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Yeah I've thought of going back to weekly, but my results don't give me a reason to do so. As I noted, if out of range, I do test within a week. My % in range is as follows since being on this schedule: 2024: 100% (so far) 2023: 96.3% 2022: 80.7% (A couple illnesses affected my INR that year...

Good question! I'll answer based on using Remote INR (now owned by Royal Philips subsidiary Cardionet). I can't speak to other services, but of course it could vary. I signed up for an every 2 week test schedule. I can test and report more often, but don't have to since I'm seldom out of range...

My severe aortic regurgitation was sudden onset at age 46. Literally overnight - I woke up with symptoms including a pulsation throughout my body, out of breath walking up a flight of stairs, unable to go more than 5 minutes on my treadmill, etc. After a month of denial (and prompting from my...

I'm not surprised Coagusense can be bought without a script, but Coagusense is a class 2 device and requires a script per the FDA. However they do wholesale to medical device companies who then sell direct to patients. Appears to be up to the medical device seller to enforce (or not enforce) the...

I wish that were true! Your FDA contact was incorrect though. CoaguChek Systems require a prescription in the US per the FDA. There are many documents available in the FDA device database. The 510k decision document gives a good summary. Here are links to Vantus and XS Plus System PT 510k...

FDA medical device classification is heavily dependent on risk/safety. Reclassifcation is possible. I think there is plenty of history of safe use by home testers but don't know how the case gets initiated with the FDA to reclassify a device for over the counter sale. Not sure it can be done...

I suspect the $59 million settlement a couple weeks ago for violating the Controlled Substances Act caused eBay to take action to clear their US site of items that require a subscription. The FDA classifies the Roche system (device and test strips) as class 2 which requires prescription. It...

The Roche U.S. site lists Vantus and XS devices. Vantus is only sold in the US, but as far as I know not directly to patients. INRange is not approved by the FDA for use in the U.S. However it is nearly identical to the Vantus device. The Roche Global site lists INRange and XS devices.

Nope.

I haven't posted here in quite some time, but decided to take a look and saw this recent post on the old Remote INR thread. My latest invoice from CardioNet was received three weeks ago for July 2022 - so billing is one year behind. The various acquisitions of Roche Remote INR > BioTel >...

Yeah I realize people manage to buy CoauguSense without a prescription but from an FDA standpoint prescription is required. The specific document for the current model is on FDA.gov. ("Prescription Use" as noted on Page 3). An example of a supplier specifying the prescription requirement here. I...

It's two different things... 1. Yes available for sale direct to patients but... 2. Still requires a prescription from a Dr. as specified by the FDA. Legit medical suppliers will specify that on their website. CoagSense made a different business decision from Roche in allowing sale direct to...

The US FDA Rx requirement applies to all INR devices I am aware of. The restriction by Roche to not allow direct sales to patients is their business decision. There is no reason for concern that it has anything to do with reliability of the device. I speculate they refuse to sell direct to US...

We covered that earlier in this thread: Post 170 Also another thread: Post 5

Update: BioTel/CardioNet finally submitted a claim for 2022. The new cost is $96.08 - about 15% lower than last year. Since these provider-insurance contracts tend to be multiyear, I'm expecting I can plan on that cost until I'm on Medicare in a couple years.

Wow! Somehow I lucked out. I used the InRatio (purchased through insurance) for 10 years without any significant issues. My understanding from the recall info and the class action lawsuit was that it was reporting inaccurate on the low side rather than high. My experience was that my out of...

Thanks for the detail. The $880 and the $20 are not relevant. These are "Chargemaster" or "list" prices. For some reason they include it on the EOB - probably just to make us think we are getting a great deal. My EOB shows the same $880. No Coumadin clinic is involved in my case. The only...

No additional charge from the provider. The service does not manage the dose. They contact the provider with the results. I manage my dose, but the provider is required to contact the patient. So I get a call which sometimes is just a vm. They are ok as long as I let them know of any dose...

The answer to that here in the US is it depends on what a given health insurance plan negotiated with the service provider and then the specific structure of the chosen plan that determines how much the patient pays and how much the insurer pays. The negotiated service rate, In-network, out of...

The service I use (Biotel Remote INR) provides 3 methods to report 1. Entry on website (this is what I use) 2. Phone call (used once, but prefer the website) 3. Bluetooth connection from the device to a mobile App (I don't use this - see below*) The service will then report it to your Provider...