Treading territory seldom seen by traditional distributors, Mike Visnich's Quality Assured Services is part of a new breed of distribution companies.

by Mark Thill

You can take Mike Visnich out of the distributor, but you can't take the distributor out of Mike Visnich.

Visnich, a 22-year veteran of medical products distribution, is taking advantage of four huge trends -- miniaturization of technology, consumer activism, disease management and the Internet -- to build a distribution company that bears little resemblance to distributors of the past.

Visnich is building his company -- Quality Assured Services, Orlando, FL (QAS) -- to be the most complete home testing resource on the Internet. Already, the suburban Orlando company is the only anticoagulation specialty distributor in the United States, distributing International Technidyne Corp.'s ProTimeª Microcoagulation System throughout the country. And he's always looking for the next new product.

For Visnich, looking ahead is nothing new. At General Medical, he was an alternate site crusader and created the company's VIP program, the first national affinity program for physicians. His last title there was vice president of alternate site marketing.

Today, the patient home testing market is as full of potential as the alternate site was 10 or 20 years ago, he says. Technology has made it possible for patients to buy devices they can use easily in their own homes. In addition, the continuing push to lower health care expenses and improve disease management -- perhaps best accomplished by prevention of disease -- leads straight to home testing.

ProTime is a perfect example. Patients on blood-thinners, such as Coumadin (warfarin), need to be tested for prothrombin time. Traditionally, that has meant monthly (or more frequent) trips to an anticoagulation clinic or doctor's office and a venous draw. But products such as ProTimeª allow them to do it in the home, with a doctor's prescription.

New Territory

To get the product to the point of use, Visnich acts as a traditional distributor: QAS receives products, stores the cuvettes in a refrigerator, then ships them out to patients via air freight.

But beyond that, the company is treading territory seldom seen by traditional distributors. For example, Office Manager Nancy Clubb spends most of her day compiling letters of medical necessity and talking to insurance companies to try to get reimbursement for the device and disposables.

It's complicated work, she says, because each state has different regulations, each employer offers different plans, and in many cases, more than one insurance company is involved in the claims. In the end, QAS is batting about .700 with insurance -- that is to say, 70% of the private insurance claims filed actually are reimbursed. (Medicare does not cover the device.) "Not everyone is a candidate for home anticoagulation testing," says Visnich. Patients who frequently miss their checkups, or who have had prior health problems, or who simply are too busy for regular checkups are best suited for the procedure. But that's a case that the company must make to insurers.

QAS is developing a network of nurse trainers to help new patients learn how to use the ProTimeª device. Moreover, the company keeps detailed information on its patients and products, tracking lot numbers, fielding complaints on the phone, and handling and reporting problems quickly. "We do a lot more record-keeping and tracking than most distributors," says Visnich. "We're on call 24 hours a day."

In addition to supplying tests to patients' homes, the company also sells CLIA-waived devices and tests to clinics and doctors. (The name of its physician sales division is Q.A. Point-of-Care Services, and it can be accessed on the Internet at qapoint-of-care.com.) The company also distributes the LXN Duet Glucose Management System to consumers and physicians. Visnich says the physician market creates a referral base of patients who are candidates for self-testing. In addition, the company pays finders fees to distributors (reps or companies) who refer patients through their doctor customers, and pledges not to market for direct physician office sales to the referring distributor's physician customers.

Dr. Sheila Dunn, a shareholder in QAS, will host the physician website with advice on CLIA and OSHA matters, and she will produce an e-mail newsletter on the subject.

Internet

QAS is building an infrastructure of product support that can put new products -- particularly home testing ones -- on the map, says Visnich. "We want to help new manufacturers gain entry into the patient self-testing and physician markets by offering them help with regulations, reimbursement, marketing and distribution," he adds.

The Internet figures to play a key role in its future. "Our strategy is to build an audience, so that when a new product comes out, we will get traffic to our site, which will be known for home testing," he says. (The company created a Home Test Medical division for consumer sales which can be accessed at www.hometestmed.com.)

Visnich's goal is to become nothing less than the most complete resource for home testing and CLIA-waived testing on the Internet, and he intends to distribute home testing devices and supplies that are featured on other websites as well as his own.

The explosion of health-care-related sites on the Web offers a golden opportunity for distributors such as Home Test Medical, he says. "Manufacturers [of home testing equipment] don't want to deal with every company that has a website. After all, these companies aren't distributors, they're information brokers." So, consumer requests for home testing devices would be funneled directly to QAS.

"We think the home testing category can be plugged into many Internet sites," Visnich says. Given his nature as a distributor, he's bound to find them.

Editor's Note: Mike Visnich and Dr. Sheila Dunn are co-authors of the chapter on home testing in the soon-to-be published book "Point-of-Care: Principles, Management and Practice," edited by Gerald J. Kost, M.D., Ph.D., University of California at Davis, McGraw-Hill. They also are working on a book that will list home test diagnostic products and information. They will publish excerpts of the book as well as product reviews on their Internet sites.

Copyright 1999 Medical Distribution Solutions, Inc.

Q.A. Services, Inc., Home Test Medical Division, Repertoire Magazine, Nov. 1999

Internet Forms Backbone Of Home Testing Company Entrepreneur rides trends to success on the Web.

If smart businesspeople are those who adapt to change, then Mike Visnich may be a genius.

Visnich, a 22-year veteran of medical products distribution, is taking advantage of four trends -- miniaturization of technology, consumer activism, disease management and the Internet -- to build what he hopes will be the most complete home testing resource on the Internet. (See "Where No Distributor Has Gone Before," June 1999 Repertoire.)

"We're just real happy," says Visnich, president of Quality Assured Services, Orlando, FL. "The site [www.hometestmed.com] is getting more patients every day."

Visitors to the website now have their choice of several technologies to choose from, including a preliminary Alzheimer's screening test; the Tenderlett and tenderfoot incision devices for obtaining blood samples; the In Charge blood glucose testing system from LXN; and the ProTime Microcoagulation System from International Technidyne for monitoring patients on blood thinners.

Next Frontier

Visnich is preparing for what he calls the "next frontier" in home testing -- Internet-based management of patients and patient results. "Eventually, any and all instruments used in the home will be linked -- either through the Internet or phone -- to the physician," he says. Hometestmed.com could become a vital intermediary in that linkage.

For example, a disease management program for anticoagulation patients might call for an intermediary to relay test results to physicians, perhaps keeping an eye out for outliers or cases of non-compliance that need to be brought to the physician's attention. In certain cases, the intermediary could actually get on the phone to non-compliant patients to find out if there's a problem. It could even provide training, counseling and technical support from nurses on how to use the home equipment -- something Visnich's company already does.

"So it's more than putting data onto the Net or a phone line," he says.

Professional Side

Meanwhile, Quality Assured Services' professional site for doctors www.qapoint-of-care.com is growing too. Through the site, doctors can buy CLIA-waived products, including, ProTime, the Duet diabetes control system from LXN, and the Bayer DCA 2000 for HbA1c.

"We intend to offer a complete line of CLIA-waved products on the site, coupled with direct mail and phone services," says Visnich. He expects the site to create a natural referral base for home testing. "The more relationships we have with doctors, the more valuable we become as a marketer for a company with an Internet-based management program," he says.

Dr. Sheila Dunn is involved in Quality Assured Services. She hosts the physician website with advice on CLIA and OSHA matters, and will produce an e-mail newsletter on the subject. Next year Dr. Dunn will begin contributing self-testing tips and guidance to consumers of the Home Test Medical consumer site as well as excerpts from the Home Test Guidebook, currently under collaborative development by Dr. Dunn and Visnich.

Copyright © 2000 Medical Distribution Solutions, Inc. All rights reserved.

First Home Test Cleared For Blood Clotting

Heart patients and others taking the blood-thinning drug Coumadin (warfarin) to prevent clotting can now test for the drug's effect at home with a prescription kit cleared by FDA.

Like other blood thinners, Coumadin is used to treat people with artificial heart valves, irregular heartbeat, and other conditions that lead to excessive blood clotting. These drugs have a "narrow" therapeutic range: Too much blood thinner can cause hemorrhage, while too little can allow clots to form and obstruct blood vessels, causing stroke or death.

Using the ProTime Microcoagulation System, a patient pricks a finger to draw a blood sample and runs the sample through a small, hand-held electronic device that displays results on a screen.

FDA previously cleared the test, known as a prothrombin time (PT) test, for use in doctors' offices, clinics, and nursing homes to check blood coagulation. The home prescription version will be for use under a doctor's supervision.

Previously, patients taking Coumadin had a PT test every one or two months during regular visits to their doctor. With the new kit, they can test themselves weekly, or as often as their doctor recommends. The system stores the 40 most recent results with a date and time stamp, enabling the doctor to review and interpret results and adjust the drug if needed. Doctors can program the appropriate upper and lower blood-clotting ranges for each patient.

FDA cleared the device after reviewing data on 84 patients at four clinics. The patients had the professional laboratory PT test at the clinics and also tested themselves with the home kit. Both types of tests showed comparable results.

International Technidyne Corp., Edison, N.J., makes the ProTime Microcoagulation System.

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Colorectal cancer. Detectable. Treatable. Beatable.

March is National Colorectal Cancer Awareness Month

Learn the Facts. Don't Be Embarrassed to Death

With 130,000 new cases of colorectal cancer and 56,000 deaths anticipated in 2,000, there is no room for embarrassment or silence about colorectal cancer. The fact is, safe and effective screening is available and the place to start is with a Fecal Occult Blood Test (FOBT.)

Biomerica Inc., is giving the EZ DetectT Fecal Occult Blood Test away FREE*

http://www.ezdetect.com as a public service during the March awareness campaign.

Colorectal cancer is the second leading cause of cancer death in the United States, with 57,000 deaths each year. So it is shocking that colorectal cancer is one of the easiest to detect and treat. More than 90 percent of patients whose colorectal cancer is caught early are cured. Because they aren't aware of the risk of this silent killer, tens of thousands of people avoid or are unaware of the simple procedures, like the EZ Detect Fecal Occult Blood Test that could save their lives.

A promising long-term study of 46,000 people, released in March 1999 by The Centers For Disease Control and Prevention, established that using a Fecal Occult Blood Test every year could prevent up to 33,000 deaths nationwide by catching and treating the disease in its early stages. The findings prompted government health officials to announce a new campaign to encourage all Americans over 50 to annually use a fecal occult blood test and led to the U.S. Senate declaring March 2000 "National Colorectal Cancer Awareness Month". (link to:(http://www.crfa.org/colorectal.htm) Recent clinical findings by The University of Minnesota and clinical trials in Denmark and England definitively confirm that screening for colorectal cancer can save lives. Detected at its earliest stages, colorectal cancer is up to 90 percent curable. Yet only 37 percent of colorectal cancer is detected at this stage.

According to The Cancer Research Foundation of America as many as 30 to 40 percent of the population over 50 have pre-cancerous adenomatous polyps in the colon and rectum. Nearly all colorectal cancer develops from these benign growths, which often can be removed during sigmoidoscopy and colonoscopy screening procedures. Yet fewer than four in ten adults over 50 now get the necessary screening for colorectal cancer, according to the Minnesota study.

Oddly enough, although physicians now routinely recommend screening for breast, cervical and prostate cancer screening for colorectal cancer is vastly underutilized. According to the University of Minnesota study, only four in 10 Americans who should be screened for colorectal cancer get the proper tests.

This may be due to the uneasiness patients or physicians feel in discussing this subject. However, as Dr. Bernard Levin, Chair of the National Colorectal Cancer Roundtable, has noted, patients are at risk of literally dying of embarrassment. Regular screening for colorectal cancer allows disease detection of early stage cancers, which are up to 95 percent curable. Four Major Screening Methods EZ Detect, a Simple At Home Test for Hidden Blood in the Stool

When these benign growths are present, there may be hidden (occult) blood in the stool. At the earliest stages of colorectal cancer blood is present in such small amounts that it is not visible to the eye.

EZ Detect is, a non-invasive, two-minute test for occult blood, which requires no dietary restrictions and no handling of stool. A user simply drops a movement. A blue-green color will appear on the tissue within two minutes if blood is detected. The test is repeated for three consecutive bowel movements, with results recorded on a Test Results Card provided with the EZ Detect Kit. The person then mails the card to his or her physician or screening center for professional evaluation.

Not all positive results indicate colorectal cancer. A positive result may also indicate ulcers, hemorrhoids, polyps, colitis, diverticulitis or fissures that may not show visible symptoms even though they are producing blood in the stool. EZ Detect can therefore serve as an early warning signal of bowel troubles that need medical attention.

An FOBT cannot detect every colon problem or abnormality and does not replace an examination by a doctor or other diagnostic procedures. However, according to the University of Minnesota study, FOBTs are of great value in screening people for further examination and colonoscopy.

Options for evaluating a positive result in a fecal occult blood test include flexible sigmoidoscopy, colonoscopy or double contrast barium enema. Sigmoidoscopy Experts also recommend that people over 50 have a sigmoidoscopy every three to five years. In this test, a flexible, narrow tube containing optical fibers is inserted into the rectum and advanced about two feet up into the colon. This method can detect up to 67 to 75 percent of polyps and 40 to 65 percent of colorectal cancers according to the Cancer Research Foundation of America.

If the FOBT and sigmoidoscopy are normal, the FOBT should be repeated annually and the sigmoidoscopy every five years according to The American Cancer Society. Colonoscopy

If there is a positive result in the FOBT, The American College of Physicians recommends colonoscopy, a visual examination of the rectum and the entire colon, performed in a hospital or clinic. If polyps are found, they can be removed during this procedure. This exam does not usually cause pain, although it can be uncomfortable. Patients are generally given medication through a vein to make them feel relaxed and sleepy. Double-Contrast Barium Enema (DCBE) or Barium X-Ray

This is an x-ray examination of the rectum and entire colon performed in a hospital or clinic. The patient is given an enema containing white dye or barium, followed by an injection of air. The barium outlines the intestine and enables the doctor or health professional to take x-rays of the lower intestine.

One disadvantage of the double contrast barium enema, however, according to the American College of Physicians, is that an abnormal examination will require subsequent colonoscopy. "Moreover, and in greater importance in our view, a barium enema may not detect large (>1 cm) adenomas in about 40% of cases. . In the United States, where colonoscopy is generally safe and accessible, the preferred strategy for evaluating a positive result on a fecal occult blood test is colonoscopy."

Who Should Be Screened For Colorectal Cancer?

· Since nine out of ten cases of colorectal cancer occur in people over 50, they should be screened on a regular basis from 50 on.
· People with a personal or family history of colorectal cancer, inflammatory bowel syndrome, diverticulitis or colitis might need to begin screening before 50.
· Women with a personal or family history of ovarian, endometrial or breast cancer also may need early screening.

What are the warning signs of colorectal cancer?

Warning signs can include:

· A change in bowel habits such as constipation or narrowing of stool
· A feeling that doesn't go away that you need to have a bowel movement
· Bleeding from the rectum or blood in the stool
· Stomach pain or decreased appetite

While blood in the stool can be a warning sign of colorectal cancer, it is often present in such small amounts at the early stages that it cannot be detected by eye. This is the reason for the growing popularity of the EZ Detect Fecal Occult Blood test.

Other sites relating to the March initiative are:

National Colon Cancer Research Alliance http://www.nccra.org founded by Katie Couric, Lilly Tartikoff and the Entertainment Industry Foundation.
The Eric Davis Foundation is planning a big event tied with the opening of the National Baseball League http://www.scorecrc.com/

http://WWW.GASTRO.ORG/drdan-colc.html

American Gastroenterological Association site's excellent education section on CRC, "Dr. Dan Talks To You About CRC" Dr. Dan is spokesperson for the Foundation and he is recommending CRC screening. The Digestive Health Initiative Colorectal Cancer Education Campaign

http://www.msnbc.com/news/195642.asp#BODY

MSNBC site about how regular screening can save lives.

http://www.msnbc.com/modules/quizzes/0910_coloncancer.asp

What's your risk for colon cancer?

Take our quiz to find out

http://www.drkoop.com/news/focus/september/colon_cancer.html

drkoop.com editorial on Saving Lives By Screening For Colon Cancer

http://cis.nci.nih.gov/fact/6_32.htm

National Cancer Institute Questions and Answers About Screening, Early Detection and Treatment for Colorectal Cancer

http://www.cdc.gov/cancer/colorctl/colorect.htm#top

Colorectal Cancer Prevention and Control Intiatives from the National Center for Chronic Disease Prevention and Health Problems

References

Cancer Facts and Figures 1999, The American Cancer Society

Landis SH, Murray T, Bolden S, Wingo PA, Cancer Statistics, 1998. CA Cancer J Clin 1998;48:6-29

Mayberry RM, Coates RJ, Hill HA, Click LA, et al, Determinants of black/white differences in colon cancer survival. JNCI 1995;87(22):1686-1693

Harvard Center for Cancer Prevention, Harvard Report on Cancer Prevention Volume I, Causes of Human Cancer. Can Causes Control 1996-7 (SI):7-15

Byers T, Levin B, Rothenberger D, Dodd GD, et al. American Cancer Society Guidelines for screening and surveillance for early detection of colorectal polyps and cancer. Update 1997, CA Cancer J Clin. 1997:47:154-160.

Ransohoff DF, Lang CA, Screening for Colorectal Cancer with the Fecal Occult Blood Test:A Background Paper, Annals of Internal Medicine 1997, V.126, N10, 811-822

Comparison of Self-Reported Fecal Occult Blood Testing with Automated Laboratory Records among Older Women in a Health Maintenance Organization. American Journal of Epidemiology 1999:150:617-21. (September 15, 1999)

Ransohoff DF, Lang CA. Screening for colorectal cancer with the fecal occult blood test: a background paper. Ann Intern Med 1997;126:811-22.

CDC. Screening for colorectal cancer -- United States, 1992-1993, and new guidelines. MMWR 1996;45:107-10.

Jack S. Mandel, Timothy R. Church, Fred Ederer, John H. Bond, Colorectal Cancer Mortality: Effectiveness of Biennial Screening for Fecal Occult Blood Jnl of the National Cancer Institute Vol. 91, No. 5, 434-437, March 3, 1999

Bresalier RS, Rothernerger D, The American Cancer Society Guidelines for Colorectal Cancer Screening: Have We Gone Too Far (Or Not Far Enough?) Gastroenterology 114:1341-1342, 1998

Levin B. Colorectal Cancer Screening:Sifting Through the Evidence J Natl Cancer Inst 91:399-400, 1999

Whelan, Elizabeth, American Council of Science and Health, Editorial:Saving Lives By Screening for Colon Cancer, http://www.drkoop.com/news/focus/september/colon_cancer.htm

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