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Title: Physician and Surgeon
Organization: N/A Private Practice
Date: 11/22/2011
This comment is written regarding the utilization of PRP concentrates in conjunction with surgical wound care in chronic ulcerations, decubitus ulcers, diabetic ulcers, and deep burn ulcerations. I am a plastic-reconstructive surgeon with more than 15 years experience in treating these types of injuries and problems with high density platelet-rich plasma (HD PRP) concentrates in many types of aesthetic & reconstructive surgery. My extensive clinical experiences have proven the value and safety of these autologous concentrates to facilitate healing of both acute, subacute and chronic wound situations.
I recently had a family member treated with use of HD PRP with amazing success, only to find that PRP was not a reimbursible treatment by Medicare.
There is extensive literature to support the use and importance of platelet derived growth factors and signal proteins for participation and enhancement of natural wound healing processes. When some of these poor vasculature wounds present in an elderly person, it is markedly less complicated, less expensive, and less time required with avoidance of skin graft surgery, etc.. In my experience and opinion, this modality of treatment should NOT be denied the Medicare patient population
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Date: 12/05/2011
As a practicing perfusionist and President of an autologous blood maanagement company I have had the unique pleasure of seeing the results first hand of the benefits of platelet concentrate on multiple wound procedures. From diabetic ulcerations to non-healing deep wounds PRP has enabled our patient population to leave the hsopitals quicker and at less cost than other more expensive treatment modalities. Our group was called to a non-healing tunneling wound several weeks ago by a plastic surgeon who just took over the care of a 32 year old women that had been in the hospital for exactly one year due to a non healing wound from a previous hip surgery. The patient received one PRP treatment and is now experiencing positive wound closure and expected to be discharged shortly from the hospital. We have seen too many wound success stories to address on this comment page by utilizing platelet concentrate. The positive results are not only inspiring but cost beneficial to the hospital and the patient as well. Please consider my comments as well as others in the field in your decision to cover platelet concentrates in wound care coverage.
Respectfully,
Tom Arnzen
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Date: 11/23/2011
[PHI Redacted] has had diabetes for 11 years and for the last 4 years has had a diabetic ulcer on the bottom of his foot. Within in the last 3 years there was no progress in healing and he had the AutoGel procedure done and the wound closed up by 75% with only 2 treatments. This procedure was stopped abruptly and the wound opened up again. We both believe that this procedure is the only procedure that worked on closing up this diabetic ulcer wound.
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Date: 11/25/2011
I would like to clarify my previous comment of 11/23/11.
The AutoGel treatment was stopped due to internal politics in the medical facility despite the good outcomes that we had and the other patients were having.
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Date: 12/06/2011
Wound care most certainly will benefit from the use of PRP. I have tried to convince my institution of its benefits, but without reimbursement, it seems the science does not matter. The patients need this.
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Title: Owner
Organization: HRN
Date: 11/28/2011
To Whom it May Concern:
I am an RN who worked with autologous blood-dervied products for chronic non-healing wounds when I was part of a team that worked with clinicians in patient applications. Even as a company representative, I was frequently impressed with the dramatic improvement in wound size and appearance. I truly found its effect to be remarkable and often a stepping stone to implement other treatment modalities and discharge to less costly care settings.
I am pleased to see the progress in bringing this modality to the public.
J Beriou, RN, MHA, CWS
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Title: Owner
Organization: HRN
Date: 12/01/2011
In reviewing my previous comment on the value of PRP in treatment of chronic non-healing wounds, I felt that it is important to cite the data that came from Cytomedix' study. I have reviewed the Cytomedix data and wish to repeat the outcomes obtained from the following analysis:
Twenty two patients with 31 wounds were treated 8 Long Term Acute Care sites. Wound etiology included: 17 pressure ulcers, 4 venous ulcers, 4 trauma wounds, 3 diabetic ulcers, and 3 wound dehiscence. The mean patient age was 59.3 years and previous wound duration was 34 weeks.
All the following data reflects the mean outcomes. In 3.3 treatments over 2 weeks, 87.1% of wounds decreased 56.5% in volume, 77.4% of the wounds reduced 48.6% in area. 100% of the wounds with undermining, sinus tracts or tunneling responded positively. Wounds with undermining (15/31 or 48%) had a mean reduction of 68.6% in 3.1 treatments over 1.6 weeks. Wounds with sinus tracts/tunneling (8/31 or 25.8%) had a mean reduction of 32.3% in 2.5 treatments over 1.4 weeks. Many of these patients had albumin and hemoglobin below normal.
The impact is simply that this rapid size reduction in long standing wounds in these compromised patients utilizing PRP Gel allowed the staff to achieve their near term goal of progressing healing and permit a timely patient discharge.
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Title: Member of Congress
Date: 12/05/2011
December 5, 2011
Lisa Eggleston, RN, MS, Lead Analyst
Centers for Medicare and Medicaid Services
Office Of Clinical Standards And Quality
Coverage and Analysis Group
7500 Security Boulevard
Mail Stop: S3-02-01
Baltimore, Maryland 21244
Email: CAGinquiries@cms.hhs.gov
Subject: Autologous Blood-Derived Products for Chronic Non-Healing Wounds (CAG- 00190R3)
Dear Ms. Eggleston:
Twenty-two Congressional Black Caucus members wrote last year urging the Secretary of the u.S. Department of Health and Human Services to "reconsider whether Platelet Rich Plasma (PRP) gel might provide an effective and cost effective option for Medicare beneficiaries suffering from non-healing wounds and ulcers". (Letter attached.)
We are pleased that the Center for Medicare and Medicaid Services (CMS) at the Department has re-opened its review of Medicare coverage of PRP gel. We urge CMS to consider the option of coverage with evidence development if the Agency determines that additional data is required.
Thank you for your consideration of these comments.
Sincerely,
/s/
Rep. Sanford D. Bishop, Jr.
Member of Congress
/s/
Rep. Donna M. Christensen
Member of Congress
January 20, 2010
The Honorable Kathleen G. Sebelius
Secretary
U. S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20515
Dear Secretary Sebelius:
We are writing to bring to your attention our concerns about the Center for Medicare and Medicaid Services' (CMS) coverage of Platelet Rich Plasma (PRP) gel, which could have a significant impact on the treatment of wounds, especially those that are diabetes-related, among African Americans nationwide.
As you may be aware, CMS has issued a national non-coverage determination for autologous, platelet-derived wound healing formulas known as PRP. PRP gel is intended to treat patients with chronic, non-healing wounds such as diabetic ulcers or pressure wounds. The data shows that the PRP gel is less expensive and more effective than current treatmcnts that Medicare does cover, such as negative pressure wound therapy (NPWT). In fact, recent Department of Health and Human Services Inspector General reports found that suppliers paid an average of$3,604 for the new NPWT pump models, compared to Medicare's purchase price of$17.165. The PRP gel, however, costs $2, I 00 for six weeks of therapy, which is the average amount of time patients receive treatment. We also understand that recent studies demonstrate that PRP gel can aid in wound healing and shorten the duration of healing time.
We would be grateful ifCMS would reconsider whether PRP gel might provide an effective and cost effective option for Medicare beneficiaries suffering from non-healing wounds and ulcers. If further data is needed, we request that CMS conducts a demonstration using the PRP gel to better determine its efficacy and cost-effectiveness compared to other advanced wound care technologies including NPWT.
Thank you again for your consideration. We look forward to working with you on this very important issue.
Sincerely,
[signatures]
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Title: EVP, Clinical Affairs and Strategic Planning
Organization: America's Health Insurance Plans (AHIP)
Date: 12/07/2011
December 7, 2011
Lisa Eggleston, RN, MS
Lead Analyst
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850
Dear Ms. Eggleston:
Thank you for the opportunity to
comment on the Centers for Medicare and Medicaid Services’ (CMS) national coverage
analysis tracking sheet for Autologous Blood-Derived Products for Chronic Non-Healing Wounds
(CAG-00190R3). America’s Health Insurance Plans (AHIP) is the national
association for the health insurance industry. Our members provide coverage to
more than 200 million Americans, offering a broad range of health insurance
products in the commercial market and demonstrating a strong commitment to
participation in public programs.
General Comments
AHIP and our member plans
support CMS’s efforts to ensure that Medicare beneficiaries receive access to
safe and effective preventive health services that can improve health outcomes,
as determined by current and robust clinical evidence. The Hayes Medical
Technology report of Autologous Platelet Concentrate for Wound Healing rated
this technology a “C” or “D” dependent on age group, based on an ABCD scale.
Per the Hayes review: “ C for the administration of autologous platelet
concentrate or gel in adult patients as a treatment of acute surgical soft
wounds (surgical incisions or dehiscence) or chronic cutaneous wounds that have
failed an adequate course of standard wound therapy; and D for the
administration of autologous platelet concentrate or gel in children, pregnant
or lactating women, patients with blood disorder or platelet dysfunction,
patients with metastatic disease or active infections, or patients with a tumor
in the wound bed. This latter rating reflects a paucity of data and raises
concerns regarding the safety of autologous platelet concentrate or gel in
these patient populations.[1]
Based on this available
evidence, our members consider this to be experimental and investigational and
therefore recommend against the adoption of this technology as a covered
service by CMS.
Sincerely,
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Title: Chief Nursing Officer
Organization: Specilaty Hospital of Washington - Hadley
Date: 12/05/2011
November 29, 2011
Dear Sir/Madam:
I am the Chief Nursing Officer of a Long Term Acute Care hospital. We have used AutoloGel PRP to treat wound patients in our facility. Consistently, we find that wounds that have stalled start healing as soon as they are treated with AutoloGel.
I was fortunate to be a co-author of a published, peer-reviewed article* looking at 65 chronic wounds in which we demonstrated that 89.2% of all wounds had 62% volume reduction in just 2.8 weeks with only 3.2 PRP Gel treatments. These patients had their wound an average of 47.8 weeks prior to this treatment. The patients and physicians were amazed at the fast turnaround in these wounds. The average age of the patients was 60.6 years, but most were Medicare beneficiaries due to multiple disabilities or co-morbidities.
An advanced wound therapy such as AutoloGel PRP should be covered for the Medicare patients so they can have access to this fast healing response rather than having to use therapies that don’t provide this type of response and cost them and Medicare more money. I absolutely support reimbursement for blood products for treating chronic wounds.
*Frykberg, R. G., Driver, V. R., Carman, D., Lucero, B., Borris-Hale, C., Fylling, C. P., et al. (2010). Chronic wounds treated with a physiologically relevant concentration of platelet-rich plasma gel: a prospective case series. Ostomy Wound Manage, 56(6), 36-44.
Sincerely,
Cathy Borris- Hale
Cathy Borris-Hale, RN, MHA, BSN
Chief Nursing Officer
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Title: Chief Medical Officer
Organization: Orogen Biosciences, Inc.
Date: 11/21/2011
Once again the CMS has decided to review the clinical efficacy and merits of platelet rich plasma (PRP) use on chronic wounds in the Medicare patient population. For this, I applaud you! Our group has been utilizing prp for over 15 years and has treated over 40,000 patients. Because of Medicare's decison not to pay for this treatment modality, randomized double blind studies have been far and few between. I have personally treated hundreds of patients with chronic diabetic ulcers and venous stasis ulcers. I would encourage you to view the website orogen.net to see a sampling of wounds treated with a version of prp. One of these patients had been suffering for over 4 years with a wound that would not heal. The VA Hospital he had been going to recommended a below the knee amputation. He had two pro bono treatments with our wound protocol and his wound resolved completely. I ask that you open your minds, eyes and ears when considering this important decision. You will pay for limb amputations but refuse to pay for a simple biological treatment that works on the majority of chronic non-healing wounds!
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Title: CAPT, USPHS, FNP-BC, CWOCN
Organization: USPHS
Date: 12/01/2011
I have used Autologel in my wound healing practice for three years. It is an efficacious and efficient adjunct therapy that facilitates and potentiates wound healing. The process for making platelet rich plasma (PRP) gel is a safe procedure that is done by licensed providers who have been trained and certified to make the PRP gel. I use clinical evidence from Cytomedix and wound healing research journals to guide how I use PRP and how I select appropriate candidates for treatment. PRP is a cost-effective wound healing modality because it re-establishes a natural, chemically balanced wound environment and potentiates the formation of granulation tissue in the wound. As a result of using PRP, the normal course of wound healing occurs in a timely manner with positive patient outcomes.
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Title: Wound care nurse
Organization: Promise Hospital LTAC
Date: 11/29/2011
I am currently involved in treating patients with Safeblood and have been for the past eight months. I have been involved in the treatment and care of 4 patients with chronic wounds. 3 with great outcomes. The 4th was just treated 2 weeks ago. The 3 patients only required one treatment; and it is in the opinion of the physician that the 4th patient will only require 1 treatment as well.
Two examples of wounds we were able to heel include diabetic foot ulcer (greater than 2 years old) with limb salvage; sacrum stage IV pressure ulcer (greater than 8 months) getting the patient back to work. Both patients were previously on negative pressure wound therapy; which we were able to discontinue.
In relation to PRP, it is my opinion that Safeblood has a higher success rate for wound healing and a results are aquired quicker. This is opinion is from clinical observation, presentations from physicians on patients treated from sister facilities, and clinical data used to measure wound healing. I was also involved in the PRP treatment of patients with chronic wounds for 9 months and 3 patients under the care of their primary MD and myself. This is how I am able have an opinion between the two therapies. While my experience may seem minute, I have also done educational research on the products before use on patients.
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Title: Deputy Chief of Surgery
Organization: Phoenix Indian Medical Center, Public Health Service
Date: 12/02/2011
My clinical experience with blood derived products (PRP) for chronic non healing wounds has been positive. As as a practicing general surgeon I have
experienced 75% of patients with wounds that have undermining or a sinus track respond to PRP. The amount of reduction in undermining or tracking is 75-100%.
My response rate in patients with chronic non healing wounds without tracking or undermining is 75%. I have experienced 25% to 100% reduction in wound size. One wound had been open for 18 months and this completely closed. I have observed improvement in wounds that had been open for longer than 6 months in several patients that had made no progress in healing and would not otherwise meet the criteria for inclusion in trials. Chronic open wounds aare a major risk factor for amputation of extremities. In my experience PRP works as well as other CMS over therapies, and would help reduce use more expensive modalities. I have used PRP in a large 10 cm x 7cm x 4cm plantar foot wound defect secondary to infection. My past experience with these large defects in diabetic population is these patients would experience episodes of cellulitis, and infection requiring admission and further surgery before healing or amputation was achieved. This patient closed her defect rapidly with no readmission for infection or further surgery. This was definitely a cost savings, most definitely contributed to limb salvage in this patient.
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Title: President
Organization: Strategic Solutions, Inc.
Date: 12/01/2011
I am not a practicing physician but have worked in wound care research for many years in the fields of basic wound care and advanced therapies. With appropriate care some 65-75% of chronic wounds will heal within 1 year. However, healing recalcitrant wounds is a difficult issue, because we lack specific algorithms that tell clinicians what should be done in regard to advanced therapies when appropriate but basic wound care is not healing the wound. This is not just a patient quality of life issue or mitigation of risk complication for certain kinds of wounds such as diabetic foot ulcers but also an economic one. Healing chronic wounds in the U.S. alone costs around $50 billion annually. That’s more than the gross domestic product for many countries.
I have worked with PRP data for over a year, and the most interesting observation I have noted is the ability of PRP to kickstart chronic wounds into a healing wound healing trajectory. That is not to say that every wound responds to PRP, but a high proportion can be classified as clinical responders [de Leon et al., Adv Skin Wound Care 2011; 2011;24:357-68]. That in itself is important as it is well known that many chronic wounds require a multifaceted treatment approach with often sequential or overlapping modes of treatment from the beginning of treatment to confirmed wound closure. Many advanced therapies promise much but have quite a limited efficacy in controlled trials or effectiveness in observational studies and many are quite expensive. We need more cost-effective products that will work with a higher proportion of chronic wounds and a higher percentage of positive outcomes, whether this is complete wound healing or reduction of wound area by 50%. Such products could also be used earlier in wounds that become chronic to reduce times to heal. In this sense, time is literally money, because the longer a wound takes to heal the more expensive it becomes as well as attendant lower quality of life for the patient and higher risk of complications. I believe that PRP is such a product. One of the other advantages of PRP is that the patient’s own tissues generate the product thus minimizing potential adverse events. Finally, the evidence level for the use of PRP as an adjunctive therapy in the treatment of chronic wounds is good [see Carter et al., ePlasty 2011; 11:e38; and references cited therein].
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Title: Student of Cardiovascular Perfusion
Organization: Midwestern University
Date: 12/02/2011
I am a Perfusion student currently on my clinical rotations. After reading various studies, I was curious of how effective PRP therapy actually was. I have now witnessed plenty of PRP therapies utilized and am thrilled with the positive outcomes it has provided.
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Title: AVP, Nursing Services
Organization: National HealthCare Corp.
Date: 11/22/2011
As a nurse practicing in Long Term Care, I
support a national coverage determination that
would include autologous blood derived products
for wound healing.
Having observed the healing capabilities of this
process and product on chronic non-healing
wounds, I believe that Medicare and Medicaid
should cover this therapy. When used on a
selected patient population, the autologous blood
derived product can significantly reduce the
healing time and wound closure time of chronic
wounds.
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Title: Podiatrist
Date: 11/18/2011
I am submitting my comments regarding platelet derived growth factor in the care of chronic non-healing wounds as an initial trial at our institution proved extraordinarily successful (3 patients over 2 weeks 70% healing in wounds > 1 year duration). My practice is in a government care system and so reimbursement in itself is not a major consideration but I believe that access to this modality for Medicare recipients would be a genuinely beneficial service. In addition, proven advanced wound care modalities are limited (Apligraf, Dermagraft and Regranex) with other dressing materials available (Graftjacket, Epifix,Provant, skin graft, etc) but not subject to the rigor that PRP has been held to. For infected necrotic wounds maggot therapy has been beneficial in addition to various surgical ablation techniques but the non healing wound has often cleared that hurdle and needs metabolic support to heal.
Knowing that amputation risk is directly related to wound duration, and that we can now identify the non-healing wound well at 2 weeks and with great accuracy at 4 weeks (Sheehan,P), the target population for advanced modalities is a known quantity making judicious use possible. Also knowing that QOL decreases with duration of a wound actually dipping below that of an amputee at about 1 year, patient centered measures would support more aggressive care.
My care paradigm following initial evaluation and care to determine if a wound will be recalcitrant is to move to Dermagraft (in many cases). Unfortunately, when I hold these wounds to the same standard of 30% healing at 2 weeks and 50% at 4 weeks there remain those that fail. It is in these instances that a robust approach that is safe and effective is still needed.
PRP has been shown to have a protective and synergistic effect for growth factors relative to isolated growth factor products. Also initial studies likely had mixed results due to variable preparations as PRP appears to have a concentration sweet spot between 3-5 x concentration (1,2,3). Studies recently more accurately reflect that potency and demonstrate better results in wound healing (4,Holloway,Atri,Knighton x 2)) and have been randomized and controlled (certain other applications such as achilles tendon injury have not but should not reflect on this application though other applications may still benefit from evaluation). It has also been shown to be completely safe as the patient's own blood is used.
Finally costs in our system for PRP are 1/6 that of Dermagraft and nearly 1/3 that of Provant (though provider preparation time is much longer partially offsetting the material cost benefits.
In summary, the availability of randomized controlled trials, the need for additional advanced modalities for unresponsive wounds make approval a sound choice and stands to improve patient QOL and reduce limb amputations, recurrent infections, hospitalizations etc.
1. Alsousou J, et al. J Bone Joint Surg 2009:91-B:987-96
2. Smith SE, Roukis TS. Clin Podiatr Med Surg 26:(2009), 559-588
3. Haynesworth, SE, Bruder, SP, et al; “Mitogenic Stimulation of Human Mesenchymal Stem Cells by PRP Suggests a Mechanism for Enhancement of Bone Repair”, Presented at 48th Orthopaedic Research Society Meeting, Dallas, TX, 2002
4. Driver et al Ostomy/Wound Management 2006;52(6):68-87
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Title: Chief of Perfusion
Organization: Stamford Hospital
Date: 12/06/2011
I have been a practicing Perfusionist and a member of the American Board of Cardiovascular Perfusion for 14 years. During that time I have seen the widespread and increasing use of platelet rich (PRP) and platelet poor (PPP) plasma concentrates used in a variety of procedures for the benefit of tissue growth. Platelets are the gatekeepers of our bodies ability to heal both healthy and unhealthy tissue. When used in the treatment of chronic wounds (i.e. diabetic ulcers), PRP has been shown to granulate tissue and promote the growth of healthy new tissue in areas of the body that are poorly perfused.
This technology represents the next frontier in medical/surgical treatment options designed to promote health and minimize the extent and expense of sequale associated with chronic and debilitating diseases. Our industry has matured through state licensure efforts and rigorous standards for graduation from accredited schools of Perfusion. As the surgical use of autologous platelet concentrates continues to grow so will the benefit to our countries aging population and our collective need for more targeted and efficacious treatment options.
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Title: perfusionist
Organization: Southern Ohio Medical Center
Date: 12/05/2011
I am a perfusionist working in a rural community in which the use of platelet gel has had an extreme effect on my patients. Due to the fact that medicare does not reimburse for this service, we have had to select our patients very carefully. Some have opted to pay for it themselves because of the effect they have seen. These are patients that have dealt with their wounds for several years and through numerous treatment options. I sincerely hope that the board takes a serious look at all the documentation with regards to platelet gel. Our facility believes in it and has taken the initiative- I truly hope that this board will do the same.
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Title: Medical Director Wound Care
Organization: Baylor Specialty Hospital
Date: 11/29/2011
Autologous Blood-Derived Products for Chronic Non-Healing Wounds
I have been using Platelet Rich plasma Gel (PRPG) since January of 2009. I have trialed the technology in various types of wounds to evaluate the clinical benefits. I published and presented 4 posters at the national wound conferences sharing my findings. The first 3 posters looked at 3 groups of wounds common to the Long Term Acute Care (LTCH) setting: Surgically debrided wounds; large post surgical abdominal wounds; and chronic pressure ulcers of the pelvic region.
SURGICALLY DEBRIDED WOUNDS:
Adding NPWT to PRPG would potentially reduce benefits of PRPG by removing it from the wound interface. NPWT with open cell reticulated (OCR) foam, however, provides macrostain and allows reapproximation of wound edges which is critical in the treatment of post-surgical wounds. Three techniques were trialed in surgically debrided wounds to optimally pair these two treatment strategies.
Case 1 kept PRPG completely separated from NPWT by an occlusive dressing, maximizing the benefits of both. The wound initially closed 35.74% in area and 60.11% in volume at 0.15cm2/day and 0.50cm3/day over two weeks. Following PRPG with NPWT, the wound contracted 76% in area and 85.33% in volume, at 0.14cm2/day and 0.19cm3/day over three weeks. Case 2 utilized fine mesh gauze to separate PRPG from OCR foam. The wound closed 25.76% in area and 39.68% in volume at 1.81cm2/day and 5.94cm3/day over the first 20 days. Once PRPG was added, the wound only contracted 1.72% in area but 43.30% in volume, at 0.11cm2/day and 4.83cm3/day. Case 3 allowed complete contact of the OCR foam with PRPG. No change was noted over the first three days with NPWT. When PRPG was added, the wound contracted 86.44% in area and ¬91.3% in volume, at 8.51cm2/day and 31.77cm3/day over seven days. Benefits were noted in all three techniques pairing PRPG with NPWT.
LARGE POST SURGICAL ABDOMINAL WOUNDS:
This case series evaluated the impact of combining PRPG with NPWT in 2 patients with abdominal wounds. Both received multiple surgical debridements for infection then subsequent placement of regenerative tissue matrix. In this Long Term Acute Care (LTAC) facility, the average healing rate in 2006 and 2007 of surgically debrided abdominal wounds utilizing standard of care advanced wound management techniques was 0.62cm2/day and 1.79cm3/day. The baseline healing rate with NPWT only in patient 1 was 1.81cm2/day and 5.94cm3/day with a 39.68 % reduction in volume over 20 days. No granulation tissue migration was achieved over the tissue matrix. PRPG was applied to the base of the wound over the exposed tissue matrix followed by an impregnated mesh gauze and the ORC foam. Granulation tissue migration was noted over the tissue matrix and wound reduced by 0.11cm2/day, 4.83cm3/day, and contracted 43.83% in volume. The baseline healing rate for patient 2 was 1.35cm2/day, 5.77cm3/day with a 70.42 % in volume over 26 days. PRPG was added in the same fashion as patient 1. The wound contracted at 0.63cm2/day, 1.26cm3/day with a 19.33% reduction in volume over 7 days. Undermined areas reduced by 50% from all directions with 80% granulation tissue coverage of the tissue matrix. Rapid reduction in undermining and coverage of exposed tissue matrix allowed both patients to transition to a lower acuity setting.
CHRONIC PRESSURE ULCERS OF THE PELVIC REGION:
Individuals with chronic Stage III and IV pressure ulcers in the pelvic region are routinely treated with offloading/bedrest and moisture retentive dressings. In long-term acute care (LTAC) settings with an average length of stay of 3-4 weeks, a prolonged wound healing time results in significant muscle weakness, approximately 12% per week (Jiricka, 2008). In this LTAC facility, the average healing rate in 2006 and 2007 in patients with Stage III and IV pressure ulcers in the pelvic region utilizing various advanced wound healing techniques and modalities was 0.3cm3/day and 0.89cm3/day, respectively. The average healing rate for surgically debrided pressure ulcers in the pelvic region was 0.55cm3/day and 1.0cm3/day, respectively. Five patients with 7 surgically debrided Stage III and IV pressure ulcers in the pelvic region were treated with moist wound healing techniques and the addition of platelet rich plasma gel (PRPG) to evaluate the impact of PRPG on the standard of care. The average rate of volume contraction of these 7 wounds prior to the use of PRPG was 1.22cm3/day. After the use of PRPG, the rate of volume contraction increased to 1.31cm3/day. Two surgically debrided Stage IV wounds on 2 patients were assessed when PRPG had been initiated on day 3 of the patients’ stay. The volume contracted at an average rate of 0.45cm3/day. Additionally, 3 non-surgically debrided Stage III and IV pressure ulcers on 3 patients were assessed using PRPG. The average rate of volume contraction prior to the use of PRPG was -2.26cm3/day. After the use of PRPG, the volume contracted at an average rate of 3.1cm3/day. This study suggests that platelet rich plasma gel, used in conjunction with moist wound healing strategies and modalities may help reduce overall time to wound closure by maximizing the rate of healing during the 3-4 week acute care stay.
The last poster presents a summary of post surgical wounds treated at our facility during 2009-2010 with PRPG combined with NPWT.
Baseline healing rates for post surgical wounds treated with NPWT during 2008-2009 at our facility were 0.47 cm2/day, with volume reduction of 1.03 cm3/day. Mean total admission Bates Jensen Wound Assessment Tool Severity (BWAT) for this group was 32.37, with a mean total discharge BWAT of 27.27 for a mean total change in BWAT score of 5.1. Similar wounds treated at our facility during 2009-2010 with a combination of PRPG and NPWT demonstrated a healing rate of 0.78 cm2/day and volume reduced by 1.47 cm3/dav. Mean total admission BWAT score for this group was 34.64, with a mean total discharge BWAT score of 26.48 for a mean total change in BWAT of 8.16. The combined treatment had an improved healing rate of 0.31 cm2/day (66%) over NPWT alone, as well as an improved volume reduction rate of 0.44 cm3/day (42.7%) and an increase in BWAT change of 3.06. This improvement was noted with generally 1-3 applications of PRPG.
The addition of PRPG to the treatment of post surgical wounds and chronic pressure ulcers has improved our rate of area and volume contraction per day and reduced our length of stay as we are able to more rapidly cover at risk structures such as bone, tendon or mesh. It has been far more effective and less costly then previously used live cell skin substitutes. It is unfortunate that this technology is not available for individuals with these chronic post surgical wounds and pressure ulcers. Better access would potentially reduce the use of more costly products, speed recovery and transition to lower acuity settings, and reduce the need for inpatient admissions.
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Title: Podiatrist
Organization: Foot and Ankle Associates
Date: 11/27/2011
I have provided this therapy, supplied by Safeblood Technologies, for 10 years. I have found this therapy to be incredibly useful for many of my patients. There is no doubt in my mind that may limbs were salvaged as a result of them receiving this therapy. I recall one particular patient that I got consulted on that had a black magic marker line drawn around her leg by a surgeon, above the knee, indicating the level of amputation he was planning to perform. She absolutely refused and had my partner, Dr. Calvin Britton, called. He performed the Safeblood procedure, and she still has her foot today. That was 9 years ago, and I saw her recently. She remains ulcer-free and doing fine. I am convinced PRP is as good a therapy in the chronic wound arena as any therapy currently available, including VAC, Regranex, Dermagraft, Apligraf, and the various other wound care modalities. It most definitely needs to be a covered benefit.
As a wound care professional, and as a certified wound care physician by AAWC, I see chronic wounds weekly. I see the toll they take on the patient, and the family. Anything we can do as physicians to speed healing is truly beneficial, and PRP is truly that.
I have treated at least 100 patients with this therapy and most have benefited greatly. On behalf of my patients, I ask you cover this technology.
Richard A Dellinger, DPM
Little Rock, AR
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Date: 12/03/2011
[PHI Redacted] is a C1 quadriplegic who has had chronic nonhealing wounds on her left ischium for over 10 years. She tried the Autologel procedure for a very deep tunnel in that area and experienced considerable success. Over a period of 21 days using Autologel, the wound reduced in size from an area of 41 cm³ to an area of 2.5 cm³, a decrease of 94%. In the years preceding the application of Autologel, she used a variety of other therapies, including wet-to-dry dressings and negative pressure wound therapy. In addition, she has had numerous debridements and hospital stays for her wounds. Because of her disability, she is a Medicare beneficiary. We estimate the cost to Medicare for these other treatments to be approximately $408,371.44, with an out-of-pocket expense to us of about $45,333.99. In contrast, the cost of three Autologel treatments is less than $1500.
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Title: CEO
Organization: Asheville Specialty Hospital
Date: 12/09/2011
We are a Long-Term Care Hospital (LTCH) and people with wounds make up a significant portion of our patient population. We are always looking for way to improve wound care outcomes in a cost effective manner. Prior practice was what I would a call Vac and forget. Wound vacs or “negative pressure wound therapy” (NPWT) were used for extended periods time, not only at our hospital but in many cases prior to admission, and at times patients are discharged on NPWT.
In exploring options, we came across the use of Protein-Rich Plasma (PRP). We did a pilot with Autologel by Cytomedix since they had FDA approval for wound care. The results were immediate and showed dramatic improvement, especially in diminishing the depth of wounds resulting in faster healing, earlier time to grafts and in some cases, no grafting was needed. In addition, the cost of this treatment was far less than traditional NPWT. We have since used this in over 60 patients with only one case showing little improvement. As far as cost, we see about a 40% reduction in cost over NPWT.
In addition to faster wound healing, the pain associated with PRP dressing changes vs. NPWT is far less and the overall procedure is less labor intensive. Many patients undergoing NPWT dressing changes have to be medicated for pain prior to the dressing change, sometimes IV pain medication and at times even conscious sedation is needed. We do not typically see this with using Autologel. Finally, nursing time for dressing changes is typically decreased by 20%.
We have also had success in some cases of using PRP to reduce the utilization of Appligafts which are extremely costly, but often used by providers over PRP since there are no charge codes under Medicare Part B for using PRP. The cost of three Autologel treatments is several hundred dollars less then one Appligraft, and in many cases multiple Appligrafts would be used. PRP does not typically eliminate the need for wound grafting, but expedites the procedure.
In closing, for inpatient use of PRP we have had superior outcomes over traditional NPWT treatments with a 40% cost reduction over traditional NPWT. Our length of stay has decreased, patients tolerate it better, and there is decreased nursing time. There is no reason that this can not be achieved on an outpatient basis, but in discussions with providers, PRP is not used as they have no way to bill for it with a CPT code. I strongly recommend the approval of Autologel.
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Organization: Asheville Specialty Hospital
Date: 12/09/2011
We are a Long-Term Care Hospital (LTCH) and people with wounds make up a significant portion of our patient population. We are always looking for way to improve wound care outcomes in a cost effective manner. Prior practice was what I would a call Vac and forget. Wound vacs or “negative pressure wound therapy” (NPWT) were used for extended periods time, not only at our hospital but in many cases prior to admission, and at times patients are discharged on NPWT.
In exploring options, we came across the use of Protein-Rich Plasma (PRP). We did a pilot with Autologel by Cytomedix since they had FDA approval for wound care. The results were immediate and showed dramatic improvement, especially in diminishing the depth of wounds resulting in faster healing, earlier time to grafts and in some cases, no grafting was needed. In addition, the cost of this treatment was far less than traditional NPWT. We have since used this in over 60 patients with only one case showing little improvement. As far as cost, we see about a 40% reduction in cost over NPWT.
In addition to faster wound healing, the pain associated with PRP dressing changes vs. NPWT is far less and the overall procedure is less labor intensive. Many patients undergoing NPWT dressing changes have to be medicated for pain prior to the dressing change, sometimes IV pain medication and at times even conscious sedation is needed. We do not typically see this with using Autologel. Finally, nursing time for dressing changes is typically decreased by 20%.
We have also had success in some cases of using PRP to reduce the utilization of Apligrafs which are extremely costly, but often used by providers over PRP since there are no charge codes under Medicare Part B for using PRP. The cost of three Autologel treatments is several hundred dollars less then one Apligraf, and in many cases multiple Apligrafs would be used. PRP does not typically eliminate the need for wound grafting, but expedites the procedure.
In closing, for inpatient use of PRP we have had superior outcomes over traditional NPWT treatments with a 40% cost reduction over traditional NPWT. Our length of stay has decreased, patients tolerate it better, and there is decreased nursing time. There is no reason that this can not be achieved on an outpatient basis, but in discussions with providers, PRP is not used as they have no way to bill for it with a CPT code. I strongly recommend the approval of Autologel.
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