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Summary Consensus Recommendations

Summary of Advisory Council on Blood Stem Cell Transplantation (ACBSCT) Consensus Recommendations to the Secretary of Health and Human Services (HHS)

April 28-29, 2008

Recommendation 1

ACBSCT recommends to the Secretary that the Food and Drug Administration (FDA) finalize its Draft Guidance for Industry on Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies.

Recommendation 2

ACBSCT recommends that the Secretary of HHS increase funding of the Center for International Blood and Marrow Transplant Research’s (CIBMTR) U24 cooperative agreement with National Cancer Institute (NCI) (U24 CA 76518).

December 15-16, 2008

Recommendation 3

ACBSCT recommends that the Secretary direct the Centers for Medicare & Medicaid Services (CMS), as a high priority, to develop an appropriate strategy for the National Coverage Determination of allogeneic stem cell transplantation as therapy for the Myelodysplastic Syndromes based on the recent evidence-based review of the literature.

Recommendation 4

ACBSCT recommends to the Secretary that the Health Resources and Services Administration’s (HRSA) C.W. Bill Young Cell Transplantation Program (Program) implement the following policies for protecting the privacy and confidentiality of cord blood donors donating umbilical cord blood units to the Program. Public Law 109-129 (42 U.S.C. 274k; Section 379 of the Public Health Service Act) defines a qualified cord blood bank participating in the National Cord Blood Inventory (NCBI) as having the following confidentiality requirements: 1) a system to confidentially maintain a linkage between a cord blood unit and a maternal donor; and 2) a system of strict confidentiality to protect the identity and privacy of patients and donors in accordance with existing Federal and State law.

May 12, 2009

Recommendation 5

ACBSCT recommends the Secretary recognize both the American Association of Blood Banks (AABB) and the Foundation for the Accreditation of Cellular Therapy (FACT) as Accreditation Organizations for the National Cord Blood Inventory (NCBI). Both organizations are expected to adhere to the Health Resources and Services Administration’s (HRSA) Specifications for Accreditation Organizations, and their continued recognition is based on ongoing adherence to HRSA Specifications. ACBSCT will review, three years from the time of the recognition decision by the Secretary, HRSA’s experience with the Accreditation Organizations with regard to meeting the HRSA Specifications.

September 21, 2009

Recommendation 6

ACBSCT recommends to the Secretary that the following informed consent principles and standards be implemented for public cord blood banking.

May 5, 2010

Recommendation 7

ACBSCT recommends to the Secretary that an expert panel be convened to review and determine indications for stem cell transplantation.

Recommendation 8

ACBSCT recommends that the Secretary mandate that Medicare and Medicaid cover patient participation in clinical trials involving hematopoietic transplantation.

Recommendation 9

ACBSCT recommends to the Secretary that cord blood collections be increased and improved.

November 15, 2010

Recommendation 10

ACBSCT recommends that the Secretary recognize hematopoietic transplantation for generally accepted indications as a covered benefit for all Federal programs for which the Secretary has appropriate responsibility and oversight.

Recommendation 11

ACBSCT recommends to the Secretary that Medicare reimburse for the acquisition of blood, marrow and cord blood products for hematopoietic transplantation on a cost basis similar to how reimbursement is made for graft acquisition in solid organ transplantation.

Recommendation 12

For cord blood units incapable of bearing a full label, ACBSCT recommends the Secretary clarify that the expiration date can be placed on an attached label provided with the unit at time of release to a transplant center.

Recommendation 13

ACBSCT recommends the Secretary work with FDA to review requirements for licensure in light of concerns over the potential for licensure requirements to result in increased cost and decreased availability of public cord blood units with the goal that FDA urgently meet with the cohort of applicant cord blood banks and representatives of transplant centers to share and resolve specific concerns regarding licensure.

Recommendation 14

ACBSCT recommends to the Secretary that models for remote collection of cord blood units be allowed with only limited, scientifically justified safety precautions. The Council also recommends that the Secretary allow for cord blood unit collection from routine deliveries without temperature or humidity monitoring of delivery rooms in hospitals approved by the appropriate bodies for hospital accreditation.

May 11, 2011

Recommendation 15

Consistent with Congressional mandates and strategic efforts to expand collection site participation, ACBSCT recommends that the Secretary recognize public cord blood bank oversight of the collection process as sufficient means to ensure safe manufacturing practices, and oppose the requirement for hospitals to register with the FDA as the establishment responsible for recovery.

Recommendation 16

Based on data from nearly two decades of practice controlled by public cord blood banks to ensure safe collection processes and protect product integrity, ACBSCT recommends that the Secretary support the collection of cord blood from uncomplicated deliveries in accredited hospitals without environmental monitoring of delivery rooms.

November 8, 2011

Recommendation 17

The Council recommends to the Secretary that the U.S. Food and Drug Administration(FDA) recognize and accept laboratory-developed testing performed in Clinical Laboratory Improvement Act(CLIA)-certified, high complexity histocompatibility laboratories.

Recommendation 18

The Council recommends that FDA broaden the investigational new drug(IND) and biologics license application(BLA) clinical indications for unrelated donor cord blood transplantation to include use for hematopoietic and/or immune reconstitution or enzyme replacement in any situation where hematopoietic stem cell transplantation(HSCT) is the appropriate approach to treatment.

Recommendation 19

The Council recommends that all cord blood products have the same IND and BLA clinical indications; this is scientifically and medically sound.

Recommendation 20

The Council recommends implementation of a transition plan, initially stated as on or before October 20, 2011, to allow time for the FDA to review recommendations 17 and 18 above and to allow for implementation of any changes by transplant centers who will need to put these changes through their institutional review boards.

Recommendation 21

The Council recommends that CBUs collected through distribution of kits sent to motivated maternal donors or obstetrical units collected by an obstetric provider, which meet all National Cord Blood Inventory(NCBI)/FDA qualifications be eligible for listing on the NCBI and for FDA licensure.

May 9, 2012

Recommendation 22

The Advisory Council recommends that the Secretary take and support all reasonable efforts to ensure that compensation for marrow, peripheral blood stem cells and similar products continues to be prohibited.

May 16, 2013

Recommendation 23

The Council recommends that the Secretary consider appropriate mechanisms to assure that the revised National Heart, Lung, and Blood Institute publication "Management and Therapy of Sickle Cell Disease" includes expert opinion about the curative option of hematopoietic cell transpolantation for this disorder.

Recommendation 24

The Council recommends that HRSA undertake educational/outreach efforts to the sickle cell disease (SCD) patient and provider community to educate them about the progressive nature of SCD, increasing morbidity and mortality in early adulthood (ages 16-35 years), and the role of HSCT and its complications.

September 15, 2014

Recommendation 25

ACBSCT recommends that the Secretary recognize hematopoietic transplantation for sickle cell disease as a covered benefit for all Federal programs for which the Secretary has appropriate responsibility and oversight.

Recommendation 26

ACBSCT recommends that the Secretary direct HRSA and other HHS agencies to collaborate with the CIBMTR to review research level data collection on allotransplants performed for sickle cell disease (SCD) and consider appropriate reimbursement to optimize research data collection. This review should include SCD-specific data elements collected, the completeness of data collection and mechanisms for reimbursement.

September 11, 2015

Recommendation 27

The ACBSCT recommends that the Secretary encourage the Centers for Medicare & Medicaid Services (CMS) to reimburse for the acquisition of blood stem cells, bone marrow, or umbilical cord blood products for hematopoietic stem cell transplant on a cost basis, consistent with CMS guidelines for solid organ transplants.

March 3, 2016

Recommendation 28

The Council recommends that HRSA adopt a funding framework that incentivizes the collection of high TNC units for a diverse population and that recognizes higher associated costs.

Recommendation 29

The Council recognizes the serious financial challenges confronting the cord blood bank sector. In order to assure sustainable cord blood bank collection and supply for the future, the Council recommends that HRSA engage experts to conduct a study of the economics of the US cord blood banking system with the intent to identify current business practices and make recommendations for ways to strengthen the financial operation of this sector to assure long term function.

September 13-14, 2016

Recommendation 30

The ACBSCT is concerned that the proposed outpatient C-APC 5244 payment rate of $15,267, published in the Federal Register on July 14, 2016, is insufficient to cover costs of procurement from different stem cell sources. The proposed payment rate does not account for the different acquisition and treatment costs associated with different sources of Hematopoietic Stem Cell Transplants (HSCTs). The ACBSCT recommends that distinct reimbursement rates be developed for different blood stem cell sources.

Recommendation 31

Based on a review by the ACBSCT of data presented at the American Society of Hematology (ASH) 2015 (Atallah, EA et al; Blood 126;195, 2015 (abstract)), and the acknowledgement that Myelodysplastic Syndromes (MDS) is an established indication for transplantation among patients younger than age 65, and to ensure that access to transplantation for Medicare beneficiaries continues, the ACBSCT recommends that CMS take one of two courses of action with regard to this indication:

September 10, 2019

Recommendation 32

Based on current data and reduction in observed and confirmed Zika infection, ACBSCT recommends that HHS review the current FDA Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components as the guidance relates to utilization of cord blood. 

September 25, 2020

Recommendation 33

HRSA should continue to support collection of high-quality cord blood units through the NCBI to support the development of a demonstration project to optimize the utilization of cord blood for transplantation by providing guidance to transplant centers on uses of cord blood and coordinate and share best practices among entities involved in cord blood collection, selection, logistics, and transplant.  

September 28, 2023

Recommendation 1