Benefits, Beneficence, and Bending Ethics: Questionable Billing Practices for Multigene Panels?

Germline multigene panel testing is the new hot thing in genetic counseling circles. For the last 15 or so years, the equation has read “Breast Cancer Genetics = BRCA Testing,” with the occasional TP53, PTEN, STK11, or CDH1 test thrown in when we thought we were being clinically astute and smarter than the non-geneticsts at Tumor Board. But now, thanks to the discovery of other genes linked to hereditary breast cancer along with the miracle of massively parallel sequencing, we can test patients for a bucketful of genes in one fell swoop without significantly increasing the cost. We debate the wisdom of including some of the genes on these panels, differences in laboratory quality, the clinical value of the information, and – everybody’s favorite – high rates of variants of uncertain significance. These are  important issues but here I want to discuss an ethically gray practice that has not received much public airing – billing health insurers for multigene panels.

Here in the beautiful Pacific Northwest, roughly half of the health insurance companies cover multigene panels. Not uncommonly, patients will request “that new gene test” that their friend told them about. Counseling issues aside, many patients are disappointed when they learn that if they want a multigene panel, their insurer will not pay for it and they will have to fork over $1500-$4100 of their own hard-earned money. But word on the street – and I am not naming names since I don’t have personal experience with this phenomenon yet – is that some patients are managing to get gene panels covered by their insurers even when their carriers have explicit policies against such testing.

I have been told – and again I acknowledge that I do not have hard proof of this – that some labs are running the panels but not letting insurers know that a multigene panel test was performed. This is partially due to the insurance coding game. The billing codes for BRCA testing are the same as the billing codes for multigene panels, so on one level, insurers are blind to the distinction between the two tests and might never know that their policyholders are not exactly getting the test that the insurer paid for. If  labs eat these costs in full, well, that’s their own business decision and not an ethical lapse (although I wonder how many write-offs a lab can absorb while still maintaining profitability).

If this deceptive billing practice is indeed taking place, it is hard to believe that labs are doing this strictly out of the goodness of their hearts or entirely out of concern for the health and well-being of patients. Genetic testing for hereditary breast cancer has become highly competitive and labs are intensely vying for market share since the US Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics opened up BRCA testing to all labsIf labs are engaging in this practice, it is likely because they want to win the favor of major cancer centers that can provide millions of dollars of business.

Billing an insurer for a test when the lab is aware that the insurer does not cover it, and not letting the insurer know which test was actually run, strikes me as dishonest rather than just bending the rules. And if we genetic counselors stand silently by and allow this to transpire, we are accessories to this moral – and legal? – infraction. It may also cause insurers like Cigna to rethink their policy of requiring a consultation with a genetic counselor before approving coverage for genetic testing. We are, after all, supposed to be conscientious about their guidelines when we order genetic testing for their policyholders.


RULES2

Now let me be clear. I am (mostly) a supporter of gene panel testing and think it should be a covered benefit, though I must admit that I am a bit disappointed in the low yield of actionable positive results beyond BRCA. I have spent an inordinate amount of time appealing these policies, with little success. It is frustrating for me and it makes patients unhappy when their insurer does not cover a test that care providers think could be useful.

Sure, we want what we think is best for patients, and yes insurance company policies can be maddening. But that does not provide moral justification for deceiving insurance companies. The ends do not justify the means. Instead, it should put the burden on us to continue to appeal the policies through established channels and to perform research studies that assess the clinical value of testing for genes such as NBN, RAD51C, or PALB2. Insurers have a valid point when they say that there are inadequate data to determine the clinical utility of multigene panel tests for their policyholders.

I hope that what I have been told is incorrect. If so, then we can write this posting off as based on unverified rumors. But if there is some truth to it, then we need to have a hard and thoughtful discussion. I am interested in hearing the experience of others with insurance coverage for multigene panels.

 

– Thank you to Emily Singh for help with the graphics.

12 Comments

Filed under Robert Resta

12 responses to “Benefits, Beneficence, and Bending Ethics: Questionable Billing Practices for Multigene Panels?

  1. Anonymous

    With the billing changes that took place recently, CPT codes are now per gene name and not based on methodology. Therefore, for any given CPT code there is no difference in the price the insurance company will reimburse for if the sequencing is accomplished by either Sanger or NGS. My understanding is there may be some more legitimate reasons for not billing for all genes included in the panel.
    1) There is a difference between tier one CPT codes and tier two codes. Most insurance companies are not reimbursing for tier two codes, so a lab may not bother to billing for tier two genes. Therefore, for a given panel only the tier one genes are billed for and the insurance company would not know that the tier two genes were also sequenced.
    2) Adding up all genes included in the panel and their potential reimbursement could make the price of a panel extremely high. Therefore a lab may cap the price at a certain profit margin; again leading to not all genes in the panel being billed for.
    I can see the concern raised in the post that this may not be a practice GC’s would want to endorse if it was purposely coming from a place of deceiving an insurance company, but we may want to keep in mind the above points as well.

  2. Erica Ramos

    This is a very important issue, but it is very possible that this is more lab choice due to the implementation of the gene-specific MoPath codes, rather than the stacked CPT codes we all came to know and love.

    For example, according to their website, Ambry bills 81211×1, 81213×1 for BRCA sequencing and del/dup testing and 81211×1, 81213×1, 81321×1, 81323×1 for their 5-gene breast panel. The first two are completely specific to BRCA testing and the second two are for PTEN and cannot be used for reimbursement for the testing of any other breast cancer-related gene. So, it appears that Ambry is not seeking reimbursement for the other three genes in the panel.

    If a lab chose to bill the insurance for only the BRCA codes in a panel, they would get reimbursed but as you said, that would be lab choice not a breech of ethics. And that might not be such a bad idea for now, if they want to collect data on the diagnostic yield, get data on VUS rates, etc. All of that data will help them significantly in establishing better reimbursement rates for the panels in the future.

  3. Anonymous2

    Additional to the comments above, many genes do not even HAVE a code assigned to them, so must be billed under a generic code, which is generally not reimbursed; so many labs do not bother to include it.

  4. Anonymous

    I agree with the comments above. Please also keep in mind that the insurance companies ARE made aware of which test is being done and the medical necessity of that testing, in the letter of medical necessity that they so often require for reimbursement. This is written by the clinician, not the laboratory, and the test ordered is documented.

  5. Anon

    I will add that the guiding principles of autonomy, beneficence, nonmaleficience, and justice should be in the forefront. How is it just to provide different services (tests) to patients with similar histories?

    NEJM recently published a major study on PALB2 mutations and the risk of breast cancer. Are we saying that we should be waiting for CMS to create and publish a 5 digit number for PALB2 before offering this testing to our patients?

    As a genetic counselor, I consider myself an ethical individual working in an ethical field hoping to improve a health care system (i.e. insurance system) that is not at all ethical. Rather than place blame on the companies that work within the system that exists in this country, we need to work to improve care for all of our patients.

  6. anon

    About 10 years ago I recall reading an insurance policy that specifically excluded coverage for “all forms of genetic testing.” Yet, they were routinely paying for amnios with karyotyping and often times also carrier screening and/or fetal single gene tests. My conclusion was that insurance companies are incapable of understanding this field and routinely write policies that they themselves do not understand.

  7. Anon

    To play devils advocate- the panels have gotten bigger, but this practice isn’t new. Some Lynch panels began including genes that weren’t reimbursed (like MUTYH) before large panels could included BRCA1/2. Labs just threw them in because it was simpler and it was good for patients. BRCA rearrangement testing was done for free on the highest risk patients, and the data eventually helped contribute to the changes in policies. It was not as obvious when it was one or two “freebies” on a panel and it doesn’t seem like anyone questioned the ethics. It may feel different when the number of genes not reimbursed gets bigger than the ones payed out, but is it really? The number of genes included doesn’t correlate to cost the way it used to.

    In non-genetic medical procedures, this happens all the time. Insurance companies will pay for parts of the procedure but not others- eg reimbursing for a basic mammogram when tomosynthesis was performed. They know what was done, they just only pay for the basic procedure code. Dental insurance pays the rate and CPT code for a metal crown when you got porcelain. Its up to the provider to determine if they want to balance bill or charge the difference. Insurance billing and reimbursement is a relatively ridiculous process across the board, not just in genetics.

    I agree that it is important for us to keep our eye on the future and practice in a way that contributes to the growing evidence for medical necessity and clinical utility in newer genes- but I don’t know if the billing practices of individual labs is going to hinder the progress.

  8. Rob, you are correct that this is happening. More to the point, it is interesting that some labs have two different TRFs and test kits, one that is online for BRCA related testing, and other that is not seen online, is associated with testing for a panel of genes, and which has a test kit of its own….most clinicians wouldn’t know the difference and can’t tell you what is on their shelves. If the labs chooses start to wean off of the former test kit, they will be directing testing strategy. Not all labs are doing this.

    As director of a company which places genetic counselors, I think that it is interesting the number of calls which I receive from ‘researchers’ for investment companies asking…what are genetic counselors doing with the panel options, what labs are they choosing, why, what do they think of the importance of variant information sharing, etc. ( I have not accepted any consultancy work in this regard, mind you)

    How we behave at this juncture is under observation. Let’s keep these discussions going.

    Bonnie Liebers MS CLGC
    Director of Clinical Services
    http://www.geneticcounselingservices.com

  9. Robert Resta

    Thanks to everyone for their thoughtful comments. I hope that this discussion will continue in multiple venues. A few points I would like to add here.

    I am not placing all the blame on labs, or even a significant portion. The US healthcare system is very, very complicated and very, very ineffecient. The complexity of billing codes would give a headache even to a Rabbinic scholar of the Talmud. I tell my patients that genetics is simple compared to insurance and billing.

    The complexity and ineffeiciency stems from many sources – not just labs, counselors, physicians, hospitals, insurers, etc. Everybody contributes to it in their own ways to varying degrees,and with varying degrees of self-awareness. In my view, while I am not a big fan of health insurers, I think one is using too broad of an ethical stroke when you paint them as the source of all evil in the health care system.

    But whatever our feelings about insurers, labs, ##@!!% billing codes, and counselors, for me it is hard to justify dishonesty. Honesty is an underlying critical aspect of autonomy. beneficence, and nonmaleficence. If we ain’t honest, we have no business pointing our fingers at anybody else. Honesty, as the saying goes, is the best policy.

    Though we may have studies that make us feel more confident about the cancer risks of some of the genes on these panels such as PALB2, we really don’t have empirical data on how knowledge of such risks improve morbidity, mortality, quality of life, emotional well-being, etc. for any specific gene beyond BRCA. In part this is because small sample sizes are an occupational hazard of genetic disorders. Which is another call for us to roll up our sleeves, get behind the mule, and start plowing the field of research.

    And I still acknowledge that I am may be making a big to do over nothing. But I haven’t yet heard from anyone saying that these possibly questionable billing practices are not happening.

  10. Pingback: VUS iz dos? Suggestions For A Reasonable Policy On Reporting Genetic Variants of Unknown Significance. | The DNA Exchange

  11. Pingback: Make Me Wanna Holler | The DNA Exchange

  12. Tom

    I’m a bit disappointed in my genetics counselor and test lab behavior. I now realize I should have been tested for only vonHippel-Lindau and PTEN, but the counselor recommended a “full” test panel. The counselor was confident my insurance would cover it and the lab would confirm. The lab never contacted me about insurance authorization. Upshot months later is BCBS Illinois denied all claims, leaving a $23,000 bill up in the air. I’m still deciding on my next course of action.
    Genetics counselors need to be aware of insurance medical policies on various genetic tests, by carrier. This information is easy to find on the internet. One thing for sure is insurance companies have stringent thresholds for deciding if they will authorize. Recommending and ordering a full panel just because it might “fly” is professional nonsense.
    Tom
    Tacoma, WA

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s