS/REPLACEMENT**

GENERAL

For the purposes of Medicare reimbursement, repairs are not synonymous with
replacements. Repairs (parts and labor) of DMEPOS items are performed on the
base item. The replacement of parts or components that make up the base item
is considered to be a repair. Conversely, the furnishing of new separately
payable accessories that were not part of the initial base item is considered
to be replacement, which is addressed in the section below.

Replacement of a beneficiary owned DMEPOS item typically involves providing an
identical or nearly identical item.

REPAIRS

The definition of a repair is found in the Medicare Benefit Policy Manual (CMS
Pub. 100-02), Chapter 15, Section 110.2.A. That section generally defines
repair as to fix or mend and to put the item back in good condition after
damage or wear.

Repairs to items which a beneficiary owns are covered when necessary to make
the items serviceable. However, "routine periodic maintenance", such as
testing, cleaning, regulating, and checking is not covered.

Medicare does not separately reimburse for repairs of:

  * Items in the frequent and substantial servicing payment category; or,
  * Oxygen equipment; or,
  * Items in the capped rental payment category during the capped rental period; or,
  * Items covered under a manufacturer's or supplier's warranty; or,
  * Previously denied items.

A new CMN and/or treating practitioner's order is not needed for repairs.

In the case of repairs to a beneficiary-owned DMEPOS item, if Medicare paid
for the base item initially, medical necessity for the base item has been
established. With respect to Medicare reimbursement for the repair, there are
two documentation requirements:

  * The treating practitioner must document that the DMEPOS item being repaired continues to be reasonable and necessary (see Continued Medical Need section above); and,
  * Either the treating practitioner or the supplier must document that the repair itself is reasonable and necessary.

The supplier must maintain detailed records describing the need for and nature
of all repairs including a detailed explanation of the justification for any
component or part replaced as well as the labor time to restore the item to
its functionality.

REPLACEMENT

The definition of replacement is found in the Medicare Benefit Policy Manual
(CMS Pub. 100-02), Chapter 15, Section 110.2.C. That section generally defines
replacement as the provision of an entirely identical or nearly identical item
when it is lost, stolen or irreparably damaged.

Beneficiary owned items or a capped rental item may be replaced in cases of
loss or irreparable damage. Irreparable damage may be due to a specific
accident or to a natural disaster (e.g., fire, flood). Contractors may request
documentation confirming details of the incident (e.g., police report,
insurance claim report).

Replacement of items due to irreparable wear takes into consideration the
Reasonable Useful Lifetime (RUL) of the item. The RUL of DME is determined
through program instructions. In the absence of program instructions, carriers
may determine the RUL, but in no case can it be less than 5 years. If the item
has been in continuous use by the beneficiary on either rental or purchase
basis for its RUL, the beneficiary may elect to obtain a replacement.

Medicare does not cover replacement for items in the frequent and substantial
servicing payment category, oxygen equipment, or inexpensive or routinely
purchased rental items.

A treating practitioner's order and/or new CMN (prior to DOS 01/01/2023), when
required, is needed to reaffirm the medical necessity for replacement of an
item.

There are special rules for the replacement of artificial arms, legs and eyes.

Adjustments and repairs of prostheses and prosthetic components are covered
under the original order for the prosthetic device.

Medicare payment may be made for the replacement of prosthetic devices, which
are artificial limbs, or for the replacement of any part of such devices,
without regard to continuous use or useful lifetime restrictions if a treating
practitioner determines that the replacement device, or replacement part of
such a device, is necessary.

Claims involving the replacement of a prosthesis or major component (foot,
ankle, knee, socket etc.) must be supported by a new treating practitioner's
order and documentation supporting the reason for the replacement. The reason
for replacement must be documented by the treating practitioner, either on the
order or in the medical record, and must fall under one of the following:

  * A change in the physiological condition of the patient resulting in the need for a replacement. Examples include but are not limited to, changes in beneficiary weight, changes in the residual limb, beneficiary functional need changes; or,
  * An irreparable change in the condition of the device, or in a part of the device resulting in the need for a replacement; or,
  * The condition of the device, or the part of the device, requires repairs and the cost of such repairs would be more than 60 percent of the cost of a replacement device, or, as the case may be, of the part being replaced.

The prosthetist must retain documentation of the prosthesis or prosthetic
component replaced, the reason for replacement, and a description of the labor
involved irrespective of the time since the prosthesis was provided to the
beneficiary. This information must be available upon request. It is recognized
that there are situations where the reason for replacement includes but is not
limited to changes in the residual limb; functional need changes; or
irreparable damage or wear/tear due to excessive beneficiary weight or
prosthetic demands of very active amputees.

**SIGNATURE REQUIREMENTS**

All signatures must comply with the CMS signature requirements outlined in the
Medicare Program Integrity Manual (CMS Pub. 100-08), Chapter 3, Section
3.3.2.4.