1. Section Editor(s): Hess, Cathy Thomas BSN, RN, CWOCN

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The Centers for Medicare and Medicaid Services (CMS) has denied a request by Augustine Medical, Inc, Eden Prairie, MN, to pay directly for the company's Warm-Up wound therapy when the product is sold through providers of durable medical equipment. CMS said that it did not feel that the research provided by the company sufficiently supported the request. However, Augustine Medical has accepted an offer from CMS to assist in designing the research related to this product that CMS would like to see.


CMS has confirmed that providers may use Warm-Up therapy in all prospective payment system (PPS) settings. In addition, the cost of Warm-Up therapy can be included in the provider's overhead where CMS is paying a prospective rate.


CMS has also assigned new unique Health Care Common Procedure Coding System (HCPCS) codes to Warm-Up therapy, effective January 1, 2002 (see the Payment Strategies column in this issue). The HCPCS codes will allow for simplified billing for use of this warmth-based wound care therapy by commercial payers and Medicaid.


Warm-Up therapy is the only noncontact normothermic wound care system available today. The system consists of a sterile wound cover, an infrared warming card, and a battery-operated controller that delivers regulated warmth to the wound.


OrCel, an engineered substitute skin from Ortec International, Inc, New York, NY, has been approved by the CMS for inclusion on the Outpatient Prospective Payment System (OPPS) Pass Through List. Inclusion on this list allows hospitals to recover their cost for OrCel when utilizing the product on a Medicare patient in the hospital outpatient environment. Within the hospital setting, use of OrCel will be reimbursed by the existing diagnosis related group (DRG).


As of January 1, 2002, CMS will cover outpatient medical nutritional therapy for Medicare recipients with diabetes and kidney disease. CMS previously had covered some nutritional services for kidney dialysis patients, but under this new decision, the counseling will be covered not only to treat an acute problem, but also to slow the progression of a common disease. This will allow Medicare recipients to benefit from nutritional therapy much earlier.


CMS has issued a national Medicare coverage policy for sacral nerve stimulation used to treat urge urinary incontinence, urgency-frequency incontinence, and urinary retention that has not responded to other forms of treatment. A national coverage policy means uniform reimbursement for sacral nerve stimulation for Medicare beneficiaries throughout the country; without it, coverage decisions would be up to the local regional Medicare carriers.


The only sacral nerve stimulation device approved by the Food and Drug Administration (FDA) is InterStim Therapy for Urinary Control from Medtronic, Inc, Minneapolis, MN.



Johnson & Johnson Wound Management, a division of ETHICON, a Johnson & Johnson company, Somerville, NJ, has received new labeling clearance from the FDA for its BIOPATCH Antimicrobial Dressing. This labeling recognizes the product's efficacy in reducing bloodstream infections due to central venous or arterial catheter infection. A controlled, randomized study of 687 patients showed that BIOPATCH Antimicrobial Dressing reduced the incidence of catheter-related bloodstream infections by 60% and reduced the incidence of local infection by 44% (P = .0001).


With the new labeling, BIOPATCH Antimicrobial Dressing is indicated for absorbing exudate and reducing local infections and for catheter-related bloodstream infections and skin colonization of microorganisms commonly related to those infections in patients. Available since 1993, BIOPATCH Antimicrobial Dressing is the only percutaneous device dressing clinically proven to reduce nosocomial infection rates compared with the standard of care.


According to new labeling approved by the FDA, DERMABOND Topical Skin Adhesive (2-octyl cyanoacrylate) acts as a barrier to microbial penetration for as long as the adhesive film remains intact. DERMABOND Adhesive is licensed by ETHICON Products, a division of ETHICON, INC, a Johnson & Johnson company, Somerville, NJ, from Closure Medical Corporation, Raleigh, NC. In vitro studies showed that DERMABOND was 99% effective in protecting against Staphylococcus epidermidis, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Enterococcus faecium.


DERMABOND Adhesive is a liquid topical skin adhesive that can be used to close surgical incisions and traumatic lacerations without stitches or staples. Approved by the FDA in 1998, DERMABOND Adhesive has proven useful in closing surgical incisions where suture removal can cause significant discomfort. The adhesive does not produce suture marks along the healed incision and, unlike stitches, a patient can shower right away without fear of compromising the incision.


LAM Pharmaceutical Corporation, Lewiston, NY, has filed a 510(k) premarket notification submission with the FDA for LAM IPM Wound Gel (formerly LAM Ulcer Matrix). LAM IPM Wound Gel is a clear viscous, aqueous, odorless gel composed principally of sodium hyaluronate, a derivative salt of hyaluronic acid. LAM IPM Wound Gel has demonstrated in human and animal trials to be of significant value in the management of certain skin ulcers and wounds where maintaining a moist environment is supportive of the healing process. In human skin, hyaluronic acid is involved in biologic functions of tissue hydration and proteoglycan organization.


LAM IPM Wound Gel is suitable for exuding wounds, such as diabetic ulcers, leg ulcers, and pressure ulcers and the management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided.


HealtheTech, Inc, Golden, CO, has been granted FDA clearance to market the HealtheTech MedGem device, a handheld portable indirect calorimeter to measure oxygen uptake. The MedGem device accurately measures respiratory airflow and oxygen uptake (VO2) and determines resting metabolic rate (RMR, the number of calories a person burns per day at rest).


The MedGem Indirect Calorimeter is the first handheld device for nutritional monitoring. The MedGem serves a large unmet need for accurate, individualized nutritional monitoring in a variety of channels throughout the health care industry. The measurement of oxygen uptake has existing Current Procedural Terminology codes, making MedGem eligible for reimbursement under Medicare and other health insurance providers for appropriate indications.



LifeNet, Virginia Beach, VA, the largest organ procurement-based tissue bank in the United States, will supply donated allograft skin tissue to LifeCell Corporation, Branchburg, NJ, for processing into cryopreserved skin and Alloderm graftable tissue on a priority basis for treatment of burn victims. LifeNet will discontinue processing cryopreserved skin; however, it will continue to distribute cryopreserved skin processed by LifeCell.


LifeCell's patented tissue matrix technology removes all cells from allograft tissue and preserves the tissue without damaging the essential biochemical and structural components necessary for normal tissue regeneration. LifeCell currently markets 3 human tissue based products:AlloDerm, for plastic reconstructive and burn procedures;Cymetra, a version of AlloDerm in particulate form for the correction of soft tissue defects; and Repliform, a version of AlloDerm for urologic and gynecologic procedures.