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The Association of Electrical Equipment and Medical Imaging Manufacturers n www.nema.org n March 2013 n Vol. 18 No. 3

ALSOI

NSIDEn Imaging and the future of Alzheimers Disea

n A glossary of medical imaging

n ESFI debuts new toolkit for older adults

n Mexico adopts a new electrical code

n NEMA/BIS forecasters rise to top for accura

Advancing the Futureo Medical Imaging andRadiation Therapy

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CONTENTS FEATURES:

NEMA electroindustrytext and cover pages are printed using SFI certifed Anthempaper using soy ink.

SFI certied products come from North American forestsmanaged to rigorous environmental standards.

SFI standards conserve biodiversity and protect soil andwater quality, as well as wildlife habitats.

SFI forests are audited by independent experts to ensure

proper adherence to the SFI Standard.

SFI participants also plant more than 650 million trees each year to keep these forests thriving.

ECO BOX

electroindustry (ISSN 1066-2464) is published monthly by NEMA, the Association of Electrical Equipment and Medical Imaging

Manufacturers, 1300 N. 17th Street, Suite 1752, Rosslyn, VA 22209; 703.841.3200. FAX: 703.841.5900. Periodicals postage paid at

Rosslyn, VA, and York, PA, and additional mailing ofces. POSTMASTER: Send address changes to NEMA, 1300 N. 17th Street,

Suite 1752, Rosslyn, VA 22209. The opinions or views expressed in electroindustry do not necessarily reect the positions of NEMA

or any of its subdivisions.

Subscribe to electroindustry at www.nema.org/subscribe2ei

Contact us at [email protected]

Follow NEMA: www.nema.org/facebook, blog.nema.org, podcast.nema.org, twitter.com/NEMAupdates,

www.youtube.com/NEMAvue, www.nema.org/linkedin

electroindustryManaging Editor / Editor in Chief | Pat Walsh

Contributing Editors | William E. Green III

Chrissy L. S. George

Economic Spotlight | Timothy Gill

Codes & Standardization | Vince Baclawski

Government Relations Update | Kyle Pitsor

Art Director | Jennifer Tillmann

Media Sales Team Leader | Stephanie Bunsick

Policies Afecting Medical ImagingSaeguarding Medical Imaging and the U.S. Economy ............. ........

Medical Imaging Advancements in Cardiovascular Disease Quantiy Cost ...............................................1

Imagings Role in the Future o Alzheimers Disease ..............................................................................1

Radiation Therapy Detects, Treats, Prevents Cancer ..............................................................................1

Industry Reinorces Commitment to Sae and Efective Care with New Standards ...................................1

Making Strides in Radiation Dose Reduction ........................................................................................1

Patient Well-Being Underscores Clinical and Economic Value o Medical Imaging ...... ............. ............. ...1

An International Perspective on Imaging

Globally Harmonized Framework Improves Patient Saety and Access ............. ............. ............. ............ 1

Medical Imaging Advocates Take to Capitol Hill ....................................................................................2

Glossary o Terms ................................................................................................................................2

Getting to Know MITA .........................................................................................................................2

Did you know...Knowledge is power, and its yours through the NEMA Intelligence Portal.

Available to members atportal.nema.org

PET imaging detects beta amyloid plaque in the brain,

indicating the presence o Alzheimers Disease. Story on

page 11. PET/MR image courtesy o Siemens Healthcare
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CONTENTS NOTES:NEMA Ocers .....................................................................................................................................................................................

Comments rom the C-Suite ................................................................................................................................................................

View rom the Top ...............................................................................................................................................................................

Learn More ..........................................................................................................................................................................................3

DEPARTMENTS:Government Relations Update ..............................................................................................................

Device Tax Creates Obstacle to Innovation and Economic Growth .....................................................................................................

Transportation Section Bries Hill Oces on Industry Priorities .........................................................................................................

Electroindustry News ..........................................................................................................................2

ESFI Debuts New Fire Saety Resources or Older Adults ...................................................................................................................2

[Re-]Introducing the Smart Grid Interoperability Panel ....................................................................................................................2

Code Actions / Standardization Trends..................................................................................................27

NEMA Joins Transatlantic Conerence to Strengthen EV and EVSE Standards ................................ ...................... ...................... ......2

NEMA Addresses the Embedded Meter .............................................................................................................................................2

Iowa Legal System Attacks Electrical Code ........................................................................................................................................2

Pacic Northwest Picks Up Pace o Code Adoption ...................... ..................... ...................... ...................... ...................... ............. 2

International Roundup .......................................................................................................................3

Mexico Adopts a New Electrical Code ................................................................................................................................................3

U.S.Mexico Smart Grid Technology & Business Conerence Scheduled this Month.......................................................................3

Economic Spotlight .............................................................................................................................3

Policy Environment Leads to Continued Uncertainty in the Diagnostic Imaging Market.................................................................3

NEMA/BIS Forecasters Leavens and Gill in Top Five or Accuracy .....................................................................................................3

EBCI Online ..........................................................................................................................................................................................3

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The Breakers Palm Beach

Take a Visual Journey at

www.thebreakers.com

NEMAS 87Annal Meen

Illuminations Weekend

Where Leaders and Ideas Meet

Friday, November 8 and

Saturday, November 9, 2013

6 About MITAThe Medical Imaging & Technology Alliance (MITA), a division o NEMA, is the leading organization

and collective voice o medical imaging equipment, radiation therapy, and radiopharmaceutical

manuacturers, innovators, and product developers. It represents companies whose sales comprise

more than 90 percent o the global market or me dical imaging technology.

www.medicalimaging.org

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NEMA electroindustry March 201

COMMENTS FROMTHE C-SUITEOcers

Chairman

John Selldorff

President & CEO

Legrand North America

First Vice Chairman

Christopher Curtis

President & CEO

Schneider Electric

Second Vice Chairman

Thomas S. GrossVice Chairman & COO

Eaton Corporation

Treasurer

Don Hendler

President & CEO

Leviton Manufacturing Co., Inc.

Immediate Past Chairman

David J. FitzGibbon

Vice Chairman & CEO

ILSCO Corporation

President & CEO

Evan R. Gaddis

Secretary

Clark R. Silcox

Evan R. GaddisPresident and CEO

Tis is a rare moment or our medical and electroindustry members. Policymakers onboth sides o the aisle are increasingly ocused on technologies that will rein in healthcacosts and make our electric grid, homes, businesses, and actories more energy ecientand competitive.

Imaging technologies (C, MR, PE, R, ultrasound, and x-ray) have revolutionizedhealthcare delivery, changing how physicians diagnose and treat diseases, ultimatelyimproving health and saving lives. MIA, NEMAs medical division, represents thecompanies that champion radiation dose optimization and management standards.

Another benet o these eorts is that imaging lowers healthcare costs. A recent studyound that the use o non-invasive coronary C imaging in the emergency room can savhospitals billions o dollars.

On the electroindustry side, our companies have the solutions to save energy, make ourelectric grid more resilient, and create jobs.

Severe weather, most recently Superstorm Sandy, coupled with an aging and overstresseelectrical inrastructure, is having a dramatic impact on the U.S.16 states experiencedoutages during Sandy. Te core principal o any major reconstruction eort should beto rebuild smartensuring that reconstruction unds maximize the deployment otechnologies to mitigate uture power outages, protect lives and property, and improveenergy eciency.

Resilient and reliable power is critical or hospitals, rst responders, communications,transportation, water treatment, emergency ood and shelter, and other vital services.

When smart technologies are in place, power outages can be avoided while lives, homes,and businesses are protected.

Examples o these technologies are sel-healing Smart Grid solutionsinormation andcommunications technologies such as smart meters and high-tech sensors to isolateproblems and bypass them automatically; microgrids and backup generators that usetheir own power sources and storage capabilities to support vital services; and wiring,cabling, and electrical components that can stand up to high winds and ooding.

In its recent publication, Storm Reconstruction: Rebuild Smart, NEMA provides aguide to making our nation more competitive and energy ecient in the afermatho severe weather.

Te 400-plus member companies o the National Electrical Manuacturers Associationand our sta o experienced engineers, medical imaging and electroindustry experts,spanning more than 50 industry sectors, stand ready to assist industry and governmentocials at all levels in saving energy and saving lives.

We have the solutions. ei
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4 NEMA electroindustry March 2013

Views rom the op

We are at a pivotal

time in ournations history

with regards

to healthcare.

While the Patient

Protection and

Aordable Care

Actmany pieces

o which will soon be implemented

provides access to care or approximately

30 million Americans, the process to

improve how healthcare is delivered is

yet to be determined.

One element that must remain in the

equation is that accurate diagnosis at

the beginning ocuses providers on

providing the best, most ecient care.

Evidence shows that not only do earlier,

more accurate diagnoses increase quality

o care in the short-term, they can also

dramatically reduce long-term healthcare

Solutions overproducts.Consistency over

variance. Andinnovation ineverything.

In an increasinglycostly, complex,

and consumer-driven U.S. healthcareenvironment, medical devicemanuacturers recognize the importance

o investing in innovative solutionsthat improve quality, accessibility, andaordability or patients and physicians.Tese solutions must be connectedacross health systems and across diseasepathways. More than the sum o cutting-edge products, synergistic solutions canreduce costs and enable aster, earlier,and more accurate diagnosis.

U.S. economy by supporting hundreds

o thousands o jobs across many statesFrom the physician reviewing a Cscan, to the technician perorminga procedure, to the actory workerassembling a machine, medical imagingprovides jobs.

MIA member companies are well-positioned to continue on the pathwayo innovation by developing sae andeective technologies to acilitate earlieand more precise disease detection,while also bolstering the domestic

economy. As we continue to ocuson improving our healthcare systemrom the inside out, the key to successwill be giving medical proessionalsthe necessary tools and techniquesto diagnose patients more accurately,treat conditions more eectively, andultimately reduce medical costs byeliminating unnecessary treatment. ei

sophisticated diagnostic tools that helpdetermine at a molecular level whichtreatment is most appropriate or aparticular patient. And it means billiondollar investments in personalizedtechnologies that can help identiy andtreat cancer, Alzheimers, and otherdevastating diseases.

While the uture o U.S. healthcare isstill evolving, the path orward involvesthree things: a solutions-based approach

that values outcomes over widgets,consistent best practices and data thatminimize variance, and innovativepersonalization that serves the mostimportant end or those involved inhealthcarethe patient. ei

costs. In essence, theres clinical and

economic value in knowing. Diagnosisand more importantlymisdiagnosis,matters.

Fortunately, this is also a time otremendous innovation in diagnostictools, rom computed tomographic (C)colonography, which has been shownto promote early detection o colorectalcancer, to positron emission tomography(PE), which oers physicians a uniquelyenhanced look inside the body, enablingthem to identiy il lnesses ranging

rom cancer to heart disease. Accurate,timely diagnosis serves the patientsbest interests and oers signicant costsavings to the broader healthcare systemby preventing misdiagnosis and ensuringappropriate treatment.

At the same time, companies thatmanuacture diagnostic and therapeutictools are improving the health o the

Te inconsistency o healthcare delivery

and outcomes rom region-to-region, and

even hospital-to-hospital, is signicant.

Evidence shows variance is bad or

patients, providers, and the healthcare

system as a whole. Managing variance

will help simultaneously improve

healthcare quality and drive down costs.

Hospitals today are using big data and

inormation technology to identiy

problem areas, better coordinate patient

care, and drive day-to-day process

improvementsincluding improved sta

scheduling and simpliying the patients

continuum o care.

Yet innovation in healthcare involves

more than process improvements

and technology advances. It also

means personalizationdeveloping

Precise Disease Detection Bolsters Economy, Diagnoses Patients More AccuratelyGreg Sorensen, MD, Chie Executive Ofcer o Siemens Healthcare North America and Chair o the MITA Board o Directors

Medical Device Manuacturers Deliver Personalized TechnologiesMarcelo Mosci, President & CEO, GE Healthcare U.S. & Canada

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Government RelationsUpdate

many patients, or multiple years. As

a result, even i a hospital or doctors

oce experiences an increase inpatients, it wi ll not necessari ly purchase

additional equipment. Despite this key

dierence, rms manuacturing imagin

equipmentand other multi-patient

devicesare required to pay this 2.3

percent tax without a substantial increa

in demand or their products.

LEviEd oN SALES, Not profit

Even companies making no prot will

pay a large tax, which makes it harder

or entrepreneurs to attract investmentrequired to support innovative new

companies. For example, a start-up

company with annual revenue o $10

million and net income o $0 would be

taxed $230,000, plunging it into the red

Although the IRS has implemented the

tax, repeal eorts are ar rom over.

Democrats and Republicans are uniting

to repeal it as a way to grow the econom

In early February, Representatives Erik

Paulsen (R-MN), Ron Kind (D-WI), and186 members o Congress cosponsored

bipartisan bill to repeal it. Concurrently

Senators Orrin Hatch (R-U) and Amy

Klobuchar (D-MN) introduced a device

tax repeal bill with the support o 28

Democratic and Republican senators.

With meaningul bipartisan momentum

and good policy on our side, MIA

continues to lead the ght to repeal the

device tax and looks orward to workin

with policymakers to protect Americaninnovation and manuacturing. ei

David Cooling, Director o State an

Federal Government Relations, MITA

[email protected]

people, creates a growing trade surplus,and develops technology essential

to advancing patient care in the U.S.and around the world. Recently,

global competition has amplied theincentives to outsource R&D and move

manuacturing abroad. Despite theseoptions, many rms have largely resisted

the trends seen in other manuacturingsectors and maintained successul

research centers and manuacturingplants domestically. A $29 billion tax

burden on these companies amplies

these pressures and has already orcedcompanies to consider nding cost

savings in their U.S. operations.

StifLiNg hEALthcArE iNNovAtioN

Te medical imaging industry is in a

state o constant innovation, which eachyear brings exciting new advances in

reducing radiation dose and improvingimaging clarity. Tese developments give

physicians new tools to diagnose andtreat diseases at earlier stages, improve

patient care, and reduce downstreamcosts. Unortunately, this tax reduces

the resources that the industry

currently uses to und R&D and investin manuacturing. Less investment inR&D slows the pace o innovation and

postpones patient access to the nextgeneration o care.

NEgAtivE iMpAct oN iNduStry

While this tax was designed tocomplement an increase in demand

or medical devices resulting rom theAordable Care Acts insurance coverageexpansions, this logic does not extend

to imaging equipment. Unlike other

devices, imaging equipment is consideredinrastructure, based in hospitals andphysician oces. While many other

devices are designed to be used onceper patient, imaging equipment is

designed to be used multiple times, on

Device Tax Creates Obstacle to Innovation and Economic GrowthOn January 1, the IRS imposed a new

$29 billion excise tax on companies

producing innovative medical devices

that are crucial to eective and ecient

healthcare. Tis tax hits the devices

and radiopharmaceuticals that MIA

members manuacture, including

computed tomography (C) scans,

magnetic resonance imaging (MRI),

x-ray, and ultrasound equipment.

Although used as a way to plug a

budgetary hole in the 2010Aordable

Care Act, this tax creates an enormous

obstacle or an industry that supports

hundreds o thousands o good-paying

American jobs.

Device manuacturers made their rst

device tax payment o nearly $100

million at the end o January. Tose

unds could have been spent on research

and development (R&D) orwith the

average medical technology industry

employee earning about $58,000

annuallyabout 1,700 jobs. According

to the Lewin Group1, the average U.S.

salary is $42,000. Compared to this,

medical technology jobs pay 38 percent

more. Tese are high-paying, Americanmanuacturing jobsthe jobs our

policies should be incentivizing.

Many pro-tax supporters say that the

revenue windal l rom healthcare

reorm will provide more than air

compensation or the device tax, but that

is a misguided argument considering the

bulk o patients who use medical devices

are already covered under Medicare.

Despite various unknown contingencies,

the negative eects o the device tax

are certain.

hArMiNg jobS ANd EcoNoMy

Te American medical technology

industry is a true economic success

story. It employs more than 400,000

1 actnder2.census.gov

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Government RelationsUpdate

o the American Association o State

Highway and ransportation Ocials(AASHO), and John Horsley, who

retired rom that position at AASHO

February. Te NEMA group thanked M

Horsley or his many years o partnersh

with NEMA on IS standards and othe

issues and brieed Mr. Wright on new

projects on which the organizations

can collaborate. ei

Craig Updyke Manager, Trad

and Commercial Afair

[email protected]

Press or a greater share o overall

ederal unding or transportation tobe devoted to technology deployment

and or associated changes in project

contracting to ocus on network and

system perormance rather than

asset management.

Tese messages, especially NEMAs

oers o assistance, were well received.

Sta plans more dialogues or the

coming months.

Te nal meeting o the day was with

Bud Wright, incoming executive director

Transportation Section Bries Hill Oices on Industry PrioritiesAs Washington, D.C., readied itselor the presidential inauguration onJanuary 17, a delegation o NEMAsransportation Management andAssociated Control Devices Section spentthe day on Capitol Hill meeting with keysta members.

Led by Section Chairman BryanMulligan (Applied Inormation), thegroup had constructive dialogueswith sta or the ransportation &Inrastructure (&I) Committee othe House o Representatives, theEnvironment and Public Works (EPW)Committee o the Senate, as well as threeSenate oces. &I and EPW are the leadcommittees in the House and Senate ortransportation legislation. In addition tothe group meetings, some members alsotook time or NEMA-acilitated meetingswith their home legislators oces. Tisevent marked the ourth consecutiveyear that a member companydelegation

visited with executive branch orlegislative decision makers.

NEMAs message was threeold:

Tank legislators or the two-yeartransportation law approved insummer 2012, known as MAP-21, and the laws support orgreater deployment o intelligenttransportation systems (IS)technologies in ederally-undedtransportation inrastructure projects.

State a strong preerence or a longer-term law to allow or better projectand business planning and oerNEMAs assistance in crafing the

next bil l or 2014.

NEMAs 3TS Section o n Capitol Hill, rom the le t: Ray Deer (Peek Trac), John Mille r (NEMA), Tom Becker (Daktronic s), Bob Rausch

(TransCore ITS), Jessie Swinea (Adaptive Micro Systems), Bryan Mulligan, Section Chair (Applied Inormation), Russ Brookshire

(Delcan Technologies), Bill Klyc zek (TraconUSA), Dan Dietrich (FLIR Systems), and Jean Johnson (NEMA). Photo by Craig Updyke

See Bipartisan Helium Bill Introduced in House, page 11.

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SAFEgUARDINg ThE FUTURE OF MEDIcAl IMAgINg


As the leading organization and collective voice o medical imagingequipment, radiation therapy and radiopharmaceutical manuacturers,innovators, and product developers, MITA has a high stake in a broad

spectrum o policy issues. Whether driving innovation and economic growth,

championing patient access to the right scan at the right time, working with

industry stakeholders to minimize radiation dose, advocating or transparent

and ecient regulatory processes, or protecting reliable access to helium,

MITA is at the oreront o political advocacy.

Saeguarding timely access to sae and eective medicaltechnologies is critical not only to ensuring quality patient care,but also driving innovation and protecting American jobs.Employing more than 400,000 workers nationwide, the medicaldevice industry generates approximately $25 billion in payroll,pays out salaries that are 40 percent higher than the nationalaverage ($58,000 vs. $42,000), and invests nearly $10 billion

in research and development (R&D) annually. In spite o this,policymakers have recently levied a new tax that will threatenthe health o the U.S. economy and its people.

Leading into 2013, MIA advocated tirelessly alongside itsmedical device industry partners or repeal o the burdensome2.3 percent medical device excise tax, which is estimatedto collect over $30 billion in taxes rom medical devicemanuacturers over the next ten years. MIA called or repeal

o the tax on the grounds that such a large, new tax wouldjeopardize thousands o American jobs and pose a serious threto companies ability to develop and bring to market lie-savingimaging technologies.

In act, in a 2012 MIA survey1 o member companies, ourout o every ten respondents anticipated having to reduce their

1 www.medicalimaging.org/2012/12/17/mita-announces-results-o-member-company-survey-

illustrating-impact-o-medical-device-tax-on-u-s-jobs-and-innovation

Policies Afecting Medical Imaging

Saeguarding Medical Imaging and the U.S. Economyban cnnell, de genmen relans, Mit
http://www.medicalimaging.org/2012/12/17/mita-announces-results-of-member-company-survey-illustrating-impact-of-medical-device-tax-on-u-s-jobs-and-innovationhttp://www.medicalimaging.org/2012/12/17/mita-announces-results-of-member-company-survey-illustrating-impact-of-medical-device-tax-on-u-s-jobs-and-innovationhttp://www.medicalimaging.org/2012/12/17/mita-announces-results-of-member-company-survey-illustrating-impact-of-medical-device-tax-on-u-s-jobs-and-innovationhttp://www.medicalimaging.org/2012/12/17/mita-announces-results-of-member-company-survey-illustrating-impact-of-medical-device-tax-on-u-s-jobs-and-innovation

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U.S. workorce in response to this new tax, while 29 percent othose surveyed expected to respond in part by reducing R&D.

Despite evidence proving the devastating allout i implemented,policymakers did not repeal the device tax, which took eecton January 1, 2013. While a stand-alone repeal o the devicetax is highly unlikely in 2013, MIA is working closely with itsindustry coalition partners to articulate the impact o the tax andcontinues to argue or ull repeal as a piece o a larger package.

Advocating Medicare PoliciesIn spite o the clear clinical and economic value o imaging,Medicare reimbursements or medical imaging procedures havebeen under constant threat o cuts. Since 2006, reimbursementrates or medical imaging procedures have been slashed eleven

times, with yet another cut set to be implemented in 2014. Tesecuts jeopardize patient access to liesaving technologies whichare critical to detecting, diagnosing and treating cancers andmany other diseases.

Additionally, several recent independent analyses haveconrmed a recent downward trend in utilization o medicalimaging procedures. Te Medicare Payment AdvisoryCommissions annual report2 to Congress in March 2012conrmed that imaging services declined by 2.5 percent in 2010,while non-imaging utilization increased two percent.

Recent data3 also shows that imaging is the slowest growingcategory in Medicare ee-or-service spending. Since 2006, perbeneciary spending on imaging services has declined by 16.7percent and advanced imaging services declined by 27.6 percent.In contrast, non-imaging services experienced 21.3 percentgrowth in spending over the same time period.

2 www.medpac.gov/documents/Mar12_EntireReport.pd

3 www.medicalimaging.org/2012/09/20/new-mita-analysis-confrms-continued-decline-in-medical-

imaging-utilization-and-spending-within-medicare/

Cutting Medicare reimbursements or medical imaging orinstituting roadblocks such as radiology benets managers andprior authorization programsboth o which require providerto obtain permission rom a third-party private contractor prioto ordering imaging serviceshave been shown to signicantldelay and even deny services without yielding signicant cost

savings or taxpayers4

. According to a 2010 national survey ophysicians by the American Medical Association, requiringphysicians to ask or preauthorization rom health insurancecompanies harms patient care and creates an expensive andconusing claims process. Delays and denials resulting romthese complications can exacerbate patients conditions,necessitating more invasive, intensive, and costly treatmentsdown the road.

As an alternative, MIA advocates or the integration ophysician-developed appropriateness criteria, which providephysicians with access to inormation at their ngertips toensure that an imaging procedure is appropriate or their

patient. In order to provide optimal care and prevent medicalerrors, physicians and technologists must account or a patientindividual needs, condition, and characteristics. Along withphysician-developed appropriateness criteria to eectivelyguide treatment decisions, MIA advocates or comprehensivetraining o hospital and imaging acility personnel who perormmedical imaging exams to ensure the sae and eective use oimaging in every setting.

MIAs Positron Emission omography (PE) Group has beenworking with the Centers or Medicare and Medicare Serviceson separate payment or diagnostic radiopharmaceuticals undethe Medicare Hospital Outpatient Prospective Payment System

Te PE group is also working to advocate or local coverageor PE tracers in neurology and cardiology (not just oncologyas well as or beta amyloid imaging (see Imagings Role in theFuture o Alzheimers Disease, page 11).

Promoting Eicient Regulatory ProcesseIn addition to enabling physicians with the necessary tools todeliver optimum care to patients, policymakers should instituttransparent and ecient regulations or medical devices,and MIA is committed to working with the U.S. Food andDrug Administration (FDA) to provide helpul resources andguidance to ensure that the agency understands the eects o it

proposals on innovation and patient access.

For example, throughout 2011 and into 2012, MIA workedclosely with FDA and industry partners to negotiate the latestMedical Device User Fee Agreement (MDUFA) to promotetimely patient access to sae and eective medical devices.Initially enacted in 2002 as theMedical Device User Fee and

4 www.medicalimaging.org/wp-content/uploads/2012/04/MITA-PAF-Imaging-Report-

Summary-4-23-12.pd

Photo courtesy o GE Healthcare
http://www.medpac.gov/documents/Mar12_EntireReport.pdfhttp://www.medicalimaging.org/2012/09/20/new-mita-analysis-confirms-continued-decline-in-medical-imaging-utilization-and-spending-within-medicare/http://www.medpac.gov/documents/Mar12_EntireReport.pdfhttp://www.medicalimaging.org/wp-content/uploads/2012/04/MITA-PAF-Imaging-Report-Summary-4-23-12.pdfhttp://www.medicalimaging.org/wp-content/uploads/2012/04/MITA-PAF-Imaging-Report-Summary-4-23-12.pdfhttp://www.medicalimaging.org/wp-content/uploads/2012/04/MITA-PAF-Imaging-Report-Summary-4-23-12.pdfhttp://www.medicalimaging.org/wp-content/uploads/2012/04/MITA-PAF-Imaging-Report-Summary-4-23-12.pdfhttp://www.medpac.gov/documents/Mar12_EntireReport.pdfhttp://www.medicalimaging.org/2012/09/20/new-mita-analysis-confirms-continued-decline-in-medical-imaging-utilization-and-spending-within-medicare/http://www.medpac.gov/documents/Mar12_EntireReport.pdf

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Modernization Act, the regulations sought to equip FDAwith the necessary resources to review medical devices moreeciently and ultimately ensure their saety and eectiveness.

MDUFA III, the outcome o the 2012 negotiations, took eecton October 1, 2012, representing an agreement between themedical device industry and FDA to increase the eciency oregulatory processes in order to reduce the time it takes to bringsae and eective medical devices to market in the U.S.

Helium Crisis RisingMIA also works closely with members o Congress to protectaccess to the critical U.S. helium supply. (See BipartisanHelium Bill Introduced in House, below.)

Helium is an essential component used in the creation andoperation o magnetic resonance imaging (MRI) machines,which are critical to the diagnosis o stroke, aneurysms, cancers,multiple sclerosis, and other deadly and debilitating diseases.

Liquid helium is the only element that can easibly cool MRImagnets to temperatures suitable or imaging; thus, MRIs inhospitals must be regularly replenished with helium in order tomaintain the necessary operating temperature.

Te U.S. has more than one billion cubic meters o heliumgas stored in Amarillo, exas, at the Federal Helium Reserve.However, we are now acing a helium shortage, and i Congressails to act this year, the Bureau o Land Management will beorced to shut down the Federal Helium Reserve. Tis will havear-reaching impact on medical imaging manuacturers as wel

computer chip and optical ber manuacturers.

In October 2012, MIA submitted a letter to Congress callingon policymakers to keep the reserve operational. oday, MIAcontinues to work with the House and Senate to pass legislationthat will help resolve the looming helium supply crisis.

From Medicare reimbursement to taxation to access to heliumMIA member companies are deeply invested in a wide spectro policy issues that aect the wellbeing o American patients athe health o the domestic economy. In 2013, MIA will continits eorts to communicate the undeniable value o medicalimaging and radiation therapy technologies to U.S. policymakstakeholders, physicians, and patients. ei

Prior to joining MITA, Mr. Connell([email protected] a legislative director on healthcare policy or a Midwesternmember o Congress.

Bipartisan Helium Bill Introduced in House

On February 7, Reps. Doc Hastings (R-WA) and Edward Markey (R-MA) introduced the Responsible Helium

Administration and Stewardship Act(HR 527) to keep the Federal Helium Reserve operational and to ensure

taxpayers get a air price or helium sold by the Department o the Interior. The bill was considered at a February

14 hearing o the Natural Resources Committee, o which Mr. Hastings is the chairman and Mr. Markey the ranking

minority member. HR 527 could be reported out o the committee to the ull House o Representatives beore the

end o March.

MITA Executive Director Gail Rodriguez welcomed the introduction o HR 527 as an important step orward in

nding a solution to the uncertainty o U.S. helium supplies. MITA and NEMA are working or passage o legislation

as soon as possible in 2013 since, under current law and absent decisive congressional action and the presidents

signature, the Federal Helium Reserve is scheduled to shut down as early as October 2013 and take as much as 30

percent o the worlds helium supply of the market. At press time, staf or Senate Energy and Natural Resources

Committee Chair Ron Wyden (D- OR) was considering an alternative legislative proposal.

Helium is an essential component used in the creation and operation o medical imaging equipment, such asmagnetic resonance (MRI) machines. Liquid helium is the only element that can easibly cool MRI magnets to

temperatures suitable or imaging; thus, MRIs must be regularly replenished with helium in order to maintain

normal operating temperatures. Helium gas is also used in the welding o stainless steel and in the manuacturing

process or semiconductor chips, including light-emitting diodes (LEDs).

Brian Connell, Director, Government Relations |[email protected]

Craig Updyke, Manager o Trade and Commercial Afairs |[email protected]
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]

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Cardiovascular diseasecommonly known as heart diseasegenerallyreers to conditions that involve narrowed or blocked blood vessels thatcan cause chest pain, a heart attack, or stroke. It is the leading cause o death

or men and women in the United States and one o the nations most costly

health problems. In act, the Centers or Disease Control and Prevention

estimates that coronary heart disease costs $108.9 billion each year, including

the cost o healthcare services, medications, and lost productivity.

Fortunately, advances in cardiac imaging are transormingthe diagnosis o heart disease and reducing healthcare costsby minimizing expensive invasive procedures and shorteningthe length o patients hospital stays. Coronary computedtomography angiogram (CCA) is one method that uses

advanced C technology, along with contrast dye, to obtainhigh-resolution, three-dimensional pictures o the heart andblood vessels. It is noninvasive and can be used to rule outor conrm a heart attack, as well as serve as a gatekeeperor triaging patients or expensive or potentially risky,invasive procedures.

With this technology, a patient today can walk into anemergency room with chest pain, receive a CCA scan thatdiscovers heart blockage and obtain a stent in two hours.Alternatively, CCA can rule out any blocked blood vesselsand the patient can be discharged and on his way homewithin hours without compromising saety. Several recent

studies have conrmed that CCA demonstrates signicantclinical and cost-eectiveness, saving lives and doing so quicklyand eciently.

In March 2012, the New England Journal o Medicine publishedresults rom the largest trial to date examining the ecacy oCCA as a triage tool or patients with suspected coronaryartery disease. Conducted by the American College oRadiology Imaging Network (ACRIN), the trial evaluated theuse o CCA vs. standard care among 1,370 emergency room

patients with acute, low-risk chest pain and possible coronaryartery disease. It ound that use o CCA allowed more

patients to be discharged rom the emergency room rather thanadmitted (49.6 percent vs. 22.7 percent) with a shorter timespent in the hospital (median 18.0 hours vs. 24.8 hours, p=.001Most importantly, the use o CCA did not compromise saetywith no signicant dierence between groups in the occurrenco heart attack or cardiac death within 30 days o the emergencroom visit1.

CCA has also proven to be benecial in non-emergencysettings when used prior to cardiac catheterization, aninvasive procedure to diagnose coronary artery disease, byselecting patients who are the best candidates or coronarycatheterization. A study published in the January 2012 issue

o theAmerican Journal o Cardiologycompared coronarycatheterization in all patients vs. selective catheterization amonpatients with greater than 50 percent stenosis (narrowed blood

vessels) as identied through CCA imaging, and ound thatuse o CCA saved an average o $3,061 per patient throughavoidance o unnecessary angiography2.

Both o these recent studies add to the body o evidence thatquanties the signicant cost savings associated with the use oadvanced cardiac medical imaging technologies such as CCAand demonstrate the value imaging technology is contributingto the diagnosis and treatment o heart disease in the U.S. ei

Mr. Eaton ([email protected]) joined NEMA asan industry manager in 1988. He holds a bachelors degree in

political science rom the Johns Hopkins University and a JD roRutgers University.

1 Litt HI, Gatsonis C, Snyder B et al. C angiography or sae discharge o patients with possible acu

coronary syndromes, N Engl J Med2012;366(15):1393-1403

2 Patel N, Pal RS, Flores F, Budo M. Utility o cardiac computed tomography angiography to exclud

clinically signicant obstructive coronary artery disease in patients afer myocardial perusion

imaging,Am J Cardiol2012;109(2):165-168

Medical Imaging

Advancements in

Cardiovascular DiseaseQuantiy Cost

ra M. Ean, de ins pams, MitA

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Positron emission tomography (PET) oers a uniquely enhanced look insidethe human body. Used in conjunction with a camera and a radioactivedrug known as a tracer, PET imaging enables physicians to identiy illnesses

such as cancer, ischemic heart disease, and neurological disorders.

For many years, Alzheimers Disease (AD) has been dicultto distinguish rom other common conditions associatedwith aging, such as dementia. PE imaging is one o the onlytools that can accurately and decisively conrm an ofenatal condition, otherwise veriable only by autopsy. Without

brain imaging, the presence o AD in a patient could not bearmatively conrmed or denied, hindering doctors ability toprovide an accurate early diagnosis.

Te U.S. Food and Drug Administration (FDA) recentlyapproved the use o a new PE tracer to help physicians makea denitive diagnosis o AD. Tis new tracer, F-18 Florbetapir(Amyvid), and several others that are expected to be approvedby the FDA, detects beta amyloid plaque in the brain. Tisplaque is an indicator o AD. When beta amyloid plaque ispresent, physicians can make treatment decisions with morecondence than just through the symptomatic indicators theyhad up until this rst approval.

Ron Petersen, MD, PhD, director o the Alzheimers DiseaseResearch Center and the Study o Aging at the Mayo Clinic,attested to the necessity o brain imaging throughout thediagnostic process, remarking that imaging can assist theclinician in being more specic regarding the cause o thecognitive impairment, especially when dierentiating a subtlememory impairment associated with early Alzheimers Diseaserom that seen in aging.

Recently, AD garnered national media attention when legendaryUniversity o ennessee womens basketball coach Pat Summittwas diagnosed with AD through the use o brain imaging.Feeling that something was o and noting that things werenot coming to her as quickly, Ms. Summitt sought a ull mentalexamination at the renowned Mayo Clinic. Tere, she receiveda PE scan, which helped her doctors distinguish AD romrontotemporal dementia, another potential cause o memoryloss. Results conrmed that Ms. Summitts lapses in memorywere mild, albeit distinct, signs o early-onset AD.

According to one caregiver, early diagnosis is critical. Tediagnosis lends itsel to quality o lie and helps the caregivermake necessary decisions beore a crisis.

Expanding Medicare Coverageo ensure that more patients like Ms. Summitt have access tocritical diagnostic tools, MIA supports expanded Medicarecoverage o PE radiopharmaceuticals and imaging procedurewhich have proven valuable in diagnosing, treating, andmonitoring a multitude o diseases. In November 2012, MIAconvened a PE Endpoints Workshop, bringing togetherindustry, government, and physician representatives to discussdevelopment o a ramework or the coverage o emerging PEprocedures by the Centers or Medicare & Medicaid Services

(CMS) and to gain a common understanding o the clinicalevidence necessary or CMS to provide coverage to beneciarie

Specically, the PE Workshop ocused on establishing aplatorm to determine how inherently the diagnoses resultingrom PE images, otherwise known as PE endpoints, should bconsidered or coverage by CMS. Given the potential o PE tosignicantly improve patient outcomes, even incrementally, theconsensus was that coverage rom CMS is warranted and neede

In addition to considering a PE coverage strategy that providits beneciaries with the earliest possible access to demonstrab

valuable imaging innovations, CMS proposed to removethe national non-coverage decision or PE ollowing theMIA PE Endpoints Workshop. I nalized, local Medicareadministrative contractors may determine coverage or newoncologic PE tracers within their respective jurisdictions,which will expand cancer patients access to the cutting-edgetools physicians need to eectively diagnose and managetreatment o their disease.

It is clear that this is an exciting time or PE manuacturers,physicians, patients, and their amilies. Tanks to new PEradiopharmaceuticals and imaging procedures, diseases thatonce eluded the medical community, like Alzheimers, can nowbe better understood and detected earlier than ever beore, whicgives us great hope o eventually nding an eective treatment.

MIA will continue to ght to protect and expand patient acceto these liesaving imaging technologies. ei

Mr. Abraham ([email protected]) was director ocoding and reimbursement at IBA Molecular prior to joining MITAHe served on MITAs PET Working Group and participated in thePET Coverage Workshop and ollow-up activities.

Imagings Role in the Future

o Alzheimers Diseaseban Aaam, Sen pl de, MitA

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Cancer is inarguably one o the most common, deadly, and costly medicalconditions that we ace. Annually, more than one million Americans arediagnosed with some orm o it, and malignancies claim a hal million lives.

National Cancer Institute statistics, however, show that the occurrence o new

cases and mortality rates are decliningtrends that may be evidence o

important gains in prevention, early detection, and treatment.

Radiation therapy (R) is a cornerstone o cancer therapy; 50to 60 percent o all cancer patients receive either external beamR (directing a therapeutic dose rom an external source) orbrachytherapy (delivering radiation rom inside the patientsbody). Tese therapies cause malignant cells to either stopgrowing or die while minimizing exposure to surroundinghealthy tissue. R provides sae and eective treatment or anincreasingly wide range o primary cancers and even or tumorsthat have metastasized. As a generally non-invasive therapy,it is typically perormed in an outpatient setting, minimizingdisruption o usual activities or more than 600,000 patientswho receive treatments annually.

Researchers have developed highly targeted and customizableradiation planning and delivery tools. In three-dimensionalconormal radiation therapy, or example, advanced imaging(MRI, PE) and specialized computer algorithms are used totailor the treatment dose to the patients anatomy, and makereal-time adjustments or even minute movement o either thepatient or the tumor.

Intensity-modulated radiation therapy, image guided radiationtherapy, adaptive radiation therapy, stereotactic body radiotherapy,stereotactic body radiotherapy (SBR), and stereotacticradiosurgery (SRS) are noninvasive techniques that allowclinicians to deliver therapeutic doses more quickly and accuratelythan ever beore. In some cases, a single treatment is all that isrequired. Tese advances translate directly into better clinicaloutcomes (e.g., longer disease-ree survival), as well as greatersaety and convenience (e.g., ewer treatment-related side eects).

Based on evidence rom a large and ever-expanding body oscientic and medical literature, recommendations or radiationmedicine have been incorporated into guidelines or bestclinical practices as a standard o care or most types o cancer.

ExAMpLES of AppLicAtioNSIn early-stage prostate cancer, radiation can enable patients toavoid surgical removal o the prostate (prostatectomy) and the

complications that may occur with invasive treatment, whileproviding disease-ree survival. Radiation treatments are a lsoa viable option or patients who cannot tolerate prostatectomyor who have an increased risk o the cancer spreading beyondthe prostate.

Te use o R as an adjuvant therapy or women who haveundergone mastectomy or lumpectomy has had a prooundinuence on survival, so it is not surprising that radiationmedicine is a dening element o breast cancer care. Evidencesupporting this therapeutic strategy is voluminous and

documents survival benets over periods as long as 15 to 20 yearA major goal and challenge in cancer care is achieving curewhile preserving vital unctions. Tis is particularly true inhead and neck cancers where the anatomy is complex. Both thecancer and therapy aect nearby structures and their unctionR is used or early-stage and advanced disease.

Radiation treatments are used extensively in managing mostmalignant and many benign primary central nervous systemtumors. Tey are ofen used ollowing surgery to decrease locarecurrence, delay tumor progression, and prolong survival. Forexample, radiation medicine is the mainstay o treatment ormalignant gliomas, which account or 70 percent o malignantprimary brain tumors diagnosed in the U.S. every year. SRShas a long history o being used very successully or treatingsmall intracranial lesions, where a single high-dose treatment iofen sucient.

Radiation therapy is also recommended or palliative careto alleviate some o the symptoms o advanced or metastaticdisease, including cancer-related pain. One-quarter o patientswith pain rom bone metastases would typically experiencecomplete relie within one month o receiving radiation; nearlyhal o all patients could expect at least 50 percent pain relie.

reatment o liver metastases is another area where R is

showing tremendous promise. A recent multi-institution studyo patients with liver metastases demonstrated that SBR is saand eective. In this study, SBR achieved local control o up t100 percent or small tumors. ei

Mr. Vastagh ([email protected]) has been on thesta o the Medical Division since 2001. During this period, hewas sta manager/director or X-Ray, MII, and RT Sections,CAD Group, TRC and international committees, and CADcompensation groups.

Radiation Therapy

Detects, Treats,

Prevents CancerSeen vasa, dicoM geneal Seea

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In recent years, medical imaging manuacturers have introduced newproducts, innovations, and patient saety initiatives or a wide varietyo medical procedures, while continually improving the ability o these

cutting-edge technologies to aid physicians in diagnosing disease,

monitoring its progression, and staging treatment options. Imaging has

become not only an essential diagnostic tool, but a critical component

o a patients course o treatment.

oday, there is no doubt that medical imaging and radiation

therapy (R) are integral to medical care, and their use reduceshospital stays and helps return patients to their amilies, lives,and work more quickly. Yet as the technology advances, theindustry has a responsibility to develop and implement thenecessary saeguards to protect patients rom the possibility ooverexposure to radiation while still receiving quality care.

Trough NEMA, MIA leads the development o standardsor medical imaging and R equipment. Tese standards are

voluntary guidelines that establish commonly accepted methodso perormance measurement, saety, design, testing, andcommunication or diagnostic imaging and therapy systemsproducts. Clearly dened technical standards are important

because they improve patient saety and create eciencies inhow care is delivered.

Once a sae and eective protocol or imaging equipmentis established, it is essential that these protocols are notinadvertently changed. NEMA XR 26Access Controls orComputer Tomography: Identifcation, Interlocks, and Logs,published in October 2012, provides an extra saeguardby standardizing quality assurance tools so that only anauthorized operator can alter the controls o a computedtomography (C) scanner.

Te industry-wide XR 26 standard requires assigning specicpermissions to selected uses beyond those needed or routinescanning, such as the authorization to alter protocols, andimplementing provisions to manually lock the user interaceto prevent unauthorized users rom accessing system controls.Te standard also contains eatures or use in a acilitys qualityassurance program, such as recording operator and patientinormation, and tracking any changes made to protocols.

As C technology continues to become more complex, itis more important than ever that C manuacturers put

saeguards in place to ensure that only authorized users canperorm or change C protocols, said Marilyn Goske, MD,chair o the Al liance or Radiation Saety in Pediatric Imagingsponsors o the Image Gentlycampaign. C manuacturers anMIAs rapid development and implementation o these new CAccess Control Standards are signs o their strong commitmento continuously improving patient care.

In November 2012, NEMA published the interventional x-raystandard XR-27 User QC Standard, which helps imagingacilities conduct quality testing and monitoring o x-ray

equipment used or interventional procedures. Interventionalradiologists use imaging to see inside a patients body, guidingcatheters through the vascular system, skin, or other pathwaysto treat diseases directly at the source without invasive surgeryQuality control user interaces provide controlled access orx-ray dose-related constancy testing, access to and exporto imaging data, electronic documentation o dose-relatedparameters in exam protocols, and direct access to radiationdose structured reports. Te addition o these new controls wilimprove the ability o medical physicists to assess regulatorycompliance and promote patient saety.

It is important to note that these latest industry standards

build on past industry-wide initiatives to develop andimplement additional patient protection eatures or diagnosticimaging and R equipment. Tis includes XR 25 ComputedTomography Dose Check, which incorporates two eaturesdonotications and dose alertsto help the operator and physiciabetter understand dose implications o protocol choices. Teseeatures have the potential to signicantly reduce exposurecaused by inappropriate scan parameter settings.

Looking orward, it is essential that we continue to workclosely with industry partners to ensure patients have accessto the saest, most innovative technologies available. MIAlooks orward to urther collaboration with the members o

its working groups to develop new standards that will allowor sae and eective use o the next generation o imagingtechnologies. ei

Mr. Abraham ([email protected])wasdirector o coding and reimbursement at IBA Molecular

prior to joining MITA. He served on MITAs PET WorkingGroup and participated in the PET Coverage Workshop and

ollow-up activities.

Industry Reinorces Commitment to Sae and

Efective Care with New Standardsban Aaam, Sen pl de, Mit

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While medical imaging includes a variety o modalities, many o themost commonly used technologiescomputed tomography (CT),x-ray, and nuclear medicineuse radiation to help physicians better detect

diagnose, and treat disease. In recent years, advances in these medical

imaging technologies have enhanced diagnosis and lowered mortality rates

across a wide range o diseases, while using less radiation than ever beore.

For example, CT scans and x-ray uoroscopy have dramatically improved the

treatment o heart disease, cancer, and stroke. Additional advances in nucleamedicine have demonstrated potential to help detect and treat complicated

neurological disorders such as Alzheimers Disease (see page 11).

o ensure the sae and appropriate use o these technologies, themedical imaging and radiation therapy industry has a long-standing commitment to eective radiation dose managementthrough a variety o collaborative and innovative initiatives.

As a proactive step toward reducing radiation dose exposure,MIA investigates dose reduction and proposes measures todecrease radiation dose. Since then, the task orce has workeddiligently to establish standards to reduce radiation, and its

collective eorts have resulted in low-dose standards or almostall radiation-emitting imaging equipment.

MIA is also a long-time partner with the U.S. Food andDrug Administration (FDA) on initiatives to promote the saeand eective use o medical imaging equipment or adultsand children. In 2012, MIA received the FDAs Leveraging/Collaboration Award or developing a collaborative networkaimed at reducing unnecessary radiation exposure rom imaginexams to pediatric patients. oday, MIA and its membersremain committed to lowering pediatric radiation dose bycollaborating with the FDA to establish regulationson premarket notications or x-ray imaging devices used

with children.

Gentle and WiseIn addition to ongoing collaborations with FDA, MIA haspartnered with the Al liance or Radiation Saety in PediatricImaging and its Image Gentlycampaign, established in 2008 toeducate medical proessionals and parents about protocols thatreduce imaging-related dose or children.

Making Stridesin Radiation Dose Reduction

oe Mal, de remsemen pl, Mit

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MIA also supports the Image Wiselycampaign, which ocuseson minimizing unnecessary radiation exposure or adults by

oering inormation and resources to physicians, radiologists,medical physicists, and patients. Additionally, MIA membersare leaders in the development o hardware and sofwareinnovations to reduce exposure and minimize medical errors.

Comprehensive training is key to ensuring any saety eaturesare properly installed and utilized by physicians, radiationtherapists, and radiation technologists. Many o the worldsleading medical imaging and radiation therapy manuacturershave developed product training programs and intensivetechnical tutorials to ensure that the lowest possible levels oradiation are utilized.

As an added measure to help ensure that the most cutting-edgetechnologies available are used saely and appropriately witheach and every patient, MIA advocates or the integration ophysician-developed appropriateness criteria into the physiciandecision-making process, as well as the mandatory accreditatioo imaging acilities. Adherence to these criteria is essential so

that patients receive the right scan at the right time withoutunnecessary exposure to radiation.

MIA and its members have a long-standing commitment topatient saety and quality care. Meaningul dose reduction ispossible through the development o hardware and sofwareinnovations, protocols, regulations and standards, as wellas collaborative eorts to improve education o physicians,radiologists, physicists, technologists and, importantly, patientand their amilies.

Tanks to the industrys leadership, patients can receive highcaliber scans with signicantly lower radiation dose thanbeore. In the year ahead, MIA members will continue tolead the development o evidence-based protocols and systeminnovations to reduce unnecessary exposure to radiationwithout compromising critical diagnostic inormation. ei

Ms. Malkoc ([email protected]) has an extensivebackground in advocacy, with a specialty in health policy. She

previously served as the director o government relations or theMuscular Dystrophy Association.

Privacy and Exposure Show Concern or Backscatter

Toward the end o last year, the Transportation Security Administration (TSA)

removed many o its controversial backscatter x-ray ull body scanners

rom major U.S. airports in avor o alternate technology equipped with

privacy sotware.

TSA concluded that it would stop using backscatter body scannersnot

over concerns raised about ionizing radiation emitted rom the devices,

but rather over a legal requirement that TSA upgrade all advanced imagingtechnology (AIT) scanners with so tware that does not show revealing x-rays

o air travelers.

But the move does not necessarily mean TSA is done with exploring the

possibility o using backscatter x-ray. The agency has commissioned a study

on the saety o backscatter AIT devices and has included the technology in

the mix o its next generation o AIT scanners.

In December 2012, the Department o Homeland Security (DHS) announced

it contracted the National Academy o Sciences to convene a committee

to review previous studies as well as current processes used by DHS and

equipment manuacturers to estimate radiation exposure resulting rom

backscatter x-ray AIT systems used in screening air travelers and provide a

report with ndings and recommendations.

This study would examine the health concerns o backscatter x-ray devices,which some suggest are more dangerous to people than the millimeter

wave devices. The privacy concerns that led to the removal o the Rapiscan

backscatter x-ray devices rom U.S. airports are a separate issue.

Harry Massey, Industry Director |[email protected]

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Computed tomography (CT) combines multiple

x-ray images taken rom diferent angles to

produce a very precise three- dimensional

image o areas inside the body. Image courtesy

o GE Healthcare

Medical imaging technologies have revolutionized healthcare deliveryin the U.S. and around the world. Oering physicians a look into thehuman body, medical imaging has become integral to disease diagnosis,

treatment, and monitoring, turning countless patients into survivors. In

addition to being undamental to standards o care, imaging technologies

help patients avoid or limit more invasive procedures and return to their

everyday lives more quickly. Peer-reviewed research confrms that medical

imaging not only improves health outcomes and saves lives, but also reduces

long-term healthcare costs.

o highlight this research, MIA published a literature reviewin December 2012, Clinical and Economic Value o MedicalImaging1, which spotlights scientic, peer-reviewed studies thatdemonstrate improved patient outcomesocused on survivaland quality o li eand cost savings associated with various

1 www.medicalimaging.org/wp-content/uploads/2012/12/Clinical-and-Economic-Value-o-Imaging.pd

imaging technologies. Te research compendium shows thatmedical imaging reduces the costs o unnecessary and invasiveprocedures, while improving patient outcomes and quality olie through early detection and more sophisticated and diversetreatment options.

Te literature review used comprehensive search methodologyto critically evaluate select publications rom the past veyears indexed in the U.S. National Library o Medicine(MEDLINE) and rom leading health policy journals. Resultin

analyses indicate that diagnostic imaging is a sound economicinvestment and eective across many disease states. Following just a summary o the overwhelming evidence rom the rev iewthat supports this conclusion.

cANcErMedical imaging has improved diagnosis and treatment o manacute and chronic conditions. Cancer treatment has benetedsignicantly rom advanced imaging, which gives physiciansthe ability to conduct minimally invasive biopsies and surgerie

Patient Well-Being Underscores Clinical and

Economic Value o Medical Imaginggal rez, Eee de, MitA

an oe Mal, de remsemen pl, MitA
http://www.medicalimaging.org/wp-content/uploads/2012/12/Clinical-and-Economic-Value-of-Imaging.pdfhttp://www.medicalimaging.org/wp-content/uploads/2012/12/Clinical-and-Economic-Value-of-Imaging.pdfhttp://www.medicalimaging.org/wp-content/uploads/2012/12/Clinical-and-Economic-Value-of-Imaging.pdfhttp://www.medicalimaging.org/wp-content/uploads/2012/12/Clinical-and-Economic-Value-of-Imaging.pdf

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and targeted radiation therapy. Computed tomography (C)and integrated positron emission tomography (PE)/C haveled to a 6.7 percent reduction in all cancer mortalities, includinga 20 percent reduction in lung cancer alone. Results o a largerandomized controlled trial estimated that low-dose spiral Cscans would lead to 130,000 additional lung cancer survivors in

2012 vs. no scans.

Breast cancer trends over the last several decades emphasizethat screening made possible by imaging saves lives. Forexample, mammography has dramatically reduced breastcancer mortality since becoming a recommended routinehealth screening. Researchers at the Medical University oVienna ound magnetic resonance imaging (MRI) to besignicantly more sensitive or detecting breast cancer than lmmammography, with 24 out o 28 detected cases o breast canceridentied by MRI (vs. 14 by mammography).

Te use o ultrasound has also been shown to be benecial orthe preoperative staging and evaluation o patients with breastcancer, yielding a cost savings o $4,682 per patient throughelimination o unnecessary procedures.

cArdiovAScuLAr diSEASE, vAScuLAr diSEASE,ANd StrokEMedical imaging is transorming the area o cardiac diagnosticsand therapeutics, as well as in the diagnosis and treatment ostroke. For instance, a study o 203 patients ound that multi-slice C eectively rules out or conrms coronary disease asthe source o chest pain in 75 percent o patients, signicantlyreducing diagnostic time and costs. A British study determinedthat providing C or MRI or all patients presenting withstroke-like symptoms is a cost-eective diagnostic strategy. Tescan all approach was reported to be less expensive than evena no scan approach; savings resulting rom shorter hospitalstays more than oset the additional costs associated withdelivering the scans.

Non-invasive imaging also plays an important role in themanagement o coronary artery disease, the leading cause odeath or men and women in the U.S. Sophisticated cardiacimaging provides anatomical and physiological inormation,allowing physicians to accurately diagnose patients, stratiythem into risk categories, and determine treatment strategiestailored to their unique needs.

orthopEdicS, oStEoporoSiS, ANd ArthritiSTe ability to more clearly visualize the structure o bones and

joints has broadened the diagnostic and treatment optionswithin orthopedic care, especially with the development ominimally invasive surgical techniques. MRI has proven a

valuable tool or assessing lesions in the knee, and studies showthat the technology not only accurately identies meniscaland anterior cruciate ligament (ACL) tears, but also avoids therisks associated with arthroscopy or those patients who do notultimately require surgical knee repairs.

Advances in diagnostic imaging have also made it possible toidentiy bone loss early, beore an osteoporotic racture occurs.Researchers at Procter & Gamble Pharmaceuticals estimatedthat bone mineral density scanning o an additional one milliowomen in 2001, ollowed by appropriate osteoporosis therapy,would have averted 35,000 ractures and generated $119 millio

in Medicare savings by 2003.

In addition, MRI changed the clinical management in hal o apatients examined with rheumatoid arthritis, with 80 percento patients showing a subsequent improvement in symptoms,according to a study conducted at the University o Virginia.

coNcLuSioN

Across a wide spectrum o disease states, imaging technologiesdetect and diagnose disease at the earliest, most treatable stageand guide physicians and patients in determining the mostappropriate and eective treatment plan. Te research compilein MIAs literature review underscores the clinical andeconomic value o medical imaging and the many ways in whicit improves health outcomes and reduces costs.

Te ull report is avai lable online at www.medicalimaging.org/wp-content/uploads/2012/12/Clinical-and-Economic-Value-o-Imaging.pd. ei

Dr. Rodriguez([email protected])has beeninvolved in imaging policy since 2008 when she served as

policy and membership director or the Institute or MolecularTechnologies. Ms. Malkoc ([email protected])has an extensive background in advocacy, with a specialty inhealth policy. She previously served as the director o governmenrelations or the Muscular Dystrophy Association.

Prepared for the Medical Imaging & Technology Alliance,

a division of the National Electrical Manufacturers Association

Clinical and EconomicValue of Medical Imaging

MITAs literature review

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An International Perspective on Imaging

Globally Harmonized Framework Improves

Patient Saety and AccessZa helze, inenanal de, Mit

Medical imaging has changed the ace o healthcare delivery in Americaand around the world. From detecting a disease in its early stages tominimizing invasive procedures, imaging technologies have proven critical

to the diagnosis and treatment o disease. Peer-reviewed research confrms

that medical imaging saves lives, improves clinical outcomes, and lowers

healthcare costs.

Its important that medical proessionals and patients aroundthe world have access to these liesaving technologies in orderto combat disease and improve health outcomes. However,impediments to international trade continue to hinder the U.S.medical device industrys export o advanced medical imagingand radiotherapy products, threatening the lives o millions opatients who would otherwise benet rom clinically-provendiagnostic and therapeutic devices. Internationally acceptedstandards and regulatory convergence where appropriate areneeded to improve access to care by enabling manuacturersand regulators to use common methods or product registrationand testing.

o help open the global market, the U.S. CommerceDepartments International rade Administration started theMarket Development Cooperator Program (MDCP), whichprovides nancial and technical assistance to support well-dened business plans that increase exports and enhance U.S.competitiveness in other markets. In November 2011, MIAwas awarded more than $200,000 as part o MDCPs GlobalDiagnostic and Terapeutic Imaging Access ImprovementInitiative to support activities to promote the export o medicalimaging products, specically to China and India.

Expanded Patient Access in ChinaMIA has ocused its MDCP eorts on working closelywith decision-makers to expand patient access to liesavingimaging technologies. MIA has made Chinas medical devicemarket, the second largest in the world, its top internationalpriority. Working with in-country regulators to improvedevice saety and integrate internationally-accepted standardsinto their regulatory regimes, MIAs eorts are alreadybearing ruit.

In September 2012, MIA

organized a workshop inBeijing on internationalstandards, during which

the State Food and DrugAdministration o the PeoplesRepublic o China (SFDA) released

a timeline outlining its transitionto IEC 60601-1 third edition. Tis isthe internationally accepted standard ortesting the saety o electrical medical equipment.

Chinas transition to this standard will ensure that doctorshave access to the newest, most innovative medical imagingtechnologies.

Furthermore, at the U.S. China Joint Commission onCommerce and rade Pharmaceuticals and Medical Devices

Subgroup meeting, which was held in coordination with theworkshop, SFDA announced the down classication o x-rayproducts. Tis development lowers the risk classication to

approve x-ray equipment or sale in line with internationalnorms. Tis will greatly reduce the time and cost it takes x-rayequipment to reach the Chinese market. Tese activities are jus

the beginning o MIAs eorts to enhance the internationalcompetitiveness o member companies as well as to improvethe associations visibility and stature as an industry leader

outside the U.S.

Brazil Increases Demandor Quality HealthcareRecently, MIA began work in Brazil, the largest market ormedical devices in Latin America. Te market in Brazil is

growing rapidly due in large part to its expanding privatehealth insurance sector, which is increasing demand or qualityhealthcare. State-run hospitals and clinics in Brazil are alsolooking to upgrade outdated equipment, which is a huge expor

opportunity or U.S. device manuacturers.

Similar to its work in China, MIA seeks toexpand access tomedical imaging and radiation therapy equipment in Brazilby working to streamline government approval processesin order to reduce the time and cost it takes or products to

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reach the market. o accomplish these goals, MIA plans to

undertake a number o market development activities that willpromote the harmonization o international standards, reduce

unnecessary regulation, and expand market access to enhance

the competitiveness o MIA member companies in Brazil.

DITTA Enhances Global ReachGrowth in MIAs international portolio is linked to ongoing

eorts with the Global Diagnostic Imaging, Healthcare I and

Radiation Terapy rade Association (DIA). DIA works toimprove the global regulatory environment or manuacturers

to ensure that they remain at the oreront o technological

innovation and are successul in the global marketplace as theycontinue to develop products that improve quality, saety, and

patient access around the globe.

DIA is composed o eight organizations, including MIA

(U.S.), COCIR (Europe), JIRA (Japan), MEDEC (Canada),HAIMED (Tailand), IMEDA (Russia), CAMDI (China),

and ABIMED (Brazil). MIAs work with DIA enhances

the global reach o US manuacturers and establishes a globalindustry voice that enables manuacturers to more eectively

advocate or harmonized standards and improved regulation.

Under MIAs leadership in 2012, DIA experienced

signicant growth. Tis included its ocial incorporation, theaddition o our new member associations, and the creation

o a ormal organizational structure and governance model.

Over the past year, DIA has worked to build its relationship

with multinational institutions such as the World HealthOrganization (WHO) where DIA is working to gain status as

an ocially recognized non-governmental organization. DIA

has also made notable gains with the Asian HarmonizationWorking Party and International Medical Device RegulatorsForum, which as a result o DIAs eorts now includesindustry representation in its management committee meeting

In September 2012, DIA convened a rst-o-its-kindroundtable meeting with the World Bank that included medicadevice industry representatives rom ve continents to discussopportunities to improve World Bank procurement processesor medical technology. Under MIAs leadership through

DIA, industry provided recommendations that would makethe procurement process more eective and reliable, which werwell received. Te World Bank agreed that an ongoing dialoguwould benet everyone, particularly borrowers in less developecountries, ensuring that doctors and patients have the tools theneed to combat diseasea common goal shared by the medicadevice industry and the World Bank. Both sides see the dialoguas critically linked to poverty reduction and economic growth.

MIA looks orward to its ongoing work with industrypartners toward a globally harmonized regulatory rameworkthat is smart, ecient, transparent, and more importantly,improves patient saety and access to the high quality medical

technologies that MIA members manuacture. Te successuldevelopment and advancement o medical imaging equipmentin the global marketplace promises to save the lives o millionso patients around the world. ei

Mr. Helzer ([email protected]) earned a mastersdegree in international studies with a concentration ininternational politics rom the Jose Korbel School oInternational Studies at the University o Denver.
mailto:[email protected]:[email protected]

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When Erika Hanson Brown fnished her prescribed course o treatmentor colorectal cancer, like many cancer survivors, she needed to visit adoctor regularly or ollow-up appointments.

Medical imaging was a routine but essential part o my doctorsvisits and checking or re-growth or new tumors, said Ms.Brown. I was ortunate to have access to these services, but thatisnt always the case.

In the ace o impending budget cuts and policy proposals thatcould impact patient access to lie-saving medical imaging andradiation therapy services, this concern resonates strongly ormany. Tats why the Access to Medical Imaging Coalition(AMIC) and the Medical Imaging & echnology Alliance(MIA) convened more than 50 patients in Washington,D.C., or the 2012 Right Scan Right ime and COLONOWNAdvocacy Academy.

Right Scan Right Time Advocates

A cALL to ActioN

Knowing how important access to medical imaging is to mysurvival story, Im concerned or the millions o patients whowill require these services in the uture to identiy their illness

and receive the best course o care, said Ms. Brown.

Imaging has already been cut twelve times since 2006, andurther proposals to reduce Medicare payments or advancedimaging and radiation therapy services or to implementburdensome prior authorization mechanisms, such as radiologybenets managers, continue to threaten patient access. InSeptember 2012, patients ew in rom across the United Statesto join AMIC and MIA in calling on Congress to protectMedicare reimbursement or advanced medical imaging and

radiation therapy services so that patients nationwide can

continue to have access to the right scan at the right time.

right ScAN right tiME AcAdEMy

In preparation or meetings on Capitol Hill, advocates spent

a day sharing their stories and diving into the complex policy

issues that impact access to these critical services. Te Advocac

Academy programming included an interactive storytelling

session and a patient all-star panel to help advocates learn ho

to communicate their unique stories eectively with media and

congressional staers.

We wanted the academy to be a truly unique and engaging

experience, with an emphasis on relationship buildingnot

only among the advocates themselves, but with their legislators

said Ms. Brown. Tats why our curriculum ocused on the

power o storytelling and ostering an understanding o the

complex policy issues at play.

MITA Director o Government Relations Brian Connel l talks to Right Scan Right Time p atient

ambassadors at the Advocacy Academy in preparation or 2012 Capitol Hill Day.

Advocates share their stories at the Ri ght Scan Right Time Advocacy Academy.

Medical Imaging AdvocatesTake to Capitol Hill

da cln, de Sae & feeal genmen relans, Mit

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MEdicArE rEiMburSEMENt: Te payment thatphysicians and hospitals receive or services rendered topatients who are covered under the Medicare program.

MuLti-SLicE ct: A medical technique o acquiring severalcross-sectional images in a single rotation o the x-ray tubeand detector assembly, allowing physicians to obtain highresolution and high speed at the same time.

NucLEAr MEdiciNE: A branch o medicine that involvesthe use o radioactive materials to help diagnose and treat a

variety o diseases.

pEt/ct: A medical imaging technique that combines PEand C, allowing images acquired rom both devices to betaken sequentially and combined into a single superposedimage, enabling physicians to more precisely measure tumor

volumes and prepare patient treatment plans.

poSitroN EMiSSioN toMogrAphy (pEt): A type onuclear medicine that uses a scanner and a small amount o

Glossary o Terms

AccESS to MEdicAL iMAgiNg coALitioN (AMic):A coalition that represents more than 100,000 physicians,medical providers, and patient organizations throughoutthe U.S. AMIC conducts public aairs, advocacy, andeducational activities to address payment reductions andpromotes the adoption o policies that ocus on medicalimaging quality and appropriateness.

AppropriAtENESS critEriA: Evidence-based guidelinesto assist reerring physicians and other providers in makingthe most appropriate imaging or treatment decision or aspecic clinical condition.

coMputEd toMogrAphy (ct): A medical imagingtechnique that combines multiple x-ray images taken romdierent angles to produce very precise three-dimensionalimages o areas inside the body.

coroNAry coMputEd toMogrAphy ANgiogrAM

(cctA): A medical imaging technique that uses advanced Ctechnology along with contrast dye to obtain high-resolution,

three-dimensional pictures o the heart and blood vessels.

iSchEMic hEArt diSEASE: A disease characterized byreduced blood supply o the heart muscle, usually due tocoronary ar tery disease.

fLuorodEoxygLucoSE (18f-fdg): A radiolabelledsugar molecule used as a radiotracer with PE to characterizeand localize many types o tumors.

Low-doSE SpirAL ct: An advanced imaging technology

in which x-ray detectors rotate around the body to produce athree-dimensional image o internal structures.

MAgNEtic rESoNANcE iMAgiNg (Mri): A medicalimaging technology that uses radio waves and a magneticeld to create detailed images o organs and tissues.

MAMMogrAphy: A breast cancer detection exam that usesx-ray technology to produce an image o inner breast tissue.

Courtesy o Siemens Healthcare

Courtesy o SonoSite

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radiopharmaceuticals injected into a patients vein to assistin making detailed, computerized pictures o areas insidethe body, providing physicians with inormation about howtissues and organs are unctioning.

prior AuthoriZAtioN: A policy that requires providersto obtain authorization beore providing imaging services.

rAdiAtioN thErApy (rt): A medical technique thatdelivers highly targeted radiation to cancerous cells,

destroying their ability to grow and divide while leavinghealthy cells intact.

rAdioLogy bENEfitS MANAgErS (rbMS): For-protcompanies that evaluate physicians orders o imagingstudies and, using proprietary systems, determine whether toapprove or deny the requested service.

rAdiophArMAcEuticALS: Radioactive substances usedin very small doses to diagnose, treat, and prevent disease.

thE MEdicAL iMAgiNg & tEchNoLogy ALLiANcE(MitA): Te leading organization and collective voiceo medical imaging equipment, radiation therapy andradiopharmaceutical manuacturers, innovators, andproduct developers. MIA, a division o NEMA, representscompanies whose sales comprise more than 90 percent o theglobal market or medical imaging technology.

uLtrASouNd: A medical imaging technology that sendshigh requency sound waves into the body and converts thereturning sound echoes into images o the inside o the body.

x-rAy: Te oldest and most commonly used orm o medicalimaging, which sends beams o ionizing radiation throughthe body to produce images o a persons internal structure.

x-rAy fLuoroScopy: A procedure that shows acontinuous x-ray image on a monitor so that the movemento a body part can be seen in detail.

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MITA is widely recognized as the leading organization and collectivevoice o medical imaging equipment, radiation therapy, andradiopharmaceutical manuacturers, innovators, and product developers.

Fittingly, MITAs sta is well-versed in a wide variety o policy issues. But

theres much more to us than meets the eye!

Gail Rodriguez, PhD, executive director, has worked in

the nuclear medicine industry or 18 years in various sales,marketing, training, and management roles. Beore becomingan expert in nuclear medicine and medical imaging, Gailranked as one o the top spellers in the United Statesin 1974,she won second place in the National Spelling Bee.

While her spelling skills remain unrivaled at MIA, DavidCooling, MIAs director o state and ederal policy, outpacesher in one distinct activity: running. In the midst o honing hishealth policy expertise in the private sector, on Capitol Hill and,ultimately, at MIA, David has managed to run six marathons.

Stephen Vastagh, general secretary and administrator or

NEMAs Digital Imaging and Communications in Medicine(DICOM) standard, has been a downhill skier his entire lie.Stephen and his wie ounded a Junior Ski Racing Program ata central Pennsylvania resort, which they managed or morethan a decade. During this time, their daughter represented theVastaghs native country, Hungary, at the Salt Lake City WinterOlympics. Stephen is still participating in amateur racingwhenever his schedule permits. Meanwhile, his daughter is nownearly six months pregnant and skiing as ast as ever until thelast minute possible.

Did you knowRichard Eaton, MIAs director o industryprograms, and Brian Abraham, director o policy are seasonedtravelers? While Rich enjoys steam train excursions, Brianpreers to venture oshore. Prior to joining MIA, Brianspent a ew years living on the sovereign island o St. Lucia inthe Caribbean.

MIAs manager o international programs, Zach Helzer,

came to MIA in 2010 afer graduating with a masters degreein international studies rom the Jose Korbel School oInternational Studies at the University o Denver. Zach joinedMIA as much or his love o international policy as he didor personal reasons. In his youth, he battled lie-threateningasthma, resulting in a childhood characterized by seeminglyendless hospital visits. Having been so acutely aware o theimportance o medical imaging afer routine chest x-rays,Zach developed a keen interest in and appreciation or medicalimaging technologies and health policy, which he has honedat MIA.

Te gif o giving prevails strongly at MIA, whose director

o government relations, Brian Connell, is married to a womanrom Santa Cl

EI_Mar13

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