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RPAM
MESSAGE
FORUM
A Professional Association
President
R.
Provenzano MD
Vice President
Robert Hillyer,
MD
Treasurer
Juan Ganum, MD
Secretary
Elisa Singson, MD
Gary
Zasuwa
Web production
Detroit, MI:
Letter from:
Robert
Provenzano MD
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Administrative Perspectives Jeff Lehman, MHA,CPA; Katrina Russll, RN, CNN: Update on the Exception Request Process
RECENT NEWS:
FRESENIUS TO PAY IN ADULTERATED BLOODLINES CASE
NMC Medical Products, Inc., a division of Fresenius Medical Care North America, admitting that it had released adulterated bloodlines used in dialysis treatments that could have seriously injured patients or led to deaths in certain circumstances, has been ordered to pay a $3.8 million fine, announced U.S. Attorney Robert J. Cleary. It is believed to be the largest misdemeanor fine in the history of the U.S. Food and Drug Administration (FDA). The agency's Office of Criminal Investigations developed the case against NMC.Last December, NMC admitted that from December 16, 1992 to October 6, 1993, it released the adulterated bloodlines, despite its own tests showing D the bloodlines could develop potentially excessive levels of air bubbles, possibly causing a fatal air embolism, according to a press release from the U.S. Department of Justice. While no deaths resulted from the release of the bloodlines, NMC said that it did receive four report of blood loss and more than 100 malfunctions, but there were no reports of an air embolism.
NMC also admitted it failed to report nearly 1,200 incidents from 1992 to 1994, when several of its devices, including dialyzers and bloodlines, may have malfunctioned or caused or contributed to a death or serious injury. FDA regulations mandate that such incidents be reported within five to 15 days. NMC, however, said it was not aware of these incidents until December 1995.
The bloodline probe began prior to the merger of Fresenius with National Medical Care (NMC).
GAMBRO FACES NEW PROBE OF BILLING RECORDS
Gambro AB, a leading provider of international dialysis services, has announced that the U.S. government agency probing billing records related to laboratory testing by its U.S. subsidiaries, Gambro Healthcare Laboratory Services, Inc., and Dialysis Holdings Laboratory Services, Inc., has notified the company of it plans to expand the review period to include 1994 and 1995.
The amounts billed to the Medicare End-Stage Renal Disease (ESRD) Program during those years were about $8.5 million and $12.7 million, respectively. These amounts are in addition to amounts dis-closed in Gambro's press release of October 1999. Company officials said they plan to continue cooperating fully with the probe and have established "a productive dialogue with government representatives."
Worldwide, Gambro treats about 43,200 dialysis patients in 581 clinics. The group, with annual revenues of approximately $2.2 billion, has about
17, 000 employees in 40 countries.
Sponsored In part by: (Click for info)
Visit their new site.
The National Kidney Foundation-Dialysis Outcomes Quality Initiative (NKF-DOQI) Clinical Practice Guidelines on Nutrition are set to be released for public review this month. The guidelines are a follow-up to those related two years ago covering hemodialysis adequacy, peritoneal dialysis adequacy, vascular access, and the treatment of anemia of chronic renal failure
(continues)
Proposed Stark Regulations Unveiled (see more)HCFA Interpretation of Self-Referral Rules Recognize Circumstances of Dialysis Providers (see more)
Where Does the ESRD Program Stand in the Budget Reconciliation Process?
INTRODUCTION
During the summer of 99', the US House of Representatives and US Senate completed work on their Medicare reconciliation bills and named their conferences for the joint Conference Committee. The Conference Committee is responsible for negotiating the final Budget Resolution that will the become the latest Omnibus budget Reconciliation Act (OBRA). continues.
POSITION PAPERS RELEASED: Nephrologists Address Assisted Suicide; ANNA Defines APNS
A nephrologist who abides by a patient's request to withdraw from dialysis or withhold treatment is not participating in physician-assisted suicide as long as the patient is competent in making those decisions and the nephrologist determines why the patient is refusing dialysis, according to a recent position paper issued by the Renal Physicians Association and American Society of Nephrology.
Physicians are legally required to honor such wishes from their patients of their surrogates, according to the paper, prepared by a committee headed by nephrologist Allen "Woody" Moss and with assistance from other associations. The six-page document addresses patients' right to decline dialysis and also encourages the use of advance care planning, or advance directives.
Once a decision is made to forgo dialysis, the dialysis team should refer the patient to a hospice or adopt a hospice-like approach. "Patients and surrogates should be informed that a death from uremia may take a week to a month (or occasionally longer) depending on the circumstances, that death from uremia is usually a comfortable one in which the patient becomes increasingly somnolent(drowsy) and then dies, and that if dialysis is not initiated or is withdrawn it will be necessary to maintain salt and fluid restriction so that oulmonary edema does not occur and mar the comfort of the dying process.
Get ready. Managed care is coming. Along with it will come major changes in the methodology of reimbursement for End-Stage Renal Disease (ESRD) care.
Patient Growth at the time the ESRD amendment to the Social Security Act was passed in 1972, there were only about 7,000 ESRD patients.
Send us your comments, suggestions or a letter to the editor. We will gladly insert job wanted postings, classified ads, or business announcements of fellow members.
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