January 2009

This month's headlines
 
IMDA, other associations join forces on input for Joint Commission. Supplier and provider organizations aligned with IMDA were poring over a document to submit to the Joint Commission as it works on an industry standard for vendor credentialing.

Affording employees’ healthcare is a challenge. How successful are you in keeping up the cost of health insurance for your employees? IMDA members weigh in.

Manufacturers toughen Code of Ethics. Your hospital customers may notice a drop-off in branded pens and Post-It notes, due to a tough Code of Ethics from AdvaMed.

Training on OR protocol available to IMDA members. Through a relationship with HealthStream, IMDA members have access to the ‘gold standard’ of training.

Tough times? When the going gets tough, the tough turn it up, says IMDA sales trainer Gerry Layo in Part 2 of this series.

‘Boxing tenor’ featured in Repertoire magazine. Bay State Anesthesia’s Marcal Souto has an interesting story to tell, as the headline suggests.

Lawsuit against manufacturer tossed out. The suit against Medtronic was dismissed based on last fall’s Riegel v. Medtronic Supreme Court decision.
 




Marcal Souto


Vendor credentialing update
IMDA, other associations join forces on input for Joint Commission

Supplier and provider organizations aligned with IMDA were at press time poring over a document that they hope to submit to the Joint Commission as the latter continues work on an industry standard on the vendor credentialing issue. “It’s a slow process,” says IMDA President Shawn Walker of Bay State Anesthesia. “But I think the issue [that is, vendor credentialing] is here to stay. So it’s a matter of how manageable and how fair we can make it.”

Walker and IMDA member Bill Vitez of Tri-anim were instrumental in gathering together a number of organizations to coordinate their positions on vendor credentialing. Those organizations are the Healthcare Manufacturers Management Council (HMMC), Health Industry Representatives Association (HIRA), Health Industry Distributors Association (HIDA), Medical Device Manufacturers Association (MDMA) and Tri-anim. Together, they call themselves the Innovative Healthcare Access Coalition, or IHAC. (See September and October 2008 IMDA Update.) “We realized that we could accomplish more if we had more bandwidth, as opposed to fighting the good fight on a stand-alone basis,” says Walker.

“Our overarching concern is that vendor credentialing can and is being used as a mechanism to keep innovative medical products out of the supply chain,” she adds. “Our intent was to reach out to organizations that we felt closely reflected the same concerns.”

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2009 IMDA Annual Conference
June 14-16, 2009
Francis Marion Hotel
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Accordingly, IHAC’s initial thrust has been on vendor credentialing as it affects clinical reps. (Work on non-clinical reps will follow, says Walker, though in fact, the issues of who is a clinical rep and who is a non-clinical rep are intertwined.)

Representing IHAC, Walker has been in close touch with the Association of periOperative Registered Nurses (AORN) and AdvaMed as those organizations prepare their own statement on vendor credentialing. The end result, presumably, will be one document submitted to the Joint Commission on behalf of all the organizations mentioned above.

IMDA and its fellow IHAC members have long been concerned about the potential costs of vendor credentialing, particularly those imposed by vendor credentialing companies that charge suppliers on a per-hospital or per-IDN basis. But IHAC members’ concerns run deeper than that.

Vendor credentialing or vendor management?

“One problem is vendor credentialing’s ugly stepsister, vendor management,” says Walker. “The terms are being used interchangeably, but they’re really not the same thing. It’s not just ‘Did you have your [vaccination] shots?’ It’s turning into a management tool. Providers are monitoring who the sales reps saw, where they went and what they’re talking about. And our concern is that this evolution promises to stifle innovation.”

Closely related is concern about how information is being collected, how it is being stored, and what will be done with it, continues Walker. “We’re concerned about the bigger issue of privacy and the safety of our information, and making sure that any standard is do-able on a national basis from a legal perspective.”

Left unchecked, acute-care customers’ demands could lead to untenable situations for vendors, says Walker. For example, in a number of states, employers are legally prohibited from demanding that their employees get drug tests without probable cause. Yet some customers are demanding that vendors show proof of such testing. “We felt it was problematic to have a standard that reps in companies headquartered in seven states would not be able to adhere to,” she adds. While it’s likely the final document will still call for drug testing, it will reference the difficulty of obtaining such tests in certain states. “While we would have preferred to have the whole thing removed from the document, at least now, we’ll be able to provide some perspective as to why the drug testing issue isn’t so cut and dried,” says Walker.

Other concerns

IHAC members have shared other concerns with AORN, AdvaMed, AHRMM and the American Association of Critical Care Nurses. As a result, the proposed document ultimately intended for the Joint Commission has undergone some revisions.

For example, at press time, the organizations were leaning toward adopting a narrower definition of “clinical rep” as one who is in “the immediate vicinity of patient care.” Says Walker, “a clinical rep is not someone who’s visiting the OR in the middle of the night, or someone visiting the ICU but staying at the desk, or someone who goes into the OR but only to talk to the manager in her office.” In other words, not every sales rep who is in a clinical area should be considered a “clinical rep,” she says. A reclassification could lead to lower fees and less exacting credentialing requirements for reps who had previously been classified as “clinical.”

IHAC also suggested that the combined groups back off the requirement that all reps -- even those whose companies don’t stock products -- carry medical product liability insurance. IHAC preferred that the document submitted to the Joint Commission call for reps to carry product liability insurance only if they stock products. Otherwise, they should carry general liability insurance, says Walker.

“We weren’t necessarily expecting that all our recommendations would be completely endorsed,” says Walker. “But we wanted to make sure we were in alignment with organizations in the industry with the people and influence to have an impact on what the Joint Commission adopts. The most important thing here is getting visibility and influence in the industry. That’s something that IMDA alone isn’t built for.”

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Affording employees’ healthcare is a challenge

How successful are you in keeping up with the cost of health insurance for your employees? IMDA members – like all U.S. businesses – are struggling with that one. Yet they are doing what they can, according to several members who responded to a recent “Listserv” question.

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Stay in touch. . .
with IMDA's listserv.

Now it's easier than ever to electronically communicate with your fellow IMDA members. It's called a listserv, and it's up and running now. It replaces the electronic bulletin board. Simply write your message, address it to the IMDA listserv address (found in the "Members Only" section of www.imda.org)  and click "send." All your colleagues will receive the message. Plug into the power of IMDA through IMDA's listserv.


By way of perspective, the cost of healthcare to business has increased 140 percent over the past 10 years, according to Tom Daschle, the designated Secretary of Health and Human Services, in his 2008 book called Critical: What We Can Do About the Health-Care Crisis. Since 2000, the cost of premiums for employer-based plans has outpaced wage growth nearly fivefold, he says. Ironically, small-business owners (such as IMDA members) are the hardest hit, says Daschle. Because they lack leverage with insurers, they often end up incurring the highest costs.

The results are predictable: The percentage of Americans covered by employer-sponsored plans has dropped from 70 percent in the mid-1970s to 64 percent in 2000 to less than 60 percent in 2006. And those who work in small companies are feeling the brunt. “No wonder small-business employees are one of the fastest-growing segments of the uninsured, and now comprise about one-fifth of the total,” writes Daschle.

Caps on expenditures

When asked how they are addressing rising healthcare costs, several IMDA members responded that they are sharing the cost of premiums with their employees, sometimes capping their (that is, the business owner’s) contribution.

“We contribute a set amount to our employees -- $200 per month – and they choose the program,” says Don Reiter, president, SRC Medical, Northridge, Calif. Plans offered by SRC’s insurer, Blue Cross of California, vary based on a number of factors, such as the employee’s age, number of dependents, amount of deductible, etc. When premiums rise, employees either bear the increase or select a less expensive plan, he says.

SRC Medical instituted its current program five years ago. Prior to that, the company had relationships with several insurers, with no standard program. “We had minimal resistance per se,” says Reiter. “But some people had to then consider the cost of the program they were selecting, where they did not before. Additionally, we try to keep our employees informed on the increase in insurance, so they know we are not the bad guys.”

St. Louis-based Bell Medical has experienced 10 percent increases in premium costs for several years, says President Kevin Lueders. In response, the company has experimented with a variety of high-deductible and low-deductible plans. “We tried a high deductible, but people did not like it, so now we are at a $500 deductible,” he says. The company currently pays 50 percent of its employees’ premiums, as well as 50 percent of their premiums for disability and dental insurance.

“The nice thing about this is that [employees] share in the decisions on coverage,” says Lueders. “We also request from our insurance company that we have a high and low option, so if an employee wants to be more aggressive and bet that they would not use insurance, then they could go with a higher deductible and save money on a monthly basis.”

Professional employer organizations

Several IMDA members have turned to so-called “professional employer organizations” -- such as Administaff, Extensis, ADP and Gevity -- to help them deal with rising healthcare costs. And while they disagree as to which is the best provider of such services, they agree that PEOs can be a big help for small companies.

‘The nice thing about this is that employees share in the decisions on coverage.’

--Kevin Lueders

Professional employer organizations are firms to which small companies can outsource administrative functions, including payroll, workers’ compensation, hiring and firing, legal assistance as it relates to employee issues, and implementation of health and welfare benefits. In some cases, the professional employer organization and the client (such as an IMDA member) “co-employ” employees. In other words, the PEO not only takes on personnel administration functions, but it also assumes liability for payment of wages and payroll taxes.

Regarding health and other welfare benefits, professional employer organizations act like group purchasing organizations in that they use the combined volume of all the companies they represent to get better prices and better coverage than individual companies can on their own. At least that’s what they say. And IMDA members agree.

SOTA Medical Products Inc., Cedar Grove, N.J., has used professional employment companies for seven years, including Extensis, Administaff and ADP, says President Keith Lambie. “We have found it necessary to change to a new PEO almost every year, as health insurance rate increases have been substantial,” he says. Still, “[s]hopping a new PEO has helped keep our health insurance costs in line, and we have been able to provide the same benefits to our employees [without] changing or significantly increasing their portion of this expense.

“[PEOs] become your HR department, payroll, and you can purchase workers comp at many times better rates,” says Lambie. They will provide employee manuals and, if the client wishes, make certain the company is compliant with rules and regulations in case an employee must be terminated.

Lambie speaks freely about disagreements he had with Administaff over unexpected charges and what he says was Administaff’s misrepresentation of the out-of-network benefits of its health insurance program. “The one thing that is important in selecting any PEO is to ask the right questions,” he says.

Kevin Trout, president of Grandview Medical Resources Inc. in Bridgeville, Penn., has enjoyed a much better relationship with Administaff since becoming a client soon after attending his first IMDA conference in 2001. “They solved a lot of my employee headaches,” he says. “They provided us with an employee handbook, which we tweaked; they provide us with significant help on recruiting by doing pre-hire background checks; they handle all of our unemployment claims from people we fire; and, much to my surprise, they provided legal representation for us at no charge in a bogus employee lawsuit.”

More to the point, “Health insurance is offered at rates significantly lower than what I could get on our own,” says Trout. “Our workers’ comp premiums dropped 40 percent when I signed on with them. At one point last year, we began looking at going it alone without them, comparing costs per service, and we determined it would actually cost us more money to leave them.”

Meanwhile, Dave Campbell, president of Centennial, Colo.-based Vital/Med Systems Corp., is another user of professional employer organizations. “We have used Administaff with success in the past, and switched to Gevity a few years ago because the insurance plan was less expensive overall,” he says.

IMDA offering?

One IMDA member – Candace Keaton of MarCal Medical Inc. in Millersville, Md., questioned whether IMDA could negotiate for a policy on behalf of its members. It has been tried in the past, but unsuccessfully, says IMDA Executive Director Katie Swartz. That said, she is in discussions with a broker about the possibility.

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Manufacturers toughen Code of Ethics

Your hospital customers may soon notice a drop-off in the number of branded promotional items – pens, Post-It pads, mini-calculators – given to them by the manufacturers who call on them. That’s because AdvaMed, the Washington, D.C.-based association of medical products manufacturers, has toughened its Code of Ethics.

IMDA Announcement
Looking for lines?

View a list of all medical devices receiving FDA marketing clearance in December by visiting the
FDA Website.
You might find a company in need of your expertise.


The changes, announced in December, are set to become effective July 2009. AdvaMed members that adhere to the revised Code are encouraged to submit to AdvaMed an annual certification to that effect. AdvaMed will publish that information to its Website, so customers can view who’s onboard.

The new Code allows sales reps to provide “modest meals” as an “occasional business courtesy in connection with business interaction with [healthcare professionals] that involve the presentation of scientific, educational or business information.” That includes substantive discussion of pricing or other contract terms. But the meals may only be provided to professionals who actually attend the meeting. “No meals for office staff where everyone does not attend,” says the Code. “No ‘dine and dash’ or take-out.”

Gifts of modest value are OK, but only if they benefit patients or serve a genuine educational function. No more non-educational, branded promo items, even if they are minimal value, such as pens, mugs, etc. No more scrubs or office supplies either. And no more cookies, wine, flowers, holiday gifts, etc.

Among other provisions:

  • Training on medical technologies or techniques must be conducted “in a setting that is conducive to the effective transmission of information.”

  • Vendors may provide grants and sponsor meals and speakers for professional conferences or organizations, but they “should be modest in value, subordinate in time and focus to the purpose of the conference, and clearly separate from the CME portion of program.”

  • Vendors may continue to pay consulting fees or royalties to clinicians who help them develop technologies. But the company must write down its criteria for such arrangements, and “[c]ompensation should be consistent with fair market value….”

  • Vendors can provide single-use products or capital equipment for the healthcare professional to evaluate. But the number of single-use products must not exceed the amount “reasonably necessary for the adequate evaluation.” And multiple-use products “should be furnished only for a period of time that is reasonable to allow an adequate evaluation.

At the request of the IMDA board, IMDA legal counsel Mitchell Kramer is investigating whether IMDA should adopt its own Code of Ethics. Expect an update at the Annual Convention in June in Charleston, S.C.

In the meantime, to read more about AdvaMed’s Code of Ethics, go to http://www.advamed.org/MemberPortal/About/code/.

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Training on OR protocol available to IMDA members

For years, IMDA members calling on the OR have been expected to demonstrate their knowledge of OR protocol, including aseptic technique, HIPAA compliance and bloodborne-pathogen regulations. Today, with vendor credentialing companies in the mix, the barriers to entry in the OR are higher still.

Did you know that for close to seven years, IMDA members have had access at special reduced rates to the “gold standard” for training on OR protocol – a series of online training courses provided by HealthStream?

Using guidelines drawn up by the Association of periOperative Registered Nurses, or AORN, HealthStream has provided training to more than 10,000 reps who call on ORs around the country. Upon completion of the course, each rep receives a wallet-sized card provided by AORN and HealthStream. That card is a door-opener.

So don’t leave home without your own HealthStream/AORN card. Enroll yourself and your sales reps in HealthStream’s RepDirect program. To learn more about the program, visit www.healthstream.com/products/sts.htm. To enroll, go to the “Members Only” portion of the IMDA Website (www.imda.org) and scroll to the box on “Surgical Environment Training.”

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Part 2
Tough times? You need to REFUSE to lose!
When the going gets tough, the tough turn it up. What will you do to refuse to lose in 2009?
By Gerry Layo

Gerry LayoEditor’s Note: In this month’s issue, Gerry Layo covers the final three letters of the acronym “REFUSE.” See last month’s issue for “R,” “E” and “F.”

When times get a little tough in selling, we often hear of some people (myself included) stating that they “refuse to participate in a recession.” As a matter of fact, this has been said so often that it is becoming a bit cliché.

We do, however, need to REFUSE some of the things that hold us back during tougher economic times. We do need to REFUSE to suffer mediocrity from ourselves or our people. We do need to REFUSE to drop our prices but instead raise the bar on our value. We need to REFUSE to let our customers get a better experience buying from a competitor. We need to REFUSE to lose! It is in this vein that I thought I would lay it out, as I often do, an acronym that I designed for a recent keynote address in Phoenix.

U’ stands for ‘understand’

In a down economy, you need to understand several things better than ever. Doing so will increase your ability and potential to stand out, add value, and become a partner in the mind of your customers. Here are a few:

  • Understand your customer’s needs of today. They don’t need to buy from you! What they do need to do, however, is use your product or service to help them accomplish something. What is that, and is it possible that their reason for buying today is less pressing than it was in the past?

  • Understand your value. What is it that you add to your customer’s business today? Do they know it? If all you bring to their business is your product, don’t be mad if all they want to talk about is your price!

  • Understand what’s coming. The current challenges of our real estate and financial markets are the result of things that have occurred for many years. The new reality will be tough to deal with and will require an adjustment in thinking and thus, behavior. The same is true of your sales efforts. The fruit is no longer hanging low in the tree, so you need to understand (or learn) how to climb!

‘S’ stands for ‘service’ (plus ONE)

Meeting the customer’s needs today is, quite frankly, the bare minimum to simply be invited to the game. Too many companies throw around the word “service” so much that we have become numb to it. In fact, when companies are forced to “tighten their belts,” it is often the little extras that get pushed to the back burner exactly when we need to be offering them.

If all you bring to their business is your product,
don’t be mad if all they want to talk about is your price!


We need to focus strongly now on every touch point that our customers experience when doing (or trying to do) business with our companies. We need to offer a Nordstrom level of experience that gets our customers saying WOW! We need to earn the right for them to come back and continue to show us their loyalty. To get that, we cannot be a little better than our competition; we have to be head and shoulders better!

Today, not tomorrow, make an inventory of every customer touch point in your organization. At every one of these points, does the customer feel important? Do they feel loved and appreciated? Do they feel like they matter? Sharpen up EVERY customer experience by paying attention to every customer interaction. Focus on PEOPLE, PROCESS, and POLICY!

‘E’ stands for ‘earn it!’

Remember, unless you actually work for the US Mint, you do not MAKE money! You have to EARN profits, EARN margins and EARN commissions. The work you performed yesterday may not be enough to get you where you want to go today. It may take a little more effort, but it may not require working (that is, selling) harder, but rather working (selling) smarter!

Look in the mirror and be truthful with yourself. Today, more than in the past several years, this is absolutely imperative. As our customers and clients face challenges that are causing them problems, ask yourself if you truly ADD VALUE to their lives or simply TAKE from them? (Take their time, take their orders, take their money….) Here’s a question that you may wish to consider: “If you had to sell for 20 percent more tomorrow, what would you do different to earn it?

We need to REFUSE to LOSE as we head into 2009. We need to refocus our attention on offering more and better things in the marketplace if we are to continue to survive and grow.

Gerry Layo is CEO of Sales Coach International, Granite Bay, Calif., which – through speaking engagements, workshops and extended coaching/consulting engagements – is dedicated to helping companies in the areas of sales, sales leadership and customer service. He conducted two IMDA training seminars in 2008. He may be reached at www.gerrylayo.com.

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‘Boxing tenor’ featured in Repertoire magazine

Marcal Souto, a sales rep with IMDA member Bay State AnesthesiaMarcal Souto, a sales rep with IMDA member Bay State Anesthesia, was featured in the “Rep Corner” department of the December issue of Repertoire magazine. “Rep Corner” features field reps who have interesting backgrounds or avocations. And Souto has both. Not only is he a first-class sales rep, but he is an accomplished tenor and former boxer who still does some training.

Growing up in Yonkers, N.Y., Souto was attracted to boxing. He joined classes and enlisted the aid of professional trainers, and began entering fights sponsored by the Police Athletic League. Today, he trains other boxers.

Boxing calls for a constant balance of mental strategy and physical agility, he told Repertoire. “Boxers are constantly moving and thinking,” he says. They’re also hurting. “Even when you are injured, you still have to fight. If you don’t go into a fight believing you’ll win, you don’t fight.

“Boxing is one of the purest sports there is. It’s just you and the other guy.”

Prior to boxing, Souto had another interest – music. He started out playing various instruments in school, then asked his mom if he could take voice lessons. “I experimented with my voice and discovered I could hit the high notes,” he says. “When boomboxes came out, I was the only one playing opera. But by then, I was such a good fighter, no one gave me a hard time!”

Eventually, Souto was good enough to audition for – and join – the Masterwork Chorus, an acclaimed New York group, which has performed Handel’s “Messiah” during the Christmas season close to 250 times – 110 of them at Carnegie Hall. Souto was with Masterwork Chorus for about 10 years. Although he has stopped singing on a regular basis, he continues to sing at weddings and church.

“To prepare for a performance, I would practice and vocalize for several hours daily, for three months,” he notes. “I would have to learn the phonetics of a language and how to interpret the music. I’d also have to work with the conductor on the tempo. When cold season came around, I’d really have to be careful,” he continues. “I wouldn’t shake anyone’s hand.”

Souto worked in the X-ray, pharmaceutical and medical imaging markets, and started his own X-ray film business in 1996. He and his wife and child lived in the Gateway Plaza residential complex, literally across the street from the World Trade Center, when the building was attacked on Sept. 11. The building was condemned, and Souto not only lost his personal belongings, but his business too. Years later, he joined Bay State Anesthesia.

Souto believes the skills he acquired through boxing and performing laid the groundwork for his ability to survive his later experiences. “When I’d get in the boxing ring, I would rely on my personal skills to survive,” he says. “When I’d walk on stage at Carnegie Hall, I would rely on my personal skills to do well. During 9/11, I depended on my personal skills to think clearly.” Today, these same skills enable him to talk to work well with his customers, he adds.

Editor’s Note: Got a field rep with an interesting background or avocation, who might make for an article in Repertoire? Send an e-mail to Mark Thill, IMDA communications director.

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Lawsuit against manufacturer tossed out
Last year’s pre-emption ruling cited

A federal judge threw out a lawsuit in January against the manufacturer of a device that most likely led to the deaths of at least five patients.

U.S. District Judge Richard H. Kyle in Minneapolis dismissed a suit against Medtronic involving its Sprint Fidelis defibrillator lead on the basis of last winter’s Riegel v. Medtronic Supreme Court decision. (See May 2008 IMDA Update.) In that decision, the Court held that once a medical device has premarket approval by the FDA, federal law bars many types of claims by users of medical devices that challenge the safety or effectiveness of the device, its design or its label.

The Sprint Fidelis lead had been surgically implanted in 268,000 patients worldwide when Medtronic concluded it was fracturing at a higher rate than that of its predecessor, the Sprint Quattro, according to a report in The Wall Street Journal. In October 2007, the manufacturer reported that five patients’ deaths were possibly caused by the wire’s fracture.

Medtronic Chief Executive Bill Hawkins was quoted as lauding Kyle’s decision for supporting "the principle that the U.S. Food and Drug Administration is the appropriate body to determine the safety and efficacy of innovative technologies."

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IMDA Update

Published by IMDA
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Staff

Katie Swartz: Executive Director
Judy Keel: Executive Vice President
Patti Perillo:  Senior Administrator
Mary Moran:  Chief Financial Officer

Mark Thill, Editor & Communications Director (847) 255-0716

Mitchell Kramer, Legal Counsel (800) 451-7466
Barbara Kramer, Legal Counsel (734) 930-5452

George Ayd, Jr., Insurance Administrator
(703) 652-1309

 

 

 

 

2009-2010 Directors

President
Kevin Trout, Grandview Medical Resources, Inc.
(412) 914-0950

President-Elect
Anthony Marmo, Martab Medical (201) 512-1100

Secretary/Treasurer
Hal Freehling, Jr., O.E. Meyer Company (419) 609-1633

Chairman of the Board
Dave Campbell, PhD, Vital/Med Systems Corporation
(303) 660-0888

Directors-at-Large
Tom Birmingham, Bay State Anesthesia, Inc. (978) 682-6321
George Howe, Mercury Medical (727) 573-0088
Philip M. Reilly, KOL Bio-Medical Instruments, Inc.
(703) 378-8600
Don Reiter, Specialty Respiratory Care, Inc.
(818) 717-8807 x19
Bill Schultz, IPV Medical, LLC (760) 212-2769

Past-President
Shawn Walker, Bay State Anesthesia, Inc. (978) 682-6321

Manufacturer Representative to Board
Tim Beevers, Beevers Manufacturing & Supply
(503) 472-9055

The ideas presented in this newsletter may or may not be applicable to your particular situation.  Always consult your tax advisor, attorney or CPA before putting them into effect.