1	Direct Access Testing The Clinical Laboratory “Goes Retail”
2	Consumer-Driven Health Care
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4	Consumer-Driven Health Care Drug companies have spent untold millions of dollars in advertising to plant the notion that you should have a say in your health care. They continue to spend millions to reinforce that notion and to build a constituency of empowered patients who demand certain drugs. These people are also more likely to search the Web for health information, get a CT scan, take vitamins and order lab tests on themselves.
5	Today’s health care consumers - - want to play a more active role in monitoring and maintaining their health - are willing to spend their own money - are increasingly educated and sophisticated in their understanding of health issues - have easy access to health information through the Web – WebMD gets 16 million visits per month Lab Tests Online gets 250 thousand visits per month
6	There has been a dramatic increase in direct providers of health products and services. CT and Ultrasound health screening Pharmacies – expanded scope of practice Health Food Stores and Grocery Stores Corporate wellness programs Health Fairs Home test kits and mail-in test kits Direct access testing
7	Home Testing Kits
8	Mail-In Test Kits
9	Direct Access Testing Consumers order laboratory tests directly from laboratories, pharmacies and other providers such as health fairs and health food stores. Consumer pays up-front, in a cash transaction. No insurance billing. Report goes directly to the consumer.
10	What are the major medical issues with Direct Access Testing? Over-utilization: ordering tests that are not necessary False reassurance from normal results Concerns that lab test results will be viewed as a substitute for a full medical evaluation by a physician
11	DAT Changes the Basic Business Relationship Traditionally, commercial laboratories have operated on a business-to-business level with hospitals, clinics and physician clients. With DAT, laboratories do business directly with customers. DAT is a retail business.
12	Business Models for Direct Access Testing Stand-alone, dedicated direct access testing laboratory Additional product line for a conventional commercial laboratory Brokerage model: Internet site contracts with commercial laboratory to draw blood, perform testing, etc.
13	Federal Regulations None, at present, since no federal programs are billed No federal restrictions on test ordering or receiving test results Federal government defers all decisions to the states But CLIAC is snooping around…
14	State Regulations on DAT Regulations -- if any -- vary widely from state to state 20 states and the District of Columbia have virtually no restrictions on DAT 12 states and Puerto Rico have some limitations on DAT 18 states prohibit DAT State regulations are changing California and New York -- recently relaxed DAT regulations
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16	"Demand:" Demand: A needed service for the growing population of health care consumers Utilizing existing infrastructure minimizes start-up and operational costs New revenue source / Retail pricing / Cash payments minimize billing costs Routine testing only / No STATs
17	CASE STUDY: Pathology Associates Medical Laboratories launches Results Direct, a direct access testing venture in the state of Washington. One and a half years later, “Howzit goin?”
18	The Results Direct Team Rosalee Allan, CBO, Chair Thomas Allerding, MD Medical Director Greg Cobb, IT Gary Gemar, Laboratory Operations Terry Kelly, Graphics Lawrence Killingsworth, PhD CSTO Matt Maynard, IT Dave Michaelsen, Toxicology Karen Miller, Customer Services Cathy Smalley, Customer Service Centers Juliette Wyatt, LIS
19	Consumer Survey Results: “How likely would you be to use the service?”
20	Survey Results: “For what reasons would you be likely to use the service?”
21	"Common medical tests," Common medical tests, with public understanding and “name recognition” Tests for a wide range of common medical conditions Automated tests that can be offered at reasonable prices with rapid turn-around time
22	"Allergy panels / inhalants and..." Allergy panels / inhalants and foods Complete blood count Blood type Cardiac lipid panel Cardiac risk comprehensive panel Chemistry survey Diabetes screen and diabetes management panel Men & women’s health panels Hepatitis A, B & C tests
23	"Mononucleosis" Mononucleosis Occult blood (take home) Pregnancy test (serum) Prostate-specific antigen Testosterone Thyroid panel Urinalysis Urine drug screen (take-home) Urine drug screen (central lab testing)
24	"Hemoglobin A1c as a separate..." Hemoglobin A1c as a separate test Blood count screen: WBC, RBC, hemoglobin & hematocrit hsCRP as a separate test Total estrogens (estradiol + estrone) GC/Chlamydia urine testing (Aptima) Discontinue reporting absolutes on the CBC
25	"Customers can choose to have..." Customers can choose to have reports mailed to them or they may pick them up at the Service Center. (Results Direct customers have shown little interest in Web-based reporting.) Results Direct will not send a customer’s results to their physician. Each test result is accompanied by a brief narrative about its clinical application. Critical values will be phoned directly to the customer by the Medical Director.
26	"Comment for All Reports:" Comment for All Reports: Lab tests provide useful information, but are not a substitute for a full medical evaluation. Results within the reference (normal) range do not ensure health. Results outside the reference range may not indicate disease. Results Direct recommends you consult your physician to discuss your test results as a part of a complete medical examination. If you are interested in more information about lab tests, Results Direct suggests the following website: http://www.labtestsonline.org.
27	"Develop key messages" Develop key messages Lab tests you can order Convenient, Simple, Confidential Deliver key messages to the public Media relations campaign // TV, radio, newspaper stories about Results Direct Newspaper advertising Direct Mail Target marketing // health clubs, athletic events, etc. Web site Signage on PAML courier cars Results Direct Brochure
28	"Direct access testing has had..." Direct access testing has had minimal / no negative impact on relations with PAML’s physician clients A few physicians are concerned that DAT is another encroachment on their practice Concerns about over-utilization Concerns about false reassurance Malpractice concerns Most physicians accept DAT as an inevitable progression of consumer-driven healthcare
29	"Results-Direct web site (www.results-direct.com" Results-Direct web site (www.results-direct.com) Home page with instructions on how to use Results Direct, contact information, video tutorial and site navigation Frequently asked questions Customer service center information with maps Test menu with pricing and interpretive comments Applications for order entry, payment and reporting at customer service centers Financial Performance monitoring tools
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42	The Results Direct Story Order Entry Application Shifting into the retail mentality means the consumer service center must have an order entry product that functions much like a “cash register.” Web-based order entry technology allows us to take a Results Direct laptop to many different settings and take orders.
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50	So, howzit goin? Business is steady, but “don’t give up your day job” Changes have been made to meet customer needs The DAT software has been optimized to improve operations and add functionality Customer satisfaction is high Results Direct provides a needed health service directly to the public Physician acceptance is good
51	Who is using Results Direct? Most Results Direct customers are “Boomers,” in their 40s to late 50s Moderate to higher income bracket Consider themselves to be in good health Want to monitor their health and be in control of their health care
52	"Shifting to a “retail..." Shifting to a “retail mentality” Understanding the customer Customer-friendly Location, location, location Make changes when necessary Maximize the impact of advertising Efficient IT applications Comprehensive Test Menu Competitive Pricing
53	Crass Commercial Message Our experience with Results Direct has enabled us to develop a real-world, turnkey software package for Direct Access Testing. This package is commercially available for laboratories that want to get a quick start into Direct Access Testing, without the expense of developing their own retail-business software. Our friendly sales staff is waiting to talk with you in the exhibit area.
54	"Questions?" Questions?