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By Mikaela VanMoorleghem, Education and Training Coordinator,  Foundation for the Accreditation of Cellular Therapy Prepare for the NetCord-FACT International Cord Blood Standards, Seventh Edition By: Andra Moehring, MHA, FACT Standards Development Manager The Seventh Edition NetCord-FACT International Cord Blood Standards for Collection, Banking, and Release for Administration  will be published on October 15, 2019 and will become effective on January 15, 2020. Programs currently pursuing renewal or initial accreditation under the Sixth Edition Standards must remain mindful of these dates and ensure timely submission of pre-inspection materials ...
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In this month’s Pharmacy SIG Literature Update: ASTCT consensus grading for CRS and neurologic toxicity, reduced intensity conditioning with fludarabine, melphalan, and total body irradiation, oral versus aerosolized ribavirin for the treatment of respiratory syncytial virus infections and much more! Literature summaries are provided as information only. Please refer to the original published articles for complete details on study methodology, results and discussion. ***        Must read. Landmark publication that affects practice **           Recommend reading. Secondary paper that adds to literature *             Consider reading. Cursory importance ...
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On April 23, the Centers for Medicare & Medicaid (CMS) released the FY2020 Inpatient Prospective Payment System (IPPS) proposed rule.  The IPPS rule addresses ways to improve payment for CAR-T therapies and is a step in the right direction. The American Society for Transplantation and Cellular Therapy (ASTCT) has been working closely with CMS to improve reimbursement for chimeric antigen receptor T-cell (CAR-T) therapy to ensure appropriate patient access to this lifesaving therapy and will continue to work with the agency on this important issue.  In the proposed rule, CMS indicates that the agency should collect more clinical data prior to creating a ...
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Earlier in May, I finally caught up with The Lego Movie 2: The Second Part . Personally, I liked the first Lego movie better. Irrespective, the theme song for both movies is “Everything is Awesome” and it got firmly stuck in my head – like CXCR4 sticks to hematopoietic stem cells, though sadly I don’t have a "plerixafor” to "unstick" the song from my grey matter! The protagonist of the movies is Emmet Brickowski (get it – from Lego ‘Brick…’) who is always upbeat irrespective of what the world throws at him. Having the song loop in my head has definitely elevated my outlook to life and I am now among the converted who believe in "think positive ...
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Growing up, Damiano Rondelli didn’t want to be a doctor. In fact, he hated the sight of blood. Born in Italy, Rondelli had other plans—he wanted to be an ambassador, traveling the world to try and fix problems that affected people of all walks of life. “I wanted to talk to people and work together,” he said. “The world was my country.” What he didn’t know then was that in his own way he would become an ambassador to the world. Rondelli is the division chief of hematology/oncology and the director of BMT at the University of Illinois at Chicago College of Medicine. He is also the chair of  ASTCT’s Committee on International Affairs, which was established ...
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By Jodi Skiles, MD, MS, Indiana University School of Medicine I saw the advertisement for the ASTCT Leadership Course in the weekly newsletter. Intrigued, I clicked on the link to find a brief description of the course inviting young leaders to apply. I remember thinking that it sounded interesting and thought about applying, but wasn’t sure if it would be a fruitful use of time, especially when time is such a precious commodity. Nonetheless, I (somewhat skeptically) applied. When I was notified a few weeks later that I had been selected to participate in the course, I was honored and my mentors were thrilled, but I still had no idea what to expect. Fast ...
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I have a confession to share – I enjoy being on "service!" I always look forward to my two-week rotation on our inpatient BMT unit. I get to spend more time with our patients. Each patient room provides a glimpse into their lives – the photo of their favorite pet, the book they are reading, the guardian teddy bear from their grandchild, the rosary they clutch when I enter the room, and the progress they have made on a puzzle that tells me how their previous 24 hours have transpired. Equally informative are the bare walls and empty window shelves for some patients, with no get well soon cards and no scribbles on the whiteboard. I get to see our awesome team ...
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Mikaela VanMoorleghem, Education and Training Coordinator Foundation for the Accreditation of Cellular Therapy Trending Clinical Outcomes By: Kara Wacker, MBA, FACT Strategic Planning Administrator Clinical outcome analysis might have started gaining renewed attention in recent years, but FACT has required such analysis since its first Standards in 1996. This puts the HPC transplant field at an advantage as more stakeholders and patients are evaluating health care institutions in the context of actual clinical outcomes. Transplant programs that have voluntarily complied with FACT Standards over the years have outcome data that can be useful ...
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In this month’s Pharmacy SIG Literature Update: Updates on the role of upfront transplantation in patients with high-risk myelodysplastic syndrome and secondary acute myelogenous leukemia, prevention and treatment of GVHD, and much more! Literature summaries are provided as information only. Please refer to the original published articles for complete details on study methodology, results and discussion. ***        Must read. Landmark publication that affects practice **           Recommend reading. Secondary paper that adds to literature *             Consider reading. Cursory importance to the practice Allogeneic Transplantation * Chamoun ...
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Michele Brown had just gotten out of a session at the TCT Meetings of ASBMT and CIBMTR when something in the program caught her eye. It was the second year the BMT RN clinical quality improvement coordinator from New York had attended the meetings. As a session she attended came to a close, she saw an oral abstract presentation was just about to start. She took a seat, listened as Ann Leen, PhD, presented her research on a clinical trial she helped conduct at The Center for Cell and Gene Therapy, Baylor College of Medicine. It used a unique type of cellular therapy to help some patients with Hodgkin’s and non-Hodgkin’s lymphoma. After Leen finished, she ...
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ASTCT’s Continued Engagement on CAR-T ASTCT remains involved in conversations with the Centers for Medicare and Medicaid (CMS) along with Capitol Hill regarding policy changes for CAR-T therapies. On March 15, CMS released a transmittal with updates on CAR-T coding and billing in the Hospital Outpatient Prospective Payment System (HOPPS) effective on April 1. The transmittal states, effective April 1, 2019 hospitals may report the new CAR-T revenue codes 087X (Cell/Gene Therapy) and 089X (Pharmacy) and value code 086X (Invoice Cost) established by the National Uniform Billing Committee when reporting claims so that the agency may track utilization and ...
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On April 23, the Centers for Medicare & Medicaid (CMS) released the FY2020 Inpatient Prospective Payment System (IPPS) proposed rule.  The IPPS rule addresses ways to improve payment for CAR-T therapies and is a step in the right direction. The American Society for Transplantation and Cellular Therapy (ASTCT) has been working closely with CMS to improve reimbursement for chimeric antigen receptor T-cell (CAR-T) therapy to assure appropriate patient access to this lifesaving therapy and will continue to work with the agency on this important issue.  ASTCT applauds CMS for being responsive to our concerns about CAR-T reimbursement by releasing some specific ...
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We at American Society for Transplantation and Cellular Therapy (ASTCT) acknowledge National Minority Health Month. ASTCT, formerly the American Society for Blood and Marrow Transplantation (ASBMT), is a professional membership organization with approximately 2,000 members across the United States and around the globe. ASTCT membership consists of physicians, advanced practice providers, nurses, pharmacist, scientists, social workers and healthcare administrators committed to blood and marrow transplantation and cellular therapy. ASTCT members treat patients with advanced blood cancers and autoimmune diseases. ASTCT is committed to achieving a diverse workforce. ...
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By Dr. Navneet Majhail, ASTCT President Thank you for the tremendous response to my first column as ASTCT President . I was impressed by the number of people who actually read it. The feedback was mostly positive – well, the only complaint was that I did not share a photo of Caesar! I did get a lot of helpful advice. And yes, I have started eating my veggies!! @BldCancerDoc advice for our new ASTCT President Dr Navneet Majhail #ASTCT 1. Prepare your newsletter way in advance 2. Eat your veggies. 3. Remember it’s only 12 months 4. You have good company use them 5. Delegate delegate and delegate Thanks for serving sg — sergio giralt (@sgiraltbmtdoc) ...
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By Mikaela VanMoorleghem, Education and Training Foundation for the Accreditation of Cellular Therapy Publication of the FACT Common Standards, Second Edition Congratulations to Dr. Paul Eldridge, FACT Standards Chair, and the FACT Common Standards Steering Committee on publishing the Second Edition FACT Common Standards for Cellular Therapies on March 15, 2019. The Standards will become effective on June 15, 2019. Committee Overview The Second Edition FACT Common Standards Steering Committee is comprised of 12 representatives who worked for 23 months on the development of the Standards. Everyone’s commitment, expertise, and experience is invaluable ...
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ASTCT’s Outreach on CAR-T The Centers for Medicare and Medicaid Services (CMS) requested comments on their Proposed Decision Memo for Chimeric Antigen Receptor (CAR-T) T-cell therapy. ASTCT submitted comments to the agency prior to the March 17 deadline. The public comment period is closed and we expect the final coverage determination to be released no later than May 17. ASTCT’s comments can be viewed here . The proposed National Coverage Analysis would require Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment. ASTCT emphasized ...
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Registration is now open for April’s Online Journal Club. Reserve your seat for this webinar through the following link and please share to all that may be interested: https://attendee.gotowebinar.com/register/6146227515136446467 Dr. Mollie Beck will highlight an in-depth review regarding the article "Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma" . The goal of these journal clubs will be to provide education and more in-depth review of literature related to the field of stem cell transplantation and cellular therapy and will be provided a few times a year. Beck is currently completing her PGY2 Hematology/Oncology ...
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Long before the TCT Meetings of ASBMT and CIBMTR became what it is today, it was just a small meeting of friends during a ski trip. There wasn’t a name to those first few meetings. More than 10 years before the “official” meetings would kick off—then known as the Tandem Meetings—a group of physicians and researchers met to discuss emerging BMT and cellular therapies. Among them was Olle Ringdén, MD, PhD. In 1980, Ringdén hopped on a plane from Sweden—his home country—to Keystone, Colorado. He was encouraged to attend by renowned physicians Robert Gale, MD, PhD; and Richard Champlin, MD. “I had started a new center in Sweden,” Ringdén recalled. “It was ...
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The ASTCT Survivorship Special Interest Group (SIG) had yet another successful annual meeting during the TCT Meetings in Houston, Texas. The meeting growth underscores the growing interest in discussing the survivorship and late effect needs of hematopoietic stem cell transplant survivors and their caregivers. The SIG was fortunate to have patient stakeholders who attended the meeting, provided input and insight, and discussed the important role of engaging patients and caregivers in ongoing efforts focused on survivorship care.   The meeting began with brief reports from collaborating groups including the Palliative and Supportive Care SIG and the newly established ...
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ASTCT submitted comments on the CMS National Coverage Analysis for Chimeric Antigen Receptor (CAR) T-cell Therapy last week. The public comment period has closed, and we expect the final coverage determination to be released no later than May 17. To read the comments, click here. ASTCT expressed concern that the coverage policy as proposed would limit patient access and recommended that the agency finalize a coverage policy that leverages existing registry reporting rather than coverage with evidence development (CED). Our comments suggested ways to revise the policy to protect patient access to approved CARs and those likely to be approved in the next five ...
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