Recent Developments in Wound Care Products.

Vendors' Wrap-Up

Kaye Martin, Manager of Reimbursement and Payor Alliance,Convatec:

One of the struggles wound care manufacturers are having is timely Medicare approval for reimbursement of new technologies--specifically, products that do not fall within existing categories. Before we can even apply for a new HCPCS code for reimbursement, the product has to be on the market for at least six months. Then, once the application is submitted, it might be as long as a year before HCFA issues a determination. If our six-month period does not coincide with the HCFA cycle, the process is delayed for one year. It's conceivable that a product could be on the market for up to a year and a half before reimbursement is approved. It's an extremely frustrating process. Residents are certainly the ones who lose the most from this process, because they do not have the advantage of benefiting from the new technology in a timely manner.

We will be releasing a new wound care product in the spring that illustrates the dilemma manufacturers face. The product uses a new biopolymer technology, targeted for difficult-to-heal wounds. Since this is a new technology and doesn't fit into an existing reimbursement category, reimbursement will be a challenge.

Peter Riddell, Director of Marketing, and Dave Carey, Alternate Site Product Manager for Wound Care, Kendall Healthcare Products:

We're trying to continue the education process of moving from traditional gauze-based products to moist wound healing, which include the calcium alginates, hydrocolloids, hydrogels, etc. It's a matter of education, because for many years everyone was taught to "let the wound heal"--expose it to air and keep it dry--but the healing process is improved by products that keep the wound moist.

Moist wound healing dressings provide a "win-win" situation for clinicians, because they produce better patient outcomes while reducing overall costs. Many studies have shown that moist wound healing dressings have longer wear times and present lower infection rates and faster healing rates than older "wet-to-dry" therapies. Moist wound healing dressings require fewer dressing changes and, therefore, reduce the nursing time required for treatment.

Generally speaking, moisture-retentive dressings are covered under Medicare Part B after the wound has been debrided. Depending on the type of dressing used, it can be reimbursed from once a week to once a day.

Keith Wright, Executive Vice-President, Molnlycke Health Care U.S.:

Our Safetac(r) technology has received much attention for addressing a wound care dilemma: There is still a concern in wound management that many dressings cause trauma to the wound and surrounding tissue when removed. Obviously, this not only causes pain to the resident but also extends the wound healing time. Products with our new technology have a hydrophobic silicone coating, which allows for ultra-gentle adherence to the surrounding skin but no adherence to the moist wound bed. Therefore, when you remove the dressing, the wound bed remains undisturbed, allowing for faster healing.

Currently, we have three types of dressings with this new technology: a contact layer that can be left in place for several days while allowing for exudate to pass through to an outer absorbent dressing, a highly absorbent foam and a scar-management dressing.

Previous to PPS, dressing selection was often based on choosing product categories that provided the most favorable reimbursement levels. Now facilities need dressings that achieve faster and better outcomes.

Jan Stanfield, RN, CETN, Director of Clinical Support and Julie Wick, Product Manager, Augustine Medical, Inc.:

Labor represents a significant portion of total wound care costs. The longer the wound is open, the more likely a patient will develop related complications. For this reason, it is essential that we look to products that promote swift, quality-enhanced wound resolution.

For example, our Warm-Up(r) active wound therapy(r) system is designed to treat pressure, diabetic and venous stasis ulcers, many of which are hypothermic, which delays wound healing and impairs the normal function of the immune system. With this therapy, the skin and subcutaneous tissues are warmed to a temperature that is closer to normothermic. Warming encourages blood vessels to dilate, which increases blood flow to the wound and periwound area, delivering more oxygen, nutrients and growth factors to the wound.

It has been shown that wounds that have not closed in months or even years of traditional treatments improve in a matter of weeks with this approach; therefore, this therapy is cost-effective.

Mark Monseau, Manager of Corporate Communications, Ortho-McNeil:

REGRANEX Gel, approved by the FDA in 1997, is the first prescription biologic that actively stimulates the body to grow new tissue and help heal diabetic foot ulcers. It is a topical gel that contains a genetically engineered, platelet-derived growth factor.

Clinical trials have shown that application of this gel once a day, in addition to good ulcer care, heals more diabetic ulcers than just wound care alone plus placebo. Good ulcer care also includes debridement, daily dressing changes, pressure relief and treatment of infection.

Don Jenkins, Technical Consultant, Summit Industries:

We haven't made many significant changes to our Lantiseptic skin protective product since it first went on the market in 1906. It's not the latest in wound care technology; it just works.

The name Lantiseptic was derived from combining the words lanolin and antiseptic. Our formula is 50% lanolin, and from the beginning the product has always had a high lanolin content. I attribute the product's effectiveness to this. Lanolin is a very skin-friendly product. It's the skin fat of sheep (wool fat), and it is almost the same chemically as sebum, which is the skin fat of humans. Essentially, it's a supplement for human skin fat.

Until the 1960s, the product was marketed for both animal and human use. Then the Food and Drug Administration divided itself into a human division and a veterinary division and announced that no product in the United States could be sold to both. Our company decided that it probably sold more for cattle than for people, and so made it an animal product. Many nursing homes that had been using it when it was labeled for human use kept using the product anyway. We would get phone calls from them asking that the company label it for human use again so that they wouldn't have to hide it from inspectors anymore. Over a decade ago we reintroduced the product for people as Lantiseptic, and it's been the fastest-growing product we've ever had.

Medicare registration isn't necessary since the product is simple, inexpensive and nonprescription.

Kathleen D. Schaum, MS, Reimbursement Director, Johnson & Johnson Medical, Division of Ethicon, Inc.:

When the MDS/RUGs Payment system went into place, each facility's administration was required to purchase, out of the RUG payment, all the wound care dressings for patients during their Medicare Part A stay. This presented new skin and wound care challenges:

* Administration had to develop skin and wound care product formularies.

* Administration had to purchase wound care dressings.

* Administration had to be sure their skin and wound care protocols were current.

* Administration had to educate their staff in the state-of-the-art skin and wound care modalities.

The initial common response to this new challenge is to purchase the lowest-cost dressings and skin care products and/or stop using skin care products. This response is a short-term gain for a long-term loss. The secret to clinical and financial success for patients at risk of skin breakdown and/or for patients who have wounds is to:

* Implement state-of-the-art skin and wound care protocols.

* Establish a skin and wound care product formulary composed of advanced modalities.

* Educate all levels of staff, including physicians, how to assess and aggressively manage wound prevention and wound care.

* Select products based on total cost of care, not cost of product.

Establish an outcomes tracking program, which can be used to acquire higher payment rates from managed care because of lower cost of care.

Implement a plan for patients covered by Medicare Part B only. The facility may purchase, bill and receive reimbursement for the dressings, or they may allow an outside supplier to assume the responsibility. In the latter case, the facility must provide complete physician orders and documentation of wound assessment to the supplier according to the Medicare Surgical Dressing Policy utilization guidelines.

Because this new skin and wound care responsibility is a large change for long-term care facilities, Johnson & Johnson Medical has clinical educators and reimbursement specialists available to help facilities implement proactive skin and wound care programs.