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Ostomy Supplies
05.00.50o

Policy

MEDICALLY NECESSARY

​Ostomy supplies that are prescribed by an eligible healthcare provider and supplied by an eligible ancillary provider are considered medically necessary and, therefore, covered when one of the following criteria are met:

  • The individual has a surgically created opening (stoma) to divert urine or fecal contents outside of the body when the ostomy supplies are being used to replace all or part of an absent body organ or the function of a permanently inoperative or malfunctioning organ.
  • The individual requires collection or drainage of postoperative related fluids (e.g., anastomotic leak, abscess).​
NOT COVERED

Pouch covers are not covered by the Company because they are not necessary for the proper functioning of the prosthetic device. Therefore, they are not eligible for reimbursement consideration.

Individual benefits for ostomy supplies must be verified, as coverage may vary by product and/or group.

REQUIRED DOCUMENTATION


The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.


STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.


PROOF OF DELIVERY REQUIREMENTS
Medical record documentation must include a contemporaneously prepared delivery confirmation or member's receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the durable medical equipment (DME) supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.


CONSUMABLE SUPPLIES (WHEN APPLICABLE)
The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately 7 days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual's medical record. Delivery of the supplies should not be done earlier than approximately 5 days before the individual would exhaust their on-hand supply.


If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments.


Refer to Attachment A for a list of ostomy supplies.

The quantity of ostomy supplies needed by an individual is determined primarily by the type of ostomy, its location, its construction, and the condition of the skin surface surrounding the stoma. There will be variation according to individual need, and needs may vary over time. The table below lists the maximum number of items/units of service that are usually medically necessary. The actual quantity needed for a particular beneficiary may be more or less than the amount listed depending on the factors that affect the frequency of barrier and pouch change.

The explanation for use of a greater quantity of supplies than the amounts listed must be clearly documented in the beneficiary’s medical record. If adequate documentation is not provided when requested, the excess quantities will be denied as not medically necessary.

USUAL MAXIMUM QUANTITY OF SUPPLIES:
Code
# per Month
A4357
2
A4362
20
A4364
4
A4367
1
A4369
2
A4377
10
A4381
10
A4402
4
A4404
10
A4405
4
A4406
4
A4414
20
A4415
20
A4416
60
A4417
60
A4418
60
A4419
60
A4420
60
A4423
60
A4424
20
A4425
20
A4426
20
A4427
20
A4429
20
A4431
20
A4432
20
A4433
20
A4434
20
​​A4436
​1
​A4437
1
A4450
40
A4452
40
A5051
60
A5052
60
A5053
60
A5054
60
A5055
31
A5056
40
A5057
40
A5061
20
A5062
20
A5063
20
A5071
20
A5072
20
A5073
20
A5081
31
A5082
1
A5083
150
A5093
10
A5121
20
A5122
20
A5126
20
A5131
1
A6216
60

Code
# per 6 Months
A4361
3
A4371
10
A4398
2
A4399
2
A4455
16
A5102
2
A5120
150

COLUMN I/COLUMN II REIMBURSEMENT EDITS

The reimbursement for the item(s) represented by the code(s) in column II are included in the reimbursement for the item represented by the code in column I.

Column I Column II
A4375 A4361, A4377
A4376 A4361, A4378
A4379 A4361, A4381, A4382
A4380 A4361, A4383
A4416 A4366
A4417 A4366
A4418 A4366
A4419 A4366
A4423 A4366
A4424 A4366
A4425 A4366
A4427 A4366

BILLING REQUIREMENTS

When codes A4450, A4452, and A5120 are used with ostomy supplies, they must be billed with the AU modifier (item furnished in conjunction with a urological, ostomy or tracheostomy supply). For this policy, codes A4450, A4452, and A5120 are the only codes for which the AU modifier may be used.
Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

Guidelines

A prescription from an eligible healthcare provider is required for the purchase of ostomy supplies.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, ostomy supplies are covered under the medical benefits of most Company products. Individual benefits for ostomy supplies must be verified, as coverage may vary by product and/or group.

Description

Ostomy is a surgical procedure used to create an exit site for a stoma (surgical opening), which is made in the small intestine, large intestine, or urinary bladder to the outside of the body.

Ostomy supplies are categorized as prosthetic devices and are used by individuals who have a stoma to divert urine, feces, or ileal contents outside of their bodies. Ostomy supplies can also be used to drain an abnormal opening or a malfunctioning organ (e.g., fistula).

Prosthetic devices replace all or part of an absent body organ or the function of a permanently inoperative or malfunctioning body organ.

References

Centers for Medicare & Medicaid Services (CMS). Federal Register. Medicare Program; End-stage renal disease prospective payment system, payment for renal dialysis services furnished to individuals with acute kidney injury, end-stage renal disease quality incentive program, durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) fee schedule amounts, DMEPOS competitive bidding program (CBP) amendments, standard elements for a DMEPOS order, and master list of DMEPOS items potentially subject to a face-to-face encounter and written order prior to delivery and/or prior authorization requirements for calendar year (CY) 2022; Final Rule. [Federal Register Web site]. 01/01/2022. Available at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/DMEPOS/Downloads/FINAL-RULE-MASTER-LIST-of-DMEPOS-Subject-to-Frequent-Unnecessary-Utilization-2018-03-30.pdf. Accessed June 1, 2023.


Centers for Medicare & Medicaid Services (CMS). Federal Register. Medicare Program; Updates to Face-to-Face Encounter and Written Order Prior to Delivery List, 88 Fed Reg, 2546 (01/17/2023). Available at: https://public-inspection.federalregister.gov/2023-00718.pdf. Accessed June 1, 2023.

 

Company Benefit Contracts.

Noridian Health Care Solutions, LLC. Local Coverage Determination (LCD) L33828 Ostomy Supplies. [Noridian Health Care Solutions Web site]. Original: 10/01/2015. (Revised: 01/01/2022). Available at:
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33828. Accessed June 1, 2023.


Noridian Health Care Solutions, LLC. Local Coverage Article. Ostomy Supplies - Policy Article (A52487). [Noridian Health Care Solutions Web site]. Original: 10/01/2015. (Revised: 01/01/2022) https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52487. Accessed June 01, 2023.​


Coding

CPT Procedure Code Number(s)
N/A

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)
N/A

HCPCS Level II Code Number(s)
See Attachment A for a list of ostomy supplies.

Revenue Code Number(s)
N/A

​Modifiers

AU - Item furnished in conjunction with a urological, ostomy or tracheostomy supply​

Coding and Billing Requirements


Policy History

Revisions From 05.00.50o:
06/30/2023

This version of the policy will become effective 06/30/2023.


The Face-to-Face requirements no longer apply to code A5121 Skin Barrier; solid, 6×6 or equivalent, each​.


Revisions From 05.00.50n:
12/05/2022This version of the policy will become effective 12/05/2022.

​​

The following criteria has been added to this policy as Medically Necessary: 

  • ​The individual requires collection or drainage of post-operative related fluids (e.g., anastomotic leak, abscess).​
​Face-to-face requirement language has been added for the following HCPCS code:
  • A5121 Skin barrier; solid, 6×​6 or equivalent, each

Revisions From 05.00.50m:
01/01/2022This policy has been identified for the CPT code update, effective 01/01/2022.

The following HCPCS code has been termed from this policy:
A4397 Irrigation supply; sleeve, each​

The following HCPCS codes have been added to this policy:​
A4436: Irrigation supply; sleeve, reusable, per month
​A4437: Irrigation supply; sleeve, disposable, per month​

Revisions From 05.00.50l:
06/02/2021The policy has been reviewed and reissued to communicate the Company’s continuing position on Ostomy Supplies,​
​08/03/2020
This version of the policy will become effective 08/03/2020.

The policy has been reviewed and reissued to communicate the Company’s continuing position on ostomy supplies.

The following Modifier has been added to this policy:
AU - Item furnished in conjunction with a urological, ostomy or tracheostomy supply

Language was added to support current use of ​the AU modifier.

Revision From 05.00.50k:
07/03/2019This policy was reviewed and reissued to communicate the Company's continuing position on ostomy supplies.
05/23/2018This policy was reviewed and reissued to communicate the Company's continuing position on Ostomy Supplies.

Effective 10/05/2017 this policy has been updated to the new policy template format.
6/30/2023
6/30/2023
05.00.50
Medical Policy Bulletin
Commercial
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No