Medical Device Daily Washington Editor

WASHINGTON — Asking a government agency to engage in statistical analyses might seem to be asking for a five-year plan, but the Centers for Medicare & Medicaid Services (CMS) has managed to “re-index” a key component of the hospital in-patient prospective payment system (IPPS) in a mere six months, despite what appears to have been a reluctance in previous years to complete the task.

Legal action spurred the effort.

Thanks to the Benefits Improvement and Protection Act of 2000 (BIPA), CMS must harvest data every three years on the occupational mix at hospitals in order to fine-tune its IPPS payments under Medicare. However, the agency applied the adjustment to only 10% of the hospital workforce in the past two fiscal years, 2005 and 2006.

According to the CMS web site, this was due to “difficulties in collecting complete and accurate data from hospitals on the mix of hospital employees.”

A total of 76 hospitals, led by Bellevue Hospital Center (New York), decided to take the government to court and won. In a decision handed down April 3, Justices Rosemary Pooler, Robert Katzmann and Barrington Parker of the U.S. Second Circuit Court of Appeals, also in New York, ruled that CMS was legally required to fully index hospital workforces.

In BIPA, Congress had instructed CMS to complete the first data collection by Sept. 30, 2003, and every three years thereafter. The agency apparently did not complete the full calculation on the first round, as indicated by a passage in the judgment in which the justices wrote that they were of the opinion that the law required CMS “to first complete the collection and measurement of data on Sept. 30, 2003” and that the failure to complete this “predicate task” does not indemnify the agency from a full collection and analysis of data three years later.

The judges handed the agency a second rebuke with the statement that “[n]ot only are the agency’s actions violative of the statute, but they are arbitrary and capricious” and further that CMS provided “no explanation given as to why 10% was chosen” as a benchmark for wage indexing, as opposed to some other portion of the hospital workforce.

The CMS announcement for the released indexing figures says that the revised occupational wage mix “has little or no effect on the DRG (diagnostic-related group) relative weights” that it announced in August, with no DRGs shifting by more than .8%. The announcement also notes that the net effect of this change leaves the IPPS outlays for FY07 budget neutral compared with the 10% adjustment, with the anticipated increased in IPPS payout remaining at roughly $3.4 billion.

Islet transplants hopeful for type 1 diabetes

As device makers scurry to couple insulin pumps and glucose meters into an inconspicuous and carefree “cure” for type 1 diabetes, researchers from the other end of the medical technology spectrum are working to leapfrog the device industry in a race to replace the pancreas.

The Sept. 28 edition of the New England Journal of Medicine provides an update on how transplanted pancreatic islets can reduce the severity of the disease and, in some cases, free a patient from the need for outside sources of insulin altogether.

James Shapiro, MD, and 30 other researchers working in the U.S., Canada and three European nations injected donated islets into the hepatic portal vein in 36 volunteers. The result is that 16 of them do not need insulin a year after the procedure. And another 10 subjects demonstrated partial function of the islets, thereby reducing the incidence of hypoglycemic unawareness, a syndrome that leaves diabetics dangerously oblivious to falling blood sugar levels.

Elias Zerhouni, director of the National Institutes of Health , said that the results of this effort demonstrate that the procedure “has promising implications for the future of treating type 1 diabetes.”

Shapiro was more guarded in his public comments, noting that the effort “really shows that islet transplantation can be tremendously successful in protecting against hypoglycemic unawareness.”

The Edmonton Protocol was originally developed by Shapiro at the University of Alberta , named after the city where the university is located. Under this protocol, roughly one million islets are required for a full transplant, typically requiring donations from at least two donors, which strictly limits the number of patients whom doctors can treat. However, researchers are hopeful that stem cells will one day serve as an exogenous source of islets.

As is typically the case with transplants, immunosuppressant drugs are needed to fend off tissue rejection. According to the National Diabetes Information Clearinghouse, patients must take injections of dacliximab (Zenapax) right after the procedure, but must maintain therapy of sirolimus (Rapamune) and tacrolimus (Prograf) for life.

The study does not say how many of the subjects lost their transplants due to having dropped the immunosuppressant therapy because of the side effects.

However, older sufferers of diabetes can take heart. The mean age of the enrollees was 41, and the average disease duration was 27 years. According to the announcement at the NIH web site, the majority of participants “had at least partial islet function after one year after their final infusion, and almost all who did had resolution of hypoglycemic unawareness, even if they were not freed from daily insulin injections.”

Canadian firm files for unique ICD-9 code

Novadaq Technologies (Mississauga, Canada) made a presentation at the Sept. 28-29 meeting of the CMS ICD-9-CM coordination and maintenance committee to persuade the agency to make a unique ICD-9 code for its SPY intra-operative fluorescence vascular angiography system. The primary use of this system will be for coronary artery bypass grafts.

SPY, which is said to enable surgeons to pinpoint the location of target vessels and to visually assess the function of bypassed and other vessel function, uses a low-intensity infrared laser source to excite a fluorescent imaging agent to deliver the images.

Bruce Ferguson, MD, associate chief at the division of vascular and CT surgery at the East Carolina University Heart Institute (Greenville, North Carolina) made the presentation to CMS for Novadaq. Other attendees in support of the SPY included Michael Shen, MD, of the Cleveland Clinic Florida (Fort Lauderdale) and Edwin McGee, MD, of Northwestern University Medical Center (Chicago).