advancing the future of medical imaging and radiation therapy

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

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E n Imaging and the future of Alzheimer’s Disease

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 accuracy

Advancing the Future of Medical Imaging and Radiation Therapy

UL-electroInd-ad-v3-FINAL-OL.indd 1 12/18/12 3:20 PM

CONTENTS FEATURES:

NEMA electroindustry text and cover pages are printed using SFI certified Anthem paper using soy ink.

• SFI certified products come from North American forests managed to rigorous environmental standards.

• SFI standards conserve biodiversity and protect soil and water 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 offices. 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 reflect the positions of NEMA or any of its subdivisions.

Subscribe to electroindustry at www.nema.org/subscribe2eiContact 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 TillmannMedia Sales Team Leader | Stephanie Bunsick

Policies Affecting Medical Imaging—Safeguarding Medical Imaging and the U.S. Economy ......................7

Medical Imaging Advancements in Cardiovascular Disease Quantify Cost ...............................................10

Imaging’s Role in the Future of Alzheimer’s Disease ..............................................................................11

Radiation Therapy Detects, Treats, Prevents Cancer ..............................................................................12

Industry Reinforces Commitment to Safe and Effective Care with New Standards ...................................13

Making Strides in Radiation Dose Reduction ........................................................................................14

Patient Well-Being Underscores Clinical and Economic Value of Medical Imaging ...................................16

An International Perspective on Imaging— Globally Harmonized Framework Improves Patient Safety and Access ...................................................18

Medical Imaging Advocates Take to Capitol Hill ....................................................................................20

Glossary of Terms ................................................................................................................................22

Getting to Know MITA .........................................................................................................................24

Did you know...Knowledge is power, and it’s yours through the NEMA Intelligence Portal. Available to members at portal.nema.org

PET imaging detects beta amyloid plaque in the brain, indicating the presence of Alzheimer’s Disease. Story on page 11. PET/MR image courtesy of Siemens Healthcare

http://portal.nema.org/Pages/default.aspx

CONTENTS NOTES:NEMA Officers .......................................................................................................................................................................................3

Comments from the C-Suite .................................................................................................................................................................3

View from the Top .................................................................................................................................................................................4

Learn More ..........................................................................................................................................................................................32

DEPARTMENTS:Government Relations Update ...............................................................................................................5

Device Tax Creates Obstacle to Innovation and Economic Growth ......................................................................................................5

Transportation Section Briefs Hill Offices on Industry Priorities ..........................................................................................................6

Electroindustry News ..........................................................................................................................25

ESFI Debuts New Fire Safety Resources for Older Adults ...................................................................................................................25

[Re-]Introducing the Smart Grid Interoperability Panel ....................................................................................................................26

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

NEMA Joins Transatlantic Conference to Strengthen EV and EVSE Standards ..................................................................................27

NEMA Addresses the Embedded Meter .............................................................................................................................................28

Iowa Legal System Attacks Electrical Code ........................................................................................................................................28

Pacific Northwest Picks Up Pace of Code Adoption ..........................................................................................................................29

International Roundup .......................................................................................................................30

Mexico Adopts a New Electrical Code ................................................................................................................................................30

U.S.–Mexico Smart Grid Technology & Business Conference Scheduled this Month.......................................................................30

Economic Spotlight .............................................................................................................................31

Policy Environment Leads to Continued Uncertainty in the Diagnostic Imaging Market .................................................................31

NEMA/BIS Forecasters Leavens and Gill in Top Five for Accuracy .....................................................................................................32

EBCI Online ..........................................................................................................................................................................................32

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??The Breakers Palm Beach

Take a Visual Journey at www.thebreakers.com

NEMA’S 87th Annual Meeting

Illuminations Weekend— Where Leaders and Ideas Meet

Friday, November 8 and Saturday, November 9, 2013

6 Ű About MITAThe Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the leading organization and collective voice of medical imaging equipment, radiation therapy, and radiopharmaceutical manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology.

www.medicalimaging.org

NEMA electroindustry • March 2013 3

COMMENTS FROM THE C-SUITEOfficers

ChairmanJohn Selldorff President & CEO Legrand North America

First Vice ChairmanChristopher Curtis President & CEO Schneider Electric

Second Vice ChairmanThomas S. Gross Vice Chairman & COO Eaton Corporation

TreasurerDon Hendler President & CEO Leviton Manufacturing Co., Inc.

Immediate Past ChairmanDavid J. FitzGibbon Vice Chairman & CEO ILSCO Corporation

President & CEOEvan R. Gaddis

SecretaryClark R. Silcox

Evan R. GaddisPresident and CEO

This is a rare moment for our medical and electroindustry members. Policymakers on both sides of the aisle are increasingly focused on technologies that will rein in healthcare costs and make our electric grid, homes, businesses, and factories more energy efficient and competitive.

Imaging technologies (CT, MR, PET, RT, ultrasound, and x-ray) have revolutionized healthcare delivery, changing how physicians diagnose and treat diseases, ultimately improving health and saving lives. MITA, NEMA’s medical division, represents the companies that champion radiation dose optimization and management standards.

Another benefit of these efforts is that imaging lowers healthcare costs. A recent study found that the use of non-invasive coronary CT imaging in the emergency room can save hospitals billions of dollars.

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

Severe weather, most recently Superstorm Sandy, coupled with an aging and overstressed electrical infrastructure, is having a dramatic impact on the U.S.—16 states experienced outages during Sandy. The core principal of any major reconstruction effort should be to rebuild smart—ensuring that reconstruction funds maximize the deployment of technologies to mitigate future power outages, protect lives and property, and improve energy efficiency.

Resilient and reliable power is critical for hospitals, first responders, communications, transportation, water treatment, emergency food 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 of these technologies are self-healing Smart Grid solutions—information and communications technologies such as smart meters and high-tech sensors to isolate problems and bypass them automatically; microgrids and backup generators that use their own power sources and storage capabilities to support vital services; and wiring, cabling, and electrical components that can stand up to high winds and flooding.

In its recent publication, Storm Reconstruction: Rebuild Smart, NEMA provides a guide to making our nation more competitive and energy efficient in the aftermath of severe weather.

The 400-plus member companies of the National Electrical Manufacturers Association and our staff of experienced engineers, medical imaging and electroindustry experts, spanning more than 50 industry sectors, stand ready to assist industry and government officials at all levels in saving energy and saving lives.

We have the solutions. ei

http://www.nema.org/Storm-Reconstruction/Pages/default.aspx

4 NEMA electroindustry • March 2013

Views from the Top

We are at a pivotal time in our nation’s history with regards to healthcare. While the Patient Protection and Affordable Care Act—many pieces

of which will soon be implemented—provides access to care for 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 focuses providers on providing the best, most efficient care. Evidence shows that not only do earlier, more accurate diagnoses increase quality of care in the short-term, they can also dramatically reduce long-term healthcare

Solutions over products. Consistency over variance. And innovation in everything.

In an increasingly costly, complex,

and consumer-driven U.S. healthcare environment, medical device manufacturers recognize the importance of investing in innovative solutions that improve quality, accessibility, and affordability for patients and physicians. These solutions must be connected across health systems and across disease pathways. More than the sum of cutting-edge products, synergistic solutions can reduce costs and enable faster, earlier, and more accurate diagnosis.

U.S. economy by supporting hundreds of thousands of jobs across many states. From the physician reviewing a CT scan, to the technician performing a procedure, to the factory worker assembling a machine, medical imaging provides jobs.

MITA member companies are well-positioned to continue on the pathway of innovation by developing safe and effective technologies to facilitate earlier and more precise disease detection, while also bolstering the domestic economy. As we continue to focus on improving our healthcare system from the inside out, the key to success will be giving medical professionals the necessary tools and techniques to diagnose patients more accurately, treat conditions more effectively, and ultimately reduce medical costs by eliminating unnecessary treatment. ei

sophisticated diagnostic tools that help determine at a molecular level which treatment is most appropriate for a particular patient. And it means billion dollar investments in personalized technologies that can help identify and treat cancer, Alzheimer’s, and other devastating diseases.

While the future of U.S. healthcare is still evolving, the path forward involves three things: a solutions-based approach that values outcomes over widgets, consistent best practices and data that minimize variance, and innovative personalization that serves the most important end for those involved in healthcare—the patient. ei

costs. In essence, there’s clinical and economic value in knowing. Diagnosis—and more importantly—misdiagnosis, matters.

Fortunately, this is also a time of tremendous innovation in diagnostic tools, from computed tomographic (CT) colonography, which has been shown to promote early detection of colorectal cancer, to positron emission tomography (PET), which offers physicians a uniquely enhanced look inside the body, enabling them to identify illnesses ranging from cancer to heart disease. Accurate, timely diagnosis serves the patient’s best interests and offers significant cost savings to the broader healthcare system by preventing misdiagnosis and ensuring appropriate treatment.

At the same time, companies that manufacture diagnostic and therapeutic tools are improving the health of the

The inconsistency of healthcare delivery and outcomes from region-to-region, and even hospital-to-hospital, is significant. Evidence shows variance is bad for 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 information technology to identify problem areas, better coordinate patient care, and drive day-to-day process improvements—including improved staff scheduling and simplifying the patient’s continuum of care.

Yet innovation in healthcare involves more than process improvements and technology advances. It also means personalization—developing

Ű Precise Disease Detection Bolsters Economy, Diagnoses Patients More AccuratelyGreg Sorensen, MD, Chief Executive Officer of Siemens Healthcare North America and Chair of the MITA Board of Directors

Ű Medical Device Manufacturers Deliver Personalized Technologies Marcelo Mosci, President & CEO, GE Healthcare U.S. & Canada


Government Relations Update

many patients, for multiple years. As a result, even if a hospital or doctor’s office experiences an increase in patients, it will not necessarily purchase additional equipment. Despite this key difference, firms manufacturing imaging equipment—and other multi-patient devices—are required to pay this 2.3 percent tax without a substantial increase in demand for their products.

LEviEd oN SALES, Not profitEven companies making no profit will pay a large tax, which makes it harder for entrepreneurs to attract investment required to support innovative new companies. For example, a start-up company with annual revenue of $10 million and net income of $0 would be taxed $230,000, plunging it into the red.

Although the IRS has implemented the tax, repeal efforts are far from over. Democrats and Republicans are uniting to repeal it as a way to grow the economy. In early February, Representatives Erik Paulsen (R-MN), Ron Kind (D-WI), and 186 members of Congress cosponsored a bipartisan bill to repeal it. Concurrently, Senators Orrin Hatch (R-UT) and Amy Klobuchar (D-MN) introduced a device tax repeal bill with the support of 28 Democratic and Republican senators.

With meaningful bipartisan momentum and good policy on our side, MITA continues to lead the fight to repeal the device tax and looks forward to working with policymakers to protect American innovation and manufacturing. ei

David Cooling, Director of State and 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 amplified the incentives to outsource R&D and move manufacturing abroad. Despite these options, many firms have largely resisted the trends seen in other manufacturing sectors and maintained successful research centers and manufacturing plants domestically. A $29 billion tax burden on these companies amplifies these pressures and has already forced companies to consider finding cost savings in their U.S. operations.

StifLiNg hEALthcArE iNNovAtioNThe medical imaging industry is in a state of constant innovation, which each year brings exciting new advances in reducing radiation dose and improving imaging clarity. These developments give physicians new tools to diagnose and treat diseases at earlier stages, improve patient care, and reduce downstream costs. Unfortunately, this tax reduces the resources that the industry currently uses to fund R&D and invest in manufacturing. Less investment in R&D slows the pace of innovation and postpones patient access to the next generation of care.

NEgAtivE iMpAct oN iNduStryWhile this tax was designed to complement an increase in demand for medical devices resulting from the Affordable Care Act’s insurance coverage expansions, this logic does not extend to imaging equipment. Unlike other devices, imaging equipment is considered infrastructure, based in hospitals and physician offices. While many other devices are designed to be used once per patient, imaging equipment is designed to be used multiple times, on

Ű 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 effective and efficient healthcare. This tax hits the devices and radiopharmaceuticals that MITA members manufacture, including computed tomography (CT) scans, magnetic resonance imaging (MRI), x-ray, and ultrasound equipment. Although used as a way to plug a budgetary hole in the 2010 Affordable Care Act, this tax creates an enormous obstacle for an industry that supports hundreds of thousands of good-paying American jobs.

Device manufacturers made their first device tax payment of nearly $100 million at the end of January. Those funds could have been spent on research and development (R&D) or—with the average medical technology industry employee earning about $58,000 annually—about 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. These are high-paying, American manufacturing jobs—the jobs our policies should be incentivizing.

Many pro-tax supporters say that the revenue windfall from healthcare reform will provide more than fair compensation for the device tax, but that is a misguided argument considering the bulk of patients who use medical devices are already covered under Medicare. Despite various unknown contingencies, the negative effects of the device tax are certain.

hArMiNg jobS ANd EcoNoMyThe American medical technology industry is a true economic success story. It employs more than 400,000

1 factfinder2.census.gov


Government Relations Update

of the American Association of State Highway and Transportation Officials (AASHTO), and John Horsley, who retired from that position at AASHTO in February. The NEMA group thanked Mr. Horsley for his many years of partnership with NEMA on ITS standards and other issues and briefed Mr. Wright on new projects on which the organizations can collaborate. ei

Craig Updyke Manager, Trade and Commercial Affairs |

[email protected]

• Press for a greater share of overall federal funding for transportation to be devoted to technology deployment and for associated changes in project contracting to focus on network and system performance rather than asset management.

These messages, especially NEMA’s offers of assistance, were well received. Staff plans more dialogues for the coming months.

The final meeting of the day was with Bud Wright, incoming executive director

Ű Transportation Section Briefs Hill Offices on Industry PrioritiesAs Washington, D.C., readied itself for the presidential inauguration on January 17, a delegation of NEMA’s Transportation Management and Associated Control Devices Section spent the day on Capitol Hill meeting with key staff members.

Led by Section Chairman Bryan Mulligan (Applied Information), the group had constructive dialogues with staff for the Transportation & Infrastructure (T&I) Committee of the House of Representatives, the Environment and Public Works (EPW) Committee of the Senate, as well as three Senate offices. T&I and EPW are the lead committees in the House and Senate for transportation legislation. In addition to the group meetings, some members also took time for NEMA-facilitated meetings with their home legislators’ offices. This event marked the fourth consecutive year that a member company–delegation visited with executive branch or legislative decision makers.

NEMA’s message was threefold:

• Thank legislators for the two-year transportation law approved in summer 2012, known as MAP-21, and the law’s support for greater deployment of intelligent transportation systems (ITS) technologies in federally-funded transportation infrastructure projects.

• State a strong preference for a longer-term law to allow for better project and business planning and offer NEMA’s assistance in crafting the next bill for 2014.

NEMA’s 3TS Section on Capitol Hill, from the left: Ray Deer (Peek Traffic), John Miller (NEMA), Tom Becker (Daktronics), Bob Rausch (TransCore ITS), Jessie Swinea (Adaptive Micro Systems), Bryan Mulligan, Section Chair (Applied Information), Russ Brookshire (Delcan Technologies), Bill Klyczek (TraficonUSA), Dan Dietrich (FLIR Systems), and Jean Johnson (NEMA). Photo by Craig Updyke

See “Bipartisan Helium Bill Introduced in House,” page 11.


SAFEgUARDINg ThE FUTURE OF MEDIcAl IMAgINg


As the leading organization and collective voice of medical imaging equipment, radiation therapy and radiopharmaceutical manufacturers,

innovators, and product developers, MITA has a high stake in a broad spectrum of 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 for transparent and efficient regulatory processes, or protecting reliable access to helium, MITA is at the forefront of political advocacy.

Safeguarding timely access to safe and effective medical technologies 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 medical device industry generates approximately $25 billion in payroll, pays out salaries that are 40 percent higher than the national average ($58,000 vs. $42,000), and invests nearly $10 billion

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

Leading into 2013, MITA advocated tirelessly alongside its medical device industry partners for repeal of the burdensome 2.3 percent medical device excise tax, which is estimated to collect over $30 billion in taxes from medical device manufacturers over the next ten years. MITA called for repeal of the tax on the grounds that such a large, new tax would jeopardize thousands of American jobs and pose a serious threat to companies’ ability to develop and bring to market life-saving imaging technologies.

In fact, in a 2012 MITA survey1 of member companies, four out of every ten respondents anticipated having to reduce their

1 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

Policies Affecting Medical Imaging— Safeguarding Medical Imaging and the U.S. Economy

brian connell, director of government relations, MitA

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-innovation

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-innovation


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

Despite evidence proving the devastating fallout if implemented, policymakers did not repeal the device tax, which took effect on January 1, 2013. While a stand-alone repeal of the device tax is highly unlikely in 2013, MITA is working closely with its industry coalition partners to articulate the impact of the tax and continues to argue for full repeal as a piece of a larger package.

Advocating Medicare PoliciesIn spite of the clear clinical and economic value of imaging, Medicare reimbursements for medical imaging procedures have been under constant threat of cuts. Since 2006, reimbursement rates for medical imaging procedures have been slashed eleven times, with yet another cut set to be implemented in 2014. These cuts jeopardize patient access to lifesaving technologies which are critical to detecting, diagnosing and treating cancers and many other diseases.

Additionally, several recent independent analyses have confirmed a recent downward trend in utilization of medical imaging procedures. The Medicare Payment Advisory Commission’s annual report2 to Congress in March 2012 confirmed 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 growing category in Medicare fee-for-service spending. Since 2006, per beneficiary spending on imaging services has declined by 16.7 percent and advanced imaging services declined by 27.6 percent. In contrast, non-imaging services experienced 21.3 percent growth in spending over the same time period.

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

3 www.medicalimaging.org/2012/09/20/new-mita-analysis-confirms-continued-decline-in-medical-imaging-utilization-and-spending-within-medicare/

Cutting Medicare reimbursements for medical imaging or instituting roadblocks such as radiology benefits managers and prior authorization programs—both of which require providers to obtain permission from a third-party private contractor prior to ordering imaging services—have been shown to significantly delay and even deny services without yielding significant cost savings for taxpayers4. According to a 2010 national survey of physicians by the American Medical Association, requiring physicians to ask for preauthorization from health insurance companies harms patient care and creates an expensive and confusing claims process. Delays and denials resulting from these complications can exacerbate patients’ conditions, necessitating more invasive, intensive, and costly treatments down the road.

As an alternative, MITA advocates for the integration of physician-developed appropriateness criteria, which provide physicians with access to information at their fingertips to ensure that an imaging procedure is appropriate for their patient. In order to provide optimal care and prevent medical errors, physicians and technologists must account for a patient’s individual needs, condition, and characteristics. Along with physician-developed appropriateness criteria to effectively guide treatment decisions, MITA advocates for comprehensive training of hospital and imaging facility personnel who perform medical imaging exams to ensure the safe and effective use of imaging in every setting.

MITA’s Positron Emission Tomography (PET) Group has been working with the Centers for Medicare and Medicare Services on separate payment for diagnostic radiopharmaceuticals under the Medicare Hospital Outpatient Prospective Payment System. The PET group is also working to advocate for local coverage for PET tracers in neurology and cardiology (not just oncology), as well as for beta amyloid imaging (see “Imaging’s Role in the Future of Alzheimer’s Disease,” page 11).

Promoting Efficient Regulatory ProcessesIn addition to enabling physicians with the necessary tools to deliver optimum care to patients, policymakers should institute transparent and efficient regulations for medical devices, and MITA is committed to working with the U.S. Food and Drug Administration (FDA) to provide helpful resources and guidance to ensure that the agency understands the effects of its proposals on innovation and patient access.

For example, throughout 2011 and into 2012, MITA worked closely with FDA and industry partners to negotiate the latest Medical Device User Fee Agreement (MDUFA) to promote timely patient access to safe and effective medical devices. Initially enacted in 2002 as the Medical Device User Fee and

4 www.medicalimaging.org/wp-content/uploads/2012/04/MITA-PAF-Imaging-Report-Summary-4-23-12.pdf

Photo courtesy of GE Healthcare

http://www.medpac.gov/documents/Mar12_EntireReport.pdf

http://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

http://www.medicalimaging.org/wp-content/uploads/2012/04/MITA-PAF-Imaging-Report-Summary-4-23-12.pdf

http://www.medicalimaging.org/wp-content/uploads/2012/04/MITA-PAF-Imaging-Report-Summary-4-23-12.pdf




Modernization Act, the regulations sought to equip FDA with the necessary resources to review medical devices more efficiently and ultimately ensure their safety and effectiveness.

MDUFA III, the outcome of the 2012 negotiations, took effect on October 1, 2012, representing an agreement between the medical device industry and FDA to increase the efficiency of regulatory processes in order to reduce the time it takes to bring safe and effective medical devices to market in the U.S.

Helium Crisis RisingMITA also works closely with members of Congress to protect access to the critical U.S. helium supply. (See “Bipartisan Helium Bill Introduced in House,” below.)

Helium is an essential component used in the creation and operation of magnetic resonance imaging (MRI) machines, which are critical to the diagnosis of stroke, aneurysms, cancers, multiple sclerosis, and other deadly and debilitating diseases. Liquid helium is the only element that can feasibly cool MRI magnets to temperatures suitable for imaging; thus, MRIs in hospitals must be regularly replenished with helium in order to maintain the necessary operating temperature.

The U.S. has more than one billion cubic meters of helium gas stored in Amarillo, Texas, at the Federal Helium Reserve. However, we are now facing a helium shortage, and if Congress fails to act this year, the Bureau of Land Management will be forced to shut down the Federal Helium Reserve. This will have far-reaching impact on medical imaging manufacturers as well as computer chip and optical fiber manufacturers.

In October 2012, MITA submitted a letter to Congress calling on policymakers to keep the reserve operational. Today, MITA continues to work with the House and Senate to pass legislation that will help resolve the looming helium supply crisis.

From Medicare reimbursement to taxation to access to helium, MITA member companies are deeply invested in a wide spectrum of policy issues that affect the wellbeing of American patients and the health of the domestic economy. In 2013, MITA will continue its efforts to communicate the undeniable value of medical imaging and radiation therapy technologies to U.S. policymakers, stakeholders, physicians, and patients. ei

Prior to joining MITA, Mr. Connell ([email protected]) was a legislative director on healthcare policy for a Midwestern member of 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 fair price for helium sold by the Department of the Interior. The bill was considered at a February 14 hearing of the Natural Resources Committee, of which Mr. Hastings is the chairman and Mr. Markey the ranking minority member. HR 527 could be reported out of the committee to the full House of Representatives before the end of March.

MITA Executive Director Gail Rodriguez welcomed the introduction of HR 527 as “an important step forward in finding a solution” to the uncertainty of U.S. helium supplies. MITA and NEMA are working for passage of legislation as soon as possible in 2013 since, under current law and absent decisive congressional action and the president’s signature, the Federal Helium Reserve is scheduled to shut down as early as October 2013 and take as much as 30 percent of the world’s helium supply off the market. At press time, staff for 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 of medical imaging equipment, such as magnetic resonance (MRI) machines. Liquid helium is the only element that can feasibly cool MRI magnets to temperatures suitable for imaging; thus, MRIs must be regularly replenished with helium in order to maintain normal operating temperatures. Helium gas is also used in the welding of stainless steel and in the manufacturing process for semiconductor chips, including light-emitting diodes (LEDs).

Brian Connell, Director, Government Relations | [email protected] Updyke, Manager of Trade and Commercial Affairs | [email protected]

mailto:[email protected]




Cardiovascular disease—commonly known as “heart disease”—generally refers to conditions that involve narrowed or blocked blood vessels that

can cause chest pain, a heart attack, or stroke. It is the leading cause of death for men and women in the United States and one of the nation’s most costly health problems. In fact, the Centers for Disease Control and Prevention estimates that coronary heart disease costs $108.9 billion each year, including the cost of healthcare services, medications, and lost productivity.

Fortunately, advances in cardiac imaging are transforming the diagnosis of heart disease and reducing healthcare costs by minimizing expensive invasive procedures and shortening the length of patients’ hospital stays. Coronary computed tomography angiogram (CCTA) is one method that uses advanced CT technology, along with contrast dye, to obtain high-resolution, three-dimensional pictures of the heart and blood vessels. It is noninvasive and can be used to rule out or confirm a heart attack, as well as serve as a gatekeeper for triaging patients for expensive or potentially risky, invasive procedures.

With this technology, a patient today can walk into an emergency room with chest pain, receive a CCTA scan that discovers heart blockage and obtain a stent in two hours. Alternatively, CCTA can rule out any blocked blood vessels and the patient can be discharged and on his way home within hours without compromising safety. Several recent studies have confirmed that CCTA demonstrates significant clinical and cost-effectiveness, saving lives and doing so quickly and efficiently.

In March 2012, the New England Journal of Medicine published results from the largest trial to date examining the efficacy of CCTA as a triage tool for patients with suspected coronary artery disease. Conducted by the American College of Radiology Imaging Network (ACRIN), the trial evaluated the use of CCTA vs. standard care among 1,370 emergency room

patients with acute, low-risk chest pain and possible coronary artery disease. It found that use of CCTA allowed more patients to be discharged from the emergency room rather than admitted (49.6 percent vs. 22.7 percent) with a shorter time spent in the hospital (median 18.0 hours vs. 24.8 hours, p=.001). Most importantly, the use of CCTA did not compromise safety, with no significant difference between groups in the occurrence of heart attack or cardiac death within 30 days of the emergency room visit1.

CCTA has also proven to be beneficial in non-emergency settings when used prior to cardiac catheterization, an invasive procedure to diagnose coronary artery disease, by selecting patients who are the best candidates for coronary catheterization. A study published in the January 2012 issue of the American Journal of Cardiology compared coronary catheterization in all patients vs. selective catheterization among patients with greater than 50 percent stenosis (narrowed blood vessels) as identified through CCTA imaging, and found that use of CCTA saved an average of $3,061 per patient through avoidance of unnecessary angiography2.

Both of these recent studies add to the body of evidence that quantifies the significant cost savings associated with the use of advanced cardiac medical imaging technologies such as CCTA and demonstrate the value imaging technology is contributing to the diagnosis and treatment of heart disease in the U.S. ei

Mr. Eaton ([email protected]) joined NEMA as an industry manager in 1988. He holds a bachelor’s degree in political science from the Johns Hopkins University and a JD from Rutgers University.

1 Litt HI, Gatsonis C, Snyder B et al. “CT angiography for safe discharge of patients with possible acute coronary syndromes,” N Engl J Med 2012;366(15):1393-1403

2 Patel N, Pal RS, Flores F, Budoff M. “Utility of cardiac computed tomography angiography to exclude clinically significant obstructive coronary artery disease in patients after myocardial perfusion imaging,” Am J Cardiol 2012;109(2):165-168

Medical Imaging Advancements in Cardiovascular Disease Quantify Cost

richard M. Eaton, director of industry programs, MitA



Positron emission tomography (PET) offers a uniquely enhanced look inside the human body. Used in conjunction with a camera and a radioactive

drug known as a “tracer,” PET imaging enables physicians to identify illnesses such as cancer, ischemic heart disease, and neurological disorders.

For many years, Alzheimer’s Disease (AD) has been difficult to distinguish from other common conditions associated with aging, such as dementia. PET imaging is one of the only tools that can accurately and decisively confirm an often fatal condition, otherwise verifiable only by autopsy. Without brain imaging, the presence of AD in a patient could not be affirmatively confirmed or denied, hindering doctors’ ability to provide an accurate early diagnosis.

The U.S. Food and Drug Administration (FDA) recently approved the use of a new PET tracer to help physicians make a definitive diagnosis of AD. This new tracer, F-18 Florbetapir (Amyvid™), and several others that are expected to be approved by the FDA, detects beta amyloid plaque in the brain. This plaque is an indicator of AD. When beta amyloid plaque is present, physicians can make treatment decisions with more confidence than just through the symptomatic indicators they had up until this first approval.

Ron Petersen, MD, PhD, director of the Alzheimer’s Disease Research Center and the Study of Aging at the Mayo Clinic, attested to the necessity of brain imaging throughout the diagnostic process, remarking that “imaging can assist the clinician in being more specific regarding the cause of the cognitive impairment,” especially when “differentiating a subtle memory impairment associated with early Alzheimer’s Disease from that seen in aging.”

Recently, AD garnered national media attention when legendary University of Tennessee women’s basketball coach Pat Summitt was diagnosed with AD through the use of brain imaging. Feeling that “something was off” and noting that things were not coming to her as quickly, Ms. Summitt sought a full mental examination at the renowned Mayo Clinic. There, she received a PET scan, which helped her doctors distinguish AD from frontotemporal dementia, another potential cause of memory loss. Results confirmed that Ms. Summitt’s lapses in memory were mild, albeit distinct, signs of early-onset AD.

According to one caregiver, early diagnosis is critical. “The diagnosis lends itself to quality of life and helps the caregiver make necessary decisions before a crisis.”

Expanding Medicare CoverageTo ensure that more patients like Ms. Summitt have access to critical diagnostic tools, MITA supports expanded Medicare coverage of PET radiopharmaceuticals and imaging procedures, which have proven valuable in diagnosing, treating, and monitoring a multitude of diseases. In November 2012, MITA convened a PET Endpoints Workshop, bringing together industry, government, and physician representatives to discuss development of a framework for the coverage of emerging PET procedures by the Centers for Medicare & Medicaid Services (CMS) and to gain a common understanding of the clinical evidence necessary for CMS to provide coverage to beneficiaries.

Specifically, the PET Workshop focused on establishing a platform to determine how inherently the diagnoses resulting from PET images, otherwise known as PET endpoints, should be considered for coverage by CMS. Given the potential of PET to significantly improve patient outcomes, even incrementally, the consensus was that coverage from CMS is warranted and needed.

In addition to considering a PET coverage strategy that provides its beneficiaries with the earliest possible access to demonstrably valuable imaging innovations, CMS proposed to remove the national non-coverage decision for PET following the MITA PET Endpoints Workshop. If finalized, local Medicare administrative contractors may determine coverage for new oncologic PET tracers within their respective jurisdictions, which will expand cancer patients’ access to the cutting-edge tools physicians need to effectively diagnose and manage treatment of their disease.

It is clear that this is an exciting time for PET manufacturers, physicians, patients, and their families. Thanks to new PET radiopharmaceuticals and imaging procedures, diseases that once eluded the medical community, like Alzheimer’s, can now be better understood and detected earlier than ever before, which gives us great hope of eventually finding an effective treatment.

MITA will continue to fight to protect and expand patient access to these lifesaving imaging technologies. ei

Mr. Abraham ([email protected]) was director of coding and reimbursement at IBA Molecular prior to joining MITA. He served on MITA’s PET Working Group and participated in the PET Coverage Workshop and follow-up activities.

Imaging’s Role in the Future of Alzheimer’s Disease

brian Abraham, Senior policy director, MitA


Cancer is inarguably one of the most common, deadly, and costly medical conditions that we face. Annually, more than one million Americans are

diagnosed with some form of it, and malignancies claim a half million lives. National Cancer Institute statistics, however, show that the occurrence of new cases and mortality rates are declining—trends that may be evidence of important gains in prevention, early detection, and treatment.

Radiation therapy (RT) is a cornerstone of cancer therapy; 50 to 60 percent of all cancer patients receive either external beam RT (directing a therapeutic dose from an external source) or brachytherapy (delivering radiation from inside the patient’s body). These therapies cause malignant cells to either stop growing or die while minimizing exposure to surrounding healthy tissue. RT provides safe and effective treatment for an increasingly wide range of primary cancers and even for tumors that have metastasized. As a generally non-invasive therapy, it is typically performed in an outpatient setting, minimizing disruption of usual activities for more than 600,000 patients who receive treatments annually.

Researchers have developed highly targeted and customizable radiation planning and delivery tools. In three-dimensional conformal radiation therapy, for example, advanced imaging (MRI, PET) and specialized computer algorithms are used to tailor the treatment dose to the patient’s anatomy, and make real-time adjustments for even minute movement of either the patient or the tumor.

Intensity-modulated radiation therapy, image guided radiation therapy, adaptive radiation therapy, stereotactic body radiotherapy, stereotactic body radiotherapy (SBRT), and stereotactic radiosurgery (SRS) are noninvasive techniques that allow clinicians to deliver therapeutic doses more quickly and accurately than ever before. In some cases, a single treatment is all that is required. These advances translate directly into better clinical outcomes (e.g., longer disease-free survival), as well as greater safety and convenience (e.g., fewer treatment-related side effects).

Based on evidence from a large and ever-expanding body of scientific and medical literature, recommendations for radiation medicine have been incorporated into guidelines for best clinical practices as a standard of care for most types of cancer.

ExAMpLES of AppLicAtioNS In early-stage prostate cancer, radiation can enable patients to avoid surgical removal of the prostate (prostatectomy) and the

complications that may occur with invasive treatment, while providing disease-free survival. Radiation treatments are also a viable option for patients who cannot tolerate prostatectomy or who have an increased risk of the cancer spreading beyond the prostate.

The use of RT as an adjuvant therapy for women who have undergone mastectomy or lumpectomy has had a profound influence on survival, so it is not surprising that radiation medicine is a defining element of breast cancer care. Evidence supporting this therapeutic strategy is voluminous and documents survival benefits over periods as long as 15 to 20 years.

A major goal and challenge in cancer care is achieving cure while preserving vital functions. This is particularly true in head and neck cancers where the anatomy is complex. Both the cancer and therapy affect nearby structures and their functions. RT is used for early-stage and advanced disease.

Radiation treatments are used extensively in managing most malignant and many benign primary central nervous system tumors. They are often used following surgery to decrease local recurrence, delay tumor progression, and prolong survival. For example, radiation medicine is the mainstay of treatment for malignant gliomas, which account for 70 percent of malignant primary brain tumors diagnosed in the U.S. every year. SRS has a long history of being used very successfully for treating small intracranial lesions, where a single high-dose treatment is often sufficient.

Radiation therapy is also recommended for palliative care to alleviate some of the symptoms of advanced or metastatic disease, including cancer-related pain. One-quarter of patients with pain from bone metastases would typically experience complete relief within one month of receiving radiation; nearly half of all patients could expect at least 50 percent pain relief.

Treatment of liver metastases is another area where RT is showing tremendous promise. A recent multi-institution study of patients with liver metastases demonstrated that SBRT is safe and effective. In this study, SBRT achieved local control of up to 100 percent for small tumors. ei

Mr. Vastagh ([email protected]) has been on the staff of the Medical Division since 2001. During this period, he was staff manager/director for X-Ray, MII, and RT Sections, CAD Group, TRC and international committees, and CAD compensation groups.

Radiation Therapy Detects, Treats, Prevents CancerStephen vastagh, dicoM general Secretary

Photo courtesy of Elekta Inc.



In recent years, medical imaging manufacturers have introduced new products, innovations, and patient safety initiatives for a wide variety

of medical procedures, while continually improving the ability of 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 of a patient’s course of treatment.

Today, there is no doubt that medical imaging and radiation therapy (RT) are integral to medical care, and their use reduces hospital stays and helps return patients to their families, lives, and work more quickly. Yet as the technology advances, the industry has a responsibility to develop and implement the necessary safeguards to protect patients from the possibility of overexposure to radiation while still receiving quality care.

Through NEMA, MITA leads the development of standards for medical imaging and RT equipment. These standards are voluntary guidelines that establish commonly accepted methods of performance measurement, safety, design, testing, and communication for diagnostic imaging and therapy systems’ products. Clearly defined technical standards are important because they improve patient safety and create efficiencies in how care is delivered.

Once a safe and effective protocol for imaging equipment is established, it is essential that these protocols are not inadvertently changed. NEMA XR 26 Access Controls for Computer Tomography: Identification, Interlocks, and Logs, published in October 2012, provides an extra safeguard by standardizing quality assurance tools so that only an authorized operator can alter the controls of a computed tomography (CT) scanner.

The industry-wide XR 26 standard requires assigning specific permissions to selected uses beyond those needed for routine scanning, such as the authorization to alter protocols, and implementing provisions to manually lock the user interface to prevent unauthorized users from accessing system controls. The standard also contains features for use in a facility’s quality assurance program, such as recording operator and patient information, and tracking any changes made to protocols.

“As CT technology continues to become more complex, it is more important than ever that CT manufacturers put

safeguards in place to ensure that only authorized users can perform or change CT protocols,” said Marilyn Goske, MD, chair of the Alliance for Radiation Safety in Pediatric Imaging, sponsors of the Image Gently campaign. “CT manufacturers and MITA’s rapid development and implementation of these new CT Access Control Standards are signs of their strong commitment to continuously improving patient care.”

In November 2012, NEMA published the interventional x-ray standard XR-27 User QC Standard, which helps imaging facilities conduct quality testing and monitoring of x-ray equipment used for interventional procedures. Interventional radiologists use imaging to see inside a patient’s body, guiding catheters through the vascular system, skin, or other pathways to treat diseases directly at the source without invasive surgery. Quality control user interfaces provide controlled access for x-ray dose-related constancy testing, access to and export of imaging data, electronic documentation of dose-related parameters in exam protocols, and direct access to radiation dose structured reports. The addition of these new controls will improve the ability of medical physicists to assess regulatory compliance and promote patient safety.

It is important to note that these latest industry standards build on past industry-wide initiatives to develop and implement additional patient protection features for diagnostic imaging and RT equipment. This includes XR 25 Computed Tomography Dose Check, which incorporates two features—dose notifications and dose alerts—to help the operator and physician better understand dose implications of protocol choices. These features have the potential to significantly reduce exposure caused by inappropriate scan parameter settings.

Looking forward, it is essential that we continue to work closely with industry partners to ensure patients have access to the safest, most innovative technologies available. MITA looks forward to further collaboration with the members of its working groups to develop new standards that will allow for safe and effective use of the next generation of imaging technologies. ei

Mr. Abraham ([email protected]) was director of coding and reimbursement at IBA Molecular prior to joining MITA. He served on MITA’s PET Working Group and participated in the PET Coverage Workshop and follow-up activities.

Industry Reinforces Commitment to Safe and Effective Care with New Standards

brian Abraham, Senior policy director, MitA


While medical imaging includes a variety of modalities, many of the most commonly used technologies—computed tomography (CT),

x-ray, and nuclear medicine—use 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 of diseases, while using less radiation than ever before. For example, CT scans and x-ray fluoroscopy have dramatically improved the treatment of heart disease, cancer, and stroke. Additional advances in nuclear medicine have demonstrated potential to help detect and treat complicated neurological disorders such as Alzheimer’s Disease (see page 11).

To ensure the safe and appropriate use of these technologies, the medical imaging and radiation therapy industry has a long-standing commitment to effective radiation dose management through a variety of collaborative and innovative initiatives.

As a proactive step toward reducing radiation dose exposure, MITA investigates dose reduction and proposes measures to decrease radiation dose. Since then, the task force has worked diligently to establish standards to reduce radiation, and its collective efforts have resulted in low-dose standards for almost all radiation-emitting imaging equipment.

MITA is also a long-time partner with the U.S. Food and Drug Administration (FDA) on initiatives to promote the safe and effective use of medical imaging equipment for adults and children. In 2012, MITA received the FDA’s Leveraging/Collaboration Award for developing a collaborative network aimed at reducing unnecessary radiation exposure from imaging exams to pediatric patients. Today, MITA and its members remain committed to lowering pediatric radiation dose by collaborating with the FDA to establish regulations on premarket notifications for x-ray imaging devices used with children.

Gentle and WiseIn addition to ongoing collaborations with FDA, MITA has partnered with the Alliance for Radiation Safety in Pediatric Imaging and its Image Gently campaign, established in 2008 to educate medical professionals and parents about protocols that reduce imaging-related dose for children.

Making Strides in Radiation Dose Reduction

orkideh Malkoc, director of reimbursement policy, MitA



MITA also supports the Image Wisely campaign, which focuses on minimizing unnecessary radiation exposure for adults by offering information and resources to physicians, radiologists, medical physicists, and patients. Additionally, MITA members are leaders in the development of hardware and software innovations to reduce exposure and minimize medical errors.

Comprehensive training is key to ensuring any safety features are properly installed and utilized by physicians, radiation therapists, and radiation technologists. Many of the world’s leading medical imaging and radiation therapy manufacturers have developed product training programs and intensive technical tutorials to ensure that the lowest possible levels of radiation are utilized.

As an added measure to help ensure that the most cutting-edge technologies available are used safely and appropriately with each and every patient, MITA advocates for the integration of physician-developed appropriateness criteria into the physician decision-making process, as well as the mandatory accreditation of imaging facilities. Adherence to these criteria is essential so that patients receive the right scan at the right time without unnecessary exposure to radiation.

MITA and its members have a long-standing commitment to patient safety and quality care. Meaningful dose reduction is possible through the development of hardware and software innovations, protocols, regulations and standards, as well as collaborative efforts to improve education of physicians, radiologists, physicists, technologists and, importantly, patients and their families.

Thanks to the industry’s leadership, patients can receive high caliber scans with significantly lower radiation dose than before. In the year ahead, MITA members will continue to lead the development of evidence-based protocols and system innovations to reduce unnecessary exposure to radiation without compromising critical diagnostic information. ei

Ms. Malkoc ([email protected]) has an extensive background in advocacy, with a specialty in health policy. She previously served as the director of government relations for the Muscular Dystrophy Association.

Ű Privacy and Exposure Show Concern for BackscatterToward the end of last year, the Transportation Security Administration (TSA) removed many of its controversial backscatter x-ray full body scanners from major U.S. airports in favor of alternate technology equipped with privacy software.

TSA concluded that it would stop using backscatter body scanners—not over concerns raised about ionizing radiation emitted from the devices, but rather over a legal requirement that TSA upgrade all advanced imaging technology (AIT) scanners with software that does not show revealing x-rays of air travelers.

But the move does not necessarily mean TSA is done with exploring the possibility of using backscatter x-ray. The agency has commissioned a study on the safety of backscatter AIT devices and has included the technology in the mix of its next generation of AIT scanners.

In December 2012, the Department of Homeland Security (DHS) announced it contracted the National Academy of Sciences “to convene a committee to review previous studies as well as current processes used by DHS and equipment manufacturers to estimate radiation exposure resulting from backscatter x-ray AIT systems used in screening air travelers and provide a report with findings and recommendations.”

This study would examine the health concerns of 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 of the Rapiscan backscatter x-ray devices from U.S. airports are a separate issue.

Harry Massey, Industry Director | [email protected]

Photo courtesy of Philips Healthcare


Computed tomography (CT) combines multiple x-ray images taken from different angles to produce a very precise three-dimensional image of areas inside the body. Image courtesy of GE Healthcare

Medical imaging technologies have revolutionized healthcare delivery in the U.S. and around the world. Offering physicians a look into the

human body, medical imaging has become integral to disease diagnosis, treatment, and monitoring, turning countless patients into survivors. In addition to being fundamental to standards of care, imaging technologies help patients avoid or limit more invasive procedures and return to their everyday lives more quickly. Peer-reviewed research confirms that medical imaging not only improves health outcomes and saves lives, but also reduces long-term healthcare costs.

To highlight this research, MITA published a literature review in December 2012, Clinical and Economic Value of Medical Imaging1, which spotlights scientific, peer-reviewed studies that demonstrate improved patient outcomes—focused on survival and quality of life—and cost savings associated with various

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

imaging technologies. The research compendium shows that medical imaging reduces the costs of unnecessary and invasive procedures, while improving patient outcomes and quality of life through early detection and more sophisticated and diverse treatment options.

The literature review used comprehensive search methodology to critically evaluate select publications from the past five years indexed in the U.S. National Library of Medicine (MEDLINE) and from leading health policy journals. Resulting analyses indicate that diagnostic imaging is a sound economic investment and effective across many disease states. Following is just a summary of the overwhelming evidence from the review that supports this conclusion.

cANcErMedical imaging has improved diagnosis and treatment of many acute and chronic conditions. Cancer treatment has benefited significantly from advanced imaging, which gives physicians the ability to conduct minimally invasive biopsies and surgeries

Patient Well-Being Underscores Clinical and Economic Value of Medical Imaging

gail rodriguez, Executive director, MitA and orkideh Malkoc, director of reimbursement policy, MitA

http://www.medicalimaging.org/wp-content/uploads/2012/12/Clinical-and-Economic-Value-of-Imaging.pdf

http://www.medicalimaging.org/wp-content/uploads/2012/12/Clinical-and-Economic-Value-of-Imaging.pdf


SAFEgUARDINg ThE FUTURE OF MEDIcAl IMAgINgand targeted radiation therapy. Computed tomography (CT) and integrated positron emission tomography (PET)/CT have led to a 6.7 percent reduction in all cancer mortalities, including a 20 percent reduction in lung cancer alone. Results of a large randomized controlled trial estimated that low-dose spiral CT scans would lead to 130,000 additional lung cancer survivors in 2012 vs. no scans.

Breast cancer trends over the last several decades emphasize that screening made possible by imaging saves lives. For example, mammography has dramatically reduced breast cancer mortality since becoming a recommended routine health screening. Researchers at the Medical University of Vienna found magnetic resonance imaging (MRI) to be significantly more sensitive for detecting breast cancer than film mammography, with 24 out of 28 detected cases of breast cancer identified by MRI (vs. 14 by mammography).

The use of ultrasound has also been shown to be beneficial for the preoperative staging and evaluation of patients with breast cancer, yielding a cost savings of $4,682 per patient through elimination of unnecessary procedures.

cArdiovAScuLAr diSEASE, vAScuLAr diSEASE, ANd StrokEMedical imaging is transforming the area of cardiac diagnostics and therapeutics, as well as in the diagnosis and treatment of stroke. For instance, a study of 203 patients found that multi-slice CT effectively rules out or confirms coronary disease as the source of chest pain in 75 percent of patients, significantly reducing diagnostic time and costs. A British study determined that providing CT or MRI for all patients presenting with stroke-like symptoms is a cost-effective diagnostic strategy. The “scan all” approach was reported to be less expensive than even a “no scan” approach; savings resulting from shorter hospital stays more than offset the additional costs associated with delivering the scans.

Non-invasive imaging also plays an important role in the management of coronary artery disease, the leading cause of death for men and women in the U.S. Sophisticated cardiac imaging provides anatomical and physiological information, allowing physicians to accurately diagnose patients, stratify them into risk categories, and determine treatment strategies tailored to their unique needs.

orthopEdicS, oStEoporoSiS, ANd ArthritiSThe ability to more clearly visualize the structure of bones and joints has broadened the diagnostic and treatment options within orthopedic care, especially with the development of minimally invasive surgical techniques. MRI has proven a valuable tool for assessing lesions in the knee, and studies show that the technology not only accurately identifies meniscal and anterior cruciate ligament (ACL) tears, but also avoids the risks associated with arthroscopy for those patients who do not ultimately require surgical knee repairs.

Advances in diagnostic imaging have also made it possible to identify bone loss early, before an osteoporotic fracture occurs. Researchers at Procter & Gamble Pharmaceuticals estimated that bone mineral density scanning of an additional one million women in 2001, followed by appropriate osteoporosis therapy, would have averted 35,000 fractures and generated $119 million in Medicare savings by 2003.

In addition, MRI changed the clinical management in half of all patients examined with rheumatoid arthritis, with 80 percent of patients showing a subsequent improvement in symptoms, according to a study conducted at the University of Virginia.

coNcLuSioNAcross a wide spectrum of disease states, imaging technologies detect and diagnose disease at the earliest, most treatable stages and guide physicians and patients in determining the most appropriate and effective treatment plan. The research compiled in MITA’s literature review underscores the clinical and economic value of medical imaging and the many ways in which it improves health outcomes and reduces costs.

The full report is available online at www.medicalimaging.org/wp-content/uploads/2012/12/Clinical-and-Economic-Value-of-Imaging.pdf. ei

Dr. Rodriguez ([email protected]) has been involved in imaging policy since 2008 when she served as policy and membership director for the Institute for Molecular Technologies. Ms. Malkoc ([email protected]) has an extensive background in advocacy, with a specialty in health policy. She previously served as the director of government relations for the Muscular Dystrophy Association.

Prepared for the Medical Imaging & Technology Alliance, a division of the National Electrical Manufacturers Association

Clinical and Economic Value of Medical Imaging

MITA’s literature review


An International Perspective on Imaging— Globally Harmonized Framework Improves Patient Safety and Access

Zach helzer, international director, MitA

Medical imaging has changed the face of healthcare delivery in America and around the world. From detecting a disease in its early stages to

minimizing invasive procedures, imaging technologies have proven critical to the diagnosis and treatment of disease. Peer-reviewed research confirms that medical imaging saves lives, improves clinical outcomes, and lowers healthcare costs.

It’s important that medical professionals and patients around the world have access to these lifesaving technologies in order to combat disease and improve health outcomes. However, impediments to international trade continue to hinder the U.S. medical device industry’s export of advanced medical imaging and radiotherapy products, threatening the lives of millions of patients who would otherwise benefit from clinically-proven diagnostic and therapeutic devices. Internationally accepted standards and regulatory convergence where appropriate are needed to improve access to care by enabling manufacturers and regulators to use common methods for product registration and testing.

To help open the global market, the U.S. Commerce Department’s International Trade Administration started the Market Development Cooperator Program (MDCP), which provides financial and technical assistance to support well-defined business plans that increase exports and enhance U.S. competitiveness in other markets. In November 2011, MITA was awarded more than $200,000 as part of MDCP’s Global Diagnostic and Therapeutic Imaging Access Improvement Initiative to support activities to promote the export of medical imaging products, specifically to China and India.

Expanded Patient Access in China MITA has focused its MDCP efforts on working closely with decision-makers to expand patient access to lifesaving imaging technologies. MITA has made China’s medical device market, the second largest in the world, its top international priority. Working with in-country regulators to improve device safety and integrate internationally-accepted standards into their regulatory regimes, MITA’s efforts are already bearing fruit.

In September 2012, MITA organized a workshop in Beijing on international standards, during which the State Food and Drug Administration of the People’s Republic of China (SFDA) released a timeline outlining its transition to IEC 60601-1 third edition. This is the internationally accepted standard for testing the safety of electrical medical equipment. China’s transition to this standard will ensure that doctors have access to the newest, most innovative medical imaging technologies.

Furthermore, at the U.S. China Joint Commission on Commerce and Trade Pharmaceuticals and Medical Devices Subgroup meeting, which was held in coordination with the workshop, SFDA announced the down classification of x-ray products. This development lowers the risk classification to approve x-ray equipment for sale in line with international norms. This will greatly reduce the time and cost it takes x-ray equipment to reach the Chinese market. These activities are just the beginning of MITA’s efforts to enhance the international competitiveness of member companies as well as to improve the association’s visibility and stature as an industry leader outside the U.S.

Brazil Increases Demand for Quality HealthcareRecently, MITA began work in Brazil, the largest market for medical devices in Latin America. The market in Brazil is growing rapidly due in large part to its expanding private health insurance sector, which is increasing demand for quality healthcare. State-run hospitals and clinics in Brazil are also looking to upgrade outdated equipment, which is a huge export opportunity for U.S. device manufacturers.

Similar to its work in China, MITA seeks to expand access to medical imaging and radiation therapy equipment in Brazil by working to streamline government approval processes in order to reduce the time and cost it takes for products to



reach the market. To accomplish these goals, MITA plans to undertake a number of market development activities that will promote the harmonization of international standards, reduce unnecessary regulation, and expand market access to enhance the competitiveness of MITA member companies in Brazil.

DITTA Enhances Global ReachGrowth in MITA’s international portfolio is linked to ongoing efforts with the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association (DITTA). DITTA works to improve the global regulatory environment for manufacturers to ensure that they remain at the forefront of technological innovation and are successful in the global marketplace as they continue to develop products that improve quality, safety, and patient access around the globe.

DITTA is composed of eight organizations, including MITA (U.S.), COCIR (Europe), JIRA (Japan), MEDEC (Canada), THAIMED (Thailand), IMEDA (Russia), CAMDI (China), and ABIMED (Brazil). MITA’s work with DITTA enhances the global reach of US manufacturers and establishes a global industry voice that enables manufacturers to more effectively advocate for harmonized standards and improved regulation.

Under MITA’s leadership in 2012, DITTA experienced significant growth. This included its official incorporation, the addition of four new member associations, and the creation of a formal organizational structure and governance model. Over the past year, DITTA has worked to build its relationship with multinational institutions such as the World Health Organization (WHO) where DITTA is working to gain status as an officially recognized non-governmental organization. DITTA

has also made notable gains with the Asian Harmonization Working Party and International Medical Device Regulators Forum, which as a result of DITTA’s efforts now includes industry representation in its management committee meetings.

In September 2012, DITTA convened a first-of-its-kind roundtable meeting with the World Bank that included medical device industry representatives from five continents to discuss opportunities to improve World Bank procurement processes for medical technology. Under MITA’s leadership through DITTA, industry provided recommendations that would make the procurement process more effective and reliable, which were well received. The World Bank agreed that an ongoing dialogue would benefit everyone, particularly borrowers in less developed countries, ensuring that doctors and patients have the tools they need to combat disease—a common goal shared by the medical device industry and the World Bank. Both sides see the dialogue as critically linked to poverty reduction and economic growth.

MITA looks forward to its ongoing work with industry partners toward a globally harmonized regulatory framework that is smart, efficient, transparent, and more importantly, improves patient safety and access to the high quality medical technologies that MITA members manufacture. The successful development and advancement of medical imaging equipment in the global marketplace promises to save the lives of millions of patients around the world. ei

Mr. Helzer ([email protected]) earned a master’s degree in international studies with a concentration in international politics from the Josef Korbel School of International Studies at the University of Denver.



When Erika Hanson Brown finished her prescribed course of treatment for colorectal cancer, like many cancer survivors, she needed to visit a

doctor regularly for follow-up appointments.

“Medical imaging was a routine but essential part of my doctor’s visits and checking for re-growth or new tumors,” said Ms. Brown. “I was fortunate to have access to these services, but that isn’t always the case.”

In the face of impending budget cuts and policy proposals that could impact patient access to life-saving medical imaging and radiation therapy services, this concern resonates strongly for many. That’s why the Access to Medical Imaging Coalition (AMIC) and the Medical Imaging & Technology Alliance (MITA) convened more than 50 patients in Washington, D.C., for the 2012 Right Scan Right Time and COLONTOWN Advocacy Academy.

Right Scan Right Time Advocates

A cALL to ActioN“Knowing how important access to medical imaging is to my survival story, I’m concerned for the millions of patients who will require these services in the future to identify their illness and receive the best course of care,” said Ms. Brown.

Imaging has already been cut twelve times since 2006, and further proposals to reduce Medicare payments for advanced imaging and radiation therapy services or to implement burdensome prior authorization mechanisms, such as radiology benefits managers, continue to threaten patient access. In September 2012, patients flew in from across the United States to join AMIC and MITA in calling on Congress to protect Medicare reimbursement for 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 AcAdEMyIn preparation for 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. The Advocacy Academy programming included an interactive storytelling session and a patient “all-star” panel to help advocates learn how to communicate their unique stories effectively with media and congressional staffers.

“We wanted the academy to be a truly unique and engaging experience, with an emphasis on relationship building—not only among the advocates themselves, but with their legislators,” said Ms. Brown. “That’s why our curriculum focused on the power of storytelling and fostering an understanding of the complex policy issues at play.”

MITA Director of Government Relations Brian Connell talks to Right Scan Right Time patient ambassadors at the Advocacy Academy in preparation for 2012 Capitol Hill Day.

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

Medical Imaging Advocates Take to Capitol Hill

david cooling, director of State & federal government relations, MitA



Right Scan Right Time Advocates

Advocates with prior Hill experience joined seasoned government relations experts during the training sessions to provide relatable experiences to the group. One experienced Right Scan advocate, Vanessa Ghigliotty of New York, N.Y., offered this advice to the academy, “It’s important for legislators to hear directly from you, because your stories make these Hill meetings real. This is your fight!”

Throughout the day, advocates practiced sharing their stories, offering feedback and assistance to hone in on what Ms. Ghigliotty calls the “hook, line, and sinker.”

MEEtiNg with poLicyMAkErSThe following day, patient advocates headed to the Hill for a breakfast briefing with AMIC and MITA leadership prior to a full day of meetings with policymakers. During a press conference, AMIC unveiled a letter to congressional leaders signed by 22 patient groups urging against the implementation of prior authorization mechanisms and cuts to Medicare reimbursement for medical imaging and radiation therapy services.

Advocates participated in more than 80 Hill meetings with senators, representatives, and congressional staff.

During Capitol Hill Day, advocates participated in more than 80 Hill meetings with senators, representatives, and congressional staff. Patient advocates put a face to Medicare cuts by sharing

their stories to further communicate the value of preserving access to medical imaging.

Additionally, several advocates stopped by other member offices on their own with the hope of speaking with a congressmen or staff. As a result, advocates from Colorado were able to have an impromptu meeting with Representative Ed Perlmutter (D-CO).

Colorado advocates meet with Rep. Perlmutter’s staff.

coNtiNuiNg thE fight for AccESS to iMAgiNgMotivated by their time in Washington, advocates continued to use Facebook and other mechanisms to expand their conversations with fellow advocates and share updates about further contact with legislators.

“As Congress looks for solutions to reduce our national deficit, I hope they keep our stories in mind and work with patients and physicians to implement thoughtful imaging policies that promote patient access to the right scan and the right therapy at the right time,” said Ms. Brown. “Cancer patients are already in the fight of their lives. Access barriers to innovative, life-saving imaging technologies available will only make this fight harder.” ei

Prior to joining MITA, Mr. Cooling worked at Pfizer on advocacy and legislative issues. He graduated from the McDonough School of Business at Georgetown University with an MBA and an emphasis on healthcare economics and pharmaceutical medical device regulation.

All photos are by Mike Kleinfeld

Ű Advocacy All Stars “I wanted to say a HUGE, HUGE thank you … for such a wonderful experience. It’s so empowering! ... All it takes is one person who is willing to make change.”

—Angela Garrett, Missouri

“The [MITA and AMIC staff] you had in our meetings were excellent! …These folks had the data and percentages and ‘lingo’ talk needed to answer those additional questions by the aides, and we were delighted to have them there with us!”

—Joanne Hoerrner, Connecticut

“I want to thank you so much for the tremendous opportunity you provided us in attending the Right Scan Right Time events. It was so meaningful and inspirational to meet so many great individuals struggling with cancer situations, and so powerful to be able to express a voice to our Congressional members. I am re-energized and more committed than ever to making a difference.”

—Linda Woltkamp, Colorado


MEdicArE rEiMburSEMENt: The payment that physicians and hospitals receive for services rendered to patients who are covered under the Medicare program.

MuLti-SLicE ct: A medical technique of acquiring several cross-sectional images in a single rotation of the x-ray tube and detector assembly, allowing physicians to obtain high resolution and high speed at the same time.

NucLEAr MEdiciNE: A branch of medicine that involves the use of radioactive materials to help diagnose and treat a variety of diseases.

pEt/ct: A medical imaging technique that combines PET and CT, allowing images acquired from both devices to be taken sequentially and combined into a single superposed image, enabling physicians to more precisely measure tumor volumes and prepare patient treatment plans.

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

Glossary of Terms

AccESS to MEdicAL iMAgiNg coALitioN (AMic): A coalition that represents more than 100,000 physicians, medical providers, and patient organizations throughout the U.S. AMIC conducts public affairs, advocacy, and educational activities to address payment reductions and promotes the adoption of policies that focus on medical imaging quality and appropriateness.

AppropriAtENESS critEriA: Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for a specific clinical condition.

coMputEd toMogrAphy (ct): A medical imaging technique that combines multiple x-ray images taken from different angles to produce very precise three-dimensional images of areas inside the body.

coroNAry coMputEd toMogrAphy ANgiogrAM (cctA): A medical imaging technique that uses advanced CT technology along with contrast dye to obtain high-resolution, three-dimensional pictures of the heart and blood vessels.

iSchEMic hEArt diSEASE: A disease characterized by reduced blood supply of the heart muscle, usually due to coronary artery disease.

fLuorodEoxygLucoSE (18f-fdg): A radiolabelled sugar molecule used as a radiotracer with PET to characterize and localize many types of tumors.

Low-doSE SpirAL ct: An advanced imaging technology in which x-ray detectors rotate around the body to produce a three-dimensional image of internal structures.

MAgNEtic rESoNANcE iMAgiNg (Mri): A medical imaging technology that uses radio waves and a magnetic field to create detailed images of organs and tissues.

MAMMogrAphy: A breast cancer detection exam that uses x-ray technology to produce an image of inner breast tissue.

Courtesy of Siemens Healthcare

Courtesy of SonoSite



radiopharmaceuticals injected into a patient’s vein to assist in making detailed, computerized pictures of areas inside the body, providing physicians with information about how tissues and organs are functioning.

prior AuthoriZAtioN: A policy that requires providers to obtain authorization before providing imaging services.

rAdiAtioN thErApy (rt): A medical technique that delivers highly targeted radiation to cancerous cells, destroying their ability to grow and divide while leaving healthy cells intact.

rAdioLogy bENEfitS MANAgErS (rbMS): For-profit companies that evaluate physicians’ orders of imaging studies and, using proprietary systems, determine whether to approve or deny the requested service.

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

thE MEdicAL iMAgiNg & tEchNoLogy ALLiANcE (MitA): The leading organization and collective voice of medical imaging equipment, radiation therapy and radiopharmaceutical manufacturers, innovators, and product developers. MITA, a division of NEMA, represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology.

uLtrASouNd: A medical imaging technology that sends high frequency sound waves into the body and converts the returning sound echoes into images of the inside of the body.

x-rAy: The oldest and most commonly used form of medical imaging, which sends beams of ionizing radiation through the body to produce images of a person’s internal structure.

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


MITA is widely recognized as the leading organization and collective voice of medical imaging equipment, radiation therapy, and

radiopharmaceutical manufacturers, innovators, and product developers. Fittingly, MITA’s staff is well-versed in a wide variety of policy issues. But there’s much more to us than meets the eye!

Gail Rodriguez, PhD, executive director, has worked in the nuclear medicine industry for 18 years in various sales, marketing, training, and management roles. Before becoming an expert in nuclear medicine and medical imaging, Gail ranked as one of the top spellers in the United States—in 1974, she won second place in the National Spelling Bee.

While her spelling skills remain unrivaled at MITA, David Cooling, MITA’s director of state and federal policy, outpaces her in one distinct activity: running. In the midst of honing his health policy expertise in the private sector, on Capitol Hill and, ultimately, at MITA, David has managed to run six marathons.

Stephen Vastagh, general secretary and administrator for NEMA’s Digital Imaging and Communications in Medicine (DICOM) standard, has been a downhill skier his entire life. Stephen and his wife founded a Junior Ski Racing Program at a central Pennsylvania resort, which they managed for more than a decade. During this time, their daughter represented the Vastaghs’ native country, Hungary, at the Salt Lake City Winter Olympics. Stephen is still participating in amateur racing whenever his schedule permits. Meanwhile, his daughter is now nearly six months pregnant and skiing as fast as ever “until the last minute possible.”

Did you know Richard Eaton, MITA’s director of industry programs, and Brian Abraham, director of policy are seasoned travelers? While Rich enjoys steam train excursions, Brian prefers to venture offshore. Prior to joining MITA, Brian spent a few years living on the sovereign island of St. Lucia in the Caribbean.

MITA’s manager of international programs, Zach Helzer, came to MITA in 2010 after graduating with a master’s degree in international studies from the Josef Korbel School of International Studies at the University of Denver. Zach joined MITA as much for his love of international policy as he did for personal reasons. In his youth, he battled life-threatening asthma, resulting in a childhood characterized by seemingly endless hospital visits. Having been so acutely aware of the importance of medical imaging after routine chest x-rays, Zach developed a keen interest in and appreciation for medical imaging technologies and health policy, which he has honed at MITA.

The “gift of giving” prevails strongly at MITA, whose director of government relations, Brian Connell, is married to a woman from Santa Claus, Indiana. But the spirit of giving also extends to the animal kingdom—Orkideh Malkoc, MITA’s director of reimbursement policy, also volunteers at a local animal rescue.

The woman who keeps the whole show running, Pamela Larbig, MITA’s senior administrative assistant to the executive director, is the daughter of summer camp owners and spent most of her childhood summers with family, and fellow campers—some of whom became lifelong friends. ei

Getting to Know MITAMITAThey’ve got the MITA touch. From left: Stephen Vastagh, Richard Eaton, Brian Connell, Pamela Larbig, Gail Rodriguez, Brian Abraham, David Cooling, Zach Helzer, and Orkideh Malkoc


Electroindustry News

• Cooking Safety Tips for Older Adults provides safety tips on cooking safely and preventing cooking fires.

• Home Electrical Safety Tips for Older Adults helps this population identify and prevent common electrical hazards that can result in a home fire.

They are available on ESFI’s website and YouTube channel (www.youtube.com/user/esfidotorg).

ESFI provides all Home Fire Safety for Older Adults Safety Awareness Program resources at no cost. We encourage local safety educators and community leaders to use these resources to promote fire safety awareness among the older adults in their communities. Families and caregivers are also urged to help older adults review this safety information and/or perform their smoke alarm maintenance activities and home fire safety checks.

Visit www.esfi.org/educators for ESFI’s Home Fire Safety for Older Adults program resources and for more information on how you can promote fire safety awareness among older adults in your family and in your community. ei

Kate Janczyk, Director of Programs, ESFI | [email protected]

The first component of ESFI’s Home Fire Safety for Older Adults Safety Awareness Program is the comprehensive program toolkit, which encourages older adults to adopt a proactive approach to home fire safety. The toolkit includes detailed safety tip sheets that provide strategies for preventing home fires related to cooking, heating, and electrical equipment—the leading causes of home fires every year. Illustrated smoke alarms and escape planning tip sheets help older adults adequately prepare for a fire emergency. Additionally, The Home Fire Safety Checklist offers a user-friendly and convenient tool for giving homes a fire safety check-up. Lastly, the Emergency Information Sheet and Smoke Alarm Maintenance Calendar are handy and easy-to-use reference tools to help older adults keep fire safety information right at their fingertips.

To complement the toolkit, ESFI has produced a safety video series with fire safety messages developed specifically for adults over the age of 65. The video series includes three professional, 60-second public service announcements that provide critical home fire prevention tips:

• Home Heating Safety Tips for Older Adults demonstrates how to prevent home heating fires.

Ű ESFI Debuts New Fire Safety Resources for Older AdultsHome fires in the U.S. are a severe problem. According to the National Fire Protection Association, U.S. fire departments responded to an estimated average of 371,700 home structure fires per year from 2006 through 2010. They caused an average of 2,590 civilian deaths and 12,910 civilian injuries annually.

Older adults are burdened with the gravest risk, and are consistently more threatened with injury or death by fire than any other age group. In fact, adults over the age of 65 have the highest risk of death from fire, and this risk increases with age. During 2003–2007, 28 percent of people fatally injured in home fires were age 65 or older. This age group only accounted for 12 percent of the population, putting them at a risk more than twice that of the general population. For those age 75 and over, the risk is 2.8 times higher. While only 2 percent of the population was 85 or older, 6 percent of the home fire deaths were in this age group, giving these elders a risk 3.7 times greater than the general population.

Raising awareness among this vulnerable population is the key to reducing home fires and preventing deaths. With that in mind, the Electrical Safety Foundation International (ESFI) has developed a multi-faceted home fire safety awareness program that provides tools to educate older adults and their families about home hazards related to major causes of fire as well as the critical importance of smoke alarms.

These program resources were developed with funds provided by a FY 2011 Fire Prevention and Safety grant from the U.S. Department of Homeland Security’s Federal Emergency Management Agency, and are part of a comprehensive multi-generational fire safety awareness campaign that encourages family members of all ages to work together to identify and correct potential home fire hazards.

http://www.esfi.org/educators


http://www.fema.gov/fire-prevention-safety-grants

http://www.fema.gov/fire-prevention-safety-grants

http://www.fema.gov/

http://www.fema.gov/


Electroindustry News

non-profit benefactors and through federal funding opportunities.

Other significant members of SGIP include NEMA, the Edison Electric Institute, the Electric Power Research Institute, NIST, the U.S. Department of Energy’s Pacific Northwest National Laboratory, and Ministries of Energy from India and Japan.

Additional information is available on the SGIP 2.0 website (http://sgip.org) or by contacting John Caskey or Paul Molitor. ei

John Caskey, NEMA Assistant Vice President for Industry Operations;

Vice Chair of the Governing Board of Directors for SGIP 2.0; and Chair of

SGIP 2.0 Technical Committee | [email protected]

Paul Molitor, NEMA Assistant Vice President for Strategic Initiatives;

on loan as Transition Manager for SGIP 2.0 |

[email protected]

organizations in other countries to continue to share lessons learned from the U.S. Smart Grid experience1.

The leadership of SGIP 2.0 also displays a remarkable level of continuity as 20 of the 25 members of the former SGIP governing board are now on the Board of Directors for SGIP 2.0. In the past, NEMA staff and its member companies have held the director positions for Commercial and Industrial Equipment Manufacturers; Consumers—Residential, Commercial, and Industrial; Power Equipment Manufacturers; and Standards and Specification Development Organizations.

In its first quarter of operations, SGIP 2.0 signed up more than 90 members totaling almost $700,000 in revenue. Further funding is being sought from

1 “The Global Smart Grid: An Introduction to Smart Grid Interoperability Panel International Task Force,” December 2012, Vol. 17 No. 12

Ű [Re-]Introducing the Smart Grid Interoperability PanelOne of the great success stories that came out of the Energy Independence and Security Act of 2007 is the National Institute of Standards and Technology (NIST) Smart Grid Interoperability Panel (SGIP). Originally established in November 2009 to provide NIST with access to the electrical industry, SGIP has become an important force in accelerating the identification and adoption of Smart Grid standards. According to Dr. George Arnold of NIST, SGIP has become the model for the structure of public-private partnerships in the Department of Commerce and the U.S. government as a whole.

Among its successes, SGIP counts the first standard in the U.S. developed from the ground up for Smart Grid, NEMA SG-AMI 1-2009. Other contributions include adaptations to Zigbee Smart Energy 2.0 and identifying the underlying standards that form the basis for the Obama administration’s “Green Button Initiative,” a method for providing electricity consumption information to consumers.

In late 2011, NIST announced that it would no longer fund the administration of SGIP and that it would turn over the panel to industry collaborators. Seizing on this opportunity, the SGIP governing board developed a business sustainment plan and formed a non-profit corporate entity, SGIP 2.0, Inc., to carry on the work.

The form and function of SGIP 2.0 is nearly an exact mirror of its predecessor. Most importantly, the standing committees dealing with Smart Grid Architectures, Testing and Certification, Implementation and Sustainability, and Cybersecurity remain intact. So too will the Priority Action Plans, or PAPs—the working groups that create requirements and recommendations for Smart Grid standards.

Internationally, SGIP 2.0 continues to pursue Letters of Intent with peer

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Code Actions/Standardization Trends

To prevent the proliferation of conflicting standards, participants agreed to continue cooperating on promoting and enabling the harmonization and alignment of standards in this area. They also recognized that governments, including the European Commission and other inter-governmental bodies, must work toward increased harmonization of relevant laws and regulations.

During the conference, NEMA member Shantanu Kothavale (ChargePoint) and Harry Massey (NEMA industry director) reported that NEMA is addressing EVSE network interoperability, which will:

• locate available, compatible charging stations

• reserve stations

• permit use at any participating station

• ease billing/payment

• initiate EVSE directory schema standard (static and dynamic information)

• support RFID card and station identification standards

• enable standard interface for authentication/authorization, charging/fault update, and billing

It is expected that the final standard and protocols will be available for ballot in the third quarter of 2013.

Scheduled to be held in United States, an International eMobility Standards Symposium is being organized by SAE International, IEEE Standards Association, and DIN German Institute for Standardization to examine EV standards strategies and major initiatives, and determine what can be done to foster EV adoption in the global marketplace through the development and implementation of standardization. ei


communication protocols is already taking place between IEC and SAE but further work is needed. Efforts are also underway to address various interoperability issues when an EV is roaming between charging networks and to address communication of electric vehicle supply equipment (EVSE) metering data.

As Smart Grid technologies evolve, communications interoperability will require intensified collaboration among relevant actors including automakers, charging network and utility providers, and SDOs.

• Wireless charging Early cooperation among standardizers is taking place, including at the international level, which will help to avoid future compatibility issues. Safety aspects and seamless charging are challenges that standardization must address.

• Safety of EV infrastructure and batteries Much standards work has been undertaken to ensure the safety of lithium-ion batteries and EVSE. Additional investigation into safe storage, transport, and interoperability aspects of EV batteries is needed, for example to support the battery exchange infrastructure market, and extensive work is still needed on testing in line with standards.

NEEd for hArMoNiZAtioNParticipants acknowledged that a number of organizations produce globally relevant standards following open, transparent, and consensus-based processes. While one global standard is always the preferred objective, intellectual property, copyright, and commercial issues sometimes result in more than one SDO working on the same or similar issues. Regulatory/ infrastructure differences between regions can also result in variations.

Ű NEMA Joins Transatlantic Conference to Strengthen EV and EVSE StandardsCooperation on eMobility standardization was the focus of a recent transatlantic roundtable organized by the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the American National Standards Institute (ANSI). It brought together technical experts from industry, government, and other stakeholders to compare and discuss standardization priorities for electric vehicles (EVs) as outlined in the October 2011 Report of the CEN-CENELEC Focus Group on European Electro-Mobility and the April 2012 Standardization Roadmap for Electric Vehicles—Version 1.0, developed by the ANSI Electric Vehicles Standards Panel.

Efforts are already underway among organizations involved in EV standardization—International Electrotechnical Commission (IEC), International Organization for Standardization (ISO), SAE International, and Underwriters Laboratories (UL).

The discussions concentrated on:

• Coupler safety and interoperability—fast charging Many relevant international standards are already in place or in progress. Dialogue between the different standards developing organizations (SDOs) is improving, and industry is working to make ISO and IEC standards address the different charging scenarios as comprehensively as possible, for instance through incorporating the SAE J1772TM combo coupler.

• Vehicle-to-grid communications—integrating EV with infrastructure There is a need for common standards for communication between the vehicle and the grid, and to address roaming of electric vehicles and smart charging. Harmonization of the



addressing embedded meters. During a recent conference call chaired by Murray Jones (ECOtality), members addressed the substance of the NIST EVSE project, which was started at the suggestion of CPUC. NIST will define the EVSE dispensed energy Method of Sales in Handbook 130 Uniform Laws and Regulations in the Area of Legal Metrology and Engine Fuel Quality. Its basic model was the gas station pump.

Once approved by the National Conference on Weights and Measures during its annual meeting, the Method of Sales will become law when adopted by local jurisdictions.

Members also considered how the NIST project will affect the work on the NEMA submetering project. ei


Agricultural Buildings (Article 547), Electrically Driven or Controlled Irrigation Machines (Article 675), and Natural and Artificially Made Bodies of Water (Article 682). These NEC articles were all designed to protect people and property from the hazards of electricity which should be allowed to be inspected and enforced in Iowa.

The moral of this story is that when politicians begin to tinker with electrical safety, safety—especially in this case—was put out to pasture. ei

Don Iverson, NEMA Midwest Field Representative | [email protected]

• It must enable customers to split bills from a single premise meter and EVSE submeter, and allow EV service providers to separately pay the submetered portion of the bill or the entire premise bill, subject to appropriate authorization by the consumer.

• It should include reasonable consumer safeguards, including requirements for customer authorization and indemnification, and ensure that lines of communication and dispute resolution are clear and defined.

NEMA offered to provide further input on whatever standardization requirements emerge. The industry’s contribution would ensure a balanced and viable process that would achieve consumer-friendly and pro-EV growth objectives as well as an expeditious outcome.

The National Institute on Standards and Technology (NIST) is also

the proponents say the inspection requirements may have cut electrical fires in Iowa by 35 percent since the requirement was enacted into law.

Unfortunately, a district judge decided in January 2013 that the state’s electrical board over stepped its bounds by including farms in the 2009 law. The judge mentions in his decision that requiring farmers to go through red tape to secure a permit and make repairs to a building that houses animals is illogical.

The National Electrical Code® (NEC) includes several important articles that directly affect agricultural settings:

Ű NEMA Addresses the Embedded Meter

Ű Iowa Legal System Attacks Electrical Code

In response to a request from the California Public Utility Commission (CPUC), NEMA expressed its support to develop a submeter protocol that would ensure consumer choice by supporting submeters embedded in electric vehicle supply equipment (EVSE). This would provide consumers with a lower cost alternative to costly second meters for EV charging purposes.

The process should address submetering protocol as follows:

• It must include appropriate standards for submeters embedded in EVSE.

• It must include a straightforward process for EVSE submeter certification and testing that it is appropriate for the technology and purpose, and that is not unduly burdensome and expensive for EV users, EVSE manufacturers, and EV service providers.

Iowa enacted a law in 2009 that required permitting and inspections of new electrical installations in all commercial, industrial, and agricultural (farms) operations. This action upset agricultural groups like the Iowa Farm Bureau, which lobbied against the new requirements.

In June 2012, the governor’s office called for the requirements on farms to be dropped because of the economic hardship to family farm operations. Opponents contend that this will allow inspectors to focus on homes and businesses rather than on farm structures that are not, in most cases, occupied by the public. However,



has also launched a strategic initiative and formed a task force on state code adoption. Task force members meet regularly to address these issues on a state-by-state basis.

Washington and Idaho currently use the 2008 NEC. By the adoption actions they are taking, they will skip the 2011 NEC and go directly to the 2014 edition. This should enable electrical industries in these states to move forward by taking advantage of new technology provisions in such areas as electric vehicle charging equipment, solar photovoltaics, data centers, and energy management systems.

Washington and Idaho are commended for moving forward with adoption of the 2014 NEC. We hope other states and jurisdictions throughout the U.S. will do the same and help their constituencies by adopting the most current codes. ei

Mike Stone, NEMA West Coast Field Representative | [email protected]

As this article goes to press, legislation has been introduced in the state of Washington that could permanently change the code adoption cycle for all construction codes from three years to six years.

Important NEC safety provisions have also been reduced in some states, including Washington and Idaho, because of supposed excessive costs. The added costs are typically only a small fraction of one percent of the overall cost of building a house, but the added safety is significant.

To maintain the highest level of safety available, NEMA has joined a coalition with the National Fire Protection Association, the International Code Council, and other industry partners. This coalition promotes, to the maximum extent possible, the unamended adoption nationwide of NEC and all the model construction codes on a three-year cycle. NEMA

Ű Pacific Northwest Picks Up Pace of Code Adoption In the Pacific Northwest, Idaho and Washington have begun the process of adopting the 2014 edition of the National Electrical Code® (NEC), becoming among the first states in the nation to do so. If adopted as planned, the 2014 edition will be effective in these states by approximately July 2014. As always, this newest edition of the NEC contains a number of updates and new articles that reflect advancing technology and improvements in the safe use of electricity.

In recent years, some states and jurisdictions, including Idaho and Washington, have fallen behind with timely code adoptions. Some of this delay was due to the perception that new codes would somehow add unnecessary requirements and costs to construction. Developers in some states have been successful in convincing legislatures and other decision makers to delay the implementation of any new regulations that would add cost, no matter how miniscule, to building new structures.


International Roundup

The results of more than one and a half years’ of efforts are now coming to fruition and generating an exceptionally large amount of interest and attention. For example, after the Mexican government published the draft revision for a mandatory 60-day period of public comments, NEMA Mexico reported that a record number of comments had been submitted. NEMA’s Mexico staff is already fielding calls from member companies asking about specific articles in the code. ei

Gustavo Domínguez, NEMA Director for Latin America |

[email protected]

Gene Eckhart, Senior Director for International Operations |

[email protected]

Ricardo Vazquez, Mexico NEMA | [email protected]

efficiency, and sustainability goals aimed at raising the country’s international competitiveness. Increased grid reliability, reduction in energy power loss, grid integration of renewables, and customer service are also creating demand for smart grid technology deployment. Although currently at an early stage, projections place it as a burgeoning multi-billion dollar market over the next decade. Hence, technologies, systems, and pilot projects are being identified and evaluated creating opportunities for U.S. Smart Grid technology firms to enter in the upstream decision-making process. ei

Gene Eckhart, Senior Director for International Operations |

[email protected]

by NEMA member companies for the last decade will now be required. This presents enormous marketing prospects, as well as opportunities to organize workshops to instruct key stakeholders on the important changes, as well as the benefits, the new code will bring about.

NEMA Mexico staff started work on the latest revision in early 2011, noting that the process was entirely controlled by the National Consultation Committee of Electrical Installation Standardization (CCNNIE), made up exclusively of Mexican organizations—government agencies, trade associations, professional organizations, and others. NEMA’s work was therefore channeled through several of the more than 22 different entities. Of particular importance was the close work between the staff experts from the Mexico offices of NEMA and NFPA, which publishes NEC.

of U.S. companies to promote their technologies as well as hear about the latest Mexican grid modernization efforts from CFE, the Mexican Ministry of Energy, industry leaders, National Institute for Standards and Technology, Smart Grid Interoperability Panel, and other Smart Grid industry associations.

The event will consist of a full day conference covering policy, regulation, interoperability standards, cybersecurity, international collaboration, technology trends and investment, and business opportunities. U.S. panel participants will be able to showcase their Smart Grid technology solutions.

Mexico’s emerging market for Smart Grid technologies is being driven by aggressive renewable energy, energy

Ű Mexico Adopts a New Electrical Code

Ű U.S.–Mexico Smart Grid Technology & Business Conference Scheduled this Month

The government of Mexico recently published the new electrical installation code known as NOM-001-SEDE-2012. The new code will go into effect nationally in May 2013. It is a major accomplishment by NEMA Mexico staff, not only because it ensures that members’ products will continue to be named as part of the regulation, but the new version takes a major leap forward by embracing the 2011 edition of the U.S. National Electrical Code® (NEC) almost in its entirety, with some national deviations necessary to ensure compatibility with the Mexican electrical installed base.

This is the first time in history that the Mexican electrical code is based on the latest (and current) version of NEC. For example, the present and soon to be obsolete code (NOM-001-SEDE-2005) was based on the 1999 NEC. All new technology introduced

For the second time in as many years, NEMA is collaborating with the U. S. Commercial Service in Mexico to organize and conduct the second annual U.S.–Mexico Smart Grid Technology & Business Conference, March 12, 2013, in Mexico City.

The event is one of a series of activities that have been launched as part of NEMA’s ongoing North America Smart Grid program, designed to ensure that the electrical grids in Canada, Mexico, and the U.S. continue to exhibit interoperability as each is upgraded to Smart Grid capability.

This high-level business development event is designed to foster the U.S.–Mexico commercial relationship in this strategic market and enable a delegation



Economic SpotlightInternational Roundup

numbers, but positive growth is now expected to take hold in the fourth quarter of this year. Meanwhile, the growth of real consumer spending on healthcare, which had not declined in many years, slowed but still remained positive through the so-called Great Recession before gaining strength in 2011. In 2012 that spending returned to less robust growth, but as the major provisions of the ACA come online in 2014, consumer spending is likely to increase significantly.

With so many factors pushing and pulling on the diagnostic imaging industry, the only thing certain about the months ahead is continued uncertainty. ei

Steve Wilcox, Director of Market Research | [email protected]

years ahead. For example, even though the ATRA temporarily forestalled SGR-related cuts, topics such as utilization rate assumption may once again be considered fair game.

The economic environment facing the diagnostic imaging industry should be less turbulent than the political situation described above. Two drivers affecting the market for imaging equipment are now, or are expected soon to be, moving in a direction that should support industry growth. After several quarters of negative growth, real investment in hospitals/care facilities construction began the first half of 2012 by providing a flicker of hope that a reversal of that trend was at hand.

Hope for a near-term turnaround dimmed with third quarter 2012

Ű Policy Environment Leads to Continued Uncertainty in the Diagnostic Imaging MarketAlthough uncertainty is a given in business, highly regulated industries face the added ambiguities brought on by political and regulatory decisions over which they have little control. The diagnostic imaging industry has faced its share of economic and political uncertainties over the years, and the twists and turns show little evidence of subsiding any time soon.

A quick review of the last couple of decades reveals challenges such as the healthcare reform efforts of the early 1990s, the nearly annual battle to hold off the Sustainable Growth Rate (SGR) cuts to Medicare reimbursement, varying Certificate of Need requirements, Deficit Reduction Act cuts to advanced imaging reimbursements, evolving restrictions on physician self-referral, multiple procedure payment reduction, changing assumptions on equipment utilization rates, and other alterations resulting from the passage of the Affordable Care Act (ACA).

Not all the changes have affected the industry negatively, and in fact it remains to be seen if the influx of newly insured patients precipitated by ACA may ultimately increase the demand for cutting-edge diagnostic equipment. Understanding where the industry is heading is simply more difficult because of the consequences, intended or otherwise, of the flurry of policy changes it must face.

Now comes the fiscal cliff and its aftermath. The American Taxpayer Relief Act (ATRA), which was passed to avert the significant budget cuts and tax increases Congress and the Obama administration built into previous debt negotiations, leaves a great deal of budgetary dilemmas unresolved. As the federal government assumes a larger role in the healthcare sector, it becomes ever more likely to be an even greater focus of cost-cutting efforts in the months and


Economic Spotlight

MoreLearn AprilComing in

• Don’t know a CT from a PET? An x-ray from an MRI? The illustrated medical imaging primer at www.medicalimaging.org/ about-mita/medical-imaging-primer puts it all in focus.

• Want to learn the impact of medical imaging on neurodegenerative disease, traumatic brain injury, or cancer? www.medicalimaging.org/publications-and-research compiles publications and research on related to medical imaging.

• DICOM (Digital Imaging and Communications in Medicine) is the international standard for

exchanging medical images and related information. DICOM has revolutionized the practice of radiology, much as the internet has done for consumer information.

• To receive MITA’s daily media report, contact [email protected].

• ESFI’s Home Fire Safety for Older Adults Safety Awareness Program encourages older adults to adopt a proactive approach to home fire safety. The toolkit includes tips on fire safety, smoke alarms, escape planning, safety check-ups, and maintenance calendars.

High performance buildings (HPBs) create demand for energy efficiency. In April, ei looks at the market-based model for HPBs with a focus on:

• public policies

• energy savings performance contracts

• performance design

• building labeling

• products manufactured by NEMA members

• case studies

a methodology designed by the Federal Reserve Bank of Atlanta. ei

How do NEMA’s forecasters expect the economy to perform in 2013? “We see economic growth in the first half of 2013 looking much like it has over the last several years,” said Mr. Gill. “But a steadily recovering housing market and more robust consumer spending gains should contribute to a stronger economy later in the year and into 2014.”

Approximately 50 forecasters serve on the Wall Street Journal panel each year, representing academia, financial institutions, consulting firms, private businesses, and industry associations. Their contributions are evaluated using

Ű NEMA/BIS Forecasters Leavens and Gill in Top Five for Accuracy NEMA’s economic forecasters Don Leavens, vice president and chief economist, and Tim Gill, director economics, finished in fifth place for 2012 in the Wall Street Journal’s Economic Forecasting Survey. The team ranked number one in 2011. It marks a notable degree of consistency during an extended period of difficult-to-predict economic conditions.

“We’ve long held that the recovery from the Great Recession was going to be slower than in past business cycles,” said Mr. Leavens. “That view has been borne out by the data over the last couple of years.”

North American conditions continued to flash strongly positive signals in February. The complete February 2013

report can be found at www.nema.org/Feb13-EBCI.

Ű EBCI OnlineNEMA’s Electroindustry Business Confidence Index (EBCI) for current

Don Leavens (seated) and Tim Gill scored high in the Wall Street Journal’s Economic Forecasting Survey for their 2012 macroeconomic forecast. Photo by Pat Walsh

Stock Art CreditCover, 1 MonkeyBusinessImages/Shutterstock.com

2 albund/shutterstock.com2 ©iStockphoto.com/TPopova7 ©iStockphoto.com/SchulteProductions9 ©iStockphoto.com/davidf

10 ©iStockphoto.com/IngramPublishing11 ©iStockphoto.com/itsmejust13 xiver/shutterstock.com14 Andresr/shutterstock.com

18 AliEnderBirer/shutterstock.com22 ©iStockphoto.com/Raycat23 ©iStockphoto.com/beerkoff25 ©iStockphoto.com/john500

http://www.medicalimaging.org/about-mita/medical-imaging-primer/

http://www.medicalimaging.org/about-mita/medical-imaging-primer/

http://www.medicalimaging.org/publications-and-research

http://www.medicalimaging.org/publications-and-research

http://medical.nema.org/



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http://www.esfi.org/index.cfm/pid/11928

Economic Spotlight

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