Payment and Care for Hematopoietic Cell Transplantation Patients: Toward a Specialized Medical Home for Complex Care Patients.

Patient-centered medical home models are fundamental to the advanced alternative payment models defined in the Medicare Access and Children's Health Insurance Plan Reauthorization Act (MACRA). The patient-centered medical home is a model of healthcare delivery supported by alternative payment mechanisms and designed to promote coordinated medical care that is simultaneously patient-centric and population-oriented. This transformative care model requires shifting reimbursement to include a per-patient payment intended to cover services not previously reimbursed such as disease management over time. Payment is linked to quality measures, including proportion of care delivered according to predefined pathways and demonstrated impact on outcomes. Some medical homes also include opportunities for shared savings by reducing overall costs of care. Recent proposals have suggested expanding the medical home model to specialized populations with complex needs because primary care teams may not have the facilities or the requisite expertise for their unique needs. An example of a successful care model that may provide valuable lessons for those creating specialty medical home models already exists in many hematopoietic cell transplantation (HCT) centers that deliver multidisciplinary, coordinated, and highly specialized care. The integration of care delivery in HCT centers has been driven by the specialty care their patients require and by the payment methodology preferred by the commercial payers, which has included bundling of both inpatient and outpatient care in the peritransplant interval. Commercial payers identify qualified HCT centers based on accreditation status and comparative performance, enabled in part by center-level comparative performance data available within a national outcomes database mandated by the Stem Cell Therapeutic and Research Act of 2005. Standardization across centers has been facilitated via voluntary accreditation implemented by Foundation for the Accreditation of Cell Therapy. Payers have built on these community-established programs and use public outcomes and program accreditation as standards necessary for inclusion in specialty care networks and contracts. Although HCT centers have not been described as medical homes, most HCT providers have already developed the structures that address critical requirements of MACRA for medical homes.

Optimal Practices in Unrelated Donor Cord Blood Transplantation for Hematologic Malignancies.

Unrelated donor cord blood transplantation (CBT) results in disease-free survival comparable to that of unrelated adult donor transplantation in patients with hematologic malignancies. Extension of allograft access to racial and ethnic minorities, rapid graft availability, flexibility of transplantation date, and low risks of disabling chronic graft-versus-host disease (GVHD) and relapse are significant advantages of CBT, and multiple series have reported a low risk of late transplantation-related mortality (TRM) post-transplantation. Nonetheless, early post-transplantation morbidity and TRM and the requirement for intensive early post-transplantation management have slowed the adoption of CBT. Targeted care strategies in CBT recipients can mitigate early transplantation complications and reduce transplantation costs. Herein we provide a practical "how to" guide to CBT for hematologic malignancies on behalf of the National Marrow Donor Program and the American Society of Blood and Marrow Transplantation's Cord Blood Special Interest Group. It shares the best practices of 6 experienced US transplantation centers with a special interest in the use of cord blood as a hematopoietic stem cell source. We address donor search and unit selection, unit thaw and infusion, conditioning regimens, immune suppression, management of GVHD, opportunistic infections, and other factors in supportive care appropriate for CBT. Meticulous attention to such details has improved CBT outcomes and will facilitate the success of CBT as a platform for future graft manipulations.

Remuneration of hematopoietic stem cell donors: principles and perspective of the World Marrow Donor Association.

Hematopoietic stem cell transplantation is a curative procedure for life-threatening hematologic diseases. Donation of hematopoietic stem cells (HSCs) from an unrelated donor, frequently residing in another country, may be the only option for 70% of those in need of unrelated hematopoietic stem cell transplantation. To maximize the opportunity to find the best available donor, individual donor registries collaborate internationally. To provide homogeneity of practice among registries, the World Marrow Donor Association (WMDA) sets standards against which registries are accredited and provides guidance and regulations about unrelated donor safety and care. A basic tenet of the donor registries is that unrelated HSC donation is an altruistic act; nonpayment of donors is entrenched in the WMDA standards and in international practice. In the United States, the prohibition against remuneration of donors has recently been challenged. Here, we describe the reasons that the WMDA continues to believe that HSC donors should not be paid because of ethical concerns raised by remuneration, potential to damage the public will to act altruistically, the potential for coercion and exploitation of donors, increased risk to patients, harm to local transplantation programs and international stem cell exchange, and the possibility of benefiting some patients while disadvantaging others.

Impact of selection of cord blood units from the United States and swiss registries on the cost of banking operations.

BACKGROUND: Over the last 2 decades, cord blood (CB) has become an important source of blood stem cells. Clinical experience has shown that CB is a viable source for blood stem cells in the field of unrelated hematopoietic blood stem cell transplantation. METHODS: Studies of CB units (CBUs) stored and ordered from the US (National Marrow Donor Program (NMDP) and Swiss (Swiss Blood Stem Cells (SBSQ)) CB registries were conducted to assess whether these CBUs met the needs of transplantation patients, as evidenced by units being selected for transplantation. These data were compared to international banking and selection data (Bone Marrow Donors Worldwide (BMDW), World Marrow Donor Association (WMDA)). Further analysis was conducted on whether current CB banking practices were economically viable given the units being selected from the registries for transplant. It should be mentioned that our analysis focused on usage, deliberately omitting any information about clinical outcomes of CB transplantation. RESULTS: A disproportionate number of units with high total nucleated cell (TNC) counts are selected, compared to the distribution of units by TNC available. Therefore, the decision to use a low threshold for banking purposes cannot be supported by economic analysis and may limit the economic viability of future public CB banking. CONCLUSIONS: We suggest significantly raising the TNC level used to determine a bankable unit. A level of 125 × 10(7) TNCs, maybe even 150 × 10(7) TNCs, might be a viable banking threshold. This would improve the return on inventory investments while meeting transplantation needs based on current selection criteria.

Awareness and acceptance of public cord blood banking among practicing obstetricians in the United States.

BACKGROUND: This study measured: 1) levels of awareness and understanding among practicing obstetricians regarding umbilical cord blood (UCB) donation and the use of UCB in transplant therapy, 2) motivations for obstetricians to support donation and collection for donation to a public cord blood bank (CBB), and 3) current practices for discussing this option with their patients. STUDY DESIGN AND METHODS: Obstetricians practicing in major metropolitan areas in the United States were randomly surveyed in 2009. Of 2041 surveys mailed, 295 were returned, 139 from obstetricians with privileges at hospitals affiliated with a public CBB (affiliated) and 156 from obstetricians without such privileges (nonaffiliated). Cross-tabulation analyses were conducted to compare responses between these two groups. RESULTS: Both affiliated and nonaffiliated obstetricians report being somewhat or very familiar with the use of cord blood in transplant therapy (88% vs. 82%, respectively; p = NS), but some misperceptions concerning clinical application exist. Eighty percent of affiliated obstetricians feel confident discussing cord blood options with their patients; however, 49% indicated that they have insufficient knowledge of cord blood donation to effectively answer patients' questions about donation. CONCLUSION: Obstetricians are generally familiar with the utility of donated cord blood in transplantation, but could benefit from additional information regarding how cord blood is used in transplantation. Further, obstetricians play an important role in encouraging women to donate their baby's cord blood to a public CBB, are willing to do so, and indicate a desire for more information so they can effectively educate their patients.

Cord blood unit access and selection: 2010 and beyond: best practices and emerging trends in cord blood unit selection.

One-fifth, more than 1000, of all transplants facilitated in 2010 by the National Marrow Donor Program (NMDP) have employed 1 or 2 umbilical cord blood units as the graft source. As the use of umbilical cord blood for unrelated allogeneic hematopoietic cell transplantation increases, several issues emerge that require additional attention and refinement. The U.S. Food and Drug Administration is now far along in its implementation of regulatory controls for umbilical cord blood. After October 20, 2011, every unrelated-donor cord blood unit transplanted in the United States must be either licensed or covered under an FDA-accepted IND. It is incumbent upon transplant physicians to review and understand the implications of the FDA's new regulations. In addition, as more transplant programs adopt umbilical cord blood for transplantation, it is important to stay current with the best practices surrounding identification and selection of the best available units. Cell dose, HLA matching, location of mismatched loci, and the role of noninherited maternal alleles are all important considerations for unit selection. This complexity in selection of appropriate units raises issues about the desired inventory of umbilical cord blood units. How many units are needed to meet the needs of all patients who might benefit from cord blood transplantation? Newly developed simulation models are being utilized by NMDP to answer this question.

Family-directed umbilical cord blood banking.

Umbilical cord blood transplantation from HLA-identical siblings provides good results in children. These results support targeted efforts to bank family cord blood units that can be used for a sibling diagnosed with a disease which can be cured by allogeneic hematopoietic stem cell transplantation or for research that investigates the use of allogeneic or autologous cord blood cells. Over 500 patients transplanted with related cord blood units have been reported to the Eurocord registry with a 4-year overall survival of 91% for patients with non-malignant diseases and 56% for patients with malignant diseases. Main hematologic indications in children are leukemia, hemoglobinopathies or inherited hematologic, immunological or metabolic disorders. However, family-directed cord blood banking is not widely promoted; many cord blood units used in sibling transplantation have been obtained from private banks that do not meet the necessary criteria required to store these units. Marketing by private banks who predominantly store autologous cord blood units has created public confusion. There are very few current validated indications for autologous storage but some new indications might appear in the future. Little effort is devoted to provide unbiased information and to educate the public as to the distinction between the different types of banking, economic models and standards involved in such programs. In order to provide a better service for families in need, directed-family cord blood banking activities should be encouraged and closely monitored with common standards, and better information on current and future indications should be made available.

Impact of the Affordable Care Act on stem cell transplantation.

The Patient Protection and Affordable Care Act, signed into law in 2010, will have a wide-reaching impact on the health care system in the United States when it is fully implemented in 2014. Patients will see increased access to care coupled with new insurance coverage protections as well as a minimum set of benefits mandated in each state known as essential health benefits. Providers are likely to see new forms of payment reform, particularly in the Medicare program, and narrower commercial provider networks. In addition, the composition of the health insurance market will broaden with the introduction of health insurance exchanges and expanded Medicaid populations in many states. Furthermore, the Patient Protection and Affordable Care Act calls for quality initiatives such as comparative effectiveness research to increase effective, appropriate and high-value care. This paper will review the main provisions of the Patient Protection and Affordable Care Act with specific attention to their impact on the field of Stem Cell Transplantation.