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Resold diabetes strips cause health concerns

Healthcare ProvidersDiabetesFood and Drug AdministrationMedicareMedicaidDiseases and IllnessesAmerican Diabetes Association

On Charles Street, inside the Belvedere Galleria, a company run from a small office offers cash for people's leftover diabetes strips, the tiny tabs used to test glucose levels, which are crucial to managing the disease.

An Internet search for "sell diabetes strips" turns up numerous websites offering to buy the strips via mail.

The demand for more affordable strips — some brands cost $1 each and the typical testing regimen runs three times a day — has created what some call a "gray" market for reselling them. Buying and selling the strips is legal, but the practice has raised concerns from the U.S. Food and Drug Administration, the American Diabetes Association and some doctors who say it poses a public health risk and advise people to use extra caution when buying strips from resellers — or not buy them at all.

The companies say they provide diabetics with cheaper medical supplies, but health officials warn that there is no clear way to know if the people who previously owned the strips stored them correctly or never opened them. They also worry that diabetics strapped for cash will sell the strips when they should be using them to monitor their condition.

"There is no guarantee of the quality because these strips are sensitive to temperature and expiration," said Katherine Rogers, executive director of the American Diabetes Association's Maryland chapter. "We don't know if the person selling the strips didn't have them in the back of their car for two weeks overheating, which ruins their efficacy."

If the vials that hold the strips have been opened by a previous owner who has pricked a finger, they may have trace amounts of blood, which pose a risk of infection, according to the FDA.

"The bottom line is that we think this is a public health concern," said Courtney Lias, an official with the FDA's Center for Devices and Radiological Health.

The FDA can take enforcement action against companies if there is evidence that the test strips are misbranded, stored incorrectly or adulterated in some other way. It is illegal to resell expired test strips, for instance, and the FDA has initiated criminal proceedings for this practice.

Companies that resell packaged strips don't need to register with the FDA, but they do if they relabel or alter the packaging, Lias said.

The FDA has issued alerts and taken action against companies that have sold counterfeit strips or strips that weren't stored correctly. In 2011, the agency issued a warning to H&H Wholesales Services Inc. in Michigan for, among other things, using a broker that didn't properly store test strips. In 2006, the agency issued a warning about counterfeit strips sold under the name One Touch Basic and One Touch Ultra.

"The FDA takes these issues very seriously," Lias said. "If we hear of illegal activity in this area, we investigate, and if there is evidence of illegal activity, we will enforce our laws."

She recommended consumers use their judgment on whether they are buying test strips from a medical facility or pharmacy. Consumers should be cautious about online outlets, and purchasing strips out of a car, truck or home might be questionable, she added.

"People should be careful about where they are buying these test strips, and people should buy them from a reputable organization," Lias said.

The resale market is growing mostly on the Internet on websites such as quickcash4teststrips.com, traderjackproducts.com and sellyourteststrips.com. Many promise quick cash, and some even offer pick-up services.

Several resellers contacted by The Baltimore Sun declined to comment. It could not be determined if any were registered with the FDA or needed to be.

According to Susan Livingstone, who said she is the owner of sellyourteststrips.com, companies like hers unjustly get a bad name. She said she makes a good living reselling strips, while helping diabetics who can't afford to buy the strips at the regular price.

The strips come from people whose diabetic relatives died, leaving unused strips, or from people who don't need them anymore, such as a mother who had gestational diabetes while pregnant but whose condition improved after delivery, Livingstone said.

While acknowledging there is no way of knowing how people have stored strips, she said she takes as many precautions as possible. She doesn't resell strips that are expired or purchased by Medicaid or Medicare. She suggested buyers compare readings on the strips to make sure they are good.

"I do the best I can to get a decent quality," Livingstone said, adding that she offers refunds if there are problems with the product. "I do everything I can to make this an above-board process. I wouldn't do anything to cause anybody any harm or distress."

On streets around Baltimore — a city where about 13 percent of adults are living with the disease — bright yellow signs beckon people to sell their unwanted strips for cash. They're ads for a small operation run out a mostly vacant retail space in the Mount Vernon neighborhood. Dollarsforstrips.com operates out of a window where customers can bring their strips for resale.

Workers at the shop declined to comment about the business on several occasions, referring questions to the owner, who they said was out of town. The owner did not return repeated phone calls and messages.

The business' website shows it is owned by Medical Supply Solutions LLC, a company based in Philadelphia, where it also has a site that buys diabetes strips. Medical Supply is a limited liability corporation that has been registered with the Pennsylvania Department of State since 2011.

Its website says it generally gives the strips, or sells them at lower costs, to diabetics who don't have insurance or can't afford them.

The medical costs for patients trying to control diabetes has long been a concern among health advocates. The number of people with the disease has grown to 25.8 million children and adults, or 8.3 percent of the population. Worldwide, the number of people using glucose machines to self-monitor blood sugar levels grew more than 50 percent from 2007 to 2013, according to Renub Research.

This demand is likely driving the diabetes resale business and raising potential for fraud, Lias said.

"My best guess is that these test strips are expensive and people don't have enough money for the number of strips that they need," Lias said. "People are trying to save money, and other people are trying to take advantage of that."

Various types of fraud associated with the strips have been investigated by the federal Office of the Inspector General. Some medical supply companies and telemarketers have worked together to scam elderly people out of personal information under the guise they will get free diabetes strips and other supplies, said Roseann Peragine, a special agent for the OIG. The patient identification numbers are then used to fraudulently bill for diabetes supplies that aren't needed or are never delivered.

Last year, the agency said it recovered a half-million dollars from two companies, Four Leaf Clover Inc. and Team Tech Solutions, for making such unsolicited calls to diabetes patients that resulted in false Medicare claims. Another OIG audit found that in 2011 Medicare paid $425 million to 5,000 suppliers for questionable bills such as submitting multiple claims for diabetes test strips for the same patient in overlapping time periods.

Medicare recipients can legally resell their test strips even though they were paid for with taxpayer money, Peragine said. But if recipients knowingly ask doctors for more strips than they need, they could be participating in fraud. That can be hard to prove, though.

"Documents can be falsified. People can lie to their physicians," Peragine said. "A lot of those things can come into effect when trying to pinpoint how many strips a Medicare beneficiary needs."

The Centers for Medicare and Medicaid Services declined to speak about the issue, referring questions to the Office of the Inspector General.

Doctors said the cost of diabetes supplies sometimes tempts patients take shortcuts in their care, such self-testing less often than they should.

"It can become challenging for patients on a fixed income to obtain all these drugs and medical supplies," said Arsalan Sheikh, an endocrinologist and chair of the department of medicine at Bon Secours Hospital in West Baltimore. "They may not take all their medicine. They may not test as much."

At Bon Secours, emergency room visits from people suffering from complications of diabetes have increased, as they have at other area hospitals.

Sheikh doesn't know of Bon Secours patients buying second-hand strips, but said the practice could be risky.

"Patients are buying this, and they don't know what they are getting," Sheikh said.

Glucose levels need to be monitored three times a day for some people, and not testing can put a person's health at risk, said Sherita Golden, associate professor of medicine and an endocrinologist at the Johns Hopkins University. Uncontrolled diabetes can lead to other health problems such as skin conditions and nerve damage, which, in turn, can lead to amputations.

Golden recalled a patient who gave his glucometer machine to a friend who didn't have one, so he wasn't testing his own glucose levels. Test strips are the most expensive part of diabetes management, she said.

"The whole issue really speaks to the need for insurers and health care providers to work together on how we can get this important expense covered for patients so they don't have to feel they need to turn to an alternative," Golden said.

The diabetes association's Rogers said she worries that companies are targeting the large number of patients who came on the Medicaid rolls under health care reform. She said this "vulnerable population" often needs cash for basic needs.

"They're incentivizing them to sell these strips," she said.

Baltimore Sun Researcher Paul McCardell contributed to this article.

andrea.walker@baltsun.com

twitter.com/ankwalker

Copyright © 2014, The Baltimore Sun
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