Medical Imaging & Technology Alliance

1. Medical Imaging & Technology Alliance

2. 2008 Organizational Chart NEMA Board of Governors Medical Imaging & Technology Alliance Board of Directors Executive Committee Division Committees Sections DICOM Standards Comte. MITA-NEMA Secretariat Other Committees MITA-NEMA Secretariats WG01 Compensation Survey Committee Magnetic Resonance Ultrasound WG02 MITA-NEMA/COCIR/JIRA Security & Privacy Committee (SPC) WG03 WG04 Technical & Regulatory Affairs Committee -Technical -Technical WG05 NEMA/SCA&I (XR) Joint Working Group -Market Data/Statistics -Market Data/Statistics WG06 WG07 Public Relations WG08 Nuclear X-Ray IEC SC62B TAG WG09 Washington Representatives WG10 IEC SC62C TAG WG11 -Standards & Regulatory -CT Group WG12 -Animal PET Scanner -Mammography Group IEC TC 87 TAG Imaging Utilization & Cost Data Committee WG13 -Standard Task Force -Market Data/Statistics WG14 -NU1 Task Force -X-Ray Tube WG15 -NU2 Task Force NAC/DSCP JT. Solicit. Task Force -Cardiovascular & Interventional Group WG16 -Market Data/Statistics WG17 -DR Group WG18 CAD Group WG19 Medical Imaging Informatics (PACS) Radiation Therapy WG20 QA – Phantom Group WG21 WG22 -Advancement of DICOM DOD/VA Task Force -PTP Testing WG23 -Privacy & Security -Market Data/Statistics WG24 -Market Data/Statistics Private Payor -Regulatory WG25 -DICOM Object Library WG26 State Group

3. Participation: MITA Board of Directors • Corporate management to participate in MITA Board to make decisions about strategy and resources for: • federal lobbying • state lobbying • imaging industry public relations • industry actions toward private insurance • external relations with ACR, ACC, etc.

4. Participation: MITA Horizontal Committees • Department management to participate in making tactical decisions for: • lobbying • public relations • reimbursement • industry actions on FDA regulation • UDI • Software documentation • market data collection, definitions, frequency

5. MITA Legislative & Regulatory Activities • Federal Legislation – Reimbursement-1 • MITA's top legislative and regulatory priority is and continues to be related to Medicare reimbursement of medical imaging and radiation oncology procedures • Why Medicare?...70 million people “insured” by CMS. Medicare payments are also used by private insurers to set reimbursement and coverage decisions • MIPPA Law (Medicare Improvements for Patients and Providers Act) – MITA is working on making implementation by CMS (Centers for Medicare and Medicaid Services) reasonable and sensible for MITA member products (e.g. eliminate duplicate or onerous requirements)

6. MITA Legislative & Regulatory Activities • Federal Legislation – Reimbursement-2 • Medical imaging is under attack • Cost of imaging up (new uses, improved products) (Analogy: Cost of CFL vs. regular A19 bulbs – cost versus savings) • Outpatient/office based imaging – accreditation • No unnecessary scanning • No duplicate scanning – MITA initiative

7. MITA Legislative & Regulatory Activities • Federal Legislation – Reimbursement-3 • MITA works with a coalition of patient advocacy groups and physician professional societies to drive the discussion towards the great value medical imaging can provide for better health outcomes • Specific reimbursement advocacy for MITA products: e.g. Cardiac Computed Tomography Angiography - MITA victory in 2008

8. MITA Legislative & Regulatory Activities • Federal Legislation – Reimbursement-4 • Anticipating future cuts – education of Members and staff of the value of radiation therapy – 2009 • All other specialties are documenting value and improved outcomes – MITA provides technical facilitation through the DICOM standard – American College of Cardiology Structured Reporting of variables defining quality and effectiveness of service provided by cardiologists

9. MITA Legislative & Regulatory Activities • Federal Legislation – Other • Importation of medical devices - new • Reporting of gifts - Grassley legislation – publication on website public access • Reporting of doctor-manufacturer relationships gifts - new • FDA related legislation: MDUFMA (Medical Device User Fee and Modernization Act ) MITA lobbies for changes at FDA • Specific imaging related legislation (e.g. mammography)

10. MITA Legislative & Regulatory Activities • FDA regulation of MITA products • Similarities/differences – UL/CSA/Intertek • MITA speaks for industry against regulatory excesses, for fair and transparent regulatory process • UDI (Unique Device Identification System for medical devices) • CAD (Computer Aided Detection) • Software evaluation • Industry satisfaction survey by MITA • Etc.

11. MITA Legislative & Regulatory Activities • Preventing FDA regulation of MITA products – self-regulation • Patient dose • Imaging of children • Difficulties of self-regulation • Forcing MITA members to make all products the same in the name of patient safety • Pressure to redesign MITA products in the name of user safety

12. MITA Legislative & Regulatory Activities • State Legislation • Certificate of Need (regulating the supply) • Reporting legislation – a jump on federal legislation • Accreditation – a jump on federal legislation

13. International Regulation • In medical, there is no difference between US preferred and global standards. The preference is international standards. Different electrical systems do not influence desired global homogeneity of medical imaging and therapy systems products • International medical device standards become regulations and requirements in most other countries (lesser extent in the US)

14. Example of further organization of the Medical Division’s Sections

15. XR