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| May 1, 2008 |
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Top
Stories |
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Clinical
Research |
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Biopharmaceutical News |
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Association
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Calendar |
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Job &
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Monthly Journal |
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eNews
Archives |
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BMT
Tandem Meetings
Feb. 11-15, 2009
Tampa, Florida |
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Last Month’s Reader Poll
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Do you think the demand for unrelated donor transplants will change over the next several years, and can your program accommodate an increase?
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| Calendar |
• May
American Society of Pediatric Hematology/Oncology (ASPH/O)
21st Annual Meeting
May 14-17
Duke Energy Center & Hyatt Regency
Cincinnati, Ohio
Myelodysplastic Sydromes and Bone Marrow Failure
European School of Haematology (ESH)
May 15-18
Albufeira, Portugal
International Society for Cellular Therapy (ISCT)
14th Annual Meeting
May 17-20
Hyatt Regency Hotel
Miami, Florida
Short Course on Preservation of Cells, Tissues and Gametes
Center for Translational Medicine
May 21-23
University of Minnesota
Minneapolis, Minnesota
Cancer Epigenetics
American Association for Cancer Research (AACR)
May 28-31
Boston Park Plaza Hotel
Boston, Massachusetts
American Society of Gene Therapy (ASGT)
11th Annual Meeting
May 28-June 1
Hynes Convention Center
Boston, MA
American Society of Clinical Oncology (ASCO)
44th Annual Meeting
May 30-June 3
McCormick Place
Chicago, Illinois
American Transplant Congress
American Society of Transplantation (AST)
May 31-June 4
Metropolitan Toronto Convention Center
Toronto, Ontario, Canada
• June
FOCIS 2008
Federation of Clinical Immunology Societies (FOCIS)
June 5-9
Boston Marriott Copley Place
Boston, Massachusetts
7th Annual International Umbilical Cord Blood Transplantation Symposium
California Blood Bank Society and Cord Blood Forum
June 6-7
Los Angeles Airport Marriott
Los Angeles, California
International Society for Experimental Hematology (ISEH)
37th Annual Scientific Meeting
June 9-12
Renaissance Boston Waterfront Hotel
Boston, Massachusetts
International Society for Stem Cell Research (ISSCR)
6th Annual Meeting
June 11-14
Pennsylvania Convention Center
Philadelphia, Pennsylvania
European Hematology Association (EHA)
13th Congress
June 12-15
Bella Center
Copenhagen, Denmark
• July
International Society for Experimental Hematology (ISEH)
37th Annual Scientific Meeting
July 9-12
Renaissance Boston Waterfront Hotel
Boston, Massachusetts
Molecular Biology in Clinical Oncology
American Association for Cancer Research (AACR)
July 11-18
Given Institute of the University of Colorado
Aspen, Colorado
Cancer Biostatistics Workshop
American Association for Cancer Research (AACR)
July 13-19
The Lodge at Sonoma
Sonoma, California
Advances in Long-Term Management of Adult Patients Undergoing Hematopoietic Stem Cell Transplantation
Fred Hutchinson Cancer Research Center
July 18-20
Hilton Union Square
San Francisco, California
Cryo 2008
Society for Cryobiology
45th Annual Meeting
July 20-23
Charlotte, North Carolina
• September
American Association of Tissue Banks (AATB)
32nd Annual Meeting
Sept. 6-9
Marriott Chicago Magnificent Mile
Chicago, Illinois
European Society for Medical Oncology (ESMO)
Annual Meeting
Sept. 12-16
Stockholm International Fair
Stockholm, Sweden
ISCT Europe Regional Meeting
International Society for Cellular Therapy (ISCT)
Sept. 14-16
Cultural Conference Center Elzenveld
Antwerp, Belgium
American Society of Multicultural Health and Transplant Professionals (ASMHTP)
16th Annual Meeting
Sept. 17-19
Radisson Plaza Hotel
Minneapolis, Minnesota
25th National Oncology Economics Conference
Association of Community Cancer Centers (ACCC)
Sept. 17-20
Hyatt Regency San Francisco
San Francisco, California
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| Top
Stories |
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Stem cell research center to aid wounded soldiers
The Pentagon is establishing the $265 million Armed Forces Institute of Regenerative Medicine to develop ways to help wounded soldiers regenerate skin, muscle and even limbs from their own stem cells. The institute will fund and focus the research efforts of two consortia of universities and hospital research centers, one led by Wake Forest University and the University of Pittsburgh, and the other by Rutgers University and the Cleveland Clinic.
Donated organs cause cancer in recipients
Two recipients of organs from a 15-year-old donor have died after contracting non-Hodgkin's lymphoma from the organs; two others had their donor kidneys removed and are undergoing cancer treatment. Doctors originally thought the donor died from bacterial meningitis, but an autopsy revealed he had the rare form of blood cancer.
Pakistan city to establish blood bank and BMT center
The city government of Karachi in Pakistan plans to build a blood bank and diagnostic center that also will provide bone marrow transplants – the only government-run facility of its kind in the city. Nine major disciplines, including hematology, clinical pathology, chemical pathology, microbiology, bone marrow transplantation, radiology and ultrasonography will be part of the center’s services.
Gene therapy turns cells into biological pacemakers
Researchers are working to develop a “biological pacemaker” that would work in tandem with electronic pacemakers. In essence, the biological pacemaker is based on a gene that works to regulate heart rate. By altering cells to carry this gene, then implanting those cells in a patient, proponents believe they can improve the function of electronic pacemakers, if not replace them altogether.
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 A Word from President Helen Heslop, MD
What would you say is a fair amount to pay for orthodontic braces? $3,000? $5,000? $7,000?
If you were a dental insurance company and needed to know, you’d probably find out by collecting claims data submitted by orthodontists and patients to determine what is usual and customary. You’d then compute means and deviations that allowed you to arrive at reimbursement rates you’d be willing to pay for orthodontic care.
The same kind of thing is happening right now with lab fees for processing of hematopoietic progenitor cells. In this case, though, it is the Center for Medicare and Medicaid Services (CMS) that is trying to determine a fair reimbursement for cell processing procedures.
If you are involved in cell processing or billing, CMS needs your help. In fact, the agency will have a hard time arriving at accurate and fair reimbursement rates without your input.
It is especially important that transplant centers and cell processing labs submit complete and accurate claims between now and the end of 2009. During this window, the agency is deciding on future reimbursement rates.
Let me explain. Until January this year, CMS did not reimburse for bone marrow/stem cell processing, except for minimal payment for “G codes” ranging from about $14 to $230 per aliquot.
It took several years for leaders in ASBMT, the American Society of Hematology, AABB and others to engineer reimbursement codes for these services. Codes 38207 through 38215 have been part of the AMA’s Current Procedure Terminology since 2003.
It then took several more years until finally, last year, CMS announced that it would begin reimbursement for cell processing – but at admittedly arbitrary rates. For example, $54.69 for cryopreservation and thawing and $222.44 for cell depletion.
The agency acknowledged its uncertainty about these rates and said that it would build a database of actual claims during the 24-month period through December 2009. Then new, more accurate rates will be set.
So far, so good. But there’s concern that claims submitted during this current two-year window might not always reflect the actual costs. This is because facilities . . .
may be in the habit of shifting or bundling cell processing costs with other services
may not be used to submitting claims for cell processing because of past coding difficulties or reimbursements so low that it hardly was worth their time and effort
may not have charged at all for cell processing because it was hard to calibrate systems to bill private payers in one way and government payers in another
What CMS does at the end of the two-year period can have ramifications for private-pay programs, because private payers often follow or are influenced by CMS. On the other hand, some private payers may now have trouble understanding why they are seeing invoices for cell processing for the first time.
What are your real costs? CMS has said that it expects charges for cell processing to be proportional to actual costs, with appropriate adjustments for institutional overhead. A lab needs to consider technician time, supplies, equipment use including flow cytometry on cell products, quality assurance procedures, equipment depreciation, liability insurance and GMP laboratory and occupancy costs such as lighting and heating. Personnel costs can include time for completing reports and supervision by a qualified non-physician.
Even if your transplant procedure is reimbursed on a case-rate basis, it is important to identify cell processing costs so that an appropriate portion of the reimbursement comes back to the processing lab.
If billing for cell processing services is something you do or supervise and you need more detailed information, there is an online presentation that the chair of our Committee on Reimbursement, Jim Gajewski, gave in February to the administrators' conference at the BMT Tandem Meetings in San Diego.
It took five years of discussions with CMS to achieve recognition of cell processing. The ball is now in our court to work toward appropriate and adequate levels of reimbursement.
– Helen
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| Clinical Research |
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Protein identified as repressor of stem cell self-renewal
Researchers at Yale University have identified the c-Cbl protein as being a critical repressor of self-renewal in hematopoietic stem cells. According to a report in the April 15 issue of Genes & Development, these cells generate two different daughter cells, one future stem cell and one cell that will further differentiate into a more specialized cell type. Imbalances in differentiation and self-renewal can lead to hematologic malignancies, like leukemia.
Molecule activates blood stem cells to treat heart damage
Using Shz-3, a synthesized molecular variant, researchers were able to activate human peripheral blood mononuclear cells to create RNAs and proteins found only in heart cells. According to a report in the April 22 issue of the Proceedings of the National Academy of Sciences, transplanting these cells into the hearts of rats with cardiac damage resulted in significant improvement. Tests showed that the human cells were alive and had incorporated themselves into the heart tissue, although the researchers could not tell whether the human cells had become fully functional, contracting heart cells.
Clinical research begins on using adult stem cells to repair heart
Doctors at the University of Miami Medical School have operated on the initial patient in an experiment to determine whether autologous transplantation of adult stem cells from bone marrow directly into the heart can repair the damaged organ. The 18-month study centers on 45 patients with heart failure in Miami and at Johns Hopkins University in Maryland. It is the first such study funded by the National Institutes of Health’s Specialized Center for Cell-based Therapy Initiative.
Menstrual cells show potential to repair heart tissue
Scientists have discovered that menstrual blood contains mesenchymal cells that can be used to develop cells similar to cardiomyocytes. According to a report published online in Stem Cells, when put in culture with cells from the hearts of rats, about 20 percent of the menstrual mesenchymal cells began beating spontaneously and eventually formed sheets of heart muscle tissue. |
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| Biopharmaceutical News |
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Takeda of Japan buying Millennium Pharmaceuticals
Takeda Pharmaceutical of Japan is buying Millennium Pharmaceuticals in the United States. Millennium’s leading product is Velcade, a blood cancer treatment, and the company has seven compounds in clinical trials to treat cancer, Crohn’s disease and multiple sclerosis.
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| Association
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Scholars selected for 2008 research training course
Sixteen young clinicians and investigators have been selected to participate in the second annual ASBMT Transplant Clinical Research Training Course, to be held in early August in Park City, Utah.
FACT launches electronic newsletter
The Foundation for the Accreditation of Cellular Therapy has launched an electronic newsletter with information about standards and accreditation for transplant centers and cord blood banks. The newsletter is intended to be a resource for accredited and applicant blood stem cell collection centers, processing laboratories and clinical facilities, as well as cord blood banks and accreditation inspectors.
Conference celebrates cord blood anniversaries
An international conference on Biology and Clinical Application of Cord Blood Cells in October in Mandelieu, near Cannes, France, will celebrate the 20th anniversary of the first cord blood transplant and 10th anniversary of the founding of the International NetCord Foundation, the association of umbilical cord blood banks.
Search, procurement information offered to payers
The National Marrow Donor Program has announced a new online resource that offers third-party payers information about the search and procurement of unrelated donors and umbilical cord blood units. The Web presentation provides guidelines and detailed information about disease treatments, referral timing, the transplant process, associated costs and outcomes.
Public comments sought on NMDP Standards
The National Marrow Donor Program is accepting public comments through May 16 on proposed changes to the 19th Edition of the NMDP Standards.
Review addresses Hurler Syndrome
Hurler syndrome is a severe inborn error of metabolism causing progressive multi-system morbidity and death in early childhood. At present, stem cell transplantation is the only available treatment for preventing CNS disease progression in HS patients. A review of stem cell transplants for HS appears in the May issue of Biology of Blood and Marrow Transplantation. It addresses long-term clinical outcomes, complications, factors that contribute to the variable outcomes and the limitations of stem cell transplants.
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