DENIED!!!! CoaguChek XS

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I haven't read all the replies but I was wondering if you have the dosing chart I've seen recommended here--perhaps if you showed that to your doctor it might be more evidence that you have carefully thought this out?
 
Susan, Freddie is not even asking to be self dosing....she just wants to be able to take her own blood samples in her own home without a vein draw. But thanks for the reminder about the chart, it's a very helpful tool to have on hand.:)
 
Great article Blanche. Bless you for finding this! It's free to register to the site, but in case anyone doesn't want to do that. Here is the article.

Interview: Jack Ansell, MD
Professor of Medicine
Boston University School of Medicine
Vice Chairman for Clinical Affairs
Department of Medicine
Boston University Medical Center
Boston, Massachusetts

Medscape had the opportunity to discuss laboratory and office-based anticoagulation monitoring with Jack Ansell, MD, Professor of Medicine, Boston University School of Medicine, and Vice Chairman for Clinical Affairs, Department of Medicine, Boston University Medical Center in Boston, Massachusetts. Dr. Ansell is the founder and past president of the Anticoagulation Forum.

* Please review the evolution of point-of-care anticoagulation testing. What have been the major advances in this field?
* What are the potential clinical benefits/outcomes of point-of-care patient testing?
* In Europe, the approach of self-testing and self-management is well accepted. Do you see this approach being more widely utilized in the US?
* Anticoagulation clinics have had a major impact on managing anticoagulation treatment. Describe the role they have played over the last 10 years and the challenges they have faced.
* Are there specific outcome data (clinical, economic) to reinforce the benefits of either of these approaches (anticoagulation clinics or physician office testing) over routine laboratory measurements?
* The demands of our population for anticoagulation testing will continue to grow with the "graying of America." What does the future hold for anticoagulation treatment and management?


Please review the evolution of point-of-care anticoagulation testing. What have been the major advances in this field?

Dr. Ansell: As we look at the evolution of point-of-care testing, this modality of care started in the mid 1980s with the development of instruments that were able to perform a prothrombin time test from a finger stick sample of blood near the patient instead of sending a venous blood sample to the laboratory. The first instrument became available in 1986 or 1987 and quickly thereafter clinical studies were initiated to determine the value of these instruments as well as their accuracy and precision. At the same time, the instruments began to appear in physicians' offices and to a very limited extent in patients' homes for self-monitoring.

From the late 1980s up to the present time there has been, unfortunately, a slow uptake of point-of-care monitoring in the United States as it pertains to home monitoring of the international normalized ratio (INR), or prothrombin time. However, there is extensive use of point-of-care anticoagulation monitoring in physician offices, anticoagulation clinics or other sites.

The major advances in the field of point-of-care testing involved the publication of clinical studies to demonstrate the effectiveness of this type of testing either in the physician's office or at home and the outcome of greater time in the therapeutic range.

In addition, over the last 20 years, there have been advances in instrumentation. Instruments manufactured today are considerably better than those that were first produced, in terms of their ease of use, electronics, visibility of the results and the ability of patients to use these instruments. In addition, they have been shown to be accurate and precise in their ability to measure an INR.

Lastly, I think the last major advance has been the overall impact on anticoagulation monitoring, whether it's in the physician's office, an anticoagulation clinic, or at home. Because of the accessibility to results immediately as well as the ability to determine an INR frequently, there is better care, fewer adverse events, and greater time in therapeutic range. And because of its impact on the overall outcomes of care, I believe it has led to a reduction in the overall cost associated with anticoagulation care.


What are the potential clinical benefits/outcomes of point-of-care patient testing?

Dr. Ansell: The potential benefits of point-of-care testing in the physician's office has to do with the ability of these instruments to facilitate a process of systematic anticoagulation monitoring, ultimately leading to better outcomes.

Having an instrument allows the physician to have immediate access to results with a patient sitting right there, enabling immediate discussion of the results and instruction to the patient on the next dose of oral anticoagulant. This leads to better patient/physician communication and ultimately to more time in therapeutic range.

There's also a certain degree of patient empowerment that comes from observing these results and discussing them with a physician as they occur, which also helps to enhance compliance and outcomes. Ultimately this type of care also will reduce some of the work in a physician's office by eliminating the need to track down results from outside laboratories. In some cases the physician never gets the results, and that leads to problems. Not needing office personnel to make multiple calls to laboratories or to patient homes, not having to give instructions in dose changes over the phone and be concerned about that the patient understands or doesn't understand the changes, all emphasize the benefits of point-of-care testing.

For the physician's office, there are economic and clinical studies that have been done to show that overall the cost of care can be reduced, again primarily by improving outcomes and reducing adverse events. The cost differential is beneficial when you consider the time required to interact and call back the patient with results from the laboratory compared to having a brief face-to-face encounter and an immediate turnaround of results with a point-of-care monitor.

Overall, in the physician's office, I think that point-of-care monitoring really leads to better care and to better outcomes and facilitates a more systematic process for managing these patients.


In Europe, the approach of self-testing and self-management is well accepted. Do you see this approach being more widely utilized in the US?

Dr. Ansell: At home, where patients have greater access to INR measurement, they can monitor their INR on a more frequent and timely basis - timely meaning that when they think they may have done something to alter their INR they can simply check their INR. It gives the patient a certain degree of freedom. It improves quality of life and patient satisfaction. And also consistency of instrumentation is important, because in the real world patients often go to different laboratories, a hospital laboratory, a private laboratory or elsewhere and they're using different reagents and different instrumentation to monitor their INR. When a patient has an instrument at home, it's a consistent instrument and reagent combination, which I believe leads to better care.

Patient self-monitoring is something that is suitable for the majority of patients -- not every patient, but the majority of patients, and this has been demonstrated through various studies to date. Patients are able to do a finger stick and monitor their own prothrombin time. For patients to actually manage their own dosing at home, that's a slightly more limited population, but still a majority of patients should be able to do that.

In the United States, this model of care has been very slow to develop. The principle barrier has been reimbursement and approval by Medicare, which sets the standard for other third party payers.

Patient self-testing was not approved for reimbursement by Medicare until the early 2000s, and then it was only for patients with mechanical heart valves who had been on an anticoagulant for at least 3 months, not for the large majority of patients who have atrial fibrillation or other problems.

Right now it is estimated that there are perhaps 10 to 20,000 patients in the United States that are performing patient self-testing at home. This really represents less than 1% of the estimated population of patients on warfarin at the current time in the United States.

In Germany, where self-monitoring and management are really involved with about 25% of the anticoagulated population, over 130,000 patients are doing self-management and monitoring; the factor that made the difference there was probably the early reimbursement for self-monitoring.

But now, with the continued growth in the use of oral anticoagulants, the aging of our population, and the increase in atrial fibrillation and other indications for anticoagulants, there has been a small resurgence in interest and desire to do point-of-care testing at home.

I do see that this type of care and management of anticoagulation will grow over the next several years to reach at least several percent of the affected population in the United States.

Anticoagulation clinics have had a major impact on managing anticoagulation treatment. Describe the role they have played over the last 10 years and the challenges they have faced.

Dr. Ansell: Anticoagulation clinics are by no means new. They've been around since at least the 1960s, if not even a little earlier. Their popularity really started to develop in the 1980s and especially in the 1990s, coincident with the growth of use of oral anticoagulants and particularly for atrial fibrillation.

Anticoagulation clinics have benefited the patients on anticoagulants by better management of dosing and better communication and education of the patients than in what might be called a routine model of care, where a physician manages a small group of his or her own patients on anticoagulants, but usually in a less systematic way, without policies and procedures and mechanisms in place to make sure patients are not lost. Anticoagulation clinics are dedicated to this one modality of care.

Anticoagulation clinic management has led to greater time in the therapeutic range, which again is the ultimate goal, and as a consequence fewer serious adverse events. Anticoagulation clinics also, because they take the burden off of the practicing physician, can ultimately lead to an increased percentage of the population on anticoagulants because anticoagulation care often is a fairly complex and labor intensive responsibility. So when you have a clinic that can do this with dedicated personnel such as a nurse or pharmacist, it allows a greater percentage of patients to be treated.


Are there specific outcome data (clinical, economic) to reinforce the benefits of either of these approaches (anticoagulation clinics or physician office testing) over routine laboratory measurements?

Dr. Ansell: There are a number of economic and clinical outcome studies that have been done to show the benefits of anticoagulation clinics. It is well documented in the literature that anticoagulation clinics achieve a greater time in therapeutic range for the patients they monitor compared to routine medical care, and that because of cost savings from fewer adverse events it improves the overall cost of anticoagulation care.


The demands of our population for anticoagulation testing will continue to grow with the "graying of America." What does the future hold for anticoagulation treatment and management?

Dr. Ansell: The future of anticoagulation treatment and management will continue on its current course with more patients being treated with warfarin over the coming years. The aging of the population is contributing to the increase in the number of patients with atrial fibrillation as well as other problems.

The one thing that will impact point-of-care testing and warfarin therapy in general is the development of new oral anticoagulants. There are currently more than a half a dozen new drugs in phase II and phase III clinical trials. These oral agents have predictable dosing, do not require monitoring, and are given on a once or twice a day basis. Based on preliminary studies, these agents are effective in preventing thrombosis. The real issue is are they as safe or safer than warfarin, particularly in any untoward side effects such as liver impairment, and are they better than warfarin in general.

It will take at least another 5 years or so to determine the results of some of the long-term studies in atrial fibrillation and other indications with these new medications.

I think the number of patients on warfarin will decrease, but there will still be a substantial population of patients on warfarin. There will be certain indications, such as patients with mechanical valves, who are not even being studied yet with these new drugs, that will continue to use warfarin and other anticoagulants.

So I think that warfarin and the need for anticoagulation monitoring will be around for many years to come and will probably never go away, but I think if these other drugs are successful, effective, and safe, that they will impact the population and the numbers who are taking warfarin.
 
Ahhh what a twit .....................

Ahhh what a twit .....................

Where did this twit study medicine and when? Does she wear floor length dresses, swoon and prescribe blood letting? What an absolute dork. Man has walked on the moon. She and her students probably can't find the moon. She most likely is a member of the flat earth society.

I understand your reluctance to push further because of the difficulty finding a new doctor. Sometimes takes years. I was so lucky my PCP listened and is still listening to my experiences with my monitor. My pharmacist says I'm the only person ordering strips from him.

I strongly urge you to go to the Toronto General Hospital's website. uhn=university health network--several hospitals--you want TGH

Google for uhn.ca

Second entry on the page that appears, click on
access TGH Clinics/Centres
then scroll down to thrombosis clinic
Dr. E. Yao is the head and his e-mail is shown.

There is also a link to Telehealth@UHN. They operate across Canada. I'd look into that too. If they could train/monitor your INR from a distance ...............
Meanwhile, I've contacted Hamilton General where my surgery was performed for their recommendations re home monitoring.
 
With everyones help; this is what I have compiled and printed thus far:

- http:www.annclinlabsci.org/cgi/content/abstract/38/1/37
- heading - "Evaluation of the Roche CoaguChek XS Handheld Coagulation Analyzer in a Cardiac Outpatient Clinic" (one page)

- http://jcp.bmj.com/cgi/content/abstract/60/3/311
- heading - "Accuracy and clinical utility of the CoaguChek XS portable international normalised ratio monitor in a pilot study of warfarin home-monitoring" (two pages)

- http://www.bmj.com/cgi/content/full/331/7524/1057?maxtoshow=...
- heading - "BMJ Helping doctors make better decisions" "Primary Care - Self Management of Oral Anticoagulation: Randomised trail" (ten pages)

- https://www.cms.hhs.gov/mcd/viedecisionmemo.asp?from2=viewd...
- heading - "CMS Centers for Medicare & Medicaid Service" "Decision Memo for Prothrombin Time (INR) Monitor for Home Anticoagulation Management (CAG-00087N) (26 pages)

*** - http://discoveryhealthcme.discovery....agulation.html ******
- VIDEO

Plus I have put together about 16 pages of tid bits from members and from other sites......more like copy and paste like the post Karlynn provided.

I don't think there''s much more I can do, but to state my case (again) with all this positive evidence.

Thank-you all for taking the time to help me.
 
Oh Yea,
I also printed out the vr.com "Must Have" Reference Links which was six pages.

And yes I DID have to change my ink cartage in the printer :D
 
Not that it's much help in your situation but over here in Auz the things are not covered on medical insurance anyway, only diabetic blood testers.

So i just went out and bought the thing myself (1500 bucks).

Best thing i ever done.

Doctor has no idea what my inr is as i never even call for adjustments after the great help from this site.

Been on average 2.8 rock solid for ages with only the occasional jump to 3.2 or drop to 2.2 when the seasons change or activity changes and i test/adjust pretty quickly.

If its an option, buy it and keep yourself in range for 12 months then do a claim for one later on...you would have to test monthy at a lab also but if you have tested at home as well it may help your cause.
 
Hey there Magic8Ball,

If I could go out and buy one...I would. But here in Canada one needs a prescription. Medical insurance doesn't cover the monitor (one company will pay a little) and some will pay for the strips.

I believe that once a Canadian has a monitor it is a must to do both - lab and home testing, so your doc can compare.

But hey, tanks for the thought :)
 
Freddie said:
With everyones help; this is what I have compiled and printed thus far:

- http:www.annclinlabsci.org/cgi/content/abstract/38/1/37
- heading - "Evaluation of the Roche CoaguChek XS Handheld Coagulation Analyzer in a Cardiac Outpatient Clinic" (one page)

- http://jcp.bmj.com/cgi/content/abstract/60/3/311
- heading - "Accuracy and clinical utility of the CoaguChek XS portable international normalised ratio monitor in a pilot study of warfarin home-monitoring" (two pages)

- http://www.bmj.com/cgi/content/full/331/7524/1057?maxtoshow=...
- heading - "BMJ Helping doctors make better decisions" "Primary Care - Self Management of Oral Anticoagulation: Randomised trail" (ten pages)

- https://www.cms.hhs.gov/mcd/viedecisionmemo.asp?from2=viewd...
- heading - "CMS Centers for Medicare & Medicaid Service" "Decision Memo for Prothrombin Time (INR) Monitor for Home Anticoagulation Management (CAG-00087N) (26 pages)

*** - http://discoveryhealthcme.discovery....agulation.html ******
- VIDEO

Plus I have put together about 16 pages of tid bits from members and from other sites......more like copy and paste like the post Karlynn provided.

I don't think there''s much more I can do, but to state my case (again) with all this positive evidence.

Thank-you all for taking the time to help me.

I wish you the best. My concern being will she/them take the time to read and understand the information you have supplied? Also if/when she agrees is she the person monitoring your INR?

Hopefully you are not talking to the wall.
 
Hi Lance,
yes she'll be the one monitoring my INR - she has been since day one. She is a really good Doctor, she just has reservations about this whole thing.

Once I give her my findings and give it some time - she might come around.
 
Freddie said:
Hey there Magic8Ball,

If I could go out and buy one...I would. But here in Canada one needs a prescription. Medical insurance doesn't cover the monitor (one company will pay a little) and some will pay for the strips.

I believe that once a Canadian has a monitor it is a must to do both - lab and home testing, so your doc can compare.

But hey, tanks for the thought :)

Wow, thats way restrictive.....so even if you have the money to buy one you still need a prescription AND they still want to stick you monthly to compare.

I suppose it has its good and bad sides, my doctor hasn't seen an up to date INR result from me for nearly 12 months....i only get my INR tested in a lab when i am getting stuck for something else.

I'm not totally trusting of my machine, I'm running out of strips and need to buy a new batch so i'll test myself a couple of times when i start on the new strips.

You could always take a trip to Australia, buy one, and take it back....;)
 
Some more references

Some more references

Freddie, here are some more references to support your case. Unfortunately many references require that you have a subscription to their service and only an abstract, and not the complete article, will be found on the web. You can either pay their fee or perhaps find a medical library that carries that journal so you can copy it. Good luck with your case, we're pulling for you! :)

Ross, you might want to include these in the reference section if they're not already there.

The Lancet, 2006 February; 367: 404-411. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis.
C Henegan, P Alonso-Coello, J M Garcia-Alamino, R Perara, E Meats, and P Glasziou
http://www.hadassah.org.il/NR/rdonl...oringoforalanticoagulationasystematicrevi.pdf

Harvard Heart Letter, 2006 July. Snail?s pace for home INR testing

International Journal of Cardiology, 2005; 99: 37-45. Guidelines for implementation of patient self-testing and patient self-monitoring of oral anticoagulation. International consensus guidelines prepared by International Self-Monitoring Association for Oral Anticoagulation.
J Ansell, A Jacobson, J Levy, H Voller, J M Hasenkam

Annals of Thoracic Surgery, 2007; 83: 24-9. Self-Management of Oral Anticoagulation Therapy Improves Long-Term Survival in Patients With Mechanical Heart Valve Replacement.
H Koertke, A Zitterman, O Wagner, and R Koerfer

CMS Manual System, Pub 100-04 Medicare Claims Processing, Transmittal 130, March 26, 2004
From: http://www.cms.hhs.gov/transmittals/downloads/R130CP.pdf
 
Freddie said:
Hey there Magic8Ball,

I believe that once a Canadian has a monitor it is a must to do both - lab and home testing, so your doc can compare.

But hey, tanks for the thought :)

I only do in-home monitoring, and I e-mail my INR and dosing suggestions to my ACT doctor; if he agrees, he e-mails a short reply, something like "sounds good" or if not, he might call me and we discuss it. Working out well for me, not sure about his end, though - I am happy to bypass the horrid phone system they have, and the non-medical person who used to phone me and tell me "the doctor says ...."

Keep fighting, Freddie, it will be worth it!
 
Lab and home sticks

Lab and home sticks

My warfarin monitor at TGH and Roche require a comparison back-to-back test of the lab and monitor once every 6 months.

So I take my monitor to the lab and both draws are taken within minutes of each other.

For the past 4 years it's worked very well.
 
lance said:
My warfarin monitor at TGH and Roche require a comparison back-to-back test of the lab and monitor once every 6 months.

So I take my monitor to the lab and both draws are taken within minutes of each other.

For the past 4 years it's worked very well.

Magic8Ball: This is what I meant - sorry if there was any confusion.

Zipper2 : Thanks for CTV web site and the news broadcast. I've printed that also.
 
Freddie:

For all the things you are printing, including Jack Ansell's article from Karlynn's post, it is most important that you copy and include the bibliographys. They show other important articles that are available, and they show that alot of research has been done on Point of care testing.

I would also suggest that you highlight some of the important information. For example, my doctor was surprised to see that 130,000 people in Germany participate in point of care testing and only between 10,000. to 20,000 people in the US participate.

Presentation is important. Make your presentation as simple as possible and point-up the important items. Make it as easy as possible for her to see the most important parts of your papers.

Also, if you can find some studies that take place in Canada, that would be a plus for your argument.

Regards,
Blanche
 

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