Medical insurance coverage

This project has put a lot of time and effort into having the prostheses paid for by medical insurance companies. But the situation has been getting worse not better.* 

Recently, came a final blow : after a surreal "inspection" the prosthesis are no longer 'medical devices'.

What does this mean?

I may no longer give cost quotes with medical certification or refer to them as having a "medical" use, which means, no clear path to payment through medical insurance. And,

VAT now jumps from reduced rate for medical devices, to the regular rate.

(in Germany, this means VAT from 7%, to 19%, in France from 5.5% to 20%, etc.).

One positive change: This should make international postage easier. (Import/export of medical devices was complicated.) 

This, and other factors have forced me to re-evaluate and change direction (see the Project Present).

Thanks to everyone who shared their ideas, discussions, letters of denial and acceptance from their health insurance companies over the years. And thank you to everyone who went through the process to get them paid for, an then continued to order from me regularly and give me regular feedback. 

To everyone who has had their prosthesis paid for regularly by their medical insurance over the years, and cannot pay out of pocket, I am really sorry - I don't know what else to say to you.

I write to people who have specifically asked to be on an information or contact list. If you've been waiting for cost coverage updates, but were not on my contact list for this, I'm sorry this couldn't work out as planned, and that you are finding out now, like this. If you want to be on an info/ collaboration list for this topic, contact me. 

What happened?

The law (or the Berlin bureau of health's interpretation of the law) makes it no longer possible for me to follow the EU Medical Device Regulation, which I've been following since it became law in 2022. (Prior to that, registered under German medical device regulations since 2015, in the USA from 2010-2015 registered with the FDA, and prior to that the work was in Germany registered as non-medical.)

I was given a set of protocols:  For example, I would need to hire people certified to evaluate or perform tests on the chemical level, periodically and for each material I use. I may no longer rely on the tests performed and published by the companies that sell to medical device companies and professionals.

And,

I would need to hire "experts" to perform clinical studies on the effect the device has on people who wear/use them. Which I find amusing at best, disturbing at worst. 

I've been informed that there are no one-person medical device companies in Berlin, although I have been a one-person medical device company under their jurisdiction, in direct contact with them, for several years - even under the new EU Medcial Device Regulation.** 

They told me that it would be really hard to find a lawyer with the expertise to help me. That, I agree with. 

They told me that "medical device" in the terms of the EU-MDR is not about what I sell, but about my "intent" : they told me that I can sell a pace-maker as non-medical if I say it is a childs toy.

I will not strengthen arguments against trans related care being paid for by medical insurance. 

But in the wording of the EU-MDR, it's easy for me to state my intent as non-medical : 1.  they are not specifically made for relief of a medical condition (I don't decide and am in no way involved in how anyone feels with their body or the prosthesis or how or whether that is a "medical condition".) 2.  The prostheses are not replacement body parts, they are extra body parts. 

This "intent" wording allows me to continue working legally, although no longer as a manufacturer of medical devices.*** 

What about prostheses/ epitheses paid for by medical insurance?

In the past few years, most people in Germany who applied for medical insurance coverage for a t2 Phase_ prosthesis were declined and offered cost coverage for an epithesis instead. 

Epitheses are "custom made devices“, so fall under different terms in the EU Medical Device Regulation. (They are formed directly to the body and usually made by people who are officially certified medical profesionals). 

So what’s a penis-scrotum epithesis in Germany?

They are solid pieces of silicone, often formed to individual preferences and painted for detail. They sit directly on the contour of an individuals body, and are fairly firm. Last I checked, the price was around 10 000Euro (ten thousand Euro). They are made by anaplastologists (Epithetiker*in), people trained in the art of creating replacement facial parts (for example, after removal due to cancer). Anaplastologists work closely with surgeons. Penis-scrotum epitheses are made to be attached with medical adhesive. 

I find the epitheses that are currently available, are a very rough idea of what they could be. 
For example: Forming a penis and scrotum to fit the contour of a specific person’s groin at rest is time consuming, for most- an uncomfortable process. Moreover, I can't imagine why it makes any sense. People walk. With each step the groin surface changes shape, the epithesis remains stiff and pulls away from the body. Also, the groin shouldn't be directly covered : the area gets sweaty, people need to use the toilet, and sex is very limited with an epithesis. 

Also, they need to be much softer so that they are comfortable to wear and more realistic to the touch, "sit" well so that they can stay attached, ... and they should have function. An epithesis (not custom made) was my original inspiration for this project back in 2002.  I'm not against their existence - They are paid for by medical insurance, and that is a good thing. 

* Changes to laws related to trans health care, and general cut backs in health care at large - in Germany and elsewhere. 

**Attitudes change : 

2015 Upon registration the bureau of health in Berlin laughingly responded 'how could this possibly be a medical device?' I sent a wikipedia link to show trans as a recognised phenomenon. And the prostheses were registered. For the next years, many people had theirs paid for by their medical insurance.

2022 Contact with the same bureau : 'I support what you're doing, I think you're doing something important' and help to understand the new EU-wide laws in order to conform to them and keep medical status. 

2026: Inspectors come and tell me it's impossible to continue - and 'how could this be a medical device anyway...? It's not about a medical condition' (as in: 'trans people are not sick') and then they went on with all the unrelated tests and studies I would need to perform and submit. 

***  Years back, I was insured that I must call the prostheses "medical devices" and have them registered, in order to be allowed to continue working. 

Now - I may not call them medical devices and cannot have them registered... laws change. 

My intend as manufacturer, in compliance with the EU Medical Device Regulation (MDR) Article 2. Definitions :  

t2 Protheses are extra parts, not replacement body parts. I make them for trans+ people and each individual has their own relationship with their body. The prostheses are objects people choose to wear/use for a variety of reasons. I am not a medical device manufacturer and the prosthesis have no intended medical purpose. 

The device is not intended to be a medical device in the terms of the EU-MDR.
I have no intent nor am I in a position to test, judge or study its effects - if any- in medical terms. 
The device is not intended to be a replacement body part, but rather, an extra body part.
My intended clients and customers fall under the very broad category of trans+. Being trans+ is not a medical condition. 
Some aspects within the broad category of being trans+ do require medical care. For some individuals, a prosthesis of this sort may be categorised as medical care, and it may be individually argued that it serves a medical purpose for the individual. My intent is not medical in nature, nor medical in purpose. 

There needs to be way to receive these devices cheaper (and for me to be paid more realisitically for my work). If you have ideas to share on this - ways to have them paid for despite current laws. I'm open to exploring options.