O-19-007

HIGHMARK COMMERCIAL MEDICAL POLICY - DELAWARE

Medical Policy:

O-19-007

Topic:

Ostomy Supplies

Section:

Orthotic & Prosthetic Devices

Effective Date:

June 3, 2019

Issued Date:

June 3, 2019

Last Revision Date:

May 2019

Annual Review:

May 2019

Ostomy supplies are prosthetic devices used by individuals who have a surgically created opening, or stoma, to divert urine, feces, or ileal contents outside of their bodies.

Tracheostomy care supplies are prosthetic devices used by individuals who have a surgically created opening, or tracheostomy, to assist with breathing when their trachea is impaired.

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

Policy Position

DELAWARE MANDATE 18 Delaware Code Sections 3361 and 3571E: Delaware law, which applies to risk (both individual and group policies) business only, requires insurers to cover certain custom orthotic and prosthetic devices. Coverage must be provided for the most appropriate model that “adequately meets the medical needs of the patient”. Further, reimbursement for orthotic and prosthetic devices must be made at the same level as the "federal reimbursement rates." The federal reimbursement rates are defined as those rates routinely promulgated by the Centers for Medicare and Medicaid Services.

DELAWARE MANDATE ORTHOSIS DEFINITION:
A custom fabricated brace or support that is designed based on medical necessity. Orthosis does not include prefabricated or direct-formed orthotic devices or any of the following assistive technology devices: commercially available knee orthoses used following injury or surgery; spastic muscle-tone inhibiting orthoses; upper extremity adaptive equipment; finger splints; hand splints; wrist gauntlets; face masks used following burns; wheelchair seating that is an integral part of the wheelchair and not worn by the patient independent of the wheelchair; fabric or elastic supports; corsets; low-temperature formed plastic splints; trusses; elastic hose; canes; crutches; cervical collars; dental appliances; and any other similar devices, as determined Secretary of the Department of Health and Social Services, commonly carried in stock by a pharmacy, department store, or surgical supply facility.

Ostomy supplies may be considered medically necessary when ALL of the following are met:

The individual has a surgically created opening (stoma) to divert urine or fecal contents outside of the body; and
The ostomy supplies replace all or part of an absent body organ or the function of a permanently inoperative or malfunctioning organ.

Tracheostomy supplies may be considered medically necessary when:

The tracheostomy supplies are prescribed following an open surgical tracheostomy which has been open or is expected to remain open for at least three (3) months.

Ostomy and tracheostomy supplies not meeting the above criteria are considered not medically necessary.

Dispensing prosthetic devices for post-operative use prior to the procedure is considered not medically necessary.

A4331	A4357	A4358	A4361	A4362	A4363	A4364
A4366	A4367	A4368	A4369	A4371	A4372	A4373
A4375	A4376	A4377	A4378	A4379	A4380	A4381
A4382	A4383	A4384	A4385	A4387	A4388	A4389
A4390	A4391	A4392	A4393	A4394	A4395	A4396
A4397	A4398	A4399	A4402	A4404	A4405	A4406
A4407	A4408	A4409	A4410	A4411	A4412	A4413
A4414	A4415	A4416	A4417	A4418	A4419	A4420
A4421	A4422	A4423	A4424	A4425	A4426	A4427
A4428	A4429	A4430	A4431	A4432	A4433	A4434
A4435	A4450	A4452	A4455	A4456	A4481	A4623
A4625	A4626	A4629	A5051	A5052	A5053	A5054
A5055	A5056	A5057	A5061	A5062	A5063	A5071
A5072	A5073	A5081	A5082	A5083	A5093	A5102
A5112	A5120	A5121	A5122	A5126	A5131	A6216
A7501	A7502	A7503	A7504	A7505	A7506	A7507
A7508	A7509	A7520	A7521	A7522	A7524	A7526
A7527	L8501	S8189

Quantity Level Limits (QLL)

Quantity level limits (QLL) for ostomy supplies are determined primarily by the type of ostomy, its location, its construction, and the condition of the skin surface surrounding the stoma.

The table lists the QLL of ostomy supplies that may be considered medically necessary.

Quantities of ostomy supplies that exceed the QLL listed on the table will be denied as not medically necessary.

Accessory	Description	Usual Maximum Replacement per month
A4357	Bedside drainage bag, day or night, with or without anti-reflux device, with or without tube, each	2 every month
A4362	Skin barrier; solid, 4 x 4 or equivalent; each	20 every month
A4364	Adhesive, liquid or equal, any type, per oz.	4 every month
A4367	Ostomy belt, each	1 every month
A4369	Ostomy skin barrier, liquid (spray, brush, etc.), per oz.	2 every month
A4377	Ostomy pouch, drainable, for use on faceplate, plastic, each	10 every month
A4381	Ostomy pouch, urinary, for use on faceplate, plastic, each	10 every month
A4397	Irrigation supply; sleeve, each	4 every month
A4402	Lubricant, per ounce	4 every month
A4404	Ostomy ring, each	10 every month
A4405	Ostomy skin barrier, non-pectin based, paste, per ounce	4 every month
A4406	Ostomy skin barrier, pectin-based, paste, per ounce	4 every month
A4414	Ostomy skin barrier, with flange (solid, flexible or accordion), without built-in convexity, 4 x 4 inches or smaller, each	20 every month
A4415	Ostomy skin barrier, with flange (solid, flexible or accordion), without built-in convexity, larger than 4x4 inches, each	20 every month
A4416	Ostomy pouch, closed, with barrier attached, with filter (1 piece), each	60 every month
A4417	Ostomy pouch, closed, with barrier attached, with built-in convexity, with filter (1 piece), each	60 every month
A4418	Ostomy pouch, closed; without barrier attached, with filter (1 piece), each	60 every month
A4419	Ostomy pouch, closed; for use on barrier with non-locking flange, with filter (2 piece), each	60 every month
A4420	Ostomy pouch, closed; for use on barrier with locking flange (2 piece), each	60 every month
A4423	Ostomy pouch, closed; for use on barrier with locking flange, with filter (2 piece), each	60 every month
A4424	Ostomy pouch, drainable, with barrier attached, with filter (1 piece), each	20 every month
A4425	Ostomy pouch, drainable; for use on barrier with non-locking flange, with filter (2 piece system), each	20 every month
A4426	Ostomy pouch, drainable; for use on barrier with locking flange (2 piece system), each	20 every month
A4427	Ostomy pouch, drainable; for use on barrier with locking flange, with filter (2 piece system), each	20 every month
A4429	Ostomy pouch, urinary, with barrier attached, with built-in convexity, with faucet-type tap with valve (1 piece), each	20 every month
A4431	Ostomy pouch, urinary; with barrier attached, with faucet-type tap with valve (1 piece), each	20 every month
A4432	Ostomy pouch, urinary; for use on barrier with nonlocking flange, with faucet-type tap with valve (2 piece), each	20 every month
A4433	Ostomy pouch, urinary; for use on barrier with locking flange (2 piece), each	20 every month
A4434	Ostomy pouch, urinary; for use on barrier with locking flange, with faucet-type tap with valve (2 piece), each	20 every month
A4450	Tape, non-waterproof, per 18 square inches	40 every month
A4452	Tape, waterproof, per 18 square inches	40 every month
A4456	Skin barrier, wipes or swabs, each	50 every month
A4481	Tracheostoma filter, any type, any size, each	62 every month
A4623	Tracheostomy, inner cannula	62 every month
A4625	Tracheostomy care kit for new tracheostomy	31 every month
A4626	Tracheostomy cleaning brush, each	2 every month
A4629	Tracheostomy care kit for established tracheostomy	31 every month
A5051	Ostomy pouch, closed; with barrier attached (1 piece), each	60 every month
A5052	Ostomy pouch, closed; without barrier attached (1 piece), each	60 every month
A5053	Ostomy pouch, closed; for use on faceplate, each	60 every month
A5054	Ostomy pouch, closed; for use on barrier with flange (2 piece), each	60 every month
A5055	Stoma cap	31 every month
A5056	Ostomy pouch, drainable, with extended wear barrier attached, with filter, (1 piece), each	40 every month
A5057	Ostomy pouch, drainable, with extended wear barrier attached, with built in convexity, with filter, (1 piece), each	40 every month
A5061	Ostomy pouch, drainable; with barrier attached, (1 piece), each	20 every month
A5062	Ostomy pouch, drainable; without barrier attached (1 piece), each	20 every month
A5063	Ostomy pouch, drainable; for use on barrier with flange (2-piece system), each	20 every month
A5071	Ostomy pouch, urinary; with barrier attached (1 piece), each	20 every month
A5072	Ostomy pouch, urinary; without barrier attached (1 piece), each	20 every month
A5073	Ostomy pouch, urinary; for use on barrier with flange (2 piece), each	20 every month
A5081	Stoma plug or seal, any type	31 every month
A5082	Continent device; catheter for continent stoma	1 every month
A5083	Continent device, stoma absorptive cover for continent stoma	150 every month
A5093	Ostomy accessory; convex insert	10 every month
A5121	Skin barrier; solid, 6 x 6 or equivalent, each	20 every month
A5122	Skin barrier; solid, 8 x 8 or equivalent, each	20 every month
A5126	Adhesive or nonadhesive; disk or foam pad	20 every month
A5131	Appliance cleaner, incontinence and ostomy appliances, per 16 oz	1 every month
A6216	Gauze, nonimpregnated, nonsterile, pad size 16 sq in or less, without adhesive border, each dressing	60 every month
A7501	Tracheostoma valve, including diaphragm, each	1 every month
A7502	Replacement diaphragm/faceplate for tracheostoma valve, each	1 every month
A7504	Filter for use in a tracheostoma heat and moisture exchange system, each	62 every month
A7506	Adhesive disc for use in a heat and moisture exchange system and/or with tracheostoma valve, any type each	62 every month
A7507	Filter holder and integrated filter without adhesive, for use in a tracheostoma heat and moisture exchange system, each	62 every month
A7508	Housing and integrated adhesive, for use in a tracheostoma heat and moisture exchange system and/or with a tracheostoma valve, each	62 every month
A7509	Filter holder and integrated filter housing, and adhesive, for use as a tracheostoma heat and moisture exchange system, each	62 every month
A7526	Tracheostomy tube collar/holder, each	31 every month
A7505	Housing, reusable without adhesive, for use in a heat and moisture exchange system and/or with a tracheostoma valve, each	2 every month
A7520	Tracheostomy/laryngectomy tube, noncuffed, polyvinylchloride (PVC), silicone or equal, each	1 every month
A7521	Tracheostomy/laryngectomy tube, cuffed, polyvinylchloride (PVC), silicone or equal, each	1 every month
A7524	Tracheostoma stent/stud/button, each	1 every month
A7527	Tracheostomy/laryngectomy tube plug/stop, each	2 every month
A4361	Ostomy faceplate, each	3 per 6 months
A4371	Ostomy skin barrier, powder, per oz	10 per 6 months
A4398	Ostomy irrigation supply; bag, each	2 per 6 months
A4399	Ostomy irrigation supply; cone/catheter, with or without brush	2 per 6 months
A4455	Adhesive remover or solvent (for tape, cement or other adhesive), per oz	16 per 6 months
A5102	Bedside drainage bottle with or without tubing, rigid or expandable, each	2 per 6 months
A5120	Skin barrier, wipes or swabs, each	150 per 6 months
A7503	Filter holder or filter cap, reusable, for use in a tracheostoma heat and moisture exchange system, each	1 per 6 months
A7522	Tracheostomy/laryngectomy tube, stainless steel or equal (sterilizable and reusable), each	1 per year

Tracheostomy/laryngectomy tube plug/stop is an alternative to a tracheostomy/ laryngectomy tube. Claims submitted for A7520, A7521 and A7522 in addition to A7527 will be denied as non-covered.

Tracheostomy shower protector, each will be denied as non-covered.

A7523

A7527

J95.00	J95.01	J95.03	J95.04	J95.09	K94.00	K94.03
K94.10	K94.13	Z43.0	Z43.2	Z43.3	Z43.6	Z93.0
Z93.2	Z93.3	Z93.6

Place of Service: Outpatient

Ostomy Supplies is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

The policy position applies to all commercial lines of business

Links

Link to Provider Resource Center for the Medical Policy Update

03/2015, Coverage Position for Ostomy Supplies

Link to References

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 or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract, and subject to the applicable laws of your state.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

Provides free aids and services to people with disabilities to communicate effectively with us, such as:
- Qualified sign language interpreters
- Written information in other formats (large print, audio, accessible electronic formats, other formats)

Provides free language services to people whose primary language is not English, such as:
- Qualified interpreters
- Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

Provides free aids and services to people with disabilities to communicate effectively with us, such as:

Qualified sign language interpreters

Written information in other formats (large print, audio, accessible electronic formats, other formats)

Provides free language services to people whose primary language is not English, such as:

Qualified interpreters

Information written in other languages
If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.