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Developing Your Breast Imaging Center of Excellence“Navigating the Emerging Technology Landscape”

Technology Evaluation and Strategic Guidance

Presenter:

Brian C. Maher, MPHThe Advisory Board Company

Washington, [email protected]

August 25, 2010

Agenda for Today’s Presentation

II. Individual Imaging Modality AssessmentsII. Individual Imaging Modality Assessments

III. Devising a Strategy for Technology EvaluationIII. Devising a Strategy for Technology Evaluation

I. Overview of Diagnostic Imaging ServicesI. Overview of Diagnostic Imaging Services

Imaging Challenges Largely Consistent Around the U.S.Addressing Today’s & Tomorrow’s Concerns

Source: Advisory Board Company research.

Common Challenges with Global Implications

Timing and Selection of Appropriate Technologies for Current, Future Needs

Adapting and Preparing for Ever‐Changing Regulations

for Imaging Services

Department Workflow and Report Turn‐Around

Patient Access, Throughput, and Exam Availability

•Challenged by the rapid pace of innovation for imaging technologies

•Oftentimes clinical evidence development falls behind adoption

•The “Buy Now vs. Buy Later”increasingly more complicated by considerable fragmentation in options

• Imaging providers continually challenged by need to provide accessible and expedient imaging services to better compete

•Hospitals must carefully balance the need to maximize outpatient volume while providing inpatient, ED imaging services

•Meeting the expectations of not only patients, but also ordering physicians, ever critical to keep business

•As imaging volume increases, greater pressures placed on administrators to reduce cost and overhead in light of diminishing payment

•New healthcare payment and delivery models expected in the years ahead

•Very tangible impact of DRA and other DRA‐like statutes placing increasing pressure on appropriate utilization in different care settings

•Role of accountable care yields unclear vision

Imaging Hardware Competing for Limited Capital DollarsRebounding from the Downturn

Percentage of Hospitals Planning to Increase Capital Expenditures in FY10 Versus FY09

Source: “Continued Progress: Hospital Use of Information Technology,” AHA, 2007; “Cost Management: Trends, Outlook, and Keys to Success,” Healthcare Financial Management Association’s Healthcare Financial Pulse, February 2010; Advisory Board Company research.

n=123

Percentage of Hospitals Reporting Area as Greatest Strategic Priority

n=123

Clinical Equipment

Information Technology

Facilities

Deals Still to be Had for New Equipment Purchases?Rebounding from the Downturn

Industry Estimates Dim for CT Sales

2008-2009

Source: “Buyers Market Continues as Demand for CT Falls” Diagnosticimaging.com, May 2010; “Philips Q1 Numbers Offer Hope for Improved Imaging Marketplace”Diagnosticimaging.com, April 2010; Advisory Board Company research.

Philips 2010 First Quarter Revenue Statement

Imaging Orders

Medical Imaging, North America

Tallying the Impact of Reform and RegulationAssessing the Future Volume, Finance Levers


Evaluating Pending Market Shocks

Market Phenomenon Driving Agency TimelineFacilities Impacted

Degree of Impact

Physician Practice Information Survey‐Based RVU Adjustments

CMS (Physician Fee Schedule)

2010‐2013 (4‐year phase in)

Non‐Hospitals

Equipment Utilization Factor Increase to 75 Percent

Congress (PPACA; Physician Fee Schedule)

2011 Non‐Hospitals

Facility Accreditation Congress 2012 Non‐Hospitals

Self‐Referral Sunshine Provision Congress (PPACA) 2010 Physician Offices

Cost‐Based Patient Steerage Private Payers, RBMs Early adoption phase Hospitals

Targeted Preauthorization (e.g., cardiac imaging, emergency imaging)

Private Payers, RBMs Early adoption phaseAll; hospitals bear emergency imaging burden

Some Stability Anticipated in Future OP Imaging Volume GrowthFuture Volume Growth


Estimated Outpatient Imaging Market Growth

Millions, 2009-20141

1Includes emergency imaging volumes

Bread and Butter Imaging Dominates CapacityFuture Volume Growth


Modality Procedure/ServicePercent of Total Volume (2009)

Percent of Total Volume (2014)

Percent of Total Volume (2019)

CT

Abdominal/Pelvic CT 35.6% 36.2% 35.4%

Head/Neck/Brain CT 34.7% 32.6% 31.3%

Chest CT 19.5% 20.1% 20.3%

Total 89.8% 88.9% 87.1%

MRI

Spine MRI 35.8% 32.7% 30.3%

Bone/Joint MRI 25.5% 27.3% 28.2%

Brain MRI 15.5% 16.0% 16.2%

Total 76.8% 75.9% 74.7%

Nuclear Medicine

Cardiology Nuclear Imaging 58.6% 62.6% 64.8%

Bone Nuclear Imaging 16.6% 14.6% 13.1%

GI Nuclear Imaging 7.5% 7.8% 8.1%

Total 82.6% 85.0% 86.1%

Procedure Mix for Advanced Modalities

A Wholly Different Operating Environment to ComeToward Accountable Care


Key Challenges for Imaging Providers Under Accountable Care

Volume

• “Right scan, right patient, right time”

• Ordering physicians to increasingly look to providers for ordering decision support

• Hospitals required to monitor emergency, inpatient imaging utilization

• Regional PACS and HIEs required to limit repeat exams

Technology

• Imaging fleet requires modalities at standard of care for high‐volume chronic conditions

• Departments “reasonably distributed” to provide outpatient services at lower‐cost sites of care without overextending reach

• More difficult to justify super‐premium technologies

Professional Services

• Radiologists go beyond traditional results reporting, providing more direct input on patient management

• Radiologists required to compete on value (and price)

• Incentives of ordering physicians to limit utilization may put pressure on radiologists’ professional fees, shake up traditional contracting model

New Delivery Model Raising Questions on Technology StrategyToward Accountable Care


Three Primary Areas of Concern

Facility Models Integration Adoption Level

• How will demand destruction impact OIC1

investment?• Will OICs require a more competitive pricing structure?

• What OIC models are ideal under accountable care?

• How will accountable care change the demands on radiology IT?

• How will radiology support physician decision‐making?

• How are imaging systems coordinating with other care management players?

• What is the value of premium purchasing under accountable care?

• How are imaging departments modulating their prioritization strategy?

Accountable Care Overturning Traditional Demand DriversToward Accountable Care


Demand DriverImaging Circa 2004

Today’s Market

Accountable Care

Assessment

Demographic Trends

Aging of population will continue to drive demand with higher utilization for older patients

Physician Practice Patterns

Recent data suggests utilization growth already modulating due to preauthorization; preauthorization, cost concerns would pressure “normal” physician ordering in ACO model

Reimbursement Trends

ACO model prompts ordering physicians to weigh cost versus payment of imaging study relative to potential for bonus payout

ConsumerismOrdering physicians have less of an incentive to acquiesce to patient requests for questionably necessary imaging tests

Self‐Referral Shared savings rewards less imaging utilization

Malpractice Concerns

While physicians are incentivized to weigh ordering necessity, promise of shared savings may not erase utilization born from malpractice fears

Assessing Imaging Utilization Drivers Under Accountable Care

Regulation and Reform to Emphasize the “Need to Have”New Purchasing Imperatives


Imaging Technology Purchasing Strategy

Degree of Urgency

Market Differentiation

FutureCurrent

High ROI

Radiologist Preference

Future Preparedness

Throughput

Throughput

Ordering Physician Preference

Market Differentiation

High ROI

Future Preparedness

Drivers of Change

• Ordering appropriateness• Tighter reimbursement• Expanded coverage access• Bundled payments• Shared savings/ACOs

High

Low

High

Low

Reform Places Greater Risk in Deviating from the Standard…New Purchasing Imperatives


Categorizing the Technology “Standards”

1 Breast‐Specific Gamma Imaging2 Positron Emission Mammography

… Yet Technology Innovation Continues at an Astounding Rate

1970 2000 2003 2006 2009‐2010

1972Debut of CT Scanner

1988 to 2002 Introduction of 2‐, 4‐, 8‐slice CT

2002 Introduction of 16‐slice CT

2004 Introduction of 64‐slice CT

2005/2006 Introduction of Dual‐Source CT

2007 to Today Next‐Generation CTs Available

• 128‐Slice CT• 160‐Slice CT• 256‐Slice CT• 320‐Slice CT• Adaptive CT Imaging• HD‐CT• Second‐Generation Dual‐Source “Flash” CT

“Premium CT”

Pace of Innovation

???

Source: Technology Insights analysis.

Despite rapid increase in number of CT scanner options in recent years, it appears the introduction of novel

systems is beginning to slow – there were no new CT scanners introduced at

the 2009 RSNA from the major CT vendors; other modalities are trending

similarly

What Will be the Role of Evidence in Purchasing Decisions?Evidence Development

Which Direction Will We Head?

PET/CT CT Colonography Tomosynthesis

• Generates three‐dimensional images of the breast for detecting breast cancer

• Debate regarding incremental benefit over standard mammography

• Despite growing clinical evidence regarding utility, still awaiting FDA approval

• Utilizes MDCT2 to visualize interior and exterior of the colon

• CMS decided not to cover screening CTC due to lack of evidence supporting cost‐effectiveness for Medicare patients

• Hybrid imaging modality primarily used in oncology treatment planning

• Use of NOPR1 led to expansion of covered indications

• Required time, resources to generate sufficient levels of data

1National Oncologic PET Registry.2Multi‐Detector Computed Tomography

“Coverage Expansion” “Marching On Despite Evidence”

“Stuck in Limbo”






Evolutionary, Not Revolutionary Innovations in Imaging SystemsDrivers of Innovation

Sources: 2009 RSNA vendor interviews; Advisory Board Company research.

Key Trends in Diagnostic Imaging Technology Innovation

Breast Imaging Technology Options Continue to Increase

Productivity‐Enhancing Features Evident Across All Modalities

Cardiac CT Imaging Taking Second Place to Dose Reduction

Wide‐Bore MRI Solidifying Its Role in Today’s Market

Nuclear Imaging, X‐Ray Add Advanced Functionality

Portability Still a Driver in Ultrasound Innovation

Increasing concerns regarding the cost of healthcare driving vendors to respond by developing cost‐saving, productivity‐enhancing features across all imaging modalities.

In the wake of vast negative publicity and concern regarding CT utilization, all vendors are developing novel means to reduce radiation dose, via both new software and hardware.

Need for improved access to more accommodating, patient‐friendly MRI scanners driving demand for more options in 1.5T and 3T wide‐bore MRI configurations.

Continued need for improvements in cancer detection rates and reducing recall rates leading to the advent of new breast imaging options which are now competing for volume.

Modalities considered fundamental and relatively static in development now seeing a resurgence with added functionality to maximize utilization and improve diagnostic capabilities.

Improvements in computer micro‐processors and increased demand for point‐of‐care testing leading to a growing number of advanced portable ultrasound options.

1 2 3

4 5 6

How Far Will We Go to the Right?Technology Adoption


CTMRI

Wom

en’s

NM/PET

Single‐Slice CT

4‐Slice CT

8‐Slice CT

16‐Slice CT

64‐Slice CT

Dual‐Source CT

Premium CT

<1.5T Fixed‐Site MRI

Low‐Field Open MRI

1.5T Fixed‐Site MRI

3T Wide‐Bore MRI

High‐Field Open MRI

7T, 12T MRI

3T MRI

Full‐FieldDigital Mammography

Breast Tomosynthesis

Single‐Head Gamma Camera

Fixed PET Mobile PET/CT

Dual‐Head Gamma Camera

Fixed PET/CT 16‐Slice PET/CT

64‐Slice / HD PET/CT

SPECT/CT

Breast MRIFilm Mammo BSGI

PEMBreast Ultrasound

1.5T Wide‐Bore MRI

“Falling Behind” “Ahead of the Curve”“Meeting the Standard”

Diagnostic Imaging Technology Adoption Curve

Radiation Dose, Advanced Applications Driving CT Innovation Computed Tomography (CT)

Primary Drivers of CT Technology Innovation


1 2 3

Addressing Mounting Concerns Regarding Radiation Dose

Exploration of Advanced, Clinically Significant Applications

Enabling Greater Speed, Coverage for Patient Safety & Workflow

• Radiation dose has emerged as a top‐of‐mind concern among patients, physicians, vendors, and regulatory bodies

• Despite the debate around the validity of evidence, long‐term cancer risks are a possibility

• Sentinel cases regarding CT radiation overdoses fueling regulatory efforts for more control over radiation dose protocols

• Despite relative lack of volume, need to improve CCTA further leads to development of next‐generation CT options

• Beyond cardiac, realization that CT can dramatically change traditional care pathways leads to novel “game‐changing” applications

• Whole‐organ perfusion imaging an emerging application best suited for higher‐end systems

• Apart from radiation dose, patient safety concerns sparking interest in novel means to reduce ancillary sources of harm, such as IV contrast and sedation

• Enhanced speed and coverage enabling reduced contrast doses, obviated need for sedation

• Taken together, these protocol adjustments may enhance workflow, patient throughput

Radiation Dose Trumping Functionality with New CT Scanners

Comparative Radiation Dose for CCTA, mSv

Vendors Introducing Novel Means to Reduce Dose Across All Applications

20 mSv

16 mSv

1 to 8 mSv 7 mSv 6 mSv8 mSv 9 mSv

4 mSv 3 mSv

Invasive Angiography

64‐Slice CT

Dual‐Source CT

256‐Slice CT

320‐SliceCT

Use of ASIR (GE Healthcare) Technology for Chest CT

Overall, 28 percent dose reduction with ASIR compared to filtered‐back projection (standard)

Siemens Adaptive Dose Shield & X‐Care

•Adaptive Dose Shield blocks unnecessary pre‐ and post‐acquisition dose during CT scans•X‐CARE turns tube off to prevent dose delivery to sensitive regions

Philips iDose

•Iterative reconstruction algorithm which passes raw data through noise and anatomical models•Can result in additional 80 percent dose reduction beyond existing Philips’ dose reduction technologies

Sources: Prakash P. et al. “2009 RSNA abstract; Siemens Healthcare; Philips Healthcare.

Computed Tomography (CT)

History of CT Radiation Dose

•Seminal research studies published in 2007 and 2008 in NEJM and JAMA ascribe an incidental cancer risk to medical radiation and 64‐slice CCTA, respectively•Considerable focus on advanced cardiac imaging, despite the relative absence of procedure volume•Initial dose‐reduction strategies target coronary CT angiography by using prospective ECG‐gating, step‐and‐shoot methods•More recent reports suggest considerable variability in the use of dose reduction strategies despite their availability on most 64‐slice CT scanners

Despite Clinical Utility, Logistical Barriers Impede CCTA Growth

Challenges and Solutions of 64-Slice CT Technology in Cardiac Imaging

High Radiation Dose Limited Resolution Coverage of Entire Heart Function & Perfusion ImagingCurrent Challenges

• CCTA a dose‐heavy cardiac exam, even with modulation (>8 mSv)

• Long‐term effects remain uncertain

Potential Solutions

• Dose modulation software now emerging from all major vendors

• Hardware options to improve speed and coverage may reduce radiation

Current Challenges

• Slow temporal resolution still causing motion artifacts, despite ubiquitous use of beta blockers

• Calcium and stent artifacts common with limited spatial resolution

Potential Solutions

• Hardware improvements such as DSCT exhibiting enhanced resolution

Current Challenges

• Limited detector size necessitates multiple rotations for heart image

• Reconstruction artifacts and increased dose common with CCTA

Potential Solutions

• Wider detector arrays that capture entire heart in one rotation

• Multiple detectors also an option

Current Challenges

• CCTA clinical utility limited to anatomical imaging of coronaries

• Hemodynamically significant lesions not identified by anatomy data alone

Potential Solutions

• Fusion of PET or SPECT with CT

• Wide detector CT to concurrently capture anatomy and perfusion data

CCTA In the Evaluation of ED Chest PainTime, Cost‐Savings Realized from the CT‐STAT Trial

N = 749

Source: CT‐STAT Trial; Advisory Board Company research.


Advantages of Coronary CTA

• 64‐slice technology now considered requisite technology to perform coronary CTA – widely available

• Growing clinical utility for outpatient, emergent, and inpatient conditions

• Safe, rapid discharge of select patients presenting to the ED – decrease in resource consumption

Disadvantages of Coronary CTA

• Billing and coding requirements suggests both cardiologists and radiologists should interpret – turf wars between specialties often complicates the appropriate interpretation and billing model

• Control of referrals, patient follow‐up a challenge• Opportunity cost significant relative to other scans

Perfusion Imaging a Next Step Towards Full-Scale CT SolutionsComputed Tomography (CT)

Stroke/Neuro Imaging –Improved image clarity via advancements in spatial resolution; addition of blood perfusion information

Thoracic Imaging – Ability to better identify and distinguish pulmonary lesions and with less radiation dose

Body Perfusion – Advanced CT allowing clinicians to determine blood perfusion in kidneys and other organs

Dual Energy Imaging – Use of two x‐ray energies allows improved characterization of lesions in liver, kidneys, and other organs.

• Clinical benefits of perfusion CT including and outside of the brain remain debated among experts and in the clinical literature

• Requires premium CT for optimal images – debate regarding which system and optimal coverage area exists

• No additional reimbursement for CT perfusion at present

Technology Advantages

Technology Disadvantages

• Ability to detect tissue susceptible to decreased blood flow emanating from hemodynamically‐significant lesions

• Potential to expedite patient care by performing anatomical and functional CT in one setting, as opposed to performing additional diagnostic tests on other modalities: MRI (stroke) and nuclear imaging (cardiac)

Perfusion Imaging In Brief

Source: Siemens Medical Solutions; Toshiba Americas Medical Systems; Advisory Board Company research.

Cardiac Imaging– Ability to determine hemodynamically significant lesions via perfusion

16-Slice CT to Remain a Workhorse, Standard of Care

CT Adoption and Application Profile, 2010

Adoption Profile

Category Laggards Late Majority Early Majority Early Adopters First Movers

Typical InstitutionRural hospitals in non‐competitive

markets

Community hospitals in

average markets

Community hospitals in competitive markets

Regional tertiary care centers and

community hospitals in highly competitive

markets

Academic medical centers and hospitals with a strong research program

Slice Count 1 2‐4 8 16 32‐40 64 Premium CT

General Imaging

Trauma

3D Imaging

CT Colonography

Peripheral CTA

Coronary CTA

Perfusion Imaging

Premium CT includes:•128‐slice, 160‐slice, 256‐slice, and 320‐slice single‐source CT•Dual‐Source CT•High‐Definition CT

Sub‐standard Meets standard of care Surpasses standard of care



Toshiba Medical Philips Healthcare

GE Healthcare Siemens Medical

AquilionONE (320)Aquilion Premium (160)

Brilliance iCT (256)Brilliance iCT SP (128)

CT750 HD(High‐Definition CT)

SOMOTOM Definition AS+SOMATOM Definition Flash

Aquilion One affords 16‐cm of coverage in one gantry rotation

Early evidence indicates Aquilion One well‐suited for brain perfusion imaging, potential to reduce MRI usage

Aquilion Premium 160‐slice CT is field‐upgradeable to the 320‐slice Aquilion One

Utilizes novel gemstone detector material and Gemstone Spectral Imaging (GSI) technology to improve image resolution

Equipped with Adaptive Iterative Statistical Reconstruction (ASIR) technology to reduce radiation dose across all studies

Definition AS+ is 128‐slice single‐source CT in Siemens’ line of field‐upgradeable systems

Definition Flash dual‐source CT utilizes two 128‐slice detectors and fastest gantry speed; Flash mode can perform < 1 mSv hearts

New iterative reconstruction (IRIS) mode reduces dose

Novel AirGlide technology allows gantry to rotate at very high rate of speed and acquire cardiac images in two rotations

Equipped with iDose iterative reconstruction software to reduce dose across all studies

Brilliance iCT SP 128‐slice CT field‐upgradeable to 256‐slice iCT

Sources: Philips Healthcare; Siemens Medical; GE Healthcare; Toshiba Medical; Advisory Board Company research.

Progressive, Premium CT Models Flooding the MarketComputed Tomography (CT)

Progressive and Premium CT Scanner Options


Is the “Extra Bang” Worth the “Extra Buck”?Computed Tomography (CT)

Paying a Premium for Niche Applications

Incremental Utility

Despite premium costs, advanced CT scanners generate fewer incremental benefits over predecessor platforms

Progressive CT = 128‐Slice, 160‐Slice, Upgradeable CTsPremium CT = 256‐Slice, 320‐Slice, Flash CT, HD CT

A Wide Range of Options Now Available for MRIMagnetic Resonance Imaging (MRI)


MRI Scanner Configurations, by Magnet Strength

0.2T – 1.0T MRI“Less Costly, Limited Applications”

1.0T – 1.5T MRI“Standard of Care Workhorse”

3T MRI“Nice, Advanced Applications”

US$100K‐$600K

Designs: Open, Closed

Primary Applications: Upper and lower extremity, general abdominal imaging

Care Settings: Community hospitals, clinics, physician office

Primary Vendors: Esaote, ONI, Hitachi, MagneVu, GE, Siemens

US$750K‐$1.6M

Designs: Open, Closed

Primary Applications: Spine, breast, abdominal/pelvic, cardiac, muskuloskeletal, head/brain imaging

Care Settings: Tertiary care, community hospitals, clinics

Primary Vendors: GE, Philips, Siemens, Toshiba, Hitachi, ONI

US$2.0M‐$2.4M

Designs:Wide‐Bore, Closed

Primary Applications: Anatomical head/brain, anatomical and functional neuroimaging

Care Settings: Academic medical centers, tertiary care hospitals

Primary Vendors: Siemens, GE, Philips

Latest MRI Developments Focusing on Productivity, Workflow


Select Productivity-Enhancing Features from MRI Vendors

Magnetic Resonance Imaging (MRI)

GE Discovery Series

Docking table allows for patient preparation outside of MR suite –option of two tables can dramatically increase patient throughput

• Available with new Discovery MR450 and MR750 scanners• Transportable docking table allows for patient to be prepped in advance outside of the MRI suite; institutions looking to increase capacity, throughput can opt for two tables

• Touch‐panel easy alignment mechanism, new operator interfaces increase workflow – tout 65 percent reduction in steps required to image patient

Built‐in coil connectors, easy alignment touch panel improve workflow

Philips MultiTransmit Technology

Siemens Day Optimizing Throughput

• Utilizes patient‐adaptive radiofrequency (RF) transmission to create a homogenous field; available with new Achieva TX 3T MRI scanner

• Improves image clarity; may be up to 40 percent faster than existing technology –potential to save 10 minutes on spine studies

• DOT engine available on new Aera 1.5T and Skyra 3T MRI scanners

• Equipped with automated protocols, step‐by‐step guidance for technologists, patient‐specific customization

• Touts 30 percent productivity increase during and between MRI scans

Standard of Care Systems Available for Emerging Markets

Getting More for Your Dollar

Siemens Essenza 1.5T GE MR360 Philips Achieva 1.5T SE

• Introduced at 2007 RSNA, now with over 200 installs worldwide

• List price of under $1 million depending upon configuration

• Equipped with TIM and many of the same software features available with Siemens’ premium systems

• GE Healthcare’s first 1.5T MRI scanner with list price under $1M

• 60 cm bore diameter

• Available in multiple configurations for hospitals and imaging centers requiring versatility, capacity

• Not geared for advanced procedures

• “Cost‐conscious” version of the established Achieva 1.5T series with a list price under $1M

• Reduced operating costs through footprint design and energy output

• Capable of being upgraded to the flagship Achieva system

Sources: Siemens Medical, GE Healthcare, Philips Medical Systems.


High-Field Open MRI Target the Claustrophobic, Obese

Magnet Field Strength

1.2T 1.5T 3.0T

Verio (70 cm)Skyra (70 cm)*

Panorama Oasis

High-Field Open MRI in Brief

Open Platforms Wide Bore Platforms

Open and Wide Bore Vendor Options

Ideal for elderly, bariatric, pediatric, and claustrophobic patientsTypically require reduced sedation versus ‘closed‐bore’ modelsWide‐bore MRI provides slightly enhanced image quality over true open MRI

1.0T

Espree (70 cm)Aera (70 cm)*


Titan 1.5T (71 cm) Titan 3T (71 cm)

* Not commercially available

MR 450w (70 cm)


3T MRI Able to Serve as Workhorse Scanner

3T Moving Toward Clinical Mainstream

Assessment of MRI Magnet Strength by Anatomical Imaging Site

By Anatomic Site, Application

Complex 3T Protocols Becoming Automated Emergence of Breast and Cardiac MRI at 3T Non‐Contrast 3T Applications Available

• Upgrade from 1.5T to 3T not an easy transition, typically, as protocols are often unique to 3T platform

• Philips automating 3T protocols with SmartExam software program; available on 1.5T systesm as well

• Dedicated coils for breast and cardiac MRI in development for 3T

• While 1.5T remains more dynamic across all applications, 3T may offer enhanced resolution for more accurate diagnosis in advanced exams

• Fears revolving around gadolinium safety have prompted development of non‐contrast MRI applications on 3T

• MR angiography and some neuro exams now being proven feasible without risk of gadolinium contrast



Magnet Strength

Extremity BreastAbdominal &

PelvicChest/ Cardiac

SpineAnatomic Head/Brain

Advanced Neuro‐Imaging

< 1.0T

1.0T‐1.5T

3.0T

Sub‐Standard Meets Standard of Care Gold Standard

Latest Entrants/Additions to the Digital Mammography Market

Mammography System Accreditation, July 2010

FFDM Firmly Entrenched as Primary Imaging ModalityBreast Imaging

Sources: MQSA Facility Scorecard, U.S. FDA; Advisory Board Company research.

GE Senographe Essential e

FujiFilm AspireHD

Hologic Selenia Dimensions 2D System

Philips MammoDiagnost DR

• FFDM platform that is for screening only

• Built on Senographe Essential D technology

• Upgradeable to include diagnostic, interventional and tomosynthesis capabilities

• US debut of FFDM system, AMULET

• First system to use two layers of a‐Se to lower noise, improve spatial resolution

• 3D Stereo Mammography‐capable with new viewing platform

• Image acquisition and simultaneous display of priors

• Selenium direct capture detector

• Upgradeable to include tomosynthesis capabilities “if and when” it becomes available

• Automatic Exposure Control and customizable user interface

• Currently only available outside of the U.S.

• Anticipated U.S. introduction not for at least one year

Annual Revenue, Screening Mammography

Aurora Dedicated 1.5T Breast MRI

Unique table design enhances patient comfortUnique table design enhances patient comfort

Aurora coil and software boast ability to effectively suppress fat and ducal tissue, reducing artifacts

Aurora coil and software boast ability to effectively suppress fat and ducal tissue, reducing artifacts

1.5 T magnet on par with standard of care MRI modalities

1.5 T magnet on par with standard of care MRI modalities

Feet‐first gantry entry reduces patient discomfort and claustrophobia

Feet‐first gantry entry reduces patient discomfort and claustrophobia

Breast MRI Options

Dedicated Breast MRI Goes Mobile

Dedicated Coil Dedicated Table Dedicated ScannerGE, Siemens, Philips,

ToshibaSentinelle Medical,

PhilipsAurora Imaging

Technology, GE, Siemens

Breast MRI Moving Towards “Must Have” Technology


Breast Imaging

Truly integrated breast MRI system capable of reducing scan time to less than 20 minutes (without biopsy)

Equipped with identical 1.5T dedicated breast system with standard features –AuroraEDGE, AuroraCAD, RODEO, etc.

Relative Costs of Breast MRI

Breast MRI Shortcomings Lead to Emergence of PEM, BSGIBSGI In Brief


• Functional breast‐specific gamma imaging (BSGI) capable of detecting early stage tumors

• Offers differentiation of tumors

• Dilon Technologies the only BSGI vendor

• At RSNA 2009 displayed system improvements focused in image resolution, addition of new detector for non‐breast imaging applications

• New mobile version available; GammaLoc needle guidance system received FDA clearance in January 2010.

Advantages, Disadvantages of Emerging Breast Imaging Technologies

Breast Imaging

PEM In Brief

• Contrast‐enhancement with radioactive FDG assists detection of lesions less than 1 cm in diameter

• Especially effective in detection of ductal carcinoma in situ (DCIS); also effective in atypical ductal hyperplasia

• Naviscan Inc. the only PEM vendor

• New stereo‐guided biopsy accessory now available with the PEM system; future improvements to come in improving image resolution and reporting capabilities

Tomosynthesis In BriefTomosynthesis In Brief• Tomosynthesis is a digital breast imaging technology that uses x‐ray to provide 3‐D reconstruction of the breast

• A rotating x‐ray tube travels +/‐ 15‐21 degrees around stationary breast, emitting low dose exposures during a short (roughly 10 second) scan

• Images are reconstructed as a cine loop or a series of thin, high resolution slices

• Benefits include less tissue overlap and structural noise, decreased breast compression, and potentially lower radiation dose

• Vendors: Hologic, Siemens, and GE all displaying tomosynthesis‐upgradeable FFDM units at 2009 RSNA

Digital Mammography versus Breast Tomosynthesis in the Screening SettingDigital Mammography versus Breast Tomosynthesis in the Screening Setting

Source: Kopans et al. “Digital Breast Tomosynthesis: NCI‐3000 Women Trial,” 2009 RSNA Abstract; Advisory Board Company research.

Waiting Game for Tomosynthesis to Continue, But for How Long?

Study in BriefStudy in Brief• Randomized study involving 2,764 women undergoing screening mammography and digital breast tomosynthesis

• Reasons for callback rate (asymmetry, calcification, mass, or other) largely similar between conventional mammography and tomosynthesis

• Mean reading time for radiologists was 35 seconds for tomosynthesis (range 7 to 122 seconds)

Impact of Tomosynthesis on Callback Rate

N = 2,76441 percent reduction in

callback rate with tomosynthesis

Breast Imaging

Will DBT Be Worth It (When Available)?Will DBT Be Worth It (When Available)?

• Multiple options expected to become available for DBT adoption (Hologic, GE Healthcare, Siemens)

• Most likely to require software upgrade to tomosynthesis‐capable systems

• Clinical results very promising suggesting lower recall rates

• For providers seeking DBT capability, will require significant price premium on equipped systems

• Complicated FDA approval process may hamper new features, options in future

• If no incremental payment, adoption prospects lower

Opportunities Challenges

Source: Siemens Healthcare; U‐Systems; Imaging Diagnostic Systems, Inc; Advisory Board Company research.

Many New, Functionally-Different Modalities on the HorizonBreast Imaging

Adoption Likelihood“Nearing Mainstream” “Confined to R&D”

Emerging Breast Imaging ModalitiesEmerging Breast Imaging Modalities

CT Laser Mammography

Automated Whole Breast Ultrasound

Breast Elastography

Molecular Breast Imaging

• Laser scan of breast to indicate areas of angiogenesis

• Adjunct to mammography

• Requires operator expertise and pending U.S. FDA approval

• May increase early detection of cancer and detect additional lesions

• Automation lowers operator variability

• Siemens introduced ABUS as part of premium ultrasound, ACUSON 2000

• Measures a lesion’s response to compressions

• Ability to distinguish between stiffer cancerous cells and surrounding tissue

• Technology added to ultrasound and MRI

• Uses technetium Tc‐99m scintimammography to detect small tumors

• Differentiates between tumors and dense breast tissue

• Functionally similar but separate technology than BSGI – uses CZT detector

Oncology Continues to Dominate Total Volume2009

NOPR, Australian Registry Confirm PET Benefits PET/CT Finds Lesions Missed by Thoracic CT

Tumor Imaging, 93%

Myocardial Imaging 5%

Brain Imaging, 2%

38%34%

NOPR APDCP

Patients with Change in Clinical Management after PET Imaging

• Results of the National Oncology PET Registry (NOPR) and Australian PET Data Collection Project (APDCP)

• 447 patients with both oncology PET/CT and thoracic CT• PET/CT detected 131 lesions missed by thoracic CT in 104 (23%) of the 447 patients who had both a PET/CT and thoracic CT

Lesions Missed by Thoracic CT and Detected with PET/CT

10%6%18%

66%

Lymph Nodes Bones Adrenals Other

N = 131

Source: Vinet J, et al. “Incidence and Characterization of 18‐FDG PET/CT Active Lesions Not Reported on Contemporary Thoracic CT”, 2008 RSNA abstract; Advisory Board Company research.

Hybrid PET/CT Now Standard of Care for Tumor ImagingMolecular & Nuclear Imaging

U.S. Coverage Policy History for FDG-PET

New CMS Coverage Framework for FDG-PET for Solid Tumor Imaging

CED Policy Leads to PET Coverage ExpansionMolecular & Nuclear Imaging

Tumor Site Initial Treatment (Formerly Diagnosis and Staging) Subsequent Treatment (Formerly Restaging and Monitoring)

Brain Covered NOPR participation required

Breast Excluding diagnosis of axillary lymph nodes, Covered

Cervix * NOPR participation required Covered

Colorectal Covered Covered

Lymphoma Covered Covered

Melanoma Not covered for initial staging of regional lymph nodes Covered

Non‐small cell lung Covered Covered

Pancreas Covered NOPR participation required

Prostate Not Covered NOPR participation required

Bone/cartilage Covered NOPR participation required

Uterus Covered NOPR participation required

Soft Tissue Sarcoma Covered NOPR participation required

All other solid tumors Covered NOPR participation required

Sources: CMS 2009‐2010 OPPS; CMS Decision Memo 04/07/2009; Advisory Board Company research.

• U.S. Centers for Medicare and Medicaid Services is the federal administrative department for determining coverage for procedures for Medicare beneficiaries

• Previous coverage policy limits number of cancers and indications

• Increased need for evidence to derive coverage policies leads to creation of National Oncologic PET Registry

• Favorable results from NOPR, other international data registrieslead to expanded coverage for FDG‐PET for solid tumor imaging

SPECT/CT Receiving Greater Interest in U.S. Markets

SPECT/CT Demonstrating Incremental Clinical Benefits Across Myriad Applications

Sources: Keidar, Z. et al. 2007 RSNA Abstract. “Hybrid Cardiac SPECT/64‐Slice CT Assessment of the Relationship between Clinically Significant Coronary Lesions/Stenoses and the Presence and Degree of Arterial Calcifications”; Advisory Board Company research.

Common SPECT/CT Applications 64‐Slice SPECT/CT In‐Practice

• 50 patients with confirmed or suspected ischemic heart disease underwent 64‐slice SPECT/coronary CTA to evaluate perfusion, presence of arterial stenoses, and coronary calcium scoring

• 26 patients had coronary calcium score of less than 100 with no significant coronary stenoses

• 12 patients had a coronary calcium score between 100 and 400, 7 of whom did not have coronary stenoses and 2 of whom had normal perfusion

• 12 patients with coronary calcium scores of greater than 400, 11 of whom had coronary lesions, normal myocardial perfusion in 6 patients; 7 of 12 patients did not have clinically significant coronary lesions

Anatomical cardiac imaging with perfusion information demonstrates clinically significant coronary lesions

Clinical Applications Summary of Clinical Utility

General SPECT ImagingGeneral Diagnostic SPECT: SPECT/CT uncovers diagnostically relevant information overlooked by SPECT alone in majority of patients often leading to a change in diagnosis and patient management.

Endocrine DiseaseThyroid Imaging: SPECT/CT impacted diagnosis in majority of patients, allowing better differentiation of metastasis and involved lymph nodes from residual thyroid tissue.

Skeletal Imaging

Spine Imaging: SPECT/CT more precisely localizes trace abnormalities in the vertebrae compared to traditional SPECT imaging, changing the diagnostic interpretation of the original exam.

General Bone Scintigraphy: SPECT/CT improves accuracy of bone scintigraphy, with better localization and classification of equivocal lesions. Specificity improved to 81% compared to 19% for SPECT alone.

Cardiac Imaging

Perfusion Imaging: CT corrects attenuation artifacts caused by surrounding fatty tissues in the chest during SPECT stress perfusion studies.

Comprehensive Cardiac Exam:With future evolution of 64‐slice SPECT/CT, marriage of CCTA and perfusion imaging soon to be a reality.

Neurological Disease

Differentiating Dementias: SPECT/CT provides important cerebral perfusion information to clinicians attempting to make a distinguishing diagnosis among dementia‐related diseases in patients with mild cognitive impairment.

Molecular & Nuclear Imaging

PET/MR a Niche Technology for Research-Driven ProgramsMolecular & Nuclear Imaging

Hybrid MR/PET Remains a Work-in-Progress for Select Vendors

Marrying Two SystemsAdvanced Neuroimaging to Benefit

• 10 patients evaluated with co‐registered PET and whole‐body MRI in the detection and classification of peripheral nerve sheath tumors

• 9 patients biopsied to determine presence of malignancy• Of the biopsied lesions, all 3 malignancies were correctly classified as malignant, and 5 of 6 benign lesions were correctly classified as benign

Diagnostic Effectiveness of Co‐Registered PET‐MRI

100%75%

88%83%100%

Sensitivity Specificity Accuracy PPV NPV

Source: Urban T, et al. “Utility of [PET‐MRI] in the Evaluation of Patients with Neurofibromatosis Type‐1 (NF1)”. 2008 RSNA abstract.

• Prototype systems available with Philips and Siemens, working in international collaboration with hospitals

• Development historically confounded by architectural issues associated with incorporating a PET ring into the MRI magnet

• Proposed Philips system utilizes a 3.0T MRI scanner, a separate PET ring, and a rotatable table between systems – maintains patient positioning with 180‐degree turn

• Availability of first clinical hybrid PET‐MRI scanner remains at least 1‐2 years away

Source: Siemens Medical; Philips Medical vendor interviews; Urban T, et al. “Utility of [PET‐MRI] in the Evaluation of Patients with Neurofibromatosis Type‐1 (NF1)”. 2008 RSNA abstract; Advisory Board Company research.

MRI PET PET‐MRI

Fused PET‐MRI yield promise for diagnosis and longitudinal evaluation of neurodegenerative diseases

Factors Driving Continued Focus on Ultrasound Innovation

Applicability of Ultrasound Expanding as a Highly Versatile Modality


Elastography, Fusion Imaging Leading Expanded Application Set

Miniaturization Affords Point‐of‐Care Diagnostic Testing

• Elastography utilizes strain imaging to determine tissue stiffness, indicative of damaged or disease tissue

• Key applications for elastography reside in breast imaging, though other anatomical sites likely to benefit as well

• Fusion imaging incorporates images acquired via CT or MRI to be displayed simultaneously with real‐time ultrasound

• Reported benefits include time, cost‐savings for interventional procedures

• All vendors pursuing elastography modes

• Traditional cart‐based models very cumbersome to move between care settings and at the patient bedside

• Improvements in microprocessors led to miniaturization of system components

• Available in laptop‐based configuration or handheld model – system design often indicative of how device will be utilized

• Siemens P10, GE Venue 40, Toshiba Viamo all new portable ultrasound systems on display at 2009 RSNA

Ultrasound





Formulating a Preparedness Assessment for Premium TechnologyDeveloping a Plan

Question Yes No Unsure

Is the organization planning to invest in a new CT scanner in the next 2 to 3 years? X

Is the organization currently willing to accept some degree of risk in pursuing premium CT technology, in that the clinical benefits of these systems have yet to be fully validated in the clinical literature?

X

Does the organization have the support from key stakeholders in radiology, both clinical and administrative, that a premium CT scanner would benefit the organization? X

Does the organization have the support from key stakeholders from other service lines that a premium CT scanner would support their growth strategies? X

If applicable, has market competition historically impacted technology decisions? X

Does the organization have a catchment population and/or physician base that is highly‐attuned to advancements in clinical technologies? X

For the next five years, does the organization anticipate seeing positive growth for imaging services, specifically outpatient CT? X

Will a premium CT scanner generate new procedures and services for the organization? If yes, provide explanation and projected procedure volume. X

Is the organization seeking to provide and take advantage of the latest innovations in radiation dose reduction, both software and hardware? X

Does the organization seek to support research endeavors in assessing the impact of premium CT technology for novel applications? X

Hypothetical List of Questions to Address When Evaluating Premium CT


Defining Your Own Standards for Technology AdoptionDeveloping a Plan


“CT Appropriateness Grid”

Case in Brief: Ridge Health System1

• Multi‐hospital, multi‐state health system

• Identified need to address technologies within a clinical and local service area framework• Goal to develop sound business case rationale for capital requests• Created “fact‐based,” objective assessment to educate local and system leadership

• Cross functional team approach included Strategy, Supply Chain, and Imaging Executives

1Pseudonym institution

Setting Hard Limits on Level of Technology by SiteDeveloping a Plan


Mandating Appropriate Levels of Technology

1Pseudonym institution

Technology Replacement CommitteeCase in Brief: Juniper Lake Hospital1

• 600‐bed hospital in Mid‐Atlantic with 10 outpatient imaging sites

• Technology Replacement Committee involved in all high‐end purchasing decisions (over $200,000)

• Attempts to purchase many new units at once and deploy at the same time

• Use standard equipment in outpatient sites; places caps on the level of technology for each site

• Technology Replacement Committee made up of varied individuals: VPs, CMO, physicians

• Discusses upcoming purchases and sets standards

• Recommendations made to SVP team and purchasing initiated

Critical Decision Points in Evaluating New Imaging TechnologiesDeveloping a Plan


Key Elements of an Effective Imaging Technology Evaluation Process

Equipment Inventory Management

• Necessary to understand the current and expected level of functionality of existing equipment

• Key metrics include vendor, model, year of installation, purchased as refurbished vs. new, remaining life, service agreement terms, modality‐specific level of functionality, and others

1 2 3 4

Utilization Analysis & Procedure Tracking

Clinical Service Impact Analysis

Technology Horizon Scanning

• Extent of maximum level of utilization a key indicator of need to add incremental units

• May reveal inefficiencies in exam process, resulting in process improvements that can improve utilization

• Necessary to track specific procedure data to ensure modality appropriateness

• Matching the modality, level of functionality to the broader health care organization’s strategic priorities can ensure appropriate use

• Aligns near‐, long‐term goals of the organization

• Ensures buy‐in from all key stakeholders involved in the decision‐making process

• Maintain knowledge of the future developments in imaging technologies and drivers of innovation

• Can influence the vendor selection process

• Failure to not consider long‐term technology implications can lead to misguided acquisitions and shorter replacement cycles

Finding the ROI In Data Analytics, PrioritizationDeveloping a Plan


Matching New Imperatives and ROI

Knowledge of diagnostic imaging landscape

Creating your own standard of care

Tracking detailed inventory information

Assessing utilization and capacity

Monitoring service costs, historic pricing

Avoidance of shortsighted purchasing decisions

Elimination of inappropriate purchases, technology overkill

Balance of needs over time to avoid spikes in capital budgets

Assurance of even wear and timing of incremental purchasing needs

Utilization of historical data to drive vendor negotiations

“navigating the emerging technology landscape” developing ... · ct 4 ‐slice8 16 64 dual...

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