Medical Device Daily Executive Editor
And MDDs

Are the troubles being experienced by drug-eluting stents (DES) having a halo effect on carotid stenting? Or it just a turf battle between surgical specialists and interventionalists?

Those are likely questions to be asked in the wake of a decision this week by the Centers for Medicaid & Medicare Services not to expand the patient pool which will be reimbursed for carotid artery stenting (CAS) procedures.

In February, CMS issued a proposed National Coverage Decision for expanded use of CAS (Medical Device Daily, Feb. 5, 2007), with the expectation that the agency would approve the expansion.

The proposal to date covers those at high risk for the surgical procedure to open carotid arteries, called carotid endarterectomy (CEA) in FDA Category B Investigational Device Exemption (IDE) trials, in FDA-approved post approval studies or in accordance with the Medicare clinical trial policy.

The proposed expansion would have covered asymptomatic patients under age 80, at high risk for surgery and have 80% or greater carotid artery stenosis, and eligible for coverage outside of a post-market study or clinical trial, as long as the procedure was performed using the FDA-approved CAS systems and embolic protection devices in a facility approved by CMS.

Several medical device makers have U.S. regulatory approval for carotid stenting, including Abbott Laboratories (Abbott Park, Illinois), Boston Scientific (Natick, Massachusetts), Johnson & Johnson (New Brunswick, New Jersey), ev3 (Plymouth, Minnesota) and C.R. Bard (Murray Hill, New Jersey).

Abbott, which markets two carotid stents, Xact and Acculink, had made a formal request to CMS to revise and expand the coverage policy and provided the agency with the data on which to make the expansion decision.

Don McLeod, a spokesperson for CMS, told Medical Device Daily: "We had been asked by the manufacturer to cover the approved application. But we decided not to do the changes."

The decision puts a damper on what all the players in this sector had been looking forward to as a way of expanding its sales.

Abbott had predicted that the expanded reimbursement would create 50%-75% market growth, or up to $50 million-$75 million on an annual basis.

The carotid stent market is currently valued at about $100 million in the U.S.

The decision not to expand coverage maintains the patient pool for the procedure at about 150,000 to 200,000 patients in the U.S.

In deciding not to move ahead with the expanded coverage, the agency cited the opposition of medical groups — not unexpectedly, those representing specialists who perform the open procedure.

Infections most common

Urinary tract diseases appear to be on the rise and are driving up the cost of medical care in the U.S. to the tune of roughly $11 billion a year, according to a new report issued by the National Institutes of Health. The report noted that Medicare is predictably stuck with a large percentage of the tab, more than $5.4 billion each year.

Urinary tract infections (UTIs) lead the march at about $3.5 billion per annum, with $2.5 billion of that sum going to treatment of women. Women account for 80% of cases, but men end up in the hospital more often and are usually out of work for twice as long as women as a result. Medicare spent almost $1.5 billion of the total expenditures for UTIs, and the more extensive use of fluoroquinolones, a newer and costlier antibiotic than the cephalosporins traditionally used to treat such infections, promises to keep costs rising and runs the risk of inducing resistance to these drugs.

Kidney stones, reportedly one of the most painful conditions a person can acquire, ring up a tab of slightly more than $2.5 billion. Kidney stones were once more likely to be treated in a hospital, but the overall incidence is up to 5% between 1988 and 1994 from 4% between 1976 and 1980.

Men are more likely to form stones than women, and whites are substantially more likely to report the condition than African Americans and Latinos, who enjoy a 70% and 35% lower respective risk of developing stones.

NIH director Elias Zerhouni, MD, said in a prepared statement that the report "sharply illustrates the immense burden of urologic diseases and the importance of studies to preempt disease processes and develop targeted treatments."

The report, titled "Urologic Diseases in America," was produced by the NIH's National Institute of Diabetes and Digestive and Kidney Diseases and took five years to write. It is available at the site for the National Kidney and Urological Diseases Information Clearinghouse.

The costs of other diseases were substantially less than for UTIs, but also significant. Prostate cancer cost the nation's economy $1.3 billion while cancers of the bladder cost $1.1 Billion. Benign prostatic hyperplasia/prostate enlargement cost the same as bladder cancers. Erectile dysfunction came in at $327 million.

The report's co-editor, Mark Litwin, MD, a urologist at the David Geffen School of Medicine at the University of California, Los Angeles said in a prepared statement that the data "have broad implications for quality of care and access to care, and helps to inform discussions about health care and research needs."

New proposal for home health update

CMS has published a proposed rule for reimbursement for home health services, which the agency estimates would boost overall payments by $140 million for calendar year 2008. However, the proposal would tighten payments for some services and would require home healthcare companies to file more quality reports with CMS.

According to the CMS statement, companies that provide the quality reports are eligible for a 2.9% health market basket update, but those that do not get their paperwork in would earn only a .9% increase, providing plenty of incentive. The quality reports will address a dozen measures, up two from the previous list of 10. The new quality reports will address emergent care for wound infections and improvement in the status of surgical wounds. Quality reporting standards became part of the prospective payment system for home healthcare in the Deficit Reduction Act of 2005.

A partial offset for that increase is provided by a change to the reimbursement for 60-day care episodes. CMS will reduce the national payment rate for such episodes by 2.75% for CY 2008 and the following two years because of "a significant increase in the observed case-mix since 2000," which CMS said was due more to "changes in coding practices rather than to treatment of more resource-intensive patients."

"These proposals represent the first major payment changes for home health agencies since 2000," CMS administrator Leslie Norwalk said in a prepared statement.

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