Remote INR taking over Coaguchek

[Timmay]

Wow. I am 100% out of pocket and I have phenomenal insurance. Here in the USA, it's frowned upon by the industry to monitor yourself ... so insurance companies generally won't cover your POS INR machine as well as not covering your test strips.

... and I bought 2 machines (one as a backup)

... and now my third box of 24 strips.

Ouch.

 

[MdaPA]

Here in the USA, it's frowned upon by the industry to monitor yourself ... so insurance companies generally won't cover your POS INR machine as well as not covering your test strips.

My understanding was that the FDA in the U.S. approved certain monitoring systems (e.g. the CoaguChek XS) for use only by professional healthcare providers for INR testing while the Coag-Sense PT INR Monitoring Device (perhaps there are others) was cleared for both professional and patient self testing. Some health insurance companies should then cover (either in or out of network) systems approved for patient self testing under medical equipment, otherwise require that you go through an INR monitoring service as I believe Roche/Phillips requires for the the CoaguChek XS.

 

[tom in MO]

Wow. I am 100% out of pocket and I have phenomenal insurance. Here in the USA, it's frowned upon by the industry to monitor yourself ... so insurance companies generally won't cover your POS INR machine as well as not covering your test strips.

... and I bought 2 machines (one as a backup)

... and now my third box of 24 strips.

Ouch.

In the US I live in, self-monitoring is encouraged.

I live in the US and both self test and self dose. My mother-in-law was encouraged to self-monitor. I live in MO she lived in WI. It's covered by Medicare. It's covered by my company's insurance plan. On my plan my monitor was free, I pay for supplies. The fees are just like any other medical equipment.

You don't have "phenomenal insurance" if they don't cover home INR testing.

 

[RAS]

Here in the USA, it's frowned upon by the industry to monitor yourself ... so insurance companies generally won't cover your POS INR machine as well as not covering your test strips.

The attitude towards home testing and experience of members of this forum varies quite a bit, but it is not the concept of home INR monitoring that is frowned upon. It is the direct purchase of devices/supplies that is not supported.

I started home testing 15 years ago with full support of my cardiologist and insurance. It was unusual at the time (I was only the 2nd person at my clinic to do this), but it has become quite common locally since then. I don't know if there were any INR home testing services at the time, but I was aware of several options for direct purchase of equipment and supplies.

My first device was a HemoSense (Alere) INRatio. Cost was 80% covered by insurance. Test strips were covered 80% as well. Eventually that system was taken off the market due to multiple issues with the device and strips. I think that was around 2015-2016.

My second device was a Coaguchek XS which I purchased outside of insurance. By that time, the services had come on the market and my insurance steered me toward that. I could have gone with one of the services covered by my insurance, but I found multiple medical suppliers who would sell the device and strips directly to patients, so I went that route even though direct purchase was not covered by my insurance. I estimated long term cost to be less even though I had to buy the device up front. My cardio was supportive as long as I communicated my INR to them.

By early 2021, I was unable to find medical suppliers who sold the test strips direct to patients and I was not comfortable buying strips from eBay, so I switched to the Remote INR service which is covered by my insurance plan. It is more expensive than what I paid before, but the cost will go down once I'm on Medicare. Medicare has been covering home INR testing for long term warfarin patients since 2008 and for mechanical valve patients since 2002.

This is speculation, but what I think what has occurred in the US is that health insurance companies only support home testing via INR monitoring services rather than direct purchase of devices and strips in order to minimize risk and enforce compliance of test frequency. The service companies require patients to test at least every 2 weeks and log results with the service company. The INR results are then transmitted to the patient's Cardio. Patients who don't comply with the test frequency and INR logging will not be allowed to continue in the program. At least that's what I've been told.

My personal experience is the US health care industry fully supports home INR testing, but only via the test service model.
Direct purchase of device and supplies is where we are limited and that is most likely due to risk and liability mitigation decisions made by health insurance and/or healthcare providers (and their lawyers)

 

[ScribeWithALancet]

In the US I live in, self-monitoring is encouraged.

I live in the US and both self test and self dose. My mother-in-law was encouraged to self-monitor. I live in MO she lived in WI. It's covered by Medicare. It's covered by my company's insurance plan. On my plan my monitor was free, I pay for supplies. The fees are just like any other medical equipment.

You don't have "phenomenal insurance" if they don't cover home INR testing.

In the USA, I live in, my doctors do not really like self monitoring. However, Medicare covers it. My health care plan prefers that you use their monitor that Medicare pays for the RENTAL of. When I showed my doctor how the fees worked, he wrote me a prescription to allow me to BUY my own monitor. The monthly rental fees for three months were less then the purchase fee for the machine. So my internist thought that the set up was crazy.

CoagUCheck machines ARE allowed for private ownership in the US. My health plan always uses the same machine for Laboratory Testing for all members in the Washington DC/Baltimore area.

Per the advice of a doctor who does remote monitoring of patients in Utah (Too Long Travel distances), I did a statistical correlation between my CoagUCheck and the Health Plan Laboratory machine and found that they followed a very close pattern. I have talked on this site with people who have used the CoagSense machines and they are equally happy with the results. Test often (weekly) or more often when trying a new medicine or supplement. But be confident that it will find most variations in your INR.

Both my mother and my wife's mother always said "follow the money trail". Medicare actively pays very high fees for rental equipment and testing. Other health plans can make lots of money from these payments. My personal feeling is that "the US health care industry fully supports home INR testing, but only via the test service model." because of this $$$ trail and less because of "risk and liability mitigation decisions made by health insurance and/or healthcare providers (and their lawyers)"

Walk in His Peace,
Scribe With a Lancet.

 

[MdaPA]

CoagUCheck machines ARE allowed for private ownership in the US.

Can you please advise where in the U.S. a patient can purchase a new CoaguChek XS machine, along with supplies (unopened box and not through a 3rd party seller like E-bay)?

My understanding is that Roche requires a patient use a monitoring service to use this machine for at-home self-testing.

I made a quick call to Wilburn Medical Equipment and Supplies and they said they will only sell and ship it it to a provider, and not the patient as that is Roche's policy. They said they will sell a patient a Coag Sense machine and supplies, just not the CoaguChek XS.

 

[TGM]

Wow. I am 100% out of pocket and I have phenomenal insurance. Here in the USA, it's frowned upon by the industry to monitor yourself ... so insurance companies generally won't cover your POS INR machine as well as not covering your test strips.

... and I bought 2 machines (one as a backup)

... and now my third box of 24 strips.

Ouch.

I think it depends on your insurer. We are in the US and my son’s monitor and supplies are covered under insurance. We just pay the 10% copay.

 

[pellicle]

Ouch

probably means you're lancing too deep ;-)
(*note that's a joke)

 

[pellicle]

Can you please advise where in the U.S. a patient can purchase a new CoaguChek XS machine, along with supplies (unopened box and not through a 3rd party seller like E-bay)?

give me a funny look, but what is wrong with eBay?

My understanding is that Roche requires a patient use a monitoring service to use this machine for at-home self-testing.

which is interesting because it would seem that's ONLY in the USA ... so much for freedom. Here in Australia you can buy one, indeed mine was given to me for free by ATS as part of some promotion.

 

[ScribeWithALancet]

Can you please advise where in the U.S. a patient can purchase a new CoaguChek XS machine, along with supplies (unopened box and not through a 3rd party seller like E-bay)?

My understanding is that Roche requires a patient use a monitoring service to use this machine for at-home self-testing.

I made a quick call to Wilburn Medical Equipment and Supplies and they said they will only sell and ship it it to a provider, and not the patient as that is Roche's policy. They said they will sell a patient a Coag Sense machine and supplies, just not the CoaguChek XS.

********************************
OOPS, I swapped the terms CougSense and CoagUCheck in my memory. I own a CoagSense not a CoagUChek XS.
You would have to have a doctor relative to buy the CoagUChek XS and then give it to you. My purchase was from Wilburn and when I bought it, they told me the same thing. OOPS, a senior moment. This is what (now diabetes doctor) Richard Bernstein did when he purchased his first home blood glucose meter. Unfortunately, most of us are not married to M.D.s that can bypass the system.
Walk in His Peace,
Scribe With a Lancet

 

[pellicle]

but it is not the concept of home INR monitoring that is frowned upon. It is the direct purchase of devices/supplies that is not supported.

firstly I'm not American so may be mistake, but I belive that the issue arises from the wording of the FDA approval for the Coaguchek XS system in the USA. The Coagsense however is freely available for purchase and while it has some issues for some users is a viable alternative.

Clearly the average users can't buy an XS off the shelf at a store, but I would argue that if you're posting here then you're not an 'average user'

 

[MdaPA]

give me a funny look, but what is wrong with eBay?

Nothing at all (just ordered a part for my clothes washer from there). I was more looking for an official medical supply/distributer here in the US that would sell A CoaguChek XS to a patient (perhaps backed by the manufacture warrantee) as it appears the manufacture, Roche and their distributors, apparently will not.

which is interesting because it would seem that's ONLY in the USA ... so much for freedom. Here in Australia you can buy one, indeed mine was given to me for free by ATS as part of some promotion.

We can buy one here through a 3rd party (eBay), just not through the manufacture or distributor(s). Not 100% sure if it's an FDA or Roche thing/decision. We do have the freedom (like anyone else) to chose other devices (e.g. the CougSense) and not be tied to a monitoring system and rental with the CoaguChek XS. Freedom of choice.

 

[RAS]

firstly I'm not American so may be mistake, but I belive that the issue arises from the wording of the FDA approval for the Coaguchek XS system in the USA. The Coagsense however is freely available for purchase and while it has some issues for some users is a viable alternative.

Yeah, I'm aware that some Roche Coaguchek XS models are for Professional use only, but there was a Coaguchek XS model approved for home use in 2007. Here is the FDA record.

The current system for home use is the Vantas which is what I received from the INR monitoring service (no up front cost). The Roche Vantas system approved in 2018 succeeds the XS home use model. FDA states in their decision summary "The CoaguChek Vantus System is intended for single patient self-testing only for adults, age 22 years and older." Here is the FDA record for that system.

And yet, the Vantas system is difficult to find for sale direct to consumer at medical device suppliers, pharmacies, etc.

The professional model of the XS system is still available from various suppliers. Wilburn Medical for example sells XS (for professional use), but not Vantas and steers home users to the CoaguSense device.

I don't think the FDA is the reason direct purchase of Coaguchek devices and supplies is so difficult here.

Pell, I'm curious can you buy your Coaguchek test strips from official/approved Medical supply distributers in Australia or do you buy from eBay?

 

[pellicle]

Yeah, I'm aware that some Roche Coaguchek XS models are for Professional use only, but there was a Coaguchek XS model approved for home use in 2007.

Ok, so why isn't it for sale to the general public in the USA? I mean this is a super common discussion point.

Pell, I'm curious can you buy your Coaguchek test strips from official/approved Medical supply distributers in Australia

Some chemist shops sell them there are also online shops. I bought from one like that while living in Finland.
I can't even find them on eBay shipped from Australia. I use medshop.com.au

 

[Timmay]

I have two CoaguChek XS meters. Why? I’m a dork and I wanted a backup as well as a confirmation device. I purchased both on eBay. Used. They both work great. I’m the type of guy that buys new. That’s probably an understatement too. But, given the issues here in the USA, we don’t have a lot of choices. So off to eBay I went. I get my test strips there too. Just make sure to get them from a retailer that advertises as a sealed box, with a good expiration, and with the code chip.

 

[slipkid]

give me a funny look, but what is wrong with eBay?

I have had SO MANY different (& some very crazy) problems with ebay sellers of all sorts of things that I do not wish to risk that encountering that sort of insanity when buying a medical device that my life kind of depends on.

Things like paying for one thing but being sent another, description of LIKE NEW (or even NEW really being POOR or FAIR at best (or obviously used when listed as new), things sent missing certain pieces, something "working" but not ALL the functions, you name it. And there's the concern on my part of these meters being used for biological testing (blood) and dog only knows how well they've been treated, abused, contaminated, if dropped from a ten story building or into a toilet including problems which are not obvious on first look etc etc etc.

Even if I could return it for not working right or smelling like dogpee or cigarette smoke I don't want to go through the hassle/time-wasting of doing that via ebay. Would rather avoid all of that entirely. If it was a TV remote then yeah I take the risk but an INR meter - no thanks.

 

[ATHENS1964]

In Greece you can order it new in a pharmacy and in 2 days you have it at a cost of about 570 euros. If you are insured in the public system your cardiologist can order it for about 80 euros. The strips cost about 65 euros in the pharmacy and the insured buys them for about 20 euros.
I helped some patients who live in Europe and I sent them the device with 570 euros and strips because in their country it cost about 800 euros.

 

[pellicle]

Why? I’m a dork and I wanted a backup

are you sure you have the nomenclature right here?

 

[pellicle]

I have had SO MANY different (& some very crazy) problems with ebay sellers of all sorts of things that I do not wish to risk that encountering that sort of insanity when buying a medical device that my life kind of depends on.
...

wow ... you must specialise in sketchy sellers. Literally in decades I've had only 2 or three iffy experiences.

 

[pellicle]

In Greece you can order it new in a pharmacy and in 2 days you have it at a cost of about 570 euros.

true, but in the USA you don't have that specific freedom.