Economics in Medical Imaging: Implications For Research and Development and Clinical Practice James H Thrall, MD Chairman, Department of Radiology Massachusetts General Hospital Professor of Radiology Harvard Medical School Utilization New transformative technologies are driving increased utilization of services and costs in diagnostic radiology ACRIN DMIST trial establishes value of digital mammography Picard study and ACRIN trial confirm efficacy of CT colonography—AGA, ACR and ACS endorse its use for screening CT colonography gets started with spiral CT Breast MRI starts to become important 1998 2000 2002 2004 Reimbursement for PET from CMS Multi-detector CTNew era of CTA and CT Colonography Reimbursement begins for limited applications of coronary CTA 2006 2008 Positive results from NLCST 2010 Reimbursement for CT colonography and lung cancer screening ? PET/CT Diverticulitis CCTA 3D Endo-luminal view Polyp CTC CTA for Pulmonary emboli False aneurysm MD/CT Acute MI Total Medicare Imaging Costs are Rising: GAO Report 2008 Compound annual growth (CAGR) rate of > 14% ~14% Of Part B Spending In 2006 Economics Of Medical Imaging Effects of legislative initiatives and the recession Direct effects Legislative assault on imaging reimbursement •DRA 2005– CT, MRI, PET reduced to HOPPS rate •PPACA– Utilization rate increased to 75% from 50% •Contiguous body part reduction increased to 50% Regulatory assault on imaging reimbursement •CMS—2010 MPFS Final Rule •Bundling of CT codes •Expansion of MPPR •Decrease in practice expense reimbursement CMS rejection of CTC and most CCTA for reimbursement Aggregate impact is several billion dollars per year Indirect effects Recession linked decrease in capital spending by hospitals and imaging centers Attack on screening mammography by USPSTF Public and professional concerns about radiation exposure and risk Increase in co-pays and deductibles by insurance companies Economic uncertainties related to health reform Impossible to directly monetize these issues but clearly impactful Legislative and Regulatory Cuts to Imaging Reimbursement • Deficit Reduction Act of 2005 – Capped the Technical Component (TC) at the lesser of the Medicare Physician Fee Schedule (MPFS) rate or Hospital Outpatient Prospective Payment Schedule (HOPPS) rate – Congressional Budget Office (CBO) projected a decrease of $1.3B in Medicare Technical (TC) payments for 2008 – $1.23 Billion from DRA in first year = 3X projected cuts of $2.8 Billion over 5 years • Additional losses as private payers adopt CMS policies and DRA cuts • Especially heavy blow to outpatient centers, the fastest growing part of imaging Health Reform Legislation 2010 • Patient Protection and Affordable Care Act of 2010 (PPACA) • $940 Billion over 10 years • 32 million more covered– 95% of legal US residents • Individual mandate– up to $695 penalty • Employer mandate– up to $2000 per employee penalty • Medicaid expansion– up to 133% of Federal Poverty Level • Private insurance reforms PPACA Imaging Provisions: Contiguous Body Part Reduction and Change in Utilization Assumption • TC contiguous body part reduction increased to 50% from 25% • Utilization: – Obama Administration legislative proposal– 95% – CMS 2010 MPFS Final Rule– 4 year phase in to 90% – Initial reconciliation proposal– 90% • Final legislative provision– 75%-- effective in 2011 for higher cost imaging devices—CT&MRI 2010 MPFS Final Rule • Utilization assumption of 90% for higher cost Diagnostic Imaging-- now moot through PPACA • Medicare Final Rule for 2010 – Practice expense cuts—phased in over 4 years 20102013 • 18% for dx • 4% for RO • ACR assessment is that practice expense data used are statistically invalid. New Mischief From CMS • CMS is proposing to extend the contiguous body part concept • Officially called the “Multiple Procedure Reduction Rule” (MPRR) • Applies to CT, MRI and Ultrasound • CMS is proposing to apply the rule whenever more than one test is done in a day • MPRR would then apply across modalities and for non contiguous body parts • CMS has just (1/1/2011) bundled CT abdomen and CT pelvis with drastic cuts in reimbursement • CMS believes this action is in the “spirit” of Congressional intent to decrease reimbursement for “over valued” services CMS Timeline FINANCE DRA ?? Health reform and CMS policy changes RADIOLOGY ASSOCIATES 2010 Note: Source: ACR Data – P. Kassing Payment Policies 2011 presentation Allowed Charges for Medicare Physician and Supplier Services, by Physician Specialty (Percentage of Medicare Part B FFS total only) 7.40% 7.20% 7.00% DRA—(Took effect 1/1/2007) Decrease> $1.0B 6.80% Dx Rad 6.60% 6.40% 20 08 20 06 20 04 20 02 20 00 6.20% 6.00% 5.80% Assembled from CMS sources by ACR staff Medicare Professional Fee Schedule --2009 • Number of advanced imaging exams (CT, PET, MRI, NM) declined by 0.1% – MRI 1.2% – CT 1.6% • Spending for advanced imaging increased by 1.2% versus 2.6% for all physician services • Overall imaging services declined 7.1% – Mammography 0.3% Impact of DRA and CMS Policy Cuts on Industry and Radiology Practice • ACR member survey—600 respondents – 41% laid of staff or altered hiring plans – 49% cancelled or postponed equipment acquisitions • DI Magazine reported: – Many imaging centers closed and valuations plummeted – “The medical device industry saw sales of CT, MR and PET fall $125M” Impact on Industrial Revenue: GE Quarterly Revenue GE Health Care 5,000 4,500 4,000 Revenue in Billions 3,500 3,000 Q4 2007 Q3 Q3 Q3 2008 2009 2010 Market for CT Scanners • US market – 2007= $2.1 Billion – 2010= $585 Million • Number of devices 2010 – US~ 700 – Europe~ 1200 Personal communication from major vendors Future Directions For Imaging– Clinical Practice And Technology Development Will Medical Imaging Survive and Flourish? Factors That Will Continue To Propel Imaging Forward • Economic recovery • Emerging markets • Consumer demands for better, safer, more effective technology– baby boom generation – All dependent on new technology • Example: Lower radiation exposure • Competition– – Inexorable advance of technology per se – Change in the business model– market share to market space • Regulation– requirements for more data and clinical trials prior to FDA approval GE Health Care Quarterly Revenue Versus S&P 500 5,500 1900 S&P 500 1700 5,000 GE Revenue 1500 4,500 1300 S&P 500 Revenue in Billions 1100 4,000 900 3,500 700 500 3,000 Q4 2007 Q3 2008 Q3 2009 Q3 2010 Economic recovery is a tide that will lift industry’s boats Potential Impact of Emerging Markets • BRIC countries’ populations – China 1,342M – India 1,192M – Brazil 191M – Russia 142M 42% of the worlds population and < 20% of medical products consumption • United States, Europe and Japan – 800M 12% of worlds population and 2/3rds of medical products consumption Quarterly Reveue GE Health Care 5,000 Supported By Emerging Markets, General 4,500 Electric Healthcare Raises Growth Projection To 10% Per Year 4,000 Kaiser Health News 11/10.10 Revenue in Billions 3,500 3,000 Q4 2007 Q3 Q3 Q3 2008 2009 2010 •China +19% •Orders -9% •Equip +8% •India +8% •Profit -20% •Profit +14% Future Growth Of Clinical Medical Imaging In The United States Reimbursement for CCTA CTC and Lung Cancer Screening etc DRA, P-4-P, RBMs, NSF, radiation scare, recession Organic growth with aging population Growth “Golden age” of imaging growth with MDCT, CTA, MRA, 3D, PET/CT, digital mammo etc 2000 MIPPA and PPACA 2007 2010 Time DRA 2, new 3rd party initiatives and Medicare cuts 2015 Single organ devices Hybrid imaging systems Massive computing Simplified devices Technology development Increased cost Decreased cost Competition Increased regulations Development of New Technology Information Technology •PET/CT •PET/MRI •US/Angio Single organ devices Hybrid imaging systems Iterative reconstruction •Data mining •CPOE Massive •CAD computing •Extremity CT •Head CT •Extremity MRI •Breast PET •Handheld US •CT •MRI “Defeatured” devices Simplified devices Lower doses Radiation concerns = number one non financial risk to radiology Emerging markets Technology development Decreased cost Increased cost FDA under the gun •BRIC countries •SE Asia •Africa Market share Competition Increased regulations Clinical trials moved offshore Increasingly difficult to initiate trials in US versus evidence based medicine R&D moved offshore All major companies Market space Number of products “footprint” in the market Percentage share for a product or service Extended product offerings Radiation Exposure • Concerns about high radiation exposure represent the number one non financial risk to radiology • New technology can reduce exposures by 90% • Should be among the highest priorities of all people associated with medical imaging Why Now? • BEIR VII (Biological Effects of Ionizing Radiation) endorsed the linear no-threshold model for extrapolating cancer induction • NCRP (National Committee on Radiation Protection) – Medical exposures have increased by 7 fold over last 25 years • Multiple journal articles and editorials – Cancer risks– 29,000 CT related cancers per year – Increasing population exposure over time • Highly publicized cases of errors resulting in over exposures of patients in both diagnostic and therapeutic radiology practices Beir VII: Health Risks from Exposure to Low Levels of Ionizing Radiation Figure 2. In a lifetime, approximately 42 (solid circles) of 100 people will be diagnosed with cancer from causes unrelated to radiation. The calculations in this report suggest approximately one cancer (star) in 100 people could result from a single exposure 100 mSv of lowLET radiation. Sponsored by the US National Academies of Science Medical radiation exposure found equal to non medical sources— ubiquitous background, consumer, occupational Radiation overexposures have undermined the public’s trust in radiology Mandatory accreditation—MIPPA 2008 Use of appropriateness criteria—PACA 2010 More requirements for clinical trials data (FDA) Gating and motion correction Regulation/ National Standards Technology development Sub mSv Goal Image post processing Iterative reconstruction Clinical practice Radiation biology– effects of ionizing radiation Education Department governance Quality assurance programs– surveillance and audit Dual source devices Better filters and multi-spectral imaging Standard reference doses, registries, patient dose tracking Optimization of CT protocols More efficient detectors Adoption of appropriateness criteria Inclusion of all stakeholders Physics of CT— what makes an acceptable scan? How to interpret relatively noisy images Technology for Sub mSv CT • • • • • • • More efficient detectors—garnet based Dual tube– high pitch fast scanning CCTA Post processing– noise reduction Better filters—reduce low energy photons Better tubes Multispectral imaging Iterative reconstruction – Partial– 30% dose reduction – Full– 70-90% dose reduction Low-dose H&N CT Dx: Bilateral Peritonsillar Abscesses CTDIvol = 2.75mGy, DLP = 51mGy.cm Estimated Dose = 0.27mSv 17 yo male with chest pain, elevated troponnin 3D Volume rendering Negative CTA obviated need for invasive angiography. Cardiac MRI confirmed myocarditis (arrows). MRI FLASH-mode radiation dose: 0.76 mSv Diffuse lung disease chest CT reconstructed with FBP and ASIR high definition mode FBPB25f FBPB46f IRT CT Dose Comparison Body Part Abdomen NCRP Report 160 2006 Annals of Internal Medicine 2009 MGH 2010 Adult Mean Eff Dose (mSv) Mean Eff Dose (mSv) Mean Eff Dose (mSv) 10 12 6.9 7 7 3.4 Chest CTA Heart 20 3.3 Head 2 2 1.0 Spine, Cervical 10 5 3.4 CTC 10 8 5.9 Change in Business Model From Market Share to Market Space What Sticks in Customer Relationships and What Doesn’t? Commodities and devices that come into a hospital on a forklift are not “sticky” The strongest bonds to a customer derive from integration of products into the work process, especially transfer of information Integrated solutions that stitch together multiple products with information systems to facilitate work and meet compliance requirements are the most valued by providers Radiology Work Flow Ordering Physician’s desktop Order entry HIS RIS Imaging device PACS Injector 3D image processing Contrast media Results reporting Work station Voice report RIS HIS •Market share-- % of “X” sold by company •Market space– Size of company “footprint” in the work flow GE Market Space: Early 1990s: “Forklift” Relationship with Customers Ordering Physician’s desktop Order entry HIS RIS Imaging device PACS Injector 3D image processing Contrast media Results reporting Work station Voice report RIS HIS •Market share-- % of “X” sold by company •Market space– Size of company “footprint” in the work flow GE Market Space 2010: “Sticky’ Relationship Through Integration Ordering Physician’s desktop Order entry HIS RIS Imaging device PACS Injector 3D image processing Contrast media Results reporting Work station Voice report RIS HIS •Market share-- % of “X” sold by company •Market space– Size of company “footprint” in the work flow Conclusions • The European and American markets are mature • Growth in the US in medical imaging is at a standstill or even contracting regionally • Multi-national corporations will increasingly turn to emerging markets for growth and to do R&D • Large corporations will seek to increase their market space for accretive growth and to become more important and more indispensible to their customers Conclusions • New technology for imaging will continue to be developed at a robust pace • Radiology will enter an era of massive computing • Rapid advances in reducing radiation dose will largely take radiation risk out of the discussion • New technology and applications will counter downward economic pressures • However, the Golden era of combined high rates of procedure growth and high per unit reimbursement for imaging are gone