Dialysis & Transplantation最新文献

During the past few years, an increasing amount of attention has been paid to living related-donor kidney transplantation (LRDKT) in China. We established a Medical Ethics Committee at Beijing Friendship Hospital to address the ethical concerns of LRDKT, thereby improving the process. The committee is devoted to conducting ethical medical reviews on donor information such as age, health condition, and the donor-recipient relationship. We have achieved satisfactory results in the 243 cases of LRDKT addressed between May 2007, and December 2009, under the supervision of the Medical Ethics Committee. Dial. Transplant. © 2011 Wiley Periodicals, Inc.

It has been established for many years that early kidney disease education can play a key role in shaping outcomes of dialysis patients. A 1993 National Institutes of Health (NIH) Consensus Panel suggested that early referral to a renal team could reduce mortality, psychologically prepare the patient, and reduce a catastrophic onset of dialysis.1 Since that time, the field of nephrology has become more organized through the establishment of a classification system for what is now formally referred to as chronic kidney disease (CKD). Furthermore, guidelines have been developed to help promote early disease awareness, and clinical performance measures have been refined.2, 3

However, our outcomes are still disappointing. The most recent U.S. Renal Data System (USRDS) database reveals that only 24.5% of incident patients have seen a nephrologist for more than 12 months prior to starting dialysis, and that only approximately 40% of patients ever see a nephrologist at all before starting care for end-stage renal disease (ESRD). This translates to a burdensome and often challenging dialysis start, a decreased opportunity for a positive outcome, and an overall spike in healthcare costs as patients transition into ESRD care. What is most daunting is that among those who have never seen a nephrologist, 89% start dialysis with a central venous catheter. However, even among those patients who have seen nephrologists within a 12-month period preceding dialysis, 55% begin care with a catheter.4

Meanwhile, patients who have been followed by the nephrologist for a median of two years demonstrate limited knowledge of their disease.5 A survey of dialysis patients undertaken by the American Association of Kidney Patients (AAKP) demonstrated that patients receive a lack of uniform, thorough information about possible treatment methods; 31% of respondents said that treatment options were not well represented, and that they were only moderately satisfied with their pre-treatment education.6

Sensing the need for legislative action, the Medicare Improvements for Patients and Providers Act (MIPPA),7 Section 152(b), added kidney disease patient education services as a covered benefit for Medicare beneficiaries with stage 4 CKD. The rule for kidney disease education services was published in November, 2009 and became effective on January 1, 2010.8 Physicians, physician assistants, and nurse practitioners are eligible providers, and dialysis facilities are excluded. The rule specifies the content. It was specifically designed to provide patients with comprehensive information to help prolong or delay the need for dialysis, manage comorbidities, prevent uremic complications, and help patients participate in an informed decision-making process regarding their options for care.

Qualified persons providing kidney disease education services must also

The approach given here was studied on one patient (her third graft) with the following result. The graft endured for 6+ years of use (electively retired), which was three times longer than her two prior grafts, which were cannulated without this approach. Figure 1A and B are examples of the cannulation care plan for this patient, defined several years apart and edited for publication clarity (no substantive change).

For consistency, this author suggests that cannulation care contacts be assigned to define the cannulation care plans (Stage 1). It takes about 30 minutes per patient to complete Stage 1. The output is the cannulation care plan (as documented on the TF). Staff who can cannulate and “use a map” can implement the cannulation care plan (i.e., complete Stage 2), which takes about 5 minutes per patient per treatment. From time to time, an update to the cannulation care plan may also be needed during Stage 2. Nevertheless, the time differential to implement the cannulation care plan does not affect patient scheduling, since the lower frequency of minor complications (infiltration, oozing, pseudoaneurysm, pain) is likely to reduce time needed for the procedure, i.e., saving time via preventive action.

These additional medical costs are approximately $2,000 per incident.2 More than 70,000 patients use grafts as their primary access.3 If 2,500 access replacements are delayed per year by cannulation care plans (assumes 50 instances per state/year), then medical savings of $5,000,000/year ($2,000 × 2,500) are predicted with this approach.

Additional savings will apply if the frequency of thrombosis, stenoses, or infection is reduced by cannulation care plans. This topic merits study, as this patient's first and second (not the third) grafts incurred thrombectomies and infection. Angioplasty did not apply for this patient. Most important, extending longevity of grafts improves quality of life for patients.

Now that the dialysis industry has been able to get acquainted with the first phase of the new bundled prospective payment system (PPS), it is time to prepare for the next phase of implementation, the quality incentive program (QIP). After a brief review of the PPS, specifics of the 2012 QIP will be presented, and, using historical performance projections, I will discuss the possible impact of the 2012 QIP on the hemodialysis industry.

H.R. 6331, the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) mandated that the Centers for Medicare & Medicaid Services (CMS) implement a bundled rate payment system to replace the historical fee-for-service payment system.1 Instead of the government paying separately for the individual components of a dialysis treatment, reimbursement will be a flat rate based on several patient metrics and a geographic wage component to account for cost of living variances. The positive financial incentives for providing more profitable drugs and services in the old fee-for-service model are now reversed, with all intravenous drugs now included, or “bundled,” into a single payment. Bundling has led to an expected decrease in drug utilization, particularly the most expensive injectable drug, erythropoietin (EPO). In the last year, Fresenius Medical Services has experienced over a 20% decline in EPO usage. With both the Government Accountability Office (GAO) and CMS having concerns with patients obtaining less medication and subsequently developing severe anemia, CMS proposed a QIP that incorporates penalties for poor anemia management.

Beginning January 1, 2012, the first mandated QIP will impact dialysis facilities based on three quality metrics. All facilities that treat Medicare patients must obtain 2% or less of patients with average hemoglobin levels <10 g/dL, 26% or less of patients with average hemoglobin levels >12 g/dL, and 96% or more of patients with average urea reduction ratio (URR) of >65%. Failure to meet these goals will result in a facility payment withhold for the subsequent year.2 The three metrics (Hgb < 10, Hgb > 12, and URR > 65%) will have weightings of 50%, 25%, and 25%, respectively.2 A greater weighting was given to Hgb < 10 to help ensure that patients will not be given too little EPO, which places the patient at risk for needing blood transfusions. For each 1% worse than the national average, the respective quality metric will lose one point out of ten.2 Ultimately, summing the score for all three metrics leads to a score out of a possible thirty, which will determine if the facility will receive a 0-2% Medicare payment penalty (in half percent increments).2 Based on the historical performances of dialysis facilities from 2007 utilizing the new scoring system, it is possible to estimate the projected financial impacts of the proposed QIPs on the industry and individual faciliti

Belatacept, an intravenous (IV) selective T-cell costimulation blocker, has been approved by the Food and Drug Administration (FDA) to prevent kidney rejection in adult transplant recipients, and is to be used in combination with basiliximab induction, corticosteroids, and mycophenolate mofetil for maintenance immunosuppresion.1 Belatacept is to be used only in patients who are Epstein-Barr virus (EBV) positive. Patients who receive treatment with belatacept have an increased risk of developing central nervous system post-transplant lymphoproliferative disorder (PTLD) and/or progressive multifocal leukoencephalopathy (PML). PML occurred in patients receiving higher than recommended doses within an immunosuppressive regimen. Therefore, a risk evaluation and mitigation strategy (REMS) is available to ensure that patients and prescribers know the benefits and risks of therapy. The REMS includes a communication plan for potential prescribers and supportive healthcare professionals, and a medication guide for patients.

Extended-release exenatide (Bydureon), for once-weekly injection, has been approved in Europe to treat type 2 diabetes mellitus.2 In the United States, the FDA issued a complete response letter to the drug's manufacturers asking for additional information on the drug's heart rate effects. A response to this letter is expected in the second half of this year.

Fidaxomicin tablets, an oral macrolide, were recently FDA-approved for treating Clostridium difficile-associated diarrhea (CDAD) in adults.3 In clinical trials, treatment with fidaxomicin was non-inferior to oral vancomycin in sustaining a clinical response for up to 25 days after therapy completion.4 The most common adverse reactions in clinical trials were nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%).

Production of iron sucrose injection (Venofer) had been temporarily halted related to the presence of particulate matter in some of America Regent's generic injectable products.5 Even though there were no specific quality issues related to iron sucrose injection, for precautionary measures, its manufacturer had stopped production. American Regent re-started production of this agent in mid-May.

At last the long-awaited generic of Levaquin, levofloxacin, has arrived.6 The FDA has approved both the tablets and IV injection dosage forms from many generic companies; therefore the price of this generic will likely be significantly less than if one generic were approved, and also less than the branded product. (Is there a Levaquin XR on the horizon, even though it is already a once-daily agent?) In recent quarterly results, Johnson & Johnson recorded $343 million in revenue from both branded levofloxacin and ofloxacin.

Sodium ferric gluconate complex in sucrose injection has been FDA-approved