A Compilation for Diabetes Management

If diabetes management were a jazz standard, the refrain might sound like a reworking of George Benson's haunting "You Don't Know What Love Is." "You Don't Know What Pain Is" would chronicle the stab of lancets — from daily shots of insulin to finger-nick tests — the woes of diabetic foot care and the agony of diabetes management gone awry.

Clearly, the sweet tooth may not be the only thing suffering in the daily life of a diabetic.

Fortunately, home health providers possess the cure for the diabetes blues. Home Health Products reveals how providers can help clients stop the sting by tapping the latest technology, including faster, nearly pain-free testing and equipment that makes living with diabetes more tolerable.

In the uphill fight for reimbursement, adding diabetic supplies to the mix might help providers boost cash sales as well.

FAST STATS

'You've Changed': Products for the Masses

"The newest meters available on the market have improved in technology from their predecessors," says Doug Kuzyk, of GEMCO Medical, a wholesale distributor in Hudson, Ohio. "They have eliminated the complicated technique once required to obtain an accurate blood glucose test."

Meters preaching accuracy have stormed the marketplace. "Meters are now smaller, faster and require less blood, and some no longer require coding, eliminating another step that can cause errors," Kuzyk says.


The average provider has to stock a lot more products than several years ago. —Frank Suess, Pharma Supply

To address consumer demands, manufacturers are producing a variety of options for glucose meters. "The industry changed with the evolution of the glucose meter," says Frank Suess, president, Pharma Supply Inc., West Palm Beach, Fla. "Most manufacturers now have a variety of monitors on the market. From very simple ones to very sophisticated ones that give you any information you could think of. There is even a European model that's built into a cell phone. Patients are getting more educated in the different products and, as long as they get reimbursed, they are getting more demanding. This means that the average provider has to stock a lot more products than several years ago."

Providers also have to stay up to date on product capabilities. "Providers should keep up with the latest technologies, so they can help the patient to make the right purchasing decision," says Suess. "It's like buying a car. If your salesman doesn't know anything about the automobile and can't answer your questions, you will go to a different dealership. Many manufacturers provide comparison sheets on glucose monitors, insulin pumps, syringes, etc."

Take a look at the latest trends for diabetic supplies:

Trend: I Robot
For those who believe interaction is the key to compliance, talking glucose meters may be the best thing to hit the market since the telephone. The latest meters assist users by giving directions — in a choice of languages — and reading test results. It could only get better if the meter actually kissed your boo-boo like mom did. The real bonus of talking meters, however, is that they assist visually impaired users, making it easy to know results instantly, says Suess.

Trend: This Will Only Hurt a Little
Perhaps the most important issue on the minds of diabetics, pain management gets an upgrade with a slew of testing products that require a tiny sample of blood for virtually pain-free application. The old motto "no pain, no gain" does not apply here. "Most systems require less than 1.5 microliters of blood," explains Kuzyk. "The smaller the blood sample required, the smaller the lancet you can use to obtain a drop of blood, which reduces the overall pain of doing a blood glucose test. Many manufacturers promote their meters as 'virtually pain free' because their small sample size is less than 0.6 microliters."


It's like buying a car. If your salesman doesn't know anything about the automobile and can't answer your questions, you will go to a different dealership. —Frank Suess, Pharma Supply

Pain-free seekers also have a friend in meters that offer alternate site testing. According to the Mayo Clinic, monitors with alternate site testing contain built-in blood-sampling devices that take blood samples from areas other than the finger, such as the arm, palm, abdomen or thigh. These tests help reduce pain experienced by pricking the finger, a highly sensitive area.

Mayo Clinic also reports that specialized lancets that adjust prick depth to accommodate differences in skin thickness and needle-free laser lancets that vaporize a pinpoint of skin on the finger help take the pain away.

Trend: Faster Than the Speed of Light
OK, not that fast, but many meters on the market take pride in quick results. "Most meters give a test result in less than 15 seconds, and several meters provide results in five seconds," says Kuzyk. Suess says many meters give results in less than 10 seconds.

Trend: Hitting the Bull's Eye
Improved accuracy is important to consumers, and new technology seeks to improve that accuracy by eliminating the possibility of user error. "The insertion of the test strip usually turns the meter on, so there is no on/off button," says Kuzyk. "The newer strips are designed to sip in the exact amount of blood, eliminating blood application errors."

Trend: Are Insulin Pumps the Answer?
Insulin pumps — which dispense rapid- or short-acting insulin 24 hours a day through a catheter placed under the skin, according to the American Diabetes Association — have been around for more than 10 years. In recent years, insulin pumps have gained in popularity for all age groups, says Kuzyk. "Approximately 300,000 people use insulin pumps, so it's a small market with only a few providers who specialize in pump training."

Insulin pumps maintain glucose levels without daily injections and can make diabetes management easier.

In addition, Suess says, "Insulin pumps are getting smaller, more reliable and easier to operate" — all great reasons for clients to consider the device.

Trend: Once Around the Track
Tracking results can help clients gain control over diabetes, and clients are getting tech savvy in the way they log results. "Some manufacturers now have simple programs to download your test results to your computer," explains Suess. "Instead of keeping a log book, you can print out your data and take it or e-mail it to your physician."

Study: Non-Invasive Device Outperforms Fasting Plasma Glucose and A1c for Diabetes Screening

'Stormy Weather': What Has CMS Done for Diabetes Lately?

The landscape for reimbursement of diabetic supplies remains steady, but competitive bidding may change the way customers purchase diabetic supplies.

While pharmacies and mail order supply houses have generally cornered the market on diabetic supplies, accreditation may offer a new opportunity for HME providers. "In 2005, approximately 62 percent of people with diabetes obtained their testing supplies from pharmacies, while only 5 percent purchased their supplies from a DME or HME," says Kuzyk. "The remainder received their supplies through mail order supply houses. However, with the changing CMS regulation requiring all providers to be accredited before they can bill Medicare, we anticipate many pharmacies will stop accepting Medicare assignment, which could cause a large shift of Medicare consumers switching from pharmacy to HME/DME or mail orders to obtain their diabetes supplies.

"With this pending legislation, there has never been a better time for DMEs to enter the Medicare (diabetes) market," he says.

In general, the Centers for Medicare and Medicaid Services (CMS) covers glucose monitors, glucose strips, lancets, lancing devices, control solutions, batteries, insulin pumps and diabetic footwear, says Suess. "Unfortunately, Medicare does not pay for insulin or syringes," he says. "Medicaid is a different story. Not all states pay for the same items or pay the same amount."

Kuzyk says that payer sources recognize diabetes management as key to preventing other medical complications. "Many studies have proved that maintaining control of blood glucose levels can lower the risk of costly complications such as heart attacks, strokes, amputation, blindness and kidney disease," says Kuzyk.

And while reimbursement differs from state to state, Medicaid generally offers no-cost strips and meters to consumers, says Kuzyk. In addition, many manufacturers are happy to provide free meters as ongoing test strip sales pay for the cost of meters.

Another trend in reimbursement, Kuzyk says, involves the way test strips are classified. "Most insurance plans only covered test strips as a pharmacy benefit," he explains. "Now they are classifying test strips as both a pharmacy and medical benefit, allowing DMEs and HMEs to better serve diabetes consumers."

Lower Limb Amputations Increase; New Guidelines Offer Help

'Love for Sale': Setting the Store for Diabetes Customers

As the industry struggles to keep its head above water in the ever-changing reimbursement sea, providers have been urged repeatedly to swim toward cash sales. Diabetic supplies just might be uncharted land for providers.

"It is well documented that people with diabetes purchase three times the average consumer who comes to (a provider's) store," says Kuzyk.


It is well documented that people with diabetes purchase three times the average consumer who comes to (a provider's) store. —Doug Kuzyk, GEMCO Medical

Suess says the trick is to get the diabetic customer into your store. "Once you get a diabetic in your store, you may be able to interest them in other items," he says. "They may not be eligible for diabetic shoes, but once they see how comfortable they are, (customers) may pay for them out of their pocket. And while you show them the shoes, let them feel the seamless diabetic socks."

But Kuzyk warns that most diabetes clients prefer to get their supplies by mail or home delivery. "Home delivery is a key change in the industry over the past 10 years," he says. "Many HMEs and DMEs are offering home delivery as a way to combat the larger nationwide mail orders."

Manufacturers are assisting providers by providing more educational materials, including training materials and logbooks. "(Manufacturers) also have 24-hour service lines that the patient can call in an emergency," says Suess. "(The) warranty on many products exceeds three years, and manufacturers make it easy for a patient to exchange a monitor. Most manufacturers provide in-service to train your customer service personnel. Patients are calling the dealer before they are calling the manufacturer, and it's important that your people can help the patient with simple problems."

Kuzyk recommends that dealers get in touch with referral sources to drive diabetic clients to their stores. "It might be wise to determine if your local pharmacies will become accredited," he advises. "If not, developing a strategic relationship with your local pharmacies for referrals might be a great way to grow your diabetes testing business."

Suess suggests participating in health fairs and purchasing local advertising to drive customers to your store. "Most diabetics also have other ailments, and you will be able to sell them other items," he says.

"Besides targeting Medicare and insurance patients, target also the millions of uninsured," says Suess. "Let them know that you carry inexpensive meters and strips. Think outside the box."

Diabetes Shoppe, Ironman Team Up to Inspire Diabetes Management

FAST STATS

The Centers for Disease Control and Prevention cite the following national statistics for diabetes:

  • 20.8 million people — 7 percent of the population — have diabetes (2005).
  • As many as 6.2 million people remain undiagnosed for diabetes (2005).
  • The estimated costs for diabetes in 2002 were $132 billion. Indirect costs (disability, work loss, premature mortality) totaled $40 billion.


Lower Limb Amputations Increase; New Guidelines Offer Help

Diabetics, prone to amputation as the condition often causes blood vessels in the foot and leg to narrow, resulting in poor circulation, have seen a marked rise in amputations. The Centers for Disease Control and Prevention cite an increase in the number of diabetes-related lower limb amputations by 227 percent between 1980 (33,000) and 2003 (75,000).

Diabetics are susceptible to infection, making it difficult for foot and leg wounds to heal. In fact, nine out of 10 non-traumatic lower extremity amputations are instigated by an infection, according to a study led by Texas A&M University. The American Diabetes Association says that diabetes is the most frequent cause of non-traumatic lower limb amputations.

The unfortunate result of these trends is that each year, 75,000 people lose their foot, leg or toe due to diabetes, and 85 percent of these losses could have been avoided, according to the International Diabetes Federation.

"Among all the complications from diabetes, amputation can be the worst," said Dr. Craig Walker, of the Cardiovascular Institute of the South, Houma, La. "Amputation affects a person's quality of life drastically, from mobility to self-image. It is also associated with a decreased life expectancy. But many amputations can be avoided by simply monitoring the symptoms and talking to a physician about your pain."

Now, new guidelines from the American College of Foot and Ankle Surgeons (ACFAS) could lead to significantly fewer foot complications and amputations. The guidelines introduce two substantial changes since their last publication in 2000: a focus on prevention and the use of multidisciplinary teams of specialists.

The changes reflect medical evidence from around the world that a multidisciplinary team approach achieves dramatic reductions in complications and amputations in diabetic feet. The guidelines also mirror an increasing emphasis on management of chronic diseases like diabetes.

"These state-of-the-art guidelines give foot and ankle surgeons and other medical professionals a powerful new tool to help improve and maintain the quality of life for millions of people with diabetes," said James L. Thomas, DPM, FACFAS, a Birmingham, Ala., foot and ankle surgeon and president of the ACFAS. "But they don't erase patients' responsibility to manage their disease, inspect their feet daily and get regular checkups."

The guidelines provide doctors with a decision-making roadmap for treating three major problems that can lead to amputations:

  • Ulcers, or sores that don't heal. They are the most common diabetic foot complication, with treatment costing an estimated $5 billion in the United States. Foot ulcers are the most common cause of diabetic hospitalizations and toe, foot and leg amputations.
  • Infections, the second most-common diabetic foot complication. Diabetes patients who suffer nerve damage in their feet do not feel pain from ulcers, cuts and puncture wounds that allow bacteria to enter.
  • Charcot foot, a severe foot deformity involving a collapse of the foot's structure, affects less than 1 percent of people with diabetes, but can lead to amputation.

Other diabetes-related foot and leg problems include corns and calluses, dry, cracked skin, nail disorders, hammertoes and bunions, brittle bones, and blocked arteries in the calf.

Sources: Spectranetics Corp. and the American College of Foot and Ankle Surgeons (ACFAS)

Visit www.footphysicians.com.


Diabetes Shoppe, Ironman Team Up to Inspire Diabetes Management

Diabetes Shoppe has teamed up with Andy "Iron Andy" Holder to motivate people to properly manage diabetes. As part of the "Managing Diabetes: Living Without Limits" campaign, Holder will embark on an inspirational tour by participating in athletic events nationwide and speaking about living with diabetes as an Ironman competitor.

Diagnosed with type 1 diabetes in 2005 at age 36, Holder was determined not to let the disease hold him back. An athlete all his life, he decided to take control of his diabetes and inspire others by becoming an Ironman competitor. As an Ironman, Holder must swim 2.4 miles, bike 112 miles and run a full marathon of 26.2 miles. Holder's endocrinologist, Certified Diabetes Educator (CDE) and local Diabetes Shoppe pharmacist help him safely manage his disease during extreme training and competition.

"With the support of my health care team, I am able to manage a disease that could have limited my ability to live my life the way I wanted," said Holder. "Because I am dealing with diabetes around the clock and learning new things every day about managing the disease, I could not train successfully for the Ironman without the knowledge, accessibility and emotional support of my Diabetes Shoppe pharmacist."

"Poor diabetes management can put patients at a greater risk for serious complications such as kidney disease, blindness and stroke or premature death. Patients should work with a health care team to control the disease and lower their risk of complications," said Jerry Meece, R.Ph., FACA, CDE, Diabetes Shoppe pharmacist, Plaza Pharmacy and Wellness Center. "Andy is a great role model to remind diabetes patients that disease management is not only important to staying healthy and active, but is key to reaching lifestyle goals."

Iron Andy completed his first Ironman July 23, 2006, in Lake Placid, N.Y., and plans to kick off the 2006-2007 leg of the "Managing Diabetes: Living Without Limits" campaign tour Nov. 12 in Miami, where he will compete in the Miami Man Half Triathlon.

The "Managing Diabetes: Living Without Limits" campaign continues with the following racing schedule:

  • Ironman 70.3, Oceanside, Calif. — March 31, 2007
  • Rock and Roll Half Marathon, Nashville, Tenn. — April 28, 2007
  • Ironman 70.3, Orlando, Fla. — May 20, 2007
  • Ironman Visit, Coeur d'Alene, Idaho — June 24, 2007
  • ADA Tour deCure, Kansas City, Mo. — June 2007
  • Ironman 70.3, Benton Harbor, Mich. — August 2007
  • JDRF Tour, Asheville, N.C. — September 2007
  • LA Triathlon, Los Angeles — September 2007
  • Try Andy's Tri, Sugarland, Texas — October 2007

Visit www.diabetesshoppe.com.


Study: Non-Invasive Device Outperforms Fasting Plasma Glucose and A1c for Diabetes Screening

A study presented at the 2006 Scientific Assembly of the American Academy of Family Physicians revealed that a non-invasive diabetes-screening device outperformed the fasting plasma glucose (FPG) test and the A1c test for identifying diabetes and pre-diabetes in individuals with one or more known risk factors. A prototype of the device identified 29 percent more patients than the FPG test and 17 percent more patients than the A1c test.

Conducted by researchers from the University of New Mexico School of Medicine, TriCore Reference Labs, InLight Solutions and VeraLight (developer of the device, named Scout), the study was a head-to-head evaluation of the Scout prototype against the FPG and A1c tests in 351 subjects at risk for diabetes or pre-diabetes. Used to screen and evaluate individuals at risk for diabetes, the FPG test measures a patient's blood sugar after an overnight fast and the A1c test measures the body's average glucose metabolism over the past 90 days. The oral glucose tolerance test, which measures blood glucose two hours after oral administration of a 75-gram glucose load, was used in the study as a confirmatory test.

The subjects in the study ranged in age from 21 to 86 years old. At the lower, impaired fasting glucose threshold of 100 milligrams per deciliter (mg/dl), the FPG sensitivity was 58 percent, the A1c sensitivity was 64 percent, while the Scout's sensitivity was 75 percent. Scout's improved sensitivity did not result in an increased rate of false positives — erroneous positive identification of an at-risk patient. As a result, the device was able to identify 29 percent more individuals with undiagnosed diabetes or impaired glucose tolerance than the FPG test and approximately 17 percent more than the A1c test.

Slated for market introduction in early 2008, Scout detects abnormal concentrations of diabetes-related biological markers found in skin from an individual's forearm in less than one minute using fluorescent light. Unlike the FPG test, the device does not require a blood draw or overnight fast prior to testing. Although the A1c test does not require the patient to fast, a blood sample is needed to perform it.

"Considering one no longer needs to provide a fasting blood sample prior to testing, the overall convenience and superior accuracy of Scout is a major breakthrough in diabetes and pre-diabetes screening that could dramatically reduce the costs and morbidity associated with this disease," said R. Philip Eaton, M.D., diabetes specialist, professor emeritus and former vice president of the University of New Mexico Health Sciences Center, in a news release.

According to medical experts, non-invasive skin detection of advanced glycation end-products, or AGEs, could replace the FPG test as the medical workhorse for screening people suspected of having diabetes. Previous studies have shown AGEs are biological markers that correlate well with diabetes and are a predictor of the disease's serious complications. Analogous to a "diabetes odometer," AGEs are a sensitive metric for the cumulative damage the body has endured due to the effects of abnormally high blood sugar and oxidative stress. They affect the proteins that make up blood vessels, connective tissue and skin, and are thought to be major factors in aging and age-related chronic diseases.

Visit www.veralight.com.

This article originally appeared in the November 2006 issue of HME Business.

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