WEBVTT

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Hello and welcome to today's webinar,

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the Value of Dex Z Codes,

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empowering payers with genetic
test identification and

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quality insights.

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Before we get started,

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I'd like to review a few
housekeeping details.

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Today's webinar is being
recorded and an online archive of

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today's event will be available
within one to two business

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days.

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If you have trouble seeing the
slides at any time during the

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presentation,

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please press F five to
refresh your screen on a PC or

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command R. If you're using a Mac,

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you may ask a question at any
time during the presentation

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by typing your question into
the q and a box located on the

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right side of your screen
and pressing enter.

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And finally,

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I'd like to remind you of
a hip's antitrust statement

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located in the link just below
the slide viewer. We will,

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as always, comply with that statement.

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Among other things,

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the antitrust statement
prohibits us from discussing

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competitively sensitive information,

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and we're very fortunate
to have with us today,

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Kristi Radford, product director at Optum.

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And Dr. Megan Landsberg from Palmetto,

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G B A a Medicare
administrative contractor.

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And at this time,

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I'd like to turn the floor
over to the speakers.

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Hi everyone, I'm Kristi Radford.

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Hold on one second while
I figured this out,

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even though we did this
like two times before.

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So as was mentioned, you know, Dr.

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Ensberg and I are here today
to talk to you about the value

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of d z codes in the commercial space.

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We're taking a little bit
different spin in the sense of,

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as you heard,

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we are both individuals with
genetics background, right?

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We're not your typical
product individuals.

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And we really wanted to
accomplish three main goals today.

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One, we wanted to everybody to
realize molecular testing is

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complex, right?

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There is a reason there
are degrees in genetics.

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We have done our best to
present this at a high level.

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However,

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I did see that there was some
people registered that have

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genetics backgrounds.

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So if in some of our
clinical examples you say,

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wait a second, that's, that's
not exactly how it works,

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that's a little basic. Or you've,

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you've missed some nuances and
some technical details yet,

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you're probably right.
We did that on purpose.

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Sometimes we get told we
nerd out a little too much.

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So we try not to do that on this call.

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Two,

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identification and quality of
genetic tests are essential,

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right? When we think about this,

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we have to be able to identify
a test and we have to be able

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to assess its quality to drive
positive patient outcomes,

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as well as to ensure
financial stewardship.

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And then three, the
value of Palmetto G B A.

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So as you've heard, Dr.

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Landsberg is an employee
of Palmetto, G B A,

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and in her section,

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what she's really gonna do is
try to show you what they do

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to ensure that tests are
identified appropriately and how

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they do technical assessments.

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So I think this is a slide
that isn't news to anybody.

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We've probably all seen it
in one way or another, right?

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Genetic tests are complex,
technology's exploding every day.

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There's more tests on the market,

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and there's a limited
number of C P T codes.

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And with this becomes challenges, right?

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It's not a one-to-one ratio.

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We can't simply say test
A is test a right? Test.

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A could be represented by test
B, C and D C P T code one,

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two, and three.

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There's so many permutations
that makes your head hurt,

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right? Every day there's more tests.

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And then when we think about
the quality in the utility of

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these tests, it gets even more confusing.

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Dr.

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Lansford and I have both worked
at laboratories ourselves,

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so we've been on the other side as well,

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and know how much time and
effort goes into making quality

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tests and translating this to the public.

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So as you heard of the intro,

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I am part of the Optum L B M team, and Dr.

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Lansford is part of the
Palmetto G B M team.

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Together with our colleagues
at Optum Genomics and also at

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Avalon Healthcare Solutions,

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we provide an end-to-end lab
benefit management solution

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that aligns health plans,
providers and labs.

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So this joint offering consists
of six main components that

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you see on this wheel. Network management,

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payment integrity, utilization management,

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clinical decision support,
policy development, and finally,

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test identification and quality.

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As you probably guessed,

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test identification quality
is what we're gonna focus on

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today.

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And we are really gonna do a
deep dive into this using the

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clinical example of carrier screening.

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So you may think carrier screening,

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if you have an oncology background
or we're hoping for that,

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yeah, please, please don't drop, right?

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You can stay on and either
learn some things or gloss over

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until we get to some other
pieces that you might be more

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interested in. But we
really wanted to, you know,

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do the deep dive here because it,

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it is a significant
amount of spend, right?

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Like when we think about the
commercial line of business,

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the commercial line of business
is different than Medicare,

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right?

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You typically don't deal with
pregnancies in me Medicare.

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So when we look at total spend,

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it really averages 10 to 20%
of a payer's spend in the

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commercial space.

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Additionally, a lot of these
genes and conditions, right?

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There's gene therapies
emerging on the market.

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This market is expected to
grow fourfold and of even more

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interest, right?

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Last year when we think about
all the novel drug approvals,

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over half of those were for rare disease.

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So this is not a market
that's slowing down and these

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therapies are not inexpensive.
They often range to,

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you know, 300,000 a year,
sometimes a million adults.

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And then finally, whether, you know, we,

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we want it to happen or not, fraud,

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waste and abuse does happen.

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And carrier screening has
made the headlines recently.

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So switching from the financial
aspects to the patient

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outcomes and the member impact,

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the other reason we chose
this is members take action.

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When you look at, you know,

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if a couple knows their
carrier screening status,

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60 to 75% do something about it.

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So that could be during
their current pregnancy,

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they make decisions, right?

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They make future
pregnancy decisions on it,

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or they use this information
to prepare for the birth of an

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affected child.

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You know, that's important.

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When we think about the
diagnostic odyssey in the us,

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the average time it takes to
diagnose some of these rare

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conditions is seven years.

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So if we know this, you know,

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prenatally or even before
an individual is pregnant,

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we're able to, you know,

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save a lot of time and
also improve outcomes.

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And then finally,

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there are a lot of autosomal
recessive conditions greater

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than 2000, right?

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And there are a lot of tests out there.

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So if we think about all the
carrier screening tests on the

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market,

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probably way greater than
250 different combinations.

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When you think about pick
a gene, pick this gene,

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use this panel, use that, I mean,

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it really makes your head hurt.

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We do this every day and you know,

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we were trying to come up with
these numbers and thinking

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like there's just way,
way too many out there.

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So in order to understand some
of the nuances we're gonna

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talk about today,

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it helps to have a basic
understanding of carrier screening.

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Carrier screening tests.

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An individual's D N A determine
their risk for having a

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child with a certain genetic condition.

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So as I said earlier,

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this information can be used
to for alternative reproductive

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options or to prepare for a
birth of an affected child.

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The most common and classic
condition is Tacs disease.

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And this is represented on
the right hand side of your

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screen. So Tacs disease,

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like many tests that are many
diseases that are screened for

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is autosomal recessive, okay?

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And by autosomal recessive,

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we mean it takes two copies
of a gene not working to have

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the condition. So if we
think about this picture,

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we have on the left side
a father with a white dot.

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That white dot means the,

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there's a mutation in what's
called the hex a gene that's

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not working. And then on the right side,

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in the purple color,

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we have a carrier mother with a white dot,

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which means that particular
gene is not working in the mom.

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So these would be considered
individuals that are carriers.

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Now, when they go on to have
children on the left side,

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you'll see what's called
an unaffected carrier.

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So in this situation, right,

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the father TA passes on that light green,

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the mother passes on that light purple.

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The child has two working
copies of that p a gene in the

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middle, that's called unaffected carrier.

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Just like the parents,

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there's one individual that
has two individuals that have a

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copy of that gene not working.

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And then on the right hand side,

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we have an affected individual.

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So as you can see,

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it's a one in four chance of
parents or carriers for that

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child to have the condition.

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Taste X is what we consider
the classic example, right?

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Because one, when we think
about diseases we test for,

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we always think of some
of the most severe,

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when we think about sac, it's
a lysosomal storage disorder.

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So think about accumulation, right?

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If the HX a gene is not working,
lots of things accumulate,

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the body can't work correctly
and the neuro system starts to

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degrade. So you have this happy,

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healthy baby and then suddenly
six months, 12 months,

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they stopped developing
correctly. And unfortunately,

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most of these individuals, you know,

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pass away and die at age by age three.

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So I think we would can all
agree that this is a pretty

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significant and severe condition, right?

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That ability to be able to
screen for these individuals,

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you know, really started the
carrier screening in the 1970s.

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So synagogues were able to use
this information and actually

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test parents not from
a genetic standpoint,

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but looking for a reduced
enzyme amount and say, yep,

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looks like you could have a kid
with this condition and they

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would arrange marriages where
the chance of having this

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condition decreased. And
these programs worked.

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So over the course of several decades,

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this actually reduced the
incidence of Tay-Sachs disease by

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90%.

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Fast forward, we were able
to test via genetic testing.

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So two mutations account for
the majority of mutations in

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Tay-Sachs in the Ashkenazi
Jewish community.

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So if you look at this gene here,

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we have two orange dots
kind of in the middle,

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one off at the side. So what
we mean by targeted testing,

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it was we,

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we would look at the gene and
test for the specific orange

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dot, okay?

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What we mean by full gene
analysis is we would read the

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entire gene. Okay?

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So there's a difference because
let's say you only looked at

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those two dots in the middle
and the person happened to have

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a dot on the left, you
would miss this, right?

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But to help make sense of
carrier screening and what to do

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over time, two main
guidelines came into play.

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So one is American College of
Medical Genetics guidelines,

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and the other is the ACOG guidelines,

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which we'll touch on briefly in a minute.

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So looking at the evolution
of carrier screening,

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as I mentioned,

250
00:10:52.550 --> 00:10:56.750
TAY Sacs in the 1970s rate
really is what kicked off carrier

251
00:10:56.750 --> 00:10:59.410
screening. Then as we
progressed through time,

252
00:10:59.410 --> 00:11:01.470
we started testing for cystic fibrosis,

253
00:11:01.470 --> 00:11:03.260
some other gennet conditions, right?

254
00:11:03.260 --> 00:11:05.490
Then as time passes, we learned,

255
00:11:05.490 --> 00:11:08.230
we can look at more places in the gene,

256
00:11:08.230 --> 00:11:09.410
we find more mutations.

257
00:11:09.410 --> 00:11:12.590
Now there's 800 plus mutations
in some of these genes,

258
00:11:12.590 --> 00:11:16.040
right? So, you know, we wanna
keep evolving and saying,

259
00:11:16.040 --> 00:11:18.870
let's look at more genes like
let's look at more pieces of

260
00:11:18.870 --> 00:11:20.450
these genes, right?

261
00:11:20.450 --> 00:11:23.950
The number of genes identified
and able to be tests for

262
00:11:23.950 --> 00:11:25.290
continues to grow.

263
00:11:25.290 --> 00:11:26.830
And then if you look at this bottom,

264
00:11:26.830 --> 00:11:28.510
I have something called Sanger sequencing.

265
00:11:28.510 --> 00:11:31.550
Think of that as that diagram
before one gene at a time or

266
00:11:31.550 --> 00:11:33.410
pieces of a gene at a time, right?

267
00:11:33.410 --> 00:11:36.330
That's why you'll see, you
know, it took a long time,

268
00:11:36.330 --> 00:11:38.240
you know, what is this like 20, you know,

269
00:11:38.240 --> 00:11:42.460
years for various screening
protocols really to emerge.

270
00:11:42.460 --> 00:11:45.350
Then technology started changing
into something we call next

271
00:11:45.350 --> 00:11:48.190
generation sequencing. So with
next generation sequencing,

272
00:11:48.190 --> 00:11:50.210
we look at a bunch of genes at one time.

273
00:11:50.210 --> 00:11:51.960
So for simplicity's sake,

274
00:11:51.960 --> 00:11:55.700
let's say all of these conditions
right here have one gene,

275
00:11:55.700 --> 00:11:57.140
all of a sudden with one swoop,

276
00:11:57.140 --> 00:11:59.990
we look at all of these
and we can say, okay,

277
00:11:59.990 --> 00:12:02.300
does this individual is,

278
00:12:02.300 --> 00:12:05.160
are they a carrier for a
mutation associated with one of

279
00:12:05.160 --> 00:12:06.350
these conditions?

280
00:12:06.350 --> 00:12:09.730
Then in 2010, things really
started changing, right?

281
00:12:09.730 --> 00:12:13.400
Technology started emerging
for what I just described as

282
00:12:13.400 --> 00:12:15.740
being able to test lots
of genes at once, right?

283
00:12:15.740 --> 00:12:19.420
We found out that cystic
fibrosis had over 2000 mutations,

284
00:12:19.420 --> 00:12:22.700
so it really didn't make sense
to be testing for only a few.

285
00:12:22.700 --> 00:12:25.400
And one laboratory came out
and said, you know what?

286
00:12:25.400 --> 00:12:26.820
We've got this new way of doing things.

287
00:12:26.820 --> 00:12:28.660
We can look at this long genetic tail.

288
00:12:28.660 --> 00:12:30.820
You don't need to look
at five or 10 conditions.

289
00:12:30.820 --> 00:12:32.400
We can now look at, you know,

290
00:12:32.400 --> 00:12:34.780
over a hundred conditions at a time.

291
00:12:34.780 --> 00:12:37.680
And that is really when expanded
carrier screening began to

292
00:12:37.680 --> 00:12:38.513
take off.

293
00:12:39.620 --> 00:12:43.180
If we overlay this with the
guidelines I mentioned briefly,

294
00:12:43.180 --> 00:12:47.240
you can see that cystic fibrosis
guidelines followed cystic

295
00:12:47.240 --> 00:12:50.470
fibrosis, you know, carrier
screening availability, right?

296
00:12:50.470 --> 00:12:53.660
Then there's more meetings,
there's more guidelines.

297
00:12:53.660 --> 00:12:56.440
So cystic fibrosis tac then hey wait,

298
00:12:56.440 --> 00:12:58.350
there's more mutations.
What do we do with this?

299
00:12:58.350 --> 00:13:00.260
More cystic fibrosis guidelines.

300
00:13:00.260 --> 00:13:03.230
Now we've got Ashkenazi
Jewish panel guidelines,

301
00:13:03.230 --> 00:13:04.640
Eastern European, right?

302
00:13:04.640 --> 00:13:06.660
You see the trend here?

303
00:13:06.660 --> 00:13:09.330
Then carrier screening happens,

304
00:13:09.330 --> 00:13:12.760
or expanded carrier screening
happens. Here's our paper,

305
00:13:12.760 --> 00:13:13.210
right?

306
00:13:13.210 --> 00:13:16.570
The the new tests are starting
to emerge and what happens?

307
00:13:16.570 --> 00:13:19.970
We suddenly see not a lot of
single gene tests anymore,

308
00:13:19.970 --> 00:13:22.730
but we see a whole heck of
guidelines. A lot of guidelines.

309
00:13:22.730 --> 00:13:27.730
So ACOG in 2011, CF only A C M G 2013,

310
00:13:27.780 --> 00:13:29.850
what should we do for expanded screening?

311
00:13:29.850 --> 00:13:31.820
Now there's another
one, what should we do?

312
00:13:31.820 --> 00:13:34.020
Okay, another one for what should we do?

313
00:13:34.020 --> 00:13:35.550
Acog, again, carrier screening.

314
00:13:35.550 --> 00:13:39.390
Now we've got a C M G
2021, and even my society,

315
00:13:39.390 --> 00:13:41.870
national site genetic
counselors in 2023 came out with

316
00:13:41.870 --> 00:13:43.210
carrier screening, right?

317
00:13:43.210 --> 00:13:47.190
So we switched from single
gene one paper to a whole bunch

318
00:13:47.190 --> 00:13:50.940
of lots of genes, and
what the heck do we do?

319
00:13:51.950 --> 00:13:55.110
So let's put this in perspective
of a patient in the clinic.

320
00:13:55.110 --> 00:13:56.950
We have a 32 year old female.

321
00:13:56.950 --> 00:13:59.420
She prevents presents for
her first prenatal visit.

322
00:13:59.420 --> 00:14:00.610
She's nine weeks pregnant.

323
00:14:00.610 --> 00:14:02.240
This seems pretty straightforward, right?

324
00:14:02.240 --> 00:14:05.420
Pretend you're the clinician, alright?

325
00:14:05.420 --> 00:14:06.180
In this visit,

326
00:14:06.180 --> 00:14:08.880
you need to discuss the
personal medical history, right?

327
00:14:08.880 --> 00:14:10.400
You need to discuss the family history,

328
00:14:10.400 --> 00:14:13.650
which also includes what's
her partner's family history,

329
00:14:13.650 --> 00:14:16.180
right? You've gotta go over
her general health exam,

330
00:14:16.180 --> 00:14:18.600
you've gotta talk about
laboratory tests and order them,

331
00:14:18.600 --> 00:14:19.150
right?

332
00:14:19.150 --> 00:14:22.110
Some of these taken form
consent that has to be covered.

333
00:14:22.110 --> 00:14:25.120
It's also stated that in this
first visit you need to cover

334
00:14:25.120 --> 00:14:26.180
carrier screening.

335
00:14:26.180 --> 00:14:28.550
And then I added on
here patient questions.

336
00:14:28.550 --> 00:14:31.640
Because in the genetics
world in OB G Y N world,

337
00:14:31.640 --> 00:14:34.080
we all know what happens a
lot of times at this visit.

338
00:14:34.080 --> 00:14:36.240
A when am I gonna get that
test that's gonna tell me the

339
00:14:36.240 --> 00:14:38.640
gender, because I really wanna
plan my gender reveal party,

340
00:14:38.640 --> 00:14:39.500
right?

341
00:14:39.500 --> 00:14:42.440
All of this information needs
to be accomplished and an

342
00:14:42.440 --> 00:14:45.590
average of typically
nine to 16 minutes, okay?

343
00:14:45.590 --> 00:14:46.700
Kind of insane.

344
00:14:46.700 --> 00:14:48.840
So we haven't even done a
deep dive into what all this

345
00:14:48.840 --> 00:14:51.740
means, but let's just take care
of your screening, you know,

346
00:14:51.740 --> 00:14:54.930
by itself and say, what
do the guidelines say?

347
00:14:54.930 --> 00:14:57.800
This is, you know, almost
word for word what they say.

348
00:14:57.800 --> 00:14:59.840
If your doctor's office,
you pick a strategy,

349
00:14:59.840 --> 00:15:02.520
you pick either ethnic
specific, you pick pan-ethnic,

350
00:15:02.520 --> 00:15:04.310
or you pick expanded carrier screening,

351
00:15:04.310 --> 00:15:06.790
those are all acceptable.
So just pick a strategy,

352
00:15:06.790 --> 00:15:09.020
stick with it and you're
okay. But guess what?

353
00:15:09.020 --> 00:15:11.740
If a patient comes in
and they say to you, oh,

354
00:15:11.740 --> 00:15:12.760
I want this other test,

355
00:15:12.760 --> 00:15:14.820
or I was on Google and I found
this other one, I want this,

356
00:15:14.820 --> 00:15:15.060
well,

357
00:15:15.060 --> 00:15:17.210
then you need to be prepared
to offer it to the patient,

358
00:15:17.210 --> 00:15:20.320
explain it to them,
neither refer or you know,

359
00:15:20.320 --> 00:15:23.630
do the informed consent
genetic counseling yourself and

360
00:15:23.630 --> 00:15:26.050
accomplish that for your patient, right?

361
00:15:26.050 --> 00:15:28.320
Then there's certain conditions
you should be including.

362
00:15:28.320 --> 00:15:32.520
So you should include cf,
ss, m a, thal, thalassemias,

363
00:15:32.520 --> 00:15:34.960
you know, fragile X depending
on the family history.

364
00:15:34.960 --> 00:15:35.680
And then wait,

365
00:15:35.680 --> 00:15:37.900
you might need to do even
more testing depending on the

366
00:15:37.900 --> 00:15:38.500
family history.

367
00:15:38.500 --> 00:15:41.620
So now you've gotta be able
to assess how do I in this 15,

368
00:15:41.620 --> 00:15:43.260
20 minutes also get all the information,

369
00:15:43.260 --> 00:15:46.090
the family history and
make sense of this, right?

370
00:15:46.090 --> 00:15:47.640
It's not realistic.

371
00:15:47.640 --> 00:15:49.140
So as a genetic counselor, right,

372
00:15:49.140 --> 00:15:52.200
we always try to take complex
information, put it in simple,

373
00:15:52.200 --> 00:15:55.890
simple ways to help our clinical teams.

374
00:15:55.890 --> 00:15:58.360
This is simple, I think
it's clear as mud, right?

375
00:15:58.360 --> 00:16:00.810
So we take the A C M G guidelines,

376
00:16:00.810 --> 00:16:03.680
it's represented by
square ACOG's, a triangle,

377
00:16:03.680 --> 00:16:06.860
and if both of them recommend
screening for a particular

378
00:16:06.860 --> 00:16:08.800
condition, it's a square.

379
00:16:08.800 --> 00:16:11.740
If we were following ethnic
specific, I would say, okay,

380
00:16:11.740 --> 00:16:14.120
that lady's Caucasian.
I'm gonna test for here.

381
00:16:14.120 --> 00:16:15.620
If we're looking at pan-ethnic,

382
00:16:15.620 --> 00:16:17.720
I would more have a
protocol that says, okay,

383
00:16:17.720 --> 00:16:22.380
I'm gonna test for those genes
that are gene mutations most

384
00:16:22.380 --> 00:16:25.610
common in all ethnicities, right?

385
00:16:25.610 --> 00:16:26.950
And if I was doing expanded,

386
00:16:26.950 --> 00:16:29.790
I would say I do pan-ethnic
plus a whole bunch of other

387
00:16:29.790 --> 00:16:31.960
conditions, which could
be 10, could be 20,

388
00:16:31.960 --> 00:16:34.410
could be hundreds, right?

389
00:16:34.410 --> 00:16:34.960
Not simple.

390
00:16:34.960 --> 00:16:37.390
Guidelines are definitely
complicated when it comes to

391
00:16:37.390 --> 00:16:38.890
carrier screening.

392
00:16:38.890 --> 00:16:40.800
So we have this 32 year old woman,

393
00:16:40.800 --> 00:16:42.250
she's nine weeks pregnant,

394
00:16:42.250 --> 00:16:44.290
her paperwork states she's Caucasian.

395
00:16:44.290 --> 00:16:46.970
She also reports a family
history of developmental delay

396
00:16:46.970 --> 00:16:49.450
autism. We go to her handy sheet,

397
00:16:49.450 --> 00:16:53.310
I'm following a ethnic
specific protocol in my office.

398
00:16:53.310 --> 00:16:56.340
Cystic fibrosis should be
done, fragile acts and SS m a.

399
00:16:56.340 --> 00:17:00.660
Alright, I got this right,
this, this makes sense.

400
00:17:00.660 --> 00:17:03.210
Well, let's talk about CF for a second.

401
00:17:03.210 --> 00:17:03.570
You know,

402
00:17:03.570 --> 00:17:06.610
we don't have time today to
talk about SS m A and fragile X

403
00:17:06.610 --> 00:17:09.230
in addition. But when we
think about cystic fibrosis,

404
00:17:09.230 --> 00:17:12.750
this is the most common life
limiting autosomal recessive

405
00:17:12.750 --> 00:17:14.890
condition in Caucasians, right?

406
00:17:14.890 --> 00:17:16.710
In in this condition,

407
00:17:16.710 --> 00:17:21.010
mutations in the CF t r gene
really make things kind of like

408
00:17:21.010 --> 00:17:22.810
mucusy sticky, right?

409
00:17:22.810 --> 00:17:25.470
So if you think about the
lungs, you get a lot of mucus,

410
00:17:25.470 --> 00:17:26.410
which what happens,

411
00:17:26.410 --> 00:17:28.970
you get a lot of infections
because germs get stuck.

412
00:17:28.970 --> 00:17:31.330
It makes it hard to breathe. That mucus,

413
00:17:31.330 --> 00:17:32.030
if you think about it,

414
00:17:32.030 --> 00:17:34.410
makes other organs kinda sticky as well.

415
00:17:34.410 --> 00:17:37.330
So when you think about the
pancreas and the stomach,

416
00:17:37.330 --> 00:17:41.650
it makes, and the GI tract, it
makes things sluggish, right?

417
00:17:41.650 --> 00:17:45.310
So this causes problems for
you end up with pancreatic

418
00:17:45.310 --> 00:17:49.000
insufficiency. In the majority
of cases in the GI tract,

419
00:17:49.000 --> 00:17:52.740
you'll end up with blockages.
And then if you're males,

420
00:17:52.740 --> 00:17:56.500
you end up with male infertility
the majority of the time.

421
00:17:56.500 --> 00:17:58.330
And then similar to Tay Sacs, you know,

422
00:17:58.330 --> 00:18:02.200
there it is unique in the sense
of there's a difference in

423
00:18:02.200 --> 00:18:03.540
the sweat GR glands, right?

424
00:18:03.540 --> 00:18:05.200
So there's more chloride,

425
00:18:05.200 --> 00:18:08.510
and you can use this as a
screening test to help identify

426
00:18:08.510 --> 00:18:12.560
individuals with the condition.
This is the classic form,

427
00:18:12.560 --> 00:18:14.950
right? Everything in
genetics starts off classic.

428
00:18:14.950 --> 00:18:17.220
Well then what happens
over time? We learn,

429
00:18:17.220 --> 00:18:18.860
not everything is classic, right?

430
00:18:18.860 --> 00:18:22.300
You have the classic form of
cystic fibrosis that presents

431
00:18:22.300 --> 00:18:24.430
as a newborn rate,

432
00:18:24.430 --> 00:18:27.620
then you can have other C
F T R related disorders.

433
00:18:27.620 --> 00:18:30.490
So maybe you end up being an
individual that has recurrent

434
00:18:30.490 --> 00:18:33.380
sinus infections and bronchitis
starting in your teen years

435
00:18:33.380 --> 00:18:35.460
and your pancreas actually works, okay?

436
00:18:35.460 --> 00:18:37.960
But it ends up you actually
have cf just a mild

437
00:18:37.960 --> 00:18:39.060
presentation,

438
00:18:39.060 --> 00:18:41.900
or you have congenital absence
of the vast devore, right?

439
00:18:41.900 --> 00:18:45.080
So male infertility and you
don't have any of the other

440
00:18:45.080 --> 00:18:45.530
symptoms, right?

441
00:18:45.530 --> 00:18:48.620
Those are three very
different presentations.

442
00:18:48.620 --> 00:18:51.900
All of those are related to
mutations in the C F T R gene.

443
00:18:51.900 --> 00:18:55.720
So if you're a laboratory
and you're interpreting your

444
00:18:55.720 --> 00:18:58.200
findings in the C F T R gene,
you better get it right,

445
00:18:58.200 --> 00:19:00.420
right? Because depending on,

446
00:19:00.420 --> 00:19:02.230
you know what you call this out,

447
00:19:02.230 --> 00:19:05.520
it's gonna impact the decisions
for this pregnancy and for

448
00:19:05.520 --> 00:19:08.100
future pregnancies. And then after birth,

449
00:19:08.100 --> 00:19:11.920
the type of mutation also can
influence therapy options,

450
00:19:11.920 --> 00:19:14.090
right? So again, going
back to the beginning,

451
00:19:14.090 --> 00:19:15.580
these are not cheap therapies.

452
00:19:15.580 --> 00:19:18.440
So if you're paying for one
of these therapies based on

453
00:19:18.440 --> 00:19:20.960
genetic, you know, genotype you,

454
00:19:20.960 --> 00:19:23.960
you wanna make sure that
test report was correct and

455
00:19:23.960 --> 00:19:26.627
accurate when you're doing this.

456
00:19:30.020 --> 00:19:34.020
So we've agreed we're
all gonna do CF testing,

457
00:19:34.020 --> 00:19:36.740
we get several reports
we're gonna walk through.

458
00:19:36.740 --> 00:19:38.900
So one test result for that lady,

459
00:19:38.900 --> 00:19:40.080
I'm the clinician that comes back,

460
00:19:40.080 --> 00:19:43.110
I have a severe mutation
and a severe mutation.

461
00:19:43.110 --> 00:19:45.620
Clearly that is not how
the reports are written,

462
00:19:45.620 --> 00:19:49.310
but in this case, one severe
from mom, one severe from dad,

463
00:19:49.310 --> 00:19:52.780
this would equal classic
cystic fibrosis. Okay?

464
00:19:52.780 --> 00:19:54.110
Now we have a second one.

465
00:19:54.110 --> 00:19:57.180
It's a severe mutation and
a mild mutation, right?

466
00:19:57.180 --> 00:19:59.550
So as the laboratory,
I've called this out,

467
00:19:59.550 --> 00:20:02.390
I've interpreted it, I've done
my homework, and this case,

468
00:20:02.390 --> 00:20:06.030
it's really gonna result
in male infertility.

469
00:20:06.030 --> 00:20:08.970
Now we have a situation where
we have a severe mutation and

470
00:20:08.970 --> 00:20:10.630
we have a quote, new variant.

471
00:20:10.630 --> 00:20:14.570
Now remember, there's over
50,000 variants in this gene,

472
00:20:14.570 --> 00:20:16.830
probably around 2000
that are disease causing.

473
00:20:16.830 --> 00:20:18.650
So new variants happen on occasion. Well,

474
00:20:18.650 --> 00:20:19.670
what does that mean? Well, we don't know.

475
00:20:19.670 --> 00:20:21.470
It could be classic cf, right?

476
00:20:21.470 --> 00:20:24.270
It could be infertility, it could be mild.

477
00:20:24.270 --> 00:20:24.810
So, you know,

478
00:20:24.810 --> 00:20:28.410
sometimes looking at the entire
gene isn't always the best

479
00:20:28.410 --> 00:20:30.970
thing because you end up in
these unknown situations on what

480
00:20:30.970 --> 00:20:32.390
do we tell the parents?

481
00:20:32.390 --> 00:20:35.410
And then here we have a situation
here where no mutation was

482
00:20:35.410 --> 00:20:38.460
identified, but the baby
actually had classic cf.

483
00:20:38.460 --> 00:20:39.940
So you're probably looking
and saying, well Christie,

484
00:20:39.940 --> 00:20:40.820
how's that possible? Right?

485
00:20:40.820 --> 00:20:42.780
That lab, like why'd they use that lab?

486
00:20:42.780 --> 00:20:46.020
Because clearly they didn't
know what they were doing. Well,

487
00:20:46.020 --> 00:20:48.040
remember at the beginning when
we talked about tac, I said,

488
00:20:48.040 --> 00:20:50.160
you can look at certain
pieces on a gene. Well,

489
00:20:50.160 --> 00:20:52.260
in cystic fibrosis over time, right?

490
00:20:52.260 --> 00:20:55.020
You start looking at more
and more pieces of a gene.

491
00:20:55.020 --> 00:20:57.630
So sometimes instead of
looking at an entire gene,

492
00:20:57.630 --> 00:20:59.910
individuals will look at the 23 quote,

493
00:20:59.910 --> 00:21:03.720
most common mutations variance in a gene.

494
00:21:03.720 --> 00:21:05.590
So if we think about a Caucasian,

495
00:21:05.590 --> 00:21:07.540
this is to represent the frequency.

496
00:21:07.540 --> 00:21:08.900
So we have certain mutations,

497
00:21:08.900 --> 00:21:12.500
one of which accounts for over
50% of the mutation scene.

498
00:21:12.500 --> 00:21:14.200
And then you start getting less common,

499
00:21:14.200 --> 00:21:16.590
less common in this long tail.

500
00:21:16.590 --> 00:21:18.920
Same thing. If we pick
another ethnic background,

501
00:21:18.920 --> 00:21:21.670
let's just say Hispanic,
whatever you want to pick,

502
00:21:21.670 --> 00:21:25.820
like this distribution of
mutations is gonna look different.

503
00:21:25.820 --> 00:21:29.160
So if we take a panel and we
target it for somebody that's

504
00:21:29.160 --> 00:21:31.100
Caucasian with the most common mutations,

505
00:21:31.100 --> 00:21:32.920
and they're not Caucasian, well,

506
00:21:32.920 --> 00:21:35.720
it's not that something that
was completely missed, right?

507
00:21:35.720 --> 00:21:39.240
It was missed because those
areas of the gene were not

508
00:21:39.240 --> 00:21:40.260
analyzed, right?

509
00:21:40.260 --> 00:21:44.320
So let's say that this patient
actually was from Texas and

510
00:21:44.320 --> 00:21:45.830
she was Hispanic.

511
00:21:45.830 --> 00:21:47.710
Well, wait a minute, she
told us she was Caucasian.

512
00:21:47.710 --> 00:21:48.000
Well,

513
00:21:48.000 --> 00:21:50.200
she just didn't feel like
checking Hispanic because when she

514
00:21:50.200 --> 00:21:51.920
was asked later, she
was told, you know what?

515
00:21:51.920 --> 00:21:54.200
I don't really relate to
my Hispanic roots anymore.

516
00:21:54.200 --> 00:21:55.750
I didn't even think about that.

517
00:21:55.750 --> 00:21:56.100
Well,

518
00:21:56.100 --> 00:21:59.320
if that laboratory and that or
that physician had ordered a

519
00:21:59.320 --> 00:22:03.210
targeted panel for Caucasian,
this would've been missed,

520
00:22:03.210 --> 00:22:04.020
right?

521
00:22:04.020 --> 00:22:07.580
And then the other parent would
not have likely been tested.

522
00:22:07.580 --> 00:22:10.540
And so it looks like there
were no mutations when in fact,

523
00:22:10.540 --> 00:22:10.820
you know,

524
00:22:10.820 --> 00:22:15.070
it was based on the limitation
of the test ordered.

525
00:22:16.090 --> 00:22:16.950
So, you know,

526
00:22:16.950 --> 00:22:18.870
question for the group now is
really a carrier screen test.

527
00:22:18.870 --> 00:22:22.750
Are they apples to apples
or apples to oranges, right?

528
00:22:22.750 --> 00:22:25.910
I, I hope everybody is
answering apples to oranges.

529
00:22:25.910 --> 00:22:29.310
I've done this before and
people actually responded higher

530
00:22:29.310 --> 00:22:31.530
than I thought that it
was apples to apples.

531
00:22:31.530 --> 00:22:34.540
So I hope they were just
messing with me because clearly

532
00:22:34.540 --> 00:22:37.750
there's a lot of variability
in testing depending on what we

533
00:22:37.750 --> 00:22:39.390
order, how we interpret guidelines,

534
00:22:39.390 --> 00:22:43.690
and then also the technical
abilities of a laboratory.

535
00:22:43.690 --> 00:22:46.170
So switching gears for the
last couple of minutes,

536
00:22:46.170 --> 00:22:48.960
now let's think about this
from an identification

537
00:22:48.960 --> 00:22:52.330
standpoint. I think we've
established quality is important.

538
00:22:52.330 --> 00:22:55.330
So going back, we've got
that 32 year old female rate.

539
00:22:55.330 --> 00:22:59.230
We know that the doctor ordered
CF S M A and fragile X for

540
00:22:59.230 --> 00:22:59.950
this exercise,

541
00:22:59.950 --> 00:23:02.050
we're gonna pretend it's
not apples to oranges.

542
00:23:02.050 --> 00:23:03.670
All tests are exactly the same, right?

543
00:23:03.670 --> 00:23:06.610
They're all apples to apples, all right?

544
00:23:06.610 --> 00:23:08.260
Doctor knows what was ordered.

545
00:23:08.260 --> 00:23:10.040
Patient might know what's ordered.

546
00:23:10.040 --> 00:23:12.060
Laboratory knows what's ordered, right?

547
00:23:12.060 --> 00:23:14.130
This is how it often comes into a payer.

548
00:23:14.130 --> 00:23:18.090
So lab A might use the
C P T code 8 1 2 2 0.

549
00:23:18.090 --> 00:23:22.310
Lab B might use the C P
T code 8 1, 2, 2, 2 and

550
00:23:22.310 --> 00:23:24.130
8, 1, 2, 2, 3, right?

551
00:23:24.130 --> 00:23:26.050
Lab C might say, I don't know what to use,

552
00:23:26.050 --> 00:23:28.150
so I'm gonna use codes that represent cf,

553
00:23:28.150 --> 00:23:31.490
S M A and fragile X lab D might say, okay,

554
00:23:31.490 --> 00:23:35.020
I'm gonna use 8 1 4 7 9 because
I'm only supposed to use one

555
00:23:35.020 --> 00:23:38.290
code and I'm ordering several genes.

556
00:23:38.290 --> 00:23:40.060
And then on the same date of service,

557
00:23:40.060 --> 00:23:43.690
they also order another test. Well,

558
00:23:43.690 --> 00:23:47.140
is this because they're using
8 1 4 7 9 for carrier testing?

559
00:23:47.140 --> 00:23:49.940
Or was this because they
actually had, let's say,

560
00:23:49.940 --> 00:23:53.440
an I P S or they had a different
genetic condition going in

561
00:23:53.440 --> 00:23:55.380
the family on in the family
and they ordered the test.

562
00:23:55.380 --> 00:23:59.720
And this is actually an
appropriate coding with, hey,

563
00:23:59.720 --> 00:24:02.830
we had two different services.
When we look at this,

564
00:24:02.830 --> 00:24:06.420
this is a different combination
of C P T codes, right?

565
00:24:06.420 --> 00:24:09.070
For the exact same test.

566
00:24:09.070 --> 00:24:12.000
This is why it gets confusing
and why the fact that there's

567
00:24:12.000 --> 00:24:14.680
lots of C P T codes or
not a lot of C P T codes,

568
00:24:14.680 --> 00:24:18.020
but a lot of genetic tests
and conditions is problematic.

569
00:24:18.020 --> 00:24:20.440
And this is also why people
get irritated with payers

570
00:24:20.440 --> 00:24:22.880
because that means often we
have to stop this somewhere,

571
00:24:22.880 --> 00:24:25.790
right? We have to stop it
and say, wait, like hold on,

572
00:24:25.790 --> 00:24:28.160
what did you actually send us?
So this could be, you know,

573
00:24:28.160 --> 00:24:31.110
at the beginning and when
prior authorization is done,

574
00:24:31.110 --> 00:24:33.560
this could be when somebody's
doing a clinical review and

575
00:24:33.560 --> 00:24:35.060
they reach out for more
information, right?

576
00:24:35.060 --> 00:24:37.640
Or this could be at the time
when payment is submitted,

577
00:24:37.640 --> 00:24:41.740
but somewhere in this process
from a payer's perspective,

578
00:24:41.740 --> 00:24:45.000
we typically have to ask for
more information. So, you know,

579
00:24:45.000 --> 00:24:45.960
this is what Dr.

580
00:24:45.960 --> 00:24:48.560
Lansford is gonna speak on
in a few minutes, really is,

581
00:24:48.560 --> 00:24:50.900
you know, why and how do we,

582
00:24:50.900 --> 00:24:54.817
we make sense of this
information in the table.

583
00:24:56.000 --> 00:24:57.860
And then, you know, as
we transition to Dr.

584
00:24:57.860 --> 00:24:59.580
Lanceford part, I really wanna, you know,

585
00:24:59.580 --> 00:25:01.650
kind of ask everybody
to think for a second,

586
00:25:01.650 --> 00:25:04.730
have you ever really looked
and said how many molecular

587
00:25:04.730 --> 00:25:07.820
geneticists and or pathologists
are employed by payers?

588
00:25:07.820 --> 00:25:08.700
Right? You know,

589
00:25:08.700 --> 00:25:12.200
it's not something that I
think we often think about.

590
00:25:12.200 --> 00:25:13.500
You know, myself,

591
00:25:13.500 --> 00:25:16.240
I was part of a reduction in
force last year at a payer,

592
00:25:16.240 --> 00:25:16.900
and I can tell you,

593
00:25:16.900 --> 00:25:19.040
then I started looking
and thinking about it,

594
00:25:19.040 --> 00:25:21.170
and the average is less than one, right?

595
00:25:21.170 --> 00:25:24.280
Most payers do not have
these individuals employed.

596
00:25:24.280 --> 00:25:25.700
So then it's the fact of, okay,

597
00:25:25.700 --> 00:25:27.330
where is this information coming from?

598
00:25:27.330 --> 00:25:30.000
Hopefully consultants, right?

599
00:25:30.000 --> 00:25:32.660
But if not really, you
know, this is, you know,

600
00:25:32.660 --> 00:25:35.870
from a multitude of papers,
there is no industry standard.

601
00:25:35.870 --> 00:25:38.640
We've really, when it
comes to carrier screening,

602
00:25:38.640 --> 00:25:41.950
let the molecular laboratories
dictate and tell us like what

603
00:25:41.950 --> 00:25:44.040
genes and conditions we should be using.

604
00:25:44.040 --> 00:25:46.900
And this keeps growing, more
tests happen, more genes,

605
00:25:46.900 --> 00:25:48.070
right?

606
00:25:48.070 --> 00:25:50.020
We've all been on that
other side where it's, hey,

607
00:25:50.020 --> 00:25:52.850
we've got the greatest, best thing, right?

608
00:25:52.850 --> 00:25:54.760
Choices and options are great,

609
00:25:54.760 --> 00:25:57.450
but we also have to be able
to sift through it and say,

610
00:25:57.450 --> 00:26:01.030
okay, of these newest and
greatest things, what are they?

611
00:26:01.030 --> 00:26:01.600
Right?

612
00:26:01.600 --> 00:26:05.020
And how do we assess this
quality and make sure that we're

613
00:26:05.020 --> 00:26:08.140
using the most appropriate
tests for our members and also

614
00:26:08.140 --> 00:26:11.520
the most appropriate, the
most cost effective price.

615
00:26:11.520 --> 00:26:13.300
So at this time, I'll turn it over to Dr.

616
00:26:13.300 --> 00:26:16.383
Landsberg to talk about the solution.

617
00:26:19.520 --> 00:26:22.100
I'm unmuted here. All
right, so essentially,

618
00:26:22.100 --> 00:26:24.020
as Christy said, this is, this
is sort of where we come in,

619
00:26:24.020 --> 00:26:26.770
right? So, oh, I didn't get that.

620
00:26:28.160 --> 00:26:29.510
There we go.

621
00:26:29.510 --> 00:26:33.310
I did. So at you're fine.

622
00:26:34.970 --> 00:26:35.690
Soo G B A,

623
00:26:35.690 --> 00:26:39.300
our molecular services program
is built on 12 years of

624
00:26:39.300 --> 00:26:41.930
operation and development
of the Moldex program.

625
00:26:41.930 --> 00:26:45.640
So this is a program that
was developed to identify and

626
00:26:45.640 --> 00:26:47.890
establish coverage and
reimbursement for molecular

627
00:26:47.890 --> 00:26:50.180
diagnostic tests for C M s.

628
00:26:50.180 --> 00:26:52.960
And these payer controls are
now being rolled out in the

629
00:26:52.960 --> 00:26:54.780
commercial payer space.

630
00:26:54.780 --> 00:26:55.100
We,

631
00:26:55.100 --> 00:26:59.080
we bring that domain expertise
by employing subject matter

632
00:26:59.080 --> 00:27:01.720
experts in the field of
molecular diagnostics.

633
00:27:01.720 --> 00:27:05.680
So our in-house team consists
of subject matter experts with

634
00:27:05.680 --> 00:27:10.080
board certifications in
anatomical and clinical pathology,

635
00:27:10.080 --> 00:27:11.660
molecular genetic pathology,

636
00:27:11.660 --> 00:27:13.940
and clinical molecular genetics,

637
00:27:13.940 --> 00:27:18.940
as well as a team of laboratory
scientists who all have

638
00:27:19.400 --> 00:27:22.240
experience in performing clinical
molecular diagnostic tests

639
00:27:22.240 --> 00:27:23.820
and laboratory management.

640
00:27:23.820 --> 00:27:28.440
So we have developed processes
and procedures for performing

641
00:27:28.440 --> 00:27:31.840
comprehensive reviews of
clinical molecular tests that

642
00:27:31.840 --> 00:27:34.590
through services that we
call technical assessments,

643
00:27:34.590 --> 00:27:37.640
providing valuation of those
services established through

644
00:27:37.640 --> 00:27:39.260
various pricing algorithms,

645
00:27:39.260 --> 00:27:43.230
and then integrating of those
reviews with the valuation

646
00:27:43.230 --> 00:27:45.220
into automated claims processing.

647
00:27:45.220 --> 00:27:48.940
And all of this information is
brought together per test in

648
00:27:48.940 --> 00:27:52.600
one platform under a unique
identifier that we assign to

649
00:27:52.600 --> 00:27:54.780
every single molecular test.

650
00:27:54.780 --> 00:27:59.230
Now that molecular
test, okay, there we go.

651
00:27:59.230 --> 00:28:01.980
That unique identifier
is called the Z code.

652
00:28:01.980 --> 00:28:05.700
So now Z codes are five
character alphanumeric codes that

653
00:28:05.700 --> 00:28:07.490
are assigned to every test submission,

654
00:28:07.490 --> 00:28:10.440
which is cataloging curated in
our software platform called

655
00:28:10.440 --> 00:28:12.770
the diagnostic exchange or decks.

656
00:28:12.770 --> 00:28:16.180
There are currently over 20,000
entries in the Dex catalog

657
00:28:16.180 --> 00:28:19.760
and growing and using these
Z codes allows for greater

658
00:28:19.760 --> 00:28:22.840
granularity of test identification
as each entry that is

659
00:28:22.840 --> 00:28:26.240
linked to that code includes a
plethora of information about

660
00:28:26.240 --> 00:28:29.440
the test, such as methodology,
the intended use of the test,

661
00:28:29.440 --> 00:28:32.460
and whether or not it has
passed one of our assessments.

662
00:28:32.460 --> 00:28:36.400
So all of this information
can then be used to facilitate

663
00:28:36.400 --> 00:28:39.680
automation strategies such
as in claims adjudication or

664
00:28:39.680 --> 00:28:41.260
prior authorization.

665
00:28:41.260 --> 00:28:45.450
Not only because it provides
all of the information that one

666
00:28:45.450 --> 00:28:47.240
would need to know what the test is,

667
00:28:47.240 --> 00:28:49.560
but it does provide that
reassurance that the test has

668
00:28:49.560 --> 00:28:53.940
already been vetted by subject
matter experts in the field.

669
00:28:53.940 --> 00:28:56.680
And it also ensures the best
quality of testing and the

670
00:28:56.680 --> 00:28:59.200
appropriate testing is made
appro is made available to

671
00:28:59.200 --> 00:29:00.960
ordering physicians and their patients.

672
00:29:00.960 --> 00:29:04.680
As Christie just described,
essentially what we're doing is,

673
00:29:04.680 --> 00:29:07.140
is separating the wheat
from the chaff here.

674
00:29:07.140 --> 00:29:11.440
So the use of Z codes also
restricts that C P T code

675
00:29:11.440 --> 00:29:13.850
unbundling that Chrissy just talked about.

676
00:29:13.850 --> 00:29:18.650
Since each s, each Z code is
assigned to a single service,

677
00:29:18.650 --> 00:29:22.200
which is also mapped to a
single C P T code. So you know,

678
00:29:22.200 --> 00:29:23.940
as Chrissy just described historically,

679
00:29:23.940 --> 00:29:26.860
we used to think that disease
gene associations were one to

680
00:29:26.860 --> 00:29:30.990
one. So mutations in gene X
are associated with disease Y,

681
00:29:30.990 --> 00:29:34.320
therefore genes were tested
one by one and billed with

682
00:29:34.320 --> 00:29:37.260
individual gene C P T codes. However,

683
00:29:37.260 --> 00:29:39.840
the number of one-to-one
gene disease relationships is

684
00:29:39.840 --> 00:29:40.240
shrinking.

685
00:29:40.240 --> 00:29:43.280
And genes with similar clinical
presentations or uses are

686
00:29:43.280 --> 00:29:45.940
all now grouped into
panels or single services.

687
00:29:45.940 --> 00:29:47.000
And as Christie described,

688
00:29:47.000 --> 00:29:49.220
with the advent of next
generation sequencing,

689
00:29:49.220 --> 00:29:52.640
we can now simultaneously
test all of those genes in one

690
00:29:52.640 --> 00:29:54.140
service. Therefore,

691
00:29:54.140 --> 00:29:57.620
we expect that single service
to be represented by a single

692
00:29:57.620 --> 00:30:01.460
priced code and not a stacking
of multiple codes represented

693
00:30:01.460 --> 00:30:06.043
by some analytes that are
within that particular panel.

694
00:30:06.920 --> 00:30:08.130
There we go.

695
00:30:08.130 --> 00:30:11.450
So this is not a new process
for many labs in this country.

696
00:30:11.450 --> 00:30:14.670
So the Moldex program for
Medicare has been implemented in

697
00:30:14.670 --> 00:30:17.470
seven Medicare jurisdictions
by four different Macs that

698
00:30:17.470 --> 00:30:19.890
cover 28 states. As you can see here,

699
00:30:19.890 --> 00:30:22.440
all in ones in blue are Moldex states.

700
00:30:22.440 --> 00:30:26.670
These max all implement the
same Moldex coverage policies

701
00:30:26.670 --> 00:30:28.830
that apply to all private
reference and hospital

702
00:30:28.830 --> 00:30:31.510
laboratories that perform
molecular testing and submit

703
00:30:31.510 --> 00:30:32.870
claims to Medicare.

704
00:30:32.870 --> 00:30:35.350
However, it does also affect
laboratories outside of these

705
00:30:35.350 --> 00:30:37.890
jurisdictions. So for example,

706
00:30:37.890 --> 00:30:41.190
the non moldex parent
company outside of a Moldex

707
00:30:41.190 --> 00:30:44.690
jurisdiction actually has
multiple laboratories.

708
00:30:44.690 --> 00:30:48.150
And any one of those laboratories
is in a moldex state and

709
00:30:48.150 --> 00:30:51.430
intends on submitting claims
from that laboratory they need

710
00:30:51.430 --> 00:30:53.810
to use Z codes.

711
00:30:53.810 --> 00:30:56.100
Now, as you can see here,

712
00:30:56.100 --> 00:30:59.110
it's not a coincidence that
the jurisdictions with the

713
00:30:59.110 --> 00:31:02.230
laboratories that receive the
most healthcare dollars for

714
00:31:02.230 --> 00:31:04.850
molecular testing are all
in mo, mostly Moldex states.

715
00:31:04.850 --> 00:31:08.170
As you can see these, all of
the little orange dots here.

716
00:31:08.170 --> 00:31:10.390
But I can tell you that
the laboratories that are

717
00:31:10.390 --> 00:31:14.470
represented by the orange
dots outside of Moldex states

718
00:31:14.470 --> 00:31:17.130
oftentimes have relationships
with ones that are,

719
00:31:17.130 --> 00:31:19.610
so they're still involved
in the Z code process.

720
00:31:19.610 --> 00:31:20.790
But the good news is,

721
00:31:20.790 --> 00:31:23.860
is that we capture all of this
information index so we know

722
00:31:23.860 --> 00:31:26.540
exactly where and how a
test is being performed,

723
00:31:26.540 --> 00:31:29.550
even if it's not the laboratory
submitting the claim.

724
00:31:29.550 --> 00:31:33.820
So the point is, it's all
about granularity and clarity,

725
00:31:33.820 --> 00:31:37.370
right? So we use established
processes, procedures,

726
00:31:37.370 --> 00:31:41.490
and controls to facilitate
automated claim adjudication for

727
00:31:41.490 --> 00:31:44.570
molecular testing by determining
a number of these things

728
00:31:44.570 --> 00:31:46.550
Rio or ahead of time, right?

729
00:31:46.550 --> 00:31:50.570
So if the specific test from
that specific laboratory is the

730
00:31:50.570 --> 00:31:53.450
appropriate test for the
patient that it claims to be

731
00:31:53.450 --> 00:31:54.720
designed for,

732
00:31:54.720 --> 00:31:57.510
does the test actually
do what it says it does?

733
00:31:57.510 --> 00:31:58.870
Is it of sufficient quality?

734
00:31:58.870 --> 00:32:01.010
And I think this one is kind
of important because we often

735
00:32:01.010 --> 00:32:02.030
hear things like, well,

736
00:32:02.030 --> 00:32:04.430
it was validated in a CLIA environment,

737
00:32:04.430 --> 00:32:07.370
or it was validated in a
CLIA lab or validated to CLIA

738
00:32:07.370 --> 00:32:07.830
standards.

739
00:32:07.830 --> 00:32:10.170
But we have to keep in mind
that the clinical Laboratory

740
00:32:10.170 --> 00:32:14.130
improvement acts were written
in 1988 and clinical molecular

741
00:32:14.130 --> 00:32:16.370
testing that as we know it today,

742
00:32:16.370 --> 00:32:18.320
didn't really exist in 1988.

743
00:32:18.320 --> 00:32:21.310
What hasn't changed is the
laboratory environment.

744
00:32:21.310 --> 00:32:24.250
So what CLIA does is ensures
that the quality standards of

745
00:32:24.250 --> 00:32:27.170
the facility or the laboratory
that the test is being

746
00:32:27.170 --> 00:32:28.750
performed in are being met.

747
00:32:28.750 --> 00:32:33.490
It does not set standards
for how to validate complex

748
00:32:33.490 --> 00:32:35.270
molecular diagnostic tests.

749
00:32:35.270 --> 00:32:39.330
So simply being performed in
a CLIA certified laboratory is

750
00:32:39.330 --> 00:32:41.790
just not enough to demonstrate
that a diagnostic molecular

751
00:32:41.790 --> 00:32:44.370
test has been properly validated.

752
00:32:44.370 --> 00:32:47.380
Additional things we we
consider are the, you know,

753
00:32:47.380 --> 00:32:50.280
is there demonstrated clinical
value for that test and is it

754
00:32:50.280 --> 00:32:51.980
being billed appropriately?

755
00:32:51.980 --> 00:32:54.720
And all of these factors play
a role in implementing payer

756
00:32:54.720 --> 00:32:56.900
controls for molecular testing,

757
00:32:56.900 --> 00:33:01.010
and they are already in use by
the MOLDEX program for C M S.

758
00:33:01.010 --> 00:33:03.450
So how do we establish if,

759
00:33:03.450 --> 00:33:04.990
if a test does what it's supposed to do,

760
00:33:04.990 --> 00:33:07.130
whether it's being used on
the right patient population,

761
00:33:07.130 --> 00:33:10.330
is it a quality test, does
it have demonstrated value?

762
00:33:10.330 --> 00:33:14.413
So we create what we call
established test types.

763
00:33:15.600 --> 00:33:18.490
Sorry, lost my slide there for a minute.

764
00:33:18.490 --> 00:33:21.390
We create these established
test types for each type of

765
00:33:21.390 --> 00:33:22.860
testing service.

766
00:33:22.860 --> 00:33:27.090
This process is performed once
prior to any test review and

767
00:33:27.090 --> 00:33:29.790
is similar to what goes into
generation of what we call

768
00:33:29.790 --> 00:33:31.450
foundational policies for Medicare.

769
00:33:31.450 --> 00:33:35.730
And they are created in
advance of test evaluation.

770
00:33:35.730 --> 00:33:36.680
For example,

771
00:33:36.680 --> 00:33:41.040
solid tumor testing on F F P E
samples using next generation

772
00:33:41.040 --> 00:33:44.880
sequencing is a test type.
But within that test type,

773
00:33:44.880 --> 00:33:48.430
there are hundreds of different
types of services that all

774
00:33:48.430 --> 00:33:50.630
fall into this category
for a variety of reasons,

775
00:33:50.630 --> 00:33:52.130
a variety of cancer types,

776
00:33:52.130 --> 00:33:55.530
and all of those types need
to be taken into account.

777
00:33:55.530 --> 00:33:59.863
So once a particular service
is selected for review,

778
00:34:01.330 --> 00:34:05.510
we perform an evidentiary
review using literature,

779
00:34:05.510 --> 00:34:06.820
practice guidelines,

780
00:34:06.820 --> 00:34:09.870
society and subject matter
expert input and other sources of

781
00:34:09.870 --> 00:34:13.910
information to formulate a
procedure for how to perform an

782
00:34:13.910 --> 00:34:16.140
assessment for that test type.

783
00:34:16.140 --> 00:34:19.730
That procedure includes a review
of the analytical validity.

784
00:34:19.730 --> 00:34:22.230
How well does that test detect
the mutation or analyte that

785
00:34:22.230 --> 00:34:23.360
it claims to detect,

786
00:34:23.360 --> 00:34:26.070
which is generally demonstrated
through both analytical and

787
00:34:26.070 --> 00:34:27.420
clinical validation.

788
00:34:27.420 --> 00:34:29.730
It's clinical validity.

789
00:34:29.730 --> 00:34:32.310
How well does that mutation
or analyte relate to the

790
00:34:32.310 --> 00:34:35.170
presence or risk of disease
and the clinical utility? How,

791
00:34:35.170 --> 00:34:36.660
how useful is this test?

792
00:34:36.660 --> 00:34:38.990
Does it actually change
patient management to approve

793
00:34:38.990 --> 00:34:40.410
patient outcomes?

794
00:34:40.410 --> 00:34:41.650
To obtain this information,

795
00:34:41.650 --> 00:34:45.070
we create forms and documents
for the laboratories to fill

796
00:34:45.070 --> 00:34:48.410
out and submit if necessary,
as part of that assessment.

797
00:34:48.410 --> 00:34:52.790
And then we also define edit
logic such as diagnosis codes,

798
00:34:52.790 --> 00:34:56.230
and we establish pricing models
for those particular test

799
00:34:56.230 --> 00:34:59.450
types. Now, once all of these
tasks have been completed,

800
00:34:59.450 --> 00:35:01.970
the test type is now
considered established,

801
00:35:01.970 --> 00:35:04.310
and technical assessments can
be performed on tests that

802
00:35:04.310 --> 00:35:06.410
fall into that test type.

803
00:35:06.410 --> 00:35:09.490
So when any test is registered index,

804
00:35:09.490 --> 00:35:12.880
it gets a Z code and then
it's reviewed based on its

805
00:35:12.880 --> 00:35:15.730
complexity, the risk to the patient.

806
00:35:15.730 --> 00:35:17.030
So as we all know,

807
00:35:17.030 --> 00:35:19.310
the effects of false positive
and false negative results for

808
00:35:19.310 --> 00:35:21.650
some disorders can be very severe.

809
00:35:21.650 --> 00:35:24.270
The risk of abuse as, as
Christie previously mentioned,

810
00:35:24.270 --> 00:35:29.270
and the cost of the test
and the risk and cost,

811
00:35:30.330 --> 00:35:33.910
the more scrutiny that test
receives and additional data

812
00:35:33.910 --> 00:35:37.380
requested from the lab required
to complete that assessment.

813
00:35:37.380 --> 00:35:38.520
Right?

814
00:35:38.520 --> 00:35:42.190
Each, each established test type has its,

815
00:35:42.190 --> 00:35:47.190
has different requirements for
data submission and has its

816
00:35:47.490 --> 00:35:51.330
own technical assessment
process. So for example,

817
00:35:51.330 --> 00:35:55.450
a next generation sequencing
panel for inherited colorectal

818
00:35:55.450 --> 00:35:59.450
cancer is quite different from
a next generation sequencing

819
00:35:59.450 --> 00:36:03.570
panel designed for the detection
of circulating tumor D N A

820
00:36:03.570 --> 00:36:06.080
in your blood for that exact same cancer.

821
00:36:06.080 --> 00:36:06.920
Therefore,

822
00:36:06.920 --> 00:36:10.350
each test type is evaluated
with its own set of criteria,

823
00:36:10.350 --> 00:36:13.490
and that evaluation is performed
by subject matter experts

824
00:36:13.490 --> 00:36:16.210
in the field according to the
procedures established for

825
00:36:16.210 --> 00:36:17.430
that task.

826
00:36:17.430 --> 00:36:19.610
The technical assessment
process is generally completed

827
00:36:19.610 --> 00:36:23.430
within 60 days of receipt of
the documentation from the lab

828
00:36:23.430 --> 00:36:25.670
and the submitting laboratory is notified,

829
00:36:25.670 --> 00:36:28.550
and those results are then
documented in our deck system.

830
00:36:28.550 --> 00:36:31.470
Now it deemed unsuccessful based
on the established criteria

831
00:36:31.470 --> 00:36:33.160
and the process that we've created.

832
00:36:33.160 --> 00:36:36.010
That laboratory is also
provided with the details of the

833
00:36:36.010 --> 00:36:37.170
deficiencies, the things that,

834
00:36:37.170 --> 00:36:40.180
that we thought needed to
be there that weren't there.

835
00:36:40.180 --> 00:36:43.210
Those final technical assessment
results of successful or

836
00:36:43.210 --> 00:36:45.270
not are then provided to the health plan.

837
00:36:45.270 --> 00:36:46.210
So in the MOLDEX program,

838
00:36:46.210 --> 00:36:48.810
those technical assessment
results are then used to make

839
00:36:48.810 --> 00:36:50.990
coverage decisions based on policy.

840
00:36:50.990 --> 00:36:53.050
So let's go back to
Chrissy's example of our,

841
00:36:53.050 --> 00:36:55.610
our pregnant woman and see how
these Z codes and technical

842
00:36:55.610 --> 00:36:58.090
assessments provide the clarity
and transparency that we're

843
00:36:58.090 --> 00:37:00.150
all looking for here.

844
00:37:00.150 --> 00:37:04.130
All right, so, all right, my
slides are a little slow here,

845
00:37:04.130 --> 00:37:05.670
so it's, okay, there we go.

846
00:37:05.670 --> 00:37:09.290
All right, so this time,
instead of this smaller panel,

847
00:37:09.290 --> 00:37:12.030
let's just say the provider
orders a guidelines based panel.

848
00:37:12.030 --> 00:37:12.570
So that's what,

849
00:37:12.570 --> 00:37:15.070
that's just what we're gonna
call it guidelines based.

850
00:37:15.070 --> 00:37:16.210
And just to be clear,

851
00:37:16.210 --> 00:37:18.690
I am not referring to any
particular panel from any

852
00:37:18.690 --> 00:37:21.150
particular laboratory.
These are just examples.

853
00:37:21.150 --> 00:37:23.770
So let's say we have five
different laboratories and they've

854
00:37:23.770 --> 00:37:24.850
all submitted, you know, we,

855
00:37:24.850 --> 00:37:29.510
they've all got their own
guidelines based panel and almost

856
00:37:29.510 --> 00:37:33.130
all of them have mapped their
panel to the unlisted C P T

857
00:37:33.130 --> 00:37:35.930
code 8 1 4 7 9. But the panel
that has five genes on it,

858
00:37:35.930 --> 00:37:37.790
sort of like Christie described earlier,

859
00:37:37.790 --> 00:37:41.510
has all of these clear C P
T codes. So, perfect, right?

860
00:37:41.510 --> 00:37:41.910
We can,

861
00:37:41.910 --> 00:37:44.650
we know what all of these codes
are and we should be good to

862
00:37:44.650 --> 00:37:45.880
go. However,

863
00:37:45.880 --> 00:37:48.550
when we look a little bit
deeper into those codes,

864
00:37:48.550 --> 00:37:50.730
we see that three of them are
represented by what are called

865
00:37:50.730 --> 00:37:53.550
common variants. So as Christy
just described, there are,

866
00:37:53.550 --> 00:37:53.850
you know,

867
00:37:53.850 --> 00:37:55.970
variants that are more
common in the cystic fibrosis

868
00:37:55.970 --> 00:37:58.880
population. So if we look
at these common variants,

869
00:37:58.880 --> 00:38:01.090
what does that exactly mean
when you're getting that test

870
00:38:01.090 --> 00:38:02.790
code, what should we expect?

871
00:38:02.790 --> 00:38:05.850
So, you know, as Christy
described in 2001,

872
00:38:05.850 --> 00:38:09.050
A C M G defined a list of 23
variants at the time that were

873
00:38:09.050 --> 00:38:11.690
the most commonly characterized
variants in the Ashkenazi

874
00:38:11.690 --> 00:38:14.130
Jewish population and
Northern European Caucasian

875
00:38:14.130 --> 00:38:16.380
populations. But as she also pointed out,

876
00:38:16.380 --> 00:38:20.850
there are thousands of variants
within the cystic fibrosis

877
00:38:20.850 --> 00:38:23.850
gene that we now know cause disease.

878
00:38:24.750 --> 00:38:25.870
And in fact,

879
00:38:25.870 --> 00:38:30.410
panels are ranging from anywhere
from 23 to 600 different

880
00:38:30.410 --> 00:38:33.530
targets have been submitted to
the deck system under the C P

881
00:38:33.530 --> 00:38:37.240
T code 8 1 2 2 0 4 common
variants. Therefore,

882
00:38:37.240 --> 00:38:40.160
even if you have a very
specific C P T code,

883
00:38:40.160 --> 00:38:43.290
what is actually being tested
from lab to lab is not always

884
00:38:43.290 --> 00:38:44.180
clear.

885
00:38:44.180 --> 00:38:46.320
And as of a couple of months ago,

886
00:38:46.320 --> 00:38:49.140
A C M G now recommends a
list of a hundred variants.

887
00:38:49.140 --> 00:38:53.630
So in this case, establishing
criteria for what,

888
00:38:53.630 --> 00:38:57.440
even for what a common variant
is defined as by published

889
00:38:57.440 --> 00:39:00.400
standards and guidelines will
help ensure consistency across

890
00:39:00.400 --> 00:39:02.260
these services.

891
00:39:02.260 --> 00:39:04.040
In addition, you know, as Chrisy noted,

892
00:39:04.040 --> 00:39:07.500
these genes are all being
assessed together on the same day,

893
00:39:07.500 --> 00:39:08.820
on the same sample,

894
00:39:08.820 --> 00:39:12.470
and one report is being issued
with all of those results,

895
00:39:12.470 --> 00:39:15.460
therefore they represent a single service.

896
00:39:15.460 --> 00:39:19.120
And that single service can
be represented by a single Z

897
00:39:19.120 --> 00:39:23.090
code mapped to a single C P
T code and not a code stack.

898
00:39:23.090 --> 00:39:23.440
Right?

899
00:39:23.440 --> 00:39:28.040
So let's take a look at labs
A and B in the very similar

900
00:39:28.040 --> 00:39:29.680
situation to what Christy
just described, right?

901
00:39:29.680 --> 00:39:34.160
So let's say the information
that you get is you've got two

902
00:39:34.160 --> 00:39:35.360
guidelines based panels,

903
00:39:35.360 --> 00:39:38.280
both of them have 14 genes on
their panel and they're both

904
00:39:38.280 --> 00:39:40.900
mapped to 8 1 4 7 9. However,

905
00:39:40.900 --> 00:39:44.600
if lab A only looks at that
subset of mutations in each gene

906
00:39:44.600 --> 00:39:47.400
that are prevalent in very
specific ethnic populations with

907
00:39:47.400 --> 00:39:52.120
one methodology and lab B scans
the entire gene for disease

908
00:39:52.120 --> 00:39:54.710
causing mutations with
a different methodology.

909
00:39:54.710 --> 00:39:56.360
Therefore, as Christie noted,

910
00:39:56.360 --> 00:40:00.140
if a physician orders tests
from lab A on a patient who is

911
00:40:00.140 --> 00:40:02.880
not one of those intended use
patient populations and that

912
00:40:02.880 --> 00:40:05.270
patient has a rare pathogenic variant,

913
00:40:05.270 --> 00:40:07.660
it's going to get missed.

914
00:40:07.660 --> 00:40:11.020
And from a payer standpoint,
under our various processes,

915
00:40:11.020 --> 00:40:15.230
we now know that the assay
performed in lab A is different

916
00:40:15.230 --> 00:40:19.040
from the assay performed in
lab B and maybe not quite as

917
00:40:19.040 --> 00:40:20.020
comprehensive.

918
00:40:20.020 --> 00:40:23.240
And pricing models may be
able to indicate that the two

919
00:40:23.240 --> 00:40:25.860
tests should be priced
differently as well.

920
00:40:25.860 --> 00:40:29.640
And all of this information
will have then be reviewed and

921
00:40:29.640 --> 00:40:32.600
supplied as part of a technical
assessment that only needs

922
00:40:32.600 --> 00:40:36.250
to be formed once and is tied
to their individual Z codes.

923
00:40:36.250 --> 00:40:37.990
Alright, so then there's lab D,

924
00:40:37.990 --> 00:40:40.760
lemme see if I can advance here. Alright,

925
00:40:40.760 --> 00:40:45.760
so lab DS guidelines based
panel has 97 genes on it. Well,

926
00:40:46.120 --> 00:40:48.400
you know why the difference?
Well, as Christie said,

927
00:40:48.400 --> 00:40:50.740
it depends on whose guidelines
a laboratory is following,

928
00:40:50.740 --> 00:40:51.000
right?

929
00:40:51.000 --> 00:40:53.700
So the American College of
Obstetrics and Gynecology and the

930
00:40:53.700 --> 00:40:56.460
American College of Medical
Genetics have very different

931
00:40:56.460 --> 00:40:59.740
guidelines when it comes to who
should get carrier screening

932
00:40:59.740 --> 00:41:01.940
panels and what should be
on those panels, right?

933
00:41:01.940 --> 00:41:03.600
So for the sake of discussion,

934
00:41:03.600 --> 00:41:06.340
I'm gonna follow a C M G
guidelines for this example. Okay?

935
00:41:06.340 --> 00:41:09.600
So let's say we're, these
are for for A C M G.

936
00:41:09.600 --> 00:41:12.620
So let's step through a few
questions that may be considered

937
00:41:12.620 --> 00:41:14.080
as part of a technical assessment.

938
00:41:14.080 --> 00:41:17.110
So this is obviously not a complete list.

939
00:41:17.110 --> 00:41:21.570
These are just some examples
of some of the things that are

940
00:41:21.570 --> 00:41:23.800
SMEs are, are looking
for during assessment.

941
00:41:23.800 --> 00:41:24.740
So just to be clear,

942
00:41:24.740 --> 00:41:28.460
this is not comprehensive and
so let's compare the answers

943
00:41:28.460 --> 00:41:31.820
that you might get with
and without that particular

944
00:41:31.820 --> 00:41:34.390
technical assessment. So the,
the first question here is,

945
00:41:34.390 --> 00:41:38.640
does that test contain all
of the genes expected for the

946
00:41:38.640 --> 00:41:41.080
intended use? Now if you are, you know,

947
00:41:41.080 --> 00:41:43.180
a payer without a detailed assessment,

948
00:41:43.180 --> 00:41:45.840
you essentially have the
laboratory's website or a high

949
00:41:45.840 --> 00:41:49.060
level summary and just this
giant list of 97 genes, right?

950
00:41:49.060 --> 00:41:51.390
And you have to assume
that if it's on that list,

951
00:41:51.390 --> 00:41:53.150
it's getting covered.

952
00:41:53.150 --> 00:41:54.010
However,

953
00:41:54.010 --> 00:41:57.160
let's say that with a more
in-depth assessment of the

954
00:41:57.160 --> 00:41:59.820
submitted documents that the
laboratory has sent to us,

955
00:41:59.820 --> 00:42:02.500
we find that the methodology
that they're using can actually

956
00:42:02.500 --> 00:42:05.360
not assess eight of those
genes on the panel. That,

957
00:42:05.360 --> 00:42:07.420
that the laboratory claims it can.

958
00:42:07.420 --> 00:42:11.900
And that result is buried
eight pages deep after the test

959
00:42:11.900 --> 00:42:14.320
has been run in a disclaimer at the very,

960
00:42:14.320 --> 00:42:16.580
very end of the test. Oh, by the way,

961
00:42:16.580 --> 00:42:18.740
we put this in our marketing materials,

962
00:42:18.740 --> 00:42:20.120
but we actually can't test it,

963
00:42:20.120 --> 00:42:22.320
and we're only going to tell
you that when the test has been

964
00:42:22.320 --> 00:42:23.153
completed.

965
00:42:24.140 --> 00:42:29.140
So that would be, you know,
considered a fail for that,

966
00:42:30.260 --> 00:42:33.740
for that particular factor.

967
00:42:33.740 --> 00:42:36.260
And you know, if anybody's
on the call from the,

968
00:42:36.260 --> 00:42:37.460
the laboratories,

969
00:42:37.460 --> 00:42:40.080
if there are genes on your
panels that are difficult to

970
00:42:40.080 --> 00:42:41.820
assess to routine routinely sequence,

971
00:42:41.820 --> 00:42:44.920
we know these things with the
particular methodologies that

972
00:42:44.920 --> 00:42:47.120
you're using. So just
make it clear upfront,

973
00:42:47.120 --> 00:42:49.790
because if you don't, we will find them.

974
00:42:49.790 --> 00:42:53.720
Alright, so it goes for the, the same,

975
00:42:53.720 --> 00:42:54.940
the similar next question.

976
00:42:54.940 --> 00:42:58.180
So does the test cover all of
the varying classes expected

977
00:42:58.180 --> 00:43:00.460
for that particular intended use?

978
00:43:00.460 --> 00:43:03.420
So a lot of times the
information that is supplied to,

979
00:43:03.420 --> 00:43:04.320
to individuals,

980
00:43:04.320 --> 00:43:07.000
even physicians or payers
for summaries of say,

981
00:43:07.000 --> 00:43:10.280
sensitivity and specificity
are sort of global for all of

982
00:43:10.280 --> 00:43:13.390
the things that, that that test,

983
00:43:13.390 --> 00:43:16.220
that test says claims to detect.

984
00:43:16.220 --> 00:43:17.290
But what happens if,

985
00:43:17.290 --> 00:43:21.030
let's say the test is really
bad at detecting a particular

986
00:43:21.030 --> 00:43:24.620
gene duplications, it's just not good,

987
00:43:24.620 --> 00:43:27.800
but you actually have no idea
because they only tested three

988
00:43:27.800 --> 00:43:29.040
samples in their validation,

989
00:43:29.040 --> 00:43:31.740
and two of them were the same
duplication. So they say, yep,

990
00:43:31.740 --> 00:43:34.060
our test is great at at
testing duplications,

991
00:43:34.060 --> 00:43:38.260
and they a hundred percent,
however, upon additional review,

992
00:43:38.260 --> 00:43:40.800
we would find that they haven't
demonstrated the ability to

993
00:43:40.800 --> 00:43:45.090
be able to, to accurately
detect that class of variance.

994
00:43:45.090 --> 00:43:48.590
Has the test been orthogonally
validated by an ortho by an

995
00:43:48.590 --> 00:43:49.450
alternative method?

996
00:43:49.450 --> 00:43:51.660
So what we say are positive
and negative samples,

997
00:43:51.660 --> 00:43:52.580
have they been,

998
00:43:52.580 --> 00:43:55.260
have they been confirmed
by another methodology?

999
00:43:55.260 --> 00:43:57.550
This is not something that
laboratories generally

1000
00:43:57.550 --> 00:44:00.320
publicized. So in scenario
one, they're gonna get a pass,

1001
00:44:00.320 --> 00:44:05.320
right? It's gonna be, yep,
that test is, but the test,

1002
00:44:06.770 --> 00:44:09.050
so in scenario two, it's gonna fail.

1003
00:44:09.050 --> 00:44:11.990
And has the performance of
that test been demonstrated in

1004
00:44:11.990 --> 00:44:15.850
the correct patient sample
type? So again, in sample one,

1005
00:44:15.850 --> 00:44:17.950
you just have to trust that it has, right?

1006
00:44:17.950 --> 00:44:22.010
There's a lot of trust going
on in scenario number one.

1007
00:44:22.010 --> 00:44:24.670
And in scenario number two,
let's just say for example,

1008
00:44:24.670 --> 00:44:27.150
the laboratory says they
accepted buccal swabs for that

1009
00:44:27.150 --> 00:44:27.490
test,

1010
00:44:27.490 --> 00:44:30.550
but there's no demonstration
that they've actually ever even

1011
00:44:30.550 --> 00:44:33.620
tested a buccal swab for,
for that particular test.

1012
00:44:33.620 --> 00:44:35.720
So I know, again, you know, lab folks,

1013
00:44:35.720 --> 00:44:37.960
you're just gonna say, well
extracted D N A is extracted,

1014
00:44:37.960 --> 00:44:40.840
d n a, what's the big deal?

1015
00:44:40.840 --> 00:44:43.040
And it it's not,

1016
00:44:43.040 --> 00:44:47.957
and a patient gets an result
because that test has not been

1017
00:44:49.710 --> 00:44:51.750
out an assessment,

1018
00:44:51.750 --> 00:44:54.290
you can only assume that these
things are being performed

1019
00:44:54.290 --> 00:44:56.130
based on statutory laboratory practices.

1020
00:44:56.130 --> 00:44:59.460
And that test passes right
through in scenario two.

1021
00:44:59.460 --> 00:45:03.250
There is much more transparency
for the performance of the

1022
00:45:03.250 --> 00:45:06.090
test and the laboratory
then gets informed of those

1023
00:45:06.090 --> 00:45:08.310
deficiencies that were identified.

1024
00:45:08.310 --> 00:45:13.180
All right? And finally
we have lab E here we go,

1025
00:45:13.180 --> 00:45:18.180
who performed a large panel
with 300 genes on it, because,

1026
00:45:18.420 --> 00:45:23.180
you know, the guidelines say
97, but then the, you know,

1027
00:45:23.180 --> 00:45:26.240
the patient walks into the
provider's office and said, Hey,

1028
00:45:26.240 --> 00:45:29.220
I saw this really cool thing
on the internet, or, you know,

1029
00:45:29.220 --> 00:45:30.910
the provider got some really, you know,

1030
00:45:30.910 --> 00:45:34.390
cool information or
whatever because you know,

1031
00:45:34.390 --> 00:45:38.110
more information is always better, right?

1032
00:45:38.110 --> 00:45:40.740
Marketing and salespeople, right?

1033
00:45:40.740 --> 00:45:43.260
But it's not all, all the time, right?

1034
00:45:43.260 --> 00:45:47.980
So these larger panels are not
recommended by any societies

1035
00:45:47.980 --> 00:45:50.720
for routine care. And
one of the reasons is,

1036
00:45:50.720 --> 00:45:54.760
is that the genes on them a
lot of times have not been

1037
00:45:54.760 --> 00:45:56.820
properly vetted and, and reviewed.

1038
00:45:56.820 --> 00:45:59.960
So they don't meet clinical
validity criteria because many

1039
00:45:59.960 --> 00:46:03.430
of them have a limited disease
genes gene relationships

1040
00:46:03.430 --> 00:46:07.080
reduced, but you don't get the disease.

1041
00:46:08.350 --> 00:46:10.210
Some of the genes on these, you know,

1042
00:46:10.210 --> 00:46:14.680
large panels may have only
had two or three variants,

1043
00:46:14.680 --> 00:46:17.010
pathogenic, causative variants
identified in them ever,

1044
00:46:17.010 --> 00:46:18.800
right? So how do we know what,

1045
00:46:18.800 --> 00:46:20.540
what these things are gonna look like?

1046
00:46:20.540 --> 00:46:22.250
And so at this time,

1047
00:46:22.250 --> 00:46:26.320
these Uber panels would fail a
technical assessment based on

1048
00:46:26.320 --> 00:46:30.430
lack of clinical validity and
clinical clinical utility.

1049
00:46:30.430 --> 00:46:32.710
Alright? So if you remember that,

1050
00:46:32.710 --> 00:46:35.370
that the slide that that
Christie ended on right before,

1051
00:46:35.370 --> 00:46:36.280
right before I started,

1052
00:46:36.280 --> 00:46:37.600
with all of these different options that,

1053
00:46:37.600 --> 00:46:40.270
that you have for picking tests,

1054
00:46:40.270 --> 00:46:42.660
what we are essentially doing
is taking all of those tests

1055
00:46:42.660 --> 00:46:45.480
and providing the information
as to whether or not it is a

1056
00:46:45.480 --> 00:46:48.920
good test based on assessment
of analytical clinical

1057
00:46:48.920 --> 00:46:51.460
validity and clinical utility
in our technical assessments.

1058
00:46:51.460 --> 00:46:54.360
So we now have the ability to
differentiate two different

1059
00:46:54.360 --> 00:46:56.980
tests that may have the exact same title,

1060
00:46:56.980 --> 00:46:59.100
the exact same number of genes analyzed,

1061
00:46:59.100 --> 00:47:01.660
mapped to the exact same C P T code,

1062
00:47:01.660 --> 00:47:06.660
but are differentiated by Z
codes and technical assessments.

1063
00:47:06.790 --> 00:47:09.360
All right? So to, to summarize,

1064
00:47:09.360 --> 00:47:10.890
this is sort of how
it's done today, right?

1065
00:47:10.890 --> 00:47:11.620
Like Chrissy said,

1066
00:47:11.620 --> 00:47:15.530
there are 8 1 4 7 9 is a C P
T code that is widely used for

1067
00:47:15.530 --> 00:47:17.850
many genetic tests because
we just don't have the codes

1068
00:47:17.850 --> 00:47:21.410
available for all of the
varieties of different services

1069
00:47:21.410 --> 00:47:23.070
that that, that are available.

1070
00:47:23.070 --> 00:47:25.450
And each time one of these
tests comes in mapped to

1071
00:47:25.450 --> 00:47:29.867
8 1 4 7 9 often requires a,
a manual clinical review.

1072
00:47:31.260 --> 00:47:33.380
And so then, and then
it circles back, right?

1073
00:47:33.380 --> 00:47:36.480
So now with implementation
of Z codes and technical

1074
00:47:36.480 --> 00:47:37.110
assessments,

1075
00:47:37.110 --> 00:47:41.050
once that service has been
reviewed and determined

1076
00:47:41.050 --> 00:47:41.870
successful,

1077
00:47:41.870 --> 00:47:44.360
there's no longer a
requirement to review it again,

1078
00:47:44.360 --> 00:47:47.880
every time it comes up around
and automated approval can

1079
00:47:47.880 --> 00:47:49.380
take place, right?

1080
00:47:51.060 --> 00:47:54.710
This reduces the amount of back
and forth between the payers

1081
00:47:54.710 --> 00:47:58.230
and the labs and abrasion and
hopefully leading to higher

1082
00:47:58.230 --> 00:48:00.490
laboratory satisfaction and,

1083
00:48:00.490 --> 00:48:03.750
and member and decrease
decreased the amount of confusion

1084
00:48:03.750 --> 00:48:05.720
for what, for what you're looking at.

1085
00:48:05.720 --> 00:48:08.940
It also leads to increased
savings. So historically, right?

1086
00:48:08.940 --> 00:48:13.940
We calculate savings based on
rejected denial and rejected

1087
00:48:14.220 --> 00:48:15.610
claims over time, right?

1088
00:48:15.610 --> 00:48:19.760
However, in in this
particular methodology,

1089
00:48:19.760 --> 00:48:22.180
the laboratories are
informed that their tests are

1090
00:48:22.180 --> 00:48:24.860
unsuccessful prior to submitting
any claims and therefore

1091
00:48:24.860 --> 00:48:27.120
just don't submit them in
the first place, right?

1092
00:48:27.120 --> 00:48:30.650
So leading to additional cost
savings through what we call

1093
00:48:30.650 --> 00:48:31.740
cost avoidance, right?

1094
00:48:31.740 --> 00:48:34.320
Those laboratories are just
not submitting anything.

1095
00:48:34.320 --> 00:48:36.980
So in fact, more than
half of the molecular,

1096
00:48:36.980 --> 00:48:39.420
the Moldex services that are
registered index have not

1097
00:48:39.420 --> 00:48:41.700
completed a technical
assessment and are therefore not

1098
00:48:41.700 --> 00:48:42.840
submitting claims.

1099
00:48:42.840 --> 00:48:45.980
So we're technically saving
the cost of all of those claims

1100
00:48:45.980 --> 00:48:49.140
that are submitted because
of the lack of a technical

1101
00:48:49.140 --> 00:48:50.660
assessment.

1102
00:48:50.660 --> 00:48:52.120
So as I previously noted,

1103
00:48:52.120 --> 00:48:55.640
this use of Z codes are already
in use by laboratories in,

1104
00:48:55.640 --> 00:48:56.660
in more than half the country.

1105
00:48:56.660 --> 00:49:00.490
And obviously the goal here is
to create a national standard

1106
00:49:00.490 --> 00:49:04.800
using those codes for test
identification and kind of get

1107
00:49:04.800 --> 00:49:08.340
everybody on the same page
and using, you know, the,

1108
00:49:08.340 --> 00:49:12.540
the same processes and making
that granularity and clarity

1109
00:49:12.540 --> 00:49:16.020
and transparency of molecular
diagnostic testing available

1110
00:49:16.020 --> 00:49:17.340
to everyone.

1111
00:49:17.340 --> 00:49:18.360
But as Christy started with,

1112
00:49:18.360 --> 00:49:21.340
this all comes back around to
we're all part of the group,

1113
00:49:21.340 --> 00:49:23.840
and this is only part of
the comprehensive laboratory

1114
00:49:23.840 --> 00:49:25.450
benefit management solution,

1115
00:49:25.450 --> 00:49:27.680
which through these joint
interactions with our various

1116
00:49:27.680 --> 00:49:29.900
partners really aligns the health plans,

1117
00:49:29.900 --> 00:49:32.640
the providers and the laboratories
from end to end with a

1118
00:49:32.640 --> 00:49:34.920
variety of services including, you know,

1119
00:49:34.920 --> 00:49:38.080
test identification and
quality utilization management,

1120
00:49:38.080 --> 00:49:40.420
clinical decision support, et cetera.

1121
00:49:40.420 --> 00:49:44.170
All right, so I think
with that, I think we,

1122
00:49:44.170 --> 00:49:48.000
we've run through everything
and we'll take any questions I

1123
00:49:48.000 --> 00:49:51.380
think from, from the listeners.

1124
00:49:51.380 --> 00:49:56.380
Thanks a lot. Everyone going
to different mode here.

1125
00:49:57.170 --> 00:49:59.920
Okay, good.

1126
00:49:59.920 --> 00:50:03.440
So the first question that we have is,

1127
00:50:03.440 --> 00:50:07.200
can you clarify the role of
TA in the commercial space

1128
00:50:07.200 --> 00:50:10.480
versus the role of the TA
in traditional Medicare?

1129
00:50:10.480 --> 00:50:12.480
Is there any difference?

1130
00:50:13.520 --> 00:50:13.980
Ah, sure.

1131
00:50:13.980 --> 00:50:16.000
Again, I can probably take that one.

1132
00:50:16.000 --> 00:50:19.200
So just so that to to
everybody on the same page,

1133
00:50:19.200 --> 00:50:23.770
the technical assessment is
performed as part of registering

1134
00:50:23.770 --> 00:50:26.280
your Z code with Dex, right?

1135
00:50:26.280 --> 00:50:29.440
So it's not for, for any particular payer,

1136
00:50:29.440 --> 00:50:30.260
it's not from a list.

1137
00:50:30.260 --> 00:50:32.660
It is if you are going
to have a Z code index,

1138
00:50:32.660 --> 00:50:35.740
the technical assessment
process is part of that.

1139
00:50:35.740 --> 00:50:39.200
Now you have your choice as
to whether or not you submit

1140
00:50:39.200 --> 00:50:41.220
your technical assessment
documents or not.

1141
00:50:41.220 --> 00:50:44.280
But what happens is you are
going to see a technical

1142
00:50:44.280 --> 00:50:47.760
assessment will be unsuccessful
and you can have an

1143
00:50:47.760 --> 00:50:51.480
unsuccessful technical
assessment essentially for three

1144
00:50:51.480 --> 00:50:52.480
different, well,

1145
00:50:52.480 --> 00:50:55.080
for two different reasons
that you just didn't submit

1146
00:50:55.080 --> 00:51:00.080
anything and your technical
assessment will be unsuccessful

1147
00:51:00.220 --> 00:51:03.590
due to, you know, lack
of submitting anything.

1148
00:51:03.590 --> 00:51:06.620
Your technical assessment may
be unsuccessful because you

1149
00:51:06.620 --> 00:51:10.040
did submit something and we
found it incomplete or your

1150
00:51:10.040 --> 00:51:12.960
technical assessment
was submitted. And we,

1151
00:51:12.960 --> 00:51:17.560
there's just for, for part,
for say for the Moldex program,

1152
00:51:17.560 --> 00:51:20.150
you're submitting a
cancer test or whatever,

1153
00:51:20.150 --> 00:51:25.150
that it does not meet any sort
of published guidelines or

1154
00:51:26.760 --> 00:51:30.080
clinical utility and does
not meet kind of the triad of

1155
00:51:30.080 --> 00:51:32.040
analytical validity, clinical validity,

1156
00:51:32.040 --> 00:51:33.380
and clinical utility.

1157
00:51:33.380 --> 00:51:35.680
So there's a lot of different
ways that that one could end

1158
00:51:35.680 --> 00:51:37.930
up successful, but not
submitting is one of them.

1159
00:51:37.930 --> 00:51:38.763
Great.

1160
00:51:42.060 --> 00:51:43.080
Thank you.

1161
00:51:43.080 --> 00:51:48.080
The next question is, what
happens if a TA is not submitted?

1162
00:51:50.820 --> 00:51:54.130
Yeah, so sort of similar to,
to the previous question,

1163
00:51:54.130 --> 00:51:56.940
if you don't submit a
technical assessment,

1164
00:51:56.940 --> 00:51:59.590
it's just going to show that
your technical assessment was

1165
00:51:59.590 --> 00:52:02.170
unsuccessful within the deck system.

1166
00:52:02.170 --> 00:52:06.870
Now that does not impact, say,
commercial payer coverage,

1167
00:52:06.870 --> 00:52:07.090
right?

1168
00:52:07.090 --> 00:52:11.030
So remember the technical
assessment is part of getting the

1169
00:52:11.030 --> 00:52:13.650
Z code and being part of the
deck system and being curated

1170
00:52:13.650 --> 00:52:16.210
in decks as getting part
of getting your Z code.

1171
00:52:16.210 --> 00:52:20.790
It is independent of coverage
and reimbursement from any of

1172
00:52:20.790 --> 00:52:21.760
the payers.

1173
00:52:21.760 --> 00:52:22.593
Great.

1174
00:52:27.950 --> 00:52:29.300
Thank you.

1175
00:52:29.300 --> 00:52:32.300
Then the next question we
have is how can a commercial

1176
00:52:32.300 --> 00:52:35.717
carrier access the Dexy code information?

1177
00:52:38.620 --> 00:52:41.060
So Dex is free there,

1178
00:52:41.060 --> 00:52:43.270
all you have to do is register
and if you go to the Dex

1179
00:52:43.270 --> 00:52:48.270
website, there are instructions
on how to, to register,

1180
00:52:48.420 --> 00:52:52.200
but just be aware that a
public viewer sees something

1181
00:52:52.200 --> 00:52:54.980
different than so our, our users.

1182
00:52:54.980 --> 00:52:57.820
But within the deck system
you'll see test descriptions.

1183
00:52:57.820 --> 00:52:59.500
You, you don't, as a public user,

1184
00:52:59.500 --> 00:53:01.220
you do not get the Z codes, right?

1185
00:53:01.220 --> 00:53:04.040
So that that is internal
proprietary information,

1186
00:53:04.040 --> 00:53:06.910
but you will be able to see if the,

1187
00:53:06.910 --> 00:53:09.500
what the description of the test is,

1188
00:53:09.500 --> 00:53:13.900
you will be able to see if it
is a Medicare covered service

1189
00:53:13.900 --> 00:53:15.420
and then what the pricing is.

1190
00:53:15.420 --> 00:53:20.140
But to get to that next
level of, of information,

1191
00:53:20.140 --> 00:53:24.473
one has to essentially
subscribe to the software. I.

1192
00:53:27.670 --> 00:53:29.090
Thank you.

1193
00:53:29.090 --> 00:53:31.840
Then another question we have is,

1194
00:53:33.180 --> 00:53:36.970
would z codes be recommended
for single gene test if there

1195
00:53:36.970 --> 00:53:40.637
is already an appropriate
single C p T code.

1196
00:53:42.960 --> 00:53:44.820
As from part, part of our system,

1197
00:53:44.820 --> 00:53:49.740
regardless of whether or not
a test has its own c p t code,

1198
00:53:49.740 --> 00:53:53.280
a z code is required, a
z code is required for,

1199
00:53:53.280 --> 00:53:55.530
for every single gene test.

1200
00:53:59.810 --> 00:54:03.060
And then I think follow up
to your previous question and

1201
00:54:03.060 --> 00:54:05.977
answer was, how does one subscribe?

1202
00:54:10.710 --> 00:54:12.870
Oh, how, how to describe for access.

1203
00:54:12.870 --> 00:54:16.010
We, we have, we have a team
of folks at at Palmetto.

1204
00:54:16.010 --> 00:54:18.470
I think that that can
help facilitate that.

1205
00:54:18.470 --> 00:54:19.290
So if there's a,

1206
00:54:19.290 --> 00:54:21.530
a particular individual that's
looking for that information,

1207
00:54:21.530 --> 00:54:25.197
we can put them in
contact with those folks.

1208
00:54:26.660 --> 00:54:30.800
And then I know we did get a
few questions about if this

1209
00:54:30.800 --> 00:54:34.240
recording will be available
and I think we'll cover that in

1210
00:54:34.240 --> 00:54:35.980
the closing statement. But yes,

1211
00:54:35.980 --> 00:54:39.920
it will be available
for re-listen fair out.

1212
00:54:42.040 --> 00:54:42.873
Okay.

1213
00:54:45.020 --> 00:54:47.437
The next question we have is,

1214
00:54:49.660 --> 00:54:52.440
is there a current comprehensive
listing of the Z codes

1215
00:54:52.440 --> 00:54:55.273
under definitions or descriptions?

1216
00:55:01.660 --> 00:55:06.660
I guess I'm not sure the, is
if the, so is the question,

1217
00:55:06.720 --> 00:55:09.060
you know, is there, you know,

1218
00:55:09.060 --> 00:55:11.820
a list of Z codes for public
use to have that? It's,

1219
00:55:11.820 --> 00:55:13.480
that's not available. So we,

1220
00:55:13.480 --> 00:55:15.480
we don't give all of the z codes out.

1221
00:55:15.480 --> 00:55:19.540
Now a a laboratory obviously
gets access to all of their

1222
00:55:19.540 --> 00:55:21.140
individual Z codes,

1223
00:55:21.140 --> 00:55:23.730
but we don't have any sort
of master list that we,

1224
00:55:23.730 --> 00:55:28.300
that we give out to folks that
acc that access is available

1225
00:55:28.300 --> 00:55:32.633
essentially through the
subscription to the program.

1226
00:55:38.950 --> 00:55:39.680
Great, thank you.

1227
00:55:39.680 --> 00:55:43.080
And then one more on that.
If, if there's no price,

1228
00:55:43.080 --> 00:55:47.080
can I assume the test is
not approved by Moldex?

1229
00:55:48.650 --> 00:55:49.483
No.

1230
00:55:51.370 --> 00:55:56.210
And, and I guess the,
so if, if the, you know,

1231
00:55:56.210 --> 00:56:00.793
if the question is, if the
test hasn't been priced yet,

1232
00:56:01.690 --> 00:56:05.170
you know, is that related to coverage?

1233
00:56:05.170 --> 00:56:05.630
So again,

1234
00:56:05.630 --> 00:56:08.030
we have to remember that
there's a successful technical

1235
00:56:08.030 --> 00:56:08.740
assessment.

1236
00:56:08.740 --> 00:56:13.630
There's whether or not within
mold X that test is a covered

1237
00:56:13.630 --> 00:56:15.690
service and then the pricing is separate.

1238
00:56:15.690 --> 00:56:19.150
So there's sort of three separate
entities and it's entirely

1239
00:56:19.150 --> 00:56:23.600
possible that that one could
have a price or not have a

1240
00:56:23.600 --> 00:56:26.660
price independent of whether
or not the test is covered.

1241
00:56:26.660 --> 00:56:29.740
I'm not quite sure I, you know,
I completely understand the,

1242
00:56:29.740 --> 00:56:31.820
the question, but if a laboratory,

1243
00:56:31.820 --> 00:56:33.200
if you were in a laboratory and you,

1244
00:56:33.200 --> 00:56:35.620
you think you have a covered
service for Medicare through

1245
00:56:35.620 --> 00:56:37.480
Moldex and you don't have a,

1246
00:56:37.480 --> 00:56:40.920
a price displayed within Dex
and you have a C P T code of

1247
00:56:40.920 --> 00:56:45.200
8 1 4, 7, 9, you know,
just let the team know.

1248
00:56:45.200 --> 00:56:47.180
And that can get fixed if the,

1249
00:56:47.180 --> 00:56:50.520
if your test is mapped to a
known C P T code that's in the

1250
00:56:50.520 --> 00:56:51.940
clinical laboratory fee schedule,

1251
00:56:51.940 --> 00:56:54.960
it will just say C fee
schedule and you can go to the

1252
00:56:54.960 --> 00:56:59.543
clinical laboratory fee
schedule to look up that price.

1253
00:57:03.360 --> 00:57:05.150
Great. Thank you.

1254
00:57:05.150 --> 00:57:08.990
I know we're coming up to the
end of our time and I see that

1255
00:57:08.990 --> 00:57:10.530
more questions are coming in.

1256
00:57:10.530 --> 00:57:13.150
We can definitely make sure
to follow up on any questions

1257
00:57:13.150 --> 00:57:15.567
that we haven't answered yet.

1258
00:57:22.550 --> 00:57:23.383
Thank you.

1259
00:57:25.230 --> 00:57:26.170
And to our speakers,

1260
00:57:26.170 --> 00:57:28.370
thank you for that great
presentation and for sharing your

1261
00:57:28.370 --> 00:57:28.700
thoughts.

1262
00:57:28.700 --> 00:57:31.330
Thank you to the audience
for participating in today's

1263
00:57:31.330 --> 00:57:33.940
webinar. This concludes
today's presentation.

1264
00:57:33.940 --> 00:57:36.250
Thank you again and enjoy
the rest of your day.