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”).
Suction equipment is 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.
Saline used for tracheal lavage is a noncovered supply.
All items used with any suction pump, such as tracheal suction catheters (A4605, A4624), sterile water, saline used for suctioning (A4216, A4217), dressings, gastric tubes, etc. (not all-inclusive) are considered to be supplies for durable medical equipment. Therefore, when supplied to beneficiaries in nursing facilities, Place of Service Codes 31 and 32, they will be denied as noncovered as DME items are statutorily excluded from payment in facilities.
Disposable wound suction devices (A9270, A9272) and related supplies will be denied as statutorily noncovered because they do not meet the DME benefit durability requirement.
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.
When billing HCPCS code(s) A4605 and/or A4624 for beneficiaries with a tracheostomy, the diagnosis code indicating tracheostomy status must be entered on the claim form.
When billing HCPCS code(s) E0600, A7002 and A7047, the diagnosis code(s) for the condition(s) that justify the need for the item(s) must be entered on the claim form.
A portable or stationary home model respiratory suction pump (E0600) is an electric aspirator designed for oropharyngeal and tracheal suction. This code also includes devices designed for purposes other than the removal of secretions. One example is a device used to apply suction via a mouthpiece to increase the size of the airway as a treatment for obstructive sleep apnea (Winx (Apnicure) or similar systems).
A portable or stationary home model gastric suction pump (E2000) is an electric aspirator designed to remove gastrointestinal secretions.
A closed system tracheal suction catheter (A4605) is a type of suction catheter that is protected by an outer sheath. It is connected to the ventilator circuit of a patient on mechanical ventilation and left in place. Suctioning is accomplished without disconnection from ventilation.
A tracheal suction catheter (A4624) is a long, flexible catheter.
An oropharyngeal catheter (A4628) is a short, rigid (usually) plastic catheter of durable construction.
An oral interface (A7047) is used as part of the Winx (Apnicure) or similar systems. This code is not to be used for oral appliances used to treat OSA or for any other type of oral suction appliances. Do not use the oral appliance HCPCS codes E0485 or E0486 for this interface.
Wound suction is provided with an integrated system of components. This system contains a pump (K0743) and dressing sets (K0744 – K0746). It does not include a separate collection canister (A7000), a defining component of Negative Pressure Wound Therapy (NPWT). Instead, exudate is retained in the dressing materials. Wound suction systems that do not contain all of the required components are not classified as wound suction systems. See below for component specifications.
HCPCS code K0743 describes a suction pump for wounds which provides controlled subatmospheric pressure that is designed for use with dressings, (K0744 – K0746) without a canister.
HCPCS codes K0744, K0745, K0746 describe an allowance for dressing sets which are used in conjunction with a stationary or portable suction pump (K0743) but not used with a canister. Each of these codes (K0744, K0745, K0746) is used for a single, complete dressing change, and contains all necessary components, including but not limited to non-adherent porous dressing, drainage tubing, and an occlusive dressing which creates a seal around the wound site for maintaining subatmospheric pressure at the wound. These dressing sets are selected based upon wound size using the smallest size necessary to cover the wound. For multiple wounds located close together, a single large dressing must be used rather than multiple smaller dressing sets if it is possible to fit the wounds under a single larger dressing set.
HCPCS code A9272 (WOUND SUCTION, DISPOSABLE, INCLUDES DRESSING, ALL ACCESSORIES AND COMPONENTS, ANY TYPE, EACH) describes a disposable wound suction device. Suction is developed through the use of any type of mechanism. This device includes all components, accessories and dressings. Code A9272 is all-inclusive. Supplies used with disposable wound suction systems are not separately billable. Examples (not all-inclusive) include: SNaP (Spiracure), PICO (Smith and Nephew), VAC Via (KCI). Disposable wound suction items other than those coded as A9272 must be coded A9270 (noncovered item or service). For example, an elastomeric suction device would be correctly coded A9270.
HCPCS code E0467 (HOME VENTILATOR, MULTI-FUNCTION RESPIRATORY DEVICE, ALSO PERFORMS ANY OR ALL OF THE ADDITIONAL FUNCTIONS OF OXYGEN CONCENTRATION, DRUG NEBULIZATION, ASPIRATION, AND COUGH STIMULATION, INCLUDES ALL ACCESSORIES, COMPONENTS AND SUPPLIES FOR ALL FUNCTIONS) describes a ventilator that integrates the function of multiple types of equipment into a single device. Code E0467 combines the function of a ventilator with all of the following:
- Oxygen equipment
- Nebulizer and compressor
- Aspirator (suction device)
- Cough stimulator (multiple products)
If the multifunction ventilator does not include all of the functions listed above, then the ventilator must not be coded as E0467. Multifunction ventilators that combine some but not all, of the listed functions, must be coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS).
Positive airway pressure (PAP) devices, respiratory assist devices (RAD), and custom fabricated oral appliances, are considered same or similar to the features of products coded E0467.
The following HCPCS codes for individual items are included in the functionality of code E0467:
- HCPCS codes E0600, A4216, A4217, A4605, A4624, A4628, A7000, A7001, A7002, and A7047
For E0467 claims with dates of service before April 3, 2020:
Claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.
In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.
Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:
- Is currently in a rental month for any of the items listed above
- Owns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.
For E0467 claims with dates of service on or after April 3, 2020:
Any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.
Claims for code E0467 with a date(s) of service that overlaps date(s) of service in a rental month for any of the items listed above are considered as a claim for same or similar equipment.
CODING VERIFICATION REVIEW
The only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC website. The effective date of the CVR is included for each code.
Effective for claims with dates of service on or after January 1, 2012:
Effective for claims with dates of service on or after January 1, 2022:
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 claim line will be denied as incorrect coding.
Suppliers should contact the PDAC Contractor for guidance on the correct coding of these items.