HCFA changes name to CMS
It’s no longer HCFA; it’s CMS.

The Department of Health and Human Services agency that runs Medicare and Medicaid is no longer the Health Care Financing Administration; in June it changed its name to the Centers for Medicare and Medicaid Services.

HHS Secretary Tommy Thompson, announcing the change at a Washington press conference, said the new name reflects a "new culture of responsiveness" at the agency.

He outlined a reorganization of the agency, to be called CMS, with three new centers of service. The Center for Beneficiary Choices will focus on the Medicare+Choice program and provide beneficiaries with information they need to make choices. The Center for Medicare Management will focus on the traditional fee-for-service program, dealing with providers. The Center for Medicaid and State Operation will focus on such programs as Medicaid, SCHIP and insurance regulation, administered by states.

Thompson said today’s action is the first in a series of reforms at the agency. CMS Administrator Tom Scully announced a $35 million campaign scheduled for this fall to improve education of seniors about their Medicare and Medicaid benefits and choices.

Urine test for vCJD may be closer than previously thought
Researchers in Israel claim to have developed a simple diagnostic test for variant Creutzfeldt Jakob disease (vCJD), the human form of BSE. They say their method can reliably distinguish between urine samples from healthy humans and samples preserved from people who died of vCJD.

They are working on making the test generally available and say it could be ready in a year. British specialists say the work is interesting, but raise questions about its accuracy.

Variant CJD — a fatal degenerative disease affecting the brain — is hard to distinguish from other degenerative diseases like Alzheimer’s.

Doctors often cannot be sure that a person has vCJD until after a post mortem examination.

So a urine test would make diagnosis much simpler and might even be used to work out how far and how quickly the disease has spread through the general population.

Mail-in microalbumin test detects kidney problems early
KidneyScreen At Home kit from FlexSite Diagnostics, Inc. enables diabetes patients to collect a urine sample at home and mail it to FlexSite’s laboratory in a dried state for testing. The test detects small (micro) amounts of albumin (a protein) in the urine (microalbuminuria), which is the earliest clinical evidence of kidney dysfunction.

According to the American Diabetes Association (ADA), 20 percent to 30 percent of patients with diabetes develop diabetic kidney disease. While kidney disease is among the most devastating complications of diabetes, it’s also highly detectable and treatable in its earliest stages.

The ADA and the American Kidney Foundation recommend that all diabetics be tested for microalbuminuria every year. However, studies have shown the test is widely underused. Supposed reasons for this include a lack of knowledge about the test, and the cumbersome nature of traditional collection methods.

With KidneyScreen At Home, the urine sample is mailed in a dried state to FlexSite Diagnostics’ CLIA licensed laboratory using the proprietary UriSite urine collection device. The product is designed for the patient and physician to use together to monitor the patient’s health and help achieve improved diabetes management.

The FDA cleared KidneyScreen At Home for over-the-counter marketing in August 2000. KidneyScreen At Home is the second product in FlexSite’s line of mail-in laboratory tests for diabetes management. The first product, A1c At Home, offers patients an at-home method to do glycohemoglobin (HbA1c) testing.

Study: Roche Diagnostics No. 1 in U.S. IVD market
Roche Diagnostics, headquartered in Indianapolis, was named the No. 1 in vitro diagnostics company in the United States, according to a marketplace analysis by Boston BioMedical Consultants. The No. 1 ranking stems from the company’s extensive product lines, which include predisposition screening, targeted monitoring, prevention, diagnosis, therapy and therapy monitoring systems, as well as its pipeline of new technology-based products.

Data suggest promising role for painless blood glucose monitoring in pediatric care
Data from a pilot study, conducted to evaluate the effectiveness of the Glucowatch Biographer in monitoring glucose levels of pediatric patients with diabetes, suggest that the device’s performance was similar to that previously observed in adults.

The studies, the results from which were presented recently at the American Diabetes Association (ADA) 61st Scientific Sessions in Philadelphia, were conducted in subjects seven to 17 years of age. The watch-like Biographer devices were worn on the forearm as approved for use in adults, or at alternative sites on the body as may be more convenient for children. This marks the first time that the Glucowatch Biographer, which received FDA approval for adult use in March 2001, was tested in children and adolescents and on wear sites other than the user’s forearm.

In the poster session, “Accuracy of the Glucowatch Automatic Glucose Biographer in Subjects 7 – 17 Years of Age with Diabetes,” researchers reported that the Glucowatch Biographer, the first automatic, non-invasive glucose-monitoring device to provide frequent and convenient blood glucose readings to the user, was tested in 22 subjects (10 male, 12 female), ages seven to 17. Twenty subjects with Type 1 diabetes and two subjects with Type 2 diabetes wore a total of 43 Biographers, one on the forearm (system 1) and one at an alternative site (system 2: upper arm, thigh, calf, abdomen, back). System 2 readings correlated highly with system 1 readings. These readings also were compared with capillary blood glucose samples that were obtained hourly and measured with a blood glucose analyzer. Results were similar among all systems used.

“These preliminary results are encouraging,” said Eba H. Hathout, M.D., director of the Pediatric Diabetes Center of the Loma Linda University Children’s Hospital in California and a leader in the study and management of pediatric diabetes. “The discomfort and inconvenience of traditional finger-stick blood glucose testing often results in too few tests, and potentially insufficient information. The frequent monitoring provided by the Glucowatch Biographer helps fill this information void, and can lead to better control of diabetes. This may vastly improve long-term outcomes for these young people who will have diabetes for the remainder of their lives.”

Misys plc acquires Sunquest
On June 25, Sunquest Information Systems announced that it agreed to be acquired by Misys plc, a leading U.K. software company for $24 per share. The boards of both companies unanimously approved the transaction.

Sunquest becomes a wholly-owned subsidiary of Misys and remains headquartered in Tuscon, Ariz.

“Sunquest’s fit with Misys, a larger and more diverse company, is an excellent one. The acquisition … should foster the continued success and growth of Sunquest and provide an excellent environment to preserve the culture of the Company, including its strong service ethic,” said Dr. Sidney Goldblatt, Sunquest’s co-founder, chairman and CEO. “The acquisition of Sunquest will consolidate Misys’ position as a leading provider of healthcare information systems, extending Misys’ presence into the acute care market with a strong position to exploit the expected growth in clinical systems.

Misys is a market leader in physician practice management systems and Sunquest is a leader in clinical data management with more than 1,250 sites worldwide.