HealthTrust members now have access to contracts covering regenerative tissue products, one of the fastest growing areas of advanced wound care treatment.
The growth is fueled by demographics, as well as by an increased focus on wound care to improve patient outcomes. According to HealthTrust’s “Regenerative Tissue for Advanced Wound Care—Assessment and Evidence Review,” the number and kinds of wounds in the United States are related to the aging population and rising rates of diabetes, obesity and other chronic conditions.
An estimated 6.5 million Americans suffer from chronic wounds, generating more than $25 billion in annual spend on treatment. The total annual wound care products market could reach $15.3 billion by 2020, and the subsequent care of scars may add an additional $12 billion, the report says.
Multiple suppliers receive initial contracts in the multisource category, says Lynn Tarkington, former assistant vice president, Physician Services, for HealthTrust. The product categories covered by the HealthTrust contract—led by contract director Ryan Wethington—include the following cellular and/or tissue-based products for wounds:
• Non-viable cells based on human tissue (i.e., human placental, amnion and/or chorion)
• Non-viable cells based on animal tissue (i.e., porcine, bovine)
• Non-cultured viable human cells from intact tissue such as human placentas
• Viable human cells, cultured in vitro: animal substrate (i.e., ovine)
• Viable human cells, cultured in vitro: synthetic substrate (i.e., neonatal foreskin)
These products have the potential for a wide range of indicated uses, including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular arterial ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds, burns and draining wounds.
Some of these products may also be used in spine, neuro and cardiothoracic procedures, according to the assessment.
Multiple Causes of Chronic Wounds
Skin is our largest organ—the average adult has nearly 3,000 square inches of skin, which contains about one-third of our total blood supply, says Mary Lee Potter, nurse manager, Methodist Skin & Wound Care Services in San Antonio, Texas. Skin becomes more fragile as we age, making it more susceptible to injury and slower to heal. Chronic diseases such as diabetes and renal failure also adversely affect the skin. And some medical treatments such as chemotherapy can suppress appetite, denying nutrients vital to skin health and healing, Potter says.
Given the long treatment time and need to change dressings regularly, chronic wound care consumes a large quantity of product, which drives up total spend.
— Mary Lee Potter, nurse manager, Methodist Skin & Wound Care Services
Wounds are considered chronic and non-healing if they have been open more than four weeks with minimal to no progress towards healing, Potter says. At that point, the wound reaches a kind of stasis or plateau, and the body quits generating healing substances. Healing requires coaxing the body to resume generating those substances, bringing the wound back into an acute inflammatory phase and stimulating the healing cascade.
That’s not easy. “If we can get all the stars to align, the average chronic wound takes nine months to heal,” Potter says.
Ordinary dry or saline-moistened gauze is ineffective in returning chronic wounds to an acute stage, so physicians use specialized ointments and dressings that can restart the healing process. Regenerative tissue products provide a “scaffold” on which healthy new cells can grow.
Given the long treatment time and need to change dressings regularly, chronic wound care consumes a large quantity of product, which drives up total spend. Care is often provided by home health clinicians or at wound care centers, as patients and family members may be unable or averse to doing it themselves. The specific products used may also change over time as healing progresses, Potter says.
HealthTrust Provides Product Use Guidance
In moving toward the contract stage, Tarkington and her team reviewed and summarized available literature on regenerative tissue products. A physician advisory committee that included HealthTrust’s then Chief Medical Officer Michael Schlosser, M.D., evaluated the findings and formulated guidelines for indicated uses.
Schlosser says there is a “fairly significant lack of clinical evidence” about most of the products in the category, aside from one product whose use in treating burns is supported by several well-designed randomized trials.
The physician advisors stressed using the products judiciously and only after reviewing available information on indications and outcomes, as well as assessing the suitability of the patient for the treatment, Schlosser says.
“Economic rigor also needs to be applied, because the products are very costly, and if used without full understanding of the reimbursement and cost implications, the result could be spending way more than a payer would reimburse and also not be helpful to the patient,” Schlosser says.
The Advanced Wound Care Specialty Committee, an advisory group made up of clinicians from HealthTrust member facilities who work in the field of wound care, met with the sourcing team to provide insight into current market trends and standards of care.
“The committee participated in several product presentations and offered expertise as the Strategic Sourcing team identified suppliers and gained a historical perspective on the use of regenerative tissue in wound care,” says Angie Mitchell, former director of Nursing Services for HealthTrust. “Much of this area was and continues to be driven more by reimbursement than by clinically validated outcomes, as Dr. Schlosser noted. This will be an area of healthcare to watch from a perspective of innovation as well as regulation.” •
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