Clin Eval 43（1）2015

PET drug regulations in the U.S. — Building from bench to bedside —Translation

Insurance coverage of PET drugs andimaging accreditation in the U.S.
─ PET Drug American Dream World History:

The 3rd Report ─＊1

Chieko Kurihara 1）

Tomio Inoue 2）1）Molecular, Imaging Center, National Institute of Radiological Sciences2）Department of Radiology, Graduate School of Medicine, Yokohama City University

Abstract
In the U.S. (United States), for public insurance coverage of PET (Positron Emission Tomography)
imaging procedures, not only FDA (Food and Drug Administration)-approval of PET drugs and PET
imaging devices, but also imaging facility accreditation is required, for the public healthcare insurance
coverage by the CMS (Center for Medicare & Medicaid Services). Here we introduce the policy andframework in the U.S. towards evidence-based decisions concerning public healthcare insurance coverage,
including the recent situation of a new PET drug used for imaging beta amyloid plaques in adults withcognitive impairment.
Key words
CMS (Centers for Medicare & Medicaid Services), CED (Coverage with Evidence Development), NOPR
(National Oncologic PET Registry), IAC (Intersocietal Accreditation Commission), ACR (American Collegeof Radiology)［Epub ahead of the issue publication］
Rinsho Hyoka（Clinical Evaluation）．2015；43：W63−W71．

＊1

This article is an English translation of the article originally written in Japanese and published in. 2013;11(10): 86-9, under the permission of the publisher, Medical Eye. The information included is not completely identical with the original one and has not been updated since the time of original publication except for some of theimportant information subsequently added.
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臨床評価43 巻 1 号

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and efficacy, but not the CMS requirements for

1．New drug approval andinsurance coverage

improved health outcomes for Medicare beneficiaries. On the other hand, there is a scheme of CED(Coverage with Evidence Development). In this1〜3）

we introduced theframework clinicians-researchers can use approved

recent situation in the U.S. (United States) of clin-

drugs, including the usage for unapproved indica-

ical development and the FDA (Food and Drugtions, being reimbursed by payers in the limited

Administration)ʼs approvals of PET (Positron

frameworks of studies under the conditions defined

Emission Tomography) drugs. Here we introduce

by the CMS. They should conduct clinical studies

the situation of Medicare national health insurance

for evidence development towards insurance cover-

coverage determinations of these drugs by the CMS

age determination by the CMS. This scheme was＊2(Centers for Medicare & Medicaid Services) ,explicitly proposed in April 2005 and finalized inas shown in Table 1. In the U.S., after the new drug

July 2006 4）. There are two types of CED: the CAD

approval by the FDA, sometimes there is a time lag(Coverage with Appropriateness Determination)

until the determination of Medicare insurance cov-in which “additional clinical data is needed”; anderage by the CMS. The CMS is not obliged to

the CSP (Coverage with Study Participation) inapprove payment for anything the FDA approves

which the procedures can be covered only “within afor clinical use. The requirements are different ‒ aresearch setting”.

In the previous articles

drug could meet the FDA requirements for safety

Table 1The situation of CMS coverage of PET drugs in the U.S.

FDA approvals

CMS coverage

Included in USP & approved by the FDA
13
N-ammonia injection
18
F-fludeoxyglucose injection
18
F-sodium fluoride injection
89
Rb rubidium chloride injection

Approved indications are covered
Specific, defined indications are covered onlyin the scheme of CED

Included in USP ＊ & not approved by the FDA
18
F-fluorodopa injection
11
C-flumazenil injection
11
C-methionine injection
11
C-raclopride injection
11
C-sodium acetate injection
11
C-carbon monoxide injection
11
C-mespiperone injection
15
O-water injection

Not covered

Not yet included ＊ in USP & approved by the FDA
18
F-Florbetapir
18
F-Flutemetamol
18
F-Florbetaben

Decision memo on September 27, 2013 tocover only 1 time of scan in the defined typeof studies within the scheme of CED.

＊ As described in the previous article, the monographs of PET drugs included in USP (United States Pharmacopeia)
but not approved by the FDA were to be removed from USP, according to FDA Modernization Act, and the drug
which was approved by the FDA is to be included in USP. Finally on December 1 of 2014, these unapproved 8 PET
drugs were omitted from the USP.
＊2

The terms shown in bold letters and underlined are explained in Box (glossary).
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Clin Eval 43（1）2015

in June 2013, it was decided almost all the solid

2．Expanded Medicare coverageof PET-FDG 5, 6）

tumor is covered, although examination for initial
treatment strategy for prostate is not covered andthere are some exceptions for initial treatment

One of the successful examples which started at

strategy for cervix, breast, melanoma 8）.

the time of beginning of CED scheme is the expan-

3．Coverage consideration ofbeta amyloid imaging

sion of coverage for indications of FDG (18Ffludeoxyglucose). In the U.S., CT (Computer
tomographie) and MRI (Magnetic Resonance Imaging) have been covered by Medicare for generalAmong the 12 PET drugs included in USP, FDG

oncologic applications since their introduction, but

and other 3 drugs have been approved by the FDA

coverage of PET-FDG had been made cautiously.

(as described in detail in our first report of thisIn 1998, the CMS decided to cover only for limited

series, the USP monographs of non-approved drugs

use of PET-FDG, and then according to the sub-come to be not effective), and the FDA-approved

missions of each of the new indications, each deter-

indications of these PET drugs are covered bymination of coverage has been made one by one.

Medicare insurance, and some of the unapproved

When CMS released the draft guidance of CED inindications of these approved drugs are covered in2005 in which they explained the idea of a coverage

the scheme of CED (Table 1). The NDA of 18F-

scheme involving a nation-wide registry of medical

Florbetapir (Amyvid Ⓡ) was approved by the FDA

records, the PET community started to develop thein 2012 for its beta amyloid imaging “to estimate

NOPR, the first registry in the U.S. which is com-β-amyloid neuritic plaque density in adult patients

patible with the standards required by the CMS.

with cognitive impairment who are being evaluatedAmong the more than 30,000 eligible NOPR-

for Alzheimerʼs Disease (AD) and other causes ofregistered cohort data, approximately 23,000 ques-cognitive decline”. (Subsequently, 18F-Flutemetamol

tionnaire data were analyzed to find doctorsʼ

and 18F-Florbetaben were also approved.)changes of management associated with PET examinations

5, 6）

Three clinical studies have supported the NDA.

(During nearly four years of operation

Study 1 showed a high accuracy rate in the 35

after the development, over 150,000 patients have“autopsy cohort” between image interpretation andundergone FDG-PET under NOPRʼs mechanism

postmortem cortical amyloid burden (truth stan-that allows for Medicare coverage of these scans.

dard); The other 2 studies showed high perfor-

http://www.cancerpetregistry.org/what.htm

Nowmance characteristics: Study 2, using an in-person

total accrual should be more expanded). Further

tutoring type of training, showed a 92% medianevidence development by the NOPR cohort andsensitivity; a 95% median specificity (using 59

clinical research under insurance coverage led tocases from previous clinical studies with postmor-

the determination of CMS to end the prospective

tem data, including 35 of study 1); and Study 3,

data collection requirements across oncologic indi-using an electronic media-based training method,

cations of FDG PET. This determination also

showed a 82% median sensitivity; a 95% medianincluded the statement that previous “cancer-by-

specificity (using imaging data of 59 cases of study

cancer consideration” for coverage “should be

2 and the other 92 cases from previous studies

7）

replaced by a more omnibus consideration”: , andwithout postmortem data (92 includes AD; other− W65 −

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Fig. 143 巻 1 号

2015

Infographic of Amyloid Brain Imaging
by SNMMI

cognitive disorders; mild cognitive impairment(MCI); and volunteers without cognitive impairment)). Study 3 also showed a high intra-reader
reproducibility (overall kappa statistic: 0.83%).
Development of a training program was requiredas the condition of the approval and now the program has been developed and provided by the sponsor company.
The CMS advisory committeeʼs opinion in
January 2013 was that there is insufficient evidence to support the benefit of amyloid imaging
examination to improve the healthcare outcome ofpatients, while several numbers of committee members support the coverage in the scheme of CED.
The SNMMI (Society of Nuclear Medicine andMolecular Imaging) and the Alzheimerʼs Association
published a report of appropriate use criteria ofamyloid PET in January 2013 9）, and in April, collaborating with other key specialists, they submitted an opinion to CMS to seek insurance coverage.
The usage criteria described in the report wassummarized in “infographic” (Fig.1), which is comprehensible to practitioners in order to educate
them that early stage examination for patients who
have not been diagnosed by experts as AD has notbeen approved and the examination is expensive at
this moment without insurance coverage. The sponsoring company, Eli Lilly, submitted for coverageto the CMS and in July 3 2013 CMS released their
proposed decision memo to state that a 1 time scanis covered in a clinical trial program under the conditions defined by the CMS (Table 2) 10）. This proposal is to be finalized in October 2013. (It was
decided in September 2013 11）).

4．Ethical, social issues of early
detection of AD
As described in this article, CMS proposed to cover a one
time scan in the scheme of CED and the proposal may be
decided in October 2013 (It was decided in September 2013).
This reproduction of this figure is permitted by SNMMI.

According to Eli Lilly in the news article inNovember 2012 12）, there are more than 300 centers− W66 −

Clin Eval 43（1）2015

Table 2

Proposal by the CMS on the coverage of PET amyloid imaging (outline)

The evidence is insufficient to conclude that the use of PET amyloid-beta (Aβ) imaging improves healthoutcomes for Medicare beneficiaries with dementia or neurodegenerative disease; however, there issufficient evidence that the use of PET Aβ imaging could be promising in the following scenarios.
Therefore, we propose to cover one PET Aβ scan per patient through the CED, under clinical studies
that meet the following criteria:(1) To exclude AD in narrowly defined and clinically difficult differential diagnoses.
(2) To enrich clinical trials seeking better treatments or prevention strategies for AD, by allowing for
selection of patients on the basis of biological as well as clinical and epidemiological factors.
Clinical study criteria:
Objectives:(1) To develop better treatments or prevention strategies for AD, or, as a strategy to identify subpopulations at risk for developing AD, or(2) To resolve clinically difficult differential diagnoses (e.g., frontotemporal dementia (FTD) versus AD)
where the use of PET Aβ imaging appears to improve health outcomes.
Design: Clinical studies must be approved by the CMS, involve subjects from appropriate populations,be comparative, prospective and longitudinal, and use randomization and postmortem diagnosis as theendpoint where appropriate. Radiopharmaceuticals used in the PET Aβ scans must be FDA approved.
Research question (one or more of the following):
With cognitive impairment suspicious for AD, or who may be at risk for developing AD:
1. Do the results of PET Aβ imaging lead to improved health outcomes?
2. Are there specific subpopulations, patient characteristics or differential diagnoses that are predictiveof improved health outcomes in patients whose management is guided by the PET Aβ imaging?
3. Does using PET Aβ imaging in guiding patient management, to enrich clinical trials seeking better
treatments or prevention strategies for AD, by selecting patients on the basis of biological as well as
clinical and epidemiological factors, lead to improved health outcomes?

that can provide amyloid imaging examination and− Influence upon QOL (Quality of Life) of know-

approximately 700 doctors who completed and haveing future possibilities of disease for which

been qualified with the educational program to readtherapeutic tools have not been well devel-

the scans. Concerning AD diagnosis, development

oped: A questionnaire survey by Harvard Schoolof drugs for prevention and/or therapy has beenof Public Health granted by Bayer found thatstrongly desired, while the following ethical issues

89% of American (respondents) say that if

have been raised but not yet completely resolved:

they were exhibiting confusion and memory− Proxy consent issue: In California, the state

loss, they would want to know if the cause oflaw did not sufficiently cover proxy consent

the symptoms was AD; of those aged 60 years

for research participation, so a nursing scien-and older, 95% say they would want to know iftist led the amendment of the law to justify

they had AD; more than 97% say that if theyproxy consent for research

13）

had a family member exhibiting problems with.

− Incidental findings of disease or condition

memory loss, they would want him or her tooutside of the research purpose: a recent

see a doctor to determine whether the cause

trend of NIH (National Institutes of Health)-was AD 9）.

funded research is to require the provision of− Discrimination in insurance and employment:“ancillary care” for the patients in such a

In the U.S. there are legislations to prohibit

situation

13, 14）

discrimination of disabled people and also to.

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臨床評価43 巻 1 号

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prohibit discrimination based on genetic test

Japan as they grant accreditations to many hospi-

results, but these do not cover the cases oftals in the world, especially in Asian hospitals

early detection of disease factors found bywhich provide the service for “medical tourists”.

the imaging procedure

12）

Both ACR and IAC have continued voluntary ini-.

For resolving and managing these issues, it istiative of imaging accreditation for more than 20

important that the SNMMI created the infographic,

years, collaborating with specialists and they now

which would limit unapproved expansion of exami-

have become the government-authorized accredita-nation and to promote appropriate use. We shouldtion organizations. The ACR focuses on all kinds oflearn from this kind of initiative.

radiology, and is not limited to imaging but also
covering radiation oncology; and the IAC focuses

5．Imaging accreditationby the IAC

on nuclear medicine and PET as well as noninvasive vascular testing, echocardiography, MRI and
CT. It is up to the sites being accredited which of

For insurance coverage in the U.S., not only

these to choose. Kurihara visited the office of IAC

PET drugs and imaging devices have to be approved

Nuclear/PET (see Photo) and met the CEO, Sandra

but also imaging site accreditation is necessary.

L Katanick, CAE and the director of accreditation,

This accreditation framework focuses on imaging

Mary Beth Farrell, MS, CNMT, NCT in February

clinical practice rather than quantitative validationof 2012 and met Ms. Farrell again at the SNMMIof imaging technology.

Annual meeting in June 2012 and exchanged e-mails

Among various aspects of health insurance refor-

and the information listed in Table 3 has been pro-mation in the U.S., “MIPPA (Medicare Improve-vided (Later in February 2014 Inoue and otherments for Patients and Providers Act)” mandated

members of the Japanese Society of Nuclear

the sites which provide “advanced” imaging technologies (PET, SPECT, CT, MRI) to acquire
accreditation by January 2012, as the condition of
Medicare health insurance coverage.
The authorized accreditation organizations are
the ACR (American College of Radiology), theIAC (Intersocietal Accreditation Commission)and the JC (Joint Commission) at this moment(Later one another organization was additionallyauthorized).
This Act excludes hospitals, because hospitals
have been getting accreditations for the entire hospital activities. So, this Act is for the non-hospital
facilities which provide imaging technology. A
well-known accreditation organization for hospitals
is the “Joint Commission (JC)” and the international network of the JC is “Joint Commission
International (JCI)”. The JCI is well-known in− W68 −The mark of accreditation by IAC

Clin Eval 43（1）2015

Table 3

Imaging accreditation by the IAC (July 2013)

At the time of July 2013, 3745 sites are accredited by the IAC in nuclear medicine and approximately 10%of those in PET imaging.
The office of the IAC occupies the entire 5th floor of a building, where more than 50 staff are working in
more than 10 rooms. Their organization is almost all managed based on accreditation fee. There are offersfrom other countries to apply for accreditation. (Answering the questions whether the IAC wants to be aninternational accreditation organization, the CEO said jokingly. “We want to accredit the whole world”.)
Accreditation is the condition of reimbursement of Medicare/Medicaid, but the decision of the CMS
influences private insurance companies and the hospital list of reimbursement items.
Now IAC is applying for ISO 9000 and 27001 (ISO for accreditation organization) (They passed ISO in
September 2013).
As of 2013, at the time of original Japanese publication

Medicine visited the office of IAC Nuclear/PET).

realization of the policy seems brilliant for us, andAnswering the questions whether or not some

we can learn much from their efforts. It is also

objections were raised because the sites which

excellent that they work together for evidence

could not get accreditation might have to stop theirdevelopment and better healthcare of the people.

operations, they said that there were several objec-

The Japanese PET community are discussing totions, but throughout the 4-year preparation period,

identify the direction to go forward and making

the Government had repeatedly explained the situ-

efforts to develop new framework. We wish toation to the people, so problems had been resolved

develop the way which finally leads to the improve-at that moment.

ment of the patientsʼ healthcare, based on an internationally standardized framework of research and6．Conclusion: Learning fromthe American Dream Worlddevelopment, regulatory authorization, and publichealthcare insurance coverage.
We hope this series of articles could provide

With the sub-title of “American Dream World”,

some insight for the Japanese PET community

we have reported our survey results of the recent

working towards the future world where a variety

regulatory reformation in the U.S. concerning PETof PET imaging technologies, not only FDG-PET,

imaging research and practice. It seems to be ais coming to be available for routine medical prac-very hard burden for the PET community to gettice.

the FDAʼs approval and the CMS insurance coverage, although there is no such principle as in Japan

Acknowledgement

to prohibit “mixed medical practice (see Box, item

We deeply appreciate the specialists in the U.S., someof CMS)”. Our friends in the U.S. suggest that theof whom appear in this series of articles and those inreal situation is far from a “dream world”, andJapan who gave us meaningful cooperation for our survey

some said that the “FDA is mysterious”. However,and for this manuscript. This report is based on the fol-as we mentioned in the beginning of this series, thelowing task force research fund. Ministry of Health,collaboration among academia, industry, and regu-

Labor and Welfare, 2011, 2012 fiscal year: Regulatory

latory people toward policy development and actual

frameworks of the United States and other countries con-

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Box

43 巻 1 号

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Basic terms to understand the situation of Medicare national insurance coverageof PET drugs in the U.S.

CMS (Centers for Medicare & Medicaid Services)
The CMS is an agency under the Department of
Health and Human Services and deals with national
health insurance, Medicare for elderly and disabled
people, Medicaid for lower income people. They
make the decisions of coverage based on evidence
generated from research studies, considering theexpert opinions of an advisory committee. The
decisions by the CMS can influence the coveragedeterminations of private health insurance companies. Medicare is administered by the federal
government so its coverage decisions are not always
the same as the coverage of Medicaid, as it isadministered by individual states. In the U.S., there
is not such a principle as in Japan to prohibit“mixed-medical practice (public health insurance
coverage for the part of practice and not coveragefor the part of not-authorized procedures in a lineof patient care)”.

covered only “within a research setting”, under theconditions defined by CMS.
NOPR (National Oncologic PET Registry)
Nation-wide registry of patient medical records,
which was sponsored by the Academy of Molecular
Imaging (now the World Molecular Imaging Society)and developed and managed by the ACR, and started
in 2006. It was designed being reviewed by multiple
agencies of the Department of Health and Human
Services, also to be compliant with the standards
defined by the CMSACR (American College of Radiology)
An American professional society composed ofradiologists, radiation oncologists, medical physicists, interventional radiologists, nuclear medicine
physicians and allied health professionals.

CED (Coverage with Evidence Development)
One type of determination by the CMS to cover theprocedures in some evidence development program
defined by the CMS. There are two types of CED:
the CAD and the CSP, explained in the following. In
these schemes, medical records are gathered incompliance with the privacy rule under HIPAA, andresearch studies should be conducted under the
regulations of human subject protection. After the
results are published in peer-reviewed journals,
CMS will analyze the evidence and make decisions
whether or not to cover the submitted new indications for clinical practice.
CAD (Coverage with Appropriateness Determination)
One type of CED in which “additional clinical datais needed”; and sometimes registry of patientsʼ dataand prospective data accumulation is required as thecondition of insurance coverage.
CSP (Coverage with Study Participation)
One type of CED in which the procedures can be

IAC (Intersocietal Accreditation Commission)- IAC
Nuclear/PET
IAC is a nonprofit organization to provide accreditation service and IAC Nuclear/PET is one division
to deal with nuclear medicine/PET accreditation.
JC (Joint Commission)
Hospital accreditation organization in the U.S. Theinternational version of the JC is the well-known
JCI (Joint Commission International).
HIPAA (Health Insurance Portability andAccountability Act)The legislation of the rules to protect privacy of
individually identifiable health information and to
set national standards for the security of electronic
protected health information, enacted in 1996.
MIPPA (Medicare Improvements for Patients andProviders Act)
A multi-faceted piece of legislation that contains
several important provisions that directly change theMedicare program, enacted in 2008.

cerning nuclear medicine diagnosis using PET drugs pro-

References

duced by an in-house PET drug synthesizer; and 2013,2014 fiscal year: Regulatory science concerning clinical

1）Kurihara C. The trend of U.S. regulations concern-

application of nuclear medicine diagnosis using PET

ing PET examination.

drugs produced by an in-house PET drug synthesizer

Japanese. English translation is available from: http://(including this publication of English translation of an. 2011; 9(11): 76-9.

homepage3.nifty.com/cont/43̲1/w37-w45eng.pdf2）Kurihara C, Inoue T. New regulations of PET drugs inarticle written in Japanese).

the U.S. and the trends in FDA approvals−PET Drug
American Dream World History: The 1st Report −.

− W70 −

Clin Eval 43（1）2015. 2013; 11(8): 108-11. Japanese. English

9）Johnson KA, Minoshima S, Bohnen NI, Donohoe KJ,translation is available from: http://homepage3.nifty.

Foster NL, Herscovitch P, Karlawish JH, Rowe CC,

com/cont/43̲1/w47-w54eng.pdf

Carrillo MC, Hartley DM, Hedrick S, Pappas V,3）Kurihara C, Inoue T. PET drug clinical trials andThies WH; Alzheimerʼs Association; Society of

networking strategy for development − PET Drug

Nuclear Medicine and Molecular Imaging; Amyloid

American Dream World History: The 2nd Report −.

Imaging Taskforce. Appropriate use criteria for. 2013; 11(9): 118-21. Japanese. English

amyloid PET: a report of the Amyloid Imaging Task

translation is available from: http://homepage3.nifty.

Force, the Society of Nuclear Medicine and Molecularcom/cont/43̲1/w55-w61eng.pdf

Imaging, and the Alzheimerʼs Association.

4）Guidance for the Public, Industry, and CMS Staff:. 2013 Jan; 9(1): e-1-16.

National Coverage Determinations with Data Collec-10）Centers for Medicare & Medicaid Services. Proposedtion as a Condition of Coverage: Coverage with Evi-

Decision Memo for Beta Amyloid Positron Emission

dence Development. Jul 12 2006. Available from: http://

Tomography in Dementia and Neurodegenerative

www.cms.gov/Medicare/Coverage/Determination

Disease (CAG-00431N). 2013 Jul 3. http://www.cms.

Process/Downloads/ced.pdf

gov/medicare-coverage-database/details/nca-proposed-5）Lindsay MJ, Siegel BA, Tunis SR, Hillner BE,

decision-memo.aspx?NCAId=265

Shields AF, Carey BP, Coleman RE. The National11）Centers for Medicare & Medicaid Services. Decision

Oncologic PET Registry: expanded medicare cover-Memo for Beta Amyloid Positron Emission Tomogra-

age for PET under coverage with evidence develop-

phy in Dementia and Neurodegenerative Disease (CAG-ment.

00431N). September 27, 2013. Available from: http://. 2007; 188(4): 1109-13.

6）Hillner BE, Siegel BA, Liu D, Shields AF, Gareen

www.cms.gov/medicare-coverage-database/details/

IF, Hanna L, Stine SH, Coleman RE. Impact of posi-

nca-decision-memo.aspx?NCAId=265

tron emission tomography/computed tomography and12）Kolata G. Awilda Jimenez got a scan for Alzheimerʼs

positron emission tomography (PET) alone on expected

after she started forgetting things. It was positive.

management of patients with cancer: initial results

New York Times. 2012 Nov 15. Available from: http://from the National Oncologic PET Registry.

www.nytimes.com/2012/11/16/health/for-alzheimers-. 2008; 26(13): 2155-61.

detection-advances-outpace-treatment-options.html?

7）Centers for Medicare & Medicaid Services. National

pagewanted=all&̲r=0

Coverage Determination (NCD) for Positron Emis-

13）Mulnard RA. Kurihara C, Takeo S, Interview. The

sion Tomography (FDG) for Oncologic Conditions (220.

nursing scientist as a principal investigator (PI) of

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

clinical trials on dementia: Interview with Associate

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

Professor Ruth A. Mulnard.

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

2011; 39(2): 385-94. English version is available

Positron+Emission+Tomography+(FDG)&CoverageSfrom: http://homepage3.nifty.com/cont/39̲2/p385-

election=Both&ArticleType=All&PolicyType=Final.

94eng.pdf&s=All&KeyWord=FDG&KeyWordLookUp=Title&K

14）Kurihara C. To find the common ground of “research

eyWordSearchType=And&bc=gAAAABAACAAAA

ethics” and “radiological protection”: Additional reflec-

A%3d%3d&tion to the educational lecture at the Annual Meeting

8）Centers for Medicare & Medicaid Services. Nationalof the Japanese Society of Radiological Technology.

Coverage. Decision Memo for Positron Emission. 2011;

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

67(6): 683-90.

2013 Jun 11. http://www.cms.gov/medicare-coveragedatabase/details/nca-decision-memo.aspx?NCAId=263− W71 −

(Published March 24, 2015)