LCD L33612

Coverage Guidance

CMS Manual System, Pub. 100.03, Medicare National Coverage Determinations Manual, Chapter 1, Section 280-1

Indications and Limitations of Coverage

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.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

• The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

• The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section. Refer to the related Local Coverage Policy Article for Suction Pumps for additional information about the statutory requirements for payment and information about correct coding.

• Refer to the Supplier Manual for additional information on documentation requirements.

• Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

GASTRIC SUCTION

A gastric suction pump (E2000) is used to remove gastrointestinal fluids under continuous or intermittent suction via a tube. Use of a gastric suction pump and related supplies are covered for beneficiaries 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 only covered for beneficiaries who have difficulty raising and clearing secretions secondary to:

• Cancer or surgery of the throat or mouth

• Dysfunction of the swallowing muscles

• Unconsciousness or obtunded state

• Tracheostomy

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

Suction catheters (A4605, 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.

Codes A4605 and A4624 are only covered for beneficiaries with a tracheostomy. Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.

• Tracheal suction catheters (A4624) are reasonable and necessary only when all of the following are met:

• The beneficiary has a tracheostomy.

• The beneficiary requires the use of a covered respiratory suction pump (E0600) as described above, for tracheostomy suctioning.

• Closed system catheters (A4605) are reasonable and necessary only when all of the following are met:

• The beneficiary has a tracheostomy.

• The beneficiary requires the use of a covered respiratory suction pump (E0600) as described above, for tracheostomy suctioning.

• The beneficiary requires the use of a covered ventilator. (Refer to CMS’ Internet Only Manual 100-03, CH 1, §280.1 for information about the coverage of ventilators.)

Claims for A4605 and A4624 suction catheters that do not meet all of the criteria above will be denied as not reasonable and necessary.

More than three A4624 catheters per day will be denied as not reasonable and necessary for tracheostomy suctioning.

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 for oropharyngeal suctioning.

A7047 is not used to remove secretions for the covered indications described above. Claims for A7047 will be denied as not reasonable and necessary.

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 exudate exceeds the capacity of conservative measures such as surgical dressings and wound fillers to contain it. However, wound suction to remove exudate 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. Refer to the related Local Coverage Policy Article for Suction Pumps for additional information about the statutory requirements for disposable wound suction items (A9270, A9272).

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.

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall 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 DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary, and document an affirmative response, 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 expected to end, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply. This is regardless of which delivery method is utilized.

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee and document an affirmative response, prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request and an affirmative response from a beneficiary. 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 beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the treating practitioners 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.

Summary of Evidence

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Analysis of Evidence

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Associated Information

DOCUMENTATION REQUIREMENTS

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 beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner'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.

GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

• SWO

• Medical Record Information (including continued need/use if applicable)

• Correct Coding

• Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

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

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.

Miscellaneous

Appendices

Utilization Guidelines

Refer to Coverage Indications, Limitations and/or Medical Necessity

Bibliography

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