Looking Back: Pharmacogenomics in 2019

    Looking Back: Pharmacogenomics in 2019 January 28, 2020 [smart_track_player url="https://media.blubrry.com/darshantalks/content.blubrry.com/darshantalks/ep156_looking_back_at_pharmacogenomics.mp3" title="Looking Back: Pharmacogenomics in 2019" color="#FF5722" social_linkedin="true" social_email="true" tweet_text="Check this @darshantalks podcast on #pharmacogenomics in 2019!"] [learn_more caption="Read Transcript" align="right"] Darshan: Hey everyone. Welcome to another episode of Darshan Talks. Today's episode is going to be about pharmacogenomics. So the first thing to ask is what exactly is pharmacogenomics? Intro: This is the Darshan Talks Podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter, @Darshantalks or the show's website at Darshantalks.com. Darshan: So pharmacogenomic tests are aimed at identifying genetic variations that suggest that a patient may have an unusual reaction to a specific medication. A pharmacogenomic test may therefore be useful if a patient has shown an unexplained or otherwise unexplainable reaction to a certain medication. However, the scientific evidence supporting pharmacogenomic testing in the vast majority of cases remains relatively slim. There are obviously exceptions to this. So coverage wise, between 2015 and 2018, Medicare payments for genetic test more than doubled. They went to well over $1 billion in 2018. So obviously these genetic tests have become a lot more common and there are financial incentives behind this. Darshan: To date, Medicare has generally recognize that pharmacogenomic testing and other genetic tests are medically necessary in only a very narrow set of cases. Some Medicare contractors have issued numerous local coverage decisions making that clear. However, where no local coverage decision is at issue, a test must still be medically necessary and thus the absence of a local coverage decision may mean that it may raise the question of whether something is reimbursable. However, just because it's not written out there doesn't mean that it doesn't meet the medical necessity standard. Darshan: The Medicare claims processing manual explains the screening tests, genetic or otherwise, are generally not covered by Medicare. A practitioner who routinely performed genetic tests on patients regardless of each patient's clinical history and presentation would therefore potentially fall foul of Medicare requirements. Now, having said all of this, the US Department of Justice announced criminal charges against 35 individuals across various jurisdictions allegedly involving genetic testing fraud and this went to over $2.1 billion, and the government asserted that these individuals had engaged in targeting seniors and disabled through various cancer screenings. So these cancer genetic tests were performed to screen patients for genes that may show whether a patient is predisposed to developing certain cancers. Darshan: The federal government has launched over 300 investigations into alleged fraud in genetic testing, many of which are actually probably ongoing. Having said all this, let's look at a couple of different examples. Outside the actual Operation Double Helix, there's the UTC lab settlements. On October 9th, pharmacogenetic pet lab test, UTC labs and three of its principles, the lab agreed to pay for $41.6 million with three separate individuals being responsible for another $1 million. The case resolved allegations brought by whistle blowers that the lab paid kickbacks to doctors as well as marketers for medically unnecessary tests. The physician kickbacks were, as the government described them, thinly disguised as seemingly legitimate payments for work done by UTC led clinical study.