HHS Startup Day pt 5 CMS Dr. Susan Miller

HHS Startup Day pt 5 CMS Dr. Susan Miller


Kevin McTigue: All righty, our next feature
speaker right before lunch is Dr. Susan Miller. Dr. Miller is a Senior Medical Officer for
the Coverage Analysis Group at the Centers for Medicare and Medicaid, and her team helps
make national determinants coverages decisions for new medical product innovation. So, please welcome Dr. Miller to the stage. [applause]>>Susan Miller: Well, thank you all for being
patient. I am here today because sometimes we are called
the 800-pound gorilla, and I would love for you all to know how to dance with us. And that is my goal today. The first thing — I know we’re getting close
to lunch. So, if you remember nothing else, on the agenda,
which is on the startup day website, under my presentation is a link to a whole bunch
of resources which basically have everything in it that I’m going to say today, and, if
you remember nothing else, you can see this little nothing, you know, 50 page innovators
guide to CMS. I commend you to read this. It will tell you about coverage. It will tell you about coding. It will tell you about payment, and this is
your first entree in to Medicare and it really is helpful. But if we’re going to concentrate on coverage
today I need to give you three basic principles of Medicare. In order for something to be covered by Medicare
it must have a benefit category. That’s the law. That’s the way it is. What is a benefit category? It’s like physician services, or therapy services,
or durable medical, equipment, orthotics, prosthetics those sorts of things. If you want a complete list benefit categories
you have two choices. You can go to the Social Security Act and
you can look at section 1861 or — also one of the references has the number 310.1 in
it. This is our clinical trials policy. And what you can do is click on that and at
the top of that policy there is a very long list of our benefit categories. And I would suggest that you just sort of
eyeball them and see if your device, your application, your whatever it is fits in one
of those benefit categories. The second thing that you have to know is
that there are certain things that we are not allowed by law to cover. And those things — for example, I don’t know
how many of you know this or not, but we’re not allowed to cover hearing aids. We’re only allowed to cover eyeglasses in
one very special situation. We’re not allowed to cover convenience items. Again, this is all in the law, and you just
have to be aware of it. That’s why your product has to fit within
a benefit category. Just make sure that you check that out, or
if you need help, you come to us and you ask. The third important factor, which is where
I want to spend most of my time, is that in order for something to be covered — in order
for an item or service to be covered in Medicare it must be reasonable and necessary for the
diagnosis or treatment of an illness or injury or to improve functioning of a malformed body
member. I have to, you know, give you the law, all
right. But what that means is that whatever it is
has to be reasonable and necessary. Now, I would love to say to you that we have
a checklist, and you can just go down it and say,
Well, I hit all the boxes this is great. But that’s not the way it works. I would also like to tell you that most people
think that reasonable and necessary is the same as the FDA’s mission of safe and effective,
and the problem is is that — or the challenge is is that just because you have received
approval or clearance from the FDA that does not make something reasonable and necessary. So, what is it that we are looking for? When we look at an item or service to see
if we’re going to cover it, translate it, pay for it, okay and we are looking for reasonable
and necessary, it means that we are looking for a health outcome that is significant to
the patient, that improves their net positive health. Okay, all makes sense? And we are looking for an outcome that is
important to the patient. So, we are looking for outcomes that improve
function, improve a physician’s ability to diagnose disease and illness. Those are the sorts of things that we are
looking for. Now, how do coverage determinations get made? Well, they can be made at the local level. We have a system of Medicare administrative
contractors all throughout the country. I don’t know. There’s maybe 10 or 12 jurisdictions. And our colleagues, who are Medicare administrative
contractors, can make local coverage determinations. You can go to each and every contractor and
ask, you know, Will my device, for example, be covered? But when — or and there are lots of times
where coverage is just given, and you really don’t need a policy. But when there are questions of — I would
say when there are questions in the country when the medical community is divided in its
opinion of a certain item or service. When there is very significant impact to the
Medicare beneficiary, we make decisions at the national level. So, therefore, we make what’s called a national
coverage determination. Now, when we do this we always ask ourselves
the same question, Is the evidence sufficient to conclude that the application of the technology
under study will provide clinically meaningful health outcomes for the Medicare beneficiary
for the Medicare patients? And, of course, as you all know that the majority
of our Medicare patients are 65 and older. Please, however, do not forget that approximately
15 to 16 percent of our Medicare beneficiaries are below the age of 65. So, as you are designing your products, keep
in mind if they’re, you know, aimed at someone younger that there might be a beneficiary
population who could benefit from your product. How do we answer that question? The question is the evidence sufficient to
conclude that the application of the technology is beneficial to our Medicare population? Well, we look at peer-reviewed literature. We look at evidence-based guidelines. We have what’s called a MEDCAC, which is a
Medicare Evidence Development and Coverage Advisory Committee, where we have independent
experts come to review evidence. We have the public come to speak about the
benefits of the item or service. We always solicit public comments in our national
coverage determinations. We are looking for a global analysis of whatever
that item and service is. The challenge that we have is that this takes
a long time. We usually put out a tracking sheet. Then, that sort of starts a comment period. Then, we look at the evidence. Then, we put out a proposed decision. We then have a second round of public comments,
and, finally, we put out the final decision. And this can take, for example, nine months. Sometimes, that timeline is a little different
depending on the kind of evidence we are soliciting. So, it does take a while. But we investigate our new technology carefully
because we have to strike a balance between innovation and patient safety. And we think that we have done that because
we’ve come up with some alternative coverage pathways which we hope that you, being the
new wave of entrepreneurs in this country, will be interested in. So, the first thing that we do is we do coverage
with evidence development. During our national coverage determination
process — again we want to see that the evidence that is presented to us about any service
or item is pertinent in a positive way to a Medicare beneficiary, but we know that for
innovative and new technology sometimes the evidence is not exactly there yet. So, we have a way, through our national coverage
determination process, that we can do coverage with evidence development to generate evidence
and help you do that sort of final push to demonstrate that your product, your item,
your service is appropriate for the Medicare beneficiary. Basically, what we do is we identify the evidence
gaps in the literature. We have questions regarding those evidence
gaps, and then you submit protocols to us which we can pay for while the protocol is
running. We can pay for the items and services while
the protocol is writing — is working through. And if we approve your protocol you can gather
evidence while Medicare pays. And we think that that is a technique by which
we can balance innovation with patient safety. We also work with the FDA. I don’t know how many of you know about the
investigational device exemption. How many of you have heard of that? But the FDA — oh, that is something that
you guys need to look into. The investigational device exemption is a
way that the FDA assigns risk to new products and to products that perhaps have an incremental
risk to them. So, in some of those instances, if you apply
to us, it is a separate application process, but we can pay for a service or an item while
it is under study if it has an investigational device exemption from the FDA. There are two categories since — I just want
to sort of educate you to ask the FDA about this, but there are two categories. One is category A, which has — these are
devices that have absolute risk to them. They haven’t been otherwise tested. But then there’s a category B where the device
has an incremental risk to it. It’s known to be safe in other waters. So, we would pay for the investigational device,
and we would pay for the routine Medicare costs that surround that. And we hope that that encourages people to
come to us with their new innovations and new technology. The final program that I want to talk about
today is our FDA parallel review program. Usually what happens is that people go to
the FDA, and they get their approval, or they get their clearance. That’s great. And then, they come to us. And then, we go, Hmm, we would have liked
in your pivotal study to have seen this outcome or that outcome. And people go, I just did, you know, a million
dollar study. You mean that wasn’t good enough? What we can do is there is a way — if you
are looking for pre-market approval or a de novo approval from the FDA, there is a way
that we can do a simultaneous review. Now, the rules and regulations of both agencies
have to be followed. Even if the FDA says that they’re going to
approve your device, we don’t necessarily say that it’s reasonable and necessary. But at least you can work with us at the same
time. And in the past we have had one product go
through this program. On the day that the FDA approved the product,
CMS opened with a proposed national coverage determination, and a final was issued in two
months. That cut off seven months from the entire
process. So, that was a success, and we have several
other projects in the pipeline now because this is the kind of thing that we really want
to do. We want to promote new technology. Now, as much as I enjoy the parallel review
program, it is not necessary that you be accepted into that program in order to get simultaneous
thoughts from the FDA and from CMS. The first thing you can do is, as you approach
the FDA, you can tell the lead FDA reviewer on your pre-subcommittee that you want CMS
at the table. And if you put that in writing, we can show
up. And, again, you can find out what the FDA
wants and what CMS wants at the same time. And then, you can go ahead and design your
study accordingly. The other thing that you can do is just call
us. We meet with people all the time. We meet with suppliers. We meet with manufacturers. We meet with patient groups who think there’s
something new on the market that we need to consider. We must have, I don’t know, three to six of
these types of meetings every week. We enjoy them. The thing is is that if we can get your technology
to our patients, that’s a win for everybody. We are out to improve the health of the Medicare
beneficiary, and we applaud your help. We applaud your thinking in helping us to
do that. So, please come to us sooner as opposed to
later. Ask us questions. Spend an evening read the innovators guide
to navigating Medicare. Again, the resources that I have given you
will talk about investigative device exemptions. It’ll talk about coverage with evidence development. It’ll talk about the parallel review program. Please let us know how we can help you make
our beneficiaries lives better. [applause]>>Bruce Greenstein: So, in another example
of the way that government should run when it comes down to government. By the way I just love the presentation. When you think about parallel review — well,
first of all, you don’t often have somebody that runs such an important part of government,
this part of Medicare, just say, Call me so I can answer your questions. It’s just refreshing to hear. But the parallel process — just think about
if you’re a company that’s seeking funding or you’re trying to compress your burn rate. Take seven months of non-revenue out of your
company that really could add to some positive margins in much, much faster time. Or if you go to the street or to the markets
to get additional funding and you’re able to explain a way that you’re going to begin
net positive revenue that much faster by this parallel process it’s great to hear. But now you must have some questions. This is good opportunity here.>>Male Speaker: Thank you so much. What are some of the most common things that
you find entrepreneurs are doing wrong when they’re approaching you, and what could they
fix to work better with CMS?>>Susan Miller: Okay, number one is the outcome
measures. So, for example, the intermediate outcome
measure — I’m just making this up. Suppose your device is to increase somebody
strength. Let’s just say that. Well, as you grade muscle strength a patient
doesn’t know whether their strength is three out of five or five out of five. They don’t care about that. What they care about is what can they do. Okay? What has been added to their life? So, that’s what I mean, by we are looking
for very specific patient outcome measures or very important outcome measures to the
patient. Obviously, mortality is important. We are not — in general, we are not looking
at cost-benefit analyses in dollars and cents, but we are looking for drops in surgery rates,
drops in amputations, drops in ER visits, hospital admissions, readmissions, stuff like
that. Think about what you would want to be able
to do, and then think about that in terms of your outcome measures. I would also say that the second thing that
entrepreneurs forget is that when you submit your evidence to the FDA it is possible for
you to pick a patient group. Well, we are interested in the Medicare patient
group. So, if you perform a study on healthy 20-year
olds that’s not really going to give us a whole lot of information. It’s not that 20-year olds are not Medicare
beneficiaries, but you have to be able to target it to the Medicare beneficiary population
that you are interested in. So, that we would be interested in that. We also do — we look at your study designs. We look at the integrity with which the study
was carried out, but I would say that the first two are the most important aspects and
the ones that, perhaps, trip people up. They’re not thinking about that when they
come and speak with us.>>Bruce Greenstein: Okay, next question.>>Dave Kelly: Thank you, ma’am. My name is Dave Kelly [spelled phonetically],
and I’m with ERPI. It’s a service-disabled veteran-owned small
business, and we’ve been helping the Department of Veterans Affairs and the Veterans Health
Administration as they, kind of, respond to the executive order to make federal government
more efficient more effective. Embedded in that is really a question of how
do you do more with less? It sounds like you’re running a very labor-intensive
process. It’s going to require that, as you get more
and more innovators coming to you, that you’re going to be able to respond to that at a both
the local and national level. How are you thinking about, kind of — and
envisioning what your future state’s going to be and then kind of moving towards that
right now?>>Susan Miller: I was afraid you were going
to ask me that. We are currently, and it’s not public yet
so I can’t go into any detail, but we are currently looking at other ways that we can
get innovative technologies out on the market much quicker than we have done in the past. And I would love to be able to give you an
example, but all I can say is stay tuned.>>Male Speaker: Thank you. Dr. Miller, when we started today Bruce started
talking about open data and open source information. I’ve been really thrilled to see how much
the CMS has shared information. We’re a small start-up here in D.C. and we
help individuals make sense of Medicare. We also have a marketplace for individuals
to purchase additional insurance. We found some great stuff on your site. But we were told we couldn’t publish that
without CMS’s approval, and then we were told we were too small for that kind of review
for a small startup. Who would we talk to just, kind of, see if
working with startups and getting data out there to the public?>>Susan Miller: Do me a favor, that’s not
my specialty, but if you write an email — Kevin [spelled phonetically], is that okay? Kevin will get that email to me, and I will
find out for you. I have a thought in my head, but I’ve never
heard the part that you said, We’re too small. I was not aware of that. So, let me check into that for you.>>Male Speaker: Sure.>>Susan Miller: And we will get you an answer.>>Male Speaker: Wonderful, thank you.>>Susan Miller: Okay?>>Benedict von Schroeder: Dr. Miller, my
name is Benedict von Schroeder [spelled phonetically]. I’m an investor. You explained your requirements of reasonable
and necessary how that’s different from the process of the FDA, but then later you said
that you also have to strike a balance between innovation and safety. And safety is something the FDA does. So, are you doubling effort there or are reviewing
that again?>>Susan Miller: No, no, no. Our colleagues at the FDA are the safety and
effectiveness experts. However, as I said, for example someone may
provide the FDA with the study results that are not pertinent to a Medicare beneficiary. So, we have to think of the specific population. So, we just can’t go willy-nilly and — does
anybody use that word anymore? [laughs] We just can’t say, you know, here
is a process and we’re just going to cover it for our beneficiaries. We want to see the evidence that it improves
the net health outcome of our beneficiaries.>>Bruce Greenstein: Any other questions? All right well thank you very — hold on. There is –>>Susan Miller: Right over here.>>Male Speaker: Hi, I’m just wondering how
a startup could go about taking risk. If that’s something that startups can do,
or if that’s only something that’s done through ACOs and you have to go through the hospital. Do you have any a notion of contracting directly
with startups that want to take risk for decreasing the cost of care?>>Susan Miller: Well, I’m not sure I understand
your question, and maybe afterwards you could give me a little more detail. But we are not concerned with cost. And perhaps I missed the point of your question,
but I would be happy to talk with you about it. Okay?>>Bruce Greenstein: All right last chance
on the questions. All right, well, let’s say thank you very
much. [applause] And now for next steps. So, it is lunch time, enjoy one hour of the
sunshine. We’re going to come back here and go at 1:05
p.m. So, you’re going to be entertained and educated
in this Shark Tank kind of process. Those that are going to be doing the — sort
of the judging, the feedback giving, remember these are people responsible for procurements
that touch the in the billions of dollars. So, this is not people just with a trite opinion. These are people that have opinions that have
shaped a lot of what the policy looks like in this department. So, please have a great lunch, come back,
be fortified, and be ready to either present or be educated. Thanks.>>Male Speaker: Produced by the US Department
of Health and Human Services at taxpayer expense.

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