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Author Topic: Is HIV Genotyping and Phenotyping for Drug Resistance experimental Procedure?  (Read 1952 times)

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Offline Ocean1617

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  • Posts: 21
I received a copy of the letter Blue Shield sent to the lab in response to the inquiry for a lab test provided:

"We have reviewed the information we received and determined that these services are considered experimental/investigational according to our medical policy HIV Genotyping and Phenotyping for Drug Resistance. The services are not in accordance with Blue Shield medical policy for the following reasons:  The efficacy of routine use of combined genotyping and phenotyping has not been validated by the peer reviewed literature. The efficacy of drug susceptibility phenotype prediction using genotypic comparison to a known genotypic/phenotypic database has not been validated by the peer reviewed literature."

My policy excludes services that are experimental or investigational so they disapprove benefits for the test. Currently, it shows $0 both for blue shiled's and my responsibility. The bill from the lab seems to accept this condition and has not charged me for the test.

Since I don't know what criteria have to be met before a procedure is considered "validated" by the peer reviewed literature,  does anybody know the answer to the following questions:

(1) Is it true that the test is not "validated" and is experimental/investigational? If the efficacy of the test has not been validated, how do I know the test is trustworthy? Should my doctor know that the efficacy of the test is not validated and not to order the test? What other tests that are considered "validated" that predict for drug susceptability? If I don't do the test how do my doctor and I know what drug to use or not use? Trial and error? Luckily, Complera seems to work on me VL goes from 59,000 to 250 in 6 weeks.

(2) Will the lab bill me for the test in the future? So far, it hasn't asked for it.

(3) Blue Shield also includes its grievance process and  Department of Insurance form for Independent Medical Review. Should I file for grievance and independent medical review? Why or why not? What would be the ramifications of filing or not filing?

(4) Do I need the test again in the future?

Thank you in advance for your expertise.

Offline Ann

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  • Posts: 28,138
  • It just is, OK?
    • Num is sum qui mentiar tibi?
Genotype testing is one of the recommended baseline tests according to the US hiv guidelines. source

If you google "hiv resistance testing" and click on the Scholarly articles link, you'll get plenty of scientific evidence making the case for resistance testing to be the standard of care. Here's two - including one that shows this has been under investigation at least as far back as 1999. Blue Shield needs to be dragged into the 21st century where this is concerned.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2898%2912291-2/fulltext (the one from 1999 which concludes "We found genotypic-resistance testing to have a significant benefit on the virological response when choosing a therapeutic alternative.")

http://cid.oxfordjournals.org/content/41/9/1316.short (from 2005 and concludes "Genotype-resistance testing of chronically HIV-infected, antiretroviral-naive patients is likely to improve clinical outcomes and is cost-effective, compared with other HIV care in the United States. Resistance testing at the time of diagnosis should be the standard of care.")

I'm sure there are other even more recent articles in the google link I gave you above, and the two study links above are just a taster. Resistance testing has been the standard of care for years now and is hardly "experimental". Insurance companies will do anything to get out of paying out and as long as people let them get away with it, they'll continue doing it. I hope you fight them.
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Offline PortlandPoz

  • Member
  • Posts: 6
Hey Ocean1617,

It's difficult enough to have to deal with this nasty disease much less have to worry about how to pay for being treated and taken care of.

If the lab you went to was in the Blue Cross network and the insurance company said they are not covering it then you shouldn't be responsible for it either assuming you have a PPO or HMO.

I agree with Ann on this- Blue Cross needs dragged up to speed here. I'd definitely take the time to appeal this and provide a letter from a board certified doctor that specializes in HIV to back up your request.

Best of luck to you!


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