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MEDICARE
A CMS Medicare Administrative Contractor
http://www.NGSMedicare.com
Jurisdiction B Supplier Manual: Chapter 8
September 2014 Update
Documentation
Documentation Overview
Before submitting a claim to the DME MAC, the supplier must have on file:
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A verbal/dispensing/preliminary order (if applicable)
Detailed written order
CMN (if applicable)
DIF (if applicable)
Proof of delivery
Beneficiary authorization
ABN (if applicable)
Information from the treating physician concerning the patient’s diagnosis, and
Any information required for the use of specific modifiers or attestation statements as defined in certain
DME 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 has 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 has been obtained for possible denial. Suppliers should
reference the local coverage determination and policy article for specific documentation requirements related to
the items being provided.
Documentation must be maintained in the supplier’s files for seven years.
Orders
All items billed to Medicare require a prescription. An order for each item billed must be signed and dated by the
treating physician, kept on file by the supplier, and made available to any Medicare contractor upon request.
Upon request by any Medicare contractor, the supplier must provide in a timely manner the detailed written order
that they received from the physician in a format that the Medicare contractor can accept. Medicare contractors
will accept any of the following forms of an order:
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An original “pen and ink” document
A photocopy
A facsimile image, or
An electronically maintained document
132_0914 Supplier Manual Update
Note: An electronically maintained document is one that has been created, modified, and stored via electronic
means, such as commercially available software packages and servers.
Items dispensed and/or billed that do not meet these prescription requirements and those listed below must be
submitted with an EY modifier added to each affected HCPCS code.
Dispensing Orders
Before dispensing any DMEPOS item to a beneficiary, the supplier must have an order from the treating
physician. Except for items requiring a detailed written order prior to delivery, the “dispensing” order may be either
a verbal order or a preliminary written order (original “pen and ink,” facsimile image, photocopy, or electronic).
Suppliers must keep a record of the dispensing order on file and this documentation must be available to any
Medicare contractor upon request.
The dispensing order must contain the following:
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Description of the item
Beneficiary’s name
Prescribing Physician’s name
Date of the order and the start date, if the start date is different from the date of the order
Physician signature (if a written order) or supplier signature (if verbal order)
For the date of the order, use the date the supplier is contacted by the physician (verbal) or the date entered by
the physician (written dispensing order). The dispensing order does not need to be as comprehensive as the
detailed written order, which is required before submitting a claim (see following section).
Note: If a written order prior to delivery is required or if a detailed written order is obtained prior to dispensing a
DMEPOS item a separate dispensing order is not required.
Written Order Prior to Delivery
A detailed written order prior to delivery is required for the following:
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Pressure reducing support surfaces (group 1, 2, and 3), including mattress overlays, air-fluidized beds,
and mattresses
Seat lift mechanisms
TENS units
Power operated vehicles
Power wheelchairs
Wheelchair seating
Negative pressure wound therapy pumps
Any HCPCS subject to Section 6407 of the Affordable Care Act, see below:
E0185
E0188
E0189
E0194
E0197
E0198
E0199
E0250
E0251
E0290
E0291
E0292
E0293
E0294
E0295
E0296
E0297
E0300
E0433
E0434
E0439
E0441
E0442
E0443
E0444
E0450
E0457
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E0470
E0471
E0472
E0480
E0482
E0483
E0484
E0570
E0457
E0629
E0636
E0650
E0651
E0652
E0655
E0666
E0667
E0668
E0693
E0694
E0720
E0730
E0731
E0740
E0744
E0745
E0747
E0782
E0783
E0784
E0786
E0840
E0849
E0850
E0855
E0856
E0968
E0969
E0971
E0973
E0974
E0978
E0980
E0981
E0982
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E0255
E0256
E0260
E0261
E0265
E0266
E1010
E1035
E1232
E1297
K0001
K0606
E0301
E0302
E0303
E0304
E0424
E0431
E1015
E1036
E1233
E1298
K0002
K0730
E0459
E0460
E0461
E0462
E0463
E0464
E1020
E1037
E1234
E1310
K0003
E0580
E0585
E0601
E0607
E0627
E0628
E1028
E1038
E1235
E2502
K0004
E0669
E0671
E0672
E0673
E0675
E0692
E1029
E1039
E1236
E2506
K0005
E0748
E0749
E0760
E0762
E0764
E0765
E1030
E1161
E1237
E2508
K0006
E0958
E0959
E0960
E0961
E0966
E0967
E1031
E1227
E1238
E2510
K0007
E0983
E0984
E0985
E0986
E0990
E0992
E0994
E1228
E1296
E2227
K0009
The supplier must have a detailed written order for these items (see following section)—original “pen and ink,”
facsimile image, photocopy, or electronic—which has been both signed and dated by the treating physician before
dispensing the item. For these items, if the supplier does not have a detailed written order prior to delivery, it will
be denied.
Note: Some HCPCS codes included in the chart above required a WOPD prior to the implementation of Section
6407 of the Affordable Care Act. If the HCPCS code is included in the chart above the WOPD must include the
prescribing practitioner’s NPI.
Detailed Written Orders
Before submitting a claim for any DMEPOS item to the DME MAC, the supplier must have a detailed written order
(original “pen and ink,” facsimile image, photocopy, or electronic) which has been both signed and dated by the
treating physician. This detailed written order is in addition to the dispensing order described above, unless the
dispensing order meets all the requirements specified in this section.
The supplier may not submit a claim based only on a verbal order. If an item requires a CMN, and if section C of
the CMN is sufficiently detailed, i.e., contains all the information described below, it may serve as the detailed
written order.
The DIF used for PEN and external infusion pumps cannot serve as the detailed written order since they are not
signed by the physician.
The detailed written order must contain all of the following:
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Beneficiary’s name
Prescribing Physician’s name
Date of the order and the start date of the order, if the start date is different from the date of the order
Detailed description of the item(s)
Physician signature and signature date
Prescribing practitioner’s NPI, if item is subject to Section 6407 of the Affordable Care Act
Items Provided on a Period Basis Including Drugs
For items provided on a periodic basis, including drugs, the detailed written order must also include:
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Item(s) to be dispensed
Dosage or concentration, if applicable
Route of administration, if applicable
Frequency of use
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Duration of infusion, if applicable
Quantity to be dispensed
Number of refills
Frequency of use information on orders must contain detailed instructions for use and specific amounts to be
dispensed. Reimbursement shall be based on the specific utilization amount only. Orders that only state “PRN” or
“as needed” utilization estimates for replacement frequency, use or consumption are not acceptable.
The detailed description of the item may be completed by someone other than the physician with exception of a
power mobility device seven element written order. However, the treating physician must review the detailed
description and personally sign and date the order to indicate agreement.
Signature and date stamps are not acceptable. Signatures must comply with the CMS signature requirements
outlined in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.4.
The detailed written order (required before submitting a claim) must be sufficiently detailed, including all options or
additional features which will be separately billed or which will require an upgraded code. The description can be
either a narrative description (e.g., lightweight wheelchair base) or a brand name/model number.
The diagnosis or ICD-9 code is not required on all written orders. Suppliers should refer to the specific local
coverage determination for the item being ordered to determine if a diagnosis is required on the order. The
diagnosis or ICD-9 code is required at the claim line level and must be specified to the most accurate fifth digit
(ex. 250.00). Suppliers are expected to work with their physicians and physician staff to ensure the proper and
most accurate diagnosis is billed. Documentation regarding the diagnosis should be found within the beneficiary’s
comprehensive medical record and a diagnosis on the order alone will not substantiate the need for the item
being ordered.
Requirements for New Orders
A routine refill prescription is not needed. A new order is required when:
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there is a change in the item(s), frequency of use, or amount prescribed
on a regular basis (even if there is no change in the order) only if it is so specified in the documentation
section of a particular medical policy
an item is replaced
there is a change in supplier
there is a change in length of need or a previously established length of need expires
by any state or federal laws
In cases where two or more suppliers merge, the resultant supplier should make all reasonable attempts to
secure copies of all active orders from the supplier(s) purchased. This document should be kept on file by the
resultant supplier and be available to the DME MAC on request.
For additional requirements for new orders please refer to the CMS IOM Publication 100-08, Medicare Program
Integrity Manual, Chapter 5, Section 5.2.4.
Section 6407 of the Affordable Care Act
Face-to-Face Encounter
Effective July 1, 2013 Section 6407 of the Affordable Care Act was implemented and established a face-to-face
encounter requirement for certain items of DME. The law requires a physician to document that the physician, PA,
NP, or CNS has had a face-to-face encounter with a beneficiary in the six months before the order is written for
certain items of DME. While active enforcement of the face-to-face requirements has been postponed until a
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future date to be announced in calendar year 2014, the delay does not impact provisions related to written orders
prior to delivery.
For additional information regarding Section 6407 of the Affordable Care Act and related documentation
requirements please refer to MLN Matters Article 8304.
Special Rules for Nurse Practitioners and Clinical Nurse Specialists
A nurse practitioner or clinical nurse specialist may provide the dispensing order and sign the detailed written
order if they satisfy all the following requirements:
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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 NPI, and
They are permitted to do all of the above in the state in which the services are rendered
Special Rules for Physician Assistants
A physician assistant may provide the dispensing order and may document and sign the detailed written order if
they satisfy all the following requirements:
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They meet the definition of a physician assistant found in Section 1861(aa)(5) of the Social Security Act
or Section 2156(A) of the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 5,
Section 5.5 and 5.6
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
For additional requirements regarding nurse practitioners, clinical nurses, and physician assistants please refer to
the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Sections 5.5 and 5.6.
Medical necessity information (e.g., an ICD-9-CM) diagnosis code, narrative description of the patient’s condition,
abilities, limitations, etc.) is not considered part of the order; although it may be entered on the same document as
the order.
Signature Requirements
CMS published instructions to contractors on signature requirements. Those requirements are found in the CMS
IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.3.2.4. (1 MB) They were
effective for claims with dates of service on or after March 1, 2010.
These guidelines apply not only to claims reviewed by the DME MAC but also to claims reviewed by the CERT
contractor, PSC, and RAC.
For medical review purposes, Medicare requires that all orders and medical records that are used in the
adjudication of claims be authenticated by the author. The method used must be a legible handwritten full
signature, handwritten initials, or electronic signature. Stamped signatures are generally not acceptable. However,
CMS will permit the use of a rubber stamp for signature in accordance with the Rehabilitation Act of 1973 in the
case of an author with a physical disability that can provide proof to a CMS contractor of his/her inability to sign
their signature due to their disability. By affixing the rubber stamp, the provider is certifying that they have
reviewed the document.
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Electronic Signature Protocols
Providers using electronic systems need to recognize that there is a potential for misuse or abuse with alternate
signature methods. For example, providers need a system and software products that are protected against
modification, etc., and should apply adequate administrative procedures that correspond to recognized standards
and laws. The individual whose name is on the alternate signature method and the provider bear the responsibility
for the authenticity of the information for which an attestation has been provided. Physicians are encouraged to
check with their attorneys and malpractice insurers concerning the use of alternative signature methods.
Electronic signature protocols must be available and provided upon request from any Medicare contractor.
Signature Logs
If the signature is illegible on an order or medical record, the physician/practitioner may provide a signature log
which includes the printed name of the author and the full signature or initials that appear on the document.
Listing the credentials of the author is encouraged.
The following is an example of a signature log:
PRINTED NAME
SIGNATURE/INITIALS
CREDENTIALS
Dr. John Smith
John Smith, M.D./JS
M.D.
Attestation Statements
If the signature is missing on an order, the order will be disregarded and the claim will be denied.
If the signature is missing from the medical records, the physician/practitioner may provide an attestation to verify
the entry. Physicians/practitioners should not add late signatures to the medical record (beyond the short delay
that occurs during the transcription process), but instead may make use of the attestation process. In order to be
considered valid for Medicare medical review purposes, an attestation statement must be signed and dated by the
author of the medical record entry and must contain sufficient information to identify the beneficiary.
Should a physician/practitioner choose to submit an attestation statement, they may choose to use the following
statement:
I _______________________ [full name of the physician/practitioner] ______________________, hereby
attest that the medical record entry for _____________ [Date of Service] ______________ accurately reflects
signatures notations that I made in my capacity as _______________________ [insert provider credentials,
e.g., M.D.] _______________________ when I treated/diagnosed the above listed Medicare beneficiary. I do
hereby attest that this information is true, accurate and complete to the best of my knowledge and I
understand that any falsification, omission or concealment of material fact may subject me to administrative,
civil or criminal liability.
Attestation statements will not be accepted where there is no associated medical record entry. Attestation
statements from someone other than the author of the medical record entry in question are not acceptable (even
in cases where two individuals are in the same group, one may not sign for the other in medical record entries or
attestation statements).
When reviewing a file the reviewer will also take into consideration the following:
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If there are reasons for denial unrelated to signature requirements, the reviewer will not proceed to
signature assessment.
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•
If the medical policy criteria cannot be met because a key piece of medical documentation contains a
missing or illegible signature, the reviewer will proceed to the signature assessment.
If the signature is illegible, the reviewers will consider evidence in a signature log to determine the identity of the
author of a medical record entry.
If the signature is missing from an order, the reviewers will disregard the order during the review of the claim.
If the signature is missing from any other medical documentation, the reviewer will accept a signature attestation
from the author of the medical record entry.
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The reviewer will not consider an attestation statement if there is not an associated medical record entry.
The reviewer will not consider an attestation statement from someone other than the author of the
medical record entry in question—even in cases where two individuals are in the same group, one may
not sign for the other in medical record entries or attestation statements.
If the reviewer determines that a claim is payable except for the signature requirements not being met, the
reviewer will send a second development letter to the supplier and ask if they would like to obtain and submit a
signature log or attestation statement from the physician/practitioner.
For more information, suppliers should also reference the CMS IOM Publication 100-08, Medicare Program
Integrity Manual, Chapter 3, Section 3.3.2.4. (1 MB) These signature requirements changes were effective for
claims with dates of service on or after March 1, 2010.
Certificates of Medical Necessity
Please refer to the Certificates of Medical Necessity/DME Information Forms chapter of this manual for detailed
information regarding this subject.
Documentation in the Patient's Medical Record
For any DMEPOS item to be covered by Medicare, the patient’s medical record must contain sufficient
documentation of the patient’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 patient’s
diagnosis and other pertinent information including, but not limited to, duration of the patient’s condition, clinical
course (worsening or improvement), prognosis, nature and extent of functional limitation, other therapeutic
interventions and results, past experience with related items, etc. If an item requires a CMN, it is recommended
that a copy of the completed CMN be kept in the patient’s record. However, neither a physician’s order, nor a
CMN, 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. There must be clinical information in the
patient’s medical record which supports the medical necessity for the item and substantiates the answers on the
CMN (if applicable) or information on a supplier-prepared statement or physician attestation (if applicable).
The patient’s medical record is not limited to the physician’s office records. It may include hospital, nursing home,
or home health agency records, and records from other professionals including, but not limited to, nurses,
physical or occupational therapists, prosthetists, and orthotists.
For many items, Medicare coverage requires that continued use must be assessed and documented by the
treating physician. Rental items such as oxygen, nebulizers, CPAP, wheelchairs, and hospital beds and recurring
supplies such as glucose test strips, urological supplies, and ostomy supplies must be periodically justified in the
beneficiary’s medical record. Ongoing need for and use of the item must be documented in the patient’s record
and provided to the documentation request contractor (if requested) in order for Medicare to continue
reimbursement for the equipment or supplies.
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The documentation in the patient’s medical record does not have to be routinely sent to the supplier or to the
DME MAC. However, the DME MAC may request this information in selected cases. If the DME MAC does not
receive the information when requested, or if the information in the patient’s 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 ABN of possible denial has been obtained.
Note: When requesting medical records and documentation, suppliers should consider the Privacy Act of 1974
and the HIPAA Privacy Rule. PHI is included in these records and all avenues should be taken to safeguard PHI.
The Indications and Limitations of Coverage and/or Medical Necessity section of the LCD contain numerous R&N
requirements. The Nonmedical Necessity Coverage and Payment Rules section of the related policy article
contains numerous nonreasonable and necessary, benefit category, and statutory requirements that must be met
in order for payment to be justified. Suppliers are reminded that:
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Supplier-produced records, even if signed by the ordering physician, and attestation letters (e.g., letters of
medical necessity) are deemed not to be part of a medical record for Medicare payment purposes.
Templates and forms, including CMS Certificates of Medical Necessity, are subject to corroboration with
information in the medical record.
A prescription is not considered as part of the medical record. 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.
Information contained directly in the contemporaneous medical record is the source required to justify payment
except as noted elsewhere for prescriptions and CMNs. The medical record is not limited to physician’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 the purpose of determining than an item is
reasonable and necessary.
Progress Notes and Templates
“Progress Notes” – visit notes, encounter notes, Evaluation and Management documentation, office notes, face­
to-face evaluation notes or any other type of record of the services provided by a physician or other
licensed/certified medical professional (LCMP) in the medical record. Progress notes may be in any form or
format, hardcopy or electronic.
“Template” – a tool/instrument/interface that assists in documenting a progress note. Templates may be paper or
electronic.
The amount of necessary clinical information needed to demonstrate that all coverage and coding requirements
are met will vary depending on the item/service.
CMS does not prohibit the use of templates to facilitate record-keeping. CMS also does not endorse or approve
any particular templates. A physician/LCMP may choose any template to assist in documenting medical
information.
Some templates provide limited options and/or space for the collection of information such as by using “check
boxes,” predefined answers, limited space to enter information, etc. CMS discourages the use of such templates.
Claim review experience shows that that limited space templates often fail to capture sufficient detailed clinical
information to demonstrate that all coverage and coding requirements are met.
Physician/LCMPs should be aware that templates designed to gather selected information focused primarily for
reimbursement purposes are often insufficient to demonstrate that all coverage and coding requirements are met.
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This is often because these documents generally do not provide sufficient information to adequately show that the
medical necessity criteria for the item/service are met.
If a physician/LCMP chooses to use a template during the patient visit, CMS encourages them to select one that
allows for a full and complete collection of information to demonstrate that the applicable coverage and
coding criteria are met.
CMNs, DIFs, supplier prepared statements, and physician attestations by themselves do NOT provide sufficient
documentation of medical necessity, even if signed by the signed by the ordering physician. See CMS IOM
Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.7 for additional information on
documentation.
Note: “Licensed/Certified Medical Professional (LCMP)” – Medical professional licensed or certified to practice in
the state in which services are rendered. For the purposes of documenting DMEPOS items, the physician or
LCMP must not have a financial relationship with the DMEPOS supplier.
For additional information regarding the use of templates, please refer to the CMS IOM Publication 100-08,
Medicare Program Integrity Manual, Chapter 3, Section 3.3.2.1.1.
Continued Use
Continued use describes the ongoing utilization of supplies or a rental item by a beneficiary.
Suppliers are responsible for monitoring utilization of 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:
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:
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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. This is deemed to be 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.
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 initial time period. 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 rental 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 be used by the beneficiary and remains reasonable and necessary. Information used to
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justify continued medical need must be timely for the DOS under review. Any of the following may serve as
documentation justifying continued medical need:
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A recent order by the treating physician for refills
A recent change in prescription
A properly completed CMN or DIF 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.
Request for Refill—Documentation
For all DMEPOS items and supplies that are provided on a recurring basis, billing must be based on prospective,
not retrospective use.
For DMEPOS products that are supplied as refills to the original order, 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 order. Contact with the beneficiary or
designee regarding refills should take place no sooner than 14 calendar days prior to the delivery/shipping date.
For subsequent deliveries of refills, the supplier should deliver the DMEPOS product no sooner than ten calendar
days prior to the end of usage for the current product. This is regardless of which delivery method is utilized.
A routine refill prescription is not needed.
For items that the patient obtains in person at a retail store, the signed delivery slip or copy of 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 either a written
document received from the beneficiary or a contemporaneous written record of a phone conversation/contact
between the supplier and beneficiary. 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:
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Beneficiary’s name or authorized representative if different than the beneficiary
A description of each item that is being requested
Date of refill request
For consumable supplies i.e., those that are used up (e.g., ostomy or urological supplies, surgical
dressings, etc.) – The supplier should assess the quantity of each item that the beneficiary still has
remaining to document the amount remaining will nearly be exhausted on or about the supply anniversary
date.
For nonconsumable supplies i.e., those more durable items that are not used up but may need periodic
replacement (e.g., positive airway pressure and respiratory assist device supplies).
o The supplier should assess whether the supplies remain functional, providing replacement (a
refill) only when the supply item(s) is no longer able to function. Document the functional
condition of the item(s) being refilled in sufficient detail to demonstrate the cause of the
dysfunction that necessitates replacement (refill).
This information must be kept on file and be available upon request.
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Billing Frequencies
For refills of surgical dressings, enteral and parenteral nutrients and supplies, immunosuppressive drugs, oral
anti-cancer drugs, intravenous immune globulin, external infusion pump drugs and supplies, and oral antiemetic
drugs, only a one-month quantity of supplies may be dispensed.
For all other refills that are provided on a recurring basis, including but not limited to DME accessories or supplies,
nebulizer drugs, urological and ostomy supplies, suppliers may dispense no more than a three-month supply at
any one time.
For additional documentation requirements, please refer to the CMS IOM Publication 100-08, Medicare Program
Integrity Manual, Chapter 5, Sections 5.7 and 5.8.
Proof of Delivery Requirements
Documentation Requirements
Suppliers are required to maintain proof of delivery documentation in their files. Documentation must be
maintained in the supplier’s files for seven years.
Proof of delivery is required in order to verify that the beneficiary received the DMEPOS. Proof of delivery is one
of the supplier standards as noted in 42 CFR, 424.57(12). Proof of delivery documentation must be made
available to the DME MAC upon request. For any services, which do not have proof of delivery from the supplier,
such claimed items and services shall be denied and overpayments recovered. Suppliers who consistently do not
provide documentation to support their services may be referred to the Office of the Inspector General for
investigation and/or imposition of sanctions.
Items that are provided on a recurring basis, including but not limited to DME accessories or supplies, nebulizer
drugs, urological and ostomy supplies, the general rule is that suppliers may dispense no more than a threemonth supply at any one time. Exceptions to this rule are:
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Surgical dressings
Enteral and parenteral nutrients and supplies
Immunosuppressive drugs
Oral anticancer drugs
Oral antiemetic drugs
For these items, only a one month quantity of supplies may be dispensed.
In addition, suppliers should be alert for situations in which the quantity of the item may change, e.g., early in the
course of treatment, an improving or worsening condition, etc. In such situations, suppliers should adjust the
quantity and frequency of their dispensing based on a beneficiary’s anticipated needs.
Delivery Methods
Note: For the purpose of the delivery methods noted below, the designee is defined as:
“Any person who can sign and accept the delivery of durable medical equipment on behalf of the beneficiary.”
Suppliers, their employees, or anyone else having a financial interest in the delivery of the item 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, etc.). 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.
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Method 1—Direct Delivery to the Beneficiary By the Supplier
Suppliers may deliver directly to the beneficiary or the designee. An example of proof of delivery to a beneficiary
would be having a signed delivery slip. The proof of delivery record must include:
•
•
•
•
•
•
Beneficiary’s name
Delivery Address
o Suppliers are to use the address for the location where the items were delivered. If delivered via a
storefront, the delivery address would be the store address. If delivered to a facility, the delivery
address would be the facility address.
Quantity delivered
Sufficiently detailed description of the item(s) being delivered (e.g., brand name, serial number, narrative
description)
Date delivered
Beneficiary (or designee) signature and date of signature
The date of signature on the delivery slip must be the date that the DMEPOS item was received by the beneficiary
or designee. In instances where the DMEPOS item are delivered directly by the supplier, the date the beneficiary
received the DMEPOS item shall be the date of service on the claim.
Method 2—Delivery via Shipping or Delivery Service
If the supplier utilizes a shipping service or mail order, the proof of delivery documentation must be a complete
record tracking the item(s) from the DMEPOS supplier to the beneficiary. An example of acceptable proof of
delivery 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 proof of delivery record must include:
•
•
•
•
•
•
•
Beneficiary’s name
Delivery address
Delivery service’s package identification number, supplier invoice or alternative method that links the
supplier’s delivery documents with the delivery service’s records.
Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number,
narrative description)
Quantity delivered
Date delivered
Evidence of delivery
If a supplier utilizes a shipping service or mail order, suppliers shall use the shipping date as the date of service
on the claim.
Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary or designee as a form of
proof of delivery. This type of proof of delivery record must contain the information specified above.
Method 3—Delivery to Nursing Facility on Behalf of a Beneficiary
When a supplier delivers items to a nursing facility, the documentation described for Method 1 is required. When
a delivery service is used to deliver the item to a nursing facility, the documentation described for Method 2 is
required. Regardless the method of delivery, for those beneficiaries that are residents of a nursing facility,
information from the nursing facility showing that the item(s) delivered for the beneficiary’s use were actually
provided to and used by the beneficiary must be available upon request.
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Items Provided in Anticipation of Discharge from a Hospital or Skilled
Nursing Facility
Exceptions to the preceding statements concerning the date(s) of service on the claim occur when the items are
provided in anticipation of discharge from a hospital or nursing facility. A supplier may deliver a DMEPOS item to
a patient in a hospital or nursing facility for the purpose of fitting or training the patient in the proper use of the
item. This may be done up to two days prior to the patient’s anticipated discharge to their home. The supplier
shall bill the date of service on the claim as the date of discharge and shall use the POS code 12 (patient’s
home). The item must be for subsequent use in the patient’s home. No billing may be made for the item on those
days the patient was receiving training or fitting in the hospital or nursing facility.
A supplier may not bill for drugs or other DMEPOS items used by the patient prior to the patient’s discharge from
the hospital or a Medicare Part A nursing facility stay. Billing the DME MAC for surgical dressings, urological
supplies, or ostomy supplies that are provided in the hospital or during a Medicare Part A nursing facility stay is
not allowed. These items are payable to the facility under Part A of Medicare. This prohibition applies even if the
item is worn home by the patient from the hospital or nursing facility. 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 to be fraudulent. These statements apply to DME delivered to a patient in hospitals, skilled
nursing facilities (POS = 31), or nursing facilities providing skilled services (POS = 32).
A supplier may deliver a DMEPOS item to a patient’s home in anticipation of a discharge from a hospital or
nursing facility. The supplier may arrange for actual delivery of the item approximately two days prior to the
patient’s anticipated discharge to their home. The supplier shall bill the date of service on the claim as the date of
discharge and should use the POS code 12 (patient’s home).
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