Contractor Name 

National Government Services, Inc.

Contractor Number 

Contractor Type 

Carrier 

Article ID Number 

A46082

Article Type 

Article

Key Article 

Yes

Article Title 

OASIS® Wound Matrix and Oasis® Burn Matrix – Related to LCD L26003

AMA CPT / ADA CDT Copyright Statement 

CPT codes, descriptions and other data only are copyright 2008 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association.© 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction 

Original Article Effective Date 

12/01/2007

Article Revision Effective Date 

01/01/2009

Article Text 

OASIS® Wound Matrix is a natural extracellular matrix that has an intact three-dimensional structure that replaces the body’s missing or failing extracellular matrix. OASIS® Wound Matrix contains key components of the dermal extracellular matrix such as collagen, elastin, glycosaminoglycans, glycoproteins, and proteoglycans. The OASIS® is a biologically derived extracellular matrix-based wound product that is compatible with human tissue.

OASIS® is unique because it is a complex scaffold that provides an optimal environment for a favorable host tissue response, a response characterized by restoration of tissue structure and function. OASIS® is comprised of porcine-derived, acellular, small intestine submucosa and retains the biological structure of extracellular molecules to provide the scaffolding to support cell proliferation and adherence.

Indications

National Government Services, Inc. will consider OASIS® Wound Matrix reasonable and medically necessary for the following indications:

• Partial and full thickness wounds
• Pressure ulcer
• Venous ulcers – when ALL the following conditions are met:
• The venous stasis ulcer has been present for greater than one month duration;
• The venous stasis ulcer has failed to respond to documented conservative measures of at least four weeks duration. A “failed response“ is defined as an ulcer that has increased in size or depth, for which there has been no change in baseline size or depth and no sign of improvement or indication that improvement is likely, such as granulation, epithelialization, or progress towards closing;
• Documentation of response or lack thereof requires measurement of the ulcer at baseline and at completion of at least four weeks of standard conservative management. Documentation should also include measurement of the ulcer immediately prior to the placement of OASIS® Wound Matrix and before each additional weekly placement;
• Conservative methods of wound care include wound tissue hydration with saline, non-adherent dressings, moisture-donating or absorptive dressing (depending on amount of exudate), and compression wraps.
• Chronic vascular ulcers
• Ankle Brachial Index (ABI) when applicable must be greater than 0.7mm HG, in the affected limb being treated.
• Diabetic ulcers - when ALL the following conditions are met:
• The patient is currently under management for either Type I or Type II diabetes mellitus;
• The non-healing diabetic foot ulcer has been present for greater than one month and has a viable wound bed with granulation tissue present;
• Standard conservative wound care measures have been tried. Conservative measures include removal of mechanical stress, debridement of necrotic tissue if present, and saline moistened dressings;
• The ulcer is located on the foot or toes and there is no exposed bone, tendon, or fascia.
• Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, wound dehiscence)

Oasis® Wound matrix should be used only in cases where the patient is competent and/or has a support system to participate in the follow-up care associated with its use.

Limitations

OASIS® is contraindicated in patients with the following history or conditions:

for individuals with rheumatoid arthritis;
history of radiation therapy to the ulcer site;
for uncontrolled congestive heart failure;
for severe arterial disease;
for persons receiving corticosteroids or immunosuppressive therapies;
for individuals with a history of collagen vascular disease;
malnutrition (albumin<2.5/dL);
known allergy to porcine-derived products;
ulcers that are clinically infected;
uncontrolled diabetes (HgbA1c> 12%);
previous organ transplant;
individuals undergoing hemodialysis;
wounds with signs of cellulitis, osteomyelitis, or necrotic or avascular ulcer beds;
for ulcers with exposed bone, tendon, or fascia;
insufficient blood supply to the ulcer (TcPO2@ < 30 mm Hg, toe or ankle brachial index < 0.7 mmHg);
active Charcot joint disease or Sickle Cell disease;
third degree burns.

The use of OASIS® on wounds with any of the above conditions is not considered medically reasonable and necessary, and will result in denial of the claim.

Documentation Requirements

Documentation supporting the medical necessity should be legible, maintained in the patient’s medical record, and available to National Government Services upon request. The records must include:

• Diagnosis with date of onset and all prior treatment modalities;
• Documentation of the initial size of the wound/ulcer(s), the size following cessation of conservative management, the size at the beginning of treatment, and periodically during treatment;
• Documentation supporting that the wound/ulcer has been treated with intensive conventional non-surgical therapy and has not decreased in size and/or depth, and the wound/ulcer has not shown any indication that improvement is likely;
• Documentation that the underlying disease state (e.g.,diabetes, peripheral vascular disease) has been and continues to be treated appropriately based on current national Standard of Care;
• Documentation of Ankle Brachial Index (ABI) when applicable;
• Documentation of the product used, including size and number of units;
• Documentation of the patient’s competency and/or adequate support system required to participate in follow-up care associated with treatment of the wound with the product;
• Documentation of regular reevaluations (at least weekly initially, sooner for certain treatments).

Utilization Guidelines

The application of all products is limited to physicians and non-physician practitioners who are skilled in wound management and have experience in the use of specific products. Podiatry providers may be limited by scope of the practice restrictions within their state Practice Acts. Podiatry is defined by state law and the individual state laws should be consulted in determining a specific podiatrist’s (or doctor of podiatric medicine) scope of practice.

The application of Oasis® Wound Matrix to human wounds is not a one time application and requires reapplication every 5-7 days. Once correctly applied, the wound should be assessed every 5-7 days and if appropriate, additional applications of Oasis® should be performed.

If wounds/ulcers managed with oasis do not evidence a measurable response after twelve weeks of applications, future applications will not be considered reasonable and necessary and will not be reimbursed.

For physicians the application code(s) (15430, 15431) will be paid no more frequently than at 90-day intervals. Though payment for the product is allowed as appropriate to the clinical considerations, it is inappropriate to bill application codes multiple times within a 90-day period. Therefore, the use of the following modifiers is not appropriate: -58 (Staged procedure), -76 (Repeat procedure by the same physician), -78 (Return to the operating room for a related procedure during the postoperative period), and/or -79 (Unrelated procedure or service by the same physician during the postoperative period). The facility may bill for application and product at a frequency appropriate to the clinical circumstances.

These codes are not intended to be reported for simple graft application alone or application stabilized with dressings (eg, by simple gauze wrap). The skin substitute/graft is anchored using the surgeon's choice of fixation (CPT 2007). If it is not medically reasonable and necessary to anchor the Oasis® Wound Matrix, (for example, due to size, depth or location of the wound), then the application is included in the appropriate E&M code and should not be submitted with the application codes.

Coding Guidelines

All claims for drugs or biologicals must be filed with appropriate HCPCS and ICD-9-CM codes.

Claims for the application of OASIS® Wound Matrix and/or Oasis® Burn Matrix are payable under Medicare Part B in the office (11), inpatient hospital (21), outpatient hospital (22), hospital emergency room (23), ambulatory surgical center (24), Skilled Nursing Facility (31), Nursing Facility (32) and independent clinic (49).

When OASIS application is related to donor sites/grafts or post-Mohs surgery:

OASIS is covered for the condition as documented on the:

UB-04 (claims submitted by hospitals, skilled nursing facilities, CORFS, or dialysis facilities) by a diagnosis code indicating the need for procedure in field locater 67 and the appropriate V-code to support donor sites/grafts or post-Mohs surgery in one of the field locaters 67A-67Q. HCPCS code xxxxxx in field locater 44 (application of OASIS) for outpatient hospital claims, and ICD-9 Procedure code xx.xx in field locator 74, or 74A – 74E for the donor sites/grafts or Mohs surgery.

CMS 1500 (claims submitted by physicians) by a diagnosis code indicating the need for the procedure and the appropriate V-code to support donor sites/grafts or post-Mohs surgery in item 21. The HCPCS code xxxxx in item 24D, the diagnosis code reference number in item 24E, the number of units in item 24G (when billing for the product itself).

Coverage Topic 

Surgical Dressings
 

CPT/HCPCS Codes 

ICD-9 Codes that are Covered 

Oasis products are contraindicated for third degree burns (948.00-948.99).

Other Comments 

Sources of Information and Basis for Decision

Diabetic Foot Disorders, A Clinical Practice Guideline, 2006. Supplement to the Journal of Foot & Ankle Surgery, September/October 2006; Vol 45 (5).

Hoode, Ernst, Hiles, An Investigation of the Long-Term Bioactivity of Endogenous Growth Factor in Oasis Wound Matrix, Jnl of Wound Care, 2005; Vol 14 (1).

McDevitt, Wildey, Cutrone, Transforming Growth Factor β1 in a Sterilized Tissue Derived from the Pig Small Instestine Submucosa, J. Biomed Mater Res, 2003; Vol 67A.

McPherson, Characterization of the Fiber Architecture and Biaxial Mechanical Behavior of Pocine Intestinal Mucosa, J. Biomed Mater Res, 1999; Vol 46.

Mostow, Harraway, Dalsing, Hodde, King, Effectiveness of an Extracellular Matrix Graft (Oasis Wound Matrix) in the Treatment of Chronic Leg Ulcers: A Randomized Clinical Trial, Jnl of Vascular Surgery, 2005, Vol 41 (5).

Niezgoda, Van Gils, Frykberg, Hodde, Randomized Clinical Trail Comparing OASIS Wound Matrix to Regranex for the Diabetic Ulcers, Adv in Skin and Wound Care, 2005; Vol 18 (5).

OASIS® Wound Matrix and Oasis® Burn Matrix, Prescribing Information, Fort Worth, Texas, Healthpoint, Ltd.; 2003.

Stillman, Wound Care, eMedicine Clinical Knowledge Base, Institutional Edition, Specialties; General Surgery, (www.imedicine.com/printtopic.asp?bookid=6&topic=2754) 2006.

U.S. Food and Drug Administration Center for Drug Evaluation and Research, 510 (K) Summary, http://www.fda.gov/cdrh/pdf6/K061711.pdf, July 19, 2006.

08/18/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00454 was removed from this LCD as the claims processing for American Samoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands was transitioned to Palmetto GBA, the Part A/Part B MAC contractor in these states.

08/10/2008 - This policy was updated by the ICD-9 2008-2009 Annual Update.

11/14/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00308 is removed from this article. Effective on this date, claims processing for Delaware is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state, and the claims processing for New York and Connecticut is performed by National Government Services under the J-13 MAC contract; carrier number 00805 is removed, and claims processing for New Jersey is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state.

11/09/2008 - CPT/HCPCS code J7341 was deleted from group 1

Revision History Explanation 

R4 (effective 01/01/2009) 2009 HCPCS Annual Update - CPT/HCPCS Code J7341 deleted. CPT/HCPCS Code Q4102 and Q4103 added. No additional comment or notice periods required and none given.

R4 (effective October 1, 2008):
Change Request: 6107
Medicare Contractor Annual Update of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM)
Effective Date: 10/01/2008
Addition of ICD-9-CM codes 707.20, 707.21, 707.22, 707.23, 707.24, 707.25, 998.30 and 998.33.

R3 (effective 08/01/2008):

Following ICD-9 codes added to the list of covered ICD-9 codes:
879.7
890.0
998.32
998.83
V58.77
V59.1
Revision of Coding Guidelines of the UB-04 and CMS 1500 forms when OASIS application is related to donor sites/grafts or post Mohs surgery.

Please note, although, Revision 3 is effective 08/01/2008, changes made to the list of “Covered ICD-9 Codes” and “Coding Guidelines” sections are effective for services furnished on or after 12/01/2007.

R2 (effective 07/18/2008):
This Article was revised to add the Jurisdiction 13 (J-13) MAC contractor numbers.

This revised Article is effective for all National Government Services jurisdictions on July 18, 2008 with these exceptions: for Connecticut – Part B the Article is effective on August 1, 2008; for Upstate New York – Part B, the Article is effective on September 1, 2008; and for New York and Connecticut – Part A, the Article is effective on November 14, 2008. For New York – Part A (contract 00308), the content of this article is currently in effect but the article will be transferred to the J-13 contract number 13201 on November 14, 2008.

R1 (effective 05/01/2008):
Revised the Utilization Guidelines section to clarify the 90 day global for facilities.

The original version of the corresponding LCD became effective on 12/01/2007.

08/18/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00454 was removed from this article as the claims processing for American Samoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands was transitioned to Palmetto GBA, the Part A/Part B MAC contractor in these states.


08/10/2008 - This policy was updated by the ICD-9 2008-2009 Annual Update.

11/14/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00308 is removed from this article. Effective on this date, claims processing for Delaware is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state, and the claims processing for New York and Connecticut is performed by National Government Services under the J-13 MAC contract; carrier number 00805 is removed, and claims processing for New Jersey is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state.

11/09/2008 - CPT/HCPCS code J7341 was deleted from group 1

Related Documents 

Article(s)
A45056 - Biologic Products for Wound Treatment and Surgical Interventions - Supplemental Instructions Article

LCD(s)
L26003 - Biologic Products for Wound Treatment and Surgical Interventions