Disclosures 4/2/2011. No conflict of interest Not representing any organization Not a billing consultant

Transcription

1 San Francisco Radiation Oncology Conference April 2, 2011 Accelerated Partial Breast Irradiation: The Conundrum of Regulation and Reimbursement Disclosures No conflict of interest Not representing any organization Not a billing consultant Paul E. Wallner, DO Senior VP for Medical Affairs 21 st Century Oncology, LLC Associate Executive Director for Radiation Oncology American Board of Radiology No consideration of clinical outcomes or technical factors No consideration of non-apbi issues Radium Implant - Breast Radium Implant - Breast 1

2 Radium Dosimetry Breast Single Plane Iridium Breast Iridium Breast Conundrum (Noun) 1. a riddle whose answer involves a pun 2. a. a question or problem having only a conceptual answer b. an intricate and difficult problem (Plural)? Source: Merriam-Webster Online 2

3 Disparate Issues What Is The Conundrum? Regulatory approval policy Payment policy Reimbursement policy Billing policy/practices Clinical, ethical, moral and societal consideration Should every new device that is safe and effective be approved for sale? Should every new device that is approved for sale be reimbursed? At what level and in what circumstances should every reimbursable device or technique be paid? Process of Technology Implementation Concept Development Testing Hardware, software, basic, clinical Regulatory approval Trial standards Payment policy development Federal, private Sales Reimbursement policy development Billing policy/practice development Responsible Regulatory Agency US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Center for Biological Evaluation and Research (CBER) Center for Food Safety and Nutrition (CFSAN) Center for Veterinary Medicine (CVM) National Center for Technological Research (NCTR) Center for Devices and Radiological Health (CDRH) 3

4 Center for Devices and Radiological Health (CDRH) Then: Office of Device Evaluation (ODE) Division of Reproductive, Abdominal and Radiological Devices (DRARD) Now: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVDDES) Division of Radiological Devices (DRD) FDA Mandate and Authority 1906 Food and Drug Act 1938 Federal Food, Drug and Cosmetic Act 1976 Medical Device Amendments 1990 Safe Medical Devices Act 1997 Food and Drug Administration Modernization Act 2002 Medical Device User Fee Modernization Act Limitations of US FDA Regulatory Approval Decades old standards Low bar standards Restrictive legislative mandate Lack of reimbursement linkage Premarket Review Process General Controls: 21CFR Classification of devices: I, II, III Level of review determination: 510(k) notification Class I or II devices Demonstration of substantial equivalence to predicate devices marketed prior to 5/26/76 Premarket Approval Application (PMA) Class III devices Not substantially equivalent Investigational Device Exemption (IDE) 4

5 FDA Device Marketing Pathways FDA Device Consideration Standards Safety Yes 510(k) notification 4000/yr Efficacy Yes Value No PMA approval 50/yr Cost and cost:effectiveness No Clinical trials No Executive Order January 18, 2010 Technological Truism Improving Regulation and Regulatory Review General Principles of Regulation Public Participation Integration and Innovation Flexible Approaches Science Retrospective Analysis of Existing Rules Many new interventions enter routine clinical use without significant regulatory and/or clinical oversight or observation and many are routinely adopted based on the principle of efficacy by proclamation * *Lester Peters 5

6 Accelerated Partial Breast Irradiation (APBI) External Beam 2-D,3D-CRT, IMRT +/- IGRT, SBRT, Particles Intra-operative therapy Brachytherapy Interstitial LDR, HDR Intra-cavitary HDR Electronic 2-Dimensional External Beam APBI 3-Dimensional Conformal IMRT +/- IGRT SBRT + IGRT (GFB) Particles (GFB³) Balloon Brachytherapy APBI MammoSite RTS Hologic, Inc., Bedford, MA FDA 510(k) notification SAVI Cianna Medical, Inc, Aliso Viejo, CA FDA 510(k) notification ClearPath North American Scientific, Inc, Chatsworth, CA FDA 510(k) notification Contura MLB SenoRx, Inc., Irvine, CA FDA 510(k) notification Biblical 510(k) Approval Parable Pudenz-Shulte s Ventricular Reservoir/Catheters (1973),. begat MammoSite RTS (2002),.which begat SAVI (2006), which begat ClearPath (2006), which begat Contura MLB (2008) 6

7 Intra-operative APBI Intrabeam Radiotherapy System Carl Zeiss Meditec, Inc. Dublin, CA 510(k) notification for US sales 1997 (brain), 1999 (full body) Energy range 50- kv x-rays Reimbursement HOPPS (new technology), $700 facility, $450 PC + planning codes Cat. III CPT code Intra-operative APBI Mobetron Intraop Medical Corp., Sunnyvale, CA (k) notification Energy range: 4 MeV 12 MeV electrons Monotherapy or boost single tx Reimbursement HOPPS (new technology), $1200 facility, $450 PC + planning codes. Cat. III CPT code Electronic Brachytherapy Axxent Controller icad, Inc., Nashua, NH HDR x-rays, IMBT 50 kv ebx System (Balloon) FDA 510(k) notification 2009 Reimbursement HOPPS new technology APC code. Cat. III CPT code Reimbursement Conundrum (Partial) Federal NCDs LCDs Inter-and Intra-Agency differences Commercial Various policies across carriers Various policies across plans 7

8 To Make Matters Worse.. EBRT HOPPS/APC Relative Reimbursement (in thousands) Facility Payment HOPPS/APC New Technology Codes Non-facility Payment MPFS CPT Editorial Panel Relative value assignments (RUC) EBRT Non-facility Relative Reimbursement (in thousands) Brachytherapy Relative Reimbursement HOPPS/APC (in thousands) 8

9 Brachytherapy MPFS Relative Reimbursement (in thousands) Comparison Reimbursement (in thousands) The Final Conundrum Thank you. Absent differences in clinical outcomes, how should reimbursement and payment policy be established? For updated PowerPoint set 9