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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).
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