A randomized trial of alemtuzumab vs. anti-thymocyte globulin induction in renal and pancreas transplantation.

The role of alemtuzumab as an immunosuppressive agent is evolving. We conducted a prospective randomized trial comparing alemtuzumab and rabbit anti-thymocyte globulin (rATG) induction in adult kidney and pancreas transplantation using similar maintenance immunosuppression. Between February 1, 2005 and June 15, 2006 (median follow-up six months), 98 patients were randomized either to alemtuzumab (n = 48) or to rATG (n = 50) induction; 77 (79%) underwent kidney alone (KA) transplant, 17 (17%) pancreas-kidney transplant, and four (4%) pancreas after kidney transplant. Of 77 KA transplants, 66 (86%) were from deceased donors and 31 (40%) from expanded criteria donors (ECD). Re-transplantation, HLA-match, antibody titer, ECD, race, cytomegalovirus status, steroid use, delayed graft function, preservation time, and immunological risk were similar between the two induction groups. Patient, kidney, and pancreas graft survival rates were 100%, 96%, and 95%, respectively. Survival, initial length of stay, delayed graft function, and overall acute rejection rates were similar between alemtuzumab and rATG groups, but acute rejection occurred in nine (20%) rATG patients compared with zero (0%) alemtuzumab patients who received KA transplants (p = 0.007). Mean induction costs differed in the alemtuzumab ($1474) and rATG ($4996, p < 0.001) groups. In the short term after kidney and pancreas transplantation, alemtuzumab and rATG induction therapies are similarly safe and effective.

Effect of the Medicare Prescription Drug Improvement and Modernization Act on the bottom line.

PURPOSE: An historical perspective on the impact of the Medicare Prescription Drug Improvement and Modernization Act (MMA) on pharmaceutical reimbursement, and the financial bottom line at health systems and various strategies to use in the inpatient and outpatient setting to improve the bottom line are described. SUMMARY: Implementation of MMA has affected the entire healthcare continuum by reducing pharmaceutical reimbursement rates and health system revenues and increasing prescription drug copayments, emergency department visits, and hospital admissions. Physician-owned clinics are less profitable than in the past because of MMA, which may prompt clinic closures and shift the patient care burden to clinics at public hospitals. Negotiating carve-outs for costly drugs and evaluating the feasibility of obtaining outlier payments can improve the bottom line in the hospital inpatient setting. Ensuring that billing codes are accurate and verifying that reimbursement was received can help minimize the impact of MMA on the financial bottom line in the outpatient setting. Negotiating favorable purchasing contracts and ensuring that drugs are used appropriately by following evidence-based guidelines can improve the financial bottom line in both the inpatient and outpatient settings. CONCLUSION: Strategies to decrease drug acquisition costs and increase reimbursement rates can help minimize the adverse impact of MMA on the financial bottom line at health systems.

Understanding basic concepts and strategies for obtaining pharmaceutical reimbursement.

PURPOSE: The rules that govern pharmaceutical reimbursement and strategies for obtaining reimbursement for hospital inpatients and outpatients and patients treated at physician-owned clinics are discussed. SUMMARY: The use of certain claim forms and provision of information about the patient location, drug, Healthcare Common Procedure Coding System (HCPCS) code, status indicator, billing unit, revenue code, and International Classification of Diseases, 9th Revision (ICD-9) code are required to obtain reimbursement for pharmaceuticals from the Centers for Medicare & Medicaid Services. Requirements for hospital inpatients and outpatients differ. Claims for patients treated at physician-owned clinics are handled differently from claims for those treated at hospital outpatient clinics, but pharmaceutical reimbursement rates are the same in the two settings. CONCLUSION: Frequent changes in the rules for obtaining pharmaceutical reimbursement present a challenge. A knowledge of the rules and requirements for different patient treatment settings is needed to obtain reimbursement.