A portable or stationary home model respiratory suction pump (E0600) is an electric aspirator designed for oropharyngeal and tracheal suction.

A portable or stationary home model gastric suction pump (E2000) is an electric aspirator designed to remove gastrointestinal secretions.

For any item to be covered, 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 statutory and regulatory requirements.

For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage.

For an item to be covered, a detailed written order (DWO) must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed DWO, the item will be denied as not reasonable and necessary.

GASTRIC SUCTION
A gastric suction pump (E2000) is used to removed gastrointestinal fluids under continuous or intermittent suction via a tube. Use of the gastric suction pump and related supplies are covered for patients who are unable to empty gastric secretions through normal gastrointestinal functions. Use of a gastric suction pump for other conditions will be denied as not reasonable and necessary.

Supplies (tubing, tape, dressings, etc.) are covered and are separately payable when they are medically necessary and used with a medically necessary E2000 pump. Supplies used with DME that is denied as not reasonable and necessary will also be denied as not reasonable and necessary.

RESPIRATORY SUCTION
A respiratory suction pump (E0600) is covered for patients who have difficulty raising and clearing secretions secondary to:

1. Cancer or surgery of the throat or mouth;
2. Dysfunction of the swallowing muscles;
3. Unconsciousness or obtunded state;
4. Tracheostomy.

Use of a respiratory suction pump for other conditions will be denied as not reasonable and necessary.

Suction catheters (A4624, A4628) and sterile water/saline (A4216/A4217) are covered and are separately payable when they are medically necessary and used with a medically necessary E0600 pump. Supplies used with DME that is denied as not reasonable and necessary will also be denied as not reasonable and necessary.

Tracheal suction catheters (A4624) are reasonable and necessary only for tracheostomy suctioning. More than three A4624 catheters per day will be denied as not reasonable and necessary tracheostomy suctioning.

Closed system catheters (A4605) are only for use with ventilators.

Non-tracheal suction catheters (A4628) are reasonable and necessary for suctioning in the oropharynx. The oropharynx is not sterile, therefore the catheter can be reused if properly cleansed and/or disinfected. More than three catheters (A4628) per week will be denied as not reasonable and necessary when used for oropharyngeal suctioning.

Sterile water/saline solution (A4216, A4217) is covered when used to clear a suction catheter after tracheostomy suctioning. Sterile water/saline will be denied as not reasonable and necessary when used for oropharyngeal suctioning.

WOUND SUCTION
Use of suction on wounds (A9272, K0743) is only appropriate in those clinical scenarios where the quantity of exudates exceeds the capacity of conservative measures such as surgical dressing and wound fillers to contain it. Wound suction to remove exudates can be accomplished with the use of non-covered disposable, suction devices (A9272) or with covered DME devices (K0743). When a non-covered alternative exists (A9272), it is not reasonable or necessary to use a covered DME item (K0743). Therefore, when K0743 is billed it will be denied as not reasonable and necessary.

Wound suction pumps and their associated supplies, which have not been specifically designated as being qualified to use HCPCS code K0743 via written instructions from the Pricing, Data Analysis and Coding (PDAC) Contractor will be denied as not reasonable and necessary.

Supplies (dressings, tubing, etc.) are covered and are separately payable when they are medically necessary and used with a medically necessary K0743 pump. Supplies used with DME that is denied as not reasonable and necessary will also be denied as not reasonable and necessary

REFILL REQUIREMENTS
For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DEMPOS products that are supplied as refills to the original order, suppliers must contact the member prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the member. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the member or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is used.

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the member or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a member. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a member’s expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the ordering physicians that any changed or atypical utilization is warranted. Regardless of utilization, a supplier must not dispense more than a 3-month quantity at a time.

Documentation Requirements

It is expected that the member’s medical records will reflect the need for the care provided. The member’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

PRESCRIPTION (ORDER) REQUIREMENTS
General (PIM 5.2.1)
All items billed 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 upon request. Items dispensed and/or billed that do not meet these prescription requirements and those below must be submitted with an EY modifier added to each affected HCPCS code.

DISPENSING ORDERS (PIM 5.2.2)
Equipment and supplies may be delivered upon receipt of a dispensing order except for those items that require a written order prior to delivery. A dispensing order may be verbal or written. The supplier must keep a record of the dispensing order on file. It must contain:

• Description of the item
• Member’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” described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

Signature and date stamps are not allowed. Signatures must comply with the signature requirements outlined in PIM 3.3.2.4.

The dispensing order must be available upon request.

For items that are provided based on a dispensing order, the supplier must obtain a detailed written order before submitting a claim.

DETAILED WRITTEN ORDERS (PIM 5.2.3)
A detailed written order (DWO) is required before billing. Someone other than the ordering physician may produce the DWO. However, the ordering physician must review the content and sign and date the document. It must contain:

• Member’s name
• Physician’s name
• Date of the order and the start date, if start date is different from the date of the order
• Detailed description of the item(s) (see below for specific requirements for selected items)
• Physician signature and signature date

For items provided on a periodic basis, including drugs, the written order must include:

• Item(s) to be dispensed
• Dosage or concentration, if applicable
• Route of Administration
• Frequency of use
• Duration of infusion, if applicable
• Quantity to be dispensed
• Number or refills

For the “Date of the order” described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

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. (PIM 5.9)

The detailed description in the written order may be either a narrative description or a brand name/model number.

Signature and date stamps are not allowed. Signatures must comply with the signature requirements outlined in PIM 3.3.2.4.

The DWO must be available upon request.

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. (PIM 5.2.3)

MEDICAL RECORD INFORMATION
GENERAL (PIM 5.7-5.9)
The Indications and Limitations of Coverage section of this policy contains numerous reasonable and necessary (R&N) requirements. The Reasons for Noncoverage section contains numerous non-reasonable and necessary, benefit category and statutory requirements that must be met in order for payment to be justified.

Suppliers are reminded that:

• 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 payment purposes.
• Templates and forms, including Certificates of Medical Necessity (CMN), are subject to corroboration with information 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 that an item is reasonable and necessary.

CONTINUED USE
Continued use describes the ongoing utilization of supplies or a rental item by a member.

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 when rental items or ongoing supply items are no longer being used by the member.

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

• Timely documentation in the member’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 member 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 the 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, member 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 of drugs, information justifying reimbursement will come from this initial time period. Entries in the member’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 member’s medical record to support that the item continues to be used by the member and remains 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 by the treating physician for refills
• A recent change in prescription
• A properly completed CMN with an appropriate length of need specified
• Timely documentation in the member’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.

REFILL DOCUMENTATION (PIM 5.2.5-6)
A routine refill prescription is not needed. A new prescription is needed when:

• There is a change of supplier
• There is a change in the item(s), frequency of use, or amount prescribed
• There is a change in the length of need or a previously established length of need expires
• State law requires a prescription renewal.

For items that the member 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 member, documentation of a request for refill must be either a written document received from the member or a contemporaneous written record of a phone conversation/contact between the supplier and member. The refill request must occur and be documented before shipment. A retrospective attestation statement by the supplier or member is not sufficient. The refill record must include:

• Member’s name or authorized representative if different than the member
• A description of each item that is being requested
• Date of refill request
• Information documenting that the member’s remaining supply is approaching exhaustion by the expected delivery date

PROOF OF DELIVERY (PIM 4.26, 5.8)
Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. For medical review purposes, POD serves to assist in determining correct coding and billing information for claims submitted for reimbursement. Regardless of the method of delivery, the contractor must be able to determine from delivery documentation that the supplier properly coded the item(s), that the item(s) delivered are the same item(s) submitted for reimbursement and that the item(s) are intended for, and received by, a specific member.

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 member (i.e., acting as a designee on behalf of the member). The signature and date the member or designee accepted delivery must be legible.

For the purpose of the delivery methods noted below, designee is defined as “Any person who can sign and accept the delivery of durable medical equipment on behalf of the member.”

Proof of delivery documentation must be available on request. All services that do not have appropriate proof of delivery 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 OIG for imposition of Civil Monetary Penalties or other administrative sanctions.

Suppliers are required to maintain POD documentation in their files. There are three methods of delivery:

1. Delivery directly to the member or authorized representative
2. Delivery via shipping or delivery service
3. Delivery of items to a nursing facility on behalf of the member.

Method 1-Direct Delivery to the Member by the Supplier
Suppliers may delivery directly to the member or the designee. In this case, POD to a member must be a signed and dated delivery slip. The POD record must include:

• Member’s name
• Delivery address
• Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)
• Quantity delivered
• Date delivered
• Member (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 member or designee. In instances where the supplies are delivered directly by the supplier, the date the member received the DMEPOS supply must be the date of service on the claim.

Method 2 – Delivery via Shipping or Delivery Service Directly to a Member
If the supplier utilized a shipping service or mail order, the POD documentation must be a complete record tracking the item(s) from the DMEPOS supplier to the member. 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 member. The POD record must include:

• Member’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.
• 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 must use the shipping date as the date of service on the claim.

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

Method 3 – Delivery to Nursing Facility on Behalf of a Member
When a supplier delivers items directly to a nursing facility, the documentation described for Method 1 (see above) is required.

When a delivery service or mail order is used to deliver the item to a nursing facility, the documentation described for Method 2 (see above) is required.

Regardless the method of delivery, for those members that are residents of a nursing facility, information from the nursing facility showing that the item(s) delivered for the member’s use were actually provided to and used by the member must be available upon request.

Policy Specific Documentation Requirements

When billing HCPCS code(s) A4605, A4624 for patients with a tracheostomy, diagnosis code V44.0 or V55.0 must be entered on the claim form.

Refer to the Supplier Manual for more information on documentation requirements.

Services not meeting the medical necessity guidelines will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Reasons for Noncoverage

Saline used for tracheal lavage is a non-covered supply.

The information below is effective 01/01/2012.

Deleted effective 01/01/2012 - Tracheal suction catheters (A4605, A4624) and sterile water, saline used for suctioning (A4216, A4217) are considered supplies for durable medical equipment.

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 members in nursing facilities, Place of Service Codes 31 and 32, they will be denied as non-covered as DME items are statutorily excluded from payment in facilities.

Deleted effective 01/01/2012 - Supplies other than suction catheters and saline are not considered supplies for DME and are therefore non-covered.

Disposable wound suction devices (A9270, A9272) and related supplies will be denied as statutorily non-covered because they do not meet the DME benefit.

Code A4605 is a closed system tracheal suction catheter used in conjunction with a ventilator. Ventilators are reimbursed under the Frequent and Substantial Servicing (FSS) pricing category. The FSS payment category is all-inclusive. There is no separate payment for options, accessories and supplies used in conjunction with a ventilator; therefore, if billed separately, code A4605 will be denied as not separately payable.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

A portable or stationary home model respiratory suction pump (E0600) is an electric aspirator designed for oropharyngeal and tracheal suction.

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.

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.

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.

Codes K0744-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-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.

*Code A9272 describes a disposable, mechanical, wound suction device. Suction is developed through the use of a nonelectric-powered spring (or similar) mechanism. This device includes all components, accessories and dressings.

*Disposable wound suction system pumps other than those coded as A9272 must be coded A9270 (non-covered item or service). For example, an elastomeric suction device would be correctly coded A9270.

*Supplies used with disposable wound suction systems must be coded as A9270 (non-covered item or service). For example, supplies (tubing, dressings, etc.) used with an elastomeric suction device would be correctly coded A9270.

*Effective 01/01/2012

The only products which may be billed using codes K0743 are those for which a written Coding Verification Review has been made by the Pricing, Data Analysis and Coding (PDAC) Contractor and subsequently published on the appropriate Product Classification List.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

CMS Manual System Publication 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Section 280.1