How can I find out if a medical device that hasnt been invented yet can be charged to medical insurace?

Question

I'm doing a project for school and am inventing a medical device that attaches to a door and will turn the doorknob when a latch is pulled so that the user does not have to use their wrist. I was wondering what kind of guidelines there are to find out whether or not it could be charged to insurance. Thanks!

Answer 1

It can't be.

Medical insurance only provides for "usual and customary" or "standard" treatment.  Not experimental, and not fantasy.  

That's not a medical device, anyway - it doesn't do anything medically, to the body.  It's an assistance device at best.  Cheaper way to accomplish the same goal:   A string, and take the tongue out of the door mechanism.

Answer 2

IF it doesnt have a procedure code for DME then its not covered. Unless if its medically necessary, you will provide a lot of records and notes just to prove that it is necessary, but that is a very long process.

Answer 3

You're asking a hypothetical question for a "future" item of DME.  No one can say.

Answer 4

First, it doesn't sound like a "medical device". per the fda's website: A medical device is any product or equipment used to diagnose a disease or other conditions, to cure, to treat or to prevent disease. The Food and Drug Administration’s Center for Devices and Radiological Health regulates medical devices to provide reasonable assurance of their safety and effectiveness.

A home healthcare medical device is any product or equipment used in the home environment by persons who are ill or have disabilities. These persons, or their providers of care, may need education, training, or other healthcare-related services to use and maintain their devices safely and effectively in their homes or in other places such as work, school, and church. Examples of some home healthcare devices are ventilators and nebulizers (to help breathing); wheelchairs; infusion pumps; blood glucose meters, apnea monitors, and other home monitoring devices.

So... It seems your invention is actually a home aid or accessory, & therefore typically not covered by health insurance.

Similar items already exist.

thanks.

Answer 5

Well, at the bare minimum, any medical device needs FDA approval to be covered by insurance.

After that, there would need to be demonstrated evidence of medical benefit.  Most insurers consider new devices "experimental" or "investigational," and don't cover them.  Generally, once Medicare agrees to start covering an item, other insurance companies start to follow suit.

However, keep in mind that devices that are primarily for medical convenience around the house (like shower chairs, raised toilet seats, etc.) aren't generally covered by insurance.  It sounds possible that the type of thing you're talking about may be considered by many insurance companies to be more of a convenience type item and thus not covered.

Answer 6

An insurance company won't even consider reimbursement till it is in use and proven to be of benefit.