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Use of anti-snoring device rises

Schneider National truck driver Charlie Resch shows a machine provided by the company he keeps in the cab of his truck to help him deal with his sleep apnea.

In three years, Medicare spending there for small bedside ventilators that help treat a serious sleep-related condition soared 324%, to $1.4 million last year.

Doctors in the central Florida town say their community is at the forefront of a national trend that has made the devices one of Medicare's fastest-growing medical equipment expenses, up 96% nationwide since 2004.

The booming sleep industry and an aging and increasingly obese population have prompted greater use of the devices, which treat sleep apnea, a condition that causes snoring, brief breathing lapses and tiredness.

"As we get older and as we get fatter, we have more sleep apnea," says Juan A. Albino, a pulmonologist and sleep specialist in Lady Lake.

Nationwide, the program for the elderly and disabled approved $571 million in payments for the devices, called continuous positive airway pressure (CPAP) machines last year, up from $291 million in 2004, Medicare data requested by USA TODAY show.

Spending could grow even faster under a new federal rule that makes it easier for patients to get the devices by testing for sleep apnea at home rather than in a sleep testing lab.

Medicare estimates that 2% to 4% of Americans have sleep apnea, which is linked to health problems such as coronary artery disease and strokes. About 10% of those over 65 and 20% of the obese suffer from the condition.

By city, Medicare data show:

Miami, Chicago and Houston led the nation in total government payments for CPAP devices.

Texas had six cities in the top 20 for CPAP spending; Florida had three.

Several cities, including Lady Lake, had spending jumps of more than 100% since 2004.

Focus on sleep apnea

CPAPs are the seventh-largest category of Medicare's $12.3 billion in spending on medical equipment. Spending on oxygen supplies, the largest category, rose 5.8% from 2004 to 2007. Spending on wheelchairs fell 17.6% after a fraud crackdown.

Sleep experts say the CPAP growth is not surprising, given the increased attention to sleep apnea.

About $2 billion worth of the devices are sold annually worldwide, with most sales in the USA, says Marketdata, a market research publication based in Tampa.

The machines cost $200 to $1,500 or more. Medicare generally pays 80%. Patients pay 20%.

Some experts warn there is a potential for unneeded prescriptions for CPAPs. "Are people getting treatment they don't need?" asks Fred Holt of the National Health Care Anti-Fraud Association, composed of health insurers and law enforcement groups.

"Not everyone with a diagnosis of sleep apnea needs CPAP," says Holt, an ear, nose and throat surgeon. "Weight loss, avoiding alcohol and sedatives at bedtime or changing sleep position could eliminate the problem for some."

For others, treatment involves sleeping with a mask connected to the CPAP machine, which blows air into the patient's nose, helping prevent obstruction to breathing.

Until this spring, Medicare would pay for CPAP machines only if a sleep center diagnosed patients with apnea. New rules say a diagnosis can be made with a test taken at home.

Opponents say home testing is less accurate. "To be adequately treated, you have to make sure patients are adequately diagnosed," says Mary Susan Esther, president of the American Academy of Sleep Medicine, a trade group representing sleep labs.

Proponents such as William Abraham, a sleep expert and chief of the division of cardiovascular medicine at Ohio State University, say the change makes it possible for more patients to get tested.

"By allowing home testing, perhaps Medicare is opening the floodgates," he says. Yet given the problems of untreated apnea, "it's not only the right thing to do, but may ultimately prove to be a cost savings."

Testing centers spread

Sleep testing centers, where patients stay overnight for observation, have boomed nationwide including in Lady Lake.

Across the USA, 1,475 centers are accredited by the sleep medicine academy, up from 857 in 2004. Sleep testing labs increased bed capacity nationwide by 13% in the past year and plan a 17% increase next year, says a July report by analyst Michael Matson of Wachovia Capital Markets.

"At one point, we had 16 beds" in sleep testing labs in the area, says Albino, whose center has four beds. "Sleep centers were seen as a profit-making venture."

Lady Lake and its surrounding community for the over-55 population, The Villages, has grown to more than 75,000 people in a few years. That's helped fuel the increase, Albino says.

Albino, who runs a sleep testing lab as part of his practice, says about four testing beds per 100,000 people is generally considered ideal. Lady Lake and its surrounding area have more than four times that number.

"This is a disease of the future," he says.         By Julie Appleby, USA TODAY


Tracing tainted produce isn't easy

Workers repackage key limes and cabbage from Mexico at ISPE Produce at the McAllen Produce Terminal Market, a focus of the salmonella probe.
By Alex Jones for USA TODAY
Workers repackage key limes and cabbage from Mexico at ISPE Produce at the McAllen Produce Terminal Market, a focus of the salmonella probe.
 TRACKING TAINTED PEPPERS

Here's the trail Minnesota food-safety investigators followed to track jalapeno peppers from a restaurant in Roseville back to Mexico.

1 On June 30, state investigators visit a restaurant in Roseville, Minn., after getting a flurry of salmonella saintpaul illness reports in the previous week. They check the credit card receipts of customers, some ill, and compare what they ate. Their focus turns to jalapenos used in a garnish. All told, 28 people are sickened. Investigators also get invoices from the restaurant showing where it got jalapenos.

2 Investigators determine that the jalapenos came from Distributor A in St. Paul that diced them.

3 Distributor A got peppers from fresh-produce Distributor B based near St. Paul on June 7, 10, 13 and 14.

4 Distributor B received peppers on June 5 from Distributor C at the McAllen Produce Terminal Market in McAllen, Texas. Distributor B also got peppers on June 9 and 13 from Distributors D and E at a produce market in Los Angeles.

5 Distributor C got produce from a distributor in Nuevo Leon, Mexico. Peppers arrived in McAllen on May 28, one day after leaving Mexico.

6 Distributors D and E got produce from two growers in Baja California in Mexico. Peppers left Mexico on June 2 and 8.

Sources: Minnesota Departments of Agriculture and Health

 

 

 Terminal Market, a 42-acre wholesale market 5 miles north of a major border crossing point for Mexican fresh produce entering the USA.

From concrete loading docks, 100 small distributors and importers peddle tons of fresh produce a day including Mexican-grown peppers, limes, mangoes and watermelon mostly to supermarket and restaurant buyers. Need a new TV or lawnmower? They're here, too.

It was jalapeno peppers that drew Food and Drug Administration investigators. Last month, they found Mexican-grown jalapenos at a small distributor here that were contaminated with the same strain of salmonella saintpaul that's sickened 1,405 people nationwide and in Canada.

Whether those peppers, or others from a different farm in Mexico, caused the outbreak is uncertain. The investigation continues. Mexico says its tests show none of the strain on suspect farms.

U.S. lawmakers have said the investigation, now in its third month, has taken too long. They've also called for stronger laws ensuring that food sellers know where their products come from so that future outbreaks can be solved faster.

But the workings of the McAllen market reveal the sometimes long, convoluted and freewheeling way that fresh produce moves from farm to fork. They also underscore how difficult traceback can be, especially when small players are involved. That's been the case in the salmonella investigation, which focused on tomatoes before turning to peppers.

"The traceback has worked. It's just been slow," says David Acheson, the FDA's food-safety chief, of the investigation.

The McAllen market is capitalism in motion. In the morning, semis, pickups and vans pour through the gates of the complex carrying fresh produce, mostly from Mexico. It's delivered to distributors who rent stalls in the market's giant warehouses.

In the afternoon, much of the produce goes out. Buyers include U.S. retailers with stores from Georgia to Illinois, local distributors who deliver to restaurants via pickups, and flea-market vendors. Buyers can walk the docks, stall to stall, eyeing the goods. Most often, they drive to the dock of a preferred supplier. Prices are spoken, not written. Crumpled cash is as common as credit. Orders for one case, or a truckload, are filled all the same.

Most of the USA's fresh produce once moved through such markets in cities from New York to Chicago to Los Angeles, says Bryan Silbermann, president of the Produce Marketing Association, which represents 3,000 grower/shippers, retailers and others. Today, the markets handle about 20%, as big retailers, restaurants and food producers have shifted to buying directly from growers and approved suppliers.

Improved traceability

The change has improved food traceability. Big companies, including Costco Wholesale, Fresh Express and Ace Tomato, say computerized systems enable them to trace fresh produce from stores to growers within hours or minutes. Key to that capability? Numbers or other identifiers that go on cases or pallets of produce and stay with the produce from the field or packing shed to the processing plant or store.

But at the McAllen market, crates and pallets of produce sometimes sit on the loading dock without such identifying information, even though sellers can say where they got them. Still, traceability in such instances is lost or at risk, says Ace Tomato President Parker Booth.

Produce in crates or pallets may be mingled with produce from multiple growers. Once unmarked produce gets to a store warehouse, it may be more easily mixed with other produce, he adds.

Booth's company won't buy from terminal markets, even though he says the produce is probably safe. "We don't know where that product came from," he says. "We want to buy direct from the grower."

Frontera Produce, one of Texas' largest fresh produce distributors, is headquartered 10 miles north of the McAllen market. In the past, it bought from market distributors if its regular suppliers ran short and Frontera needed more fruits or vegetables to fill orders for customers such as Wal-Mart, Kroger and Safeway. Spot buying like that is common in the industry, says Frontera CEO Will Steele.

A year ago, Frontera eliminated purchases from distributors who couldn't track produce to the field. About six of several dozen failed to meet the new rules. Some were from the McAllen market, says Steele.

"Eighty percent of the industry has good traceback, 20% doesn't, and they put all of us at risk," he says.

The contaminated jalapeno peppers that the FDA said it found at the McAllen market were handled by distributor Agricola Zaragoza. On July 21, it recalled the peppers, which had been shipped to customers in Texas and Georgia in plastic crates and bags with no brand name or label, according to a company statement. The company refused further comment.

'One up, one back'

Federal law, adopted as part of The Bioterrorism Act after the 9/11 terrorist attacks, requires food producers, distributors and others to record to whom they sent product and from whom they received it.

In documents published in 2004, the FDA said 20% of food traceback investigations ended prematurely because of inadequate record-keeping by the industry.

The one-up, one-back requirement fell short of what the FDA had wanted, says William Hubbard, a former FDA official who oversaw policy at that time. He says the FDA wanted distributors or wholesalers to keep records tracking a food back to its source. One-up, one-back was settled upon after food companies argued that a full accounting would be too onerous, given that multiple distributors may handle food as it moves through the supply chain, Hubbard says.

Nearly everybody can fulfill one-up, one-back, Steele says. But the FDA's Acheson says broad use of paper records by smaller companies involved in the salmonella traceback delayed FDA investigators.

The FDA also lost hours trying to reconcile records company-to-company along the supply chain, asserts Rep. Bart Stupak, D-Mich. At a congressional hearing last month, Stupak displayed a box from a California supermarket that had no identifying information except "tomatoes" and "USA."

The delays cost tomato producers dearly. Their sales tanked throughout June amid FDA suspicions that tomatoes were to blame for the outbreak before the agency's focus shifted in July to peppers. The FDA is currently warning consumers to avoid raw jalapeno and serrano peppers grown in Mexico and foods that contain them.

"A faster system would allow (us) to exclude products faster and give you a source faster," Acheson told lawmakers.

Many foods can be hard to track. A package of hamburger that's ground in a store, for example, may include beef from multiple suppliers. Stores, regulated by local and state laws, may not be required to keep grinding records, says Ben Miller, traceback coordinator for the Minnesota Department of Agriculture.

Fresh produce is particularly tough. It moves fast so it doesn't perish. It may be repacked, sold in bulk and handled by a half-dozen companies with different tracking capabilities.

On a recent morning at the McAllen market, Javier Topete worked off four computer screens in an air-conditioned room off the loading dock of his company, Soles Produce.

Within minutes, Topete determined the Mexican orchard in which a particular case of mangoes were grown. The mangoes were headed to retailers including Wal-Mart and Sam's Club.

Nearby, Romeo and Gracie Gutierrez,owners of GTZ Produce,worked their stall together. Romeo does the buying; Gracie waits for buyers on the dock, swatting flies in the midday heat.

GTZ buys produce from a broker, who buys from growers in the USA and Mexico, says Romeo. One of GTZ's frequent customers is a distributor that sells to a regional grocery chain, he adds.

Following a one-up, one-back trail can be fast. It took Minnesota food-safety officials three days to track a contaminated jalapeno garnish from a restaurant there through three U.S. distributors to two growers and a distributor in Mexico, says Miller. One of the three unidentified U.S. distributors was at the McAllen market, but it was not Agricola Zaragoza. The FDA says it was first led to the McAllen market by other state investigators' tracebacks.

Setting new standards

Getting that kind of speed in every traceback is needed, proponents of new standards say. Since late last year, companies such as Frontera have joined trade associations and retailers, including Food Lion, to set new traceability standards.

The Produce Traceability Initiative calls for numbers on cases of produce that identify producers, lot numbers and harvest dates, and scanners that record cases' movements through shipping. Ace Tomato's system costs about 1 cent a box, whether the box sells for $6 or $13, Booth says. Even for small firms, the cost would be "minimal" over time, he adds.

Backers of the initiative expect to set deadlines for adoption of electronic records within weeks. Compliance will be voluntary. The FDA's Acheson says mandatory rules may be needed.

Either way, Frontera's Steele says change is needed. "There will always be outbreaks," he says. "What matters is whether we can go to a store and say, " 'We've detected a problem, and it's isolated to this particular pallet or box and let's keep doing business.' "


For More Information Contact:

Faith M Gray, M.D.
3993 Lawrenceville Hwy., Suite A115, Lilburn, GA 30047
Tel: 770-806-8710
FAX: 770-806-0564
Internet: administrator@faithmgray.com

 

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Last modified: August 14, 2008