| Article for GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair and GRAFTJACKET® XPRESS Flowable Soft Tissue Scaffold – Related to LCD L26003 (A49404) |
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| Original Article Effective
Date | 10/01/2009 | Article Revision Effective
Date | 07/01/2010 | Article Text | Abstract: | GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair is donated allograft human dermis, aseptically processed to remove cells and freeze-dried to remove moisture while preserving biologic components and the structure of the dermal matrix. GRAFTJACKET® XPRESS Flowable Soft Tissue Scaffold is a micronized form of the very same product, provided as a powder and reconstituted with sterile saline solution. For the purpose of this article, re-application refers to an additional application of skin substitutes to the same ulcer within the same treatment period. Retreatment is a new treatment period where the same ulcer is being treated again because the initial treatment was insufficient or failed. Indications: GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair will be considered reasonable and necessary for the following indications:
GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair must be used in conjunction with the following standard conservative measures:
Limitations: The use of GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair on ulcers with any of the following conditions is considered not reasonable and necessary.
Use of GRAFTJACKET® XPRESS Flowable Soft Tissue Scaffold is considered investigational and is not covered. The scope of the practice for 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 GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair (CPT codes 15330, 15331, 15335 and 15336) as well as any subsequently accepted similar product is considered a physician service. As such, GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair may only be applied by a physician. Documentation Requirements: The patient's medical record must contain documentation that fully supports the medical necessity for services included within this coverage article. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. Coding Guidelines: Payable places of service for the application of GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair (CPT codes 15330, 15331, 15335, 15336): office (11), urgent care facility (20), 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). Payable places of service for GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair (HCPCS code Q4107) if billed by the facility: outpatient hospital, (22), emergency room (23), ambulatory surgical center (24) and skilled nursing facility (31). Payable places of service for GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair (HCPCS code Q4107) if billed by the physician or non-physician practitioner: office (11), urgent care facility (20), nursing facility (32) and independent clinic (49). The following modifiers were effective for dates of service on or after 01/01/2009:
Regarding application codes: 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 GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair, (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. For dates of service prior to April 1, 2010, FQHC services should be reported with bill type 73X. For dates of service on or after April 1, 2010, bill type 77X should be used to report FQHC services. Utilization Guidelines: A single application of Acellular Dermal Tissue Matrix for any particular ulcer is usually all that is required to achieve wound healing in those wounds that are likely to be helped by this therapy. Treatment with GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair is usually expected to last no more than twelve (12) weeks and to involve a maximum of two applications for any ulcer that initially qualifies for treatment. The use of more than two applications for the same ulcer is not considered reasonable and necessary. Re-application of GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair within three weeks for the same ulcer is not considered reasonable and necessary. Re-application of GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair where initial application has resulted in no decrease in size or depth of the wound or increase in granulation tissue, epithelialization, or progress towards closing, will be denied as not reasonable and necessary. Retreatment within one year following the last successful application with GRAFTJACKET® Regenerative Tissue Matrix-Ulcer is not considered reasonable and necessary. Retreatment of an ulcer following two failed GRAFTJACKET® Regenerative Tissue Matrix-Ulcer Repair applications is not considered reasonable and necessary. The application code(s) (15330, 15331, 15335 and 15336) 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. |
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