Clin Eval 43（1）2015

Interview

Interview with Dr. Louis B. Jacques
on insurance coverage policyof CMS focusing PET imaging
─ Scientific evidence and social, ethical implications
1
concerning healthcare reimbursement ─＊Louis B. Jacques ＊ 2
Senior Vice President & Chief Clinical Officer, ADVI Reimbursement & Health Policy Consultancy

Interviewer: Chieko Kurihara ＊ 3
Molecular Imaging Center, National Institute of Radiological Sciences (NIRS)(June 13, 2014, ADVI, Washington D.C., United States)

Abstract
This is the record of an interview with Dr. Louis Jacques, M.D., Senior Vice President & Chief Clinical
Officer, ADVI Reimbursement & Health Policy Consultancy, on June 13, 2014, at his office in Washington
D.C., United States. He had just left CMS (Centers for Medicare & Medicaid Services) at the end of
February 2014 after 11 years of contribution. He is a key-person to whom the Society of Nuclear Medicine
and Molecular Imaging (SNMMI) and Alzheimerʼs Association presented arguments seeking a positive
decision of the CMS on Medicare coverage of beta-amyloid imaging PET (Positron Emission Tomography)
scan for finding cognitive disease. He was a responsible person, as the Director, Coverage and Analysis
Group, Center for Clinical Standards and Quality, at the time of final decision memo of the CMS whichallowed only a 1-time scan of amyloid imaging to be covered in the CMS-approved studies under thescheme of CED (Coverage with Evidence Development).
He also talked about the profound idea of the scientific, social, and ethical implication of the diagnosis
of Alzheimerʼs disease, as well as a rationally designed framework of the CED. We Japanese can learnmuch from this talk to consider future perspectives of the design of health insurance coverage of advanced
medical technologies to conquer many of our incurable diseases.
Key words
CMS (Centers for Medicare & Medicaid Services), PET (Positron Emission Tomography), amyloid-beta,
CED (Coverage with Evidence Development), NOPR (National Oncologic PET Registry)［Epub ahead of the issue publication］
Rinsho Hyoka（Clinical Evaluation）．2015；43：W73−W84．

＊1
＊2

＊3

Japanese translation of this interview is published in. 2015; 43(1). Forthcoming．
Previously, Director, Coverage and Analysis Group, Center for Clinical Standards and Quality, Centers for Medical& Medicaid services
Research Center for Radiation Protection; Research Governance and Human Research Protection Office, NIRS；
Editorial staff, Rinsho Hyoka（Clinical Evaluation− W73 −

臨床評価43 巻 1 号

2015
Dr. Louis Jacques leads ADVIʼs strategic product development
initiatives by spearheading focus on a top down commitment to change,
recognizing that public and private payer “pay for value constructs”
will require evidencing value and tying remuneration of our clientʼsofferings to the evidencing of that value. Dr. Jacques is a graduateof Georgetown University and The University of Maryland Schoolof Medicine.
A Distinguished Career in Government Service and in Medicine:
Director, Coverage & Analysis Group (CAG), Centers for Medicare and Medicaid Services (CMS) since 2009
Division Director, Items and Devices within CAG from 20042009
Led CMS collaborations with Food and Drug Administration(FDA) including Entrepreneurs in Residence Program
Practiced medicine as an attending physician for almost 20 years,
and was an Associate Dean at Georgetown University School of
Medicine before coming to CMS

Passionate about Change and Innovation:
Implemented Coverage with Evidence Development (CED) under
Dr. Louis Jacques, M.D., Senior Vice
the Medicare program
President & Chief Clinical Officer, ADVI
Co-created joint parallel review pilot between CMS and FDA
Reimbursement & Health Policy Consultancy
Responsible for updating Medicare coverage in FDA IDE trials
Coauthored over 60 Medicare National Coverage Determinations
Developed program oversight of the Local Coverage Determination process
Invited speaker at national policy and professional society meetings nationally and abroad
Authored or coauthored original research and commentaries in peer reviewed medical journals
Awarded FDA Leveraging/Collaboration Award (TVT Registry Team) 2013; FDA Parallel Review Team Award 2012;
CMS Leadership Awards 2006, 2010; Golden Apple (Teaching Award - Georgetown University School of Medicine)
Source: http://www.advi.com/(Coverage with Evidence Development) and how it

1．Background of PET scan
coverage

was implemented for PET (Positron Emission
Tomography) examination. First, please introduce
background story about the coverage of PET in theInterviewer Thank you so much for yourU.S. (United States).
Jacques

acceptance of todayʼs interview. It is fantastic thatThank you for coming here for suchyou moved from CMS (Centers for Medicare &interesting discussion. PET in the U.S. (United

Medicaid Services) to this company, ADVI. I came

States) was originated as a research tool, and it

here as you were addressed in the letter of Augustwasnʼt until about 20 years ago that there was sig-

1）

1, 2013 , from Gary Dillehay, the President of thenificant interest in using it as a mainstream medical

Society of Nuclear Medicine and Molecular Imaging

imaging tool. That raised some challenges to the(SNMM) of the time, requesting the CMS for cov-

use of PET because FDG ([18F]-fluorodeoxyglucose)erage of amyloid-beta (Aβ) PET imaging forisnʼt owned by one company. Because of that itdementia and neurodegenerative disease. Also I am

didnʼt seem that there was a unique responsible

very much interested in the scheme of CEDparty to oversee the generation of clinical evidence− W74 −

Clin Eval 43（1）2015

to determine whether or not FDG/PET imaging isstaging, re-staging and monitoring response toclinically valuable as opposed to just being a scien-

therapy. That was a very awkward classificationtific curiosity. There was a lot of political pressure

because in this space before the treatment, staging

in the U.S., from Congress, to cover PET scans.

information helps to inform diagnosis, and diagnos-Interviewer

tic information helps to inform staging. Itʼs not likeIn the Congress?

I was informed at the time that thethe doctor orders the test and says, “Well, youdeveloper of PET had influence in Congress. So

know, this is 30 percent for diagnosis and 70 per-the Medicare program was essentially told to find acent for staging.” Thatʼs not how it works. So

way to cover PET. So they developed this “cover-instead of 4 categories, we divided it up into 2 cat-age with evidence development” which is a para-egories. We also heard from oncologists that thedigm where the PET is covered if additional

concept of re-staging is not really a common para-clinical information is collected. That led eventu-

digm in cancer because you have whatever stage

ally to the NOPR (National Oncologic PET

you had when you were first diagnosed. Now you

Registry) registry for cancer, in the framework of

may be in remission but you are still stage 4 in

2, 3）

remission. You donʼt become a stage zero or a stage

Jacques

CED (Coverage with Evidence Development).

There are other covered uses of PET like rubidium

1 patient.
So NOPR moved forward, looking for evidence

and ammonium for cardiology but theyʼre relatively

that FDG PET imaging changes physician manage-

smaller uses.
But it was not clear in the setting of cancer

ment of the patient in a way that improves patientwhether FDG/PET would actually be informative

outcomes. In cancer, because the treatments them-or not to help physicians make decisions that pro-selves can be lethal, there are clinical utilities fromduce better outcomes for patients because there

avoiding unnecessary treatment. Because so muchare some tumors that are not FDG avid, e.g., ade-is known about the treatment side of cancer, younocarcinoma of prostate.

could say that if you have evidence, for example,

The Medicare rules from Congress are not very

that if a woman is suspected of having cervical can-flexible so Medicare has to make decisions in cer-

cer and she has a positive supraclavicular node thattain ways; so Medicare did a series of national

cure is not expected; itʼs more palliation and symp-

decisions to say first that most oncologic FDG

tom control; so that patient would be able to avoid

PET was covered only with further study. We

surgery, for example, and we think avoiding sur-divided PET imaging into 2 big categories. If thisgery if you donʼt need it is a benefit for patients.

is used to guide initial definitive anticancer therapy,

Thus, in the cancer space, we were able to say

we said there are PET scans leading up to thethat if there was persuasive evidence that physi-

choice of the initial therapy and then there arecians were actually going to change their manage-

PET scans afterwards for people who have failed

ment that we would cover it. What was interesting,therapy or who had therapy and youʼre trying to

the way that PET is paid for in the U.S., the PET

monitor them for recurrence.

imager isnʼt necessarily related to the cancer doc-

Interviewer

Diagnosis and management, you

tor so these people were going to be paid or notbased on whether a different group of physicians

mean?
But thereʼs a nuance there because

were going to submit data. The oncologists, even

Medicare originally divided PET into diagnosis,

though they didnʼt get paid to participate in NOPR,

Jacques− W75 −

臨床評価43 巻 1 号

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nonetheless, oncologists are, I think, accustomed topatients tend to accumulate amyloid-beta anyway.

working in a protocol and to reporting the informa-

So the challenge becomes if a patient is going totion so they kindly essentially volunteered. So overhave amyloid-beta in their brain anyway, and if thethe course of about 5 years, we removed the NOPR

amyloid-beta theory has not really been firmly con-requirement, first for PET scan in this initialclusively established, finding amyloid-beta in an

period 4）, and then later on in PET scan for thisolder patient is of uncertain clinical value unlessperiod after completion of initial anticancer treat-

there are meaningful treatments that would follow

5）ment, with the exception of prostate cancer . PET

a positive scan result. If there is a patient within prostate cancer here remains non-covered.

early signs and symptoms that might suggest a progression to Alzheimerʼs, those patients may be

2．Medicare Coverage concerning
beta amyloid imaging

younger than Medicare age anyway; I mean iftheyʼre 55, itʼs not primarily a Medicare issue. Itʼsreally a private insurance issue.

JacquesInterviewer

Now that is different than what hap-

pened with beta amyloid PET imaging. Because

But Medicare will have impact on

private companies.
Jacquesthese agents are made by specific companies,

It can. It depends. Some private com-thereʼs clearly one company thatʼs responsible forpanies seem to hide behind Medicare decisions evenmanufacturing each beta amyloid PET tracer, andif the issues are different for a younger population

they undergo formal review by the U.S. FDA (Foodor an older one. The other advantage that privateand Drug Administration). The reason why we cov-

companies have is they can do prior authorization.

ered beta amyloid PET with CED in Medicare was

They can review the claim first and then decide

explained in the decision memo. One, the treatment

whether to cover the scan. Medicare does in generalof Alzheimerʼs disease is not as well developed or

not have prior authorization. The way the Medicare

understood as the treatment of cancer. We had

program is designed means that it doesnʼt have theexpert physicians saying even if the scan were neg-

national flexibility to say, “Well, this person can

ative they would treat the patients as if they had

get a scan; not that person; this person can based

Alzheimerʼs anyway because everybody feels des-on our review of their medical record.”
Interviewer

peration. So there really was a lack of persuasive

I understand. I read the final ver-evidence for Medicareʼs purposes that beta amyloidsion of the decision memo by CMS 6）. Your namescanning actually results in an improvement for thewas at the top of it, as the Director of Coveragepatients. Thatʼs why Medicare said we will only

and Analysis Group. It was dated on September 23,

cover it in clinical study.

2013. Now before coming here I attended theWhatʼs happening now is that the Alzheimerʼs

Annual Meeting of the SNMMI in St. Louis , where

community is working on study protocols thatpeople discussed that itʼs not just clinical trial pro-

Medicare could cover, and one study is currently ingram but a NOPR registry trial could be covered

progress. One of the challenges with Alzheimerʼsby CMS. Is that correct?

disease is that the amyloid-beta theory is really

JacquesYes, depending on the methodologic

one of several theories. Even the FDA-approved

rigor of the registry. So the NOPR registry can belabeling for an agent says this is not diagnostic oftied to a later use of Medicare claims data to see

Alzheimerʼs Disease. We understand that older

whether the patient had other outcomes. Thus, a− W76 −

Clin Eval 43（1）2015

simple registry might not be sufficient for “cover-

3．CMS policy for Coverage

age with evidence development” program because“coverage with evidence” program has to look atclinical outcomes. The Medicare program guidanceInterviewer The description in the decision

on practices around “coverage with evidence” devel-

memo is explained in such way; similar to the deci-

opment has evolved since the original guidancesion about the expanded use of FDG?

7）

describing CED as

Jacques Yes. What would happen is when the

including both Coverage with Appropriatenessclinical trials or clinical studies are completed andDetermination (CAD) and Coverage with Study

published, Medicare would reconsider the policy

document was published 2006

3）

Participation (CSP) . So coverage with evidence

decision and consider evidence not only throughdevelopment initially could allow a regular registry

NOPR or other coverage with evidence develop-

under CAD. Later on, CAD was set apart on its

ment studies but if anyone else were doing clinicalown and CED reached a point where there needed

trials or clinical studies, they would go ahead andto be a requirement that there be some reported

do that. They would look at that evidence as well.

outcomes about that cohort in the registry ‒So whether itʼs FDG in the past or amyloid-beta

whether it was mortality or whether it was hospi-

now, Medicare also covers in NIH trials. For exam-

talization or something else. But fundamentally theple with FDG PET, the cancer imaging group atregistry worked well in the cancer imaging setting

National Cancer Institute (NCI) had clinical trials

and doesnʼt necessarily work quite so well in otherwhere they also wanted to use PET in the protocol.

settings.

Medicare paid for PET in that study because it

Interviewer

According to the discussion in thewas part of a clinical trial.
As for the amyloid imaging, because there really

SNMMI meeting other amyloid-beta probes, notjust florbetapir, are also covered by the coverageareapparentlynoeffective

treatments

forwith evidence development system.

Alzheimerʼs, the interest in PET scanning seems toYes. What Medicare does (which isbe if there are patients with Pickʼs disease or fron-what many insurance companies do) is they gener-

totemporal dementia or something else, who should

ally donʼt cover based on the brand-name. They

not get certain anti-cholinesterase inhibitors.

cover by the class. So for example, a surgical pro-

There may be some benefit early in that population

cedure maybe covered and the insurance company

but not more broadly because people struggle withdoesnʼt necessarily get into the details of thiswhat to do with Alzheimerʼs disease anyway. The

device or that device. So with PET scanning forquestion in the U.S. is if someone has a scan andamyloid-beta imaging in the context of dementia,

itʼs positive or negative, what do you do next? I

the decision applies to any subsequently approved

mean the stakeholders acknowledge that there

amyloiditʼsreally is no need to progressively scan someone

flutemetamol, florbetaben or something else, they

over and over again. If a patient has symptoms andall are automatically brought into the decision. So

donʼt have significant amyloid-beta at that point,

any future FDA-approved amyloid-beta PET agent

then Alzheimerʼs is not the cause of their symp-

falls under the current decision and could go into

toms.

Jacques

PET

imaging

agent.

WhetherInterviewer So at this moment, the coveragecoverage with evidence development.

is only for 1 time of scan?
− W77 −

臨床評価43 巻 1 号

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JacquesYes. Coverage for FDG is different.

because youʼre already demented here.
Interviewer

So this is in the context of a cancer therapy that

I understand very well. But how

clearly evolves as the patient responds to treat-

about if we say we cover the use of 2 or 3 PET

ment or undergoes second. There are 3 PETs cov-

scans in very limited well-designed clinical trial

ered nationally here; and then the local Medicare

during some years to find something, for example,

contractors can decide if they want to cover more.

to assess development of the disease like accumula-

For amyloid scanning, only one scan is covered. Buttion of the amyloid beta, or to determine the clini-the way Medicare system is designed, there is cen-

cal condition of these people being scanned?
Jacquestral Medicare and then there are about 10 local

Medicare pays the routine cost in a

Medicare contractors that are free to make any

clinical trial as well as the investigational item ordecision as long as they donʼt conflict with the cen-

service depending on policy. But Medicare by law

tral one.

doesnʼt pay for the administrative cost in a clinicalBecause there is already evidence that people

trial. Medicare primarily is an insurance agent. Itʼsaccumulate amyloid in their brain as they get older,

not the National Institutes of Health. The Medicare

and the issue is that if the symptoms comes and the

mandate really has not been around researchscan shows you donʼt already have amyloid, by cur-because that is not what health insurance is pri-rent definition you donʼt have Alzheimerʼs disease.

marily for. Healthcare insurance is ideally for

You have some other kind of dementia. And because

things that are firmly established. So even if you

you already have a non-Alzheimerʼs dementia here,

have a clinical trial where Medicare is paying all

no one has proven the clinical value of testing you

the routine cost plus paying for one CT scan, at

again, letʼs say 5 years later or 10 years later,some point, I think the sponsor institution has to− W78 −

Clin Eval 43（1）2015

take responsibility for some of the costs of theof time, as long as the patient is adequately

trial because theyʼre the ones who are going to

informed, you know. I think the issue is that maybe

make the money if the trial is successful. I mean,patients are not being told the complete story about

Medicare doesnʼt get a share of the profit if thethe test. If the doctor says, “Thereʼs an Alzheimerʼsdrug is successful.

scan for you. Weʼre going to help diagnose yourInterviewer

Do you mean that 2 or 3 addi-

Alzheimerʼs.” Then the patient doesnʼt realize thattional scans would be regarded as a part of thethat is a very, very shortened explanation of all theclinical trial administrative cost?

concerns around diagnosing Alzheimerʼs.

Theyʼre clinical costs but theyʼre non-Interviewer This is an illustration 8） based on

covered clinical costs. So either the sponsoring

their very well written literature on usage criteria

institute (if they were NIH) or the company (if theof amyloid-beta imaging 9）. After the publication ofcompany was the sponsor) would need to pay forthat literature, SNMMI developed this kind of

those.

illustration on “appropriate use” to explain how to

JacquesOkay, I understand very well. Itʼs

use the amyloid-beta scan. They are saying thatvery similar to the Japanese situation because inamyloid-beta scans should be very much carefully

Japan all of these cannot be covered at this stage ofused to avoid abuse.

Interviewer

clinical trial. However, I think there is a good pol-Additionally, there is some ethical standpoint inicy of CMS, different from a policy in Japan. If it

what you said about there being no treatment foris according to the agent, this something investiga-

Alzheimerʼs at this moment There should be sometional part can be covered depending on the situa-kind of support for such kind of people. One goodtion, according to the decision It seems to lead topoint I think is that people can manage their remain-such strategy that early approval FDA and promo-

ing life if they can know about their situation.

tion of evidence development partially covered by

5．Background culture to support
elderly people

CMS.
Jacques

It depends on the situation, yes.

4．Ethical issues

Jacques Given the differences between Japaneseculture and American culture especially with

Interviewer

A little bit different point. In this1）

regards to family and elderly people, in the U.S.,

addressed to you, there are aitʼs not uncommon for the older person withnumber of claims not only about coverage but also

Alzheimerʼs to live very far away from their family

there is some ethical viewpoint mentioned here thatand from their children. They may well be living

if the coverage applies only to those entering aalone or living in a nursing home. Is Japanese soci-clinical trial, it would be something like coercion to

ety more cohesive so that the older family members

enter the trial.

arenʼt alone or is it starting to become more like

Jacques

Western societies where the grandparents are justletter from SNMMIIn any clinical research, people voice

concerns about the motivations of patients. Iʼm notalone?

saying that these are not legitimate concerns forInterviewer Generally it is true that there isdiscussion. Iʼm just saying that weʼve clearly man-a conventional way of life that Japanese elderly

aged to conduct clinical research for a long period

people live with their family, if comparing with

− W79 −

臨床評価43 巻 1 号

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Western society. However, recent trend in Japan is

6．Clinical benefit of beta-amyloid
scanthat these elderly people are coming to be in hospital or some other facilities.
How do you connect this kind of social situationof Alzheimerʼs people with the issue on PET
scan?
JacquesInterviewer

In your personal opinion as a phy-sician apart from being involved in the CMS policy,
One of the things that people had sug-gested was that PET scans could help people withhow do you think is the effect of PET scanning or
amyloid PET scanning in terms of social value?
Jacquestheir financial planning and with things like that.

I think itʼs unclear because right now

The challenge is that financial planning is not aitʼs based on an amyloid-beta proposition which has

health insurance issue. There may be many things

not been definitively proven. I have an example I

that might be beneficial for a society but itʼs not ause. I tell men, “I have a test that is 100 percent

health insurance role to go fix it. For example, if

sensitive for prostate cancer. Itʼs a Y-chromosome.

Medicare pays for something it would increase

Every person who has or is going to develop pros-

employment in the factory but Medicare should nottate cancer has a Y-chromosome. If you donʼt havebe concerned that if we donʼt pay for this, this willa Y-chromosome you donʼt get prostate cancer.” Soclose the factory in some town or unemployment or

the knowledge that every men anywhere if he lives

things like that. There are many things that arelong enough will get prostate cancer, it is not reallyclearly beneficial like eyeglasses. Theyʼre cheap.

actionable because thereʼs no preventive strategy

Theyʼre customizable or they can work in a powerfor prostate cancer. The treatments (whether itʼs

failure. They help you very well. But Medicare bysurgery or anything else) have side effects that

law cannot pay for eyeglasses or hearing aids or

people donʼt want. What you end up with then is a

modifications to the home. If you have an older

population of people who become focused on thepatient who may have osteoporosis and they may

possibility of prostate cancer when in fact theyʼrefall in their home, it might make a lot of sense to

more likely to die of heart disease or lung cancer

modify their home so that they are less likely toor something else depending on their health habits.

fall, and if they fall theyʼre less likely to be injured.

The Kaplan-Myer curve for any trial if you study

But health insurance generally doesnʼt pay for

it long enough everybody dies in both arms. So if

modifying your home.

we accept in the long run that we are all going toInterviewer I understand that CMS policy isdie of something, the issue is not to identify everything that might possibly kill you but to identify thelimited to the clinical benefit, not social benefit.
Yes, and itʼs the clinical benefit of thethings that will cause you your early death and dis-patient because there are no family insurance poli-ability that you can actually act on and do some-cies in Medicare. So if doing something to thething about. Otherwise, you simply face the reality

patient helps the family member but doesnʼt helpthat life is short.

JacquesInterviewer

the patient, Medicare canʼt deal with it.

So which kind of evidence should

be expected and which type of study is necessary
for amyloid-beta scans?
Jacques

What would be needed in amyloid beta

(because the therapeutic side is unclear) would be− W80 −

Clin Eval 43（1）2015

evidence that patients who are managed based on ain Japan. Some Japanese doctors are informing

amyloid-beta scan have better outcomes thanstudy subjects of their future plan to take thepatients who are not; and that, if one uses the can-patientʼs brain tissue after their death. But somecer paradigm, would be either that they are tar-doctors are hesitant to mention such kind of things

geted for early treatment of Alzheimerʼs and thus

especially to very elderly patient whose brains arethey have fewer symptoms, or that a significant

okay, or their cognitive situation is okay. They

proportion of them are able to avoid therapies that

hesitate to explain these things to patients in clini-has significant burdens, whether itʼs adverse events

cal trial, especially if the physical condition of theor whether itʼs something else. Thatʼs essentiallyelderly patient is very bad. Such kind of patient iswhatʼs needed. And because the therapeutic side ofa good recruitment candidate for study to the com-

Alzheimerʼs is so unclear, that really requires apare PET imaging and brain tissue. But in Japanese

longer term study than if the therapies were very

culture, there is hesitancy to say to these people

well known. For example, with colorectal cancer

that after your death we would like to take yourand the use of

testing was adopted

tissue. I have spoken about this with some Europeans

fairly quickly because so much was known about

and Americans. They say this kind of thing should

the treatment options in colorectal cancer and what

be explained very clearly to the patient. (This isthe benefit would be, whereas with Alzheimerʼs

the separate issue from the authorization of thethatʼs just not that clear.

family after the death of this research subject.) So

testing,

this is a cultural difference. How do you think

7．Research study for future
development and ethicalconsiderations

about this issue? This is very much ethical question, I know.
Jacques Clearly someone would need to give
permission (whether itʼs the patient or whether itʼs

JacquesThis is actually about genetic testing.

their family) afterwards. Even in the U.S., autop-

This is a copy of Archive Biomarkers. Itʼs a similarsies are no longer routine. Most patients when theyissue here in the sort of what do you do, especially

die they go to a funeral home and they go fromwith Alzheimerʼs because what you may be dealing

there. Studying Alzheimerʼs is fraught for a num-with are archived brain. You can have this. You canber of reasons. One, itʼs very sensitive topic thatkeep it.

can be politicized, itʼs like studying certain cancer.

Because in Alzheimerʼs, patients donʼt realisti-

But at the same time, if we make decisions based on

cally get a brain biopsy so many of the studies haveinsufficient evidence because weʼre afraid to do thebeen based on archived tissue samples which is notdefinitive thing, we run the risk of mistreating an

unlike the paradigm in certain cancer trials. This is

entire generation of patients because we were notthe chief of biometry at the National Cancer

brave enough to actually either acknowledge to

Institute so he is very influential, and he proposed

these patients that they were being treated on scantan evidentiary paradigm for biomarkers to acknowl-

evidence or to say, yes, we really do need to study.

edge that studying a biomarker is harder thanItʼs very difficult for physicians to admit that they

studying a therapeutic treatment.

donʼt know. Thereʼs tremendous pressure to giveInterviewer

Yes. One point you mentioned isthe patient an answer even if the answer is a poorly

about brain tissue examination. Itʼs also a problem

informed answer. And I think that desperation,− W81 −

臨床評価43 巻 1 号

2015

unfortunately, is bad motivation for good sciencethe money. Especially with declining birthrates, itbecause desperation makes one take great leaps

becomes a greater and greater burden on a smaller

without actually doing good science.

and smaller number of people. So if there are things

Interviewer So youʼre saying that for athat can either help the younger generation scien-

researcher to conduct good science, it is also nec-

tifically/medically or help them financially byessary to support these people by telling them whatassuring that the things that they are responsible

will actually happen after their death, and this isfor are things that actually work as opposed tovaluable for good science.

funding a generation of long experiments, social

JacquesYes. Itʼs something like ‒ we may notexperiments, maybe thatʼs persuasive.

be able to help you but we might be able to help

8．Business, family, and future
generation

your children ‒ because most parents already madegreat sacrifices for their children even whiletheyʼre alive so the idea that a parent would continue to make a sacrifice for the benefit of theirInterviewer

Thank you so much, it is very

children later on, I think, can be a compelling one,

important point. Just one last question. Could you

not only a scientific one but also a financial one. In

introduce your personal history. After working in a

the United States, thereʼs a lot of conversations

university hospital, you joined CMS. And what isthat the grandparentsʼ generation has all the dis-the prospective of this company.

posal income and the grandchildrenʼs generation is

JacquesI left CMS at the end of February offinancially facing the burden of supporting their

this year (three months and a half before) to comeelders meanwhile the elders are the ones with all

and join ADVI. ADVI is a consultancy that helps− W82 −

Clin Eval 43（1）2015

companies in the life sciences whether itʼs drugs,

medical process. So whether the head of coveragediagnostics, or devices. We also deal with healthis a lawyer or a physician, I donʼt think ultimately

plans, drug plans, private insurance; things likematters that much because if itʼs run by a physician

that. So weʼre essentially a consultancy with part-you still need legal input. If itʼs run by a lawyer you

ners and then a larger number of staff, and we work

still need medical input. So it would be a different

with both large companies and small companies.

model but I think it could be successful with either

Interviewer

How about your joining CMS

model.
Interviewer So collaboration would be impor-after your work in the university?
Jacques

I basically went to CMS because I

tant.
Jacques Yes, because she and I had offices

didnʼt want to miss my daughterʼs soccer games. My
daughter played in high school, and my son also

next to each other, so we used to talk everyday.

played sports. I worked at Georgetown. It was aInterviewer So thank you very much. It wasvery long drive and I was afraid I would miss somevery precious experience to talk with you and heardof the things with my children. And I had alreadyabout some parts of policy and philosophy of reim-

been at the university then for 8 years, and I

bursement in the U.S.

decided to work closer to home.
Interviewer
Jacques

Really. You are a good father.

Acknowledgement

Thatʼs why I went to Medicare ‒ towatch my daughterʼs soccer games.
Interviewer

Between your work in the univer-sity and this company, you only worked in CMS?
Jacquesand Welfare, 2014 fiscal year research fund: Regulatory
science concerning clinical application of nuclear medi-

Yes. Eleven years.

Interviewer

This interview was during the visit to U.S. as a partof the following task force. Ministry of Health, Laborcine diagnosis using PET drugs produced by an in-house

I heard that after you left CMS,PET drug synthesizer.

next person is a lawyer.
JacquesYes. She was my deputy. Sheʼs very

References

good. Her name is Tamara Syrek Jensen. Here is anarticle written with her on the issue of reimburse-

1）Gary Dillehay, President, SNMMI. Addressed to Louis.

Jacques, Director, Coverage and Analysis Group, Office

Thank you, it is meaningful infor-of Clinical Standards and Quality, Centers for Medi-mation for Japanese readers, they are deeply inter-care & Medicaid Services. Re: CAG-00431N Beta amy-

ment of regenerative medicine
Interviewer

10）

ested in how to reimburse for regenerative medicine,stem cell therapy, or other kinds of advanced technologies. Is it often that lawyers get appointed to
CMS positions?
Jacquesloid Positron Emission Tomography in dementia andneurodegenerative disease. August 1, 2013. Available
from: http://www.snmmi.org/files/docs/SNMMI%20
Amyloid%20Comments%20to%20CMS%208%201%20
13.pdf

The job historically has been filled in2）Lindsay MJ, Siegel BA, Tunis SR, Hillner BE,

recent years by physicians, although Medicare as a

Shields AF, Carey BP, Coleman RE. The National

public governmental insurer is essentially a legal

Oncologic PET Registry: expanded medicare cover-entity. Medicare is not a hospital. Medicare is aage for PET under coverage with evidence develop-

creation of Congress, which means that Medicare isment.

really the result of a legal process rather than a− W83 −

. 2007; 188(4): 1109-13.

3）Kurihara C, Inoue T. Insurance coverage of PET

臨床評価

43 巻 1 号

2015
nca-decision-memo.aspx?NCAId=265

drugs and imaging accreditation in U.S. − PET Drug
American Dream World History: The 3rd Report −.

7）Guidance for the Public, Industry, and CMS Staff:. 2013; 11(10): 86-9. Japanese. English trans-

National Coverage Determinations with Data Collec-

lation is available from: http://homepage3.nifty.com/

tion as a Condition of Coverage: Coverage with Evi-

cont/43̲1/w63-w71eng.pdf

dence Development. Jul 12 2006. Available from: http://4）Centers for Medicare & Medicaid Services. National

www.cms.gov/Medicare/Coverage/Determination

Coverage Determination (NCD) for Positron Emis-

Process/Downloads/ced.pdf

sion Tomography (FDG) for Oncologic Conditions (220.

8）Society of Nuclear Medicine and Molecular Imaging.

6.17). 2010 Aug 4. Available from: http://www.cms.

Brain Amyloid Imaging Infographic. May 7, 2013.

gov/medicare-coverage-database/details/ncd-details.

Available from: http://interactive.snm.org/index.

aspx?NCDId=331&ncdver=3&NCAId=85&NcaName=

cfm?PageID=12610

Positron+Emission+Tomography+(FDG)&CoverageS9）Johnson KA, Minoshima S, Bohnen NI, Donohoe KJ,

election=Both&ArticleType=All&PolicyType=Final

Foster NL, Herscovitch P, Karlawish JH, Rowe CC,&s=All&KeyWord=FDG&KeyWordLookUp=Title&K

Carrillo MC, Hartley DM, Hedrick S, Pappas V,

eyWordSearchType=And&bc=gAAAABAACAAAA

Thies WH; Alzheimerʼs Association; Society of

A%3d%3d&

Nuclear Medicine and Molecular Imaging; Amyloid

5）Centers for Medicare & Medicaid Services. National

Imaging Taskforce. Appropriate use criteria for

Coverage. Decision Memo for Positron Emission

amyloid PET: a report of the Amyloid Imaging Task

Tomography (FDG) for Solid Tumors (CAG-00181R4).

Force, the Society of Nuclear Medicine and Molecular2013 Jun 11. http://www.cms.gov/medicare-coverage-

Imaging, and the Alzheimerʼs Association.

database/details/nca-decision-memo.aspx?NCAId=263. 2013; 9(1): e-1-16.

6）Centers for Medicare & Medicaid Services. Decision10）Jensen TS, Jacques LB. Medicare coverage: engag-

Memo for Beta Amyloid Positron Emission Tomogra-

ing on evidence.

. 2011; 6(6 Suppl):99-101.

phy in Dementia and Neurodegenerative Disease (CAG-(Published March 24, 2015)00431N). September 27, 2013. Available from: http://
www.cms.gov/medicare-coverage-database/details/＊＊− W84 −＊