Medicare and Medicaid programs; conditions for coverage for end-stage renal disease facilities. Final rule

This rule finalizes the February 4, 2005 proposed rule entitled "Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities." It establishes new conditions for coverage that dialysis facilities must meet to be certified under the Medicare program. This final rule focuses on the patient and the results of care provided to the patient, establishes performance expectations for facilities, encourages patients to participate in their plan of care and treatment, eliminates many procedural requirements from the previous conditions for coverage, preserves strong process measures when necessary to promote meaningful patient safety, well-being, and continuous quality improvement. This final rule reflects the advances in dialysis technology and standard care practices since the requirements were last revised in their entirety in 1976.     

Medicare program; payment change for home dialysis--HCFA. Final rule

This final rule implements section 6203(b) of the Omnibus Budget Reconciliation Act of 1989, which limits Medicare payment for home dialysis equipment, supplies, and support services. Also, in accordance with section 6203(b), we are requiring that, for Medicare payments to be made to a supplier of home dialysis supplies and equipment when the patient's self-care home dialysis is not under the direct supervision of a Medicare approved renal dialysis facility, the patient must certify that the supplier is the sole supplier of his or her dialysis supplies and equipment. In addition, the supplier must agree to receive payment on an assignment basis only and must certify that it has entered into a written agreement with an approved dialysis facility, under which the facility agrees to furnish the patient with all home dialysis services. We are also providing a one-time-only opportunity for certain home dialysis patients to immediately change their current method of payment.     

Medicare program; standards for quality of water used in dialysis and revised guidelines on reuse of hemodialysis filters for end-stage renal disease (ESRD) patients--HCFA. Final rule

This final rule revises the Medicare conditions for coverage of suppliers of end-stage renal disease services. The revisions remove general language in the regulations regarding water quality; incorporate by reference standards for monitoring the quality of water used in dialysis as published by the Association for the Advancement of Medical Instrumentation (AAMI) in its document, "Hemodialysis Systems" (second edition); and update existing regulations to incorporate by reference the second edition of AAMI's voluntary guidelines on "Reuse of Hemodialyzers."     

Medicare program; payment for physician outpatient maintenance dialysis services and other physician services for ESRD patients--HCFA. Final rule

This final rule reinstates a modified version of the initial method of payment for physician dialysis services and clarifies and modifies some of the principles of the monthly capitation payment method. Under both the initial method and the monthly capitation payment method, we specify that, to be payable, physician services must meet certain requirements that distinguish services furnished to individual patients from services furnished to facilities that benefit the facilities' patients generally. The reinstatement of a modified version of the initial method is necessitated by a court order.     

Health Care Financing Administration--conditions for coverage of suppliers of ESRD services; revocation of requirements for emergency generator and ground fault interrupters. Final rule

These amendments remove the requirements for emergency generators and ground fault interrupters in end-stage renal dialysis (ESRD) facilities. The purpose is to reduce unnecessary and burdensome requirements which are not necessary to the health and safety of patients.     

Tracking plant, fungal, and bacterial DNA in honey specimens

Consuming honey can result in adverse effects owing to poisoning by bacterial (botulism) or plant toxins. We have devised a method to extract polymerase chain reaction (PCR) amplifiable DNA of up to c. 400 bp in length based on dialysis of a 15-mL honey sample for 18 h against deionized water followed by sequential extraction using phenol, phenol/chloroform/isoamyl alcohol, chloroform/isoamyl alcohol, and ether. Sequence analysis of PCR products obtained using "universal" plant, fungal, and bacterial primers targeted to the ribosomal RNA genes has allowed us to identify six different orders of plants (Apiales, Fabales, Asterales, Solanales, Brassicales, and Sapindales), two orders of fungi (Entylomatales and Saccharomycetales), and six orders of bacteria (Sphingomonadales, Burkholderiales, Pseudomonadales, Enterobacteriales, Actinomycetales, and Bifidobacteriales) in a single honey specimen.     

Medicare program; end-stage renal disease (ESRD) payment exception requests and organ procurement costs--HCFA. Final rule

These final regulations specify the criteria HCFA uses to determine if a facility that furnished dialysis services to Medicare patients with end-stage renal disease (ESRD) qualifies for a higher payment under an exception to its prospectively determined payment rate and the procedures HCFA uses to evaluate ESRD payment exception requests. These regulations also revise the way HCFA computes acquisition costs for organs that are transplanted into Medicare beneficiaries.     

Home blood transfusions: the medical, economic, and legal issues surrounding a new treatment procedure

Blood transfusions have almost always been confined to hospital settings in the past. Recent medical care trends have shifted some therapies (e.g., renal dialysis, hemophilia treatment) into the patient's home. Transfusions are now being given in increasing numbers to stable patients in their homes. This paper examines the medical aspects, the economic issues, and the legal implications of such transfusions. Candidates for home transfusion must be carefully chosen primarily according to the medical guidelines for such treatment. Any legal issues must be satisfactorily answered before approval is given. The paper concludes that if done properly, home transfusions can be safe, cost-effective, and convenient for a carefully selected segment of patients.     

Sudden death in hemodialysis patients

Hemodialysis patients may die suddenly and unexpectedly from a number of causes. These may be divided into those deaths due directly to and occurring during hemodialysis, those deaths occurring while the patient is not undergoing dialysis, and those deaths that may occur at any time. The first group includes brain herniation, air embolism, acute hemorrhage as a result of machine malfunction or fistula rupture, electrocution, cardiac arrhythmia caused by hypokalemia, complications of subclavian intravenous catheter insertion, third-degree heart block as a result of triglyceride emulsion, and disseminated intravascular coagulation (DIC) or hyperkalemia caused by overheated dialysate. The second group includes deaths due to pericardial tamponade because of effusion and suicidal causes of death (exsanguination, electrolyte imbalance as a result of excessive intake of salt, fluid, or potassium) as well as more conventional methods of suicide. The last category includes people dying of arteriosclerotic cardiovascular disease, hypertensive cardiovascular disease, and internal hemorrhage. Investigation of these deaths, including pertinent historical, laboratory, and autopsy data and investigation of dialysis equipment, is discussed.     

Subacute fatal aluminum poisoning in dialyzed patients: post-mortem toxicological findings

The population of Cura?ao, Netherlands Antilles (133,000) shows a very high prevalence of end-stage renal disease (approximately 1 per 1,000). These patients are often treated chronically with haemodialysis. As the drinking water on the island is prepared by distillation of sea water, the haemodialysis fluid used to be prepared with tap water without further treatment. In 1996, the 27 patients of one of the dialysis centers on the island presented with nausea, vomiting, and hypercalcaemia in a short time span, which was initially diagnosed as 'hard water syndrome'. In spite of treatment with low-calcium dialysate, microcytic anaemia and neurological symptoms developed. Ten patients died of convulsions, sepsis, and coma. As aluminum (Al) intoxication was suspected, Al in serum (AlS) was measured. Ante mortem AlS was 808 microg/l (n = 7; range 359-1189); in the survivors AlS was 255 microg/l (n = 17; range 113-490). Normal AlS is < 10 microg/l, and <50 microg/l in asymptomatic dialyzed patients. The court requested post-mortem toxicological analysis of four patients. Al concentrations in liver, bone, and cerebral cortex were significantly increased as compared with background levels. Al intoxication was, therefore, considered to be the most likely cause of death in these patients. Investigations of the tap water supply revealed that a few weeks before the onset of the symptoms, a water conduit pipe to the dialysis unit had been replaced, which was lined with Al- and Ca-rich cement mortar. These ions leached into the distilled water and caused both Ca- and Al-intoxication through uptake from the dialysate into the patients' circulation. The symptoms of the latter were initially not recognized as they were masked by the symptoms of hypercalcaemia.     

Comparison of extraction methods for methamphetamine and its metabolites in tissue

Five extraction methods were examined for analysis of methamphetamine and its major metabolites in tissue samples. The extraction methods studied were an acetone extraction method, an ethanol extraction method, an ammonium sulfate method, dialysis, and a direct solvent extraction. Acetone, ethanol, and dialysis methods showed no interference from endogenous components using thin-layer chromatography and gas chromatography, and gave satisfactory recovery of methamphetamine, amphetamine, and p-hydroxymethamphetamine when added to rabbit liver. These methods, however, proved time-consuming. The ammonium sulfate method and direct solvent extraction method were simple and more rapid, but recovery of the polar metabolite was poor.     

Medicare, Medicaid and CLIA programs; revisions of the laboratory regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 programs; correction--HCFA. Final rule; correction notice

This document makes some technical corrections to parts 405, 416, 483 and 493, as amended or added, as applicable, by our final rule on March 14, 1990, 55 FR 9538, which generally is effective September 10, 1990. In addition to correcting a number of typographical errors, we are correcting 42 CFR 405.2163, Condition: Minimal service requirements for a renal dialysis facility or renal dialysis center, to restore current text.     

透析法显现涂抹掩盖字迹的实验

作者利用研制的透析液,采用透析法对被掩盖字迹的显现效果进行了研究，讨论了涂抹掩盖方式、掩盖层厚度和透析液厚度等7种因素对显现效果的影响，以期为提高涂抹掩盖字迹的显现效果提供依据。     

Medicare programs: changes to the end-stage renal disease prospective payment system transition budget-neutrality adjustment. Interim final rule with comment period

This interim final rule with comment will revise the end-stage renal disease (ESRD) transition budget-neutrality adjustment finalized in the CY 2011 ESRD Prospective Payment System (PPS) final rule for renal dialysis services provided on April 1, 2011 through December 31, 2011. We are revising the transition budget-neutrality adjustment to reflect the actual election decision to receive payment under the ESRD PPS for renal dialysis services furnished on or after January 1, 2011 made by ESRD facilities, rather than projected elections using the same methodology as described in the ESRD PPS proposed and final rules. This results in a zero percent adjustment for renal dialysis services furnished April 1, 2011 through December 31, 2011.     

"Theory of Mind" and Executive Functioning in Forensic Patients with Schizophrenia

Abstract:  Previous studies in forensic patients with schizophrenia have shown that delinquent patients may outperform nondelinquent patients with regards to "theory of mind" (ToM). Findings were, however, confounded by a lack of control for executive functioning. We examined 33 forensic patients with schizophrenia regarding ToM, intelligence, executive functioning, and psychopathology. Results were compared with a nonforensic schizophrenia sample and a group of healthy controls. Both patient groups performed more poorly on most measures compared with controls. Forensic and nonforensic patients did not differ in task performance. In the forensic group ToM correlated inversely with "excitement" and cognitive symptoms. When "excitement" was covaried out, forensic patients outperformed nonforensic patients with regards to ToM. This study supports the hypothesis that schizophrenic patients with a criminal record are equally impaired in their ability to infer mental states compared with nonforensic patients, but for different reasons associated with a divergent psychopathological profile.     

透析法测定钢笔墨水字迹的书写时间

本文通过最新研发的透析液,根据透析的原理,对书写在不同种类纸张上的不同种类的钢笔墨水字迹进行了书写时间测定。在基本保证透析液的浓度、厚度和钢笔字迹色料浓淡一致的基础上,考查了不同种类钢笔墨水字迹和不同种类纸张对透析结果的影响,得出了一般性规律,并介绍了该项新技术的原理和操作方法。     

Stumbling toward equity: the role of government in kidney transplantation

In Mortal Peril, Professor Epstein is critical of the current, regulated system for organ donation and suggests that a market for organ tissue would better meet the needs of patients. In this response to Professor Epstein, Professor Laura Dooley and Dr. Robert Gaston pair their skills to attack Professor Epstein's analysis. As they have done on several other occasions, Professors Dooley and Gaston argue that the kidney donation and transplantation arena is fraught with racial inequity, and that Professor Epstein's proposal for a market in kidneys will exacerbate this inequity. The authors maintain that to prevent the poor from being excluded from transplants, the government plays a critical (if imperfect) role in the allocation of these scarce resources. Furthermore, government intervention is acceptable to correct past discrimination because there is scientific evidence that the disproportionate incidence of kidney failure in African Americans is related to the evolutionary pressures of slave trading and slavery. Professors Dooley and Gaston also defend their previous efforts to change the government system of allocation and characterize the government's willingness to adopt their recommendations as an appropriate response to scientific research rather than a governmental susceptibility to lobbying from special interest groups. Finally, the authors criticize Professor Epstein's argument that dialysis is a viable alternative to transplantation because there are significant differences in "quality of life, morbidity and survival." Professors Dooley and Gaston conclude that government intervention is necessary for maintaining the equity in kidney transplantation that a market system would not.     

Fatal air embolism during renal dialysis

Air embolism during renal dialysis is extremely rare because of the safeguards built into the apparatus and procedures currently used. This case is attributable to improper techniques used with venous access outside the monitored system.On completion of dialysis and disconnect from the machine and its safeguards, this patient had leg cramps. This common postdialysis complaint is routinely treated with intravenous saline from a fresh bag hung outside the machine for this purpose. Unfortunately, a previously used bag had not been replaced and soon ran empty after being connected to the patient's venous access. It was replaced hurriedly with a new bag without first bleeding the system of air.The patient collapsed, was transported to a hospital, and died 72 hours later without regaining consciousness. The diagnosis was confirmed by radiological and pathological examinations.The various mechanisms and pathways of venous to material transit are discussed.     

Medicare program; protocol for the reuse of dialysis bloodlines--HCFA. Final rule

This final rule implements section 1881(f)(7) (B) and (C) of the Social Security Act, added by sections 9335(k) and 4036(c) of the Omnibus Budget Reconciliation Acts of 1986 and 1987. That legislation precludes end-stage renal disease (ESRD) facilities from reusing dialysis bloodlines after July 1, 1988 unless the Secretary has established a protocol for their reuse and the facility follows the protocol. These provisions constitute both a Medicare condition of coverage for ESRD facilities and a condition for payment for dialysis treatment involving reused bloodlines for those facilities which elect to reuse them.     

Mentally ill and non-mentally-ill patients' abilities to understand informed consent disclosures for medication

The perormance of two groups of hospitalized mentally ill patients (schizophrenia and major depression) and two groups of non-mentally-ill patients (patients hospitalized for ischemic heart disease and non-ill primary care patients) was compared on a standardized, objective instrument for assessing patients' understanding of information relevant for patient decision making (consent) about treatment with medication. Generally, hospitalized schizophrenic patients manifested significantly poorer understanding of informed consent disclosures about potential medication than did the other groups. Considerable variance, however, was apparent within the schizophrenic group and was related to a number of clinical and demographic variables. The results are interpreted with reference to issues of compatence to consent to or refuse treatment.This research was supported by the Research Network on Mental Health and the Law of the John D. and Catherine T. MacArthur Foundation. We wish to acknowledge Cynthia Wickless, Elizabeth Cote, and Kathryn Cranford for their assistance in this study and to thank several colleagues for helpful comments on an earlier draft: William Gardner, Steven K. Hoge, John Monahan, Stephen Morse, Ed Mulvey, and Henry Steadman.