Pneumatic Compression Devices - Policy Article

**NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES**

For any item to be covered by Medicare, it must 1) be eligible for a defined
Medicare benefit category, 2) be reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a malformed
body member, and 3) meet all other applicable Medicare statutory and
regulatory requirements. Information provided in this policy article relates
to determinations other than those based on Social Security Act 1862(a)(1)(A)
provisions (i.e. "reasonable and necessary").

Pneumatic Compression Devices (PCDs) are covered under the Durable Medical
Equipment benefit (Social Security Act 1861(s)(6)). In order for a
beneficiary's equipment to be eligible for reimbursement, the reasonable and
necessary (R&N) requirements set out in the related Local Coverage
Determination must be met. In addition, there are specific statutory payment
policy requirements, discussed below, that also must be met.

PREVENTION OF VENOUS THROMBOEMBOLISM

A PCD that provides intermittent limb compression for the purpose of
prevention of venous thromboembolism (E0676) is a preventive service. Items
that are used for a preventative service or function are excluded from
coverage under the Medicare DME benefit.

Therefore, claims for E0676 (INTERMITTENT LIMB COMPRESSION DEVICE (INCLUDES
ALL ACCESSORIES), NOT OTHERWISE SPECIFIED) will be statutorily denied as no
Medicare benefit.

**REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed.
Reg Vol 217)**

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a
Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the
DME MACs provide a list of the specified codes, which is periodically updated.
The 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).

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol
217) that do not meet the face-to-face encounter and WOPD requirements
specified in the LCD-related Standard Documentation Requirements Article
(A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied
as not reasonable and necessary. If the WOPD is not obtained prior to
delivery, payment will not be made for that item even if a WOPD is
subsequently obtained by the supplier. If a similar item is subsequently
provided by an unrelated supplier who has obtained a WOPD, it will be eligible
for coverage.

**POLICY SPECIFIC DOCUMENTATION REQUIREMENTS**

In addition to policy specific documentation requirements, there are general
documentation requirements that are applicable to all DMEPOS policies. These
general requirements are located in the DOCUMENTATION REQUIREMENTS section of
the LCD.

Refer to the LCD-related Standard Documentation Requirements article, located
at the bottom of this Policy Article under the Related Local Coverage
Documents section for additional information regarding GENERAL DOCUMENTATION
REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed
below.

**GENERAL**

For PCDs coded E0650 or E0651 the medical record must contain sufficient
detailed and specific information to show that the applicable coverage
criteria for I - LYMPHEDEMA or II - CHRONIC VENOUS INSUFFICIENCY WITH VENOUS
STASIS ULCERS (CVI) are met.

For PCDs coded as E0652 the medical record must contain sufficient detailed
and specific information to show that the applicable coverage criteria in III
- LYMPHEDEMA EXTENDING ONTO THE CHEST, TRUNK AND/OR ABDOMEN are met.

**Certificate of Medical Necessity (CMN)**

Providers and suppliers no longer need to submit a Certificate of Medical
Necessity (CMN) 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 may act as a
substitute for the standard written order (SWO) if it contains the same
information as required in a SWO. The CMN for pneumatic compression pumps is
CMS Form 846. The initial claim must include an electronic copy of the CMN. 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.

For dates of service for which a CMN is required, if question #1 on the CMN
("Does the beneficiary have chronic venous insufficiency with venous stasis
ulcers?") is answered "Yes," documentation reflecting all of the following
must be in the beneficiary's medical record and made available upon request:

    1. The location of venous stasis ulcer(s),
    2. How long each ulcer has been continuously present,
    3. Previous treatment with a compression bandage system or compression garment, appropriate dressings for the ulcer(s), exercise and limb elevation for at least the past 6 months,
    4. Evidence of regular practitioner visits for treatment of venous stasis ulcer(s) during the past 6 months.

Refer to the Supplier Manual for more information on documentation
requirements.  
  
 **CODING GUIDELINES**  
  
PCDs consist of an electrical pneumatic pump and an inflatable appliance that
encloses the applicable body part. The pump fills the appliance with
compressed air to predetermined pressures and intermittently alternates
inflation and deflation to preset cycle times. The pressures and cycles vary
between devices and, in some devices, are user-adjustable.

PCDs for the Treatment of Lymphedema or Chronic Venous Insufficiency (CVI)
With Ulcers

PCDs used for the treatment of lymphedema or CVI with ulcers are coded based
on the characteristics of the compression pump. The only HCPCS codes for PCDs
used to treat lymphedema or CVI with ulcers are:

E0650 - PNEUMATIC COMPRESSOR, NON-SEGMENTAL HOME MODEL

E0651 - PNEUMATIC COMPRESSOR, SEGMENTAL HOME MODEL WITHOUT CALIBRATED GRADIENT
PRESSURE

E0652 - PNEUMATIC COMPRESSOR, SEGMENTAL HOME MODEL WITH CALIBRATED GRADIENT
PRESSURE

The HCPCS codes used for the inflatable appliances used with PCDs E0650 -
E0652 are:

E0655 - NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR,
HALF ARM

E0656 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, TRUNK

E0657 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, CHEST

E0660 - NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR,
FULL LEG

E0665 - NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR,
FULL ARM

E0666 - NON-SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR,
HALF LEG

E0667 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL
LEG

E0668 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL
ARM

E0669 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, HALF
LEG

E0670 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR,
INTEGRATED, 2 FULL LEGS AND TRUNK

E0671 - SEGMENTAL GRADIENT PRESSURE PNEUMATIC APPLIANCE, FULL LEG

E0672 - SEGMENTAL GRADIENT PRESSURE PNEUMATIC APPLIANCE, FULL ARM

E0673 - SEGMENTAL GRADIENT PRESSURE PNEUMATIC APPLIANCE, HALF LEG

A non-segmented pneumatic compressor (E0650) is a device that has a single
outflow port on the compressor. Pressurized air from the single outflow port
is transmitted to an appliance with single or multiple segments. The
segment(s) inflate and deflate based on the compressor-specified pressure and
cycle times. The number of segments contained in the appliance does not affect
HCPCS coding of the compressor. Appliances appropriate for use with an E0650
PCD are E0655, E0660, E0665, E0666, E0671, E0672 and E0673.

Segmental gradient pressure pneumatic appliances (E0671, E0672, E0673) are
appliances/sleeves which are used with a non-segmented pneumatic compressor
(E0650) but which achieve a pressure gradient through the design of the tubing
and/or air chambers.

A segmented pneumatic compressor (E0651, E0652) is a device that has multiple
outflow ports on the compressor. The pressurized air from each outflow ports
is transmitted to corresponding segments on the appliance. The segments
inflate and deflate based on the compressor-specified pressures and cycle
times.

A segmented device without calibrated gradient pressure (E0651) is one in
which either the same pressure is present in each segment or there is a
predetermined pressure gradient in successive segments. E0651 PCDs cannot
individually set or adjust pressures in separate appliance segments. In an
E0651 PCD, the pressure is usually set by a single control on the distal
segment. Appliances appropriate for use with an E0651 PCD are E0667, E0668,
E0669.

A segmented device with calibrated gradient pressure (E0652) is characterized
by manual control on at least three outflow ports that can deliver an
individually determined pressure to each corresponding appliance segment. Use
of tubing and/or appliances that can create a pressure gradient independently
from the compressor does not qualify to classify the compressor as E0652.
These methods are not considered as calibrated gradient pressure. Appliances
appropriate for use with an E0652 PCD are E0656, E0657, E0667, E0668, E0669
and E0670.

All limb appliances (E0655, E0660, E0665, E0667, E0668, E0669, E0670, E0671,
E0672, E0673) used with PCDs E0650, E0651, E0652 must enclose the affected
limb(s) sufficiently to prevent retrograde edema fluid flow (distally). All
limb appliances (E0655, E0660, E0665, E0667, E0668, E0669, E0670, E0671,
E0672, E0673) used with PCDs E0650, E0651, E0652 must avoid a tourniquet
effect during compression that would prevent distal fluid from moving
proximally. Appliances that create a tourniquet effect or cause retrograde
flow of edema fluid must be coded A4600 - SLEEVE FOR INTERMITTENT LIMB
COMPRESSION DEVICE, REPLACEMENT ONLY, EACH.

PCDs for the Treatment of Peripheral Artery Disease

The only HCPCS code for PCDs used for the treatment of peripheral artery
disease is:

E0675 - PNEUMATIC COMPRESSION DEVICE, HIGH PRESSURE, RAPID INFLATION/DEFLATION
CYCLE, FOR ARTERIAL INSUFFICIENCY (UNILATERAL AND BILATERAL SYSTEM)

The HCPCS codes used for the inflatable appliances used with PCD E0675 are:

E0667 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL
LEG

E0668 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, FULL
ARM

E0669 - SEGMENTAL PNEUMATIC APPLIANCE FOR USE WITH PNEUMATIC COMPRESSOR, HALF
LEG

An E0675 is a PCD that delivers high pressure and rapid inflation/deflation
cycles for the treatment of arterial insufficiency (peripheral artery
disease). HCPCS code E0675 is all-inclusive, i.e. all product variations in
pressures, cycle characteristics, timing, control systems, appliance
configurations (not all-inclusive) are considered as described by the code.
Appliances appropriate for use with an E0675 PCD are E0667, E0668, E0669.

PCDs for Deep Venous Thrombosis (DVT)

The only HCPCS code for PCDs used for the prevention of DVT is:

E0676 - INTERMITTENT LIMB COMPRESSION DEVICE (INCLUDES All ACCESSORIES), NOT
OTHERWISE SPECIFIED

An E0676 is a PCD that delivers pressure and inflation/deflation cycles for
the prevention of deep venous thrombosis. HCPCS code E0676 is all-inclusive,
i.e. all product variations in pressures, cycle characteristics, timing,
control systems, appliance configurations (not all-inclusive) are considered
as described by the code.

The appliance(s) and any other accessories, options, and supplies used with
PCD E0676 are included in the payment for HCPCS code E0676 at the time of
initial issue and must not be billed separately to Medicare. If a supplier
chooses to bill separately for these items at the time of initial issue, then
HCPCS code A9900 - MISCELLANEOUS DME SUPPLY, ACCESSORY, AND/OR SERVICE
COMPONENT OF ANOTHER HCPCS CODE must be used to bill Medicare for the item(s).

HCPCS code A4600 - SLEEVE FOR INTERMITTENT LIMB COMPRESSION DEVICE,
REPLACEMENT ONLY, EACH is used only when the appliance used with an E0676
device is being replaced. HCPCS codes E0655, E0656, E0657, E0660, E0665,
E0666, E0667, E0668, E0669, E0670, E0671, E0672, E0673 must not be used when
billing for appliances used with E0676 devices.

Miscellaneous

When a foot or hand segment is used in conjunction with any leg or arm
appliance respectively, there must be no separate billing for this segment. It
is considered included in the code for the leg or arm appliance.

The only products that may be billed to the DME MACs using codes E0650, E0651,
E0652 and E0675 are those for which the Pricing, Data Analysis, and Coding
(PDAC) contractor has completed a Coding Verification Review. The coding
determination subsequently is published on the appropriate Product
Classification List (PCL).

Information concerning the documentation that must be submitted to the PDAC
for a Coding Verification Review can be found on the PDAC website or by
contacting the PDAC.

If a product is billed to Medicare using a HCPCS code that requires written
CVR, but the product is not on the PCL for that particular HCPCS code, then
the clam line will be denied as incorrect coding.