Local Coverage Determination (LCD)

Suction Pumps

L33612

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33612
Original ICD-9 LCD ID
Not Applicable
LCD Title
Suction Pumps
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 01/01/2024
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

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Issue

Issue Description

The LCD is revised to align refill requirements with CMS Final Rule CMS-1780-F. This revision allows contact with the beneficiary regarding refills to take place no sooner than 30 calendar days prior to the end of the current supply and to document an affirmative response.

Issue - Explanation of Change Between Proposed LCD and Final LCD

No proposed LCD issued.

CMS National Coverage Policy

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

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

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:

  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 (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

NA

Analysis of Evidence (Rationale for Determination)

NA

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

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

Sources of Information

CR 7411
NCD 280.14

Bibliography

NA

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
01/01/2024 R7

Revision Effective Date: 01/01/2024
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “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.”
Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “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.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

  • Provider Education/Guidance
  • Other (CMS Final Rule CMS-1780-F)
04/01/2023 R6

Revision Effective Date: 04/01/2023
HCPCS CODES:
Revised: Long descriptor for HCPCS code A4628

04/13/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because they are non-discretionary updates to CMS HCPCS coding determinations.

  • Revisions Due To CPT/HCPCS Code Changes
01/01/2020 R5

Revision Effective Date: 01/01/2020
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: Statement to refer to ICD-10 Codes that are Covered section in the LCD-related PA
Added: Statement to refer to ICD-10 code list in the LCD-related Policy Article
GENERAL:
Revised: Order information as a result of Final Rule 1713
REFILL REQUIREMENTS:
Revised: “ordering physicians” to “treating practitioners”
CODING INFORMATION:
Removed: Field titled “Bill Type”
Removed: Field titled “Revenue Codes”
Removed: Field titled “ICD-10 Codes that Support Medical Necessity”
Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity”
Removed: Field titled “Additional ICD-10 Information”
DOCUMENTATION REQUIREMENTS:
Revised: “physician’s” to “treating practitioner’s”
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: “Prescriptions (orders)” to “SWO”

02/20/2020: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because they are due to non-discretionary coverage updates reflective of CMS FR-1713.

  • Provider Education/Guidance
  • Other
01/01/2019 R4

Revision Effective Date: 01/01/2019
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: Statement to refer to diagnosis code section below
Added: Refer to Covered ICD-10 Codes in the LCD-related Policy Article
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Moved: All diagnosis codes to the LCD-related Policy Article diagnosis code section per CMS instruction
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Moved: Statement about noncovered diagnosis codes moved to LCD-related Policy Article noncovered diagnosis code section per CMS instruction

  • Other (ICD-10 code relocation per CMS instruction)
01/01/2017 R3 Revision Effective Date: 01/01/2017
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Standard Documentation Language
Added: New reference language and directions to Standard Documentation Requirements
Added: General Requirements
Revised: Refill Requirements
DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: General Documentation Requirements
Added: New reference language and directions to Standard Documentation Requirements
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: Direction to Standard Documentation Requirements
Removed: Supplier Manual reference under Miscellaneous
Removed: PIM citation under Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article
  • Provider Education/Guidance
07/01/2016 R2 Effective July 1, 2016 oversight for DME MAC LCDs is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the LCDs.
  • Change in Assigned States or Affiliated Contract Numbers
10/01/2015 R1 Revision Effective Date: 10/31/2014
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility
Revised: Diagnosis code references
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation Language to add who can enter date of delivery date on the POD
Added: Instructions for Equipment Retained from a Prior Payer
Added: Repair/Replacement section
Revised: Diagnosis code references
  • Provider Education/Guidance
N/A

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
12/07/2023 01/01/2024 - N/A Currently in Effect You are here
04/05/2023 04/01/2023 - 12/31/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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