National Coverage Analysis (NCA) View Public Comments

Extracorporeal Photopheresis

Public Comments

Commenter Comment Information
Smith, M.D., Eileen Title: Assoc. Dir., Clinical Res. Div. Hematology & HCT
Organization: City of Hope
Date: 11/03/2006
Comment:

The physicians in the Division of Hematology and Hematopoietic Cell Transplantation (HCT) at City of Hope support Medicare coverage for extracorporeal photopheresis (ECP) for chronic graft versus host disease (cGVHD). As the largest provider of HCT in California and one of the largest centers nationally, we believe that ECP is the current standard of care for select patients with cGVHD.

We agree with the scientific studies reviewed for this proposal supporting the clinical efficacy

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Donato, Michele Title: Attending physician
Organization: Hackensack University Medical Center
Date: 11/03/2006
Comment:

I have been a bone marrow transplant physician since 1997 practicing at MD Anderson Cancer Center in Houston until 2005 and presently practicing at Hackensack University Medical Center in NJ. I was the senior author for the paper published in the journal "Blood" in Dec 2005 and have extensive experience in this field.We have demonstrated the efficacy of photopheresis in patient with chronic graft versus host disease, with a response rate 61%. Photopheresis is a lifesaving procedure for many

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Marques, Marisa Title: Associate Professor of Pathology
Organization: Univeristy of Alabama at Birmingham
Date: 11/03/2006
Comment:

As a Transfusion Medicine physician, I have been using photopheresis for more than 10 years in the management of patients with heart transplant rejection at the University of Alabama at Birmingham Hospital. By now, 104 patients with this diagnosis have been treated by our service. I am very excited with the new Medicare proposal because it is our combined experience at UAB that photopheresis is highly effective in these patients. Some of our observations have been published before and

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Bolwell, Brian Title: Chairman, Dept of Heme/Onc & Blood Disorders
Organization: Cleveland Clinic Foundation
Date: 11/03/2006
Comment:

Thank you for allowing me the opportunity to make a public comment concerning the use of extracorporeal photopheresis for the treatment of refractory, chronic graft versus host disease (cGVHD).

I have been Director of the Bone Marrow Transplant Program at the Cleveland Clinic for the past 20 years. I have extensive experience with chronic GVHD and its therapy.

GVHD is arguably the most vexing problem associated with allogeneic bone marrow/stem cell transplantation. Part

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Barr, Mark Title: Associate Professor of Cardiothoracic Surgery
Organization: University of Southern California and Childrens Hospital Los Angeles
Date: 11/02/2006
Comment:

November 1, 2006

To: Centers for Medicare and Medicaid Services

Re: Extracorporeal Photopheresis

I am thanking you in advance for permitting me to share my thoughts regarding the use of extracorporeal photopheresis in the fields of both heart and lung transplantation. Although I am expressing my personal opinions as an individual involved in the cardiothoracic transplant field for almost twenty years, by way of my position as the Immediate Past President of the

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van Besien, Koen Title: Director Stem Cell Transplant Program
Organization: University of Chicago
Date: 11/01/2006
Comment:

Extracorporeal photopheresis has been useful in the management of patients with steroid dependent and steroid refractory chronic GVHD. This is a debilitating complication of allogeneic transplantaton for which few other therapeutic options exist. ECP therefore fulfills an important unmet need.

Reddy, Vijay Title: Assistant Professor
Organization: University of Florida
Date: 11/01/2006
Comment:

I am a physician treating patients with graft-versus-host disease (GVHD). Patients developing GVHD particularly the chronic form have few options after they have failed conventional first line treatment with corticosteroids. The data with extra corporeal photopheresis (ECP) is very promising and it is my personal opinion that this should be available for patients who have failed standard treatment options. This is a very debilitating condition and difficult to treat with poor quality of

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Kalaycio, Matt Date: 11/01/2006
Comment:

I appreciate the efforts of CMS in reviewing the pertinent literature with regard to the utility of extracorporeal photophoresis (ECP) in the management of chronic GVHD. As a transplant physician, I can attest to the efficacy of ECP in the management of cGVHD. If find it particularly useful for cutaneous GVHD. I support the CMS decision.

Jagasia, Madan Title: Asst Prof of Medicine, Director, Out Patient Trans
Organization: Vanderbilt UNiversity Medical Center
Date: 10/31/2006
Comment:

Extracorporeal photopheresis (ECP) is a important and scientifically established was to treat GVHD, both acute (steroid dependent or steroid refarctory) and chronic GVHD. Recent data suggests earlier intervention with ECP may be beneficial. It has an importand advantage that it does not increase risk of systemic infections. The development of this modality has been hampered by lack of thrid party coverage and thus has been used as a last resort where the data still looks convincing. Earlier

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Ferrara, James Title: Director, BMT program
Organization: University of Michigan
Date: 10/30/2006
Comment:

ECP is increasingly important in the treatment of GVHD. We have seen a steady increase in the demand for this service in the past 3 years. The treatment is non-toxic, and we have had particular success in being able to wean steroids for patients whose GVHD is otherwise steroid dependent. We were skeptical of its efficacy at first, but the majority of attendings will now sign up their patients shortly after steroid has started because the demand is so high and the waiting list is long.

Rook, Alain Title: Professor of Dermatology
Organization: University of Pennsylvania School of Medicine
Date: 10/30/2006
Comment:

We have utilized photopheresis to treat heart transplant rejection since 1993. It continues to produce an extraordinarily high response rate among previously treatment refractory patients. Among over 25 patients treated, only one has failed to respond to photopheresis and that patient had antibody mediated rejection. Similarly, for patients with refractory graft versus host disease, photopheresis has produced significant benefit for the majority of treated patients. Photopheresis is

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Becker, Joanne Title: Chief, Division of Laboratory Medicine
Organization: Roswell Park Cancer Institute
Date: 10/23/2006
Comment:

I wish to thank the committee for their recognition of extracorporeal photopheresis as a beneficial modality in the treatment of graft vs host disease for hematologic and solid organ transplant. I have seen patients benefit from this therapy for 10 years and I am pleased that it will now be available for the patients who will benefit.

Shore, Tsiporah Date: 10/23/2006
Comment:

I support the use of extrcorporeal photopheresis in the management of chronic graft versus host disease. I am of the opinion that it is most effective if used early in the course of the disease rather than exhausting other immunosuppressive drugs that are ineffective. If the patient is steroid refractory, this option should be available. The frequency of the treatments should be at the physician's discretion based on patient tolerance. Initially it would be ideal to offer 3 treatments

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Siegel, Don Title: Professor and Vice-Chair, Pathology & Lab Medicine
Organization: University of Pennsylvania Medical Center
Date: 10/23/2006
Comment:

I think that Medicare coverage for photopheresis would be valuble for treatment of graft-vs-host disease and heart/lung transplant rejection because of the accumulate evidence for its efficacy along with a developing understanding of the way in which photopheresis induces an immunomodulatory effect.

Benson, Kaaron Title: Director, Blood Bank/Director HLA/Immunogenetics
Organization: H. Lee Moffitt Cancer Center & Research Institute
Date: 10/23/2006
Comment:

Extracorporeal photopheresis for chronic graft vs. host disease following allogeneic stem cell transplantation is a widely accepted form of treatment for this disease. I have found that the majority of adult patients that we treat with this therapy have benefited and particularly when other forms of therapy are no longer effective. In particular, we have found that patients on ECP can be tapered off of steroids and have better quality of life as a result.
Kaaron Benson,

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Wong, Edward Title: Director, Hematology/Assoc. Dir, Transfusion Med
Organization: Children's National Medical Center
Date: 10/23/2006
Comment:

The use of extracorporeal photopheresis for chronic graft vs. host disease s/p allogeneic stem cell transplantation is a widely accepted form of treatment for this disease. I have seen great improvement in the disease in pediatric patients from this treatment when other treatment modalities have failed. This is a very cost effective procedure and successful use outweighs the cost of the procedure especially when the high morbidity and mortality and the associated costs are taken into

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Sachais, Bruce Title: Director of Transfusion Services
Organization: UPENN
Date: 10/23/2006
Comment:

I commend the CMS for its recommendation on coverage for photopheresis for GVHD and treatment resistant cardiac transplant rejection. These are difficult diseases to treat and existing data are compelling such that coverage is warrented.

Cook, Susan J. Title: Blood Bank/HLA Supervisor
Organization: H. Lee Moffitt Cancer Center
Date: 10/22/2006
Comment:

Coverage for GvHD both chronic and acute is extremely necessary for both patient populations to receive the treatment necessary for their disease management. The treatment is crucial as a way to manage symptoms and provide a benefit to the paitient's daily life.

Roseff, Susan Title: Medical Director
Organization: VCU TrANSFUSION mEDICINE
Date: 10/22/2006
Comment:

We have seen excellent results in our patients with chronic GVHD - both in decreasing immunosuppressive therapy and improving symptoms. In zddition, our CT surgeons are intersted in pursuing this therapy - anything to help make this treatment more available is essential.

Zakarija, Anaa Title: MD
Organization: NOrthwestern Memorial Hospital
Date: 10/22/2006
Comment:

Interested in use of photopheresis for cardiac tranplant rejection.

Daniel-Johnson, Jennifer Title: Dr.
Organization: VCUHS
Date: 10/22/2006
Comment:

We perform ECP virtually daily at VCUMC, and just anecdotally during my pathology residency have noted incredible results. Many of our patients are off immunosupressives, and have an excellent quality of life.

Zhao, Yong Title: Medical Director
Organization: Christiana Care health System
Date: 10/21/2006
Comment:

The extracorporeal phtopheresis is very effective to treat patients with steroid- resistant GVHD after BMT.

nayaksnayak, shaila Date: 10/21/2006
Comment:

IT IS NICE THAT FINALLY THE CMS UNDERSTANDS THE PATIENTS NEEDS AND ACCEPT IT RESPONSIBILITY.ATLANTICARE

Kuriyan, Mercy Title: Professor of Laboratory & Transfusion Medicine
Organization: Robert Wood Johnson Medical School
Date: 10/21/2006
Comment:

The Robert Wood Johnson Univesity Hospital has been working towards acquiring a Photopheresis machine for the past 5 years. Finally thanks to a persist patient and family and the generous contributions from a Pharmaceutical Company we have the machine which was delivered within a week of the PO being placed. Thanks to the donating corporation and Therakos we look forward to making many a NJ patient well and happy and cut down on distances the need to travel to get this very vital

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smith, james Date: 10/21/2006
Comment:

As a current provider of photopheresis therapy, we see beneficial reaponses in patients with CTCL, GVHD, cardiac transplant rejection, and lung transplant rejection. We are pleased to see CMS endorsing coverage for GVHD and cardiac transplant rejection, and would encourage looking at lung transplant rejection. Thank you, James W. Smith, MD, PhD

Trainor, Lance Date: 10/21/2006
Comment:

Reimbursement of extracorporeal photophoresis is supported.

Matteu, Nydia Date: 10/21/2006
Comment:
this treatment is useful for our patients. Our patient states "I better following treatment".
Boctor, Fouad Title: Transfusion Medicine Director
Organization: Geisinger Health System
Date: 10/21/2006
Comment:

We haqve aqn exelolent results usung photophoresis to treat patient with GVHD secondry of allo BMT.

Kwiatkowska, BEATA Title: Medical Director
Organization: United Blood Services
Date: 10/21/2006
Comment:

The demand for photopheresis is visibly incrising. Espesially the number of patients with GvHD is incrising.

FLOWERS, MARY Title: MD
Organization: Fred Hutchinson Cancer Research Center
Date: 10/20/2006
Comment:

I strongly support the overvall CMS recommendation in determining that extracorporeal photopheresis (ECP) is a resonable and necessary treatment for patients with chronic GVHD. The data provided is complete, adequate and does support the ECP treatment for patients suffering from chronic GVHD that failed to respond to corticosterodis.

Bisaccia, M.D., F.A.C.P., Emil Title: Director of Photopheresis
Organization: Morristown Memorial Hospital/ Atlantic Health System
Date: 10/19/2006
Comment:

I am the Medical Director of the Photopheresis Center at Morristown Memorial Hospital. We are one of the largest Photopheresis treatment centers in the United States. We have been involved in several published research studies that involve treating patients with Photopheresis, who have Cutaneous T Cell Lymphoma, cardiac and lung transplant rejection, and chronic Graph verses Host Disease. Our experience has been published in several peer review journal articles. The most recent appeared in

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Gonzalez, Joselyn Title: Physician
Organization: Morristown Memorial Hospital
Date: 10/18/2006
Comment:

I believe that approving coverage of photopheresis for patients with cGVHD and acute transplant rejection will provide many patients with a much needed alternate therapy for those that are refractory to standard immunosuppressive therapies. This treatment can provide an improved quality of life and at times they can again re-enter the work force.

ward, david Title: Professor of Medicine
Organization: University of California, San Diego
Date: 10/18/2006
Comment:

I am a physician working in transplantation medicine at Univ of California San Diego, and I provide photopheresis for patients with Graft Versus Host Disease and for Cardiac or Lung Transplant Rejection. It works better, and has fewer side effects, than other treatments. There are many Americans who would actualize the expected potential of expensive and difficult transplant procedures if photopheresis treatment were more widely available.

McSweeney, Peter Date: 10/17/2006
Comment:

I am a bone marrow transplant physician. ECP has been a valuable reatment for patinets with grafter versus host disease. Frequently major improvements occur leading to improved quality of life and reduction in immune suppressing medicines.

Rosenthal, MD, Joseph Title: Director, pediatric BMT
Organization: City of Hope national Medical Center
Date: 10/17/2006
Comment:

Chronic graft-versus-host disease (ChGVHD) is a major problem after allogeneic bone marrow transplantation. In my experience, in patients who failed multiple other immunosuppressive modalities, extracorporal photopheresis (ECP) was able to offer significant improvement. The cure rate for steroid-resistant ChGVHD treated with ECP approached 35%. If not for its heavy demand on resources, on the individual patient and his/her family as well as the medical institution, it would be used at a

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yuan, shan Title: Physician
Organization: City of Hope
Date: 10/17/2006
Comment:

As a physician who works with cancer patients who have undergone bone marrow transplants, I know from first-hand experience that photopheresis makes a dramatic difference in the clinical symptoms and the quality of life for many patients who develop GVHD. These treatment sessions allow them to embark on their road to full recovery and resume a normal life . It is a crucial part of their medical treatment.

Grodman, Howard Title: Director, Pediatric Bone Marrow Transplantation
Organization: Tufts-NEMC and Floating Hospital for Children
Date: 10/13/2006
Comment:

I have had multiple experiences with the use of ECP for cGVHD. I have found this intervention, when used correctly, to have been highly effective on selected patients. I support the decision to approve the use of ECP in cGVHD.

Johnston, Susan Title: Clinical Educator
Organization: Leukemia/BMT Program of B.C.
Date: 10/12/2006
Comment:

I support the preposed coverage. I have witnessed dramatic benefits from this treatment, especially for patients with cGVHD of the skin.

Emmons, Robert Title: Associate Professor
Organization: Temple University
Date: 10/12/2006
Comment:

Our bone marrow and stem cell transplant program has found extracorporeal photopheresis to be useful in the treatment of chronic GVHD of the skin. To a lesser extent it has been successful in sicca syndrome and GI issues.We fully agree with the decision to support this and believe the current literature is adequate to support such a decision.

Boh MD PhD, Erin Title: Professor and chief Dermatology
Organization: Tulane University Health Sciences Center
Date: 10/11/2006
Comment:

Absolutely think photopheresis should be covered for GVHD as it provides therapy for patients unresponsive to conventional therapy and has a proven efficacy in these patients

Agura MD, Edward Title: director
Organization: Baylor University medical center
Date: 10/11/2006
Comment:

This is a very valuable therapy for patients which are not responding to oral medications. I have treated dozens of patients with this approach and find it valuable, effective and safe.

Zic, John Title: Asst Professor of Dermatology
Organization: VUMC Dermatology
Date: 10/11/2006
Comment:

I approve of the recommendation that ECP treatment of cGVHD and acute cardiac graft rejection by a covered service of medicare and medicaid. The experience at VUMC is in line with the published literature.

Girardi, Michael Title: Associate Professor
Organization: Yale University School of Medicine
Date: 10/11/2006
Comment:

I am in complete agreement with the proposed decision by the CMS to approve Photopheresis for cGVHD and cardiac transplant rejections. The literature, as well as our extensive experience using Photopheresis in the treatment of these conditions, is overwhelmingly clear to me that this is appropriate.

However, I am disappointed in the lack of such support for the use of Photopheresis for the treatment of scleroderma and pemphigus vulgaris.