Questions About Home Testing

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I am only posting the facts. Feel free to contact the manufacturer ITC (International Technidyne Corporation) directly at 1-800-272-1252 x282-Jay Patel. They will confirm what I have told you.

If you bought your cuvettes from someone who is not licensed to sell to patients and you have problems with your cuvettes you will not get technical support from ITC or from us!!! I am just looking out for your best interests.

Christina,

I truly understand not having insurance coverage. It sounds like you are also buying your cuvettes from a medical supply house. I can let you know that we are having a meeting with ITC about this issue and they will be cracking down on people who cannot sell to patients as this is against FDA regulations.
 
Hi Michele,

I appreciate the information you provide and have always been very pleased with QAS service. I do buy my supplies from you but my insurance Blue Shield of Ca. PPO denied coverage for the unit and supplies, so it can get very costly if one has to test often.

If it is illegal as you say, I would not want to get involved. If it's legit then it would certainly be of benefit to those of us who pay 'out of pocket'. I'm sure you can understand that. As always, we in this forum try to help one another with information and I'm sure the intentions were sincere and meant to be helpful.

Zipper
 
Christina

Christina

I just posted a little awhile ago under coumadin .under Leo's thread..and asked Al..why would anyone want to test more than 4 weeks. I pay $2.00 each but I do not want to run down to basement every 3 days and get a cuvette out because I THINK my INR may be off.Plus, I am leaving on a long trip Friday and do not want to take Protime with me.. Hoping to hear from him on my questions. Bonnie
 
I totally understand where you are coming from. I am just trying to give you the facts so I urge you to call ITC the manufacturer and talk to them. Thanks.
 
Michele:

Is QAS the only FDA approved source of supplies for individuals for the ProTime Microcoagulation monitor?

If an individual can not legally purchase cuvettes from a Medical Supply Company for $135, could that individual's doctor legally purchase the supplies for the patient? Does this have to be the physician who monitors the Coumadin? Could it be the individual's neurologist or the individual's neurosurgeon?

Since ITC is the only manufacturer for the cuvettes, and medical supply companies receive the cuvettes for sale to physicians, wouldn't ITC be required to provide support for problems. How would an individual, one who had not read your recent correspondence, know that the company would not stand behind its products for individuals?

I would truly like to know how an individual would know that this activity is illegal. Is there something in writing that might help me understand. Like others here, I have always been more than satisfied with QAS service. And, like others here, we pay for our own supplies. In a free market economy, one has every right to price shop. I wouldn't buy a garbage disposal without comparing prices. The same principle seems to hold with other purchases.

I would appreciate your help in understanding this. It is hard for me to grasp that supply houses can sell the same identical product, identical in every way, to doctors for 55% less than to individuals. And, if an individual purchases the product they are in violation of the law, and the manufacturer will provide no technical support????

Appreciate your assistance.

Blanche
 
Blanche,

I have stated in my last posts all the facts. Medical Supply Houses are licensed to sell to physicians. And physicians get that price for their cuvettes because they buy in volume to test patients in their office.

I just got off the phone with ITC and they state "if you buy your cuvettes from a facility that does not have a license to sell to patients they will not honor technical support for those supplies." We keep on file the lot numbers of all the strips that we send to our patients - information that is also available to ITC.

If you call some of these supply houses - ask them up front if they have a license to sell to patients. Anyone who is authorized to sell to patients would ask for a prescription to be kept on file for that patient in case of an audit from the FDA. Just like all prescription drugs there are guidelines that have been set by the FDA to be followed. And if companies don't follow those guidelines ITC will not want them respresenting their company.
 
Congrats to QAS

Congrats to QAS

I just felt the need to send an unsolicited congratulations and thank you to the entire staff of QAS. It is almost 3 years since I began to use the Pro-Time home monitor system. The instrument has been great and the support of the QAS staff has been great. They have been there through technical issues and through some thorny insurance issues and have come through every time. Thank you guys (and gals)!!
 
I agree with mbalfour - the home testing has been great. I had to go to the hospital for my blood tests because my doctors nurse stuck me 3-4 times to get blood, every time i came in. It was always a big production

I've got to believe that its cheaper for the insurance company in the long run. They initially rejected it, but my wifes persistance, along with help from QAS, changed their minds
 
Me too!!

QAS worked very hard to get my Pro Time covered by insurance.

I called them lots about the status of my claim and they were ALWAYS patient and polite and most helpful.

The paperwork they did was remarkable.

The machine is a Godsend. I can't imagine being without it.

I have used two labs for double checking my machine and both came in with a difference of .6.

Blue Cross C to C has covered 80% thanks to QAS and their persistence.

Also, I hope to remain on the AVR list even tho I don't post too often. Too tired after 12 hour work days but have to say since my AVR I have never felt soooo good.

Thank you all for pulling me through this.

Donna
 
Too expensive for me

Too expensive for me

I tried along time ago, I think just after surgery to obtain a protime and my insurance just would not cover it. I wrote letters, appealed and did everything I could think of to get some help from my ins. co. but to no avail. I just can't afford to outright buy one of these machnes and I can't imagine the cost of supplies out of pocket for the rest of your life. So I'll just be a lab rat I guess. But to those of you who do have ins. coverage I congratulate you on finding the lowest price possible. Right or wrong, it has come down to the bottom line for all of us who have any medical condition. I heard just tonite on cnn that the gov.s medical perscription plan will be outdated in 2006 because of the 20% rise of medical costs in that period of time. Talk about the fleecing of america. I'll stop there and climb down, I think we all know the cost and how exagerated it is, for whatever reason. So back to the point any of you who can lower your cost I applaud you. A wise man said once a penny saved is a penny earned. Any way you get it. $135 versus $300 I know which way I'd go.

Good health and live long and prosper !!
 
Boomer: Let QAS help you

Boomer: Let QAS help you

Boomer:
Contact the folks at QAS and let them help you get the machine covered. If it is at all possible, they will be able to make it happen. Good luck.
 
Manny

Manny

Been there done that. They sent an appeal to the ins co. after they filed the paper work the first time. And to be honest that was it, I got the feeling that they just did want to fool with me. Too much hassle. You know too many other cases that were easier too get handled. So that's ok I'll just be a lab rat for the rest of my life.
 
Michelle, can you provide additional information regarding QAS's position that it is "illegal" for other venders to sell protime supplies to individuals. I do understand your statement that your price is higher because QAS adds in the cost of technical support into the product however there will be individuals who are of the opinion that they will waive customer support in favor of a much lower per unit price. What specific laws are other vendors breaking by selling the required supplies for products they sell. I am not asking about contractual arrangements or marketing practices but specifically your comment regarding the term "illegal."
 
Appeal process

Appeal process

Our insurance department works with patients on trying to get their monitor covered. We usually will go through the appeals process twice. There are a lot of factors that have to be considered each time we go through an appeal. We will have to get additional information from the patient and they have to contact their insurance company to see what kind of time line they have to do an appeal and if a provider can do the appeal process for them. There are usually additional letters that have to be written from your doctor and the patient as well. There are also variables as to why the monitor was denied. If you would like to contact me directly I can pull your file and see if we can do anything else for you. Please call me at 1-800-298-4515, x 2616.
 
Dick,

I think I was confusing in previous posts. Cuvettes are FDA controlled just like a prescription drug - and they need a prescription. If your friend sold you a prescription drug and was not licensed to do so wouldn't that be illegal? A vendor that is selling cuvettes to patients would be licensed from the manufacturer to do so and would be asking for a prescription to keep on file for the FDA.

We don't include any additional costs in our cuvettes for technical support. We pride ourselves on our customer service. According to the FDA and manufacturer guidelines, we HAVE to provide technical support for all our customers.

The manufacturer has set the price for the cuvettes at $12 each for patients. We are a distributor not the manufacturer.

If you have any other concerns, please call me at 1-800-298-4515, x 2616.
 
Hi Dick,

I remain confused on this issue as well. I have spoken to vendors (which will remain unnamed) that assure me they are not violating any FDA regulations by selling supplies such as cuvettes. They, however state they do not sell the units (machines) to individuals as they are only allowed the sale of those to physicians.

I buy my supplies from QAS and have no problem with them at all. I have received excellent service. Of course I have no objection to saving money if possible and legal.

I would like to hear from any others that have spoken/contacted any vendors and what info they were given. I hope people aren't avoiding posting anything they've learned. We all need to have definitive answers in my opinion.

Zipper :confused:
 
Michelle,

Regarding your statement that the manufacturer sets the price at $12.00 for patients, I gather this is a different price than that for a physician. Is this correct?

Most venders who sell over the web really do not make a distinction between the two. For example, I found a vender and verified via phone that they would sell me any of the below items at these prices. I cut and pasted this off their site. I explained that I was an individual and did not have a PX and they were eager to accept my money. The price below is a little less than $5.00 per cuvette.

Description Item# Quantity Price
Pro-Time Microcoagulation System $1499.00
Pro-Time 3 Cuvettes 1 bx. of (25) $123.00
Pro-Time 5 Cuvettes 1 bx. of (25) $123.00


The whole process took less than 5 minutes. As many people who use any of the machines on the market, most are interested in the price of supplies, especially individuals who can not file through their insurance.

While QAS may feel these companies should not sell to individuals at lower prices than QAS, if they do, people will utilize their services.

Michelle, I am not picking on you. People are curious to know if there are alternatives regarding Protime units and related supply sales over the web.
 
Supplies

Supplies

Hello Everybody, it's been awhile since I posted, but I have been keeping up with reading them. So I am going to try to defuse and inform all on the subject of purchasing patient monitors and supplies.

Everyone remembers that when they first needed their instrument we needed to get a Rx from your physician. Also, the Rx had to say Supplies either lifetime or ongoing. This is, of course, on file for the FDA at our Corporate Location. We have never or will never sell these FDA-regulated Supplies to anyone without having a Rx on file. Without the Rx you're not purchasing from us unless it's going to a Clinic or Dr's Office, Lab or Health Care Facility - it's not a matter of just showing us the money. We know what the FDA and manufacturer mandates of us. If a company who is not licensed with the manufacturer sells these items to patients they are in jeopardy with the FDA & Manufacturer. Fines can be levied & a loss of their Distribution Rights could be mandated by the Manufacturer. This does become a catch 22.

Some of you remember how cheap I am, in Vegas I was using Bus Transfer tickets to go back and forth from the strip to downtown. So I understand the need to save money. We have worked hard without great reward for the past six years, developing procedures and laying groundwork for Insurance Companies to cover the Instrument for all Patients. We have been moderately successful with these Institutions.

So now that home testing is more common, the Regulations are still in place. There are several web sites that tell you this and even have two disclaimers saying they can only sell to professionals (http://www.newlinemedical.com/Pro-Time_system.html). This is exactly what ITC requests of their other Distributors that are allowed to sell Professionally.

There will always be people in business looking for loop holes till they get busted. Sometimes it takes longer than others.

We care about our patients. We have successfully worked with millions of special circumstances. We are not looking towards Sainthood here, like any business we strive to be profitable. But don't be mad at us if we go after the Business' that are nipping at our structure without the proper credentials.

Brian Woodard aka Woody
Sales Manager
 
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