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.
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:
- The location of venous stasis ulcer(s),
- How long each ulcer has been continuously present,
- 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,
- 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.
