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Is HIV Genotyping and Phenotyping for Drug Resistance experimental Procedure?
Aug 15, 2012

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, can you please address 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.

Response from Mr. Chambers

(1)I disagree and encourage you to appeal the denial. Genotyping and phenotyping are no longer experimental or investigational. There is ample peer reviewed literature to support this.Your doctor will be able to point to you literature and studies that support they are no longer experimental. There is documentation of states approve them as appropriate under Medicaid. Medicare, as I recall, covers them also. Blue Cross/Blue Shield even agrees according to this document.

(2) Let the lab know you are appealing the denial. They may be able to assist with the appeal by providing documentation as well.

(3) Absolutely you should appeal to your state's Department of Insurance and appeal the denial directly to BC/BS as well. An appeal is the only way to get their decision reversed.

(4) Future tests will depend on your doctor. I would assume there will be future tests.

However, if they reverse the experimental denial it is entirely possible they will then try to deny it as "Not Medically Necessary."

Should that happen, I encourage you to continue work with your doctor and lab to show that it is necessary, and I'm sure your doctor can find ample documentation supporting its necessity to HIV infected persons.

Please appeal. Your booklet and the denial letter should both give you directions on how to appeal. Your doctor should be willing to help you with this.

Good luck, Jacques



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