The Wall Street Journal and other news sources have recently covered a new development in health care coverage and the at-home DNA test sold by 23andMe. Because of its FDA-approved reports, US customers of 23andMe can request reimbursement for part of their testing. Other at-home DNA testing companies have not received FDA approval yet, so the IRS ruling only affects 23andMe testers at this time.
Grouping 23andMe’s test into a category with clinical sends a mixed messages. So I am going to fill in some gaps for you…
23andMe has two test options: Ancestry-only and Health + Ancestry. The same test is run on your DNA sample, but reports pertaining to medical conditions are not available unless you pay more for the latter option.
The portion of the test for which a customer spends extra to get the “Health” reports can now be paid for using funds from a tax-advantaged account, like a FSA or HSA account. In other words, the difference in cost between the Ancestry-only and Health + Ancestry options at the time you bought your test is the amount you can pay for or seek reimbursement for per the new IRS categorization of 23andMe health testing as “medical” expense. This is the new development.
How much money are we talking?
Since DNA kits can go on sale or you can buy an Ancestry-only test and later upgrade to the Health + Ancestry without having to submit more DNA, the amount customers have spent and will spend on the “health” portion of the 23andMe test fluctuates over time. (There are also different options available to residents of different countries, based on laws. But note this new IRS development only affects US residents.)
23andMe has an online calculator posted on their website to determine what the amount would be depending on when someone purchased a test and where they live. The difference in cost is probably around $100 (US dollars) for most people.
What’s this mean?
This means the IRS has decided to lump a 23andMe test together with other health-related DNA tests, in so far as both are eligible medical expenses for health savings accounts.
It’s important to know that experts who understand DNA tests and technologies will advise you to get follow-up clinical testing before acting on a 23andMe finding.
Not everyone thinks of or treats the 23andMe test the same as others. Even 23andMe tells you in the fine print to get follow up testing in a clinical setting!
If you are confused, you are not alone.
Fortunately there is a specially-trained set of professionals ready and waiting to help you.
Does the IRS ruling mean 23andMe is medical DNA testing?
Not exactly. 23andMe can be helpful for identifying some genetic risks in some people who test, but there are a lot of caveats. Let me use a comparison to flu shots to explain.
Anyone who gets the flu shot is warned that the flu shot can only lower the chances of the flu. It can’t fully protect you as it only covers some strains of the flu.
Similarly, 23andMe’s DNA test only covers some of the variants that have medical significance.
Just like you can still get the flu if you have a flu shot, you can still be a BRCA carrier, have a child affected with cystic fibrosis, have a high risk for Parkinson’s or another genetic disease, etc. even if your 23andMe test doesn’t catch it.
Like I wrote earlier, 23andMe knows this and they tell you test limitations in the fine print before you consent to testing.
23andMe gives more details about caveats in each individual report, in the scientific details section. They also warn you not to consider their test clinical-grade testing.
But who reads the fine print!? I know I rarely do. Except for DNA tests, of course, because this happens to be my area of specialty and I understand how the details can make a huge difference!
Isn’t 23andMe good enough for me to use for medical information?
There are powerful forces pushing the DNA testing market ahead. The messages of promise and hope are so strong, who wants to hear about limitations and weaknesses? Cracking your DNA code and learning about the secrets inside seems like a pretty good deal for less than $200. But like everything that seems just too good to be true, there is a catch.
Read the fine print I screen-captured from the 23andMe website:
With millions of testers, there are bound to be stories of how 23andMe saved someone’s life. For those fortunate folks, 23andMe turned out to be helpful. For most people, a different, more complete, carefully-selected DNA test will give better and more complete information.
So what, then?
Before you spend the health care dollars you have saved in an FSA or HSA account on a 23andMe test, know that it might not give you the medical information that matters for you and your family. Those same dollars could have been spent on a different DNA test or out-of-pocket genetic counseling (OR your health insurance might automatically cover both of those - you might not know unless you take the extra steps to check first).
You might have a significant DNA variant (a DNA letter change) that leads to a genetic risk or predisposition that 23andMe’s test does not cover. Conversely, 23andMe might identify a variant that actually won’t ever lead you to have any medical issues.
Same as other companies on the market like Ancestry and MyHeritage, 23andMe uses microarray technology, a technology that has its purposes (limited ones). For genetic screening, microarray tests are quite often inferior to sequencing tests. It’s a good test for what it tests and bad for what it misses (which is a lot).
In addition to these two test types, there are other DNA tests that give information that microarray and sequencing tests do not. These include technologies like karyotyping, microsatellite testing, STR, RFLP, and methylation studies (which is different from the type of “methylation” talked about by nutrigenomics people).
So then should I ignore all of this IRS stuff?
If you’ve already taken a 23andMe test, by all means try to get back some of your money.
You can then take those recovered dollars to invest in other genetic tests that will supplement and add to what you know about your DNA. I have found the following medical-grade tests helpful (more helpful, actually), than my 23andMe reports:
**NOTE: I AM NOT AFFILIATED WITH NOR DO I MAKE ANY FINANCIAL GAIN FROM ANY TESTS SOLD BY ANY TESTING COMPANY!**
Invitae’s proactive health panel
A combined Promethease report using as many raw data files as you have collected with a filtering process applied to narrow it down to the top 8-12 variants (then MyGeneCounsyl to get confirmation of the remaining variants)
Counsyl’s carrier screen
But won’t those tests cost a lot of money?
Not necessarily! You can get equal or better financial coverage for a DNA test that is a better fit for you. This is true whether you pay out of pocket for a test like an Invitae proactive panel (which is what we did in my family) or seek insurance coverage for a test your doctor orders from another company like GeneDx (have sought this for one family member for whom we were seeking out a genetic diagnosis).
There are at least ten DNA testing companies other than 23andMe that I can think of off the top of my head to recommend. Which one I would recommend and which test from the company depends on other information.
If you have a positive family medical history or are having medical symptoms yourself, or simply want to limit DNA testing to ones that will give you information to act on — each of these matters.
These are all pieces of information that come together to create an arrow pointing you to the best test (or tests) for you.
There’s a place for companies like 23andMe in the world, just like there are places for people like myself who are trying to fill in the missing pieces and paint a more complete version.
I feel strongly that everyone should do what’s best for them.
It’s your prerogative to take an at-home test, and being a savvy customer is on you.
I can offer medical DNA test guidance consults for residents of the US, for about half of the US states. Send me an inquiry if you’re interested and want to know if I’m licensed in your state. I’d love to work with you!