Regulatory Open Forum

Greetings everyone!

I've been tasked with figuring out if our class II SaMD is FSA/HSA eligible. As I did some online digging, I came across this Guide to HSAs/FSAs for your Digital Health Product/Service, according to which, medical software and hardware devices can indeed be purchased with HSA/FSA accounts: 

A Guide to HSAs/FSAs for Your Digital Health Product/Service - Rocket Digital Health

Our SaMD is used to predict of likelihood of ear infection, so we feel we could advertise it as being HSA/FSA eligible. Does anyone know if there's a specific law or regulation that can provide a more definitive answer?  Thanks in advance!

Hi Carol

It's an IRS rule. Publication 969 on health savings accounts says "Qualified medical expenses are those expenses that would generally qualify for the medical and dental expenses deduction. These are explained in Pub. 502." Publication 502 gives a lot of examples of things that do and don't qualify, and a general explanation:

What Are Medical Expenses?
Medical expenses are the costs of diagnosis, cure, mitigation, treatment, or prevention of disease, and for the purpose of affecting any part or function of the body. These expenses include payments for legal medical services rendered by physicians, surgeons, dentists, and other medical practitioners. They include the costs of equipment, supplies, and diagnostic devices needed for these purposes.

Medical care expenses must be primarily to alleviate or prevent a physical or mental disability or illness. They don't include expenses that are merely beneficial to general health, such as vitamins or a vacation.

Medical expenses include the premiums you pay for insurance that covers the expenses of medical care, and the amounts you pay for transportation to get medical care. Medical expenses also include amounts paid for qualified long-term care services and limited amounts paid for any qualified long-term care insurance contract.

If you need to dig deeper, you can look at the internal revenue code and associated tax court decisions.

https://www.irs.gov/privacy-disclosure/tax-code-regulations-and-official-guidance

Greetings everyone!

I've been tasked with figuring out if our class II SaMD is FSA/HSA eligible. As I did some online digging, I came across this Guide to HSAs/FSAs for your Digital Health Product/Service, according to which, medical software and hardware devices can indeed be purchased with HSA/FSA accounts: 

A Guide to HSAs/FSAs for Your Digital Health Product/Service - Rocket Digital Health

Our SaMD is used to predict of likelihood of ear infection, so we feel we could advertise it as being HSA/FSA eligible. Does anyone know if there's a specific law or regulation that can provide a more definitive answer?  Thanks in advance!